Stefan Ewert, Ph.D. joined Novartis in 2004 and currently holds the position of a Senior Investigator within the NIBR Biologics Center. After establishment of a process for assessment of technical developability already during the antibody selection process he is currently responsible for antibody phage display selections done in Basel. From 2002 to 2004 he held a lab head position in ESBATech, Zürich, Switzerland where he was responsible for the identification of one of the current clinical lead antibody fragment ESBA105. He did his Ph.D. in the group of Andreas Plückthun at the University of Zürich, Switzerland on antibody stability.

Jacob Glanville, CSO, Distributed Bio LLC

Jacob Glanville is the Chief Science Officer and co-founder of Distributed Bio: his published work and active research emphasizes the computational engineering and optimization of immune responses in antibody libraries, animal models, and human immune interventions. He began researching computational immunology methods with Glenys Thomson at UC Berkeley, began publishing computational immunology methods at UC Berkeley with Kimmen Sjolander’s Berkeley Phylogenomics Group. At Pfizer as a Principal Scientist he engineered phage display libraries, developed repertoire analysis algorithms, and published multiple methods for deep repertoire sequencing and antibody library optimization. He publishes research in multiple areas of human immunology including oncology, vaccination, allergy and autoimmunity in the Computational and Systems Immunology PhD program at Stanford University, and is a Scientific Advisory Board member for the University of San Francisco Biotechnology PSM program. At Distributed Bio, he leads the computational and physical biologics engineering initiatives. He developed the science and algorithms behind AbGenesis - the world-leading licensable platform for advanced repertoire analysis, advanced library engineering, and in-vivo immune repertoire analysis now used ubiquitously in biologics research. His antibody library optimization has resulted in multiple antibody libraries, including the AbAccel antibody optimization technology in partnership with AbCheck, the 10^13 VHH Camelot library in partnership with Isogenica, and Distributed Bio’s internal SuperHuman discovery library and Survivor library for precision discoveries in oncology.

Carol A. Harley, Ph.D., Research Scientist, Structural Biochemistry, IBMC- Instituto de Biologia Molecular e Celular

Dr Carol Harley obtained her Ph.D from the University of Edinburgh, Scotland, UK and was a Postdoctoral Researcher at the University of Massachusetts Medical School and Albert Einstein College of Medicine in the USA. She then held a Group Leader position within the High Throughput Screening Facility of Pfizer Pharmaceuticals, Groton CT. Since 2008 she is a Research Scientist at the IBMC, Instituto de Biologia Molecular e Celular in Porto, Portugal.

Tammy L. Kalber, Ph.D., EPSRC Fellow, Metabolism & Experimental Therapeutics, Centre for Advanced Biomedical Imaging (CABI), University College London

Tammy Kalber is an EPSRC fellow and leads the Cell Imaging Research Portfolio at the University College London Centre for Advanced Biomedical Imaging (CABI). She specializes in the development of innovative molecular imaging approaches with nanochemistry techniques to produce next-generation cell labelling methods for the in vivo assessment of cell trafficking. Her multimodality (PET/SPECT/CT/MRI/Optical) imaging approach allows the correlation of quantitative delivery with cell localization and assessment of cell viability to investigate the efficacy of cell therapies in a wide range of disease models across scale (whole body to micrometer range). Her research has therefore largely focuses on supporting the advance of T cell and stem cells therapies in animals and man. She previously obtained her Ph.D. in the field of Biochemistry at St. George’s Hospital Medical School University College London and has designed many novel imaging agents for a range of applications in molecular imaging for numerous imaging systems including protein-based and antibody targeting.

Geir Åge Løset, Ph.D., Researcher, Centre for Immune Regulation and Department of Biosciences, University of Oslo; CSO, Nextera AS

Dr. Løset earned his PhD in Molecular Immunology at the University of Oslo (2005), and spent parts of his later post doctoral training at the CSIRO Molecular and Health Technologies in Melbourne, Australia. Prior to this, he spent several years as Research Scientist in Affitech A/S. His work spans from basic structural and functional studies of different antibody isotypes to construction of large antibody phage libraries and target selection for clinical development. For the last 10 years he has been a senior member of Professor Inger Sandlies group at the University of Oslo where he currently holds a position as Researcher at the Centre for Immune Regulation/Oslo University Hospital. The focus of this work has been to use phage display for engineering T cell receptor structures that allow for detailed molecular characterization of T cell responses in myeloma and Celiac disease. Dr. Løset is also the lead inventor, co-founder and CSO of Nextera AS – a Norwegian biotech company focusing on a unique phage display technology allowing for T cell response delineation and exploitation for therapy and immune monitoring.

John McCafferty, Ph.D., Co-Founder, Director and CEO, IONTAS Ltd.

John McCafferty was one of the founders of Cambridge Antibody Technology (now Medimmune) and was principle inventor of antibody phage display in 1990. In 2002 John set up a group at the Sanger Institute developing and utilizing methods for protein generation and recombinant antibody isolation in high throughput for research applications. More recently John formed a laboratory at the Biochemistry Department at University of Cambridge utilizing phage display technology to develop functionally blocking antibodies with potential in cancer and stem cell biology. In 2012 John formed IONTAS, a small innovative biotechnology company using phage display to develop novel antibody therapeutics.

Ralph R. Minter, Ph.D., Fellow, Antibody Discovery and Protein Engineering, MedImmune Ltd.

After completing a PhD in Immunology at the University of Durham in 1999, Ralph joined the Antibody Engineering Department at Cambridge Antibody Technology (now MedImmune) in the group of Tris Vaughan. In this role he worked on the isolation and optimisation of antibodies which are now undergoing clinical trials, including the recently-approved BenLysta. For several years Ralph then headed the Lead Optimisation team, which used phage and ribosome display to optimise the potency of over 50 antibodies, many of which are currently in preclinical and clinical studies, either in house or with collaborators. Ralph is currently a Fellow in the Antibody Discovery and Protein Engineering group at MedImmune and is running a wide range of projects, covering novel target discovery, protein engineering and novel therapeutic platforms.

Vera Molkenthin, Ph.D., Chief Scientist, AbCheck s.r.o

Dr. Molkenthin is the Chief Scientist of AbCheck s.r.o, an Antibody Discovery company located in Plzen, Czech Republic. AbCheck uses a unique combination of Phage and Yeast Display for Antibody Discovery and has several ongoing collaboration projects with biopharmaceutical companies. Vera was part of the founding team of AbCheck in 2009. Prior to joining AbCheck she was heading the Antibody Discovery group of Affimed Therapeutics in Heidelberg.

Dario Neri, Ph.D., Professor, Chemistry and Applied Biosciences, Swiss Federal Institute of Technology (ETH Zürich)

Dario Neri is a Full Professor at the Department of Chemistry and Applied Biosciences at the Swiss Federal Institute of Technology (ETH Zürich) and a co-founder of Philogen, a Swiss-Italian Biotech group.

Yanay Ofran, Ph.D., Founder, Biolojic Design Ltd.

Yanay Ofran is the founder and CEO of Biolojic Design and the head the Lab of Systems Biology and Functional Genomics at Bar Ilan University near Tel Aviv, where he is an associate professor. He got his PhD (with distinction, 2004) in the Dept. of molecular biophysics at Columbia University. His work focuses on the study of protein interaction using computational and molecular approaches. A major focus of Dr. Ofran’s research is antibodies and the way in which they specifically recognize their cognate epitopes. Biolojic Design, founded in 2010, developed a combined computational-molecular platform for the design of antibodies against pre-selected epitopes on difficult targets.

Ernest S. Smith, Ph.D., Senior Vice President, Research & Chief Scientific Officer, Vaccinex, Inc.

Dr. Smith joined Vaccinex at its inception in 1997 and was a key developer of its core cDNA library and antibody discovery technologies. In his current position, Dr. Smith is responsible for and contributes to the company’s research and technology development projects, and is a member of the clinical development team. Dr. Smith has a Ph.D. in Microbiology and Immunology from the University of Rochester.

William S. Somers, Ph.D., Vice President, Global Biotherapeutic Technologies, Pfizer

Will Somers completed Post-Doctoral research in Genentech’s Protein Engineering department before joining Genetics Institute in 1994 to set up a new X-ray crystallography group. In Wyeth he went on to lead an expanded group that also included molecular modeling and protein biochemistry that provided protein reagents to groups throughout the company and collaborated with teams on structure based small molecule design. Most recently he headed the Global Biotherapeutic Technologies group at Pfizer that is responsible for discovering and optimizing biotherapeutics in collaboration with all the Research Units. The group has a diverse portfolio consisting of antibodies, antibody drug conjugates and endogenous proteins. One of the groups strengths were the use of innovative structure based engineering techniques that were successfully applied to improve both the potency and properties of therapeutic leads. These methods have contributed to a pipeline of differentiated biotherapeutics that are currently in development.

Jens Thostrup Bukrinski, Ph.D., Senior Scientist, Biopharma R&D, Novozymes A/S

Jens Thostrup Bukrinski is a Senior Formulation Scientist employed as project manager at Novozymes A/S. He has 10+ years’ experience in protein and peptide drug development from the biopharmaceutical industry within pre-formulation, formulation, drug delivery and regulatory filing of early stage clinical trials. His experience ranges from small synthetic peptides to large recombinant proteins such as mAbs and coagulation factors for the treatment of diabetes, obesity, hemophilia and autoimmune diseases. Jens holds a master in Dairy Science and a Ph.D. in Bioinorganic Chemistry and Structural biology From the Royal Veterinary and Agricultural University of Copenhagen followed by an academic carrier at Centre for Crystallographic studies, University of Copenhagen, as assistant professor and later in Protein Structure group at the Carlsberg Laboratory as associate professor.

Tristan J. Vaughan, Ph.D., Senior Director, Antibody Discovery & Protein Engineering, MedImmune Ltd.

Tristan (VaughanT@medimmune.com) first joined Cambridge Antibody Technology (CAT) in 1993. Following the acquisition of CAT by AstraZeneca, he is currently responsible for generating around two thirds of the antibody portfolio for MedImmune, AstraZeneca’s biologics business. His teams utilises the core technologies of phage and ribosome display, as well as in vivo platforms to discover and engineer mAbs and, together with Protein Sciences and High Throughput Screening teams, support four disease areas. Prior to his current appointment, Tristan held key operational responsibilities as part of the successful CAT-AstraZeneca strategic alliance and prior to that for CAT’s Milestone and Royalty based Alliances, including that with Human Genome Sciences that delivered Benylsta^®. He also developed the platform technology to build antibody libraries of > 1010 members and was a key member of the team that discovered Humira^®. Before joining CAT, he was a postdoctoral fellow at the University of Toronto. Tris is a University of Leeds graduate from the Genetics Department.

Trevor A. Wattam, Ph.D., Manager, Biopharm Discovery Group, GlaxoSmithKline

Gregory A. Weiss, Ph.D., Professor of Chemistry, Molecular Biology and Biochemistry, University of California, Irvine

Dr. Gregory Weiss is a professor of Chemical Biology in the Department of Chemistry at U.C. Irvine. He earned a B.S. in Chemistry from the University of California, Berkeley and a Ph.D. in Chemistry from Harvard University. Awarded a Ruth Kirschstein National Research Service Award from the NIH, he pursued post-doctoral studies at Genentech. In 2000, he joined the faculty at the University of California, Irvine where his laboratory focuses on the interface between chemistry and biology, including the study of membrane proteins, harnessing viral diversity, and bioelectronics. Tenured in 2006, he is a full Professor and former Vice Chair of the Department of Chemistry. His awards include Outstanding Professor in the School of Physical Sciences at UC Irvine (elected by the graduating students), Beckman Foundation Young Investigator, and election as a Fellow of the American Association for the Advancement of Science. Selected by the US National Academy of Sciences to represent young scientists from the US at two World Economic Forum “Summer Davos” meetings in China, he was twice elected to be Co-Chair of the Global Young Academy, which includes around 200 top young scientists nominated by the national academies of 55+ countries. The textbook Prof. Weiss co-authored with David Van Vranken, Introduction to Bioorganic Chemistry and Chemical Biology, was short-listed for the best undergraduate textbook award by the Society of Biology in 2013.

Bispecifics and Novel Products

Sarah Batey, Ph. D., Principal Scientist, Tumour Biology and Protein Science, F-star Biotechnology Ltd

Sarah Batey completed a BSc in Chemistry and Biological Chemistry from the University of St. Andrews before undertaking a Ph.D and post-doctoral work in protein folding at the University of Cambridge. She made the transition into industry at Cambridge Antibody Technology (later MedImmune UK) where she worked as a Scientist in the Protein Sciences department. She subsequently moved to Covagen AG, a biotechnology company based in Zurich, Switzerland, and worked on the optimisation of their lead molecule which is currently entering clinical trials for the treatment of inflammatory diseases. At F-star Biotechnology in Cambridge, UK, she led the research efforts of the lead programme through to IND submission. The lead programme was later licenced to BMS. Sarah has several peer-reviewed papers and is named as an inventor on a number of patents and patent applications.

Felix Bohne, Ph.D., Principal Investigator, Institute of Virology, Helmholtz Centre Munich

Dr. Bohne studied Biology at the University of Konstanz and graduated on the blue-light regulated biosynthesis of carotenoids in single celled green algae. For his PhD in Cologne, Germany, he switched to the field of virology and generated chimeric antigen receptors redirecting T cells towards HBV-infected hepatocytes for the treatment of chronic hepatitis B. As a post doc in Barcelona, he was working on transplantation tolerance in chronically HCV-infected liver recipients which seem to regulate organ acceptance through a virus mediated hypo responsiveness of immune cells. At the moment, Dr. Bohne is a group leader at the Institute of Virology in Munich and is developing novel immunotherapeutic antibodies for therapy of chronic hepatitis B and HBV-associated tumors.

Ulrich Brinkmann, Ph.D., Expert Scientist, Roche Pharma Research & Early Development, Roche Innovation Center, Penzberg

Ulrich Brinkmann is a member of Roche’s Large Molecule Research organization within Pharma Research & Early Development at the Roche Innovation Center Penzberg, Germany. His work focuses on protein & antibody engineering, bispecifics, and on delivery platforms for targeted payload delivery. Prior to joining Roche, he served as CSO in functional genomics and pharmacogenetics companies Xantos and Epidauros. His work in Ira Pastan’s Molecular Biology Lab at the NIH/NCI in Bethesda, USA focused on antibody stabilization and engineering technologies, and on generating recombinant immunotoxins for cancer therapy. Dr. Brinkmann is author of numorous publications and inventor of many patents covering recombinant antibodies, pharmaco- & functional genomics, immunotoxins and protein engineering.

Mark Chiu, Ph.D., Associate Director, Multispecific Biologics Engineering, Biologics Research, Janssen Research & Development LLC

Mark received his training from: A.B. Biophysics at U.C. Berkeley, Ph.D. Biochemistry at U. Illinois Urbana-Champaign, and conducting Post-doctoral work at ETH-Zürich and Biozentrum of U. Basel. His work experience has spanned from being an Organic Chemist at Microgenics developing chemical conjugation of enzymes; Chemistry Professor at Seton Hall University getting grants on prokaryotic membrane protein biochemistry; Research Investigator at Abbott Labs on Mammalian Membrane Protein Drug Discovery; and now currently as Associate Director at Janssen Research and Development leading the Discovery and pre-clinical development of multi-specific Biotherapeutics.

Marshall Dunlop, Group Leader, Recombinant Antibodies R&D, Randox

Marshall Dunlop is a graduate of Queen's University Belfast where he studied an undergraduate degree in Genetics and a Master’s Degree in Medical Science. Marshall has been developing applications of recombinant antibodies for the last fifteen years at Randox Laboratories. He is currently group leader of recombinant antibodies R&D at Randox and is researching therapeutic and diagnostic applications of humanised single domain antibodies.

Jeremy Fry, DPhil, Director, Sales, ProImmune

Jeremy gained his DPhil in Transplantation Immunology from the University of Oxford under the direction of Prof. Kathryn Wood developing viral-based gene therapy strategies to induce immunological tolerance in transplantation. He joined ProImmune in 2001 as Research Scientist developing a new generation of MHC multimer staining reagents. He now leads a team within the company focusing on providing innovative solutions for clients that radically improve our understanding of both desired and unwanted immune responses.

Tariq Ghayur, Ph.D., Distinguished Research Fellow, DVD-Ig and Novel Biologics, Global Biologics, AbbVie, Inc.

Tariq Ghayur received his Ph.D. (1986) in Immunology from Department of Physiology, McGill University, Montreal, Canada. He did his post-doctoral training at McGill (1986-’88) and Dana Farber Cancer Institute (1988-’90). Prior to AbbVie, Tariq worked at BASF Pharma (1990 – 2001) and Abbott Laboratories (2001 – 2012). He has worked on both small molecule and therapeutic antibody discovery programs, mainly defining the biology/pathology of selected targets (target validation) and developing assays for high throughput screening and/or candidate selection. From 1998-2004, he led two therapeutic antibody discovery project teams and delivered 2 drug development candidates. In 1999, Tariq initiated the dual – / multi – targeting biologics program that resulted in the discovery of dual-variable-domain (DVD) – Ig^TM molecules and other multi – targeting biologics. Currently four DVD-Ig molecules are in clinical development.

Jijie Gu, Ph.D., Senior Principal Research Scientist, Global Biologics, AbbVie Bioresearch Center

Jijie Gu received his Ph.D. in Biochemistry and Molecular Biology from Chinese Academy of Medical Sciences. He did his post-doctoral training in Tumor Immunology and Cancer Biology at Harvard. He joined Abbott Laboratories in 2002. Jijie Gu has more than 13 years of industry experience in therapeutic antibody and novel biologics engineering, discovery and early development in several therapeutic areas including metabolic diseases, neuroscience, immunology, oncology and ophthalmology. As a project leader or co-leader, he has initiated and delivered several drug development candidates including the ones currently in clinical trials. Currently he is leading a group at AbbVie Global Biologics to work with therapeutic areas to build and progress AbbVie Biologics Pipeline in Oncology and Ophthalmology. He is a co-author for many peer reviewed articles and a co-inventor for several issued and filed US and international patents. He is also on the editorial board of mAbs journal

Tomoyuki Igawa, Ph.D., Group Manager, Discovery Research, Chugai Pharmaceutical

Dr. Igawa joined Chugai Pharmaceutical in 2001. He was established pH-dependent binding antibody and bispecific antibody technologies, and served as project leader of antibody therapeutic projects now in late-stage clinical study. Currently, he is group manager of Discovery Research Department, antibody engineering and optimization, library display, protein science and early CMC development.

Israel Lowy, M.D., Ph.D., Vice-President, Clinical Sciences; Head, Translational Science and Oncology, Regeneron Pharmaceuticals, Inc.

At Regeneron since 2010, Israel Lowy, MD, PhD has been Vice President of Translational Science and Clinical Oncology since 2012, leading efforts to advance multiple anti-tumor immunotherapy approaches into the clinic. The first Regeneron agents are REGN2810, an anti-PD-1 fully human antibody, and REGN1979, a CD20xCD3 fully human bispecific full length antibody. Trained in infectious diseases, Dr. Lowy was at Medarex Inc. from 2002 through its 2009 acquisition by BMS. At Medarex, he led numerous efforts in infectious diseases including a landmark phase 2 study of anti-Clostridium difficile mAbs to prevent recurrent diarrheal disease. In anti-tumor immunotherapy, he led multiple early studies with anti-CTLA-4 (MDX-010, ipilimumab) in non-melanoma indications, and the first single and landmark multi-dose clinical studies of anti-PD-1 (MDX-1106, nivolumab) and anti-PD-L1 (MDX-1105). He also led the landmark first combination study of ipilimumab and nivolumab prior to moving to Regeneron.

Krzysztof Masternak, Ph.D., Head, Biology, Research, Novimmune SA

Krzysztof Masternak received his Ph.D. in biology from the University of Lausanne. He worked at the Geneva University Medical School before joining Novimmune in 2002. As Head of Biology, he currently runs -antibody discovery at Novimmune.

Yvonne McGrath, Ph.D., Chief Scientific Officer, Complix NV

Dr McGrath joined Complix as CSO in May 2014. Prior to joining the Complix team, she held the post of Head of Development at Immunocore, UK. In this position, she successfully developed and executed the late preclinical and early clinical strategy for a novel platform technology, managed meetings with European and US regulatory authorities and led manufacturing and CMC strategy for a new biological entity targeting cancer. Dr McGrath’s previous experience includes being a Project Manager at the UK subsidiary of the German biotech company MediGene AG, and Senior Scientist at BioVex (now part of Amgen). She has a PhD from the University of Wales, College of Medicine.

Matthias Peipp, Ph.D., Group Leader, Stem Cell Transplantation and Immunotherapy, Christian-Albrechts-University of Kiel

In 2003, Matthias Peipp received his Ph.D. at the chair of genetics, Friedrich-Alexander-University, Erlangen-Nuremberg, Germany. In 2004, he moved to the Christian-Albrechts-University of Kiel (Kiel, Germany), where he studied effector mechanisms mediated by fully human EGFR-directed antibodies. Since 2006, Matthias is head of a research group at the Division of Stem Cell Transplantation and Immunotherapy (Kiel, Germany). In mid-2015 Matthias was awarded an endowed professorship for experimental antibody-based cancer immunotherapy from the German Cancer Aid. His current work is focused on the generation and functional characterization of engineered therapeutic antibodies and antibody derivatives to modulate immune effector cell recruitment.

Christine Rothe, Ph.D., V.P., Discovery & Alliance Management, Pieris Pharmaceuticals, Inc.

Christine Rothe serves as VP Discovery & Alliance Management at Pieris Pharmaceuticals, Inc. In this position she oversees technology development as well as the discovery process of selecting and profiling of Anticalin^® proteins. In addition, she holds responsibility for the Alliance Management team. She joined Pieris in 2010 as Senior Director Alliance Management. Prior to joining Pieris, she worked for 13 years at MorphoSys AG in various positions in R&D and Alliance Management, being responsible for technology development as well as therapeutic antibody project teams. She received a Ph.D. in Cell Biology from the University of Regensburg, Germany. Before joining industry she held a research position at the University of Regensburg.

Jonas V. Schaefer, Ph.D., Head, High-Throughput Binder Selection Facility, Biochemistry, University of Zurich

Dr. Schaefer is currently heading the High-Throughput Binder Selection Facility of the Department of Biochemistry, automating the Ribosome Display technology and various High-Throughput screenings. With his team, he develops new methodologies enabling the generation and screening of several thousand binders per week which are used in numerous international collaborations. Prior to his current position, Jonas performed his PhD studies with Prof. Andreas Plückthun on the engineering of full-lengths IgGs and other antibody fragments in various academic and industrial collaborations, focusing on aspects of stability, aggregation and unfolding kinetics using many biophysical techniques.

Janine Schuurman Ph.D., V.P. Research, Genmab B.V.

Dr. Janine Schuurman has been working in the field of Antibody Biology for about 20 years. In 1997 she got a PhD in Immunology from the University of Amsterdam. During her PhD at Sanquin Research. After a few post-doc positions at Sanquin Research and the University Utrecht she started in 2001 at Genmab Current research of Janine focuses on Antibody Biology, Product Innovation and the development of novel antibody formats such as the monovalent antibody platform UniBody^®, the bispecific antibody platform DuoBody^®and the enhanced IgG platform HexaBody^TM.

Laura Sun, Ph.D., Senior Research Associate/Project Lead, Translational Oncology, Genentech, Inc.

Dr. Sun is currently working in the department of Translation Oncology at Genentech, leading the research efforts in developing T-cell dependent bispecific antibodies as potential therapeutics for B cell malignancies. Prior to Genentech, she obtained her Ph.D. in Biochemistry and completed her post-doctoral training in Cell Biology at Washington University in St. Louis.

Nels Thorsteinson, Scientific Services Manager, Biologics, Chemical Computing Group

Nels Thorsteinson joined Chemical Computing Group (CCG) in 2008 as an Applications Scientist and is now a Scientific Services Manager and specializes in biologics applications. He is responsible for providing scientific support, programming custom applications, instructing at workshops, presenting at conferences, and guiding CCG's 3D biologics modeling applications development. Before joining CCG, Nels majored in biomedical computing at Queen's University in Canada and went on to complete his graduate studies at the University of British Columbia focusing on bioinformatics and computational chemistry.

Maria Wendt, Ph.D., Head, Science, Biologics, Genedata

Since joining Genedata in 2001, Dr. Wendt has been designing and developing laboratory workflow, data management and data analysis solutions for pharma and biotech companies to support their drug discovery and development programs. She led the design of a novel, integrated biologics registration and workflow support system for antibody and protein screening, engineering, and production. This culminated in the Genedata Biologics platform currently used at many major biopharma laboratories today. Previously, she also worked on solutions for target validation, biomarker discovery, and drug safety. She earned her Ph.D. at Iowa State University in chemical engineering.

Cancer Biotherapeutics

Amrik Basran, Ph.D., CSO, Therapeutics, Avacta Lifesciences

Dr. Amrik Basran has over 10 years’ experience of both the biotech and pharma industries. He previously worked for GSK where he was Head of Topical Delivery (Biopharm Discovery Unit), supporting the development of biotherapeutics across the GSK portfolio. Prior to this Amrik was Director of Protein Biosciences at Domantis.

Matthew Brown, Ph.D., Scientist, Malvern Instruments Ltd.

Stephen Beers, Ph.D., Associate Professor, Cancer Sciences Unit, Faculty of Medicine, University of Southampton

Stephen Beers joined the University of Southampton, Faculty of Medicine in 2002. He leads a research group within Cancer Sciences studying antibody drugs and their mechanisms of action. The group’s research is currently focussed on two main areas: 1) the mechanisms of action of immunomodulatory mAb, and 2) how the tumour microenvironment affects antibody effector function and how this might be manipulated to enhance patient outcomes. Their work utilises a portfolio of complimentary models incorporating in vitro 3D modelling, appropriate in vivo model systems and primary clinical material.

Seung Y. Chu, Ph.D., Associate Director, Cell Biology, Xencor, Inc.

Dr. Seung Y. Chu joined Xencor in 2001 and is currently Associate Director of the Cell Biology Group responsible for discovery, in vitro, and ex vivo development for all Xencor therapeutic candidates. He obtained his Ph.D. from the University of Rochester in Cell and Molecular Biology and conducted his post-doctoral studies in macromolecular structure determination at the University of Maryland.

Vijay Chudasama, Ph.D., Lecturer, Chemistry, University College London

Dr Vijay Chudasama (VC) is a Lecturer in the Chemistry department at University College London. He has won multiple prestigious prizes and awards (departmental, faculty, national and international) throughout his academic career such as the UCL Faculty of Mathematical and Physical Sciences Medal (2008), Science, Engineering and Technology (SET) Chemistry Student of the Year (2008) and the Ramsay Medal (2011). Moreover, he was recently highlighted by both Scientific American (2013) and Forbes Magazine (2015) to be a future leader in the field of Chemistry. He has research interests in the development and application of novel methodologies in Chemical Biology, resulting in over 30 publications and patents (http://chudasama-group.eu/). In addition, he has been highlighted as a future leader in the field of Chemical Biology by Chemical Communications in a recent special issue (Emerging Investigators 2015). He is also one of the founders, and the Technical Director, of UCL spin-out ThioLogics™

Diego Ellerman, Ph.D., Senior Research Associate, Protein Chemistry, Genentech, Inc.

Diego Ellerman received his PhD in Biology from the University of Buenos Aires. He then studied protein-protein interactions involved in the process of gametes binding and fusion at the University of California, Davis. After a short incursion into the field of mAbs for diagnostics, Diego joined Genentech in 2009 where he has been working on the production and characterization of bispecific antibodies in general, and on their use for T-cell redirecting strategies.

Rakesh Dixit, Ph.D., Vice President, Safety Assessment, Medimmune (A member of AstraZeneca)

Rakesh is a Vice President, R & D and the Global Head of the Biologics Safety Assessment comprising of Toxicology, Pathology and Laboratory Animal Resources functions where he is responsible for overseeing the biologics safety assessment of the entire MedImmune biologics portfolio in all therapeutics areas (2006-todate). Prior to joining MedImmune in 2006, Rakesh served as Senior Director of Toxicology in Johnson and Johnson and Associate Director-Research Fellow in Toxicology in Merck and Co., Inc. (1992-2005). Rakesh has over 25 years of experience in developing pharmaceutical and biotechnology-derived drugs and is the author of over 60 peer-reviewed scientific publications and has been invited to deliver Rakesh is regarded as a Key Opinion Leader in Toxicology community. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and an Associate Editor of Toxicology and Applied Pharmacology and Journal of Toxicology and Environmental Health- all key major toxicology journals.

Joseph Dukes, Ph.D., Head, Preclinical Biology, Cell Biology, Immunocore Ltd.

Joseph Dukes received his PhD from the University of Bath (United Kingdom) where he spent some further time carrying out postdoctoral research. He joined Immunocore in 2011 and now currently Heads the Preclinical Biology group in the Cell Biology department. The Preclinical Biology group is responsible for the in vitro cellular testing of ImmTAC molecules to assess for drug potency and specificity, and producing preclinical packages and reports for submission to regulatory bodies for clinical trial approval.

Christian Klein, Ph.D., Head, Oncology Programs, Roche Pharmaceutical Research & Early Development, Roche Innovation Center Zurich

Christian Klein, Distinguished Scientist is Head of Oncology Programs at the Roche Innovation Center Zurich, Roche Pharmaceutical Research and Early Development, Switzerland specialized in the discovery, validation and preclinical development of antibody based cancer immunotherapies and bispecific antibodies. During his >14 years at Roche he has made major contributions as research project leader to the development and FDA/EMA approval of GAZYVA/GAZYVARO (obinutuzumab, GA101), the preclinical development of four bispecific antibodies currently in active clinical development: 1) CEA-IL2v immunocytokine RG7813 (Ph I), 2) anti-Ang-2/VEGF CrossMAb RG7221 in oncology (Ph II), 3) anti-VEGF/Ang-2 CrossMAb RG7716 in ophthalmology (Ph I) and 4) CEA-CD3 T cell bispecific antibody RG7802 (Ph I), as well as the development of Roche’s novel proprietary bispecific antibody platforms e.g. the CrossMAb technology.

Lars Linden, Ph.D., Head, Protein Biochemistry, Global Biologics, Cell and Protein Sciences, Bayer Healthcare

Lars Linden is currently Head of the Protein Biochemistry group and responsible for production of research compounds and tools in biologics projects of Bayer Healthcare’s early research pipeline. Lars joined Bayer in 2007 during the acquisition of Schering AG were he had worked as a lab head in protein biochemistry. Between 2000 and 2006 he worked for a small biotech company “m-phasys” in the field of characterization and crystallization of GPCRs and ion channels. Lars received his PhD from the Technical University in Munich in 2000 for his work on structural biology of plant enzymes, being member of Robert Huber’s X-ray crystallography group at the Max-Planck Institute for Biochemistry.

Tim Lowinger, Ph.D., CEO, Mersana Therapeutics

Dr Lowinger joined Mersana in 2008 and is responsible for preclinical research and discovery, as well as CMC. Prior to joining Mersana he contributed to the discovery of over 15 clinical drug candidates in the areas of oncology, asthma, inflammation, virology, obesity and diabetes during his career at Bayer Pharma in the US, Japan and Germany. He is a co-inventor of the marketed drugs Nexavar and Stivarga, and is a member of the Scientific Advisory Board for Keystone Symposia.

J. Joseph (Jos) Melenhorst, Ph.D., Director, Product Development & Correlative Sciences, Center for Cellular Immunotherapies, University of Pennsylvania

After his training in translational immunology at the Leiden University Medical Center, Leiden, Netherlands, Dr. Melenhorst completed a post-doctoral position at the National Institutes of Health in Bethesda, Maryland where he continued as a staff scientist in the field of hemato-oncology. His focus areas were a) the in vitro generation and analysis of leukemia-, virus-, and allo-reactive T cells; b) immune pathogenesis of graft-versus-host disease and immune reconstitution post-transplant and immunotherapy; c) and biomarker discovery in immunotherapy.

In August 2012, Dr. Melenhorst was appointed as Deputy Director of Clinical Cell and Vaccine Production Facility within the Center for Cellular Immunotherapies, Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, and in October of 2013 he assumed the role of Director of the Product Development & Correlative Sciences (PDCS) laboratory. Dr. Melenhorst’s interest in translational research is continued at the PDCS lab where his work focuses on the improvement of the potency of chimeric antigen receptor-expressing T (CART) cells in certain leukemias and solid tumors, the understanding of the in vivo potency of CART cells, and biomarkers of immunotherapy. Dr. Melenhorst is a highly original scientist who has originated and contributed to innovations at the National Institutes of Health and the University of Pennsylvania.

Philipp Müller, Ph.D., Project Leader, Biomedicine, University Hospital of Basel

Dr. Philipp Müller obtained his PhD in Biochemistry at the University of Basel where he is currently holding a position as project leader within the group of Cancer Immunology at the Department of Biomedicine. He is working on and interested in the design and function of ADCs, bispecific antibody formats as well as agonistic antibodies, such as anti-CD40, and their therapeutic combination with immune-checkpoint blockade.

David Poon, Ph.D., Senior Director, External R&D and Alliances, Zymeworks, Inc.

David is the Senior Director for External R&D and Alliances and has been at Zymeworks for 7 years. During this span, he held various positions including overseeing all wet-lab operations and made key contributions to the development of the Azymetric™ and AlbuCORE™ platforms. He currently oversees and manages Zymeworks’ strategic collaborations with Celgene Corp., Eli Lilly & Co., and Merck & Co. and other in- and out-licensing activities. David received his Ph.D. in Chemistry from the University of British Columbia with a focus on studying the structure-function relationship of enzymes using NMR spectroscopy.

Tobias Raum, Ph.D., Scientific Director, Lead Generation, AMGEN Research (Munich) GmbH

Tobias Raum (Ph.D.) is heading the “Lead Generation group” in the ”BiTE Technology department” of Amgen Research Munich since the acquisition of Micromet (Munich) by Amgen in 2012. He held the equivalent position at Micromet since 2001. His group is involved in the selection and optimization of human antibody fragments as starting point for novel antibody and BiTE programs. Several candidate specificities selected by Tobias’ group are currently in clinical trials or advanced preclinical phase. Furthermore Tobias is also heading Amgen Munich Research’ “BiTE Biology group” since 2007 which is involved in the evaluation of BiTE antibodies against new indications. Prior to this, Tobias headed the Molecular Design group at Connex GmbH (Munich) after having received his PhD from the University of Munich in 1999.

Pavel Strop, Ph.D., Associate Research Fellow, Protein Engineering, Rinat-Pfizer

Dr. Strop received his Ph.D. in 2002 from Caltech, where he worked on structural elucidation of mechanosensitive ion channels. Afterwards, he moved to Stanford where he studied proteins involved in synaptic transmission. In 2008, he joined Rinat-Pfizer's protein engineering department where he develops and applies novel technologies including bispecifics and antibody drug conjugates.

Martin Treder, Ph.D., CSO, Affimed

Starting his position in January 2015 Dr. Treder is responsible for further developing Affimed’s proprietary bi- and trispecific TandAb platforms, expanding the company’s internal pipeline and providing scientific support for its clinical programs and for collaborations with corporate partners. He has 13 years of professional experience in biotherapeutic research and development and broad experience in immuno-oncology discovery and pre-clinical development of antibodies. He joined Affimed from CT Atlantic AG, a Swiss biotechnology company focused on the identification and development of human-derived monoclonal antibodies for cancer treatment. As co-founder and CSO he was responsible for establishing a broad research pipeline of preclinical and clinical development programs. Prior to CT Atlantic Dr. Treder was co-founder of U3 Pharma AG, a German biotech company developing targeted cancer therapeutics, and Program Director responsible for heading the company’s portfolio of innovative anti-HER3 therapeutic antibodies. Dr. Treder graduated from Monash University in Melbourne, Australia and obtained a diploma in Biology at the University of Würzburg, Germany. He earned his PhD at the Max Planck Institute of Biochemistry in Martinsried-Munich, Germany.

Optimisation & Development

Vanessa Baeriswyl, Ph.D., Scientist, Covagen AG, one of the Janssen Pharmaceutical Companies of J&J

Vanessa Baeriswyl was born in Geneva on August 20, 1980. She received her Master of Science from the University of Lausanne (Switzerland). During her master thesis she studied the role of a specific receptor expressed by natural killer cells within the process of tumor cell killing. From 2005 to 2009, Vanessa Baeriswyl did her PhD in the research group of Prof. G. Christofori at the University of Basel, where she worked on tumor immunology as well as on tumor progression. From 2010-2014, she focused on the generation of bicyclic peptide ligands to disease-associated targets as a postdoctoral fellow in the laboratory of Prof. C. Heinis at the Swiss Federal Institute of Technology (EPFL). In 2014, she joined the dynamic team of Covagen to work on FynomAb development.

Mathieu Cinier, Ph.D., Scientific Director, Affilogic

Throughout his Ph.D., Mathieu Cinier acquired extensive training in protein engineering and led the development of a novel protein biochip on a glass side coated with zirconium phosphate. He further expanded his qualification in nanotechnologies at the Nanobiomedical Center in the University of Cincinnati, a world-renown nanotechnology laboratory. He has since joined Affilogic, and successfully led 40+ Nanofitin generation programs for a wide range of applications, 3 of them being currently developed as drug candidates in collaboration with international pharmaceutical partners. He also applied its protein engineering knowledge to expand the potential of the Nanofitin technology, before taking the position of Scientific Director in Jan. 2015.

William Finlay, Ph.D., Senior Director, Global Biotherapeutics, Pfizer, Inc.

Jonny Finlay is Senior Director of the Protein Discovery and Optimisation Group (PDOG), Global Biologic Therapeutics, in Pfizer. The PDOG is responsible for the discovery and molecular engineering of novel protein therapeutics for use in indications across all Pfizer Research Units. Prior to joining Pfizer, Jonny carried out postdoctoral research in recombinant protein engineering at several institutes, including the Centre for Biologics Evaluation and Research, FDA, National Institutes of Health.

Nicolas Fischer, Ph.D., Head, Research, Novimmune SA

Nicolas Fischer obtained a PhD in Biology from the Department of Molecular Biology University of Geneva on the structure and function of photosynthetic complexes. As a postdoctoral fellow he joined the Group of Sir Greg Winter at the MRC Department of Molecular Biology in Cambridge UK to study protein folding and Antibody engineering using phage display. In 2001 he joined NovImmune and led several therapeutic antibody discovery programs that have reached clinical development stage. He is now heading the Research Department and developing next generation bispecific antibody formats.

Joanna Hay, Ph.D., Customer Solution Science Manager, Novozymes Biopharma UK

Joanna Hay obtained a B.Sc. in Biochemistry from the University Of Birmingham (UK) and a Ph.D. in Biochemistry from University of Leicester. Joanna Hay joined Novozymes Biopharma UK in 2006 as a Scientist working with the R&D team on the development and optimization of albumin for half-life extension technology Veltis ®. Currently Joanna is working as a Customer Solution Science Manager in Novozymes BioPharma, working with drug developers wanting to evaluate the potential of the Veltis ® Technology in their drug development programs.

Christian Heinis, Ph.D., Professor, Institute of Chemical Sciences and Engineering, Ecole Polytechnique Federale de Lausanne (EPFL)

Christian Heinis studied biochemistry at the ETH in Zurich where he also did a PhD in the research group of Prof. Dr. Dario Neri. He was a postdoctoral fellow in the group of Prof. Dr. Kai Johnsson at the EPFL in Lausanne and in the group of Sir Gregory Winter at the Laboratory of Molecular Biology (LMB) in Cambridge, UK. In 2008 he was appointed Assistant Professor with tenure track for Bioorganic Chemistry at EPFL. The general research interest of Christian Heinis is the development of novel and innovative therapeutic strategies using chemical and biological methodologies. Christian is a scientific founder of the start-up company Bicycle Therapeutics.

Laura Lin, Ph.D., Director, Global BioTherapeutic Technologies, Pfizer, Inc.

Laura Lin is Head of Biophysics, Analytics, and Bioconjugation Group, Global BioTherapeutic Technologies at Pfizer. Laura has been with Pfizer since 2009 when the company acquired Wyeth Pharmaceuticals, where she had been a group leader in Structural Biology and Computational Chemistry supporting both biologics and small molecule programs within Wyeth Discovery. Her current group at Pfizer is focused on providing comprehensive, early stage molecular characterizations to enable the design and development of biologics pipeline with optimal properties. Laura received a PhD in Biophysics from New York University. She was an American Cancer Society Post-doctoral Fellow at the Massachusetts Institute of Technology and the Friedrich Miescher Institute of Novartis Research Foundation, Basel, Switzerland.

Paul Moore, Ph.D., Vice President, Research, Cell Biology & Immunology, MacroGenics, Inc.

Dr. Moore has approximately 20 years’ experience working in biotech, coordinating efforts focused on the discovery and development of novel biologic based therapies. He began his biotechnology career at Human Genome Sciences, where he directed genomic-based target discovery programs and the preclinical development of various protein and mAb based therapeutics for the treatment of cancer, metabolic, and autoimmune diseases. Notably these efforts led to the discovery of BLyS as a B-cell survival factor providing the basis for the development of Benlysta for the treatment for lupus. At MacroGenics, Dr Moore leads a group dedicated to the discovery, characterization and development of novel antibody based therapeutics including Fc-optimized and bispecific based DARTs for the treatment of cancer or autoimmune disease. Dr Moore obtained his PhD from University of Glasgow, performed post-doctoral work at Hoffman La Roche.

Eriko Murata, Master of Pharmacy, Research Scientist, Discovery Research, Chugai Pharmaceutical Co. Ltd.

Eriko Murata is a research scientist at Discovery Research department in Chugai. Since 2012 she has worked on identification and engineering/optimization of antibody and development antibody technology including TwoB-Ig technology. She started her career in 2007 and had been in charge of high-throughput screening of small molecules until 2012. She studied and received master degree at Tohoku University.

Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director, Preclinical Development & Research, Genmab B.V.

Prof. Dr. Paul Parren worked in antibody biology and biotechnology for almost 30 years. He holds a PhD in molecular immunology from the University of Amsterdam (1992). Dr. Parren was an Associate Professor at The Scripps Research Institute in La Jolla, California, where he studied the role of human antibodies in protection against viral infections. In 2002, he joined Genmab where he serves in the position of Senior Vice President and Scientific Director. He heads the Genmab Utrecht site and leads an international group of about 130 employees responsible for Pre-clinical development and Research. Dr. Parren is also a Professor of Molecular Immunology at the Leiden University Medical Center in Leiden, the Netherlands and an Adjunct Professor of Translational Cancer Research at the University of Southern Denmark in Odense, Denmark.

Dr. Parren is dedicated to translate antibody biology and immunotherapy knowledge into innovative antibody therapeutics and technologies. Currently his studies focus on antibody structure-function relationships, antibody effector functions, bispecific antibodies, antibody-drug conjugates, antibody drug discovery and development. He is an inventor of the therapeutic antibodies ofatumumab (licensed world-wide), daratumumab (phase III), teprotumumab (Phase II), HuMax-TF-ADC (Phase I) and the DuoBody and HexaBody technologies.

Andreas Plückthun, Ph.D., Director and Professor, Biochemistry, University of Zurich

Richard B.M. Schasfoort, Ph.D., IBIS Technologies B.V.

Richard B.M. Schasfoort defended his PhD thesis for a new approach to biosensor operation in 1989. In 1996 he founded IBIS Technologies. At the University of Twente, The Netherlands, Richard started the Biochip group and is co-author of > 80 peer reviewed papers and editor of the Handbook of Surface Plasmon Resonance. The IBIS MX96 for label-free profiling of 96 biomolecular interactions using Surface Plasmon Resonance (SPR) imaging technology was launched in 2011. The instrument is applied for e.g. affinity screening, binning of competing antibodies, epitope mapping at unrivaled speed. The IBIS MX96 instrument has been adopted by large pharmaceutical multinationals, biotech companies and research institutes and recognized by well known researchers [W. de Lau et al. Nature 476, 2011) 293-297].

Michael Siedler, Ph.D., Section Head, NBE Formulation Sciences & Process Development, AbbVie Deutschland GmbH & Co KG

Michael joined AbbVie (previously Abbott) in 2007 in Germany till 2010 when he Head of the Preformulation and Discovery Support Group at the AbbVie Bioresearch Center in Worcester, MA, USA. In 2014 he became a Section Head at AbbVie GmbH & Co KG, Germany. Prior to AbbVie (previously Abbott), he worked at Scil Technology GmbH in Martinsried, Germany. He received his PhD in chemistry from the University of Hamburg in 2002.

Alain C. Tissot, Ph.D., Head, Immune Biology, Large Molecule Research, Pharma Research and Early Development, Roche Innovation Center, Penzberg

Alain Tissot is leading the Immune Biology department within the Large Molecule Research (LMR) unit of the Pharma Research & Early Development organization at the Roche Innovation Center Penzberg. His department group generates antibodies through immunization technologies and B cell cloning procedures. He has been supervising for the last seven years a portfolio of Biologics for the LMR unit in the field of Immunology, Oncology and Neuroscience, as well as a technology program to develop an antibody based module to drive penetration of Biologics to the brain. Previously, he has worked for a vaccine company, developing vaccines in Immunology, Neuroscience and Hypertension from discovery to Phase II.

Peter Ulrichts, Ph.D., Senior Scientist, ArGEN-x

After receiving his PhD from the University of Ghent, Peter joined arGEN-X in 2010 where he currently holds the position of Senior Scientist. He was involved in various discovery and pre-clinical therapeutic antibody programs within arGEN-X and is now coordinating the pre-clinical characterization of the ARGX-113 molecule.

Tristan J. Vaughan, Ph.D., Senior Director, Antibody Discovery & Protein Engineering, MedImmune Ltd.

Frank Walsh, CEO, Ossianix and Professor, Kings College London

Frank Walsh is a senior Pharma and Biotech executive with extensive experience of Drug Discovery and Development. He was a former EVP and global head of research at Wyeth Pharma, SVP and head of the Neurology CEDD at GSK and VP of Neuroscience at SB. Prior to that he had a successful academic career in Neuroscience research and was the Sir William Dunn Professor of Pathology at Guy’s Hospital, London. Currently he is CEO of Ossianix, a founder of Antagonis and was Chairman of Covagen and Protaffin.

Aggregates & Particles

Paolo Arosio, Ph.D., Marie Curie Postdoctoral Fellow, Dept of Chemistry, University of Cambridge

Paolo Arosio obtained his master’s degree in chemical engineering from the Politecnico di Milano in 2007, and his PhD from the Swiss Federal Institute of Technology ETH Zurich in 2011. Since 2012 he is a post- doctoral researcher at the Department of Chemistry at the University of Cambridge, UK, where he is currently the recipient of a Marie Curie fellowship. His research interests, at the interfaces between engineering, biophysics and physical chemistry, focus on biomolecular reactions, in particular understanding and controlling the protein assembly and protein interaction processes that underlie problems of key fundamental and practical importance in biology and biotechnology.

Tudor Arvinte, Ph.D., Chairman & CEO, Therapeomic, Inc.; Titular Professor of Biopharmaceutics, School of Pharmacy, University of Geneva

Tudor Arvinte, Ph.D., received his academic training in physics at the University of Jassy, Romania, and his Ph.D. in biophysics from the University of Düsseldorf, Germany. He performed his doctoral work and postdoctoral stage at the Max-Planck-Institute West Germany and held numerous research positions in Europe and the USA: at C.N.R.S., Orléans, France, at Cornell University, New York, at Texas A&M University, and at the Biophor Corporation, College Station, Texas, USA. In 1989 he joined Ciba-Geigy Pharmaceuticals in Horsham, England, and in 1994 he moved to Ciba- Geigy in Basel, Switzerland. Until 2002 he worked as Head of Exploratory Formulation, Novartis Biotechnology Development & Production, Basel. T. Arvinte worked on the characterization and formulation of more than 130 protein and peptide drugs. T. Arvinte has over 80 publications and holds 13 patents on formulations of proteins: one patented formulation for hirudin is used in the marketed product. Since 2001 he is Invited Professor at the School of Pharmacy, University of Geneva, Switzerland where he is teaching a post-graduate course on “Formulation and delivery of protein biopharmaceuticals”. T. Arvinte is also Visiting Professor at the Department of Pharmacy, School of Health and Life Sciences King’s College London, UK. In 2003 T. Arvinte co-founded Therapeomic, Inc., a biotech company focused on developing formulations for biopharmaceuticals in collaborations with pharmaceutical companies.

Francis Carroll, Development Scientist, Technical Development, Genzyme Ireland Ltd.

Francis was awarded a B.Sc. in Plant and Microbial Biotechnology from University College Cork in 2003. Francis worked for 2 years as a Production Biochemist for Trinity Biotech where he specialised in Rapid HIV Diagnostics. He moved to Genzyme in 2006 and has worked in both the QC Chemistry and Microbiology at Genzyme. Francis is currently a Development Scientist in the Technical Development group and has experience in lyophilisation, thermal analysis, protein characterisation, analytics and tech transfer.

Richard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

Dr. Richard Cavicchi earned his bachelor’s degree at M.I.T., Ph.D. in physics at Cornell University in 1987, was a post-doc at AT&T Bell Labs, and then joined the research staff at the National Institute of Standards & Technology in 1989. His work has covered a variety of microfabricated sensors, and research on measurement methods such as nanocalorimetry and nanosecond microphotography. Present research focuses on characterization of protein aggregates.

Daniel Christ, Ph.D., Associate Professor of Medicine, Head Antibody Therapeutics, Immunology Program, Garvan Institute of Medical Research, Sydney

Associate Professor Daniel Christ is Head of Antibody Therapeutics at the Garvan Institute of Medical Research in Sydney. He holds degrees from the Swiss Federal Institute of Technology (ETH) and Cambridge University, where he worked with biotechnology pioneer Sir Gregory Winter on the development of single domain formats. Professor Christ's work focuses on the stability engineering of human antibody reagents for therapeutic purposes.

Terrence M. Donohue, Ph.D., Professor, Internal Medicine, University of Nebraska Medical Center

Terrence M. Donohue, Jr. Place of Birth: St. Paul, Minnesota, USA Education: Baccalaureate: University of St. Thomas St. Paul, MN 1965-1969, B.A. - Biology, 1969 Postgraduate: Marquette University Milwaukee WI 1969-1972, M.S.-Biology, 1972 University of Nebraska Medical Center Omaha, NE 1974-1978, Ph.D. - Biochemistry, 1978 Post-degree and Continuing Education Training: National Cancer Institute Postdoctoral Fellow Biology Division Oak Ridge National Laboratory Oak Ridge, TN 1978-1981 . Current Academic Appointment: Professor and Graduate Faculty Member & Fellow Departments of Medicine and Biochemistry/Molecular Biology, Pathology/Microbiology & Environmental Health & Toxicology,University of Nebraska Medical Center, Omaha, NE.

Anja Langenkamp, Ph.D., Principal Scientist, Immunopathology, Pharamceutical Sciences, Pathology, Roche Pharmaceutical Research & Early Development, Roche Innovation Center Basel

Anja has 9 year experience in the field of pre-clinical immunosafety. Her focus is on tailor-made and mechanistic studies for safety and immunogenicity risk assessments mainly for biologics in early phase programs. Before joining Roche in 2006 Anja held research positions in clinical and academic institutions in Freiburg and Cologne in Germany. A biochemist by training, Anja received her PhD at the University Witten/Herdecke in Germany in 2002 and did her doctoral work at the Basel Institute of Immunology and the Institute for Biomedical Research in Bellinzona in Switzerland.

Jun Liu, Ph.D., Senior Group Leader and Principle Scientist, Genentech, Inc.

Dr. Jun Liu is currently a senior group leader and principle scientist at the Late Stage Pharmaceutical Development group at Genentech, Inc. He received his Ph.D. degree in Biochemistry from the University of New Hampshire. He then worked as a postdoctoral fellow at Genentech, Inc. for studying protein structure, function and stability. Dr. Liu has over 22 years of experience in the biopharmaceutical research and development. He has successfully developed formulations and drug delivery systems for a number of protein therapeutics that are currently on the market. He has numerous scientific publications and patents in fields of protein characterization, formulation and product development. He is currently leading a late stage formulation group where he has the responsibility for the development of antibody drug conjugates, combination products, protein formulation, drug delivery systems and biophysical characterization methods.

Peter Matthiessen, Ph.D., Sr. Manager, Formulation, Fill/Finish, Baxter Innovations GmbH

University:

1972-1975 Chemistry in Muenster/Westfale.

1975-1979 Chemistry in Freiburg/Breisgau

Job experience.

1979-1983 Ph.D. thesis at Max-Planck-Institute for Immunology, Freibur.

1983-1986 PostDoc at Pharmaceutical Institute, Free University Berlin, German.

1986-1991 PostDoc at Neurological Hospital in Duesseldorf, German.

1991-1993 Head of R&D in small Biotech Company “IBV Enzym GmbH” in Baesweiler, Germany

1993-2005 R&D Manager at Immuno AG/Baxter AG in the area of downstream process development and product suppor.

2005-2014 R&D Manager/Senior Manager at Baxter Innovations GmbH in the area of formulation development and device qualificatio.

Since 2014 Senior Manager at Baxter Innovations GmbH leading Formulation, Fill/Finish

Jennifer McManus, Ph.D., Lecture, Chemistry, Maynooth University

Dr. Jennifer McManus is a lecturer in chemistry at Maynooth University and associate principle investigator at the National Institute for Bioprocess Research and Training, in Ireland. She received her B.Sc. and Ph.D. degrees from University College Dublin. After a period of postdoctoral research at the Massachusetts Institute of Technology working in the group of Prof. George Benedek she took up the position of Science Foundation Ireland lecturer. Her current research focus is the self-assembly of soft materials, in particular proteins. Her research group explores protein phase transitions and in particular how protein surface chemistry drives the assembly process. Her group are also interested in the mechanisms leading to protein aggregation.

Ankit Patel, Ph.D., Scientist, Late Stage Pharmaceutical development, Genentech, Inc.

Ankit Patel is a Scientist in the Late Stage Pharmaceutical Development department where he leads a team responsible for formulation development, product characterization, support of drug product manufacturing processes, and process characterization/validation studies to support licensure. Since joining Genentech 8 years ago, he has led Phase III and commercial pharmaceutical development activities for a wide range of antibody and antibody-drug conjugate (ADC) projects including high concentration products, lyophilized dosage forms, and combination products. More recently, he has been leading early stage cross-functional technical development teams for both bispecific and antibody drug conjugate (ADC) projects. He has active research efforts in the areas of interfacially mediated aggregation, ADC linker chemistry and stability, and novel particulate characterization technologies. Prior to joining Genentech, Dr. Patel received his Ph.D. in Chemical Engineering from Stanford University where his work focused on self-assembly of biomolecules.

Anacelia Rios Quiroz, MSc., Late Stage Pharmaceutical and Process Development, Pharmaceutical Development & Supplies, PTD Biologics Europe, (PTDE-PF), F. Hoffmann-La Roche, Ltd.

Anacelia Ríos completed her University studies as Industrial Pharmaceutical Chemist in the Polytechnic National Institute (IPN) in 2008 followed with Master studies in Pharmacology in the Centre of Research and Advanced Studies (CINVESTAV) in 2011, both in Mexico City. During this time she became an expert on protein chemical synthesis and spectroscopic characterization of metal-to-protein binding sites in the frame of anti-amyloid peptide drug design.

In 2012, she started her research experiments in Pharmaceutical Technology in collaboration with Basel University and F. Hoffmann-La Roche Ltd., in Switzerland. She works in Late Stage Pharmaceutical and Process Development in the field of protein particle characterization techniques. Her contributions aim to increase our understanding on the applicability of emerging technologies as analytical tools for the pharmaceutical industry.

Antonio Ribeiro, Ph.D., Professor, Pharmaceutical Technology, University of Coimbra

Professor António J. Ribeiro is professor of Pharmaceutical Technology at the Faculty of Pharmacy of Coimbra. He received graduate training in both Europe and North America, has held academic positions in several Faculties of Pharmacy of Portugal. He is a specialist on pharmaceutics by training and has been working in the design and testing of biotechnology/biopharmaceuticals delivery systems for several years. Since 2001, he has managed to develop in Coimbra a competitive research group with the aim of oral delivery of insulin. He is currently the leader of a 15-member research team. Prof.Ribeiro is the author of more than 100 publications including more than 50 peer review publications, 3 books’ chapters and 2 patents which have covered important areas in drug delivery, biotechnology and biopharmaceuticals.

Joost Schymkowitz, Ph.D., Professor, VIB Switch Lab, Department of Cellular and Molecular Medicine, KULeuven

Joost Schymkowitz obtained his PhD in 2001 from the University of Cambridge (UK) where he worked on mechanisms of protein folding in the laboratory of Sir Alan Fersht. He then moved to the European Molecular Biology Laboratory in Heidelberg (Germany) where he did postdoctoral work in the laboratory of Luis Serrano. There he contributed to the development of several structural modeling tools. He is now one half of a group leader duo at the Flanders Institute for Biotechnology (VIB) at the Catholic University of Leuven (Belgium) where he conducts research on mechanisms of protein misfolding and aggregation.

Michele Vendruscolo, Ph.D., Professor, Department of Chemistry, University of Cambridge

Prof. Michele Vendruscolo has obtained a PhD in Condensed Matter Physics in 1996 at the International School for Advanced Studies in Trieste (Italy). After postdoctoral experiences at the Weizmann Institut (Israel) and at the University of Oxford (UK), he joined the Department of Chemistry of the University of Cambridge (UK) in 2001 where he is now Professor of Biophysics. Prof. Vendruscolo has made pioneering contributions to our current understanding of the physico-chemical principles of protein solubility and aggregation and to the development of rational therapeutic strategies for combating protein aggregation diseases. He holds several patents for methods of predicting protein solubility and aggregation and actively works in collaboration with pharmaceutical companies to apply such methods.

Salvador Ventura, Ph.D., Chair & Professor, Department of Biochemistry and Molecular Biology, Group Leader, Protein Folding and Conformational Diseases Lab, Universitat Autonoma de Barcelona

Cordoba, 1967. Salvador Ventura is the Prof. at the Dep. of Biochemistry and Molecular Biology and leader of the Protein Folding and Design group at the Institute of Biotechnology and Biomedicine, Autonomous University of Barcelona (UAB). He has authored more than 80 peer-reviewed research and review papers on protein folding and proteomics, apart from several book chapters and patents. He got his Ph. D. in Biology at the UAB in 1998 and worked as postdoctoral fellow (1999-2001) at EMBL-Heidelberg under the supervision of Dr.Luis Serrano. He has been researcher at Harvard Medical School (USA) andKarolinska Institutet (Sweden) among other centres. He rejoined UAB as a Ramon y Cajal researcher in 2003. Dr. Ventura received the UAB 2008 Excellence Research Award. In 2009 the ICREA-Academia Award for excellence in Biological and Medical Sciences

Characterising Biotherapeutics

Peter Bernhardt, Ph.D., Sr. Scientist, Analytical Development, Shire

Peter obtained his PhD in Biological Chemistry from MIT and conducted postdoctoral research at UCSD’s Scripps Institution of Oceanography working on small molecule biosynthetic pathways and protein structure/function. He joined Shire Pharmaceuticals in 2012 and is currently leading a group supporting all aspects of analytical development for two Enzyme Replacement Therapy programs.

Erica Bortolotto, Ph.D., Scientist, Bioassay Development, UCB Pharma

Dr Erica Bortolotto joined UCB Pharma (Belgium) in September 2011 as Bioassay Development Scientist in the Analytical Sciences for Biologicals department. She is working on potency assays method development, validation and transfer as well as release of products from preclinical phase to phase 3 in a GMP environment.

Eggehard Holler, Ph.D., Research Scientist III and Professor, Neurosurgery, Cedars-Sinai Medical Center

Educated as a chemist, I received my Ph.D. at the University of Frankfurt/Germany in 1967, then served as a postdoc at Cornell and Berkeley (1968-72) and advanced to Professor of Biochemistry at the University of Regensburg/Germany (1980). Major contributions followed in the fields of biochemistry of gene translation; nucleotide signaling; DNA replication and proofreading; pharmacology and mechanism of platinum compounds; discovery, bio production and characterization of biopolymers from microorganisms; polymer biosynthesis and chemistry; conjugation chemistry of polymalic acid with proteins in vivo and in vitro; rational synthesis of multifunctional nanoconjugates and their characterization. Molecular biology of myxomycetes, in particular Physarum polycephalum. Interim head of Institute fuer Biophysik und Physikalische Biochemie. Since 2005, Emeritus Professor of Biochemistry at University of Regensburg, Germany. At present Professor of Neurosurgery, head of the synthetic group at Nanomedicine Research Center/Neurosurgery of Cedars-Sinai Medical Center. Multi-drug antibody conjugates with polymalic acid. Successful targeting, treatment and imaging of preclinical human breast and brain tumors. More than 200 publications. Academic involvement and multiple honors in Europe, Russia, India and USA. Co-founder of Arrogene Inc.

Anne Goupil-Lamy, Principal Field Application Scientist, BIOVIA Science Council Fellow, BIOVIA

Anne Goupil-Lamy, Ph.D., principal field application scientist and Science Council Fellow at BIOVIA, obtained her doctorate in molecular biophysics from the University of Pierre and Marie Curie (Paris VI, France). She studied protein dynamics and denaturation using molecular dynamic simulations and neutron scattering experiments under the supervision of Professor Jeremy C. Smith. Goupil-Lamy joined MSI (now BIOVIA) in 1998 as a support scientist and gained expertise in the many modelling areas supported by BIOVIA' life science modelling tools. While managing BIOVIA' contract research group for many years in Europe and worldwide, she performed feasibility studies, developed proposals and was involved in the delivery of structure-based design and ligand-based design projects with one contract resulting in a patent. As a pre-sales scientist, she has performed several validation studies in fragment-based design and protein-protein interactions that were presented at conferences and to customers. She is also involved in biotherapeutics projects focusing on antibody design.

Vishal Kamat, Ph.D., Scientist, Biomolecular HTS Center, Therapeutic Proteins, Regeneron Pharmaceuticals

Vishal Kamat graduated from Drexel University with a Ph.D. in Biomedical Engineering. After his graduation, he took a position as a post-doctoral scientist in Regeneron Pharmaceuticals. He has 10+ years of experience studying protein-protein interactions using diverse real-time, label-free biosensor platforms. Currently, he is working as a Scientist in HTS Biomolecular Center and his group is responsible to develop label-free assays to support Regeneron’s drug discovery pipeline. He is part of the core drug discovery team, responsible for identifying therapeutic monoclonal antibodies for different disease indications. He utilizes his expertise in biomolecular interactions to characterize therapeutic antibodies for clinical development. He has supported more than 50 projects in Regeneron for different disease indications. He has developed epitope binning techniques and also pioneered high-throughput antibody binding kinetics assay which are routinely used in the HTS Biomolecular Center. He supports pre-clinical group by devising novel label-free assays to characterize anti-drug antibodies and is also responsible for writing reports for the filing of PCT and IND.

Huijuan Li, Ph.D., Director, Analytical Development, Biologics Bioprocess Development, Merck Research Laboratories

Dr. Huijuan Li is currently the director of analytical development leading Forced Degradation, Impurity Characterization/Isolation and protein mass spectrometry center of excellence within the Biologics Bioprocess Development, Merck Research Laboratories, Kenilworth, NJ. Dr Huijuan Li oversees analytical method development, characterization and applications to cell line, process and product development from early discovery through to regulatory filing for all biologics modalities. Dr Huijuan Li was previously an integral part of GlycoFi, a subsidiary of Merck & Co., Inc., leadership team responsible for the analytical and downstream process development functions. Huijuan led multidiscipline teams with staffs of diverse scientific/engineering disciplines in the development of biologics, including monoclonal antibodies, Fc fusion proteins, PEGylated and other therapeutic glycoproteins.

Kelly Loyet, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Genentech, Inc.

Kelly Loyet received her Ph.D. in Biochemistry from the University of Wisconsin-Madison, where her research concentrated on protein-phospholipid interactions in regulated exocytosis. After teaching an undergraduate biochemistry course at the UW-Madison, she joined Genentech Research in as a postdoctoral fellow in the Protein Chemistry Department performing proteomic mass spectrometry methods to profile Th1 and Th2 cell membrane proteins and studying protein characterization and interaction, in particular the co-receptor interaction between the CD28 and TNFR family members B and T lymphocyte attenuator and herpesvirus entry mediator. After her postdoctoral training, Kelly joined what is now the Department of Biochemical and Cellular Pharmacology (BCP) at Genentech as an Associate Scientist and was later promoted to Scientist. She and her team develop pharmacokinetic, pharmacodynamic, anti-therapeutic antibody, potency, cell-based, enzymatic, and characterization assays using a variety of different platforms to support investigative and preclinical studies from early and late stage research to early development for large molecule therapeutic projects. She is a lab head and represents BCP on various immunology, infectious disease, and ocular biotherapeutic project teams.

Jesper Pass, Ph.D., Principal Scientist, Novo Nordisk A/S

Brief Biographical notes: • M.Sc Biochemistry from the University of Copenhagen, Denmark • Ph.D on mechanisms in tissue degradation and cancer invasion, at the Finsen Laboratory at the Copenhagen University Hospital. • >10 years at Novo Nordisk, department of Antibody Technology. • Responsible for characterization and purification of antibodies for therapeutic use. • Responsible for generation of therapeutic- and assay mAbs. Responsible for implementing methods for high throughput antibody characterization.

Erdmann Rapp, Ph.D., Head of Bio/Process Analytics, Bioprocess Engineering, Max Planck Institute for Dynamics of Complex Technical Systems

Dr. Erdmann Rapp studied chemistry at the universities of Konstanz and Tübingen in Germany. During his PhD, he was stipendiary of DFG graduate school for analytical chemistry at the Eberhard Karls University of Tübingen and did fundamental research and method development on miniaturized separation techniques coupled to MS and NMR. He was invited research fellow at the NMR Centre of Wageningen University (The Netherlands), studying fluid dynamics in miniaturized separation systems via NMR-imaging. In 2001 he got research associate and head of the Laboratory for Miniaturized Separation Techniques at the Institute of Process Engineering of the Otto von Guericke University in Magdeburg (Germany). He continued his fundamental research on fluid dynamics in electrokinetically and hydrodynamically driven open tubular and packed capillaries and its impact on the analysis of biomolecules. Since 2003 till present, he is head of Bio/Process Analytics at Max Planck Institute for Dynamics of Complex Technical Systems in Magdeburg (Germany). He and his team are working on the development and implementation of innovative cutting edge bio/process analytical tools for a deeper understanding of bio(techno)logical processes - in particular, on high-throughput tools for proteomics, glycoproteomics and glycomics to be able to handle large sample numbers arising along bioprocess development and biomarker discovery.

Tilman Schlothauer, Ph.D., Senior Scientist, Biochemical and Analytical Research, Large Molecule Research; Roche Pharma Research and Early Development (pRED), Roche Innovation Center Penzberg

Tilman Schlothauer joined Roche in 2004 as a Post-Doc in the Department of Biochemistry. He studied chemistry at the University of Marburg. He started his Ph.D. at the University of Freiburg at the Institute for Biochemistry and Molecular Biology and finished it at the Center of Molecular Biology Heidelberg (ZMBH) in 2004. Since 2006 Tilman is in a Group Leader position in the Department of Biochemical and Analytical Research and since 2008 also Project Leader in the Technology Project Immune Effector Functions.

Alok Sharma, Ph.D., Head, Analytical Development, Lupin Pharmaceuticals

Alok Sharma is Principal Scientist & Head at Analytical Development Lab, Biotech Division, Lupin Limited, India. Prior to Lupin he was Associate Director at Biologics Division of Hospira Healthcare in Chennai, India heading Bioanalytics and stability studies. He has also held positions at Panacea Biotec, Intas Biopharmaceticals, Virologik Gmbh. He has been part of research and development teams that have developed Biosimilars and Vaccines from the concept to commercials. He has more than 15 years of experience in development of analytical methodologies and also advanced structural characterization techniques. He supervised the analytical laboratories and implemented new sensitive methods for characterization, biosimilarity assessment and comparability exercises of proteins and mAbs. He holds a Ph.D in Molecular Microbiology from the GB Pant University of Pantnagar and was a postdoctoral researcher in the areas of protein structure biology at the Helmholtz Centre for Infection Research, Braunschweig, Germany. He has authored and co-authored 20+ international research papers in this area and has published several review articles.

He is also serving as US Pharmacopoeia Expert Panel Member for therapeutic proteins (2011-2015).

Whitney Shatz, Ph.D., Senior Research Associate, Protein Chemistry, Genentech, Inc.

Whitney Shatz is a Senior Research Associate at Genentech in the Protein Chemistry Research Department. She received her M.S. in Biochemistry and Molecular Biology from the University of California in Santa Barbara, characterizing bacterial enzymes involved in the epigenetic process of DNA methylation. During her 8-year tenure at Genentech, she has made significant contributions to the investigation of structure activity/relationship in ADCC and the development of novel bispecific technologies. More recently, her focus has shifted to sustained drug delivery in ocular diseases. Currently, she is also working on a distance M.S. in Pharmaceutical Chemistry through the University of Kansas.

James Sutter, MSc, MBA, Associate Manager, Biotech Process Sciences, Down Stream Process, Merck Serono

I hold a Master in Sciences (Biochemistry) and a Master in Business Administration. Since 2005, I lead a Unit of Process Development in Down Stream Process at Merck Serono, in Vevey Switzerland. Beside Screenings and Experimental designs, we are involved as well in Validation activities like Characterisation, Robustness and Clearance studies. In parallel, I lead a small Unit active in supporting Manufacturing and/or Process Development Upstream Process Units. Our scales extend from few micrograms to hundreds of grams. Before that, during a 5 years period, I occupied a lead position in Analytical Department at Serono, in Aubonne Switzerland. During that period I used, improved and developed analytical methods used as In-Process Control for Market Productions. Earlier and for another 5 years period, I occupied a lead position in DSP activities for Market Productions

Alison Turner, BSc., Group Leader, Biophysics/Biochemistry, V-Region Discovery and Engineering, Biology, UCB Pharma

Joined the Chemistry department at UCB Pharma (formerly Celltech) in 1983. Currently working as Group Leader of a Biophysics team as part of Discovery Biology involved in screening/predicting antibody stability for developability using different biophysical methods and in silico approaches. Over the past 30 years at UCB as Senior Scientist/Principal Scientist, expertise and experience has been gained from working across different departments and disciplines in a range of therapeutic areas. Work has been published including the development and characterization of multi-specific chemically cross-linked antibody molecules; immunoconjugates (both drug and radiolabelled macrocycles for imaging and therapeutic applications); targeted liposomes for gene delivery, PEGylation and general protein modification.

Stefanie Wohlrab, Ph.D., Post-Doc, Pharma Technical Development, Roche Diagnostics GmbH

Stefanie Wohlrab studied chemistry at the University of Bayreuth (Germany), where she received her Diploma in 2010. She did her PhD under the supervision of Prof. Dr. Thomas Scheibel (University of Bayreuth, Germany) on the subject of modification and characterization of recombinant spider silk proteins for medical applications. Since 2014 she has worked as a post-doc at Roche Diagnostics GmbH in the department of Pharma Technical Development. Her research focuses on the development of high-throughput methods for the analysis of classical and novel biotherapeutics.

Li Zang, Ph.D., Sr. Scientist, Analytical Development, Biogen

Li Zang is currently a Senior Scientist and a group leader in Analytical Development department at Biogen. Her group supports the detailed structure characterization of all the biological programs in Biogen Idec development pipeline from R-to-D transition to post-approval. In addition, she extended the application of mass spectrometry to enhance the understanding of bioprocess development, e.g. raw material and media analysis; proteomics analysis of cell lines and detailed characterization of host-cell proteins. She obtained her Ph.D. from Northeastern University in 2005 and has since worked for Biogen. Her doctoral research focused on development of sensitive separation and proteomics methods for breast cancer biomarker discovery.

Roman A. Zubarev, Ph.D., Professor and Head, Department of Medical Biochemistry & Biophysics, Karolinska Institutet

Prof. Roman Zubarev (Ph.D. – Ion Physics / Analytical Chemistry), is currently head of the Division of Physiological Chemistry I at the Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden. He received MSc in Engineering Physics in Moscow (1986) and PhD from the Uppsala University, Sweden (1997). After a short postdoc training in Cornell, he became Associate professor of biological mass spectrometry in Odense, Denmark (1998), and then – professor of proteomics in Uppsala (2002). In 2008 he accepted professorship at the Karolinska Institutet in Stockholm. Recipient of several international research awards, including Biemann medal. Scientific interests include: proteomics-based methods for drug development and deciphering the mechanisms of human diseases, origin-of-life studies, biological effects of stable isotopes and fundamental research in reversibility of biochemical reactions.

Purification Technologies

Karin Felderer, Ph.D., Associate Director, Protein Production, Protein Sciences, MorphoSys AG

Dr. Karin Felderer studied Chemistry at the Technical University in Munich, Germany. She received her PhD at the Max-Planck-Institute of biochemistry in Martinsried with focus on structural biology. Following her postdoctoral research at the University of California in Berkeley, USA and a scientist position at Sloning GmbH she joined MorphoSys AG in 2010 and is currently Associate Director in the Protein Sciences Department. She and her team are responsible for the production and purification of antibodies, antigens and tool proteins to support therapeutic antibody discovery and development.

Sophia Hober, Ph.D., Professor, Protein Technology, Biotechnology, KTH Royal Institute of Technology

Sophia Hober is Professor of Molecular Biotechnology at KTH, Stockholm, Sweden. The focus of her current research group is development of predictable and robust systems for protein purification and detection by protein design and various selection methodologies. Her key scientific achievements includes characterization of the folding pathway of IGF-1, design and development of gene fusion systems for selective ion-exchange purification and improvements of the alkaline tolerance of protein A and protein G for industrial purification of IgG/HSA (Currently a product sold by GE-Health care). Moreover, small bispecific protein domains with ability to strongly and selectively bind to two different proteins recently have been developed. She has also been part of the executive management team within the Human Proteome Atlas, where she was responsible for the production, purification and analysis of proteins (PrESTs) and antibodies. Moreover she has been appointed dean of faculty at KTH-the Royal Institute of Technology, Stockholm, Sweden and thereby part of the executive management team of the university.

Anass Jawhari, Ph.D., CSO, CALIXAR

Anass Jawhari, has a strong experience in biochemistry and structural biology of macromolecular assemblies of proteins and antibodies. He holds a Ph.D. in biochemistry & structural biology from Louis Pasteur University (Strasbourg, France), obtained under the supervision of Professor Dino Moras (IGBMC & French academy of Science). After that, he worked as research associate at the Scripps Research Institute (La Jolla, US) and at the Gene Center (Munich, Germany) before joining Transgene as Research Investigator. He is now Chief Scientific Officer at CALIXAR. He has more than 15 year experience in research & development projects related to molecular aspects of cancer & infectious diseases. Anass is also member of the French GPCR research group (GDR RCPG Physio-Med) and Editor of SOJ immunology.

Svend Kjaer, Ph.D., Head, Protein Purification, Structural Biology Science Technology Platform, Francis Crick Institute

Dr. Kjær holds a PhD from the University of Aarhus, Denmark and has post-doctoral experience from the Karolinska Institute, Stockholm, Sweden and from the Lincoln’s Inn Fields laboratories at Cancer Research UK in London, where he has pursued structural studies of, amongst other projects, the GDNF-GFRa1-RET system. He subsequently headed the Protein Purification Facility at CR-UK for 7 years before joining the Structural Biology Science Technology Platform at the recently opened Francis Crick Institute in London.

Christian Kress, Dipl.-Ing, Scientist, Biochemical and Chemical Engineering, Laboratory of Thermodynamics, Technical University of Berlin

Christian Kress studied chemical engineering at the Technical University Dortmund and obtained his Dipl.-Ing. from the Department of Biochemical and Chemical Engineering in September 2012. Since October 2012 he works as a Ph.D. student in the Bioprocess Separations group under guidance of Dr. Brandenbusch at the laboratory of thermodynamics of Prof. Dr. Sadowski. The subject of his Ph.D. is the estimation of protein phase behavior in aqueous two-phase systems.

Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied Structural Biology, The Hebrew University of Jerusalem

Dr. Mario Lebendiker is in charge of the Protein Purification Facilities at the Wolfson Centre for Applied Structural Biology, The Hebrew University of Jerusalem. He is actively involved in many collaborations for structural and biochemical studies within the Hebrew University, others Universities in Israel, as well as with biotech and pharmaceutical companies. Dr. Lebendiker received a PhD in Biochemistry in 1982 from the Animal Virology Center (CEVAN), in Buenos Aires University, Argentina. Together with many other laboratories, he found the Protein Production and Purification Partnership in Europe (P4EU) network; a platform for the exchange of information, know-how and materials between core facility labs in the field of protein expression and purification.

Dirk Linke, Ph.D., Professor, Molecular Microbiology, Biosciences, University of Oslo

I studied Biochemistry at the Free University Berlin, and did my PhD in Biophysics at the Technical University of Berlin. My interest in membrane protein structure, function and evolution lead to a PostDoc assignment at the Max Planck Institute for Developmental Biology in Tübingen, Germany in 2003. There, I started my own (mostly grant-funded) research group in 2007, working on bacterial cell wall proteins and adhesins. I moved my research group to the University of Oslo in 2013, where I am a full professor for Molecular Microbiology since 2015.

Lorenz M. Mayr, Ph.D., Vice President & Global Head, Reagents & Assay Development, Innovative Medicines/Discovery Sciences, AstraZeneca

Lorenz is working since September 2012 as Vice President, Reagents & Assay Development with global responsibility for generation of biological reagents and assay development activities at AstraZeneca. This includes generation of proteins and cell lines for hit finding, hit-to-lead and lead optimisation activities including structure & biophysics activities across all therapeutic areas, the generation of tool antibodies, transgenic animals, stem cells and primary cells as tools for target validation studies and lead optimisation programmes. His department in the UK and Sweden is responsible for assay development activities for biochemical, cell-based and phenotypic assays for all therapeutic areas at AstraZeneca.

Before that, he has been working as Executive Director at Novartis Pharma in Basel/Switzerland, at Bayer Pharma Research in Wuppertal/Germany, at Bayer Central Research in Leverkusen/ Germany and at the M.I.T./Whitehead Institute in Cambridge/Massachusetts (U.S.A.).

He has published more than 50 papers in peer-reviewed journals and serves on several editorial and scientific advisory boards, including two terms at the Board of Directors for the Society of Biomolecular Sciences (2004-2011) and working as the Conference Chair of the MipTec Drug Discovery Conference, Europe’s largest drug discovery event, held in Basel/Switzerland.

José Paulo Mota, Ph.D., Professor, Chemical and Biochemical Engineering, Animal Cell Technology, iBET & FCT-Universidade Nova de Lisboa

José Paulo Mota is full professor of chemical and biochemical engineering at the Faculty of Science and Engineering (FCT-UNL) of Universidade Nova de Lisboa, Portugal, and a member of IBET’s Animal Cell Technology Unit; IBET (www.ibet.pt) is a private not-for-prof t research organization in the area of biotechnology and life sciences. He has over 100 publications in the fields of transport phenomena, separation processes, and process simulation, with a particular focus on adsorption science and technology. He is one of the world experts in the field of continuous chromatography and simulated moving bed (SMB) technologies. He is a member of the Scientific Council of Sciences and Engineering of the Portuguese National Science Foundation; the Board of Directors of the International Adsorption Society; and the Scientific Committee of the International Symposium on Preparative and Industrial Chromatography and Allied Techniques (SPICA).

Juergen Nett, Ph.D., Associate Director, High Throughput Expression, Adimab LLC

Dr. Juergen Nett received his PhD in Biochemistry from the Technische Universitaet Kaiserslautern in 1992. He then undertook postdoctoral work in Dartmouth Medical School from 1994 – 2001 before joining GlycoFi Inc as a scientist and later a group leader from 2001 to 2014. In March 2014 he joined the team at Adimab LLC, where he is currently leading the high throughput expression group.

David O’ Connell, Ph.D., Lecturer & Director, MSc Programmes in Biotherapeutics, Biomolecular & Biomedical Research, University College Dublin

David O'Connell has a PhD in molecular biology from UCD, postdoctoral research experience in antibody engineering at UCSF, and is currently Director of taught masters programmes in biotechnology & biotherapeutics at UCD. Through patenting of the EF affinity technology he has funded a series of research grants that have developed a strong research team and a dynamic collaborative effort with industry and academic labs to develop and commercialise the technology.

Ana Cecília Afonos Roque, Ph.D., Assistant Professor, Chemistry, UCIBIO, Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa

Cecília Roque is an Assistant Professor and head of a research group at Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa. She holds a degree in Chemical Engineering and a PhD in Biotechnology from Instituto Superior Técnico. Cecília has been a Visiting Scholar at the University of Cambridge and at the Catholic University of America, a Post-doctoral researcher at the Institute of Biotechnology (University of Cambridge) and at INESC-MN (Lisbon, Portugal). Her research focus on biotechnology, namely on the development of novel affinity receptors towards important biopharmaceuticals, as well as on the design of smart-responsive platforms for bioseparation, biosensing and biomedical applications. Cecília has been the recipient of several national and international awards, and received in 2014 a prestigious Starting Grant from the European Research Council.

Stefan Schmidt, Ph.D., Vice President, Process Science & Production, Rentschler Biotechnologie GmbH

Dr. Stefan R. Schmidt MBA, currently serves as Vice President at Rentschler Biotechnology, being responsible for all USP and DSP operations including manufacturing science and process development. Previously he held the CSO position at ERA Biotech in Barcelona, directing the company’s R&D efforts focusing on fusion peptides. Prior to that he worked at AstraZeneca in Sweden where he led the unit of Protein Sciences as Associate Director. In the last 10 years he worked intensively with fusion proteins, publishing the first comprehensive book on that topic in 2013.

Saurabh Sen, Ph.D., Principal Scientist, Immune Modulation and NBE Discovery, Boehringer Ingelheim Pharmaceuticals, Inc.

Saurabh Sen, Ph.D., is a research scientist with a domain expertise in membrane proteins (GPCRs) and CNS disorder (Parkinson’s disease). In his current position at Boehringer Ingelheim, he is primarily working on engineering antibodies towards developing new drug for unmet medical needs. Saurabh holds a PhD from the University of Helsinki, Finland and completed his postdoctoral research at Washington University School of Medicine at St. Louis and University of Alabama at Birmingham. Through his Ph.D., postdoc and during his tenure at Lucigen Corporation, his research was focused mainly dealing with various aspects of GPCRs: from ‘clones to crystals’. Saurabh’s scientific background and research interests are based on the comprehensive understanding of the field of membrane proteins and GPCRs, the most sought after drug target of the pharmaceutical industry and he wishes to contribute to the field of drug discovery research by developing novel molecules.

Gregory A. Weiss, Ph.D., Professor of Chemistry, Molecular Biology and Biochemistry, University of California, Irvine

The Weiss laboratory applies diverse techniques to approach the challenges of characterization and diagnosis of tumorigenesis. In collaboration with Profs. Reg Penner and Phil Collins, they have developed systems for direct interface of biological recognition with electronics. For example, they have recently reported “virus electrodes,” which feature filamentous bacteriophage tether directly to electrodes. They can tailor the phage to bind to the prostate specific membrane antigen for direct, reagentless, rapid, real-time detection of this cancer marker. This bioelectronics interface can be pushed down to the single molecule level, where Dr. Weiss plans to study differences in dynamics between wild-type and cancer-associated proteins. They also apply phage-displayed protein libraries to identify soluble, yet functional, variants of cancer-associated proteins. For example, recently they identified a soluble variant of caveolin, and used phage-displayed shotgun scanning to map the sidechain requirements for caveolin function associated with cancer. Structural studies of caveolin and other proteins are underway in the laboratory.

Bioreactor Design & Engineering

Frank Baganz, Ph.D., Senior Lecturer, Biochemical Engineering, University College London

After completion of a first degree in Chemical Engineering/Biotechnology (FHO Emden, Germany) he carried out a Ph.D. in Applied Biosciences at UMIST (Manchester, UK). Following a short postdoctoral period in the Department of Biochemical Engineering at UCL he became a Lecturer in 1999 and currently holds a position as Senior Lecturer. He has an established track record in modelling, engineering and scale-up/down of fermentation and cell culture processes. In recognition for his contributions to the development of miniature bioreactor technologies, he received the 2010 Pharmaceuticals Division Plenary Award from the AIChE.

Andrew Bradbury, MBBS, Ph.D., Group Leader and Research Scientist, B Division, Los Alamos National Laboratory

Andrew Bradbury has worked in the field of phage display and antibody engineering for almost thirty years. His present research interests lie in improving in vitro display technologies in order to make in vitro antibody selection the preferred method to generate highly specific, reproducible, high affinity antibodies. Within this context he has developed an NIH funded antibody selection pipeline that combines phage and yeast display in methods that exploit the advantages of each. This has recently been recently applied to the selection of tumor targeting antibodies in collaboration with the University of New Mexico. He maintains an active interest in technology development as it relates to display methods and antibody engineering, and also has a long-standing interest in the role auto-antibodies play in the etiology of Celiac disease.

Joaquim M.S. Cabral, Ph.D., Professor and Head, Bioengineering, Instituto Superior Técnico, University of Lisbon

Joaquim M.S. Cabral is Professor of Biological Engineering, in the Department of Bioengineering at Instituto Superior Técnico (IST), University of Lisbon, Portugal. He is the Founding Head of Department, and Director of the Institute for Bioengineering and Biosciences.

Trevor Deeks, Ph.D., QA and QC Consultant, Teva Biopharmaceuticals USA, Inc.

More than 35 years of pharmaceutical manufacturing, QC and QA experience. Senior management roles in QA, QC and Process Development. Formerly a Registered Qualified Person (QP) for many years in the UK. Led a number of new facility startups, technology transfers and validation projects with involvement in the development and commercialization of a number of currently marketed products. Editor-in-Chief of a Peer-Reviewed Journal in Europe for 1996-2000, published over 30 papers, and several books and book chapters. An active presenter and workshop leader at PDA, ISPE, and independent conferences.

Jens Fricke, Ph.D., Project Assistant, Bioprocess Engineering, Environmental Engineering and Technical Biosciences, Vienna University of Technology

Dr. Jens Fricke. University assistant at the Department of Biochemical Engineering at TU Vienna since December 2014. He finished his doctoral thesis at the Research & Transfer Center for Bioprocess Engineering & Analytical Techniques headed by Prof. Dr.-Ing. R. Luttmann in 2014. His work is mainly focused on Monitoring, Control and automation of pharmaceutical integrated bioprocess based on cell cultivation as well as modeling and data analysis for bioprocess development. As a consequence, he has a strong background in QbD, PAT, DoE and MVDA principles

Maria J. De Jesus, Ph.D., COO & Vice President, Process Sciences, ExcellGene SA

Maria De Jesus graduated in Environmental Engineering from the University of Lisbon and pursued her PhD at the Swiss Federal Institute of Technology in Lausanne, Switzerland and continued post-doctoral studies at the Laboratory of Prof. Wurm. In 2002, Maria was the founding scientist of the privately owned company ExcellGene SA, where she trained and led a team of engineers and scientist for the manufacturing of recombinant proteins made with CHO cells. Maria joined the Board of Directors of ExcellGene in 2006 and was promoted to Chief Operating Officer in 2009. Maria has published over 40 highly-referenced papers on process sciences. She invented and designed TubeSpin®bioreactors, a widely used system for small-scale process development.

Krist Gernaey, Ph.D., Professor, Chemical and Biochemical Engineering, Technical University of Denmark

Krist V. Gernaey is professor in industrial fermentation technology ("The Novozymes professor") at DTU Chemical Engineering. He is also the director of the CAPEC-PROCESS Research Center at DTU Chemical Engineering, and chairman of the EFCE working party on Quality by Design. Krist has an MSc (1993) and a PhD degree (1997) from Ghent University (Belgium). He has co-authored about 160 ISI listed scientific papers, and about 15 contributions to books. The current research activities of his group have focus on large-scale fermentation, mathematical modelling, investigation of mass transfer issues across scales, application and development of computer-aided tools for elucidation of (bio)process kinetics, Process Analytical Technology (PAT), continuous production, and process simulation.

Clemens Lattermann, Dipl.-Ing., Scientific Staff, Biochemical Engineering, RWTH Aachen University

Clemens Lattermann studied mechanical engineering at RWTH Aachen University from 2003 – 2010 and started his work as scientific assistant at the Chair of Biochemical Engineering at RWTH Aachen University in the end of 2010. He left the Chair in 2015 and is currently finishing his PhD about shaken small-scale screening bioreactors. He recently started to work for Kuhner Shaker GmbH, Aachen, as head of sales and service.

Marco Marques, Ph.D., Post-Doctoral Research Associate, Biochemical Engineering, University College London
After completion of first degree in Biotechnology Engineering (ULHT, Portugal), he carried out a Ph.D. in Biotechnology at IST (Lisbon, Portugal). Following a postdoctoral period at IBB (IST, Portugal) he joined the Microfluidics Laboratory at the Department of Biochemical Engineering (UCL).
He has an established track record in engineering and scale-up/down of fermentation and biocatalytic processes. His work is focused on the implementation of microreactor technology in bio-based manufacturing processes.

Yasser Nashed-Samuel, Ph.D., Principal Scientist, Process Development, Amgen, Inc.

Yasser Nashed-Samuel, is currently a principal scientist at Amgen (Thousand Oaks, CA), Attribute Scientist, Process Development, Operation. Since joining Amgen in 2003, he established and led the leachables and extractables (L/E) program. The L/E group engages in assessing product contact for manufacturing equipment, bulk containers, primary delivery containers, devices, product development, raw materials, regulatory filings and incident investigations for both clinical and commercial products.

Matthias Reuss, Ph.D., Professor & Acting Senior Director, Stuttgart Research Center Systems Biology, University of Stuttgart
1970, Ph.D. (Dr.-Ing.) in Chemical Engineering from the Technical University of Berlin; 1971-1976 Research Assistant in the Department of Biotechnology at the GBF Braunschweig; 1977-1987 Professor of Biochemical Engineering Technical University of Berlin; from 1988-2009 (retirement) Professor of Biochemical Engineering and Director of the Institute of Biochemical Engineering at University Stuttgart; 2006-2013 Director of the Centre Systems Biology at University Stuttgart. 2013 NGI Distinguished Visiting Scientist (Kluyver Centre Delft and NICSB Amsterdam) in the Netherlands. Honors & Awards – Fellow of the International Institute of Biotechnology; 1992 Research award of the State of Baden-Wuerttemberg; 2006 Doctor honoris causa TU Delft, The Netherlands.

Francesca Scargiali, Ph.D., Assistant Professor, Dipartimento di Ingegneria Chimica, Gestionale, Informatica e Meccanica, Università degli Studi di Palermo

Francesca Scargiali is Assistant Professor of Chemical and Biochemical Plant Design at Palermo University. She graduated in Chemical Engineering at Palermo University in 1991. After a ten years period as an engineer at SARAS Refinery technical offices in Milan she got back to research and got her PhD in Chemical Engineering with a thesis entitled “Gas-Liquid dispersions in mechanically agitated contactors”. The research activity carried out has led to over 60 scientific publications which mainly regarded the study, modelling and development of single phase and multiphase bio-reactors and mixed tanks. She developed several original experimental techniques, especially for assessing mass transfer performances of gas-liquid bioreactors and mixing phenomena. She has also been involved in the use of Computational Fluid Dynamics (CFD) techniques as a tool for the solution of complex modelling tasks. In 2005, she received the Senior Moulton Medal from the UK Institution of Chemical Engineers (IChemE), a prize awarded to the authors of the best paper published by the Institution during the year.

Stefan Schillberg, Ph.D., Head, Molecular Biology, Plant Biotechnology, Fraunhofer Institute for Molecular Biology

Prof. Stefan Schillberg is head of the Department for Plant Biotechnology and the division Molecular Biology at the Fraunhofer Institute for Molecular Biology and Applied Ecology IME in Aachen, Germany. He received his Ph.D. in Molecular Biology from the RWTH Aachen University in 1994. Current activities in his laboratory focus on recombinant protein production in various host systems, downstream processing and recombinant protein analytics as well as metabolic pathway engineering and the analysis of molecular factors affecting cell productivity. He holds an honorary professorship at the Justus-Liebig-University in Giessen.

Marcos Simón, Ph.D., Founder, Bolt-on Bioreactor Project

Marcos Simon graduated in Pharmacy from the University of Navarra at Pamplona and in Food Science and Technology from the University of Zaragoza. He was awarded his Ph.D. degree from the Technical University of Denmark in Lyngby and spent some years as a researcher at the Royal Veterinary and Agricultural University of Denmark before moving to northern Spain, where he founded three biotech companies, all of them focused on bioprocess development. His experience with available tools for adherent cell culture spurred the development of the Bolt-on Bioreactor project.

Robert Steinhoff, MSc, Scientist, Chemistry and Applied Biosciences, ETH Zurich

Robert Steinhoff studied chemistry at the Technische Universität München with research internships at the Ecole Normale Superieur, Lyon, France and BASF, Ludwigshafen, Germany. Robert joined the mass spectrometry division in the lab of Prof. Zenobi at ETH Zurich in 2012 as a European Marie Curie fellow for Ph.D. studies. His research activities focus on the role of mass spectrometry in the context of bioprocess optimization, including the analysis of monoclonal antibodies and small molecules.

Ana Teixeira, Ph.D., Lab Head, Bioengineering and Systems Biology, Animal Cell Technology, IBET Instituto de Biologia Experimental e Tecnológica
Ana P. Teixeira graduated in 2003 in Chemical Engineering at FCT-UNL, and completed in 2008 her Ph.D. degree in Biochemical Engineering at the same University. During her doctoral studies, she acquired advanced knowledge on animal cells bioprocessing, process modeling, monitoring and control. During her stay as a post-doc at the Animal Cell Technology Unit (ACTU) of ITQB UNL/iBET, she developed work on metabolic modeling of brain cells. Currently, she is associate researcher at ITQB-UNL/iBET, being responsible for the Systems and Synthetic Biotechnology research area of the ACTU. Her main focus has been on understanding metabolic regulation during growth and recombinant protein production to identify targets for improving cellular and bioprocess performances. She has used a combination of computational, genetic and analytical tools to quantify the cell fluxome on animal cells. In parallel, she has been resorting to synthetic biology tools to develop next generation insect cell platforms tailored for fast production of complex proteins by site specific genomic integration.

Scaling-Up & Down

Dorothee Ambrosius, Ph.D., Senior Vice President, Global Bioprocess and Pharmaceutical Development, Boehringer Ingelheim Biopharmaceuticals GmbH

Dorothee joined the leadership team of Boehringer Ingelheim on October 1, 2010 as Senior Vice President, Global Bioprocess and Pharmaceutical Development. Her knowledge and over 20 years experience in research and development of Biopharmaceuticals has enabled her to serve as an asset to the organization as she leads the Bioprocess and Pharmaceutical Development organization globally. This organization consists of Process Science Austria (microbial expression systems, protein refolding, purification and analysis), Process Development Germany and Process Science Fremont (both focusing on mammalian production systems, protein purification, formulation and analysis) and encompasses process development from DNA to clinical trial supplies. Dorothee started her industrial carrier in 1989 at Boehringer Mannheim, Biotech Research Center in Penzberg and spent 8 years at various research portions in the field of identification and development of novel therapeutic protein medicines. Since 1997, she was at Roche Diagnostics GmbH and spent 6 years as Head of Biochemistry and Protein Science in NCE and NBE (antibodies) development. She joined Boehringer Ingelheim in 2003 as Head of Downstream Development.

She studied Biology / Biochemistry at the RWTH Aachen and did her doctorate at the Deutsches Wollforschungsinstitut (German Woll Research Institute), Aachen. She is a member of the organizational committee of the Halle Conference for Protein Production, has written a book chapter, several publications, developed new trademark protected technology platforms and holds many patents in the area of Biotechnology.

Ravinder Bhatia, MSc, Scientific Director, PDMS/API-LM, Janssen Research & Development

Ravi is a Scientific Director of Cell Technology department at Janssen R&D, where he is leading a process development team to develop and scale-up cell therapy, and viral vaccines based products. Previously at Janssen R&D, Ravi led a team to develop and implement industry’s first large-scale single-use bioreactor (1000L) and a single-use fluidized bed centrifuge technology for biopharmaceutical manufacturing.

Stanislas Blein, Ph.D., Senior Director and Head, Antibody Engineering, Biologics Research, Glenmark Pharmaceuticals S.A.

Stanislas joined the Biological Research Center of Glenmark Pharmaceuticals in 2007. His group focuses on the isolation and optimization of therapeutic antibodies. The group also develops new platform technologies relevant to bispecific antibodies. His range of expertise includes selection and rational design of antibodies, biophysical analysis and in-silico modelling to solve problems in antibody and protein engineering. Prior to joining Glenmark Pharmaceuticals, Stanislas was a Senior Scientist at Domantis in Cambridge UK where he worked on the development of therapeutic domain antibodies. He performed his doctoral and post-doctoral work at the University of Edinburgh with Prof. Paul Barlow. Using high resolution NMR spectroscopy, he solved 3D structures of multi-modular proteins from the complement system.

Stefan Kol, Ph.D., Protein Biochemist, CHO Cell Line Engineering Core Facility, Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark

Educated in the city of Groningen in the Netherlands, I now live and work in the Copenhagen area in Denmark. Until recently, I have worked at the Novo Nordisk Foundation Center for Protein Research on hard-to-express proteins with a focus on human membrane proteins. Currently, I am employed as a protein biochemist at the Novo Nordisk Foundation Center for Biosustainability, where we engineer Chinese Hamster Ovary cell lines to improve the use of the CHO cell platform for production of new and improved recombinant therapeutics. In addition, we develop methods to better manipulate CHO cells and to improve the analysis of the model therapeutics we use to characterize our engineered cell lines

Eric LaCoste, Ph.D., ADC Team Leader, Chemistry & Biotechnology Development, Sanofi-Aventis Research & Development

I am ADC Team Leader and Head of the BioOrganic lab within Sanofi. I supervise process development for Protein Conjugates to support research programs and up to commercial launch readiness. I also oversee cGMP manufacturing and am responsible for process transfer to internal partners or CMO. I hold a PhD in Organic Chemistry and joined sanofi in2007 to develop ADC process research.

Jose C. Menezes, Ph.D., Professor, Bioengineering and Biosciences, Technical University of Lisbon

My current interests and experience are on:
MSAT - Manufacturing-Sciences & Technologies - bio/pharma specialist (ca. 20 y industrial experience of small and large molecules) on using Quality as Manufacturing-Science (e.g., DMAIC-based QbD & L6S approaches).
Late stage product/process development, industrialization, routine manufacturing and troubleshooting. LCM (Lifecycle Management) and E2E data-based DMAIC approaches.
Consistent QbD (Quality by Design) implementations and Process/Product Designs delivering Six-Sigma (DFSS) founded on Knowledge-Management Systems.

Antonio Moreira, Ph.D., Vice Provost for Academic Affairs, Provost’s Office and Center for Advanced Sensor Technology; Professor, Chemical and Biochemical Engineering, University of Maryland

Dr. Antonio Moreira is Vice Provost for Academic Affairs and Professor of Chemical, Biochemical and Environmental Engineering at UMBC. Prior to UMBC, he spent nearly 10 years in the private sector with Schering-Plough Corp. (now Merck) leading the development of biopharmaceutical products such as alpha interferon-2b. He has an active research program in regulatory science and biomanufacturing and is author/co-author to over 200 publications and presentations. He holds a BS degree in chemical engineering from the University of Porto, Portugal and MS and PhD degrees in chemical and biochemical engineering from the University of Pennsylvania in the USA.

Kerstin Otte, Ph.D., Professor, Molecular Biology and Gene Technology, Pharmaceutical Biotechnology, University of Applied Sciences Biberach

Kerstin Otte is a biologist trained from the Phillipps-University of Marburg, Germany and obtained her Ph.D. at the SL-University in Uppsala, Sweden. After a postdoctoral fellowhip at the Gurdon Institute at Cambridge, UK, she gained industry experience as senior scientist at Graffinity Bioscience and LION Bioscience, both Heidelberg, Germany, in preclinical drug development. Since 2006, Kerstin Otte holds a professorship for molecular and cell biology at the University of Applied Sciences Biberach, Germany, at the Faculty of Pharmaceutical Biotechnology. Her research focuses on cell line development for the production of biopharmaceuticals.

Alan G. Ryder, Ph.D., Senior Lecturer, Nanoscale Biophotonics Laboratory, School of Chemistry, National University of Ireland, Galway

Dr. Alan G. Ryder is a Senior lecturer in the School of Chemistry at the National University of Ireland, Galway (NUIG). He has a B.Sc. and Ph.D. in chemistry from NUIG. After a stint as a postdoctoral researcher in UCC, he rejoined NUIG in 1997 to work on developing quantitative Raman spectroscopy based methods for measuring illicit narcotics. In 2003, he formed the Nanoscale Biophotonics Laboratory (NBL) which is focussed on the use of photonics and chemometrics technologies for life and physical science applications. In 2006 obtained tenure in the School of Chemistry at NUIG where he lectures mainly in spectroscopy and has two core research areas: Analytical Sciences and Photonics which cover a wide range of applications. In the Analytical Sciences domain, his main research area is the development of rapid, quantitative analytical methods for the analysis of complex materials with particular focus on biopharmaceutical manufacturing and cell culture media analysis. Key methods employed include Raman and Fluorescence spectroscopies and chemometrics. He has collaborated with a range of industry partners including Bristol-Myers Squibb, Janssen-Biologics, Merck, Agilent, and Kaiser Optical Systems. He has authored in excess of 80 publications, generated 3 patents, graduated 12 Ph.D. students.

Mark Smales, Ph.D., Professor, Biotechnology, Biosciences, University of Kent

Professor Smales is currently Professor of Biotechnology at the University of Kent and the Director of the Centre for Molecular Processing. His research interests cover all of upstream bioprocessing and host cell protein flux during bioprocessing including reverse cell engineering approaches, systems/synthetic biology, and the identification of target genes/proteins for manipulation (or markers for screening purposes) in order to enhance therapeutic protein production from in vitro cultured mammalian cells. A major focus of his work is reducing heterogeneity of recombinant protein products from mammalian cells. He is currently an Executive Editor of Biotechnology Letters and on the board of Biotechnology and Applied Biochemistry. He has given multiple keynote presentations at international conferences and published widely in the area.

Oliver Spadiut, Ph.D., Group Leader, Integrated Bioprocess Development, Biochemical Engineering, Vienna University of Technology

01/09-09/10 Post-Doc position at the Division of Glycoscience at the Royal Institute of Technology KTH, Stockholm, Sweden

09/10-present University Assistant at the Research Division of Biochemical Engineering at the University of Technology VUT, Vienna, Austria

Since 02/14 Habilitation in Biotechnology - process ongoing; Habilitation Thesis “Horseradish peroxidase – from genome to protein”

01/15-present Group Leader “Integrated Bioprocess Development”

Ralf Takors, Ph.D., Director, Biochemical Engineering, University of Stuttgart

Reseach area: systems metabolic engineering and synthetic biology;
CV: process engineering study at RWTH Aachen; doctoral degree (1997); ‘Habilitation’ for metabolic engineering (2004, Forschungszentrum Jülich GmbH & RWTH Aachen); employee at Evonik Industries AG, responsible for bioprocess development and systems biology with C. glutamicum. Since 07/2009 director of the Institute of Biochemical Engineering (IBVT). Chair of the Section Biochemical Engineering at DECHEMA e.V., Germany. Member of various editorial boards.

Moritz von Stosch, Ph.D., Lecturer, Chemical Engineering and Advanced Materials, Science, Agriculture and Engineering, Newcastle University; CEO, HybPAT Technologies

Dr. Moritz von Stosch works as a Lecturer at the School of Chemical Engineering and Advanced Material, Newcastle University and he also is the CEO of HybPAT, a spin-off which will provide Hybrid modeling solutions for an efficient implementation of PAT. Before he has been working as a Postdoctoral researcher at the Systems Biology and Engineering group of the University Nova de Lisboa He successfully accomplished his PhD at the Faculty of Engineering of the University of Porto in 2011. Prior, in 2006 he received his Diploma in Engineering from the RWTH-Aachen University.

Engineering Expression Systems

Kirill Alexandrov, Ph.D., Professor, Institute for Molecular Bioscience, Australian Institute of Bioengineering and Nanotechnology, University of Queensland

Professor Kirill Alexandrov obtained his master’s degree in Invertebrate Zoology at the Leningrad State University, Russia in 1989 and completed his Ph.D. in Cell Biology at EMBL Heidelberg, Germany in 1995. He went on to postgraduate work at the Department of Physical Biochemistry at the Max-Planck Institute in Dortmund, Germany, and remained with the Institute for 12 years, becoming a group leader in 1999. He co-founded the German biotechnology company Jena Bioscience in 1998. He joined the Institute for Molecular Bioscience and the Australian Institute for Bioengineering and Biotechnology of the University of Queensland, Australia in 2008 as an Australian Research Council Future Fellow. His research interests are in the development of platform technologies for production, evolution and analysis of proteins, structure and function of macromolecular protein complexes, design of protein biosensors and gene expression in Leishmania protozoa.

Niall Barron, Ph.D., Program Leader, Mammalian Cell Engineering, National Institute for Cellular Biotechnology, Dublin City University

Dr. Barron is a Lecturer in Biotechnology at Dublin City University and Deputy Director of the Irish National Institute for Cellular Biotechnology (NICB) (2014-present). He was previously a Program Leader in Mammalian Cell Engineering, NICB (2000-2014) and Postdoctoral Fellow at Baylor College of Medicine in Houston, Texas, USA (1997-2000). He earned his Ph.D. in the Department of Applied Biological & Chemical Sciences, University of Ulster, Northern Ireland (1997). Research interests include expression profiling of CHO production clones with desirable characteristics with a view to identifying key genes in various phenotypes, as well as engineering CHO cell lines for biopharmaceutical production by manipulation of the expression of individual or groups of genes.

Simon Fischer, Ph.D., Scientist, BP Process Development Germany, Boehringer Ingelheim Pharma GmbH & Co. KG

Simon Fischer works as a scientist at the Department of BP Process Development at Boehringer Ingelheim Pharma, Biberach, Germany and is responsible for implementing novel technologies in Cell Line Development. Simon acquired his Ph.D. in Pharmaceutical Biotechnology at the Institute of Applied Biotechnology Biberach, as a fellow of the International Graduate School in Molecular Medicine of Ulm University. Before, he received the Master of Science (MSc) degree in Biomedical Engineering from the University of Applied Sciences Albstadt-Sigmaringen and the Bachelor of Science (BSc) degree in Pharmaceutical Biotechnology from the University of Applied Sciences Biberach. He also gained relevant industry experience by working with Novartis Pharma AG at Basel, Switzerland, as well as Boehringer Ingelheim Pharma. Furthermore, he was guest researcher at the Donders Institute for Brain Function, Cognition and Behaviour at the Radboud University Nijmegen, The Netherlands. Simon built up the miRNA research platform in mammalian production cell systems at the IAB Biberach, including the development of various cell-based high-content miRNA screening systems.

Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator, Novo Nordisk Foundation Center for Biosustainability, Technical University of Denmark

Helene Faustrup Kildegaard is Co-Principal Investigator at the Novo Nordisk Foundation Center for Biosustainability at Technical University of Denmark. She received her Ph.D. degree in cellular and molecular biology from the Danish Cancer Society/Technical University of Denmark. She was then awarded a postdoc grant on therapeutic protein production in CHO from the Lundbeck Foundation and the Technical University of Denmark. Her current research focuses on applying -omics data and developing efficient genome editing tools to engineer CHO cell factories for increased production and improved quality of therapeutic proteins.

Francesc Gòdia, Ph.D., Professor, Chemical Engineering, Universitat Autònoma de Barcelona

His research activity is focused on the field of Biotechnology and Biochemical Engineering, and more specifically in the culture of mammalian cells for the production of proteins with interest in diagnostic and therapy of diseases, vaccine candidates and the cellular, metabolic and tissue engineering. He has also worked in the development of industrial fermentation processes, immobilised biocatalysts and bioreactor design. He is the Overall Manager of the MELiSSA Pilot Plant, a facility of the European Space Agency and UAB devoted to the development of biological life support systems for long-term manned missions in space. His teaching activity is focused on Chemical Engineering and Biotechnology. He is the coordinator, with Paula Alves, of the ESACT Course on Animal Cell Technology, from 2011. He is author of more than 85 papers, 5 patents and advisor of 27 Ph.D. theses. He is one of the founders of the spin-off company HEXASCREEN Culture Technologies, focused on the development of single-use of minibioreactors for screening in Biotechnology. He is currently the President of Fundació Parc Taulí (Sabadell, Barcelona) and member of the BOD of the Blood and Tissue Bank of Barcelona.

Kyle J. Lauersen, Ph.D., Faculty of Biology, Algae Biotechnology & Bioenergy, Center for Biotechnology, Bielefeld University

Dr. Kyle J. Lauersen is originally from Kingston, Ontario, Canada, where he completed his Bachelor’s of Science (Honours), Bachelors of Education, and Master’s of Science at Queen’s University. Prior to finishing his Bachelor’s degree, Kyle was able to gain experience as a field research assistant in Paleolimnology in eastern Canada, sexual mating pattern ecology in Western California and Oregon, as well as advanced molecular biology training with transgenic poplar trees in the Phytotron greenhouse of Queen’s University. His Master’s degree in Biology investigated the molecular mechanisms of freezing stress tolerance in perennial grass through RNA interference, understanding native ice binding proteins, and transformation of monocot grass species. This diverse background and desire to further investigate plant-based biotechnology led Kyle to seek other green systems for his doctoral studies. In 2011, Kyle was awarded a three-year scholarship with the Cluster Industrial Biotechnology Graduate Cluster at the Center for Biotechnology in Bielefeld, Germany. He completed his Ph.D. in 2014, investigating the potentials of synthetic biology for microalgae biotechnology. Dr. Lauersen currently works as a Postdoctoral Research Associate in the Algae Biotechnology and Bioenergy group within the CeBiTec at Bielefeld University.

Eszter Majer, Research Scientist, Plant Virus Biotechnology Research Group, Instituto de Biología Molecular y Celular de Plantas, CSIC-Universidad Politécnica de Valencia

Eszter Majer is about to obtain her Ph.D. degree in Biotechnology at the Instituto de Biología Molecular y Celular de Plantas (CSIC-Universidad Politécnica de Valencia), Spain. Her work focuses on the development virus-based vectors to co-express proteins in plants and improve the content of natural products.

Jacopo Marino, Ph.D., Research Scientist, Chemistry and Biochemistry, Gene Center, University of Munich

Dr. Jacopo Marino obtained a Master’s degree in Molecular Biology in Italy. During his Ph.D. at the University of Zurich in Switzerland, Jacopo has worked on different aspects of membrane protein biophysics. Approaching the problem of poor expression of heterologous membrane proteins in E. coli, his studies have led to the discovery that the presence of extra, untranslated mRNA sequences introduced upstream the gene of interest, can have a pronounced effect on the quantity and the quality of the protein expressed. Following his interest in the relationship between protein folding and translation, Jacopo is now carrying out a joined postdoc between the cryo-EM laboratory of Prof. Roland Beckmann at the University of Munich, Germany, and the laboratory of Prof. Gunnar von Heijne in Stockholm, Sweden.

Diethard Mattanovich, Ph.D., Professor, Microbial Cell Design, University of Natural Resources and Life Sciences, Vienna and Director, Area Systems Biotechnology and Microbial Cell Engineering, Austrian Centre of Biotechnology

Diethard Mattanovich is Professor of Microbial Cell Design at the University of Natural Resources and Life Sciences, Vienna, and Director of the Area Systems Biotechnology and Microbial Cell Engineering of the Austrian Centre of Biotechnology. His research is focused on systems biotechnology for the development of microbial strains for production of heterologous proteins and biochemicals. He has pioneered systems biology of the Pichia pastoris expression platform leading to numerous patents and publications on engineering of metabolism, gene expression and protein secretion in this yeast and other production platforms. He is Vice President of the European Federation of Biotechnology and Associate Editor of Microbial Cell Factories and Microbiology.

Lorenz M. Mayr, Ph.D., Vice President & Global Head, Reagents & Assay Development, Innovative Medicines/Discovery Sciences, AstraZeneca

Ray Owens, Ph.D., Head, Oxford Protein Production Facility-UK, Research Complex at Harwell and Professor, Molecular Biology, University of Oxford

Ray Owens has extensive experience of the production of recombinant proteins for structural biology both in industry and academia. He obtained his Ph.D. in biochemistry at the University of Cambridge, UK, and has a longstanding interest in protein structure and function. He is currently a Professor of Molecular biology at the University of Oxford and Head of the Oxford Protein Production Facility-UK. This is a National Resource Centre for protein production and crystallisation, based at the Rutherford Appleton Laboratory, near Oxford.

Oliver Schlenker, Ph.D., Senior Research Scientist, Protein Engineering, Heptares Therapeutics

Dr. Oliver Schlenker is Senior Research Scientist in Protein Engineering at Heptares Therapeutics. He is responsible for construct design and optimisations aiming to improve protein expression, homogeneity and crystallisation. He also establishes purifications for new targets and purifies protein for crystallisation trials. Longstanding experience in the topic from gene to structure has been achieved in his postdoctoral work at the National Institute of Medical Research (MRC) and Ph.D. in Structural Biology at Heidelberg University. Current work includes a target, for which new promising leads were identified and a novel X-ray structure determined.

Zhiwei Song, Ph.D., Principal Scientist, Lead PI for GlycoSing Programme, Bioprocessing Technology Institute, A*STAR

Dr. Zhiwei Song obtained his Ph.D. degree in Biochemistry from the University of Michigan where he worked on protein glycosylation. His postdoc work was done in the Biology Department at MIT where he studied the genetic control of apoptosis in Drosophila. He then worked in Dr. Daniel I.C. Wang’s lab at MIT for a year and a half. In 2002, Zhiwei moved to Singapore. Now he is a Principal Scientist at the Bioprocessing Technology Institute (BTI) of A*STAR. His research has been focused on protein glycosylation, production of recombinant antibodies using CHO cells and apoptotic cell death in cultured mammalian cells.

Gregory A. Weiss, Ph.D., Professor of Chemistry, Molecular Biology and Biochemistry, University of California, Irvine

Dr. Weiss earned a BS in Chemistry from the University of California, Berkeley and a Ph.D. in Chemistry from Harvard. Awarded a Ruth Kirschstein National Research Service Award from the NIH, he pursued postdoctoral studies at Genentech. In 2000, he joined the UC Irvine faculty, where his laboratory focuses on the interface between chemistry and biology, including the study of membrane proteins, harnessing viral diversity and bioelectronics. Tenured in 2006, he is a full Professor and former Vice Chair of the Department of Chemistry. His awards include Outstanding Professor in the School of Physical Sciences at UC Irvine (elected by the graduating students), Beckman Foundation Young Investigator and election as a Fellow of the American Association for the Advancement of Science. Selected by the U.S. National Academy of Sciences to represent young scientists from the U.S. at two World Economic Forum “Summer Davos” meetings in China, he was twice elected Co-Chair of the Global Young Academy, which includes ~200 top young scientists nominated by the national academies of 55+ countries. The textbook he co-authored with David Van Vranken, Introduction to Bioorganic Chemistry and Chemical Biology, was short-listed for the best undergraduate textbook award by the Society of Biology in 2013.

Applying Expression Platforms

Alejandro Aranda, Ph.D., Principal Investigator, Vectors Development Lab, END-ICAP Unit, INSERM, University of Versailles – Saint Quentin en Yvelines

Alejandro Aranda, Ph.D. in Molecular Biology and Biochemistry by University of Buenos Aires, is a PI in the Vectors Development Lab of END-ICAP unit of INSERM at University of Versailles and Saint Quentin en Yvelines. He (Diamante, Argentina 1978) studied Biotechnology at the University of Quilmes (2001) and obtained his Ph.D. at the Instituto de Química y Fisicoquímica Biológicas (IQUIFIB, Buenos Aires) in 2006. During his Ph.D. thesis he worked under the supervision of Dr. Cristina Nowicki on the molecular and biochemical characterisation of malate dehydrogenase isozymes in trypanosomatids. After a short stage in Italy, at the Centro Studi Fegato (CFS, Trieste) he joined the University of Navarra (Spain) as a research associate in the Gene Therapy and Hepatology Department, located at CIMA since 2008, where he worked four years as a postdoctoral fellow in the laboratory directed by Dr. Cristian Smerdou. His main focus was the development and improvement of expression vectors systems based on Semliki Forest virus in collaboration with 3P Biopharmaceuticals. In June 2013, he moved to Faculty of Medical Sciences of University of Versailles and Saint Quentin en Yvelines. There, he has started working with Herpes Simplex type 1-based vectors for gene therapy of sensorial neurons.

Johannes Auer, Ph.D., Principal Scientist, Large Molecule Research, Roche Pharma Research & Development, Roche Innovation Center Penzberg

In 1979, Dr. Auer completed his studies of Biology at the Ludwig-Maximilians University of Munich, earned his Ph.D. in Microbiology there in 1985 and worked there as a Postdoctoral Fellow in 1989. The next year, he held the role of Group Leader in the department of Genetics at Boehringer Mannheim, Penzberg. In 1998, he functioned as Senior Scientist at various departments of Roche Diagnostics with a focus on Molecular Biology. Since 2011, he has been in his current role as Principal Scientist, Large Molecule Research, Cell Line and Molecule Development at Roche.

Cecília Calado, Ph.D., Professor, Chemical Engineering Department, ISEL-Instituto Superior de Engenharia de Lisboa, Instituto Politécnico de Lisboa

Cecília Calado has been Professor at the ISEL-Instituto Superior de Engenharia de Lisboa (Instituto Politécnico de Lisboa) since September 2014, where she coordinates the R&D laboratory in Health BioEngineering. From May 2004-September 2014 she was Professor at the Engineering Faculty (Catholic University of Portugal), coordinating the BSc and MSc in Biomedical Engineering and the R&D Lab in Medical BioEngineering. From 1998-2003 she was a researcher at the BioEngineering Research Group at the Instituto Superior Técnico (Universidade Técnica de Lisboa). She has a Ph.D. in Biotechnology, an MSc in Biochemical Engineering and a degree in Biochemistry. She teaches in the area of Biotechnology, Protein Engineering and Pharmacology. She presents broad experience in R&D in BioProcess Engineering and on Discovery and Development of New Drugs. She has coordinated scientific projects, financed by external agencies to the host institution over 1 000 000€. From 2010-2014, she was a member of the Executive Board of the Portuguese Chapter in Engineering in Medicine and Biology Society of IEEE. She is a member of the IEEE, of the European Federation of Biotechnology, for Pharma and Medical Biotechnology and for Biochemical Engineering Science. Simultaneously with these multiple projects, she has promoted various activities to enhance public awareness to science, such as presentations on patents and technology transfer.

Neil Dixon, Ph.D., MRSC, BBSRC David Phillips Research Fellow, Manchester Institute of Biotechnology, Faculty of Life Sciences, University of Manchester

Dr. Neil Dixon received his Ph.D. for investigating drug-protein interactions of the Vacuolar (H+)-ATPase transmembrane protein, using a combination of synthetic chemistry, biochemistry and biophysical techniques from the University of Leeds, UK. As a postdoc at the University of Manchester, UK, he was a leading scientist on a chemical biology project, where he re-engineered the naturally occurring RNA-based regulatory control components, riboswitches, to provide novel orthogonal tools for genetic regulation [Dixon et al PNAS 2010]. Currently he is involved in the development and demonstration of this novel gene expression technology for use in the biomanufacture of human therapeutic proteins (biopharmaceuticals). He has authored 16 peer-reviewed research articles, and is a named co-inventor on UK and international patent applications. He has been supported through a number of BBSRC grants and fellowships and currently holds a BBSRC David Phillips Fellowship entitled “Development and Application of Next Generation Synthetic Biology Tools”. He is interested in developing novel gene expression devices, to provide higher-order synthetic biology circuits and systems, tunable periplasmic secretion systems, for co-expression challenges and upstream bioprocess optimisation.

Claudia Götzberger-Schad, Ph.D., Senior Scientist, Global Biologics, Bayer Pharma AG

Dr. Claudia Götzberger-Schad is Senior Scientist at Global Biologics in Bayer Pharma AG. She has over 15 years of experience in the field of high-throughput protein screening and lab automation. With her team she provides robotic and software support to various processes in discovery, optimization, expression and production of biologics. In this function she has been responsible for the automation and data handling for the Cell Line Development group for two years. Before she joined Bayer she was working for two Biotech companies, Direvo Biotech and BioLeads GmbH in the field of high-throughput screening of proteins and natural products. She holds a Ph.D. in Biology from Technical University Munich.

Peer Heine, Ph.D., Field Application Scientist, MaxCyte. Inc.

Dr. Heine studied Neurobiology in Mainz (Germany) and obtained his Ph.D. at the Max-Planck-Institute for Brain Research in Frankfurt am Main (Germany). Following a postdoctoral position at Duke University in North Carolina, Dr. Heine worked for several years at Lonza as a Scientific Product Specialist focused on Transfection. Since 2011, Dr. Heine has been with MaxCyte, Inc., where he serves as the European Field Applications Scientist.

Ian Hodgson, Ph.D., BSc, Head, Molecular Biology, FUJIFILM Diosynth Biotechnologies

Ian Hodgson, Ph.D. heads the Molecular Biology function within R&D for FUJIFILM Diosynth Biotechnologies. He has over 25 years experience in molecular biology and in particular design, construction and testing of protein expression vectors for biopharmaceutical production (eukaryotic and prokaryotic).

Christian Schrøder Kaas, Research Scientist, Mammalian Cell Technology, Novo Nordisk A/S

I completed my Master’s of Engineering in Biotechnology with honours from The Technical University of Denmark in 2012. Currently I am working as an industrial Ph.D. student at the department for Mammalian Cell Technology at Novo Nordisk A/S and the Technical University of Denmark. Mammalian Cell Technology has developed mammalian cell lines to support more than 10 Novo Nordisk projects now in clinical trials for hemostasis or inflammation disorders. My work is a part of a current Novo Nordisk technology development program aiming at -omics approaches for characterisation of CHO cells producing complex proteins like Coagulation Factor VIII.

Yoshimi Kikuchi, Ph.D., Principal Researcher, AJINOMOTO CO., INC.

Dr. Kikuchi obtained his Bachelors, Masters and Doctorate degrees from Tohoku University in Japan. Specializing in the field of Molecular Biology and Applied Microbiology, he joined Ajinomoto in 1988. He started his career working on strain development of various amino acids. He then shifted his work towards protein expression in 1998, leading to the invention of Corynex. He is currently the Principal Researcher and Associate General Manager responsible for R&D of Corynex.

Georg Klima, Executive Director, Process Science Austria, Biopharmaceuticals Division, Boehringer Ingelheim

Georg Klima is Executive Director of Process Science in the Biopharmaceuticals Division at Boehringer Ingelheim RCV in Vienna, Austria. His current responsibilities include host engineering, upstream, downstream, analytical and technology development. Prior to this, he served in various roles in Quality, Validation and Regulatory Affairs. During his time at BI RCV, Georg contributed to the development and registration of 10 biopharmaceuticals. Georg graduated in biotechnology at the University of Applied Life Sciences in Vienna, Austria.

Pierre Moretti, Ph.D., Head of Cell Line Development, Glenmark Pharmaceuticals

Pierre graduated from the Leibniz University in Hanover (Germany) and completed his Ph.D. thesis with a focus on stem cell and cytokine research in the group of Prof. Thomas Scheper. He joined Glenmark Switzerland in 2010 and developed ever since cell line platforms for the expression of NBE such as monoclonal antibodies and new bispecific formats. He is currently Head of Cell Line Development and scientific adviser for Early Upstream Process Development.

Volker Sandig, M.D., Ph.D., CSO, ProBioGen

Volker Sandig initiated ProBioGen’s cell line development program in 2000. Together with his team he has created a leading platform for high-producer CHO cell lines based on sophisticated vectors, proprietary culture media and a set of preselected starter cell lines. He is co-inventor of glycan engineering technologies (GlymaxX). In addition, his work aims at modernising vaccine manufacturing processes through customised design of new cell lines from primary sources that now support a wide range of viruses. Prior to joining ProBioGen, he lead a research group at Merck Research Laboratories, USA, focusing on the development of manufacturing systems for gutless adenoviruses. Using his knowledge of viral vectors, he also participated in Merck’s HIV vaccine program. After finishing medical training, Volker Sandig received his Ph.D. in Molecular Biology from the Humboldt University, Berlin.

Guido Seidel, Ph.D., Managing Director, Operations, Wacker Biotech GmbH

Guido Seidel, Ph.D., is with WACKER since 2007 and he is currently responsible as managing director for the operational departments at Wacker Biotech. Originally trained as fermentation specialist, followed by roughly ten years in bioprocess development at sanofi, he has build-up a broad know how on biopharmaceutical manufacturing processes. Over the last 15 years he developed a strong background in overall and integrated bioprocess development and GMP-production, having experiences from small high throughput systems, GMP production for clinical supply as well as commercial production under GMP in large industrial scales. Therefore he oversees the technology development at WACKER and ensures that the technologies are developed to be applicable throughout the whole pharmaceutical value chains, this means they help clients to be fast in clinics, but they are also robust and reliable to enable products to reach approval phase.

Zhiwei Song, Ph.D., Principal Scientist, Lead PI for GlycoSing Programme, Bioprocessing Technology Institute, A*STAR

Johannes Spehr, Ph.D., Research Scientist, Recombinant Protein Expression, Helmholtz Centre for Infection Research

Johannes Spehr is currently Postdoc at the Helmholtz Centre for Infection Research, Department for Structure and Function of Proteins, in the research group for Recombinant Protein Expression. He studied Biotechnology at the University of Braunschweig where he was working on tissue regeneration using human mesenchymal stem cells for his Diploma thesis. Thereafter, he continued as a Ph.D. student in the field of structural biology in the junior research group Macromolecular Interactions of Christiane Ritter at the Helmholtz Centre for Infection Research. There he was investigating structures and functions of different components of the Curli apparatus of Escherichia coli. Now as a member of the European research project ComplexINC he changed track back to Biotechnology, where he is improving mammalian cell lines for recombinant protein expression. With his expertise he is bridging the gap between the needs of structural biology and protein production.

Marlitt Stech, Ph.D, Research Scientist, Cell-Free Bioproduction, Fraunhofer Institute for Cell Therapy and Immunology (IZI), Branch Bioanalytics and Bioprocesses Potsdam-Golm (IZI-BB)

Marlitt Stech is a postdoctoral scientist working in the Cell-Free Bioproduction Department at the Fraunhofer Institute for Cell Therapy and Immunology (IZI), Branch Bioanalytics and Bioprocesses Potsdam-Golm (IZI-BB), Germany. Her current research is focused on eukaryotic cell-free systems for the synthesis and modification of antibodies and antibody fragments. Marlitt received her Ph.D. at the University of Potsdam. During that time she contributed to the development of novel cell-free protein synthesis systems and formats, cell-free synthesis of single-chain antibody fragments and their functional characterisation. Marlitt graduated in biotechnology at the Beuth University of Applied Sciences in Berlin, Germany.

Gerald Striedner, Ph.D., Assistant Professor, Biotechnology, University of Natural Resources and Life Sciences

Dr. Striedner earned a master’s in Food and Biotechnology and Ph.D. with a focus on bioprocess engineering at the Department of Biotechnology at the University of Life Sciences and Natural Resources (BOKU), with Venia docendi in Bioprocess Engineering. His current position is Assistant Professor at the Department of Biotechnology (BOKU), head of the working group microbial fermentation and principal investigator in the Austrian Center of Industrial Biotechnology (ACIB). The working group has established an integrated systems approach for bioprocess development and is focused on the implementation of PAT and QbD concepts in bioprocessing and rational host cell design. Dr. Striedner is member of the Austrian Association of Molecular Life Sciences and Biotechnology, the European Federation of Biotechnology and the International Society for Pharmaceutical Engineering.

Mark Trautwein, Ph.D., Senior Research Scientist, Cell and Protein Sciences, Bayer HealthCare

I received a diploma in biochemistry from University of Tübingen, Germany, in 2001. A stay at University of Manchester Institute of Science and Technology (UMIST), UK, enabled me to gain experience in mass spectrometric analyses of protein and peptides. My doctoral thesis was concerned with intracellular protein and membrane transport in the yeast Saccharomyces cerevisiae. The deliberate choice of this model system allowed me to comprehensively analyse a cell-biological problem under biochemical, molecular biological and genetic aspects. Benefiting from this longstanding expertise, I was able to extend these works with a focus on post-Golgi secretion in Saccharomyces cerevisiae during my postdoctorate at the Biozentrum in Basel, Switzerland. In 2008, I joined Bayer in the newly founded “Protein Therapeutics” research function as Senior Research Scientist and contributed to establishment and optimisation of transient and stable protein expression in mammalian cells. Since a new organisational setup within “Cell & Protein Sciences”, my technical responsibility also comprises cell line development and novel expression technologies, for both antigen and antibody production. During all that time at Bayer, I have been working as project leader for projects of different degrees of maturity within oncology as well as ophthalmology.

Gang Yin, Ph.D., Principal Scientist, Protein Biochemistry, Sutro Biopharma, Inc.

Dr. Yin has over 10 years of experience in protein and antibody expression, and the development of antibody drug conjugates, bispecifics and vaccines. He has also published multiple peer-reviewed journal articles and patent applications.

Formulation & Stability

Ernesto Freire, Ph.D., Professor, Biology and Biophysics, Johns Hopkins University

Ernesto Freire is the Henry Walters Professor at the Johns Hopkins University. He has been a member of the Department of Biology and Biophysics since 1986. He also holds a joint appointment in the Department of Biophysics and Biophysical Chemistry at the Johns Hopkins Medical School. Dr. Freire obtained his doctorate in Biophysics from the University of Virginia. Dr. Freire is a world recognized expert in biological thermodynamics. He performs research in the thermodynamics of protein stability, protein-protein interactions, and protein-ligand binding. Dr. Freire is the author or co-author of over 250 publications and several patents.

Gesche Graf, Ph.D., Analytical Development Manager, Novaliq GmbH

Gesche Graf obtained her PhD in the field of Biophysical Chemistry working with self-assembled structures at the University Halle-Wittenberg in 2011. Her subsequent Post-Doc at Malmö University focused on developing new methodologies for measuring hydration of proteins. In 2013, she joined Novaliq’s R&D group and is currently leading a team of scientists working on applications of Semifluorinated Alkanes (SFAs) and biopharmaceuticals.

Thomas Hey, Ph.D., Director, Biochemistry, Innovation Center Complex Formulations, Fresenius-Kabi Deutschland GmbH

Thomas Hey is Director Biochemistry at the Innovation Center Complex Formulations at Fresenius Kabi. He received his Ph.D. in biochemistry from the University of Bayreuth, Germany. After working for Scil Proteins (Halle/Germany) on alternative scaffold proteins he joined Fresenius Kabi, where he is now responsible for the bioconjugation activities within the HESylation^® Technology platform.

Vanessa Jully, MSc., Université Catholique de Louvain, Advanced Drug Delivery, GSK

During my master degree in Pharmacy, I had the opportunity to work in the laboratory of Professor Veronique Preat (Université Catholique de Louvain, UCL). Beforethat, I worked during 5 months in the Department of Pharmaceutical Technology INSERM (University of Lille II, France) directed by the Professor Juergen Siepmann. Since two years, I am PhD Student at GSK under a Cooperative Research and Development Agreement with the Université catholique de Louvain. The subject of my thesis is the development of a High-throughput Screening platform for the formulation of aluminium-containing vaccines.

Lisa A. Kueltzo, Ph.D., Staff Scientist, Formulation Development, Vaccine Production Program Laboratory, National Institutes of Health

Dr. Kueltzo received her B.S. in Pharmacy from Purdue University. She obtained her Ph.D. in Pharmaceutical Chemistry at University of Kansas in 2002, under Dr. C. Russell Middaugh, followed by post-doctoral experience under Dr. John Carpenter in the Department of Pharmaceutical Sciences, University of Colorado between 2002 and 2005. Her work focused on the characterization, stabilization and process instability studies of multiple therapeutic proteins and monoclonal antibodies. Following her post-doctoral studies, Dr. Kueltzo led the analytical development efforts at Globeimmune, Inc. in Louisville, Colorado, focusing on immunotherapy approaches to treatment of cancer and infectious disease targets. Dr. Kueltzo currently leads the Formulation Development program at the Vaccine Production Program within the National Institutes for Allergy and Infectious Disease at the NIH. During her time there she has led efforts in early stage formulation of monoclonal antibody, vaccine-like particles and ferritin-nanoparticle based vaccine candidates.

Daniel Lund, Ph.D., Product Manager, Unchained Labs

Dan has over twelve years of experience biophysically characterising diverse, novel protein molecules and in the life science tools industry. For the last seven years he has been involved in the development and marketing of stability characterisation and screening instrumentation and is currently responsible for the UNit, which lets you look at more protein stability parameters than any other tool out there.

Ajit Narang, Ph.D., Principal Scientist, Drug Product Science & Technology, Bristol-Myers Squibb Co.

Ajit Narang works for the Drug Product Science & Technology Department of Bristol-Myers Squibb, Co. (BMS) in New Brunswick, NJ. He is a Principal Scientist involved in the development of oral solid dosage forms of small molecule drugs and parenteral solution dosage forms of antibodies and antibody-drug conjugates (ADCs). He also serves as Adjunct Faculty at the Universities of Tennessee and Phoenix; Industrial Advisory Board member of Western Michigan University; Editor of Bentham Pharmaceutical Journal; and a panel member of the Biopharmaceutics Technical Committee (BTC) of the Pharmaceutical Quality Research Institute (PQRI) in Arlington, VA.

Ajit earned his Ph.D. from the University of Tennessee in Memphis, M.S. from the Banaras Hindu University in India, and B.S. from the University of Delhi in India. He has over 13 years of pharmaceutical industry experience working for BMS, Ranabxy, and Morton Grove Pharmaceuticals in different capacities. Ajit has contributed to several commercialized drug products including ANDAs, 505B2, and NDA. He has published over 40 peer reviewed articles; 2 books; 7 patent applications; 20 invited talks; 60 presentations at various scientific meetings. Ajit is a long standing (>10 yrs) AAPS member and has served the AAPS in different capacities including organization of the open forum for the FDD/PPB section (2014), member of Content Advisory Committee for the AAPS newsmagazine (2012-present), FDD section Focus Group Liaison (2014-present), founding Chair of University of Tennessee Student Chapter (2003), and organization of several sessions at AAPS annual meetings over the years.

Christian Schöneich, Ph.D., Takeru Higuchi Distinguished Professor and Chair, Dept of Pharmaceutical Chemistry, University of Kansas

Dr. Schöneich is the Takeru Higuchi Distinguished Professor and Chair in the Department of Pharmaceutical Chemistry at The University of Kansas. He received his Ph.D. in Chemistry in 1990 from the Technical University Berlin, Germany. Between 1987 and 1991 he worked in the Department of Radiation Chemistry at the Hahn-Meitner Institut in Berlin, Germany. His research focuses on oxidation reactions of peptides and proteins in vivo and in vitro, and their potential consequences for the development of stable protein pharmaceuticals, biological aging and age-related pathologies. He has published > 200 papers in the field of peptide and protein oxidation reactions

Erik Sedlak, Ph.D., Associate Professor, Centre for Interdisciplinary Biosciences and Department of Biochemistry, P.J. Šafárik University in Košice

Erik Sedlák received his Doctorate in Biochemistry at P.J. Šafárik University (UPJŠ) in Košice, Slovakia, in 1998. After several postdoctoral periods at universities in Europe and USA (Universität Bayreuth, Germany with Prof. Mathias Sprinzl; The University of Texas Health Science Center, San Antonio with Prof. Neal C. Robinson; The Rice University, Houston with Prof. Pernilla Wittung-Stafshede; and The University of Zürich with Prof. Andreas Plückthun), he joined Institute of Centre of Interdisciplinary Sciences and Department of Biochemistry of UPJŠ. Presently, he is an associate professor at the Department of Biochemistry at the same university. His research interest is in using display technologies for modifying protein properties, such as stability and solubility, and in the investigation of relations between local/global stabilities and function of proteins and on related questions such as how can be properties of proteins (stability and function) modulated by properties of solvent.

Syed Reza, MD, Ph.D., Director, Business Development, Octoplus NV

Syed Reza is a physician scientist with over ten years Business Development experience in pharmaceutical sciences. Syed has worked on diverse formulation development projects involving peptides, siRNA, proteins and small molecules. Syed is currently the Director of Business Development for OctoPlus N.V specializing in controlled release technologies for injectibles. From 2008 to 2011 he was the Business Development Manager for Hoffmann-LaRoche in Boulder Colorado responsible for developing the contract peptide manufacturing business. Syed has also chaired the Annual Boulder Peptide Symposium since 2009. Syed obtained his MD-PhD from Rutgers University in 2003 and his B.S in Chemistry from The George Washington University in 1993.

Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Dept of Industrial and Physical Pharmcy, Purdue University

Elizabeth M. Topp is Dane O. Kildsig Chair and Head of the Department of Industrial and Physical Pharmacy at Purdue University in West Lafayette, Indiana. She received a bachelor’s degree in chemical engineering from the University of Delaware in 1979 (B.Ch.E.), a master’s in chemical and biochemical engineering from the University of Pennsylvania in 1984 (M.E.) and a Ph.D. in pharmaceutics from the University of Michigan in 1986. Dr. Topp’s research addresses the chemical and physical stability of protein drugs, with particular emphasis on the solid state. She is a Fellow of the American Association of Pharmaceutical Scientists. She recently completed a term as a Committee on Institutional Cooperation Academic Leadership Fellow.

Malgorzata Tracka, Ph.D., Scientist II, Formulation Sciences, MedImmune Ltd.

Malgorzata obtained her MSc degree at University of North Carolina at Charlotte in Dr Joanna Krueger’s biophysical chemistry lab. Her research focused on protein-protein interactions and stability. Then, she worked in pharmaceutical industry where she gained knowledge about small molecules. Currently, she holds Scientist II positon in Formulation Sciences, Medimmune Ltd, UK. Her work focuses on methodologies to aid formulation development of biologics.