DAY 1:
13:30 - 18:20 Training Seminars in Session
18:20 - 19:30 Welcome Reception (Rio Pavilion)
DAY 2:
8:30 - 18:30 Training Seminars in Session
12:45 Lunch Provided
Refreshment breaks and exhibit hall viewing hours also provided.
TS7A: Intro to Bispecifics: History, Engineering, and Applications
Room 5B
Regis Cebe, MSc, Scientific Technical Leader, Novartic Biologic Center, NIBR, Novartis Pharma AG, Switzerland
Rakesh Dixit, PhD, DABT, President & CEO, Bionavigen
Intro to Bispecifics will be organized as an informative and practical guide to get up to speed on critical aspects of bispecific antibody therapeutics. Topics will include historical successes, failures, and lessons learned. Specific practical instruction
will span mechanisms of action, engineering, developability, regulatory considerations, and translational guidelines. Perspectives on ideal implementation of bispecifics as targeted and immunomodulatory approaches will be discussed.
DAY 1:
13:30 – 15:45 Training in Sessions
History and Making of Bispecific Antibodies
Regis Cebe, MSc, Scientific Technical Leader, Novartis Biologic Center, NIBR, Novartis Pharma AG, Switzerland
This first session will include an introduction on therapeutic antibody engineering to get everyone up to speed on challenges inherent to bispecific antibodies.
We will then focus on:
- Brief history of bispecific antibodies: more than 50 years of progress, from the first concept to a collection of over 100 formats known today.
- Engineering bispecific antibodies: strategies to design of bispecific antibodies and overview of available platforms.
15:45 – 16:15 Refreshment break (Foyer D)
16:15 – 18:20 Training in Sessions
Modes of action and applications of Bispecific Antibodies
Regis Cebe, MSc, Scientific Technical Leader, Novartis Biologic Center, NIBR, Novartis Pharma AG, Switzerland.
In this session we will review main modalities described for bispecific antibodies. Combinatorial versus obligate concepts will be discussed.
Examples of mechanisms of action we will cover:
- Engaging two cells by cross-linking
- Binding two different targets on one cell
- Binding two different epitopes on a protein target
- Piggybacking
- Neutralizing two soluble ligands
18:20 – 19:30 Welcome Reception (Rio Pavilion)
End of day
DAY 2:
7:45 – 8:30 Morning Coffee (Foyer D)
8:30 – 10:35 Training in Sessions
Preclinical Safety, Pharmacology, PK-PD, Translational Sciences and Early Clinical Development Consideration for Bispecific Oncology Biologics Development
Rakesh Dixit, Ph.D., DABT; President & CEO, Bionavigen, LLC; Chief Scientific Officer, SenecaTherapeutics
- Selection of targets and formats for bispecific development
- Consideration for selecting full antibody, BiTE0-like molecules, bispecific CAR-T, bispecific-TCRs, bispecific ADC
10:35 – 11:15 Coffee Break (Rio Pavilion)
11:15 – 12:45 Attending concurrent conference tracks
12:45 – 13:45 Lunch Provided
13:45 – 14:15 Dessert Break (Rio Pavilion)
14:15 – 16:20 Training in Sessions
Preclinical Safety, Pharmacology, PK-PD, Translational Sciences and Early Clinical Development Consideration for Bispecific Oncology Biologics Development
Rakesh Dixit, Ph.D., DABT; President & CEO, Bionavigen, LLC; Chief Scientific Officer, Seneca Therapeutics
- FDA's Guidance on bispecific nonclinical and clinical development
- Nonclinical safety, PK-PD strategies for bispecfics
- Translational strategies for early clinical development of bispecific
- Clinical experience in the development of bispecifics
16:20 – 17:00 Refreshment Break and End of Training Seminar (Rio Pavilion)
Meet the Instructors:
Regis
Cebe, MSc, Scientific Technical Leader, Novartic Biologic Center, NIBR, Novartis Pharma AG, Switzerland
During the past 19 years, I have worked on protein engineering and protein production at the Novartis Institutes for BioMedical Research. What motivates me is applying science and creativity to design proteins with desired properties. I got my first degree
from the POLYTECH school of Engineering in Marseille. Attracted by the concepts of protein evolution, I joined Pr. Andreas Pluecthun group at the University of Zurich for one-year postgraduate. I started to apply these principles of molecular evolution
at Novartis for production of tool proteins used for structural analysis. Finally I moved to our Biologic Center and could focus on the engineering of therapeutic proteins. I was first involved in the optimization of mAb for better activity and developability
before to concentrate on multispecific modalities. Over past year, I contributed to the development of a technology platform that enables efficient discovery, engineering and production of several bispecific formats.
Rakesh Dixit, PhD, DABT, President & CEO, Bionavigen
Dr. Dixit is currently the President and CEO of Bionavigen. He conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University
of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. In August 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics
Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In this position as a Vice President of R &D since 2010, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical
toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops
in national and international meetings. Rakesh is one of the most invited speakers in the biotechnology industry. Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small
molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh is a recognized expert
in safety and pharmacology biomarkers and their applications. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was
selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National
Academy of Sciences and US National Institutes of Health, including National Cancer Institute.
Training Seminar Information
Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment
breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the
seminar, but after these have been distributed, no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars
are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.
