Cambridge Healthtech Institute’s 4th Annual

Optimization and Development of Biologics
3-4 November 2014


This track focuses on refinement of biotherapeutics for use in preclinical tox studies and further down the line in clinical development and ultimately for the marketed product. Research with industry experts reveals a huge concern for controlling half-life and stability, and for avoidance of aggregation and immunogenicity. Moreover, the wide range of therapeutic areas being addressed calls for unique delivery approaches. Manufacturability with good yields of potent and consistent batches is another important goal. This track will include all of these topics as well as reports from the pioneers in preclinical and clinical development.

 

 

I am looking for in-depth case studies on the following: 

1. Optimization of product properties such as potency, stability and half-life 

2. Measures to avoid aggregation and immunogenicity 

3. Engineering for special delivery. For example: nebulizers; sub-cutaneous delivery; sustained release, and/or for overcoming dose limitations

4. Optimization of manufacturability. For example: yield and purity; control of glycosylation; avoidance of bridging studies after scale-up

5. Preclinical development. For example: Development of suitable animal models; reports on IND enabling studies; case studies on specific products; risk assessment from a developability point of view; PKPD and tox studies

6. Clinical development. For example: Strategies for entering the clinic; proof-of-concept studies; dose and efficacy data; how preclinical predictive studies translate in the clinic

 

If you would like to submit a proposal to give a presentation at this meeting, please click here.

 

 

Deadline for submission is 21 March 2014 

 

 

 All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.  


For more details on the coference, please contact: 

Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489
Email: nlyscom@healthtech.com 

 

For exhibit & sponsorship opportunities, please contact: 

Carol Dinerstein
Director, Business Development
Cambridge Healthtech Institute
Tel: 1 781-972-5471
Email: dinerstein@healthtech.com