More and more therapeutic biological drug candidates are entering into preclinical drug development programs. The preclinical development of biological drug candidates requires an approach and expertise that is different than that used for the development of small molecules. This three-day track will focus on the interdisciplinary preclinical development of biologic drug candidates.  

Topics which may be included are:

• Proof of concept/pharmacology 

• Toxicology

• Immunogenicity

• Pharmacokinetics/pharmacodynamics

• Selecting the appropriate animal models 

• Surrogate animal models - When are they necessary?

• Translation of animal data to pick the first in man dose

• Development and validation of bioanalytical assays, .e.g., activity assays, immunogenicity assays 

• Prelinical work that continues during the clinical program to support registration

• Regulatory guidance and challenges

• Available tools and technology which can add value to preclinical studies

• Case studies which demonstrate an interdisciplinary approach to preclinical development 

Researchers (discovery and preclinical development) and regulatory affair specialists involved in the evaluation and development of biological drug candidates are encouraged to submit a title and a short 3-5 sentence abstract of your experience/data that may be suitable for this conference. 

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program.

Please click here to submit your proposal. 

The deadline for submission is August 15, 2008. 

For more information, please contact:
Leslie C. Lilly, BSN, RN 
Conference Director
Cambridge Healthtech Institute
250 First Avenue, Suite #300
Needham, MA 02494
Phone: 978 371 5942
Fax: 781-972-5425
email: llilly@healthtech.com 

For sales information, contact:
Carol Dinerstein
Tel: 781-972-5471 
email: Dinerstein@healthtech.com