10:00 am - 1:00 pm
(SC3) PROGRAM MANAGEMENT FOR SCIENTISTS
Congratulations! You have been promoted to Program Manager. Now what? Can your bench-top scientific experience in proteins - expression, characterization, development of protein-based therapeutics, bioprocessing, etc. - lead to success in people/business management? Most scientists train for years in their prospective fields but must learn business management “on-the-fly.” This course is designed for scientists who have recently been promoted to program/product manager or are planning ahead.
Course Instructor:
 Patricia Seymour, M.B.A., Senior Consultant, BioProcess Technology Consultants
Patricia Seymour has over 20 years of experience in the biotechnology industry. Her expertise spans the development and commercialization spectrum, including biologics and small molecule development and manufacturing, supply chain strategy and management and operations leadership. Her current activities include: developing overall CMC strategies for diverse product pipelines, developing and implementing outsourcing strategies, managing outsourced process development and manufacturing activities from drug substances through to distribution, steering clients through CMC regulatory requirements and overall CMC operations including project management and budgeting. Prior to joining BioProcess Technology Consultants, Ms. Seymour was Senior Director, Global Investigational Supply Operations at Millennium Pharmaceuticals, Inc., where she worked with other senior leaders to develop and implement CMC strategies including outsourcing. She was previously Director of Business Development at Covance Biotechnology Services (now Diosynth) where her responsibilities included negotiating contact manufacturing projects. As Senior Director, Corporate Development at Collaborative BioAlliance she was instrumental in launching the new contract manufacturing business unit. Before Collaborative, Ms. Seymour held research and development positions at ImmunoGen, Dana Farber and Sloan Kettering. Ms. Seymour received her B.S. from Villanova University and her M.B.A. from Boston University. Ms. Seymour is Certified Supply Chain Professional (APICS).
2:00-5:00pm
(SC5) ANTIBODY-DRUG CONJUGATES
Moderator:
Pamela A. Trail, Ph.D., Vice President, Oncology, MedImmune, Inc.
- Linker technology and drug characteristics
- Site-specific antibody modifications
- Use of alternative scaffolds for delivery
- Recent clinical proof of concept data
2:00 Introduction and Opening Comments
Pamela A. Trail, Ph.D., Vice President, Oncology, MedImmune, Inc.
2:15 Antibody-Drug Conjugates: Technology Advances in Linkers and Cytotoxic Agents
Ravi V.J. Chari, Ph.D., Exective Director, Chemistry & Biochemistry, ImmunoGen, Inc.
Multiple antibody-drug conjugates (ADCs) made with ImmunoGen’s tubulin interacting maytansinoid cell killing agents are undergoing clinical evaluation. ImmunoGen has developed approaches to tailor the design of each maytansinoid conjugate to achieve the best performance for the specific cancer target. My talk will discuss ImmunoGen’s technology and also highlight advances in linker design and new effector molecules for use in ADCs.
3:00 Cysteine Engineered Antibodies for Site-Specific Antibody-Drug Conjugates
Changshou Gao, Ph.D., Principal Scientist, Antibody Discovery & Protein Engineering, MedImmune
Significant progress has been made most recently in using recombinant strategies to generate antibody-drug conjugates with predetermined sites and stoichiometries for drug attachment. Here, I discuss our recent effort in cysteine engineered antibodies with reactive thiol groups for site-specific labeling in order to improve conjugation efficiency and product homogeneity.
Changshou Gao, Nazzareno Dimasi, and Herren Wu.
3:45 Refreshment Break
4:00 Antibody-Drug Conjugates Targeting the Tumor Neo-Vasculature
Dario Neri, Ph.D., Professor, Chemistry & Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zürich
In collaboration with Philogen (www.philogen.com), my laboratory has developed seven antibody derivatives which are currently being investigated in Phase I and Phase II clinical trials.
In this lecture, I will present preclinical data on antibody-drug conjugates, which selectively target the tumor neo-vasculature with residence times of weeks and which release potent drugs at the site of disease without the need for antibody internalization.
4:30 Safety Assessment of Antibody Drug Conjugates
Kirsten Achilles Poon, Senior Toxicology Research Associate, Development Sciences Safety Assessment, Genentech, Inc.
Antibody drug conjugates (ADCs), or immunoconjugates, are hybrid molecules usually comprised of monoclonal antibodies conjugated with potent cytotoxins that are being developed for the treatment of a variety of cancers. Since ADCs contain both biologic and small molecule components, standard approaches for pre-clinical safety evaluation for either component may not be
appropriate or adequate and regulatory expectations are not well defined. This presentation will highlight safety assessment challenges, development strategies and case examples of the toxicology associated with certain ADCs.
5:00 Close of Short Course
*Separate Registration Required
|