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).
(SC4) ESSENTIAL CONSIDERATIONS FOR DEVELOPMENT OF ANTIBODY-BASED THERAPEUTICS FROM DISCOVERY TO THE CLINIC
The biologics market continues to witness an impressive rate of growth, and the Antibody-Based Therapeutics (ABTs) market in particular has contributed remarkably to the expansion of this segment within the pharmaceutical industry. ABTs exhibit exclusive specificity for the target antigen they recognize. This unique characteristic discriminates ABTs from other therapeutic modalities such as small molecule drugs. Successful strategies for development of ABTs require integration of relevant knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, pharmacokinetic (PK)-pharmacodynamic (PD) properties, biophysical characterization and antibody cross-reactivity across species from the early stages of antibody development. This introductory course will evaluate critical considerations necessary for effective development of ABTs.
• This introductory course will evaluate critical considerations necessary for effective development of ABTs
• Integration of relevant knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, pharmacokinetic (PK)-pharmacodynamic (PD) properties, biophysical characterization and antibody cross-reactivity across species from the early stages of antibody development
• Key learnings will include: Considerations for target selection, screening and preclinical development; Affinity and biophysical characterization; Translational Considerations
Course Instructors:
Mohammad Tabrizi, Ph.D., Vice President, Preclinical Development, AnaptysBio, Inc.
Gadi Bornstein, Ph.D., Principal Scientist, AstraZeneca R&D
Scott Klakamp, Ph.D., Research Fellow, Biophysical Chemistry and Bioinformatics, Takeda
AGENDA
10:00 - 10:05 Introduction
Mohammad Tabrizi, Ph.D., Vice President, Preclinical Development, AnaptysBio, Inc.
10:05 - 10:55 Considerations for Target Selection, Screening and Preclinical Development
Gadi Bornstein, Ph.D., Principal Scientist, AstraZeneca R&D
10:55 - 11:05 Networking Coffee Break
11:05 - 12:00 Affinity and Biophysical Characterization
Scott Klakamp, Ph.D., Research Fellow, Biophysical Chemistry and Bioinformatics, Takeda
12:00 - 12:50 Translational Considerations
Mohammad Tabrizi, Ph.D., Vice President, Preclinical Development, AnaptysBio, Inc.
12:50 - 1:00 Q&A
*Separate Registration Required
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