Cambridge Healthtech Institute’s Inaugural
ADC Development and Manufacturing
Strategies for the Safe and Efficient Production of ADCs
Part of the Tenth Annual PEGS: the essential protein engineering summit
May 7-8, 2014| Seaport World Trade Center | Boston, MA
Developing and producing highly potent small molecules conjugated with monoclonal antibodies presents a host of challenges ranging from chemistry to analytics, processing to formulation. Advanced analytics and ADC-specific assays are required for batch comparability and toxicity detection; process optimization and scaling-up are critical to ensure a smooth transition from clinical to commercial phase, while dosage and formulation hold the key to patient safety and efficacy. This conference offers a platform for scientists and engineers to share creative strategies to overcome the production challenges of ADCs from early development to commercial phase.
Process Development and Scale-Up Strategy from Early Phase Development to Commercial
Nitya G. Ray, Ph.D., Senior Vice President, Manufacturing, Process Sciences/Manufacturing, Progenics Pharmaceuticals, Inc.
Development and Manufacture of ADCs – The Seattle Genetics Perspective
Nathan C. Ihle, Ph.D., Executive Director, CMC Strategy & Management, Seattle Genetics, Inc.
Antibody-Drug Conjugates: Challenges and Critical Considerations for Developing Early-Phase Clinical Manufacturing Processes
Marie M. Zhu, Ph.D., Director, Process Sciences, Technical Operations, Agensys, Inc. (an affiliate of Astellas, Inc.)
Effective Manufacturing of Antibody-Drug Conjugates
Aad van de Leur, MSc, COO, Biopharmaceutical Development, Synthon Biopharmaceuticals B.V.
Next-Generation Antibody-Drug Conjugates Designed with Fleximer Platforms Enable High Drug-Loading (DAR >15) of Payloads with Excellent Biochemical Properties and Pharmacokinetics and Potent Anti-Tumor Activity
Peter U. Park, Ph.D., Vice President, Biology, Mersana Therapeutics, Inc.
Addressing Tumor Heterogeneity and Resistance: Production of Homogeneous Multispecific ADCs with Combination Warheads
Trevor Hallam, Ph.D., CSO, Sutro Biopharma
Optimizing ADC Development Using PK/PD Modeling and Simulation
Dhaval K. Shah, Ph.D., Assistant Professor, Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, SUNY Buffalo
Pfizer Case Study of ADC Formulation and Process Optimization
Shannon MacMillan, MSc, Principal Scientist, Biotherapeutic Pharmaceutical Sciences R&D, Pfizer, Inc.
Analytical Challenges in Characterization of Heterogeneities of Antibody-Drug Conjugates: A Case Study
April Xu, Ph.D., Senior Principal Scientist, BioBtx-ARD, Pfizer
Considerations about Analytical Methods Used for the Measurement of the Level of Unconjugated Antibody (UmAb) Present in Maytansinoid ADCs
Alex Lazar, Ph.D., Head, Analytical and Pharmaceutical Sciences, Immunogen, Inc.
Strategies and Challenges in Bioassay Development for ADCs
Debra M. Meyer, BSc, Senior Principal Scientist, Analytical R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.
Challenges of Outsourcing ADCs— Perspectives from the Client
Deborah Meshulam, Director, Contract Manufacturing, ImmunoGen, Inc.
Establishing a Fully Outsourced Supply Chain for an ADC
Jesper Valbjørn, Vice President, CMC Operations, Genmab
PEGS is the leading protein and antibody engineering conference worldwide. The conference covers all scientific aspects from design and engineering to final product characterization. I come to PEGS every year as often talks are about new and exciting work that has never been shown before."
Antibody Engineering, Biologics Research, Glenmark Pharmaceuticals S.A.