Thursday, September 15, 2022
1:00–2:00 PM ET
Arnold & Porter and Lachman Consultants
Register
Cell and gene therapies provide tremendous hope to patients and their healthcare providers in curing and mitigating serious, often previously incurable, diseases and conditions. Because these products are complex, novel, and derived from biological sources, the manufacture of these products creates unique challenges throughout product development and commercialization.
In this webinar, Arnold & Porter attorneys and experts from Lachman Consultants will discuss current GMP requirements, FDA inspections, manufacturing challenges, quality agreements, and other practical considerations for cell and gene therapy products. Our speakers will address these matters, from product development through commercialization, and highlight real-world scenarios and best practices based on their experience. They will also cover challenges, concepts, and approaches to compliant manufacture of other novel biopharmaceuticals.
Speakers
Howard Sklamberg, Partner, Life Sciences and
Healthcare Regulatory, Arnold & Porter
Phillip V. DeFedele, Senior Associate, Life
Sciences and Healthcare Regulatory, Arnold & Porter
John McShane, Vice President, Biologics and
Manufacturing Data Integrity, Lachman Consultant Services,
Inc.
Keith A. Lamb, Executive Director, Lachman
Consultant Services, Inc.