FDA Manufacturing Compliance and Inspections for Cell and Gene Therapies and Other Innovative Biologics

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.