From Research to Reality: Overcoming CMC Challenges in Cell & Gene Therapy Webinar

Translating a research and development (R&D) asset into a human therapeutic is a high-risk endeavor, often complicated by a variety of development and manufacturing challenges.

Small biopharma companies and academic institutions frequently face significant hurdles in these areas due to limited resources, specialized expertise, and the time required to develop a comprehensive and robust manufacturing process. In this context, crafting a Chemistry, Manufacturing, and Controls (CMC) strategy becomes essential to mitigate risk, proactively identify gaps in process, analytics, and compliance, and prevent costly delays.

This webinar explores the importance of adopting a Quality by Design (QbD) approach in the development process while integrating regulatory and CMC strategies for maximum efficiency and benefit.

 

The session will provide an introduction to:

  • How to develop and define a Target Product Profile (TPP) and Quality Target Product Profile (QTPP), and implement Quality by Design
  • How to build and implement an integrated regulatory and CMC strategy
  • How to develop and implement phase-appropriate Good Manufacturing Practice (GMP) manufacturing processes

About the Speakers

Gregg Nyberg, Ph.D., Chief Technology Officer
Gregg Nyberg, Ph.D., joins Landmark Bio with over 20 years of experience in the biopharmaceutical industry. Most recently, he served as associate vice president at Merck, where he led the biologics process development and clinical manufacturing teams. Prior to that, Dr. Nyberg spent nearly 15 years at Amgen, holding leadership positions in process development, as well as in cell sciences and technology.
Dr. Nyberg holds a Ph.D. in chemical engineering from the Massachusetts Institute of Technology and a B.S. in chemical engineering and petroleum refining from the Colorado School of Mines.

 

Michael Covington, Chief Quality & Regulatory Officer
Michael Covington brings 30 years of expertise in biotechnology, cellular, and gene therapy, with a focus on regulatory affairs, regulatory compliance, quality, validation, and manufacturing. He has successfully supported the development of innovative therapies, including adeno-associated vector (AAV) gene therapies, autologous genetically modified hematopoietic stem and progenitor cell therapies for rare diseases, autologous genetically modified T cell immunotherapies, and recombinant protein therapeutics.
Most recently, Mr. Covington served as the Vice President of Regulatory Chemistry, Manufacturing, and Controls (CMC) at Novartis Gene Therapies. Before that, he was Vice President of Regulatory CMC at Orchard Therapeutics and held leadership roles at Juno Therapeutics, Dendreon, and Amgen. He holds a B.A. in biology, with a focus on cellular and molecular biology, from the University of Missouri-Columbia.