DECEMBER 10 | 12pm - 1pm ET

BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, shares scientific insight focused on the bioanalytical strategies for cell and gene therapies. Gene therapies as multi-component therapeutics will be one of the strategies discussed on how they should be implemented and executed. As the industry trends continue to evolve, there are several considerations to be aware of for regulatory guidelines. Dr. McNally would then enjoy the opportunity for a live Q&A session to discuss how BioAgilytix provides a consultive approach to program strategies and support bioanalytical assays for cell and gene therapy programs. 

During the webinar, Dr. McNally shares:

  • An overview of the evolution of therapeutic modalities and the need for more sophisticated bioanalytical assays
  • Industry trends for cell therapy and the applications that your projects should consider in the assay strategy
  • Bioanalytical considerations for CAR-T Therapies

ABOUT THE PRESENTER

Jim McNally, Ph.D. has an extensive background in bioanalytical assay development and program leadership spanning nearly 20 years working in the pharmaceutical and biotechnology industry.

Prior to joining BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics, where he led a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono, and Shire which have given him broad experience in the development of large molecule, gene therapy, and cell therapy biotherapeutics.

Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance.