Regenerative cell and gene therapies (or Advanced Therapy Medicinal Products) have recently undergone some spectacular clinical successes and offer potential to significantly redefine medical treatments. However, with diverse and evolving regulatory expectations, researchers are often left to interpret a myriad of guidelines and develop studies on a case-by-case basis for IND/IMPD submissions.
In mid-March, Brian McIntosh, Study Director for Safety Assessment, and Paul Byrne, Lead Scientist for Cell and Gene Therapy at Covance will speak during the Society of Toxicology (SOT) meeting. Brian and Paul will discuss the regulatory considerations surrounding IND/IMPD submissions for regenerative therapies and how those align to the early development of individual cell or gene products.
In this session, Covance will bring its multidisciplinary expertise to bear on this exciting and challenging field. Our leaders in cell and gene therapy will discuss the regulatory considerations surrounding IND/IMPD submissions for regenerative therapies and explore how those must fit the scientific need of individual cell or gene products.
The session will highlight the analytical support--nonclinical and Chemistry, Manufacturing, and Controls (CMC)—that Covance provides for our client’s cell and gene products. Brian and Paul will also discuss the validation considerations for the nonclinical biodistribution studies and present the CMC requirements for various cell and gene therapies, including details of phase appropriate validation plans.
Covance Session Presenters
Brian McIntosh - Study Director, Safety Assessment. Brian is a member of Covance’s Advanced Therapies Drug and Device Development Group, with overall responsibility for the scientific and technical conduct of the company’s nonclinical safety assessment studies. With more than 20 years of experience in laboratory research, Brian is an expert in regenerative biology and the development of cellular, gene and regenerative therapies. He is also the author or co-author of more than a dozen professional journal articles and conference presentations.
Paul Byrne - Lead Scientist, Cell and Gene Therapy. Paul has over 20 years’ experience in the CRO industry and has worked at various levels of Covance, including Study Director and Head of Molecular Biology. He currently focuses on the analytical support required for Cell and Gene Therapy molecules within the preclinical, CMC and clinical testing areas.
Covance Exhibitor-Hosted Session Details
“Nonclinical Development Considerations for Cell and Gene Therapies”
12:00pm - 1:00pm, Monday March 11, CC Room 340
About the SOT Conference
March 10-14, 2019
The SOT conference is expected to bring 6,000+ scientists from 50 countries together to learn about the latest advances in toxicology research. The full SOT program includes over 100 featured and scientific sessions, and as well as more than 2,100 individual presentations.
Covance is an exhibitor at the accompanying ToxExpo 2019 at booth 4015. Come visit us at the Expo or attend our exhibitor-hosted session!