Destination BLA, First Stop IND! Considerations for Designing Your Gene Therapy Preclinical and CMC Development Strategies

Speakers

Key Opinion Leader: Ashley Winslow, Ph.D., President & Chief Scientific Officer, Odylia Therapeutics

Ashley Winslow is President and Chief Scientific Officer of Odylia Therapeutics, a nonprofit biotech focused on developing gene therapies for rare diseases. Odylia develops therapeutics in collaboration with patient groups and a strategic network of CROs, academic partners, and industry to bring life-changing therapeutics to patients.

Ashley received her PhD in Medical Genetics from the University of Cambridge and completed her postdoctoral work at Massachusetts General Hospital and Harvard Medical School. Before joining Odylia, Ashley worked in the Precision Medicine and Human Genetics and Computational Biomedicine group at Pfizer and the Orphan Disease Center at the University of Pennsylvania. She has experience overseeing drug development from target discovery to early-phase clinical programs. She brings to Odylia more than 15 years of drug development experience in academic, industry, and non-profit sectors. Ashley serves on the International Angelman Syndrome Research Council (INSYNC-AS), CHAMP1 Scientific Advisory Board, and the RARE-X/ Global Genes Scientific Advisory Board.

Vibhor Gupta, Ph.D., Director – CGT Business Operations at Pharmaron

Vibhor Gupta, Ph.D., is the Director of Business Operations at Pharmaron, and has supported Cell & Gene Therapy services since August 2018. Dr. Gupta completed his Ph.D. in Biochemistry and Oncology at Jawaharlal Nehru University, New India, in 2010. He moved to the United States in early 2011 to pursue his postdoctoral fellowship at the University of Pennsylvania-Philadelphia. While working at Greenberg laboratory, Dr. Gupta focused his research on Autoimmune diseases and inflammatory responses. In 2016, Dr. Gupta joined the Gene Therapy Program as a Senior Research Investigator and Regulatory Writer at the University of Pennsylvania. Working closely with Prof. James M. Wilson, Dr. Gupta contributed to several Cell & Gene Therapy projects and drafted several INDs for the FDA. During his research career, Dr. Gupta has experienced numerous molecular biology techniques, developed biochemical assays, published more than ten manuscripts/review articles and presented his work worldwide in diverse fields of life sciences including Metabolism, Oncology, Autoimmune diseases, and Cell & Gene Therapy.

Linda Randall, Ph.D., Associate Vice President, Biologics Development, Manufacturing and Control at Pharmaron Gene Therapy

Linda and her team support their clients by developing and manufacturing gene therapy products. Linda established and grew the gene therapy capabilities at the Pharmaron UK site and, since 2016, has been actively engaged in the CMC development of these products, with a career highlight leading the development and clinical supply of a CRISPR gene editing product for retinal disease. Linda is passionate about forming strong collaborative relationships to support product development and innovation in this field.  In addition to her 15 years in senior roles in biologics development, Linda has held senior roles in drug product formulation and pharma manufacturing.  She has a PhD in chemistry and is a fellow of the Royal Society of Chemistry.

Moderated by:

Vatsala Naageshwaran, Ph.D., Vice President, Head of Business Development, US Lab Services and CGT, Pharmaron