VISIT CONTRACT PHARMA AT #1115

Cell and Gene Therapy Landscape

11.12.19

Heather Myler of PPD provides current insight into the growing field of Cell and Gene Therapies



Heather Myler, Ph.D. of PPD participated in several workshops at AAPS PharmSci360 providing an overview of the Cell and Gene Therapy Landscape, as well as Best Practices and Bioanalytical Strategies for Cell and Gene Therapies including:
  • Key bioanalytical and biomarker strategies and best practices to support cell and gene therapy drug development
  • Regulatory perspectives
  • Insight into the technical challenges related to the "new" technologies used to support cell and gene therapy
  • Designing and executing bioanalytical strategies in support of cell and gene therapy drug development


Heather Myler, Ph.D.
Heather Myler, Ph.D., currently serves as the director of R&D, immunochemistry at PPD Laboratories leading a group of scientists responsible for PK, biomarker, ADA and neutralizing antibody bioanalytical method development, tech transfer, validation and automation supporting biosimilars and novel biologics. Heather has a strong external scientific presence, currently serving as past-chair of the Bioanalytical Community within AAPS and actively participating on multiple bioanalytical and cross-functional initiatives. Specifically, Heather is currently leading a team focused on the harmonization of ADA validation testing and reporting, comprised of more than 30 KOLs from across industry and various health authority agencies with a strong FDA presence.