NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Theresa L. Gerrard, PhD

Practice Area Focus

  • Biosimilars
  • Biologics
  • Therapeutic Proteins
  • Development Strategy
  • Immunogenicity
  • CMC

Biography

Theresa Gerrard joined NDA Partners as an Expert Consultant in 2013. Dr. Gerrard is an expert in the area of biologics and biosimilars. She was the Director of FDA’s Division of Cytokine Biology (now called the Division of Therapeutic Proteins) for over 10 years and was an executive at Amgen Inc., responsible for oversight of clinical, regulatory, and product development for several recombinant protein products for rheumatoid arthritis, hepatitis C, and oncology.

Since 1998, Dr. Gerrard has provided independent consulting for sponsors in product development strategy from discovery research through phase IV. She has led teams in clinical development in the field of immunogenicity of therapeutic proteins. Her work has included preparation for meetings with the FDA, providing assistance with IND and NDA/BLA submissions, management of CMC issues for protein therapeutics, and planning for scale up and manufacturing changes for protein therapeutics.

Dr. Gerrard is the author of numerous publications in the science of biologics and related fields, and has presented lectures and participated in discussion panels for many organizations and conferences such as the Drug Information Association and the FDA.