CATO SMS Appoints Vice President of Regulatory Strategy Cell and Gene Therapy

SEPTEMBER 30, 2021

CARY, N.C., September 30, 2021– CATO SMSa global provider of specialized clinical research solutions, announced today the appointment of Jessica Lee, M.D., Ph.D., as vice president, Regulatory Strategy, Cell and Gene Therapy. A board-certified oncologist and regulatory expert, Dr. Lee brings to CATO SMS nearly 20 years of clinical practice and health authority experience. 

Dr. Lee joins CATO SMS from AstraZeneca where she was a medical director responsible for medical monitoring and assessment of safety-related issues throughout the life cycle of immuno-oncology products. Highlights of Dr. Lee’s previous experience include:

  • serving as senior physician and acting team lead at the Oncology Branch within the Office of Tissues and Advanced Therapies at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)  
  • serving as a consulting physician at the Office of In Vitro Diagnostics and Radiological Health within the Center for Devices and Radiological Health (CDRH), FDA
  • acting as the primary clinical reviewer for more than 120 active investigational new drug applications (INDs) at CBER
  • evaluating clinical safety and efficacy as a clinical consulting physician for a variety of medical devices through different developmental stages at CDRH
  • serving as oncology director at Atlantic General Hospital and spearheading a new center for cancer treatment
  • providing treatment and follow-up care to oncology patients as an attending physician at major hospitals within the United States
  • publishing research papers and articles in scientific journals and presenting scientific abstracts at academic and industry society meetings

 “Dr. Lee brings to our team a unique blend of extensive clinical and regulatory experience,” said Mark A. Goldberg, M.D., executive chairman, CATO SMS. “Dr. Lee’s background working as a senior regulator and as a physician caring for patients will provide invaluable perspective and guidance to our small and emerging biopharmaceutical clients who are focused on developing cell and gene therapies for the treatment of cancer.”

Dr. Lee earned her doctorate in neuroscience from Johns Hopkins University School of Medicine in Baltimore. She earned her doctor of medicine degree from the National Yang-Ming University School of Medicine in Taipei, Taiwan.

CATO SMS is a provider of specialized clinical research solutions including regulatory consulting, clinical pharmacology, clinical trial operations and biometrics. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies — from strategy to approval ⁠— in complex indications and modalities across a variety of therapeutic areas with a proven center of excellence in oncology. CATO SMS’ regulatory, therapeutic and operational expertise enables the company to meet goals and exceed expectations. Visit for more information.

Patty Collinsworth

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