Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA

Original Air Date: Wednesday, October 2, 2019
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)

Completion of pivotal clinical trials is often viewed as the critical path item to submitting a marketing application to the FDA. Experience has shown that planning your marketing application should come long before completion of the pivotal clinical trials; in fact, investors will demand it. Cato Research advises a serious, methodical re-evaluation of the regulatory, clinical, nonclinical, and chemistry, manufacturing, and controls (CMC) development programs to assess NDA/BLA-readiness long before completion of the pivotal clinical studies. This re-evaluation will allow for early identification of issues and allow for more focused interactions with the FDA.

A panel of CATO regulatory experts will discuss the benefits of a gap analysis as part of the planning process for a marketing application. While every marketing application is unique, specific advice pulled from Cato Research’s experience with marketing applications will be discussed.

This panel includes three of Cato Research’s senior regulatory scientists:

  • Greg Hileman, Ph.D., VP Regulatory Strategy
  • Sheila Plant, Ph.D., MHS, RAC, Director, Regulatory Strategy
  • Michelle Villasmil, Ph.D., RAC, Assistant Director, Regulatory Strategy, Pharmaceutics

Webinar Key benefits for You:

  • Identify a strategic framework for your marketing application
  • Fill gaps while your phase 3 studies are ongoing
  • Avoid late stage critical path issues and submission delays
  • Hear case studies illustrating cost avoidance and time savings

About the Presenters

Greg Hileman, Ph.D.
Vice President, Regulatory Strategy

Dr. Hileman more than 35 years’ research and industrial experience, including 25 years in strategic regulatory affairs. He has led drug development meetings with most FDA divisions and contributed to submission of multiple fast track designation requests, breakthrough therapy designation requests, FDA meeting packages, INDs, NDAs, and BLAs. Dr. Hileman currently leads Cato’s regulatory strategy group and serves as primary FDA contact for multiple sponsors. Dr. Hileman has clinical and product development experience in neurology, psychiatry, oncology, gastroenterology, cardiology and women’s health.

Sheila Plant, Ph.D., MHS, RAC
Director, Regulatory Strategy

Dr. Plant has 16 plus years’ of experience in biomedical sciences, including more than 9 years in clinical research. Her therapeutic areas of experience include dermatology, hematology, neurology, cerebrovascular, cardiovascular, and oncology. She has authored FDA meeting packages, developed regulatory strategies, prepared for and attended multiple face-to-face meetings (including an oncology advisory committee meeting) with the FDA, and managed both IND and NDA submissions. In addition, Dr. Plant has many project-level responsibilities, including writing and reviewing regulatory, clinical, and scientific documents; clinical trial management, pharmaceutical development, and regulatory project management; providing scientific consulting; and assisting with the preparation of business development proposals. She is also responsible for managing the daily operations of the Regulatory Strategy department.

Michelle Villasmil, Ph.D., RAC
Assistant Director, Regulatory Strategy, Pharmaceutics

Dr. Villasmil has more than 16 years’ experience in biological research, with extensive experience in molecular biology, cell biology, and regenerative biology. As a scientist at Cato Research, Dr. Villasmil has many responsibilities, including management of regulatory submissions to the FDA; acting as a regulatory contact for interactions with the FDA; writing and reviewing regulatory, clinical, and scientific documents; assisting with clinical trial management and pharmaceutical development; management of regulatory projects (e.g., INDs, NDAs, BLAs, ANDAs); providing scientific consulting; and assisting with the preparation of strategic development plans. She has gained project experience in therapeutic areas such as infectious diseases, oncology, regenerative medicine, and cardiology. Dr. Villasmil also manages the daily operations of the Cato Research Fellows Department.

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