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

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.

Dr. Plant has 16 plus years’ 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.

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.