William E. Gannon, Jr., M.D.
Chief Scientific Officer & Medical Director
Dr. Gannon has acquired extensive experience in the management of clinical trials including designing the trials and building operational teams to ensure their successful completion. Additionally, Dr. gannon has matching expertise in the regulatory arena, both U.S. and International, with over twenty years experience in filings, meetings, submissions and approvals.
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- Download Oncology Experience
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ARTICLES AND PRESENTATIONS:
Medical Consulting Services:
Pre-clinical and clinical program development, operations management and recruiting.
CAPABILITIES INCLUDES:
- Strategic Planning (Corporate, Clinical, & Regulatory)
- Protocol Design (Phases I – IV – Drugs, Biologics and Devices)
- Medical & Safety Monitoring
- Medical Affairs (Post-Mktg) Program Development & Copy Review (DDMAC Compliance)
- Regulatory Affairs - FDA & EU expertise (pre-IND, IND, IDE, BLA, 510k, PMA – filing, reporting and associated processes)
- Operations Management
- Team Assessment & Building
- Medical Writing
- GCP Auditing and Compliance
- DSMB Committee Formation or participating member
- IBC Committee Formation or participating member
- IRB Committee member
Areas of Clinical Trial/Development Experience:
THERAPEUTIC CATEGORIES:
- Oncology
- Gene Therapy
- Vaccines
- Medical Devices
- OB/GYN
- GI
- GU
- Women’s Health
- Intranasal Drug Delivery
- Cardiac
- Neuro / CNS
- Pediatrics
- Nanotechnology Applications