Capital City Technical Consulting

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.

• Download Resume
• Download Bio
• Download Oncology Experience
• Download CNS Experience
• Download Safety Experience
• Download Medical Device Experience
• Download Imaging Experience
• Download Allergy Experience
• Download Vaccine Clinical Regulatory Experience
• Download Phase I Experience
• Download Clinical/Regulatory Experience
• Download Summary of DDMAC/OPDP Experience

ARTICLES AND PRESENTATIONS:

• White Paper: Needle-Free Jet Injection in Workplace Influenza Clinics
• White Paper: Use of Needle-free Jet Injection Technology Can Increase Immunization Coverage in Workplace Health Influenza Clinics - Addressing an Unmet Need for Workplace Health Influenza Immunizations
• The Value of EDC in Early-stage Clinical Trials
• Phase I and Pharmacokinetic Studies of CYT-6091, a Novel PEGylated Colloidal Gold-rhTNF Nanomedicine
   

Medical Consulting Services:

Pre-clinical and clinical program development, operations management and recruiting.

CAPABILITIES INCLUDE:

• 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 501 (6)2 – filing, reporting and associated processes
• Clinical and General 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
• Promotional Materials(s) Review Committee (PRC) Formation or Member of

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