CLINICAL TRIAL DESIGN & OVERSIGHT, MEDICAL MONITORING
- 19 years of experience in pharmaceutical industry; 10 years in medicine and laboratories.
CMO; Protocol Design and Writing; Medical Monitoring; Clinical Trials Phases 1-4; Clinical R&D/Operations Oversight; Data Analysis; Safety/Pharmacovigilance Assessments; Medical Affairs; Medical Writing – Clinical Study Reports, Regulatory Documents (NDA), IND Updates, Safety Reports, Investigator Brochures, Abstracts, Posters, and Publications; Budgeting and Resource Allocation; KOL Recruitment and Liaison; Pipeline Strategy; Business Development; Presentation Support. Medical Areas of Expertise: Infectious Diseases and Internal Medicine.
MD from John Hopkins University School of Medicine; has authored 29 publications and 45 abstracts.
Villano Consulting Services
Clinical consulting to the pharmaceutical industry, focusing on clinical protocol design and writing; medical monitoring; data analysis; safety/pharmacovigilance assessments; writing of clinical study reports, clinical summaries and other regulatory documents; and clinical presentations (abstracts, posters, and publications).
Vice President, Clinical and Medical Affairs, Paratek Pharmaceuticals
Medical oversight of clinical studies for lead antibacterial omadacycline, including integration of clinical data from new and legacy studies. Responsible for medical support: contract medical monitoring and pharmacovigilance. Medical Affairs responsibility for planning publications and presentations, writing abstracts and manuscripts for clinical data, identifying and interfacing with key opinion leaders, and planning for commercial positioning of the lead compound. Clinical/regulatory review of Business Development opportunities, both internal pipeline and external opportunities.
Vice President, Clinical Research & Development and Business Development, ViroPharma Incorporated (subsequently acquired by Shire Pharmaceuticals)
Led clinical R&D activities for all projects, Phases 1, 2, 3, and 4. Major programs included the development of compounds directed against hepatitis C virus (HCV), cytomegalovirus (CMV), and Clostridium difficile; clinical support of the marketed products Vancocin (oral vancomycin) and Cinryze (C1 inhibitor for treatment of hereditary angioedema); and major contribution to a CTD for Cinryze, resulting in European Marketing Authorization for Cinryze in three different indications. Responsible for all medial oversight of clinical studies, drug safety/pharmacovigilance, and medical writing, with extensive involvement in clinical communication and interaction with regulatory agencies, and clinical publications/presentations. Responsible for budgeting and resource allocation within Clinical R&D. Reviewed Business Development opportunities, including niche/specialty markets and orphan drugs in many therapeutic areas.
Medical Director, ViroPharma Incorporated
Oversaw the Clinical Operations Department, Clinical Data Management/ Programming, Drug Safety/Regulatory, and Medical Writing Groups in the development of antiviral compounds directed against picornaviruses, hepatitis C virus (HCV), respiratory syncytial virus (RSV) and cytomegalovirus (CMV), encompassing development Phases 1-3. Wrote and edited protocols, clinical/statistical study reports, IND updates, safety reports, and investigator brochures. Primary author of major sections of NDA regulatory documents, including ISS, ISE, and Advisory Committee briefing package, and primary responder for clinical questions from FDA and its Advisory Committee for the antiviral pleconaril.
Medical Director, Virology, Medical Science & Development, DuPont Pharmaceuticals Company
Led clinical team developing two investigational HIV NNRTIs, requiring close interaction with Project Management, Discovery Research, Clinical Operations, Regulatory Affairs, and Marketing. Wrote investigator brochures, Phase 2 protocols, and clinical study reports. Monitored all Phase 3/4 DuPont-sponsored clinical trials with the HIV NNRTI efavirez (Sustiva), including writing and review of abstracts and study reports. Interacted with other departments and clinical investigators to plan and design Phase 2 and 3 trials for an investigational HIV NNRTI.