PhD in Biochemical Pharmacology (1978) from SUNY Buffalo School of Pharmacy
Postdoctoral Fellow at The University of Arizona (1978-1980) at the Schools of Pharmacology and Medicine
16 years of experience in the pharmaceutical industry (Mead Johnson, Hoffman La Roche, Merrill Dow (aka Marion-Merrill Dow), Procter & Gamble, Medisorb) including hands on research and management experience in preclinical and regulatory management of global projects
CRO experience since 1996 (Kendle Intl and LBR Regulatory) including VP of Global Regulatory and QA
Preclinical Research in Cardiovascular and Cardiovascular Safety Testing for all study drugs in clinical development
Regulatory administration and regulatory project management in IND and NDA/BLA projects in cardiovascular, pulmonary, autoimmune diseases, women’s health, analgesia, gastrointestinal, vaccine, OTC projects in analgesia and respiratory, pediatric respiratory and autoimmune diseases
Writing IND and NDA sections (preclinical, clinical, CMC and benefit/risk, package insert); white paper defenses for regulatory agencies; orphan drug application writing and compilation
Experience in writing and converting submissions to eCTD format
FDA liaison (Drug, Biologic, Device and Veterinary Divisions), FDA advisory committee preparation
Negotiations with the FDA on behalf of a Sponsor regarding labeling, study-design, study result issues, deficiencies in submissions, compliance issues
Quality assurance auditing of clinical sites, clinical reports, regulatory submissions, and regulatory compliance manufacturing experience in drugs and devices and SOP development
Manufacturing experience in both regulatory CMC and regulatory oversight of manufacturing facility
Regulatory Project management for US and Global Projects
Rx to OTC switch including regulatory management of project and writing sections of the NDA
Policy development for OTC products and Torsades de Pointe
Experience in assisting Indian manufacturing firm to obtain US FDA standards and approval of ANDA at manufacturing firm
Clinical Monitoring of Phase 3 studies
Clinical Project Director Level Management for clinical studies
Experience in providing training in GCP, monitoring, and preparation of INDs/NDAs
For-Cause auditing in Europe, South America and U.S.
Site inspection readiness visits in Europe, South America and U.S.
Routine clinical site auditing in Europe, South America and U.S.
The University of Arizona: 2 years of basic research
Toxicology and Pathology Services, Inc: 3 years of toxicology experience conducting studies and 1 year as GLP officer
8 years experience in defense of drug product liability litigation involving drugs and devices
CRO experience since 1996 (Kendle International and LBR Regulatory)
Preclinical Experience: GLP officer, writing protocols and reports for toxicology studies and project management of toxicology studies
Clinical Experience: Site selection, qualification and initiation, study start up, monitoring, project management of Phase 3 clinical studies. Writing protocols, ICFs, CSRs, INDs, INADs, briefing documents, and NDAs, including ISS, ISE and Clinical Summaries for drugs, biologics, vaccines and veterinary drugs (in paper and eCTD format). Performed QC and QA of CSRs and data listing for toxicology and clinical CSRs.
Regulatory Consulting: Provided pharmaceutical companies with advice regarding FDA regulations, patient safety issues, IRB concerns, and general product exposure issues
Legal/Financial: Negotiating site contracts and budgets for clinical studies.
For-Cause auditing in Europe and U.S.
Site inspection readiness visits in Europe and U.S.
BS in Biology (1983) from Kutztown University of Pennsylvania
Medical Technologist (MT) ASCP Certification (1984)
19 years of experience in the pharmaceutical Industry (Wyeth Research) including Global Clinical Trial Operations Management, Clinical Scientist-Women's Healthcare, Clinical Product Liability Litigation (Redux/Fen-Phen),Clinical Data Management and Clinical Database Design
CRO Experience since 2007 including Phase 2 and 3 Clinical Project Management and Regulatory Project Management and Administration in women's health and oncology
Quality assurance auditing of IND Annual Reports, Clinical Study Reports, and NDA submissions;