1125 Boone Aire Road,
Florence, KY 41042
Call (859) 426-5035

Our Staff

LBR is committed to staffing every project with the most qualified and experienced personnel available. (Click name to reveal qualifications)

  • 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.
  • BS, Biology from Niagara University in 1974
  • JD from Seton Hall Law School, 1988
  • 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.
  • Routine clinical site auditing in Europe and U.S.
  • BS in Nursing (1993) from Northern Kentucky University, Kentucky
  • Licensed Registered Nurse in Ohio and Kentucky (1993)
  • CRO experience since 1995 (Kendle and LBR Regulatory)
  • Clinical Project Management for Phase III studies in Women's Health and Oncology
  • Clinical site monitoring in CNS, Respiratory, GI, Urology, Women's Health, Vaccine, Musculoskeletal, Cardiac
  • Experience in writing & reviewing SOPs
  • Experience in writing safety narratives
  • Quality assurance auditing at sites and for clinical TMFs
  • PhD in Nursing Research from University of Cincinnati, College of Nursing (1996)
  • MSN in Maternal Child Nursing from Loyola of Chicago, Marcella Niehoff School of Nursing (1986), Alpha Sigma Nu and Sigma Theta Tau
  • 17 years' experience in CRO industry (Kendle, OmniCare, Covance)
  • Global Division Head of Operations, including Project Management and Clinical Operations for Covance's Early Clinical Development (Phase 1 patient – Phase 2a) 144+ professionals
  • North American department head of Covance's Late Stage Project Management (Phase 2b – Phase 3) Group of 100+ professionals
  • Senior Director, Project Director, Project Manager for research studies of all sizes and indications spanning Phase 1 (patient studies) through Phase 4.
  • Accomplished "trouble shooter"
  • PMP certification through the Project Management Institute
  • Six Sigma Greenbelt certified • Developed and implemented quality improvement processes
  • Experienced in Medical Writing of Clinical Study Reports, project manuals and SOPs.
  • Skilled in budget negotiation • Excellent communication and team building skills
  • Assistant Professor of Clinical Nursing and Clinical Director of the Neonatal Nurse Practitioner Program at University of Cincinnati
  • Accomplished editor of the AJN Book of the Year, "Protocols in Neonatal Nursing" and accompanying physiology textbook, "Comprehensive Neonatal Nursing: A Physiologic Perspective" .
  • 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;
  • Clinical monitoring of Phase 3 clinical studies
  • Experience in preparation of INDs/NDAs
  • Experience in SOP development and writing
  • Experience in budget negotiation
  • PhD in Pharmacology (1993) from the University of Cincinnati College of Medicine
  • Postdoctoral Fellow at the University of Cincinnati College of Medicine (1993 – 1996)
  • 6 years of experience in the pharmaceutical Industry (Procter & Gamble, ICOS Corp, and Elan Pharmaceuticals) including Regulatory project management of small molecule and biologic programs
  • More than 10 years of experience in the CRO industry (Kendle Intl and LBR Regulatory) including regulatory project management of small molecule, biologic and vaccine programs
  • CMC Regulatory expertise in drugs and biologics
  • Regulatory project management in IND and NDA/BLA projects in oncology, cardiovascular, pulmonary, autoimmune diseases, women’s health, neurology and vaccines
  • Experience writing IND, NDA/BLA, sections (preclinical, CMC, package insert); Complete ANDAs; Orphan drug applications; and Clinical reports
  • FDA liaison with various Divisions within CDER and CBER; Authorized representative for small companies
  • Experience in Pre-IND, End of Phase 2, and Pre-NDA Meeting Preparation and Lead
  • Quality assurance auditing of clinical reports and regulatory submissions
  • Experience in SOP development and writing
  • Clinical monitoring and clinical project management experience