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Click here or scroll down to respond to this candidateCandidate's Name , PhD, JD, FAHABuffalo, NY EMAIL AVAILABLE Street Address -238-6229 https://LINKEDIN LINK AVAILABLE VP of Regulatory Affairs VP of Medical AffairsMedical regulatory executive with unique combination of legal, scientific, regulatory expertise, communication, and negotiation skills. Expertise in navigating regulatory requirements and advising Top 10 pharmaceutical companies to make essential business decisions ensuring compliance and driving innovation and growth. Success in guiding drug and medical device developers through product development life cycle, R&D, testing, manufacturing, CMC, marketing, distribution and medical affairs. J.D., University at Buffalo Law School with a focus on Intellectual Property Law Ph.D. in Physiology, SUNY Buffalo, with 30+ years in research and teaching, physiology, toxicology and pharmacology 100+ publications in peer-reviewed journals, book chapters, reviews, and abstracts. Member, American Bar AssociationServed for 4 years as Vice Chair on the Rights and Responsibilities of Scientists Committee Advocated for changes to the Common Rule (45 CFR 46) for protection of human research subjects, resulting in the 2018 revision. SCIENCE. SAFETY. SUCCESS.Saved billions by forestalling unnecessary recalls and successfully negotiated positive outcomes with FDA.Motivated sweeping changes in regulatory processes.Saved lives by uncovering and discrediting fraudulent research reporting.Cleared approval paths for critical cancer, cardiovascular, and metabolic treatments.Preserved data integrity to support labeling and reduce risk over 200 times.Preferred advisor for dozens of major global medical manufacturers.Specially requested to serve as outside science and regulatory counsel for GSK (17 years). CORE SPECIALTIESScientific, legal, and analytical tactics.Harmonize product messaging and product labels (MLR review) to avoid misbranding, including scientific communications(including reviews of abstracts, posters, presentations and manuscripts).KOL strategy and development - worked with 100s of scientific and medical experts on medical/scientific and regulatory issues.Life-cycle management (preclinical/clinical) and commercialization.Global regulatory affairs and compliance (FDA, EMA, PMDA, IND, NDA, BLA, CTA, PMA, 5010(k)).Clinical trials regulation and IRB, cGMP, cGLP, cGCP, SOP, data privacy, and GDPR compliance.Clinical trial design, results, and registration (Phases I-IV).Adverse event reporting and postmarketing surveillance.Medical device digital/wireless technology regulation, compliance and cybersecurity.Regulatory affairs and safety boards (DSMB), risk assessment, and mitigation.Application of HEOR, RWE, RWD to evidence-backed marketing strategy, communications, labeling, corporate brand and development goals.Candidate's Name , PhD, JD, FAHA Buffalo, NY EMAIL AVAILABLE PHONE NUMBER AVAILABLE 2Product liability in multiple arenas, including vaccines, antidepressants, cancer drugs, antidiabetics, antiemetics and medical devices.Root cause analysis and investigation.Compassionate use (Right to Try and FDA Expanded Access program).Interviewing, onboarding, planning, and performance assessments.Design and training, certification systems, tutorials, and white papers. PROFESSIONAL HISTORY AND SELECTED HIGHLIGHTSPHILLIPS LYTLE, LLP Buffalo, NY 2004 - presentSpecial Counsel, Product Liability and Regulatory Affairs Assigned continuous, progressive responsibility to provide counsel, coordinate and develop scientific defenses in high-stakes health effects litigation and complex product liability cases involving medications, medical devices, and consumer products. Guide company executives and scientists through medical affairs matters, regulatory agency planning, applications, investigations, warning letter responses, recalls, and litigation involving regulatory compliance matters and communications. Client sampling: GSK, Merck, Pfizer, Novartis, AbbVie, Exact Medical Manufacturing, Sanabit, and Grnenthal. Risk MitigationSaved more than $1B in potential litigation costs by providing evidence to halt planned recall.Identified mathematically biased FDA and EMA analytical models and navigated internal politics to communicate findings.Persuaded the global head of biostatistics to reexamine clinical trial results.Developed a program to recheck adverse DSMB clinical trial findings.Catapulted a major restructuring of the biostatistics division, crisis management group, and communication processes.Defended the FDA in its prescriptive warnings about drug effects on children.Cleared last-minute barriers for the manufacturing of a sonography device.Satisfactorily addressed a post-trial FDA concern.Prompted the company to revisit its corrective and preventative action procedures (CAPA). Regulatory Planning and Pathway DevelopmentRaised investor confidence and cleared the path for additional funding for a bone healing device.Developed regulatory pathway for dual human/animal medical device, now part of the company vision. High Stakes Litigation StrategyKey role in discrediting research that linked vaccines to autism.Conducted an internal investigation to reveal false claims of medical degrees.Translated complex information into digestible form for juries, executives, and media.Coordinated, harmonized testimony by subject matter experts, key opinion leaders, internal company witnesses. Pre-Clinical Data Collection and Study Design Post Marketing Surveillance Candidate's Name , PhD, JD, FAHA Buffalo, NY EMAIL AVAILABLE PHONE NUMBER AVAILABLE 3Saved pharma developers more than $4B through data review.Reviewed literature, consulted with SMEs/KOLs to address questions about liver toxicity, arrhythmias, MI/stroke, GI issues, and birth defects for drugs in multiple classes, including bisphosphonates.Stewarded critical label changes focused on interactions between cancer drugs and antidepressants.Discredited claim of birth defects related to an anti-emetic.Successfully refuted resurrected claims centered on thalidomide by revisiting historical litigation and clinical data. UNIVERSITY AT BUFFALO SCHOOL OF MEDICINE AND BIOLOGICAL SCIENCES 30 Years of Research and Teaching Assistant Professor, Department of Physiology and Biophysics Received major funding through NIH and American Heart Association. Served on NIH and AHA committees as grant reviewer. Trained more than one dozen undergraduates, medical, Masters, PhD, postdoctoral, and visiting scholars. Currently teaching as an adjunct faculty: endocrinology, gastrointestinal, and renal pathophysiology.(Full academic CV and publication list available upon request.) EDUCATIONJ.D., University at Buffalo Law School, Buffalo, NY, Concentration: Intellectual Property Law Ph.D., Physiology Bachelor of Science in Biology, SUNY, Buffalo, NY Additional QualificationsPostdoctoral Fellowship, University of Iowa College of Medicine, Department of Internal Medicine, Division of Cardiology Current Board Memberships and AffiliationsBoard of Directors and Chief Science Officer, Suneels Light Foundation (Muscular Dystrophy) Fellow of the American Heart Association, Council on Basic Cardiovascular Sciences and Council on High Blood Pressure Research Member, Regulatory Affairs Professionals SocietyChair, Supervisory Committee for the Ukrainian Federal Credit Union Fluent in Ukrainian |
