George Hajduczok
Regulatory and Medical Affairs Executive | Expertise in FDA, EMA, Global Regulatory Standards | Advisor to Top 10 Pharma | Connecting Science and the Law to Advance Clinical Research with Effective Compliance
- Role
- Special Counsel, Product Liability and Regulatory Affairs at Phillips Lytle LLP
- Location
- Buffalo, NY, US
- LinkedIn followers
- 500 followers
About George Hajduczok
The intersection of science, law, and medicine has defined my career and gives me a…
Experience
Special Counsel, Product Liability and Regulatory Affairs
Jan 2004 — Present · Buffalo, NY, US
Provide counsel; coordinate, develop scientific defenses in high-stakes litigation and complex product liability cases involving medications, medical devices, and consumer products. Guide company executives and scientists through regulatory agency planning, applications, investigations, warning letter responses, recalls, and litigation involving regulatory compliance matters.(Clients include GSK, Merck, Pfizer, Novartis, AbbVie, and Grünenthal.) IMPACTS:Saved >$1B in potential litigation costs by halting planned recall.•Identified mathematically biased FDA and EMA analytical models. Persuaded the global head of biostatistics to reexamine clinical trial results.•Developed a program to recheck adverse DSMB clinical trial findings. •Catapulted major restructuring of the biostatistics division and crisis management group.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.Raised 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, witnesses.Saved pharma developers >$4B through data review.•Addressed questions about liver toxicity, arrythmias, stomach issues, and birth defects for drugs in multiple classes, including bisphosphonates. •Stewarded critical label changes focused on interactions between cancer drugs and antidepressants. •Successfully refuted resurrected claims centered on thalidomide.
Education
State University of New York at Buffalo
Bachelor of Arts (B.A.)
State University of New York at Buffalo - Law School
Doctor of Law (J.D.)
State University of New York at Buffalo - School of Medicine & Biomedical Sciences
Doctor of Philosophy (Ph.D.)
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