Oncology Drug R & D, ICH GCP, Drug Patent Validity

Specialties & Experience of this Expert Witness

Additional Information

Dr. Frederick (Fred) Hausheer is a physician-scientist with over 37 years of executive leadership and management experience in US and international (EU, JP, China, others) commercial pharmaceutical research and development (Phase I-III), preclinical translational and clinical medicine, clinical pharmacology, ICH GCP compliance and commercial development strategy and risk management of novel cancer therapeutics. His commercial research and development experience includes cytotoxic agents, targeted agents, immuno-oncology therapeutics, cell therapies (BMT, CAR-T), and supportive care medicines. He is an inventor/co-inventor on more than 400 issued United States and international pharmaceutical patents, and author/co-author of more than 200 scientific/medical publications. He is an experienced former CEO and Chief Medical Officer with several biopharma companies and a former NCI-Designated Clinical Investigator, NCI-Institutional Review Board voting member, and NCI-Experimental Therapeutics Study Section member, and an ad hoc external expert medical advisor for the US FDA. Some of his major awards include the American Cancer Society Fellowship Awards, the National Scientific Research Award, and the Smithsonian-ComputerWorld Award for Breakthrough Science in Medicine. US Board Certified in Internal Medicine and Medical Oncology. He received MD degree from the University of Missouri-Columbia and completed Fellowship in Medical Oncology at the Johns Hopkins Hospital and the Johns Hopkins Oncology Center where his oncology training was focused on development and clinical pharmacology of investigational anticancer therapeutic agents in the Experimental Therapeutics and Pharmacology division at Johns Hopkins. His undergraduate degree is in Biology from Graceland University and graduate degree is in Physiology and Biophysics from the University of Illinois, Champaign-Urbana. Expert opinion and testimony on oncology pharmaceutical research and development, drug patent validity/invalidity and infringement, technical assessment of relative value of patents for damages, breach of contract/reasonable efforts for commercial oncology Phase I-III drug development, go/no-go decision analysis and justification, commercial analysis of clinical trial results/outcomes, ICH GCP non-compliance, commercial gap and risk assessment, analysis and opinions regarding regulatory interactions, pharmaceutical/biotechnology license agreements and obligations/reasonable efforts provisions, Contract Research Organization contracts and obligations requirements. Experienced in research and development of oncology therapeutic modalities and pharmacology including cytotoxic agents, targeted therapies (small molecules, antibodies, bispecifics, and BiTEs), immuno-oncology (checkpoint inhibitors, agonists, others), and cell and gene therapies (eg., BMT, CAR-T) in a variety of solid tumors and hematologic malignancies. Expertise on drug safety assessments, monitoring and regulatory reporting, expedited serious unexpected adverse drug reactions/toxicity - medical and regulatory compliance. I have provided written expert opinions, deposition and testimony on several major high stakes litigation (US Federal Court, US and Swiss International Courts of Arbitration and other jurisdictions) cases involving pharmaceutical development for cancer treatments. Areas of expertise include pharmaceutical patent validity and invalidity (infringement, exclusivity), written description, enablement, anticipation, obviousness, conception, and priority as well as determinations of reasonable commercial efforts for international pharmaceutical development, ICH Good Clinical Practice compliance/non-compliance in breach of contract, assessment of relative technical value of licensed patents for damages, validity/justification of go/no-go decision analyses in pharmaceutical research and development, and commercial pharmaceutical development regulatory strategy.