Enablement Expert Witnesses

Princeton, New Jersey

Chemistry & Chemicals, Pharmaceutical Research - Synthetic Organic/Medicinal Chemistry, ANDA Expert Witness, DPP4 SGLT2 ANDA, HatchWaxman, Obviousness, Enablement, Infringement, Invalidity, Paragraph IV, Patent IP and Litigation, Osimertinib EGFR, GLP-1 agonists, Sitagliptin, drug discov. and development, Dapagliflozin, venclexta bcl2, btk Ibutinib, Adagrasib KRASG12C, FLT3, POSITA

With over 10 years of experience as an expert witness at DJ Augeri Pharma Consulting LLC, I specialize in pharmaceutical patent litigation, specifically in the areas of synthetic organic and medicinal chemistry, drug discovery, and CMC/API process development. I provide critical support for legal clients, offering expert reports, prior art review, claims interpretation, and testimony in U.S. and Canadian courts. My work spans patent infringement, validity, obviousness, and enablement analyses, as well as consulting on ANDA/Hatch-Waxman litigation, with a focus on diabetes and oncology drugs. I am committed to advancing pharmaceutical innovation by combining my expertise in medicinal chemistry, structure–activity relationships, and drug development, from preclinical research to IND submissions. My technical contributions include designing alternative compounds, optimizing drug properties, and overseeing CMC facets of clinical development. I strive to provide high-quality, data-dri...

Austin, Texas

Oncology, Pharmaceutical Regulation - Oncology Drug Development, Patent Validity, ICH GCP, Written description, Enablement, Obviousness, Anticipation, Pharmacology, FDA, EMA, NMPA/China, PMDA/Japan, Drug formulation, Medical Safety, Phase 1-3 Clinical Trials, Drug Product Safety, Medical Oncology, Breach of Contract - Pharma/Biotech, Commercially Reasonable Efforts, Damages

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 Ther...