Publications

• Discovery and Preclinical Profile of Saxagliptin (BMS-477118): A Highly Potent, Long-Acting, Orally Active Dipeptidyl Peptidase IV Inhibitor for the Treatment of Type 2 Diabetes
• An inhibitor of Bcl-2 family proteins induces regression of solid tumours
• Discovery of a Potent Inhibitor of the Antiapoptotic Protein Bcl-xL from NMR and Parallel Synthesis
• Synthesis of Novel Pot...
• The Thermodynamics of Binding, The Medicinal Chemistry of Drug Design and Of Late-Stage Structural Optimization
• NMR-Based Screening of Proteins Containing 13C-Labeled Methyl Groups
• Article 2: An inhibitor of Bcl-2 family proteins induces regression of solid tumours
• Dr. David J. Augeri, PhD Expert Witness/Expert Medicinal Chemist - January 2026.pdf

Pharmaceutical IP Litigation Expert Witness

Specialties & Experience of this Expert Witness

Additional Information

–Current Practice- Expert Witness at DJ Augeri Pharma Consulting, LLC practicing in Expert Witness/Expert Consultant in Princeton, New Jersey since 2016 –Expert Consultant/Witness handling18 Cases in US and Canadian Federal Court, Oncology, Diabetes; DPP4 and SGLT2 ANDAs - (Hatch/Waxman - 2 tenets of obviousness est. 2012; mostly for SGLT2 and DPP4 Reports written in academic style of Chemical Reviews or Acts of Chemical Research. Discovery, depositions, testimony. consulting, handling 18 cases in US Fed Court as both Expert Chemistry Consult and Expert Witness - 3 depositions in last 4 years and 3 testimonies in last 4 years. –Education-NIH Postdoc in Natural Product Chemistry, Princeton University 1995 and PhD in Synthetic Organic Chemistry University of California-Irvine 1993 Partial Case History: • Amgen Canada Inc. & Onyx Therapeutics Inc. v. Dr. Reddy's Laboratories Ltd. 2024, AitkenKlee Expert Witness •. Shionogi, Hoffmann-La Roche, and Genentech vs. Norwich Pharma. 2023 ---expert consultant • Merck. Canada ANDA. Expert regarding Januvia. 2021 – 2023 Expert Witness • AstraZeneca 2020-2022 (saxagliptin ANDA; Mylan, expert for Onglyza)--ANDA • Aurobindo vs. B.I., Canada. 2021 – 2023 Expert Witness • Prollenium vs. Allergan. Expert regarding U.S. Patent No. 8,450,475. 2021 – 2022 •. Merck (sitagliptin ANDA, expert witness 2018 – 2019) - ANDA • Mylan, Teva et al. vs. BMS (saxagliptin ANDA, expert witness 2018 – 2019)- ANDA • BI vs. Zydus--Empagliflozin- Expert regarding Jardiance. 2019 -- OBVIOUSNESS • ANDA Trazodone, 2020 – 2021 Expert Witness • University of Michigan. Expert regarding Genzyme sphingosine-1-phosphate and ceramide signaling, 2020 – 2021 Expert Consult •. Pharmacyclics v. Acerta, 2014 - 2016 (BTK, acalabrutinib/ibrutinib expert consultant)---enablement, infringement main issues –SCIENCE CAREER IN PHARMA 20 years as skilled Medicinal Chemist (credited with FDA-approved discovery of saxagliptin at Bristol-Myers Squibb and at AbbVie credited with the optimal design of the acylsulfonamide chemotype that advanced Venclexta, the bcl2 inhibitor for cancer approved in 2015. As Director of Medicinal Chemistry, Immunology at Lexicon Pharma high performing group of 16-18 PhD/MS chemists to file 3 INDs over 10 years. Writing: 40+ published journal articles, inventor on >52 issued U.S. Patents. –SAXAGLIPTIN, DPP4 inhibitor, Bristol-Myers Squibb, Diabetes, T2DM; credited with the design of saxagliptin, made the final changes to the molecule based on the pharmacology data of the putative metabolite-ID studies. –VENCLEXTA, Bcl-2 inhibitor, AbbVie, ONCOLOGY, CML, B-cell Cancers; Venclexta, an acylsulfonamide, resembles my lead molecule, the first acylsulfonamide that led to Venclexta. –MY THERAPEUTIC AREAS OF EXPERTISE TARGETS IN ONCOLOGY: Btk (ibrutinib, acalabrutinib), EGFR (TKI inhibitors, erlotinib (Tarceva) gefitinib (Iressa), Osimertinib (Tagrisso), ERK1, ERK2, KRASG12C (Sotorasib-Lumakras and Adagrasib-Krazati) and KRASG12D, 20S Proteosome (multiple myeloma) use of bortezomib, carfilzomib; HER-2, Bcl-2, Taxol, Venclexta), p53, Anti-PD-1 Inhibitors (Nivolumab (Opdivo, BMS), Pembrolizumab (Keytruda, Merck), Anti-PD-L1, PARP, mTOR. Topoisomerase, Irinotecan, TARGETS IN DIABETES: SGLT2, DPP4, TZDs, GLP-1 agonists, Sulfonylureas-(glimepiride, Amaryl), immunology targets. and Expert Consultant on 18 cases in US and Canadian Courts in last 10 years. –Skills-Expert Synthetic Organic Chemistry -continuous general reading of the chemical literature, advanced knowledge of patents (construction of provisional apps, conversion to non-provisional app in EU, authored many of the sections of issued US Patents), served on cases focused on enablement, infringement cases and obviousness. Skilled scientific & medical writer (see publications/US Patents), depositions and testimony, patent analysis for Markman hearing or for Discovery.