David J. Augeri - Career Research Achievements - Active Consultant Synthetic, Organic, Medicinal Chemistry, and Drug Discovery
- UC-Irvine PhD, Synthetic Organic Chemistry - Prepared natural deoxypolypropionates using a novel hydrazone - mediated diastereoselective alkylation to generate 1,3-skipped alkyl chains.
- Princeton University NIH Postdoctoral Fellowship - Natural Product Synthesis - prepared calicheamicin oligosaccharide as recognition element and measured the DNA binding affinity.
- FDA Drug Discovery - AbbVie - Designed acylsulfonamide lead directly from a ternary NMR structure that launched the Venclexta (bcl-2, cancer) project to treat B-cell blood cancers.
- FDA Drug Discovery - Bristol-Myers Squibb, discovery of saxagliptin (Onglyza, DPP4 inhibitor, Type II Diabetes Mellitus, T2DM) with FDA Approval 2009.
- 3 INDs in 10 years with a talented group of 16 medicinal chemists from the best chemistry departments in the world (Princeton Univ, California Institute of Technology, Columbia Univ, Harvard Univ, Univ Texas-Austin, UC-Irvine, Stanford Univ, UC-Berkeley, Michigan Univ, Penn State, Ohio State). This group worked hard, asked excellent questions, taught me new things lots.
- Academic Funded Grant Proposals:Â During academics I wrote 7 grant proposals as co-PI that were funded. 5 NIH R01s, 1 DoD grant, 1 NIHR21. I collaborated with bio- professors who added me as a PI and allowed me to write a proposal with emphasis of the program shifted from studying a biologically active protein to developing a drug discovery program with that biologically active protein as the target and added the necessary scientists to the proposal to have impact on the programs.
- Publications: Published 47 peer-reviewed journal articles over my career, 11 as primary and/or corresponding author.
- Patents:Â I hold 63 issued US Patents and approximately two dozen published non-provisional applications.
David J. Augeri - Expert Consultant and Expert Witness Case History - Pharma Patent Litigation
Pharmacyclics v. Acerta, BTK, acalabrutinib/ibrutinib, infringement/enablement, consult. 2014 - 2016
Merck v. Mylan, sitagliptin ANDA, expert witness 2018 – 2019
BMS v. Mylan, saxagliptin ANDA, expert witness 2018 – 2019
BI vs. Zydus, empligliflizin-Jardiance, expert consultant and expert witness
AstraZeneca v. Mylan, saxagliptin, ANDA, expert witness
Merck. Canada ANDA. Expert regarding Januvia. 2021 – 2023 Expert Witness
Linagliptin vs. B.I., Canada. 2021 – 2023 Expert Witness
Prollenium v. Allergan, U.S. Patent No. 8,450,475, 2021 – 2022
Shionogi, Hoffmann-La Roche, and Genentech v. Norwich Pharma, ANDAÂ 2023
Amgen Canada Inc. & Onyx Therapeutics Inc. v. Dr. Reddy's Laboratories Ltd. 2024, AitkenKlee Expert Witness
Expert Witness: Since 2012 – 18 interesting cases. I certainly gained experience with ANDA cases in the US and interpretation of the Hatch-Waxman law by the courts was frequent during Markman hearings. The US and Canadian Federal Courts require lengthy background reports on either the drug or the general drug class to read in preparation for the case. Provides careful US Patent review containing inventorship of drug/drug class involved. Review/report of any documents submitted for Discovery by opposition. Report relevant questions for Discovery to counsel. Provide Testimony for Depositions and Cross-Examinations.
Several Cases were never known to the public. Those that were made public are listed above.