Areas of Expertise: Intellectual Property; IP License; IP Infringement; Patents
–Currently Principal Consultant, DJ Augeri Pharma Consulting, LLC practicing in drug discovery and Expert Witness/Expert Consultant in Princeton, New Jersey
–Editor of Journal of Medicinal Chemistry, the Bentham Science edition, 2-year term.
–Principal of DJ Augeri Pharma Consulting, LLC—independent med chem consulting (examples of drug discovery client projects in CV and Cover Letter) Expert Witness
–PhD in Synthetic Organic Chemistry University of California-Irvine
–Postdoc (NIH Fellowship) in Natural Product Chemistry, Princeton University
–20 years as skilled Medicinal Chemist (credited with 2 FDA-approved drug discoveries at AbbVie, Bristol-Myers Squibb) and served as Director of Medicinal Chemistry, Immunology for 10 years at Lexicon Pharma with a group of 16 PhD/MS chemists.
–Throughout career I was Legal Dept contact for delivering completed non-provisionals, manage the conversion of provisional to non-provisional, write the chemistry experimentals, see that the general synthetic methods are displayed followed by the chemical examples with experimental protocol.
–saxagliptin, DPP4 inhibitor, Bristol-Myers Squibb, Diabetes, T2DM; responsible for design of saxagliptin, a hydroxyadamantane that was consistent with the pharmacology of the putative metabolite that showed long-lasting Pharmacodynamics, PD, where the parent compound disappeared after 15 min but >80% in vivo DPP4 inhibition.
–Venclexta, Bcl-2 inhibitor, AbbVie, ONCOLOGY, CML, B-cell Cancers; responsible for designing the lead molecule for B-cell program; introduced acylsulfonamide chemotype
–Expert Witness Areas of Expertise – DIABETES DRUGS, ONCOLOGY DRUGS, IMMUNOLOGY DRUGS
–Targets- Cancer: Btk (ibrutinib, acalabrutinib), EGFR (TKI inhibitors gefitinib (Iressa), ERK1, ERK2, KRASG12C and KRASG12D, erlotinib (Tarceva), 20S Proteosome (multiple myeloma) bortezomib, carfilzomib, HER-2, Bcl-2, Bcl-xL Venclexta), p53, Anti-PD-1 Inhibitors (Nivolumab (Opdivo, BMS), Pembrolizumab (Keytruda, Merck), Anti-PD-L1, PARP, mTOR. Diabetes: SGLT2, DPP4, TZDs, GLP-1 agonists, Sulfonylureas-(glimepiride or Amaryl), Biguanides (metformin).
– 47 journal publications
– 60+ issued US Patents
–served as Expert Witness and Expert Consultant on 18 cases in US and Canadian Courts in last 10 years.
–3-4 depositions
–4 testimonies in last 4 years
–Skills—-working in or running MED CHEM PROJECTS—drug design; choosing project pharmacology, chemotype/starting point; structure/fragment-based design; safety biomarker correlation; lead optimization improving BOTH potency and physical properties simultaneously; PK-PD experiments; managing highly skilled interdisciplinary research groups; IND-Enabling studies with full gene tox; NOAEL, calculate Therapeutic Index; ADME/PK experiments; synthetic route selection.
Partial Case History:
- Pharmacyclics v. Acerta, 2014 — 2016 (BTK, acalabrutinib/ibrutinib expert consultant)
- Merck (sitagliptin ANDA, expert witness 2018 – 2019)
- BMS (saxagliptin ANDA, expert witness 2018 – 2019)
- Empagliflozin-BI vs. Zydus. Expert regarding Jardiance. 2019
- AstraZeneca 2020-2022 (saxagliptin ANDA; Mylan, expert for Onglyza)
- ANDA Trazodone, 2020 – 2021 Expert Witness
- University of Michigan. Expert regarding Genzyme sphingosine-1-phosphate and ceramide signaling, 2020 – 2021 Expert Witness
- Merck. Canada ANDA. Expert regarding Januvia. 2021 – 2023 Expert Witness
- Linagliptin vs. B.I., Canada. 2021 – 2023 Expert Witness
- Prollenium vs. Allergan. Expert regarding U.S. Patent No. 8,450,475. 2021 – 2022
- Shionogi, Hoffmann-La Roche, and Genentech vs. Norwich Pharma. 2023
- Amgen Canada Inc. & Onyx Therapeutics Inc. v. Dr. Reddy's Laboratories Ltd. 2024, AitkenKlee Expert Witness