David J. Augeri –Career Research Achievements--Synthetic Organic and Medicinal Chemistry and Drug Discovery

  1. UC-Irvine PhD, Synthetic Organic Chemistry – prepared natural deoxypolypropionates using a novel hydrazone-mediated diastereoselective alkylation to generate 1,3-skipped alkyl chains.
  2. Princeton University NIH Postdoctoral Fellowship – Natural Product Synthesis – prepared calicheamicin oligosaccharide as a recognition element and measured the DNA binding affinity.
  3. 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. 
  4. FDA Drug Discovery – Bristol-Myers Squibb, discovery of saxagliptin (Onglyza, DPP4 inhibitor, Type II Diabetes Mellitus, T2DM) with FDA Approval 2009. 
  1. 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, and taught me new things lots.
  2. Academic Funded Grant Proposals: 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 on the program shifting 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 an impact on the programs.
  3. Publications: Published 47 peer-reviewed journal articles over my career, 11 as primary and/or corresponding author. 
  4. Patents: I hold 63 issued US Patents and approximately two dozen published non-provisional applications.

A Strong Scientific Background Provides For Creative Experimental Design

A diagram of the chemical structure for an alcohol.
  • Designed novel backup chemotype for Insmed by reinterpreting original PDB files used by AZ for the design of DPP1 inhibitor brensocatib for neutrophil-driven lung conditions. Few people “push” a structural complex to yield more data than a primary complex. A secondary structure is oftentimes possible.
  • Assisted Kodikaz Therapeutics to select special desferoxamine DFO linker to link to DNA vaccine and to chelate to Zr-89 (the 3 hydroxamic acid moieties known to dump lone electron pairs into Zr89 D-orbitals). The DFO was linked through a thioisocyanate to the guanine –NH2 of the terminal DNA base of the DNA vaccine. Kodikaz was pleased to observe it to localize in the liver, the desired target tissue for unresectable hepatic carcinoma in this in vivo imaging study.
  • Ongoing collaboration on conformation and 5-HT2A binding of lysergic acid diethylamide and close analogs between Professor Bryan Roth, MD/PhD AND Professor Ryan Gumpper of UNC-Chapel Hill (KOL, Neuroscience drugs), Professor D. Nichols at Purdue U., D. Augeri at Princeton, NJ, and Dr. Mary McDonald and Dr. Robert Kline at National Institutes on Drug Abuse, NIH. My analysis of the reduction and my prediction of diastereoselectivity was convincing enough to prompt rerunning of the experiment by Prof. B Roth and should be nearly completion in early Fall 2024.

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, ANDA  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.