DAVID AUGERI
Princeton,NJ
Summary
Accomplished Principal Consultant at DJ Augeri Pharma Consulting, LLC, with a proven track record in drug discovery and development. Expert in drug discovery having made two 2 FDA-approved drug discoveries: BMS, saxagliptin (Onglyza), DPP4 inhibitor for T2DM, FDA2009 and AbbVie, venetoclax (Venclexta), bcl2 inhibitor for B cell hematologic cancer, FDA2015. Expert in regulatory compliance and analytical chemistry, having led 3 CMC 1.0KG Phase 1 campaigns; authored multiple patents and led successful IND submissions. Renowned for fostering cross-functional collaboration and driving innovative solutions in pharmaceutical research.
Overview
49
49
years of professional experience
Work History
Principal Consultant
DJ Augeri Pharma Consulting, LLC
01.2012 - Current
- Initiated academic collaboration with professors at UNC Chapel Hill and NIDA, NIH in 2023.
- Designed novel DPP1 inhibitor for Insmed in 2022, utilizing PDB file from AstraZeneca's brensocatib.
- Assisted Kodikaz Therapeutics in developing radiolabeled DNA vaccine for in vivo cancer study.
- Consulted for Exion Laboratories to develop proprietary LPEI polymerbased products.
- Authored ICH-guided Phase 2a clinical trial protocol for oncology group at Capital Health Hospitals.
- Managed three CMC campaigns to produce 1.0 KG small molecule API for IND filing.
- Provided expert consultation in 18 legal cases since 2014 on various drug inhibitors and formulations.
- Conducted GAP analysis of equipment compliance with FDA guidelines for clinical trials.
SAB Member
Urania Therapeutics
01.2021 - 01.2023
- Reviewed the program portfolio, raised questions, evaluated progress, and offered guidance.
Med Chem and CMC Consultant FTE
Rapafusyn
03.2022 - 11.2022
- Redesigned the library to infuse heterocyclic congeners of Alpha Aas (such as subst.). Pyrimidine for phenyl of Phe, N-Me pyrazole for phenylglycine, substituted a morpholine ring for pyrrolidine in a D-Pro, and all three reduced macrocycle CLogP from 8.87 to 4.92.
- Managed the full spectrum of CMC while steering the synthesis of 1.0 kilo API under both GLP and GMP guidelines.
- Oversaw CMC facets of Phase 1, GLP, and GMP-API for the rapadocin drug, facilitating the FIM study post-IND submission.
- Organized CDMOs, scrutinized chemistry capabilities, timelines, costefficiency, drug substance production from API, IV formulations, delivery dates, and analytical chemistry in compliance with all eCTD-driven documents of IND for Modules 2 and 3.
Professor of Synthetic Organic/Medicinal Chemistry
State Univ of New Jersey - Rutgers
01.2013 - 02.2020
- Taught graduate synthesis course(s). - Asymmetric Organic Chemistry, pericyclic reaction mechanisms, and polycyclic ring construction strategies.
- Terpene indole alkaloids illustrate nature's way to diversify the shape and physical properties of isomeric compounds by varied placement of the bridgehead nitrogen. Particular attention was paid to strychnos (the MacMillan and the Overman synthesis of strychnine), aspidosperma (aspidospermidine, tabersonine), iboga (corynanthe), and the Woodward landmark synthesis of the yohimbine alkaloid (reserpine). Conformational analysis is carefully covered for select syntheses.
- Fostered relationships with industry professionals and research organizations to form collaborations.
- Collaborated with PIs; co-authored NIH R01-5 funded R01s ($2.8-3.1 million), 1 funded R21, and 1 funded DoD grant ($2.8 million).
Director of Medicinal Chemistry
Lexicon Pharmaceuticals Inc.
06.2003 - 08.2012
- Led teams of 16 to 18 scientists (PhDs, MS) who achieved 3 INDs for RA (rheumatoid arthritis) and MS (multiple sclerosis).
- Mentored the group in the optimization of potency and physical properties with a single structural change; analogs showed higher binding affinity and improved features of permeability, EC50, and PK.
- Mentoring PhD journal manuscripts and external presentations.
Research Investigator
Bristol Myers Squibb
09.1999 - 06.2003
- Invented ONGLYZA (saxagliptin), FDA Approval 2009 as DPP4 TD2 |Augeri et al., J. Med. Chem., 2005, 48, 5025-5037.
Research Investigator
AbbVie
05.1995 - 09.1999
- Research Investigator, NMR Group, Oncology-Fragment-Based Drug Discovery, Abbott Laboratories, Abbott Park, IL.
- Innovative Design of Acylsulfonamide Lead for Venclexta (venetoclax), FDA Approval 2015-launched AbbVie Bcl-2 ProgramLinker is both isosteric replacement for Bcl-2 Site #1 acid and links to Site #2 to precisely place Site #2 ligand.
- Published three papers that highlighted structure-based design and fragment-based methods fundamental to my approach to generating a lead molecule (over 6,500 citations for the three papers).
USN Active Duty
United States Navy: Intel(RAF/TAF), 2nd Recon. Div. USMC, NC
07.1977 - 07.1983
- 1977-81 Embed. Medic, 2nd Recon. Div. USMC, Camp Lejeune, NC.
- 1981-1983, Pharmacy Technician, US Naval Submarine Medical Center, US Sub-Base, Groton, CT, specified on DD-214.
Education
NIH Postdoctoral Fellow - Natural Products Chemistry
Princeton University
Princeton, NJ04-1995
Ph.D. - Synthetic Organic Chemistry
University of California, Irvine
Irvine, CA12-1992
Skills
- Drug development
- Clinical trial management
- Regulatory compliance
- Analytical chemistry
- Project management
- Data analysis
- Industry Leadership Engagement
- Data-driven Decision Making
- Efficient and Effective Lead Optimization
- OptPK-PD
- Drug Discovery
- Innovation
- Multidisciplinary Team Leadership
- Cross-Functional Collaboration
- Inventor listed on >60 issued US Patents
- Author of >20 Provisional Patent Applications
- Patent and IP Expert Litigation Expert
- Expert Witness and Testimony
- Pharmaceutical & FDA Compliance
- Radiochemistry Synthesis and Studies
- NIH-NSF Funded Investigator
- Phase I CMC (10 kg API)
- Dotmatics, Data Warrior, and StarDrop
- Drug Design
Accomplishments
- UC-Irvine PhD, Synthetic Organic Chemistry - prepared deoxypolypropionate subunits using a novel hydrazone-mediated diastereoselective alkylation to generate 1,3-skipped syn-or 1,3-skipped anti-dialkylated chains.
- Princeton University NIH Postdoctoral Fellowship - Natural Product Synthesis - prepared calicheamicin oligosaccharide and measured the associated DNA binding affinity.
- FDA Drug Discovery - AbbVie - Designed the acylsulfonamide lead compound that launched the Venclexta project (bcl-2, cancer). FDA Venclexta 2015.
- 2002 Bristol Myers Squibb names Saxagliptin 'Molecule of the Year.'
- FDA Drug Discovery - Bristol-Myers Squibb, saxagliptin (Onglyza, DPP4 inhibitor, T2DM). FDA Onglyza 2015.
- Awarded 5 funded NIH R01 grant proposals
- Published 47 peer-reviewed journal articles
- Inventor listed on > 60 issued US Patents
- 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)
- Merck. Canada ANDA. Expert regarding Januvia. 2021 - 2023 Expert Witness
- Linagliptin vs. B.I., Canada. 2021 - 2023 Expert Witness
- Amgen Canada Inc. & Onyx Therapeutics Inc. v. Dr. Reddy's Laboratories Ltd. 2024, AitkenKlee Expert Witness
Timeline
Med Chem and CMC Consultant FTE
Rapafusyn
03.2022 - 11.2022
SAB Member
Urania Therapeutics
01.2021 - 01.2023
Professor of Synthetic Organic/Medicinal Chemistry
State Univ of New Jersey - Rutgers
01.2013 - 02.2020
Principal Consultant
DJ Augeri Pharma Consulting, LLC
01.2012 - Current
Director of Medicinal Chemistry
Lexicon Pharmaceuticals Inc.
06.2003 - 08.2012
Research Investigator
Bristol Myers Squibb
09.1999 - 06.2003
Research Investigator
AbbVie
05.1995 - 09.1999
USN Active Duty
United States Navy: Intel(RAF/TAF), 2nd Recon. Div. USMC, NC
07.1977 - 07.1983
Ph.D. - Synthetic Organic Chemistry
University of California, Irvine
NIH Postdoctoral Fellow - Natural Products Chemistry
Princeton University
Activities
Maintains physical fitness consistent with rock climbing at 5.10a+
Public Speaking Engagements
- N-AziridinylImines; Synthetic Methodology for the Efficient Construction of Skipped 1,3-syn and Skipped 1,3-anti Deoxypolypropionate Natural Products, The 33rd IUPAC International Symposium on Macromolecules International Symposium on Organic Chemistry, 1990-07-09
- 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, June 4-7, 2006, Hershey, Pennsylvania, 2006-06-04
- Inhibition of S1P Lyase for the Treatment of Rheumatoid Arthritis, First Disclosures Session, The 239th American Chemical Society Meeting, 2010-03-21
- Saxagliptin: A Rutgers Case Study, Part1 David J Augeri, PhD, Rutger's University, 2015-10-28
Awards
- Roland Ward Thesis Award for the Outstanding Undergraduate Research Thesis, 1986, UConn
- National Institutes of Health NRSA Postdoctoral Fellowship in Natural Product Synthesis, 1993, Princeton