Data Analytics Medicinal Chemistry

DAVID AUGERI

*****@*******************.*** 609-***-**** Princeton, NJ 08540-1624

WWW: https://www.linkedin.com/in/david-augeri-83b0a849/WWW: https://www.djapharmaconsulting.net Summary

Accomplished Principal Consultant at DJ Augeri Pharma Consulting, LLC, with a proven track record in drug development and clinical trial management. 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. 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

• Opt.PK-PD

• Drug Discovery

• Innovation

• Drug Design

• 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

• Module 2/4 eCTD

• NIH-NSF Funded Investigator

• Phase I CMC (1.0 kg API)

• Dotmatics, Data Warrior, and StarDrop

Experience

DJ Augeri Pharma Consulting, LLC

Princeton, NJ

Principal Consultant

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 polymer- based 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.

Urania Therapeutics Strasburg, France

SAB Member

01/2021 - 01/2023

• Reviewed the program portfolio, raised questions, evaluated progress, and offered guidance.

Rapafusyn Baltimore (consulted Remote

Princeton, NJ, MD

Med Chem and CMC Consultant FTE

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, cost- efficiency, 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, part of Module 4. State Univ of New Jersey - Rutgers

Piscataway, New Jersey

Professor of Synthetic Organic/Medicinal

Chemistry

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). Lexicon Pharmaceuticals Inc. Princeton,

NJ

Director of Medicinal Chemistry

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. Bristol Myers Squibb Princeton, NJ

Research Investigator

09/1999 - 06/2003

• Invented ONGLYZA (saxagliptin), FDA Approval 2009 as DPP4 TD2

Augeri et al., J. Med. Chem., 2005, 48, 5025-5037. AbbVie North Chicago, IL

Research Investigator

05/1995 - 09/1999

• Research Investigator, NMR Group, Oncology-Fragment-Based Drug Discovery, Abbott Laboratories, Abbott Park, IL.

• Invented a lead molecule that launched AbbVie Venclexta—NMR structure-based design of a bcl-2 inhibitor (acylsulfonamide) that initiated a 15-person effort that discovered VENCLEXTA (venetoclax, bcl-2 inhibitor, CML, and B-cell cancer).

• published seven 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 seven papers). United States Navy, 2nd Recon. Div.

USMC, NC, Camp Lejeune (Camp

Johnson), NC

USN Active Duty

07/1977 - 07/1983

• 1977–1981 Embedded 2nd Recon. Div. USMC, Camp Lejeune, NC TAC/FAC Officer, and Field Medic.

• 1981-1983, Pharmacy Technician, US Naval Submarine Medical Center, US Sub-Base, Groton, CT.

Education and Training

Princeton University Princeton, NJ

NIH Postdoctoral Fellow in Natural Products Chemistry 04/1995

University of California, Irvine Irvine, CA

Ph.D. in Synthetic Organic Chemistry

12/1992

Activities and Honors

• Maintains physical fitness of expert rock climber, 5.11a+

• Average 8 KM running/hiking per calendar day 2020 to present

• Rigorous weightlifting 90 min 3-4 times weekly

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 directly from a ternary NMR structure that launched the Venclexta (bcl-2, cancer) project. FDA Venclexta 2015.

• 2002 Bristol Myers Squibb names Saxagliptin "Molecule of the Year."

• FDA Drug Discovery – Bristol-Myers Squibb, discovery of saxagliptin (Onglyza, DPP4 inhibitor, T2DM, FDA2009).

• 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) University of Michigan. Expert regarding Genzyme sphingosine-1-phosphate signaling, 2020 – 2021 Expert Witness

• 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 References

• Dr. Marion Chiattello, Chief Technology Officer, Exion Labs, 2627 Abraham Drive, Cedar Falls, Iowa 50613; ******.**********@*********.***

• Dr. Jeffrey Bagdanoff, Principal Investigator, Novartis Pharmaceutics, Cambridge, Massachusetts; *******.*********@********.***

• Dr. James Tarver, Director of Medical Research, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; *****.******.***@*****.***

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