David J. Augeri, PhD

ad12mj@r.postjobfree.com • 609-***-****

linkedin.com/in/david-augeri-83b0a849/ • Princeton, NJ, 08540, US

Synthetic Organic and Medicinal Chemist, Drug Design Expert and Patent Litigation Consultant, Expert Witness, Diabetes and Oncology.

Accomplished and resourceful professional with distinguished track record of propelling innovation, inspiring fellow colleagues and driving excellence in Preclinical and Drug Development, scientific communication, and industry partnerships.

Instrumental Synthetic Organic and Medicinal Chemist with >100 journal publications and issued U.S. Patents and a robust consultancy background managing IND-Enabling Studies and drug supply, CMC management (Phase 1-2a), and recognized expert Credited with discovering DPP4 inhibitor saxagliptin (Onglyza) at BMS for T2DM, FDA 2009 and credited with designing lead bcl2 inhibitor in NMR Research Group to launch Venclexta program at AbbVie, cancer, FDA 2015. Demonstrated history of synthesizing scientific data and implementing technology strategies. Expertise at Director level in managing multidisciplinary teams and deploying continuous improvement initiatives. Committed to elevating drug discovery and development lifecycle through exceptional consulting and advisory support.

Areas of Expertise

Industry Leadership Engagement Data-driven Decision Making Efficient and Effective Lead Optimization Opt.PK-PD. Drug Discovery Innovation Multidisciplinary Team Leadership Cross-Functional Collaboration Patent and IP Expert Litigation Expert Expert Witness, Pharmaceutical & FDA Compliance Module 2/3, CTD NIH-NSF Funded Investigator Manage Phase I CMC (!.0 kg API) Dotmatics, Data Warrior and StarDrop.

Career Experience

DJ Augeri Pharma Consulting, LLC 2012 – Present

Synthetic-Organic & Medicinal Chemist/Consultant

Biotech Preclinical/IND Enabling/CMC Management GLP/GMP API, Regulatory/FDA

Head operations associated with setup and management of consulting firm offering range of services to market-leading clientele, including Merck, BMS, AstraZeneca, Insmed Pharma, Exion Labs, Capital Health Hospitals NJ, Kodikaz Therapeutics, PsychoGenics, and Riverside Pharma. Direct design and development of innovative backup series for a small molecule med chem program within the pharmaceutical sector with keen focus on swift adoption of program among internal teams, augmenting series completion and facilitating patent filings. Steer all facets of CMC management while ensuring seamless collaboration between CDMO/CRO laboratories. Oversee full lifecycle of API synthetic routes review, IND studies coordination, compound supply management, and entire Regulatory-CMC-Compound Supply chain. Utilize latest tools and technologies, including but not limited to Dotmatics, Data Warrior, and StarDrop Data Management systems.

Spearheaded planning and execution of 3 API campaigns, 2 at Lexicon and 1 at Rapafusyn.

Routinely performed GAP analysis on manufacturing equipment, conditions and chemistry.

Designed novel chemotype reinterpreting original PDB files to back up DPP1 inhibitor brensocatib for Insmed, NJ, USA.

Undertook roles in small molecule expert reports, depositions, and testimonies as expert consultant/expert witness while enriching attorneys' arsenals with critical data from literature, journals, and patents.

Lead impactful academic collaborations with CNS experts, such as B. Roth at UNC, D. Nichols at Purdue U., D. Augeri at Princeton, NJ, and M. McDonald and R. Kline at NIDA, NIH.

Pioneered advances in PROTACs, structure-based design, fragment-based discovery, and properties-based design, while employing cutting-edge Modeling-Med Chem approaches.

Delivered astute consultation to prominent NY investment house, guiding CNS biotechnology ventures toward leveraging psychedelics and bioactive indole alkaloid natural products as foundational elements for new CNS disease treatments.

Acted as pivotal expert witness in 3 ANDA cases, involving major pharmaceutical litigation for DPP4 drugs (Januvia-Merck, Onglyza-AZ, Tradjenta-BI) while contributing to comprehensive reports that covered aspects from obviousness and enablement to direct infringement.

Rapafusyn Pharmaceuticals, Baltimore, MD 2022

Head of Medicinal Chemistry R&D and CMC - Pharmaceutical Research

Delivered exceptional leadership support in revamping of library to infuse heterocyclic congeners of Alpha AAs to curtail CLogP. Managed full spectrum of CMC while steering the synthesis of 1.0 kilo API under both GLP and GMP guidelines.

Designed alternative compounds for RapaDOCin while initiating preliminary investigations for RapaPROTin.

Oversaw CMC facets of Phase 1/GLP + GMP-API for the rapadocin drug, facilitating FIM study post-IND submission.

Led organization of CDMOs, scrutinizing chemistry capabilities, timelines, cost-efficiency, drug substance production from API, IV formulations, delivery dates, and analytical chemistry in compliance with IND-21 CFR-Part 11 standards.

Rutgers University, Piscataway, NJ 2013 – 2020

Professor of Synthetic Organic Chemistry

Taught graduate synthesis course - Asymmetric Synthetic Organic Chemistry and Terpene indole Alkaloid Synthesis while engaging in seminars and workshops. Oversaw development and update of course curricula to reflect latest advancements in field. Led identification of external funding opportunities to support research initiatives and collaborate with colleagues on interdisciplinary projects.

Collaborated with PIs; multidisciplinary NIH R01s Multiple R01s funded.

Provided guidance and mentorship to students through advising, research projects, and academic support.

Integrated practical applications and real-world scenarios into the curriculum to prepare students for future careers.

Fostered relationships with industry professionals, research organizations, and community stakeholders to facilitate collaborative projects and experiential learning opportunities.

Lexicon Pharmaceuticals, Princeton, NJ 2003 – 2012

Director of Immunology Medicinal Chemistry

Led teams of 16 to 18 scientists (PhDs, MS) that achieved 3 INDs. Taught group how to optimize both potency and physical properties with a single structural change such that analogs had higher binding affinity and improved permeability (EC50) and PK profile. Established ideal research culture within the group and mentored team in writing papers and external presentations.

Completed 3 IND-ENABLING STUDIES for IND filing; (CMC) SPHINGOSINE-1-PHOSPHATE LYASE, Phase II) and Mst1 Kinase Phase 1 studies for RA, MS, autoimmune disease; J Med Chem 2010, 8650-8662.c

Additional Experience

Board Member - SAB, Urania Therapeutics / NovAliX, LLC, Strasbourg, France

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

Research Investigator I/II - Metabolic Diseases Research, Bristol-Myers Squibb, Princeton, NJ

Invented ONGLYZA (saxagliptin), FDA Approval 2009 as DPP4 TD2 Augeri* et al., J Med Chem 2005, 48, 5025-5037 Safety tox, DeNovo Design, and Property-based drug design.

Research Investigator, NMR Research Group, Oncology-Fragment-Based Drug Discovery, Abbott Laboratories, Abbott Park, IL Invented Venclexta Lead Molecule--Structure-based design of LEAD bcl-2 inhibition (acylsulfonamide) that launched VENCLEXTA full program. (Nature 2005 >3850 citations)

U.S. Navy--6 years active duty HM2 honorable discharge 1983—FMF 2nd Recon Div. US Marines, Camp Lejeune, NC; TACP officer-reconnaissance. Then US Naval Hospital Submarine Medical Center, US Sub Base, Groton, CT.

Education

NIH Postdoctoral Fellow--Princeton University

Department of Chemistry, Natural Products Synthesis, achieved Total Synthesis of the Calicheamicin Oligosaccharide, Advisor, Professor D. Kahne

PhD in Synthetic Organic Chemistry, University of California, Irvine,

Department of Chemistry; Introduced novel Synthetic Methodology to Prepare Deoxypolypropionate Polyketide Natural Products; Advisor, Professor A.R. Chamberlin

Two Key Publications (2 of 46). Google scholar profile for DJA:

Augeri, David J.*; Robl, Jeffrey A.; Betebenner, David A. ; Magnin, David R.; Khanna, Ashish; Robertson, James G.; Wang, Aiying; Simpkins, Ligaya M.; Taunk, Prakash; Huang, Qi; Han, Song-Ping ; Abboa-Offei, Benoni; Cap, Michael; Xin, Li; Tao, Li ; Tozzo, Effie; Welzel, Gustav E.; Egan, Donald M.; Marcinkeviciene, Jovita; Kirby, Mark S.; Biller, Scott; Parker, Rex A.; Hamann, Lawrence G.* 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 J Med Chem 2005, 48, 5025-5037 (>700 citations).

Oltersdorf, Tilman; Elmore, Steven W.; Shoemaker, Alexander R.; Armstrong, Robert C.; Augeri, David J.; Belli, Barbara A.; Bruncko, Milan; Deckwerth, Thomas L.; Dinges, Jurgen; Hajduk, Philip J.; Joseph, Mary K.; Kitada, Shinichi; Korsmeyer, Stanley J.; Kunzer, et al. An inhibitor of Bcl-2 family proteins induces regression of solid tumours. Nature, 2005, 435, 677-681 (>3800 citations).

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