United States
With over 10 years of experience as an expert witness at DJ Augeri Pharma Consulting LLC, I specialize in pharmaceutical patent litigation, specifically in the areas of synthetic organic and medicinal chemistry, drug discovery, and CMC/API process development. I provide critical support for legal clients, offering expert reports, prior art review, claims interpretation, and testimony in U.S. and Canadian courts. My work spans patent infringement, validity, obviousness, and enablement analyses, as well as consulting on ANDA/Hatch-Waxman litigation, with a focus on diabetes and oncology drugs. I am committed to advancing pharmaceutical innovation by combining my expertise in medicinal chemistry, structure–activity relationships, and drug development, from preclinical research to IND submissions. My technical contributions include designing alternative compounds, optimizing drug properties, and overseeing CMC facets of clinical development. I strive to provide high-quality, data-driven insights that meet the highest academic and professional standards for the benefit of my clients and their groundbreaking projects.
SERVICES FOR LEGAL CLIENTS · Expert witness for pharmaceutical patent review with associated synthetic chemistry · Prior art review and claims interpretation · Expert reports written on drug/drug class in the academic style of Chemical Reviews · Depositions and courtroom testimony (U.S. federal and Canadian courts) · Patent infringement, validity, obviousness, and enablement analyses · ANDA / Hatch-Waxman litigation consulting where still applicable · Technical consulting on CMC, API synthesis, and formulation development AREAS OF EXPERTISE · Medicinal and Synth. Org. Chemistry · Drug Discovery & Development (Preclinical → IND) · Structure–Activity Relationships (SAR) & Mech of Action · CMC & API Process Development · ADME, PK/PD, and Translational Sciences · Regulatory Science & INDs · eCTD (modules 2/3) · IP Strategy, Patents and Litigation Support · Diabetes and Oncology, Drug Discovery and Early Dev. · Obviousness (SGLT2 and DPP4 inhibitors for diabetes, ANDAs) REPRESENTATIVE CASES · Pharmacyclics vs. Acerta – BTK / Acalabrutinib / Ibrutinib litigation (ENABLEMENT expertise) · Merck vs. Multiple Generics – Sitagliptin (Januvia) ANDA litigation · AstraZeneca vs. Mylan – Saxagliptin (Onglyza) patent defense · Boehringer Ingelheim vs. Zydus – Empagliflozin (SGLT2) infringement (OBVIOUSNESS expertise) · Prollenium vs. Allergan – U.S. Patent 8,450,475 · Multiple Canadian ANDA cases (diabetes & oncology) *Confidential and ongoing matters are not listed* Relevant Experience: · 25+ years in pharmaceutical R&D (Pfizer, Bristol-Myers Squibb, Abbott, Lexicon) · Inventor of 60+ issued U.S. patents, author of 40+ peer-reviewed publications, recipient of 5 funded NIH R01 grants. · Credited with the discovery of saxagliptin (Onglyza, T2DM, FDA2009). · Conceived the lead molecule design for Venetoclax (Venclexta, oncology, FDA2015). · Extensive expert witness experience in U.S. and Canadian patent litigation, ~18 cases.
I gained considerable experience in all avenues of medicinal chemistry, drug discovery and necessary preclinical experiments during two FDA-approved drug discoveries; saxagliptin (DPP4 inhibitor, FDA2009) and Venclexta (bcl2 inhibitor, FDA2015). I published 7 papers about fragment-based design that were important to the field (>6,500 citations for the 7 papers). 2016-2025: DJ Augeri Pharma Consulting, LLC Princeton, NJ. DJ Augeri, PhD, Principal –Current in 2025---Academic Collaboration that I established with Profs. B.Roth, R. Gummper at UNC, Chapel Hill (pharmacology and biology) and Dr. Mary MacDonald/Dr. Robert Kline, NIDA, NIH to probe binding to 5HT2A between LSD and its D-ring reduced olefin analog, 9,10-dihydro-LSD. –Designed a novel backup DPP1 inhibitor for Insmed (NJ) in 2022 to follow brensocatib in the clinic). –Assisted Anthony Johnson, CEO of Kodikaz Therapeutics 2021-2023 to design a radiolabeled DNA vaccine to conduct an in vivo study to determine the uptake and concentration of cancer vaccine in the target tissue, the liver. –Consulted Exion Laboratories (Iowa, US, 2021-2023) to develop proprietary (LPEI)-polymer based products. –Authored a Phase 2a clinical trial ICH-guided protocol for a Phase 2a “cyberknife” trial used to examine an advanced motion-sensitive radiation therapy in nonresectable pancreatic adenocarcinoma. –Managed 3 CMC campaigns to generate 1.0 KG small molecule API for programs headed for First-In-Man FIM Studies /Phase 1-eCTD compliant.
Head operations associated with setup and management of consulting firm offering drug discovery assistance or expert witness/patent litigation assistance to market-leading clientele, and their senior management, including Merck (sitagliptin ANDA, expert witness), BMS (saxagliptin ANDA, expert witness), AstraZeneca (saxagliptin ANDA; Mylan, expert witness), Insmed Pharma (I designed /discovery consulting), Exion Labs (materials science, antiviral polymer), Capital Health Hospitals (wrote Phase 2a Cyberknife study ICH:NCCN protocol for unresectable pancreatic cancer) NJ, Kodikaz Therapeutics (radiolabeled DNA vaccine imaging study), and PsychoGenics (collaborated on novel antipsychotic).
Redesigned library to infuse heterocyclic congeners of Alpha AAs into the macrocyclic framework to decrease lipophilicity (designed Phe as a pyrimidine in place of phenyl, a N-Me Pyrazole to replace a phenylglycine and the pyrrolidine of a D-Pro was replaced by a morpholine ring. These 3 changes on a 500 MW macrocycle? Lowered CLogP from 8.87 to 4.92. 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 - there were no backup considerations. • 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, synthetic routes, timelines, cost-efficiency, drug substance production from API, IV formulations, delivery dates, and analytical chemistry in compliance with the eCTD (modules 2, 3, sometimes 4)
Board Member - SAB, Urania Therapeutics / NovAliX, LLC, Strasbourg, France Reviewed program portfolio and raised questions, evaluated progress, and offered guidance. Additional Experience Includes: Bristol-Myers Squibb 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. AbbVie Research Investigator, NMR Research Group, Oncology-Fragment-Based Drug Discovery, AbbVie Laboratories, Abbott Park, IL Structure-based design of LEAD bcl-2 inhibitor (acylsulfonamide) that launched VENCLEXTA full program. (Nature 2005 >3700 citations)
NOTE: Faculty allowed to continue consulting for 30% of their time. 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 5 R01s, 1 DoD, 1 R21 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.
Taught graduate synthesis course(s). - Asymmetric Organic Chemistry, pericyclic reaction mechanisms, 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. 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 carefully covered for select syntheses.