Expert Details

Scientifically focused industry contributor with extensive experience developing pharmaceuticals, nutraceuticals, foods, and cannabis-based consumer and pet products. Background includes leadership roles supporting formulation design, manufacturing scale-up, regulatory submissions, and GMP/ISO quality systems across domestic and international operations. Recognized for high-impact consulting, expert testimony, and multidisciplinary problem solving in complex technical, regulatory, and IP-driven environments. Delivers solutions that integrate chemistry, materials science, and manufacturing principles to advance product quality and commercial success.

Scientist and consultant with deep cross-industry expertise in pharmaceutical and nutraceutical formulation, regulatory strategy, and product development. Experienced expert witness with contributions across litigation, government cases, and industry audits. Widely published author with more than 70 technical works spanning pharmaceuticals, food science, and cannabis.

• Extensive experience with formulation, drug delivery, coatings, and microencapsulation

• Leadership across pharmaceutical, nutraceutical, food, and cannabis product development

• Expert witness contributions for litigation, regulatory matters, and product labeling disputes

• Proven ability to scale products from bench to commercial manufacturing

• Deep regulatory knowledge including INDs, IMPDs, ANDAs, NDAs, and CMC documentation

• Strong background in quality systems, GMP, ISO 9001, and audit preparation

• Advanced scientific writing, technical analysis, and project management capabilities

• Experience supervising teams, training staff, and managing multi-stakeholder programs

• Tablets (ODT, controlled-release, chewable), capsules, oral liquids, powders, semi-solid topicals

• CBD/THC products, nanoemulsions, tinctures, gummies, topicals, pet products

• Drug delivery systems, coatings, microencapsulation, soft chews, beverages, confections

• LC/MS/MS, HPLC, spectroscopy (NIR, FTIR, Raman, UV-VIS), dissolution testing

• QbD, process validation, scale-up, stability studies, risk assessments

• Regulatory frameworks: GMP, ISO 9001, DSHEA, FDA/EMA CMC requirements

• Consultant / Scientific Expert, Cantor Consulting (01/2011–Present)

• Expert, Class Action Lawsuit – Lemberg Law (01/2025–10/2025)

• Expert, U.S. Department of Justice (04/2023–10/2024)

• Chief Scientific Officer, OMRUT/CERES Naturals (08/2019–10/2022)

• Scientific Expert, Hahn Loeser & Parks LLP (11/2019–12/2019)

• Scientific Expert, Taylor English Duma LLC (05/2018–07/2018)

• Principal Scientist, Ei Solutionworks/Endev Labs (08/2016–06/2018)

• Scientific Expert Witness, Milbank, Tweed, Hadley & McCloy LLP (05/2017–09/2017)

• Scientific Expert, Susheela Verma, Esq. (01/2016–03/2017)

• CMC Consultant, Agios Pharmaceuticals (09/2015–07/2016)

• R&D Consultant, Proteus Digital Health (12/2014–08/2015)

• Writer/Editor, Handbook of Pharmaceutical Excipients (2011, 2015, 2023)

• Formulation Scientist (Contractor), Advanced Bionutrition (06/2013–07/2014)

• Post-doctoral Scientist, Food & Drug Administration (01/2012–06/2013)

• IP Consultant, TreMonti Consulting (04/2011–04/2016)

• Global Regulatory Analyst/Project Manager, Pfizer Consumer Healthcare (10/2009–04/2011)

• Senior CMC Regulatory Scientist, ICON Development Solutions (06/2008–06/2009)

• Senior R&D Manager, Capricorn Pharma (07/2000–06/2003)

• Food Chemist/Sr. Technical Services Representative, TIC Gums, Inc. (11/1992–07/2000)

• Developed numerous pharmaceutical and nutraceutical dosage forms, including ODTs, controlled-release tablets, nanoemulsions, and encapsulated ingredients

• Served as expert witness across multiple high-profile legal cases, including patent challenges and class action matters

• Led GMP and ISO 9001 quality system development, authoring 60+ SOPs and quality manuals

• Scaled multiple products to commercial volumes, including soft chews up to 900-pound batches

• Contributed to three editions of the Handbook of Pharmaceutical Excipients

• Published more than 70 articles and book chapters across foods, nutraceuticals, cannabis, and pharmaceuticals

• Received notable awards, including IFAH Top 100 Healthcare Leaders

• Ph.D., Pharmaceutics/Industrial Pharmacy, University of Maryland, 2008

• M.S., Food Science, University of Georgia, 1990

• B.S., Chemistry, SUNY Oneonta, 1986

• ISO 9001 Lead Auditor Certification

• Drove successful commercialization of complex pharmaceutical, nutraceutical, and cannabis dosage forms by resolving technical barriers in formulation, stability, manufacturability, and regulatory readiness.

• Strengthened regulatory outcomes for sponsors through authoritative CMC strategy, high-quality documentation, and rapid problem solving for FDA and international agency inquiries.

• Enabled legal teams to secure favorable rulings and settlements through clear, defensible expert analysis, deposition testimony, and scientifically rigorous opinion reports in patent, mislabeling, trade secret, and regulatory cases.

• Elevated manufacturing performance and compliance by designing GMP- and ISO-aligned quality systems, authoring extensive SOP frameworks, and guiding organizations through audits and certification.

• Delivered multimillion-dollar operational and cost efficiencies by optimizing formulations, reducing raw material expenditures, improving process yields, and enhancing product robustness across scale-up.

• Advanced industry knowledge through 70 publications, book chapters, and technical contributions, shaping scientific understanding across pharmaceuticals, foods, nutraceuticals, and cannabis product development.

• Served as a cross-industry technical catalyst, integrating chemistry, materials science, analytical methods, and regulatory expertise to accelerate innovation and reduce risk across the product lifecycle.