Expert Details

Expert in Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues

Expert ID: 733446 North Carolina, USA

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Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience working with CMO's, setting up a lab, selecting equipment & formulation ingredients, product costing & product labels/claims.

His expertise includes various manufacturing unit operations: wet granulation (fluid bed, high shear, foam), spray drying, encapsulation, & development of controlled release technologies.

Expert has excellent oral and written communication skills & 66 publications with 11 articles on pharmaceutical topics. Expert has deep IP knowledge with 10 years expertise across healthcare (ex. drugs & nanotechnology).
Expert has knowledge of FDA regulations governing pharmaceuticals & nutraceuticals. His experience includes global regulatory affairs (strong project management & regulatory/CMC writing skills). He has managed the writing, compiling, and editing of CMC sections (drug substance/drug product) for two IMPD's (lyophilized biologics: recombinant growth factor and hormone) and BLA (interferon). He has also written sNDA's (topical product), parts of NDA's, and IND's (small molecule for schizophrenia).

Experience with 4 cases as a scientific expert witness (IP & trade secrets) with nutraceuticals/pharmaceuticals (Helped win first case at trial).

Expert may consult nationally and internationally, and is also local to the following cities: Charlotte, North Carolina - Greensboro, North Carolina - Winston Salem, North Carolina - Fayetteville, North Carolina - High Point, North Carolina - Gastonia, North Carolina - Concord, North Carolina - Columbia, South Carolina - Greenville, South Carolina

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Education

Year Degree Subject Institution
Year: 2008 Degree: Ph.D Subject: Pharmaceutics and Industrial Pharmacy Institution: University of Maryland
Year: 1990 Degree: MS Subject: Food Science Institution: University of Georgia
Year: 1986 Degree: BS Subject: Chemistry Institution: State University of New York

Work History

Years Employer Title Department Responsibilities
Years: 2016 to Present Employer: Undisclosed Title: Principal Scientist Department: Responsibilities: Expert managers deliverables for six client projects, both U.S. and international. He develops R&D-scale generic formulations for clients (solution, cream, ointment, gel, spray, medicated pads) using a Quality by design (QbD) approach. He also answers FDA, QBR and CMC questions related to client drug substance and drug product questions.
Years: 2015 to 2016 Employer: Agios Pharmaceuticals Title: Pharmaceutical CMC Consultant Department: Responsibilities: Expert reviews and provides scientific input on pharmaceutical documentation for tablet/capsule development and manufacturing scale-up.
Years: 2014 to 2015 Employer: Proteus Digital Health Title: Pharmaceutical R&D Scientist and Consultant Department: Responsibilities: Expert has designed and conducted formulation experiments for developing tablet, tablet-in-tablet (core coating), and capsule prototypes containing an embedded FDA-cleared ingestible semiconductor sensor (moisture-sensitive) medical device. He has also written R&D development and feasibility reports on chemistry and stability for new potential drug products.
Years: 2013 to 2014 Employer: Advanced BioNutrition Title: Formulation Scientist Department: Responsibilities: Expert developed coating systems which improved vitamin A stability against oxidation as compared against the competitor's technology. He also developed nutraceutical (e.g., antioxidants, vitamins) encapsulation technologies. He informed senior management and project teams on key findings. The nutraceuticals used include olive leaf extract, resveratrol, vitamin C, alpha-lipoic acid, vitamin E, and rosemary extract, among other ingredients.
Years: 2012 to 2013 Employer: FDA Title: Pharmaceutical Research Scientist Department: Responsibilities: Expert formulated an Orally Disintegrating Tablet (ODT) containing taste-masked clindamycin beads. He also utilized HPLC, particle size, surface area, DSC/MDSC, TGA, FTIR, NIR, Raman, UV-VIS spectrometers, Types I&II Dissolution, and PXRD to evaluate API and formulations. Additionally, he conducted spectroscopic and analytical work to analyze melamine. He also devised stability studies to evaluate the interaction of gelatin capsules with various excipients using different temperature and humidity levels. Published 2 papers & presented posters at AAPS & FDA.
Years: 2011 to 2016 Employer: TreMonti Consulting Title: Pharmaceutical Consultant Department: Responsibilities: Expert wrote 50+ reports on IP assessment for various U.S. and foreign universities and hospitals. His fields of specialization were Pharmaceutical, Biotechnology, Nutraceutical, Medical Device, and Chemistry.
Years: 2009 to 2011 Employer: Pfizer Consumer Healthcare Title: Regulatory Analyst; Project Manager; Consultant Department: Responsibilities: Expert provided scientific and regulatory assessment of a variety of manufacturing plant post-approval change controls and communicated information to stakeholder affiliates in key global markets: U.S./Canada, Asia, Europe, Middle East, and Central/South America.
Years: 2008 to 2009 Employer: ICON Development Solutions Title: Senior CMC Regulatory Scientist Department: Responsibilities: Expert managed writing, compiling, and editing of CMC sections (drug substance/drug product) for two IMPDs (lyophilized biologics: recombinant growth factor and hormone) and BLA (interferon). He also wrote and compiled sNDA (semisolid) to support manufacturing site change (SUPAC). He wrote IND for small molecule psychiatric drug (capsules) and parts of NDA for controlled-release tablet product.

During this time Expert also conducted significant regulatory consulting, including the assumption of lead CMC role during client conferences. He provided global clients with regulatory strategy and provided regulatory advice on ANDA and NDA. He handled clinical supply chain management issues and managed client project timelines to ensure on-time and on-budget deliverables. He published two articles during this time.
Years: 2000 to 2003 Employer: CAPRICORN PHARMA (now IZEEN Pharma) Title: Senior R&D Manager Department: Responsibilities: Expert successfully took nutraceutical & OTC products from lab concept to manufacturing scale-up (900# batches). He developed sugarless softchews, bars and rapid-dissolve Dextromethorphan tablets. He also developed a variety of nutraceutical soft chew products (both sugar-based) and sugarless. Soft chews could also contain gelatin which would vary the chew properties. Goals included bone health, joint health, antacid, anti-gas, weight loss, energy, immunity, breath freshening, and fiber. His responsibilities also included Business Development, wherein he wrote marketing literature and presented prototype products to senior management at Fortune 500 companies. He filed two provisional patents as co-inventor. He was also responsible for all phases of project management.
Years: 1992 to 2000 Employer: TIC GUMS, Inc. Title: Food Chemist / Senior Technical Services Representative Department: Responsibilities: Expert gained working with hydrocolloids to create flavor emulsions, suspensions, and semi-solid formulations. He worked with vitamin-mineral premixes to create a variety of beverage products. He also evaluated the stability of emulsions via accelerated studies, and particle size using the Coulter counter.

Government Experience

Years Agency Role Description
Years: 2012 to 2013 Agency: USA/FDA Role: Post-doc Research Scientist Description: Conducted formulation research & published 3 papers.

Career Accomplishments

Associations / Societies
AAPS, American Chemical Society (ACS)
Professional Appointments
Expert was invited to serve as a writer and editor for the 7th and 9th editions of the Handbook of Pharmaceutical Excipients (London). The handbook is used in pharmacy schools internationally.

He has also been invited to serve as scientific editor for the Journal of the Association of Official Analytical Chemists International. He has edited 60 manuscripts thus far from foreign universities, taking into account content, aspects of pharmaceutical chemistry, spectroscopic analysis, and analytical method validation.
Awards / Recognition
FDA- Medical Counter Measures – Best Technical Poster Award
Phi Kappa Phi & Rho Chi Honor Societies
AAPS Maryland Student Chapter Travel Award
PDA Pharmaceutics Fellowship: $20,000
GRASP, Brooklyn, NY: Best research poster
Publications and Patents Summary
Expert has 65 publications. Topics include nutraceuticals, regulatory/policy, food product development and ingredients, and pharmaceuticals. More information available upon request.

Additional Experience

Expert Witness Experience
Expert is currently a Retained Scientific Expert (January 2016-present) regarding Nutraceutical and Pharmaceutical Litigation.
He lends his expertise in tablet and capsule formulation, CMC issues, manufacturing, and trade secret and patent infringement.
He has developed experience reviewing/summarizing deposition testimony and writing opinion rebuttal report (76 p.) for the CEO defendant to answer the plaintiff's expert report (30 p.). He has experience giving deposition testimony.
This case involves several trade secret infringment claims by the Plaintiff against the defendant. Lawyer trying to get expert report of Plaintiff thrown out as net opinion, they did not provide adequate scientific justification for their case while I did. I successfully defended my points during my deposition and was not intimidated by being cross-examined by plaintiff's attorney. Experience giving deposition testimony (Trial: Jan. 2017). Excellent oral and written communication skills.
Other Relevant Experience
Expert has consulted to MedTech Insight (2009) and 3DDD Research (2015) by writing and editing market research chapters on pain management therapies, arthroplasty implants, lab-on-a-chip technology and devices, and proteomics. He also wrote Market Research chapters on Age-related Macular Degeneration (AMD) and Diabetic Retinopathy. In this capacity he covered clinical summaries, market forecast, and strategic pharmaceutical product analysis.

Expert also briefly worked with Bristol Myers Squib, where he prepared wet, foam, and MADG granulations (using silicon dioxide) of Metformin, Aspirin, APAP, and Atazanavir. He studied differences in particle size, morphology, and surface area. He studied mechanical properties of the different API granulations using Hiestand Indices. The manuscript was published in Powder Technology with Expert as first author.

Language Skills

Language Proficiency
English (written and oral) Excellent

Fields of Expertise

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