Expert Details
Pharmaceutical Regulatory Affairs; FDA/cGMP Compliance; Drug & Device Regulatory Submissions; Regulatory & Quality Systems Consulting; Expert Witness
ID: 735397
Connecticut, USA
Expert began an industrial career in analytical and formulation chemistry roles supporting pharmaceutical, consumer product, and specialty chemical development, before joining the FDA's Center for Drug Evaluation and Research as a review chemist in the Office of Generic Drugs, where Expert reviewed CMC sections of generic drug applications, contributed to national policy committees, and supported international regulatory harmonization efforts. Expert then moved into pharmaceutical industry regulatory leadership, rising to divisional Vice President of Drug Registration and Regulatory Affairs at a major pharmaceutical company, where Expert set new industry standards for generic drug application review and bioequivalence study design.
For the past 25 years, Expert has led an independent regulatory affairs and CMC consulting practice, providing global regulatory filing strategy, cGMP compliance auditing, technical due diligence, and interim regulatory leadership services to pharmaceutical, biologics, medical device, and generic drug manufacturers worldwide, including numerous engagements supporting FDA-approved drug and drug-device products and Consent Decree/Warning Letter remediation. Expert has also served as a CMC and regulatory affairs subject matter expert and expert witness in approximately a dozen pharmaceutical litigation and arbitration matters involving generic drug patent disputes, product liability, and regulatory compliance issues. Expert is a co-inventor on multiple patent filings related to capsaicin-based pharmaceutical formulations and has authored peer-reviewed research on pharmaceutical analytical methods.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1992 | Degree: Master of Business Administration | Subject: International | Institution: University of Bridgeport |
| Year: 1988 | Degree: Master of Science | Subject: Biochemistry | Institution: New York Medical College |
| Year: 1982 | Degree: Bachelor of Science | Subject: Chemistry | Institution: Virginia Commonwealth University |
| Year: 1980 | Degree: Bachelor of Science | Subject: Biology | Institution: Virginia Commonwealth University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1996 to Present | Employer: Undisclosed | Title: Principal | Department: |
Responsibilities:For 30+ years as a consultant in his own pharmaceutical development advisory firm, he has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls to current Good Manufacturing Practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services is furnished to institutional investors.He has contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues. Expert has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness for several cases. As a retained consultant, clients have furnished services in the areas of global regulatory filing review, writing, Agency negotiation, strategic advisories, contracted management services, and executive search. Filing services include review/writing of Chemistry and Manufacturing Controls (CMC) sections for NDA, ANDA, IND (biologicals and new chemical entities), 505(b)(2), DMF, 510(k), Type I & II, MAAs/CTX, and International filings. Other services include cGMP (QC/QA), due diligence, mock pre-approval inspections, R&D portfolio, and Business Analysis. |
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| Years | Employer | Title | Department |
| Years: 2002 to 2005 | Employer: AlgoRx, Inc. | Title: Vice-President | Department: Regulatory Affairs |
Responsibilities:Serving as Vice-President of Regulatory Affairs and Quality Operations for the “virtual” development-stage pain management firm, CMC, Formulation, QA/QC, and Regulatory filing management furnished to out-sourced domestic and international development units for three products in Phases 1, 2, and 3:• Synthetic new chemical entity (NCE); pre-formulation studies -- proof of concept, and first in man trials. • AdleaTM parenterally administered formulations of ultra-purified, and synthetic Capsaicin (currently in Phase 3). • ZingoTM (PowderJect® lidocaine) needle-free anesthetic. Drug-device 505(b)(2). NDA approved, 2007. • Filing of INDs, CTXs, staffing; external vendor selection, and cGMP compliance oversight, batch record review; international/domestic clinical study supplies management; regulatory strategy and Agency meetings. |
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| Years | Employer | Title | Department |
| Years: 1994 to 1996 | Employer: Sandoz Pharmaceuticals Corporation | Title: Sr. Associate Director/division VP | Department: Regulatory Affairs |
Responsibilities:Successfully guided, educated, and project managed the domestic and international regulatory and manufacturing functions within Sandoz, toward preparation and timely submission of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) to the FDA for Sandoz products, which have and/or are due to come off-patent.Clozapine Tablets and Drug Master File (SANDOZ Clozaril®) ANDA approved 1995 First US generic product to employ a patient-based bioequivalence study First-time generic product approved in 7 months from its first filing Cyclosporine Capsules and Drug Master File (SANDOZ Sandimmune®) ANDA approved 2000 Successfully guided, educated, and project managed the domestic and international regulatory and manufacturing functions within Sandoz, toward preparation and timely submission of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) to the FDA for Sandoz products, which have and/or are due to come off-patent. Set the standard for review of competing generic filings through the preparation of five first-of-their-kind original ANDAs for Clozapine, Cyclosporine, and Bromocriptine dosage forms, as part of a larger strategy to promote Sandoz brand protection. Filed landmark citizen’s petition in conjunction with the preparation of first-of-their-kind patient-based clinical bioequivalence studies (Clozapine) to set the industry standard for review by the Agency; similar legal and strategic advisories rendered for the other flagship products. Coordinated the activities of outside consultants. Regulatory advisories in the areas of cGMP compliance, Chemistry and Manufacturing Control documentation, and bioequivalency standards, from first-hand knowledge of FDA/OGD expectations. Business development and licensing advisories provided in the context of OTC switches, joint ventures, site changes, and new products. Promotion from Associate Director to Senior Associate Director for Drug Registration and Regulatory Affairs (DRRA) for Sandoz and awarding of the title of Vice-President of DRRA for the Creighton Pharmaceuticals generics division. |
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| Years | Employer | Title | Department |
| Years: 1992 to 1994 | Employer: US Food and Drug Administration (USDA) | Title: Review Chemist | Department: Office of Generic Drugs (OGD) |
Responsibilities:Drafting deficiency or approval letters in the course of a thorough review of chemistry and manufacturing controls sections of original and supplemental ANDAs and DMFs, resulting in fewer required review cycles for applicants. Sought and obtained expanded assignments at other FDA offices within the Centers for Drug Evaluation and Research (CDER), reviewing INDs and supplemental NDAs. Delegated branch supervisory duties in the absence of the branch chief. Contributions to several policy-crafting CDER committees: Chemistry and Manufacturing Controls Coordinating Committees (CMCCC) preparation of policy and procedure guides (PPGs) for bioequivalence evaluation of topicals.Employed superior communication skills in drafting coherent deficiency or approval letters in the course of a thorough review of chemistry and manufacturing control sections of original and supplemental ANDAs and DMFs, resulting in fewer required review cycles for applicants. Sought and obtained expanded assignments at other FDA offices within the Centers for Drug Evaluation and Research (CDER), reviewing INDs and supplemental NDAs. Delegated branch supervisory duties in the absence of the branch chief. Contributions to several policy-crafting CDER committees: Chemistry and Manufacturing Controls Coordinating Committees (CMCCC), prepared policy and procedure guides (PPGs) for bioequivalence evaluation of topicals. Contributions to drug monographs performed in conjunction with the preparation of FDA guidances for presentation to the International Conference on Harmonization (ICH). Appointed to the position of Program Manager for the industry visitation initiative. Serving on the Committee for Continuing Training and Educational Development, headed up favorably received visitations to 16 sites planned and scheduled on behalf of 40 OGD review staff to broaden reviewers' technological exposure and to promote industry-Agency dialog. Program slated to expand to include other CDER offices. |
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| Years | Employer | Title | Department |
| Years: 1987 to 1992 | Employer: Bayer Pharmaceuticals USA, Miles Laboratories division | Title: Associate Scientist | Department: Quality Assurance |
Responsibilities:Group leadership responsibilities, including the training and coordination of the assigned workloads of 8 technicians for the finished product and raw materials Quality Assurance laboratory. Recommendations implemented for equipment upgrades; delegated with laboratory supervision in the absence of managers.Sharpening existing and new methods for clarity and editing/validation of analytical methods for NDA and IND submissions accomplished, conforming European (Bayer AG) methods to USP protocols. Scheduling of analytical testing for parenteral, cremes, ointments, lotions, otic solutions, tableted products, and raw materials and timely coordination with manufacturing toward negotiated product and packaging release timetables. |
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| Years | Employer | Title | Department |
| Years: 1984 to 1987 | Employer: Purdue Pharma | Title: Scientist | Department: Research and development |
Responsibilities:Development of stability protocols and bioassay methods and validations, employed to determine drug and metabolite levels in plasma and serum in pre-clinical animal and clinical patient studies for newly developed drug formulae (Phases I and II). Preparation and group presentations of technical reports, detailing data, which linked chemistries to critical pharmacokinetic studies; editing of test methods of European subsidiaries to conform to USP protocols. Participation in DEA and FDA audits.Acquired comprehensive credentials in industrial pharmacy: Tableting and granulating techniques (experimental and clinical sustained release narcotic, antibiotic, and vasodilator formulations), film coating, freeze-drying, Accelocoata fluid bed drying, and Glatt mixing equipment. |
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| Years | Employer | Title | Department |
| Years: 1982 to 1987 | Employer: Clinton Research Consultants, Inc. | Title: Consultant | Department: |
Responsibilities:Provided contracted consumer products, applications research, and development services, including concurrent placements as:• Nabisco Brands, Inc., Technology Center, Wilton, CT — Research Technologist — product development, surfactant, pilot plant, and sensory studies. • The Foxboro Company, Analytical Instrumentation, Norwalk, CT — Applications Scientist — IR spectral software programming for a new analytical instrument product launch. • Shaw Mudge and Company, Fragrance Formulators, Stamford, CT — Formulations Chemist — fragrance product development, QA, and rabbit conjunctival irritation studies. |
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Additional Experience
| Expert Witness Experience |
|---|
| Expert has served as a testifying and consulting CMC/regulatory affairs subject matter expert in approximately 12 litigation and arbitration matters between 2011 and 2019, retained by both plaintiffs and defendants, drawing on Expert's background as a former FDA review chemist and pharmaceutical regulatory affairs executive. Subject matter has included: generic drug patent and Hatch-Waxman-adjacent disputes, including antitrust-related litigation alleging delay of generic drug entry; a CMC/technology dispute involving a specialized drug manufacturing process; a sterile pharmaceutical product labeling dispute; product liability and alleged contamination matters involving pharmaceutical and compounded products; a diagnostic medical device regulatory matter; and a business/consulting services arbitration. |
Career Accomplishments
| Associations / Societies |
|---|
| • Food and Drug Administration Alumni Association • Regulatory Affairs Professional Society • American Association of Pharmaceutical Scientists • American Chemical Society |
| Licenses / Certifications |
|---|
| • Continuing education: Leadership-4 Performance Management — Charter Oak Consulting Group • Continuing education: Communication and Team Building — Gatto Training Associates • Continuing education: Positive Power and Influence — Situation Management Systems • Continuing education: Bioequivalence, Bioavailability, and Therapeutic Substitution — Technomic Publishing • Continuing education: Biotechnology — Center for Drug Evaluation and Research Staff College • Continuing education: ISO 9000/Q90 Documentation Standards — Quality Alert Institute • Educational Development Modules in Pharmaceutics — University of Maryland (Capsule Formulation/Filling/Manufacture; Dissolution and Bioavailability; Metered Dose Inhalers; Creams, Ointments, and Lotions Formulation; Sustained Release Formulation; Parenterals; Packaging) |
| Publications and Patents Summary |
|---|
| • 1 peer-reviewed journal publication (co-author): a method for quantification of polyethylene glycol 300 in drug formulations using flow injection analysis/mass spectrometry, published in International Journal of Pharmaceutics (2004) • 5 patent filings (co-inventor), relating to the synthesis, purification, and gel formulation of capsaicin/capsaicinoids, including U.S., international (PCT), and European patent applications (2004–2005) |
Fields of Expertise
pharmaceutical dissolution, pharmaceutical analytical chemistry, pain medication, drug development, Food and Drug Administration compliance, pharmaceutical start-up plant, Food and Drug Administration chemical registration, generic drug, biologic (product), CMC, FDA, cGMP, 505(b)(2), DMF, 510(k), IND, Office of Generic Drugs, CDER, Consent Decree, Warning Letter, Drug-Device Combination Product, Good Distribution Practice, Pharmaceutical Litigation, API, Common Technical Document, ICH, Generic Drug Regulatory Strategy, Pharmaceutical Due Diligence, Consent Decree Remediation, gene therapy, Current Good Manufacturing Practice, bioequivalence, Quality Systems, regulatory affairs