Expert Details
Pharmaceutical Development
ID: 735397
Connecticut, USA
For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert 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 are furnished on-site, and worldwide 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 data integrity, Form 483, Warning Letter, and Consent Decree issues.
He has also been called upon to serve in interim and contracted Sr. Regulatory and Quality management roles for start-ups. mid-sized, and large pharma, as well as has served as a US Agent for firms located outside the US.
Expert has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness for several cases.
He began his career in pharmaceutical research and development with Purdue Pharma (Stamford, CT – MS-Contin®, Uniphyl®, Oxycontin®)(3 years), and continued on to Bayer (West Haven, CT – Mycelex®, Cort-Dome®, Adalat®, Kogenate®, Cipro®) where he served in Quality Control for 5 years. He was hired by the US Food and Drug Administration (Rockville, MD)(FDA) as a Review Chemist in 1992, where he served at Centers for Drugs Evaluation and Research, Office of Generic Drugs, reviewing and granting approvals for Chemistry and Manufacturing Controls (CMC) submissions. The Branch in which he served was dedicated to reviewing and approval of Topicals, Solutions, and Semi-solids as well as low dosage orals. He was the primary reviewer of and issued the first generic approvals among others for Timolol Maleate Ophthalmic solutions, Tretinoin creams, and he approved the first generic versions of Xanax® (alprazolam).
He was hired away from the Agency in 1994 to head up as division VP of Regulatory Affairs, the successful brand protection, anti-generic defensive strategies for Sandoz Pharmaceuticals Corporation (East Hanover, NJ), employing the contributions of staff based in the US and in Switzerland. In this role, he traveled frequently to Basel to work with and oversee both Regulatory staff and galenical/drug operations in what became the successful abbreviated new drug applications (ANDA) and drug master files (DMF) for Clozapine (Clozaril®) and the 11- (circular) polypeptide chain, Cyclosporine (Sandimmune®). With the merger of CIBA and Sandoz to form Novartis, he formed my own consulting firm.
The Expert's company celebrated its 23rd year in business in 2019 as a pharmaceutical regulatory affair, quality, GxP compliance, and due-diligence consulting firm.
A uniquely inter-disciplined individual, melding comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. A recognized professional with demonstrable successes in the guidance and preparation for final review of regulatory filings, and the rendering of strategic advisories, bearing upon domestic and international regulatory and business affairs.
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 25+ 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 | 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:Contracted consumer products, applications research, and development servicesNABISCO BRANDS, INC., Technology Center Wilton, CT • Research Technologist, product development, surfactant, pilot plant, and sensory studies. THE FOXBORO COMPANY, Analytical Instrumentation • Applications Scientist, IR spectral software programming for a new product launch, the MIRAN 1-B. SHAW MUDGE AND COMPANY, Fragrance Formulators • Formulations Chemist, fragrance product development, QA, and rabbit conjunctival irritation studies |
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Additional Experience
| Expert Witness Experience |
|---|
| CMC Regulatory Affairs, Former FDA Subject Matter Expert Witness on behalf of the Plaintiff, testimony in deposition regarding regulatory generic labeling requirements. Resolution in favor of Plaintiff. Case settled. CMC Regulatory Affairs Subject Matter Expert on behalf of the End-payor Plaintiff(s) in the case. Resolution in favor of Plaintiff; as to defendant 1: “agreement in principle,” as to defendant 2: Case settled. CMC Regulatory Affairs Subject Matter Expert on behalf of the Plaintiff(s) in the case, anti-trust litigation. The work done is confidential. Decision: Case settled. CMC Subject Matter Expert Witness on behalf of defendant in the case, (Southern District, Houston, TX) being sued for alleged product contamination. Decision: Defendant. Case dismissed Regulatory Affairs Subject Matter Expert Consultant on behalf of a defendant in the case, liability litigation. Civil Action. CMC Subject Matter Expert on behalf of plaintiff, (SETTLED in Phila. Cnty. Court of Common Pleas). CMC Subject Matter Expert on behalf of defendant, (SETTLED in Phila. Cnty. Court of Common Pleas). CMC Subject Matter Expert Witness on behalf of plaintiff, (PENDING in Southern District, NY). CMC Subject Matter Expert Witness on behalf of plaintiff, Civ. Action. (PENDING in D. Mass) CMC Subject Matter Expert Witness on behalf of defendant, (SETTLED in Southern District, NY). Medical Diagnostic Device Regulatory Affairs, FDA Subject Matter Expert engaged on behalf of the Plaintiff, (arbitration pending in Essex County, New Jersey) |
Career Accomplishments
| Associations / Societies |
|---|
| MEMBERSHIPS: Food and Drug Administration Alumni Association Regulatory Affairs Professional Society American Association of Pharmaceutical Scientists American Chemical Society |
| Publications and Patents Summary |
|---|
| PATENTS AWARDED AND PROVISIONAL PATENTS PENDING (Co-inventor): Synthesis and Purification of Capsaicin Synthesis and Purification of Capsaicin Preparation and Purification of Synthetic Capsaicin (European patent application) Capsaicinoid Gel Formulation and Uses Thereof Capsaicinoid Gel Formulation and Uses Thereof Publications: 1 |