Pharmaceutical Quality Compliance and Regulatory Affairs Expert - Drug, Device, and Biologics

Expertise

• Chemistry and Manufacturing Controls (CMC).
• Regulatory strategy; domestic and international.
• cGMP compliance drug: 21 CFR 210, 211.
• cGMP compliance nutritional supplements/NSF Certification: 21 CFR 111.
• cGMP compliance drug device combination: 21 CFR 4.
• Quality systems regulation: 21 CFR 820, ISO 13485.
• Merger and acquisitions - 3rd party vendor due diligence.
• Regulatory filing: pre-submission review, writing: NDA, ANDA, 505(b)(2), 510(k), PMA, BLA, DMF, IND., type I and II variations, and MAA (EU).
• eCTD Module 2 and 3 review, revision and authorship.
• Interim regulatory and quality management; maternity coverage.
• Mock pre-approval inspections.
• Compliance remediation: Consent decree, Warning letter, and Form 483 response.

Expert Witness Experience

• Generic industry CMC Regulatory Affairs Subject Matter Expert - Case involving anti-competitive practices litigation.
• CMC Subject Matter Expert - Case; alleged product contamination.
• Regulatory Affairs Subject Matter Expert - Case; Pharmacy products liability litigation.
• Oxycontin® patent litigation.
• Workplace gender discrimination dispute.
• CMC Subject Matter Expert - Case: Failure of updating product.
• CMC Subject Matter Expert - Case: Failure of generic firm to pay a royalty.

Experience

Undisclosed Company, Principal, 1996 - Present

Consultant, and Expert in the following areas, Subject Matter, Senior Regulatory Affairs (CMC), Senior Bio-Analytical, CGMP, Project Manager, Senior Clinical and Pre-Clinical Expert

• Medtronic: Endeavor® Zotarolimus drug eluting stent, IDE, CTA, and PMA filings.
• NuPathe: Zecuity® sumatriptan dual reservoir patch NDA approved.
• Intelliject/Sanofi: Auvi-Q® epinephrine injector; NDA approved.
• Millennium: Module 2 & 3 eCTD services to early stage BLA candidates (MEPACT®).
• BMS; compliance submissions Initiative; EU filings, eCTD Type I and II variations.
• Clinical supplies cGMP Quality Systems SME, Boehringer Ingelheim; mock-PAI.
• SME, MDS-Pharma; 5-year retrospective bioequivalence review mandated by FDA.
• cGMP, U.S., pharmacopoeia - promoting the quality of medicines.
• cGMP compliance, Corpak Medsystems, warning letter resolution; medical device.
• cGMP compliance, Lonzo Biologics; Q7 mock-inspection, warning Letter remediation.
• cGMP compliance Wyeth, and GSK, consent decree remediation.
• Quality systems SME, Memorial Sloan-Kettering Cancer Center. Establishment of a regulatory and cGMP compliant quality system/SOPs for 11 clinical investigator's and API synthesis labs. IND preparation and review (biologics, radio-labeled peptides, devices, and new chemical entities).
• Regulatory affairs, CMC Project Management Consultant, Allergan; redesign of change control systems, regulatory affairs, Manufacturing Quality Change Control Review board; regulatory affairs, management succession plan, and department work-flow re-structuring.
• As acting Vice-President, Regulatory Affairs and Quality, OptiNose, U.S, Inc. lead filing and licensed partnership regulatory submission management for company's first 505(b)(2) NDA for Sumatriptan Breath Powered™ Powder Delivery system (AVP-825). Outsourced due diligence, vendor selection, and development of regulatory strategies for Fluticasone Breath Powered™ Bi-Directional device (OPN-375).
• As acting Vice-President, Regulatory Affairs, Taro Pharmaceuticals, U.S.A., Inc., U.S, Israel, Canada regulatory functions were coordinated, toward submission of U.S., Canadian, and International filings. Approvals obtained for 19 ANDAs, and 2- 510(k)s, 10 original DMFs, and an MAA for UK. Accomplished senior level (i.e., Director and VP) staffing of regulatory departments for Taro in Canada and NY.
• As acting Director of Regulatory Affairs, Boehringer Ingelheim; Site change and supplemental filing s for MICARDIS-HCT®.
• As Acting Regulatory Affairs Manager, CMC (maternity coverage), GENZYME; supplement European (EU) eCTD filings, Renvela®. Site change control.
• As acting Director, Quality Assurance and Regulatory GMP/GLP, Oread, Inc., starting-up Oread's Rapid Response Laboratory, including SOP review/revision/composition, senior staff sourcing, establishment of laboratory GLP and GMP compliance systems, client support, regulatory liaison and advisory.

AlgoRx Pharmaceuticals, Inc., Secaucus, NJ, Vice President, 2002 - 2005

• As Vice-President of Regulatory Affairs and Quality Operations for the "virtual" development-stage pain management firm, AlgoRx, Inc. (now, Anesiva), CMC, Formulation, QA/QC, and regulatory filing management furnished to out-sourced domestic and international development units for three products, Phases 1, 2 and 3:
• Synthetic new chemical entity (NCE); pre-formulation studies -- proof of concept, and first in man trials.
• Adlea™ parenterally administered formulations of ultra-purified, and synthetic Capsaicin (now in Phase 3).
• Zingo™ (PowderJect lidocaine) needle-free anesthetic. Drug-device 505(b)(2) NDA approved, 2007.
• INDs, CTXs, staffing; external vendor selection, and cGMP compliance oversight, batch record review; international/domestic clinical study supplies management; regulatory strategy and agency meetings.
• Pre-clinical GLP protocol execution and study site auditing in U.S. (Charles River Labs), Canada (CTBR- Inveresk) and Quintiles Transnational (Edinburgh, Scotland, U.K.)

Sandoz Pharmaceuticals Corporation, East Hanover, N.J., 1994 - 1996

Senior Associate Director, and Division Vice President

• Successfully guided, 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 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 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 and 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.

United States Food and Drug Administration, Rockville, MD, Review Chemist, 1992 - 1994

• Employed superior communication skills in drafting coherent deficiency or approval letters in the course of 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 with 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 preparation of FDA guidances for presentation to the International Conference on Harmonization (ICH).
• Appointed to 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.

Bayer AG, West Haven, CT, Associate Quality Assurance Scientist, 1987 - 1992

• 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.
• Increased group productivity, efficiency, and time savings by training staff in instrumentation troubleshooting techniques and maintenance toward safe and effective operation of standard equipment and automated control devices (HP-3350A).
• Sharpening existing and new methods for clarity and editing and validation of analytical methods for NDA and IND submissions accomplished, conforming European (Bayer AG) methods to USP protocols.
• Scheduling of analytical testing for parenterals, creams, ointments, lotions, otic solutions, tableted products, and raw materials and timely coordination with manufacturing toward negotiated product and packaging release timetables.

Purdue Pharma L.P., Yonkers, NY, Scientist, Experimental Formulations, 1984 - 1997

• 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.

Honors & Publications

Academic and Professional Affiliations

• Regulatory Affairs Professional Society
• Food and Drug Administration Alumni Association

Publications

• Co-Author: A flow injection analysis/mass spectrometry - quantification of polyethylene glycol 300, drug formulations (partial topic)

Patents

• Capsaicin (Synthesis and Purification)
• Synthetic Capsaicin, (European) Preparation and Purification

Education

• MBA International Business, University of Bridgeport, Bridgeport, CT
• M.S. Biochemistry, New York Medical College, Valhalla, NY
• B.S. Chemistry, Virginia Commonwealth University, Richmond, VA
• B.S. Biology, Virginia Commonwealth University, Richmond, VA