Chemistry, Manufacturing and Controls (CMC) and Regulatory Strategy Expert

Expertise

CMC Specialties in Pharmaceutical and Biopharmaceutical Industries

• CMC regulatory strategy, critical review and assessment, related to the content of the drug substance, Active Pharmaceutical Ingredient (API) and drug product quality modules (Module 2: Quality Overall Summary (QOS) and Module 3: Quality of the Common Technical Document (CTD) for regulatory Submissions).
• Interpretation and application of CMC regulatory regulations and guidances for Investigational New Drugs (IND), New Drug Applications (NDA), and Drug Master Files (DMF).
• Strategic advice on the interpretation and application of CMC regulatory guidances, legal requirements of CMC regulations and establishment of CMC case study precedence.
• CMC regulatory strategy development and implementation inclusive of quality, safety and efficacy Interconnections.
• CMC regulatory gap analysis for identification, assessment and provision of CMC regulatory mitigation strategies for remediation.
• Mitigation strategies for CMC regulatory conformance and compliance.
• CMC regulatory planning, preparation and participation for FDA (Food and Drug Administration) or European Medicines Agency (EMA) meetings.
• CMC regulatory problem solving related to Active Pharmaceutical Ingredient (API), drug product, dosage form, Contract Manufacturing Organization (CMO) or technology transfer.
• CMC regulatory sciences due diligence for assessment, analysis, summary and recommendations for potential startups, joint ventures, acquisitions or business partnerships.
• CMC regulatory affairs with various global pharmaceutical companies (Pfizer, Wyeth, Bristol-Myers Squibb, DuPont Pharmaceutical Company and Rhone-Poulenc Rorer).
• Demonstrated expertise in leading multidisciplinary, cross-function teams for successful CMC strategic planning, execution and approvals of global regulatory submissions.
• CMC leader of regulatory approvals for New Molecular Entities (NME) and drug product dosage forms, reformulations and line extensions for medicines including: TAXOTERE%uFFFF, GLIADEL%uFFFF, Wafer, LYBREL%uFFFF, CONBRIZA%u2122, PREMARIN%uFFFF, and PREMPRO%u2122, several of which achieved global sales of more than $U.S. 1 billion.

Experience

Undisclosed Company, President, Present

• Interpretation and application of CMC regulatory regulations and guidances for Investigational New Drugs (IND), New Drug Applications (NDA), and Drug Master Files (DMF).
• Strategic advice on the interpretation and application of CMC regulatory guidances, legal requirements of CMC regulations and establishment of CMC case study precedence.
• CMC regulatory strategy development and implementation inclusive of safety and efficacy interconnections.
• CMC regulatory gap analysis for identification, assessment and provision of CMC regulatory mitigation.
• Strategies for remediation mitigation strategies for CMC regulatory conformance and compliance.
• CMC regulatory planning, preparation and participation for FDA (Food and Drug Administration) or European Medicines Agency (EMA) meetings.
• CMC regulatory problem solving related to Active Pharmaceutical Ingredient (API), drug product, dosage form or Contract Manufacturing Organization (CMO).
• CMC regulatory sciences due diligence for assessment, analysis, summary and recommendations for potential startups, joint ventures, acquisitions or business partnerships.

Pfizer Inc., Collegeville, PA, Senior Director, Global Regulatory Affairs CMC, 2009 - 2010

• Primary liaison between Chemical Research and Development (CR&D) and Active Pharmaceutical.
• Ingredients (API) Technical Operations & Product Supply (TO&PS) organizations and Global Regulatory Affairs (GRA) CMC for strategic CMC regulatory issues related to APIs .
• Provided CMC regulatory strategy, critical review and assessment, related to the content of the drug substance / Active Pharmaceutical Ingredient (API) and drug product quality modules; (Module 2 : Quality Overall Summary (QOS) and Module 3 : Quality) of the Common Technical Document (CTD) for regulatory submissions.
• Provided CMC strategy for regulatory agency meetings on API issues (Quality by Design (QbD), comparability protocols, bridging strategies, genotoxic impurities qualification strategies, etc.)
• GRA CMC representative on the API late development council governance body.
• GRA CMC representative to the Genotoxic Impurities Specification Subteam (GISS), API and drug product Specifications Committee and Impurities and Excipients Oversight Board (IOB) governance bodies.
• Subject Matter Expert (SME) assigned to conduct regulatory and technical due diligence for the in-licensing assessment of New Molecular Entities (NCEs) or novel innovative technologies.
• Responsible for the recruitment, contracts, budget, utilization and allocation of a network of external CMC regulatory experts and consultants to support key, strategic regulatory issues.
• Involvement in API Vendor selection and Quality Agreements to provide critical assessment and solutions for strategic CMC issues related to API Contract Manufacturing Organizations (CMOs).
• Provided internal and external regulatory training on API issues for the New Products & Process Department, (NPPD), Chemical and Pharmaceutical Development (CPD) and API TO&PS and GRA Organizations
• Wyeth representative for API regulatory initiatives with the pharmaceutical research and manufactures of America (PhRMA) Analytical Technical Group (ATG) Subteam on Genotoxic Impurities and PhRMA Support Team for the Expert Working Group (EWG) on development of ICH Q11 guidance for "Development and Manufacture of Drug Substances (chemical entities, biotechnological and biological entities)."

Wyeth, Collegeville, PA, Senior Director, Global Regulatory Affairs CMC, 2002 - 2008

• Management of Women's Health franchise for CMC Regulatory Affairs Team.
• Global responsibility for life-cycle CMC regulatory support for Women's Health products: Lybrel%u2122, (0.09 mg levonorgestrel/0.02 mg ethinyl estradiol tablets), Alesse%uFFFF (0.1 mg levonorgestrel/0.02 mg ethinyl estradiol tablets), Lo/Ovral%uFFFF tablets (0.3 mg norgestrel and 0.03 mg ethinyl estradiol tablets), Premarin (conjugated estrogens), vaginal cream, Premarin(conjugated estrogens tablets, USP), Premarin Intravenous (conjugated estrogens, USP for injection), PREMPHASE%uFFFF (conjugated estrogens / medroxyprogesterone acetate tablets), PREMPRO (conjugated estrogens / medroxyprogesterone acetate tablets), Triphasil%uFFFF (levonorgestrel and ethinyl estradiol tablets - triphasic regimen).
• CMC global regulatory responsibility for New Drug Applications (NDA, MAA, NDS) or Marketing Applications - Low Dose PREMPRO%u2122, conjugated estrogens/Trimegestone, Lybrel (90%u03BCg levonorgestrel/20%u03BCg ethinyl estradiol tablets), Viviant%u2122 / Conbriza (bazedoxifene), DUAVEE%uFFFF (conjugated estrogens/bazedoxifene).
• CMC global regulatory responsibility for clinical trial applications for six (6) development projects.
• Responsible for CMC regulatory interactions and strategy planning within Wyeth and as the liaison with third party Contract Manufacturing Organizations (CMO).
• Responsible for the coordination of responses to worldwide regulatory agency questions or inquires related to CMC, organization of CMC meetings with the FDA, CMC regulatory contact with FDA CDER, office of pharmaceutical sciences.
• Lead multidisciplinary CMC registration teams and appointed as the CMC regulatory affairs representative to global development teams, technology transfer teams, global brand teams, global regulatory teams.
• Appointed Wyeth representative to the Product Quality Research Institute (PQRI) for the PQRI sulfonate esters working group.

Bristol-Myers Squibb Company, Sciences CMC, Princeton, NJ, 2001 - 2002

Associate Director, Global Regulatory

• CMC Life-Cycle regulatory responsibility of antibiotic ANDAs, antibiotic Type II DMFs and planning for ANDA supplements or MA variations.
• CMC global regulatory responsibility for original IND, development product in CNS, cohorts in the Anti-Viral / HIV therapeutic area, Phase 2 IND, CTXs and CTA and amendments.
• Regulatory interactions and strategy planning with third party contract manufacturers organizations.
• Coordination and execution to provide responses to worldwide regulatory agency questions or inquires related to CMC.
• Organization of CMC meetings with the FDA.
• Appointed CMC regulatory contact with FDA CDER, Office of Pharmaceutical Sciences, Anti-Virals Division.
• Appointed Team Leader for coordination and provision of company comments on draft regulatory guidances to CPMP EMEA.
• Appointed Interdisciplinary Team member for BMS IND Reform Initiatives.

DuPont Pharmaceuticals Company, Wilmington, DE, 1999 - 2001

Director, Worldwide CMC Regulatory Affairs

• CMC life-cycle regulatory responsible for: Cardiovascular products development in the, CNS, oncology and anti-viral and HIV therapeutic areas, and vitro diagnostic device.
• Provided global regulatory guidance, coordination, review and approval of CMC sections for (5) Phase 1 and First in man studies, CMC sections for INDs, CTXs, CTAs and CMC sections for multiple Phase 1, Phase 2 and Phase 3 INDs, CTXs, CTAs amendments.
• Served on DuPont Pharmaceuticals Company Commercial and Research and Development Stability Review Board committees to provide global regulatory requirements for issues related to stability.
• Appointment: DuPont Pharmaceutical Company CMC Regulatory Affairs Subject Matter Expert representative for in-licensing activities to provide global CMC regulatory assessment for cardiovascular product
• Appointment: CMC Regulatory Affairs Representative, as a member of the multidisciplinary team formed to address requirements for electronic preparation and submission of CMC sections of global regulatory submissions in the Common Technical Document (CTD) format.
• In-licensing activities to provide global CMC regulatory assessment for a cardiovascular product.

Chairperson and Contract Administrator

• CMR International for Benchmarking CMC Survey Taskforce.

Rh%uFFFFPoulenc, Collegeville, PA, 1977 - 1999

Senior Manager, Worldwide CMC Regulatory Affairs Liaison, 1995 - 1999

• CMC Regulatory Affairs Department Subject Matter Expert (SME) responsible for preparation, filing and approval of CMC NDA and NDS supplements and MAA variations for Taxotere (docetaxel) and, GLIADEL Wafer (polifeprosan 20 with carmustine implant)
• Responsible for CMC regulatory affairs for the Mutual Recognition Procedure for approval of GLIADEL Wafer (polifeprosan 20 with carmustine implant) in Europe and supported NDS approval for Canada and international markets (Australia, South Africa).
• Responsible for preparation and filings of CMC sections for eleven (11) INDs / CTXs / CTAs for oncology, anti-hypertensive, anti-asthmatic, anti-parkinsonian, anti-stroke, anti-diabetic, anti-emetic, anti-thrombotic (iv and oral), cardioprotective and anti-restenotic agents and maintenance for CMC amendments.
• Responsible for coordination and support for international implementation of CMC changes by working directly with International RPR regulatory affiliates in Europe (U.K. and France), Australia, Canada, Mexico and South Africa.
• Appointed regulatory contact with FDA CDER, Office of Pharmaceutical Sciences, Oncology and CardioRenal Divisions.
• Responsible for agency interactions with FDA, CPMP EMEA and MCA for meetings, agency inquires and responses.
• Appointed to represent CMC Regulatory Affairs on four (4) global project teams for either development or marketed products in cardiovascular, oncology and anti-inflammatory therapeutic areas,
• Appointed as the CMC Regulatory Affairs representative and Subject Matter Expert for the in-licensing
• Evaluation Task Force (New Business Development) to provide the CMC regulatory assessment on potential business opportunities for one (1) hormonal agent and two (2) cardiovascular agents.

Other Positions Held:

• Senior Manager, Worldwide CMC Regulatory Affairs Liaison, 1995 - 1999
• Department Director, Chemical Process Research Department, Collegeville, PA, 1977 - 1995