Michael Kopcha, Phd, Rph Email & Phone Number

Silver Spring, Maryland

Providing executive leadership, technical management, and operational direction of eight subordinate offices each containing division-level subunits with a multidisciplinary staff of 1370+ medical, scientific, and professional support staff.Overseeing and coordinating the overall regulation of pharmaceutical quality in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research. Responsibilities include submission review, manufacturing facility and process assessment/inspection, policy development, regulatory research, and surveillance of the state-of-quality in the pharmaceutical industry. Leading the design and execution of all office programs and the coordination of partnerships between various FDA offices, centers, and other government agencies needed to perform assigned program responsibilities. Ensuring the quality and availability of new, biotechnology, generic, and OTC drugs in the US market.

Led the R&D Cough/Cold/Respiratory (CCR) Franchise Team in the design and execution of the Global R&D CCR Franchise strategic plan and projects to drive innovation and accelerate growth.Led, managed and worked with R&D associates in Project Management, Clinical Research, Clinical Development, Medical Affairs, Drug Safety, Global Product Development, and Global Regulatory Affairs.Evaluated medical, pharmaceutical, and regulatory market trends, consumer needs and opportunities, and planned product innovation priorities accordingly. Managed and drove third-party alliance teams and ensured success by creating consensus on a global basis.Drove the development of innovation solutions to resolve scientific, manufacturing and commercialization issues.

Completely restructured and reorganized Global Product Development to yield a Category- focused (Pain, Digestive Health, Cough/Cold, and Established Products), globalized organization driving over 100 innovation, development and maintenance-of-business projects to meet five-year product pipeline deliverables on time and within budget. Developed, implemented and drove aggressive, strategic off-shoring/outsourcing program to increase project capacity by 25% with savings of almost $3MMSuccessfully planned, designed, built and transitioned R&D associates to a state-of-the-art development facility in Hyderabad, India.Directed New Technologies and Product Innovation group to identify, evaluate and implement new breakthrough technology platforms to deliver a robust R&D innovation strategy and pipeline aimed at addressing unmet consumer needs.

Led and managed New Technology Platform teams responsible for search, screen and qualification for development of new technologies applicable for strategic categories and brands.Identified, evaluated and implemented new breakthrough technology platforms to deliver R&D innovation strategy.Led Intellectual Property creation, Open Innovation, and Sensory Guidance strategies.

Defined, secured support for, and executed the strategic plan to supply over 150 technically-superior OTC pharmaceutical dosage forms through the leadership of the Pharmaceutical and Analytical Development functions. Approximately 25 projects were managed through External Development which reported through Pharmaceutical and Analytical Development. Led and managed the development of new technology platforms applicable to strategic categories and brands.Spearheaded Quality by Design and new product development and technology transfer process to enhance rapid product development and commercial introduction through standardization and harmonization of global processes. Conducted routine and rigorous resource and capacity planning for formulation development, process development to scale-up, analytical method development, and validation to enable the rapid and accurate development of new OTC brands across four global development sites.

Provided functional leadership through directing and managing Analytical Research and Development, Product Development, Process Development and Technology Transfer, Stability, Drug Delivery, Project Management, and External Alliance for branded and generic products. Executed budgeting activities that included active pharmaceutical ingredient sourcing and procurement as well as bioequivalence studies and staffing.Developed 166 internally and externally assigned ANDA and NDA projects.

Provided global functional leadership through directing and managing Analytical Research and Development, Formulation Development, Technical Operations, Biopharmaceutics, Project Management and Active Pharmaceutical Ingredient Sourcing in support of global generic pharmaceutical objectives. Completed development of 35 internally and externally developed projects that resulted in 28 ANDA submissions.

Actively interacted with Ethicon’s Business Units in establishing their strategic direction on drug/device and drug delivery discovery and development programs.Mapped out and executed drug/device and drug delivery programs.Worked with internal and external partners (e.g., Alza, Corporate Biomaterials and Advanced Technologies, J&J Pharmaceutical Research and Development) to develop and execute programs.

Implemented, managed and drove the Strategic Life Cycle Management process for products in Johnson & Johnson’s global pharmaceutical portfolio.Worked closely with the Global Commercial Leaders and Global Product Leaders to ensure Life Cycle Opportunities were identified, prioritized and executed.

Ph.D., Pharmaceutical Science

M.S., Pharmaceutical Science

B.S., Pharmacy