Overview
Over the past few decades there has been a dramatic decline in domestic production of active pharmaceutical ingredients (APIs), raising important questions about patient safety, national security, drug availability, vulnerability, and quality. These concerns have only grown since the COVID-19 pandemic. This webinar will cover the roots and consequences of declining domestic API and finished dosage manufacturing on the drug supply chain, regulatory options for improving the quality of foreign-produced APIs and/or increasing domestic API production, and what changes can be made by companies, FDA, or Congress to strengthen the drug supply chain.
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Speakers
Jeffrey K. Francer, Senior Vice President and General Counsel, Association for Accessible Medicines (AAM) and Member, FDLI Board of Directors
Michael Ganio, Senior Director, Pharmacy Practice and Quality, Center on Medical Safety and Quality, American Society of Health-System Pharmacists (ASHP)
Ronald T. Piervincenzi, CEO, US Pharmacopeia
Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, FDA
Moderated by Beth P. Weinman, Counsel, Ropes & Gray LLP
JEFFREY K. FRANCER is Senior Vice President and General Counsel of the Association for Accessible Medicines, where he leads legal and international trade advocacy. Jeff served as Associate Chief Counsel of the Food and Drug Administration from 2003 to 2005, where he advised agency leaders on issues involving the regulation of drugs and biologics including clinical investigation, manufacturing, promotion, enforcement and legislative matters. After leaving the FDA, Jeff served as Associate General Counsel, US Compliance Officer, and Chief Privacy Officer of Biogen Idec, Inc. At Biogen Idec, he was the primary in-house counsel on FDA issues, fraud and abuse prevention and patient privacy. Jeff was also responsible for overseeing the US corporate compliance program. Immediately prior to joining AAM, Jeff served as Vice President and Senior Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) where he was the principal counsel to the association on issues relating to the research, development and regulation of medicines in the US and globally. Jeff received his AB in Public Policy and Economics from Brown University, his MPP from Harvard University, and his JD from the University of Virginia. He serves on the Board of Directors of the Food and Drug Law Institute (FDLI) and previously served on the Editorial Advisory Board of the Food and Drug Law Journal.
MICHAEL GANIO joined the staff at ASHP as Director of Pharmacy Practice and Quality in January of 2018. As a member of the Center on Medication Safety and Quality team, his responsibilities span the practice of pharmacy and include drug shortages, pharmaceutical quality, sterile and non-sterile drug compounding practices, hazardous drug safety, and other practice-related topics. Dr. Ganio earned his PharmD from the Rutgers University Ernest Mario School of Pharmacy and his Master’s degree in Health-System Pharmacy Administration from The Ohio State University College of Pharmacy. He completed a PGY1 Pharmacy Practice residency at The Ohio State University Wexner Medical Center. Dr. Ganio is a Board Certified Pharmacotherapy Specialist (BCPS) and is a Certified Professional in Healthcare Information and Management Systems (CPHIMS). Dr. Ganio has nearly 20 years of hospital and health-system experience. His previous job roles have included clinical pharmacy practice, pharmacy informatics and technology, and outpatient oncology pharmacy operations. He has extensive knowledge of drug shortage management, pharmaceutical quality, pharmacy informatics and automation, medication billing and reimbursement, sterile compounding, and outpatient infusion and ambulatory-care practice models.
RONALD T. PIERVINCENZI has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,400 across sites in Rockville/USA, Brazil, China, Ghana, and India. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Under his leadership, USP has modernized its operations and launched innovative new science, including in the areas of digital medicine, cutting-edge manufacturing technologies and advanced biologics. USP is also better connecting to its stakeholders and customers through new initiatives including the Hyderabad Training Institute in India, the Quality Institute, and USP’s new Impurities for Development service. Dr. Piervincenzi also provides oversight and leadership of USP’s global public health initiatives, including sites in Ethiopia, Indonesia, Nigeria and the Philippines. Dr. Piervincenzi served as Chair of the Council of Experts, USP’s scientific standards-setting body of 24 Expert Committees and over 750 standards-setting experts until June 2015, when he transferred this responsibility to USP’s new Chief Science Officer. Dr. Piervincenzi brings more than 20 years of industry experience across pharmaceutical sciences, research and business strategy. Before joining USP, Dr. Piervincenzi served as Vice President of Development Sciences with Biogen Idec, Inc., where he designed and launched Biogen’s value-based medicine group focusing on applying tools and technologies of personalized medicine in the treatment and management of multiple sclerosis. Dr. Piervincenzi was a partner and leader in McKinsey & Company’s global pharmaceutical and medical products practice for over 12 years. In this capacity, Dr. Piervincenzi launched McKinsey’s global drug safety, medical and regulatory service line. With McKinsey, Dr. Piervincenzi also led the global research and information analytics team, managing staff in New Jersey, London, Brussels, and India. Dr. Piervincenzi earned his MS and PhD from Duke University in Biomedical Engineering, with research focused on protein engineering. He is the proud co-founder and chairman of the board for the Newark Mentoring Movement.
ANAND SHAH is the Deputy Commissioner for Medical and Scientific Affairs. Dr. Shah leads the agency’s operations as it relates to medical and scientific affairs. He is responsible for developing and leading high-priority FDA policy initiatives and oversees cross-agency teams in support of FDA’s public health mission. Dr. Shah began his government service at FDA. He has provided guidance to industry and academia on medical product development, clinical trial design, and regulatory pathways to accelerate public access to new and effective therapies. He co-led and scaled Information Exchange and Data Transformation (INFORMED), a science and technology incubator designed to harness the power of big data and advanced analytics to improve disease outcomes. Dr. Shah developed organizational and technical infrastructure for modern approaches to evidence generation in support of regulatory decisions. Dr. Shah is an attending radiation oncologist at the National Institutes of Health (NIH) where he specializes in the early detection, surveillance, and treatment of prostate cancer. He developed and leads an NIH survivorship clinic in the care of patients on cancer clinical trials. Dr. Shah served as an Adjunct Senior Fellow at the Leonard Davis Institute of Health Economics at the University of Pennsylvania. He has led the development and evaluation of novel risk-based Medicare payment and service delivery models at Columbia Business School. He completed a health economics fellowship at the University of Pennsylvania where he developed and applied significant expertise with economic, financial, and valuation modeling of emerging therapeutics. Dr. Shah was on Duke University faculty where he led the Center for Excellence in Surgical Outcomes as its Associate Director. He has received research funding from government and philanthropic sources. His scientific track record includes publications in the New England Journal of Medicine, Cancer, and Nature Reviews Drug Discovery. Prior to his government service, Dr. Shah served as an advisor to a US venture capital firm. Dr. Shah was chief resident during his radiation oncology residency at Columbia University. He concurrently earned his MD from the University of Pennsylvania and an MPH in health care management and policy from the Harvard School of Public Health. Dr. Shah graduated with honors from Duke University with a degree in economics. He also served as a Canada-US Fulbright Scholar.
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