Pharmaceutical Compliance and Enforcement to Achieve Drug Quality: Establishing a Strategic Framework of Outcomes with Performance Indicators

Mayflower Hotel • Washington, DC November 14-15, 2016

Biographies

Barbara Allen, PhD is Senior Director for Global Quality Systems for Eli Lilly and Company. Dr. Allen joined Eli Lilly and Company in 1991 in Ireland and has since held various assignments in API Manufacturing Technical Services, New Product Introduction, Quality Assurance, and Global Quality Systems, in Ireland and in the USA. In 2002, she began her current position in Global Quality Systems, where she is responsible for providing quality systems for Lilly manufacturing and for ensuring that Quality Systems are integrated across the corporation. Dr. Allen was a member of ICH Q10 EWG (Expert Working Group) representing PhRMA and currently serves as a member of IFPMA RPTS and PhRMA GQMC.

Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. This Office also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses certain policy issues related to drug-device combination products. Prior to joining CDER, Ashley spent nearly 20 years in

the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH). Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.

Thomas (Tom) Cosgrove, JD, is Acting Director of CDER’s Office of Compliance (OC) and leads efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Mr. Cosgrove has led OC’s Office of Manufacturing Quality (OMQ), directing CDER’s compliance activities with respect to current good manufacturing practices (CGMP) and product quality. He also led OC’s Office of Unapproved Drugs and Labeling Compliance (OUDLC), where he was responsible for compliance divisions covering drug approval and labeling issues. Before coming to CDER, he worked in FDA’s Office of Chief Counsel as a litigator, was an attorney with Covington & Burling

in Washington, D.C., and clerked for Judge Catherine Blake on the United States District Court of the District of Maryland. Mr. Cosgrove holds a bachelor’s degree in psychology from Clark University in Worcester, Mass., a master’s degree in clinical psychology from New York University, and a juris doctor degree from the University of Michigan Law School.

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Charles Cooney, PhD is the Robert T. Haslam (1911) Professor of Chemical and Biochemical Engineering, Emeritus in the Department of Chemical Engineering and was the founding Faculty Director of the Deshpande Center for Technological Innovation. His degrees include a Bachelor's degree in Chemical Engineering from Penn and Master's and Ph.D. in Biochemical Engineering from MIT. He was elected (2009) to the first class of American Chemical Society Fellows and awarded Honoris Causa by Ramon Llull University in Barcelona in 2013. He serves as a consultant to a number of biotech and pharmaceutical companies, and sits on the Boards of Directors of Mitra Biotech, GreenLight Bioscience, Axcella Health, Inc., Boyd

Technologies, Levitronix Technologies, LayerBio and Innovent Biologics (China). He was previously on the Boards of Genzyme, Cuno, Inc., Pall Corp., Biocon (India), Polypore International and Astra AB. He chaired the FDA Advisory Committee for Pharmaceutical Science from 2004-2006. His research interests include: manufacturing in the pharmaceutical, biotech and bioprocess industries, bioprocess design, operation and control, processing of pharmaceutical powders and technological innovation strategy. In addition, Prof. Cooney is a Trustee Emeritus of Boston Ballet, and an Overseer of the Boston Symphony Orchestra. Other interests include: high altitude mountaineering (with assents of Denali, Ama Dablam, Mont Blanc, Kilimanjaro, Huascaran), scuba diving, skiing and antique map collecting.

Alonza Cruse is Director, Pharmaceutical Quality Programs within the Office of Regulatory Affairs. His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM). Additionally, Mr. Cruse is leading ORA’s pharmaceutical collaboration efforts under our program alignment initiative. From 2013 – 2015 Mr. Cruse served as the Director, (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as GDUFA implementation, pharmacy compounding, and the development of a New Inspection Protocols Program. Since 2000, Mr. Cruse was the

Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his Bachelor of Science degree in Medical Technology from York College (City University of New York).

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Gregory Daniel, PhD, MPH is a Clinical Professor in Duke's Fuqua School of Business and Deputy Director in the Duke-Robert J. Margolis Center for Health Policy at Duke University. Dr. Daniel directs the DC-based office of the Center and leads the Center's pharmaceutical and medical device policy portfolio which includes developing policy and data strategies for improving development and access to innovative pharmaceutical and medical device technologies. This includes post-market evidence development to support increased value, improving regulatory science and drug development tools, optimizing biomedical innovation, and supporting drug and device payment reform. Dr. Daniel is also a Senior Advisor to

the Reagan-Udall Foundation for the FDA and Adjunct Associate Professor in the Division of Pharmaceutical Outcomes and Policy at the UNC Eshelman School of Pharmacy. Previously, he was Managing Director for Evidence Development & Biomedical Innovation in the Center for Health Policy and Fellow in Economic Studies at the Brookings Institution and Vice President, Government and Academic Research at HealthCore (subsidiary of Anthem, Inc). Dr. Daniel’s research expertise includes utilizing electronic health data in designing research in health outcomes and pharmacoeconomics, comparative effectiveness, and drug safety and pharmacoepidemiology. Dr. Daniel received a PhD in pharmaceutical economics, policy and outcomes form the University of Arizona, as well as an MPH, MS, and BS in Pharmacy all from The Ohio State University.

Jennifer Devine, JD, LLM is Vice President, Global Legal Affairs, at USP. In this role, she serves as legal counsel to the organization’s global scientific and standards-setting activities. She provides legal and policy advice and representation to USP management and staff, and the Council of Experts, to help ensure the integrity of USP’s standards and standard setting processes. Ms. Devine returned to USP after serving in several leadership roles at the United States Food and Drug Administration, first in CDER’s Office of Compliance and then as Associate Commissioner for Global Regulatory Operations and Policy. In these positions, Jennifer helped shape and implement FDA’s globalization strategy, providing

direction and oversight, as FDA worked to address the challenges of a global supply chain. Jennifer also spent a year at the Agency for Healthcare Research and Quality where she helped implement the Patient Safety and Quality Improvement Act. Prior to joining FDA, Ms. Devine spent ten years in USP’s Office of General Counsel, working on a variety of scientific, regulatory, international, legislative, and patient-centered issues. Ms. Devine earned her undergraduate degree at University of Maryland, College Park and her Juris Doctorate from Delaware Law School. She also holds a Master of Laws (LL.M.) in International Law from Georgetown University Law Center.

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Joseph Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active in aligning industry and international regulatory authorities around policy and harmonization, and also heads the company’s inspection readiness, GMP auditing and is integral to determining the company's compliance strategies, among other duties. Mr. Famulare joined Genentech in 2009 as the Senior Director of Genentech's Quality and Compliance External Collaboration function after a 32-year career at FDA. He is the former Deputy Director, CDER Office of Compliance, FDA, where he led an extensive team heading GMP, GCP, and GLP Compliance programs. He was a founding

member and served on the Council of Pharmaceutical Quality. He also held a number of progressive roles at FDA throughout years of public service. As a Member of ISPE for more than 15 years, he served as Industry Co-Chair of the ISPE/FDA/PQRI Quality Manufacturing Conference, and has led ISPE’s PQLI® Initiative, serves on the Regulatory Compliance Committee and Drug Shortages and Quality Metrics Initiatives. He is active in ISPE global activities as a speaker and panelist and chaired the 2013 ISPE Pharmaceutical Quality System (ICH Q10) Conference in China and has co-chaired successive ISPE/FDA co-sponsored conference over the past 5 years. Joe Famulare has actively participated on the International Leadership Forum (ILF), now the Global Manufacturing Leadership Forum (GPLMF). He recently co-led the publication of PQLI's Quality System Guideline on Process Performance and Product Quality Monitoring. He was elected to the ISPE International Board of Directors in 2010 and has served 2015 as Chairman of the Board and is now Past Chair. Mr. Famulare has a BS in Biology and Environmental Studies from St. John's University and extensive training in manufacturing, microbiology and chemistry, regulatory risk management and leadership.

Maxine Fritz is Executive Vice President, NSF Health Sciences Pharma Biotech Consulting. Ms. Fritz has 25+ years of combined FDA and industry management experience and has successfully managed and consulted on large complex compliance projects including corporate Warning Letter, mass seizure, Consent Decree(s), Application Integrity Policy (AIP) prosecution, and import detentions. She is a former United States Food and Drug Administration (FDA) investigator who specialized in biological and pharmaceutical product inspections and served as the Biologics Team Leader. Currently, as Executive Vice President at NSF Health Sciences Pharma Biotech Consulting, Ms. Fritz oversees a team of regulatory and quality systems experts

providing client services in areas such as remediation, quality assurance, senior management, validation, vendor qualification, internal and external audits, batch record review, product release, investigation of non-conformances, current Good Manufacturing Practices (cGMP) training, and aseptic manufacturing. During her tenure with FDA, she was responsible for two Consent Decrees, multiple Warning Letters, several new product approvals, and three prosecutions. Ms. Fritz received several FDA Awards including: Investigator of the Year – Los Angeles District, 1997 and 1998; FDA Outstanding Achievement Award, 1998; Biologics Team National Award, 1996; Recognition Award for assistance provided during the SCPDG / OCRA, Grassroots Imports, and Biotechnology Conferences; Recognition Award for performance of high priority plasma sampling of an HIV contaminated pool (first samples collected in US); Recognition Award for training of Los Angeles laboratory personnel in inspectional basics; Recognition Award for precedent setting Bioresearch Monitoring Program (BIMO) criminal case; and Crisis Team Management Award for role as a lead investigator during a National New Year’s Eve crisis involving misbranded drugs.

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Ted Fuhr is a McKinsey & Company Partner based out of New Jersey. He is a member of the Operations and Pharmaceutical and Medical Products leadership teams where he leads our cross-industry Quality, Compliance and Remediation practice in North America. Ted has extensively served numerous pharmaceutical and medical product firms and regulators on operations and quality. He has authored numerous articles on Quality and Product Development and delivered featured presentations at FDA’s annual CDER on CMC conference and DIA. He has convened industry and regulators on Medical Device Quality Enhancement and Pharmaceutical CMC and Quality. Prior to joining McKinsey, Ted led the Clinical Supply Department at Pfizer with

responsibility for clinical supply manufacturing, packaging and distribution and headed up Murad‘s (OTC pharma) operations. His first career was as a submarine officer in the US Navy.

Andrew Gonce, is Chief of Staff to the SVP of Technical Operations, Purdue Pharma. He is responsible for global operations strategy design and execution and the global operational excellence programs. Andrew joined Purdue and its network of independent affiliated companies last year, after nine years at McKinsey & Co., where he led the Pharmaceutical and Medical Device Manufacturing practice within North America. He also was seconded from McKinsey to Hospira as VP, Performance Systems, in 2011 and 2012, responsible for their remediation program, quality systems, operational excellence, and global health and safety. Andrew’s experiences have taken him to 30+ pharmaceutical API and finished dosage sites on

four continents where he has led diagnostics, diligences, and turnarounds. He is a Six Sigma Black Belt from Ford Motor Company and has studied Lean Manufacturing in Japan, taught Operational Excellence at the University of Virginia, and implemented programs in both branded and generic pharmaceutical companies. Andrew received an MBA from the Darden Business School at the University of Virginia, and a BS in Engineering and a Master in Engineering Management from Duke University.

Henry Grabowski, PhD specializes in the investigation of economics in the pharmaceutical industry, government regulation of business, and the economics of innovation. His specific interests within these fields include intellectual property and generic competition issues, the effects of government policy actions, and the costs and returns to pharmaceutical R&D. He has been publishing research papers for over four decades, from his earlier work, “The Effects of Regulatory Policy on the Incentives to Innovate: An International Comparative Analysis” with John Vernon and Lacy Glenn Thomas, to his more recent projects including, “Impact of Economic, Regulatory and Patent Policies on Innovation in Cancer Chemoprevention” with

Jeffrey L. Moe. His latest research studies include other such titles as, “Mergers and Alliances in Pharmaceuticals: Effects on Innovation and R&D Productivity” with Margaret Kyle; “Should the Patent System for New Medicines Be Abolished?” with J.A. DiMasi; and several others. Professor Grabowski has served as an advisor and consultant to various organizations, offering his ideas and insights gained through his extensive investigations to the National Trade Academy of Sciences, the Institute of Medicine, the Office of Technology Assessment, the Federal Trade Commission, and the General Accounting Office. His latest project involved an analysis for the FTC concerning public policy, competition and investment in the “Next Generation of Biologics.”

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CAPT Valerie Jensen, RPh is Associate Director of the Drug Shortage Program at the Food and Drug Administration. She received a B.S. degree in Pharmacy from the University of Iowa in 1990. She completed an American Society of Health-System Pharmacists Specialized Residency in Ambulatory Care at the White River Indian Health Service hospital in White River, Arizona in 1991. She worked as a clinical pharmacist for Indian Health Service hospitals in Arizona and New Mexico for nine years before joining FDA. She has been with the Drug Shortage Program at FDA for the past sixteen years. Mark McClellan, MD, PhD is the Robert J. Margolis Professor of Business, Medicine, and Policy, and Director of the Duke-Margolis Center for Health Policy at Duke University with offices at Duke and in Washington DC. The new Center will support and conduct research, evaluation, implementation, and educational activities to improve health policy and health, through collaboration across Duke University and Health System, and through partnerships between the public and private sectors. It integrates the social, clinical, and analytical sciences to integrate technical expertise and practical capabilities to develop and apply policy solutions that improve health

and the value of health care locally, nationally, and worldwide. Dr. McClellan is a doctor and an economist, and his work has addressed a wide range of strategies and policy reforms to improve health care, including such areas as payment reform to promote better outcomes and lower costs, methods for development and use of real-world evidence, and more effective drug and device innovation. Before coming to Duke, he served as a Senior Fellow in Economic Studies at the Brookings Institution, where he was Director of the Health Care Innovation and Value Initiatives and led the Richard Merkin Initiative on Payment Reform and Clinical Leadership. He also has a highly distinguished record in public service and in academic research. Dr. McClellan is a former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA), where he developed and implemented major reforms in health policy. These include the Medicare prescription drug benefit, Medicare and Medicaid payment reforms, the FDA’s Critical Path Initiative, and public-private initiatives to develop better information on the quality and cost of care. Dr. McClellan is the founding chair and a current board member of the Reagan-Udall Foundation for the FDA, is a member of the National Academy of Medicine and chairs the Academy’s Leadership Council for Value and Science-Driven Health care, co-chairs the guiding committee of the Health Care Payment Learning and Action Network, and is a research associate at the National Bureau of Economic Research. He has also previously served as a member of the President’s Council of Economic Advisers and senior director for health care policy at the White House, and as Deputy Assistant Secretary for Economic Policy at the Department of the Treasury. He was previously an associate professor of economics and medicine with tenure at Stanford University, and has twice received the Kenneth Arrow Award for Outstanding Research in Health Economics.

Caleb Michaud is a Special Assistant to the Associate Commissioner of Planning within FDA’s Office of the Commissioner/Office of Planning. In this role he primarily serves as a consultant to FDA Centers, Offices, and Programs on strategic planning, organizational development, and performance management. Prior to working at FDA, he worked for the USDA-Foreign Agriculture Service, and as a Peace Corps Volunteer stationed in Ghana, West Africa.

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Karla M. Miller, PharmD is the Vice President of Pharmacy Services & Clinical Therapeutics for Hospital Corporation of America (HCA) in Nashville, Tennessee. In her current position she oversees the medication management system for the Hospitals, Ambulatory Surgery Centers, and Physician Practices in HCA. She oversees the Clinical Pharmacy Program, Antimicrobial Management Program, Barcode Medication Administration, Venous Thromboembolism Prevention, as well other clinical and medication management programs. She is co-executive sponsor for the clinical pharmacy surveillance software that was implemented to prevent life-threatening medication errors, improve patient outcomes and reduce drug waste.

Dr. Miller is the Pharmacy Sub-committee Chair for the Federation of American Hospitals. Prior to her current position she served in the Corporate Medication Use and Safety Position. Her interest in safety started with her work in Safety as a Psychiatric Clinical Specialist at Centennial Medical Center in Nashville, TN. She is a board certified psychiatric pharmacist. Dr. Miller is also an Assistant Professor at the University of Tennessee College of Pharmacy and leads the Medication Safety selective class. She received her Doctor of Pharmacy degree from West Virginia University. She completed a pharmacy practice residency at Johns Hopkins Hospital in Baltimore, Maryland, and a two-year fellowship in neuropsychiatry at The Ohio State University in Columbus, Ohio.

Richard (Rich) A. Moscicki, MD joined the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), as Deputy Center Director for Science Operations. A nationally recognized expert in clinical research and development, Dr. Moscicki brings to the position executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Before joining CDER, Dr. Moscicki served as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer

and SVP of biomedical and regulatory affairs in 1996 -- holding that post until 2011. Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty of Harvard Medical School.

François Sallans, PharmD is the Vice President and Chief Quality Officer of Johnson & Johnson. In this role, Mr. Sallans leads the Johnson & Johnson Quality & Compliance function and maintains oversight and governance of Quality operations across the Johnson & Johnson Family of Companies. He serves on the Johnson & Johnson Compliance Committee, the Enterprise Governance Council, the Johnson & Johnson Medical Safety Council, and the Johnson & Johnson Regulatory Policy Council; he is a member of the Johnson & Johnson Supply Chain Leadership Team, and he chairs the Johnson & Johnson Quality & Compliance Leadership Team. Mr. Sallans has enterprise leadership responsibility for Quality

and Regulatory Compliance and also has responsibility for Sterility Assurance, Bioresearch Quality & Compliance, and Quality Systems & Services. Mr. Sallans earned a Doctor of Pharmacy degree, with a specialization in biopharmacy, from Université de Toulouse, France.

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Neil Stiber, PhD is the Acting Deputy Director for the Office of Surveillance in the U.S. FDA’s CDER / Office of Pharmaceutical Quality. Using risk-based approaches and decision analytic tools, he provides leadership and strategic direction for programs that advance pharmaceutical quality. Previously, he was the Director of the Risk Management Staff in the FDA’s Office of Regulatory Affairs and for eight years was an environmental scientist at the U.S. EPA. Prior to joining the federal government, he worked as an environmental consultant specializing in site investigation and risk assessment. Dr. Stiber received a B.S.E. in civil engineering from Duke University, a M.S. in civil engineering from Northwestern University, and

M.S & Ph.D. degrees from the Department of Engineering and Public Policy at Carnegie Mellon University.

John Troiani, MD, PhD is the Senior Medical Advisor in the Office of Compliance in the Center for Drug Evaluation at FDA, a position he has held for two years. Prior to that he was a Medical Reviewer for 5 years in CDER’s Division of Gastroenterology and Inborn Errors of Metabolism. Dr Troiani has been a board-certified pediatrician since 1991, and holds an MS in Biostatistics and PhD in Medical Informatics. Martin Van Trieste, PharmD is the Chairman of the Parenteral Drug Association (PDA) Board of Directors. The PDA represents over 10,000 members, and is the leading global facilitator of scientifically sound, practical technical information, quality systems and expertise to advance pharmaceutical / biopharmaceutical manufacturing science and regulation so members can better serve patients. He recently retired as the senior vice president of Quality at Amgen. He was responsible for all aspects of Quality Assurance, Quality Control, Compliance, Operational Excellence, Environment, Health and Safety along with Training at Amgen. Prior to joining Amgen, VanTrieste was with Bayer HealthCare’s Biological Products Division

as vice president of Worldwide Quality and Abbott Laboratories as the vice president of Quality Assurance for the Hospital Products Division. While at Abbott, VanTrieste held various positions in Quality, Operations, and Research and Development. He started his career at Abbott in 1983 after obtaining his Pharmacy degree from Temple University School of Pharmacy. He is the founder of Rx-360 and first Chairman of the Board of Directors. Rx-360 is a nonprofit international supply chain organization that enhances patient safety by increasing the security and quality of all parts of the biopharmaceutical supply chain. VanTrieste has been actively involved with various professional and trade organizations, including United States Pharmacopeia (USP), Pharmaceutical Quality Research Institute (PQRI), Pharmaceutical Research and Manufacturers of America (PhRMA), and AdvaMed. PharmaVoice in 2012 named VanTrieste as one of the 100 most inspiring people in the pharmaceutical industry and call him “a man with a mission.” The Medicine Maker in 2016 named him one of the top 100 most influential people in the world of drug development and manufacture saying, “he is known throughout industry for his work on advancing quality assurance and helping to ensure a more reliable supply of high-quality medicines.”

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Keith Webber, PhD is Senior Director of Regulatory Affairs for the Rx Division at Perrigo Company where he oversees the regulatory activities for a wide variety of new and generic drug products. Prior to joining industry, he served at the US Food and Drug Administration in both the Center for Drug Evaluation and Research and the Center for Biologics. During his 18 years with the Agency, his roles included Director of the Office of Pharmaceutical Science, Director of the Office of Generic Drugs, Director of the Office of Biotechnology Products, and Director of the Division of Monoclonal Antibodies. While in government service, Dr. Webber led the

development of policies on environmental assessments regarding drugs and the production of drugs in recombinant plants. He also served as the Quality Lead for CDER’s representatives to the International Conference on Harmonization during the development of the Q8, Q9, and Q10 guidelines. While Directing the Office of Generic Drugs, Dr. Webber was a member of the FDA’s negotiating team that established the first Generic Drug User Fee Amendments (GDUFA-I) that led the way to modernization of FDA’s generic drug review program. He also served on the industry team during negotiation of GDUFA-II. Dr. Webber’s educational background includes a Bachelor of Science degree in Chemistry from the University of Denver, Colorado, a Doctorate in Biological Chemistry from the University of Michigan, and post-doctoral research at the National Institutes of Health where he studied the genetic control of embryonic developmental and antibody engineering for cancer detection and treatment.