2nd Priority Review Voucher Summit -

2nd Priority Review Voucher Summit
October 26 - 27, 2017
Boston, MA

Understand the FDA's Priority Review Voucher Programs and Discuss the Challenges With Respect to Valuation, Market Access and the Regulatory Landscape

Faculty – 2nd Priority Review Voucher Summit

Phyllis Arthur
Managing Director, Infectious Diseases and Diagnostics Policy, BIOTECHNOLOGY INNOVATION ORGANIZATION (BIO)

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Phyllis Arthur is Managing Director for Infectious Diseases and Diagnostics Policy at the Biotechnology Innovation Organization (BIO). In this role, Ms. Arthur is responsible for working with member companies in vaccines, antimicrobial resistance, molecular diagnostics and biodefense on policy, legislative and regulatory issues.

Ms. Arthur joined BIO in July 2009 as the Director of Healthcare Regulatory Affairs. Prior to joining BIO, she worked in numerous marketing and sales positions for Merck & Co Inc in their Vaccine Division. Over her 16 year career in vaccines, Ms. Arthur launched several exciting new vaccines in the United States and internationally, including the first HPV vaccine GARDASIL. During her years in Marketing, she worked closely with clinical and academic thought leaders in infectious diseases, oncology, and public health. In addition, Ms. Arthur also led a large vaccine sales organization of over 75 representatives and managers covering 14 states.

Before graduate school, Ms. Arthur worked as a research assistant for two economists at the Brookings Institution in Washington, DC. There she conducted economic analyses related to savings and investment policies for the OECD countries.

Ms. Arthur received her B.A. in 1987 in Economics and International Politics from Goucher College and her M.B.A. in 1991 from the Wharton School of Business at the University of Pennsylvania.

Michelle Berg
Vice President, Patient Advocacy, ABEONA THERAPEUTICS

Beatrice M. Biebuyck, J.D., MBA, RAC
Head, Global Regulatory Policy and Intelligence, ALEXION PHARMACEUTICALS

Clarke B. Cole

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Clarke Cole is a Researcher at the Access to Medicine Foundation working on the Access to Medicine Index. She holds a Master of Science degree in International Health Policy from the London School of Economics, where she completed her dissertation on transparency in the pharmaceutical industry. She completed a Bachelor of Health Sciences (Hons.) from McMaster University with a specialization in global health. Before joining the Foundation, Clarke conducted research for organizations including LSE Health, the Global Strategy Lab @ University of Ottawa and the Centre for Ethical, Social, and Cultural Risk, Toronto. Her research has focused in areas such as global health governance, global health ethics and access to medicines.

Phillip L. Gomez, Ph.D

Patrick Lucy
Chief Business Officer, PFENEX

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Patrick Lucy, a member of the founding team at Pfenex, has served as our Chief Business Officer since 2009. Prior to joining us, Mr. Lucy held the position of Director of Business Development at DowPharma, a business within The Dow Chemical Company, a chemicals manufacturer, from 2002 to 2009. From 1999 to 2002, he held the position of Director of Business Development at Collaborative BioAlliance, Inc., a biotechnology company, which was acquired by The Dow Chemical Company. From 1996 to 1999, Mr. Lucy worked at Lonza Biologics Inc. a chemicals and biotechnology company. While at Lonza Mr. Lucy held roles spanning Quality, Operations and Capital Project Management, playing a key role in the design, construction and commissioning of large scale biologics manufacturing facilities. From 1991 to 1996, Mr. Lucy worked at Repligen Corporation, a life sciences company, in various leadership roles focused on biochemistry.

Mr. Lucy holds a Bachelor’s degree in Biology from Villanova University.

Scott V. McGoohan, J.D.
Director, U.S. Regulatory Policy and Intelligence, VERTEX PHARMACEUTICALS

Timothy J. Miller, Ph.D.

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Timothy J. Miller, Ph.D. is President and Chief Executive Officer and a Director of Abeona Therapeutics Inc. He has 18 years of business development, scientific research, product development and clinical operations expertise, with a focus on transitioning novel biotherapeutics through pre-clinical phases and into Phase 1 and 2 human clinical trials. Dr. Miller was President & CEO of Red5 Pharmaceuticals from 2013 until 2015 and was CEO-in-Residence at BioEnterprise Inc in 2015. He was Senior Director of Product Development at SironRX Therapeutics from 2010 to 2013. Between 1996 and 2010 Dr. Miller held various positions at several biotech companies focusing on gene therapy and regenerative medicine. Dr. Miller earned his Ph.D. in Pharmacology with a focus on Gene therapy/Cystic Fibrosis from Case Western University. He also holds a B.S. in Biology and M.S. in Molecular Biology from John Carroll University (Cleveland, OH).

He has raised over $100M for therapies in rare diseases, cystic fibrosis, cardiovascular disease, wound healing, and dermal disease to advance these therapies into clinical trials. As a serial entrepreneur, he has managed all aspects of research and development, manufacturing of biologics, and clinical program start-up in both public and private companies, with direct experience engaging Food and Drug Administration (FDA) and NIH advisory agencies on multiple Investigational New Drug (IND) submissions. During his career, he has contributed to multiple patent applications, managed intellectual property, and published research in several internationally recognized journals. He has a passion for supporting patient advocacy and developing potential therapeutics for patients with rare disease, and recently returned from a successful summit climb of Mt. Rainier on a rare disease awareness and fundraising adventure.

Jeffrey Moe, Ph.D.
Professor of the Practice of Global Health, DUKE GLOBAL HEALTH INSTITUTE

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Moe was co-author and principal investigator on the research collaboration with Ridley and Grabowski summarized in “Developing Drugs for Developing Countries” (Health Affairs, March/April 2006) which led to the Sec. 524 amendment in the Food and Drug Administration Amendments Act of 2007. The article recommended, and the legislation made into law, a new incentive for neglected tropical disease medicines: the priority review voucher (PRV). A PRV is awarded for US registration of a new medicine (new chemical, biological) for a voucher-eligible disease (19 high burden and emergent diseases including TB, malaria and Ebola). An awarded voucher is exercised on a second drug that receives priority review as a reward for registration of the disease-eligible drug. FDA awarded the first voucher to Coartem® in 2009 and 11 vouchers have been awarded as of late June 2016. The PRV program was amended in 2012 to make pediatric cancer medicines voucher-eligible.

His research interests include incentives to stimulate research and development of new medicines for global diseases; identification and replication of health care delivery innovation, global health ethics and “reverse innovation” where new products and services introduced in Southern low resource settings have application in the higher income West. Moe received his Ph.D. in Organization Development and Behavior from the University of North Carolina at Chapel Hill, 1981. He graduated from the Kellogg School, Northwestern University, Executive Development Program in 1997. Moe has previously been a lecturer at the University of Witwatersrand in Johannesburg, South Africa.

Sandra Panem, Ph.D.

Scott Requadt, J.D., MBA
Managing Director, CLARUS

David Ridley, Ph.D.
Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY

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David Ridley is the Dr. and Mrs. Frank A. Riddick Associate Professor of the Practice of Business and Economics. He is also the Faculty Director of the Health Sector Management program at Duke University’s Fuqua School of Business. David has published articles in a variety of journals, including The Lancet, Nature Reviews Drug Discovery, and the Journal of Industrial Economics. In his research, David examines innovation and pricing, especially in healthcare. David was the lead author of the paper proposing the priority review voucher program to encourage the development of drugs and vaccines for neglected diseases. The voucher program became law in the U.S. in 2007. David teaches in the daytime MBA and executive MBA programs. He received a Ph.D. in economics from Duke University.

Khyati Roberts
Senior Director, Regulatory and Policy Intelligence, ABBVIE

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Khyati Roberts is currently Senior Director of Regulatory Policy and Intelligence at AbbVie. She leads regulatory policy advocacy efforts for the U.S. and Canada and is involved with international harmonization efforts on key regulatory policy initiatives. She joined AbbVie in 2012 and has over 25 years of regulatory experience. Khyati has also served as a regulatory consultant to the biopharmaceutical industry providing support on product strategies and has experience conducting safety analysis for drug trade names and preparing regulatory submissions. Khyati was also at the U.S. FDA for 14 years where she developed and implemented policies applicable to the FDA, specifically the Center of Drug Evaluation and Research (e.g., patient safety, counterterrorism, good manufacturing practices, prescription drug user fees, pediatric, and research activities). Khyati attended Rutgers, College of Pharmacy where she obtained her pharmacy degree.

Andrew Robertson, Ph.D., J.D., AVP
Head of Regulatory Science and Policy, North America, SANOFI U.S.

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Andrew Robertson is the Head of Regulatory Science and Policy NA at Sanofi, where he helps advance regulatory science and strategically influence regulatory policy in North America. Andrew has more than 14 years of collective experience working in life sciences, policy and law, including as a faculty researcher at the Wellcome Trust Sanger Centre, a Science Policy Advisor at the HHS Office of Preparedness and Response, and as the Chief Policy Officer at BIO Ventures for Global Health through a grant from the Bill & Melinda Gates Foundation. Andrew has authored multiple peer-reviewed articles on topics pertaining to health product development, in vitro diagnostics, health technology law and innovation incentives. He holds a J.D. from the University of California, Berkeley, School of Law; a Ph.D. in molecular biology from Cambridge University (as a Gates Cambridge Scholar); and an M.S. and B.S. in genetics from the University of California, San Diego.

Glenn Rockman

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Mr. Rockman started his career at J.P. Morgan, where he advised universities, research institutes, charitable foundations and other non-profit organizations on a wide variety of financing activities over more than 10 years in the firm’s investment banking division.  His time at J.P. Morgan also included three years with the firm’s Social Finance group, which has been a pioneer in the emerging field of impact investing.

After working closely with the Bill & Melinda Gates Foundation to structure and launch the Global Health Investment Fund, he left J.P. Morgan in 2014 to join the GHIF investment management team.

He received an AB from the Woodrow Wilson School of Public and International Affairs at Princeton University.

David Shoultz, Ph.D., M.S., MBA
Global Program Leader, Drug Development, PATH

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David Shoultz, PhD, MS, MBA, leads PATH’s Drug Development program, which seeks to discover, develop, and deliver safe, effective, and affordable treatments for neglected diseases.

Prior to joining PATH in 2014, Dr. Shoultz served as the director of grantee and partner engagement and as a member of the leadership team at the Bill & Melinda Gates Foundation. Previously, he served as a deputy director in the foundation’s Global Health Program, Infectious Diseases, where he was central to strategy, planning, and management for four strategic program teams, including malaria, enteric diseases, pneumonia, and the neglected tropical diseases.

Prior to his roles at the foundation, Dr. Shoultz worked as a member of the senior management team for a number of clinical research organizations participating in the development of new medicines, including PPD Development, PRA International, and Biomedical Systems. He has been a member of the affiliate faculty for the departments of Global Health and Epidemiology at the University of Washington since 2000 and teaches in the Executive MPH program at the School of Public Health.   In addition, he is a faculty member at the Albers School of Business & Economics at Seattle University, where he teaches in the Executive MBA program.

Dr. Shoultz earned his Ph.D. and MS from the School of Public Health and Community Medicine at the University of Washington after receiving his Bachelor’s degree from UW, as well. He holds an MBA from Seattle University.  In addition to his other activities, Dr. Shoultz sits on the Board of Directors at the Geneva Foundation, where he also previously served as the inaugural chair of the Scientific Advisory Committee from 2012-2017.

Ed Yoshida, J.D.
Deputy General Counsel and Director, Legal Affairs, PATH

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Ed Yoshida, JD, is a deputy general counsel at PATH and manages the Legal Affairs department. In addition to managing Legal Affairs, Mr. Yoshida provides legal counsel and support to our Diagnostics Program, transactions originating in PATH’s country offices, and several projects in the Policy, Access, and Introduction group of PATH’s Center for Vaccine Innovation and Access. Mr. Yoshida is also director of commercialization for our Drug Development Program.

Mr. Yoshida has more than 30 years of legal experience in the life sciences sector. Prior to joining PATH in 2012, he spent about 10 years with Merck & Co., Inc., where he was a managing counsel. Mr. Yoshida has extensive experience in negotiating and drafting intellectual property and technology licensing agreements, clinical trial agreements, and research collaboration agreements, and in providing practical legal counsel.  He has also been involved in taking two biotech companies public.

Mr. Yoshida has a BSME from the University of Washington and a JD from the University of San Francisco.

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