2018 Speaking Faculty

Amal Agarwal, D.O., MBA, is a board-certified emergency room physician with clinical, entrepreneurial, administrative and operational experience. Dr. Agarwal’s mission is to help with the necessary transition from a fee-for-service model to a value-based-care model through patient and physician engagement. By merging both patient and health care provider data, he hopes to improve patient outcomes.

Dr. Agarwal is uniquely leveraged, having functioned as a chief medical officer for a health analytics platform, a pharmaceutical consultant for Navigant, health care consultant for Accenture and now as a medical director in the Executive Physician Immersion Program at Humana. After completing his Six Sigma green belt training, he is a firm believer that poor results are primarily attributed to process rather than people.

Outside of work, Dr. Agarwal advises several health care startups. He received his MBA from the University of Illinois, his medical degree from Des Moines University and his B.S. in finance and accounting from Washington University in St. Louis. He completed his residency in emergency medicine at the University of Florida.

John Alter is currently Vice President of Patient and Health Impact for Pfizer’s Essential Health business unit, which has worldwide sales of more than $20B from a portfolio of over 700 molecules including biosimilars, sterile injectables and solid oral dosage forms. The portfolio is the result of Pfizer’s research and development as well as acquisitions of Warner Lambert, Pharmacia and Upjohn, Wyeth and most recently Hospira. Pfizer is the world’s leading biosimilars company based on audited sales and its portfolio of biosimilar molecules is for the treatment of inflammation, oncology and supportive care.

Pfizer’s Patient and Health Impact team covers the functions of Pricing, Access, Reimbursement, Health Economics, Outcomes Research and Real World Data. John has been with Pfizer for over 18 years in multiple roles of increasing responsibilities, the last three years in his current role. He has presented at several biosimilars conferences on the topic of pricing and access and in 2016 was a guest lecturer on the subject of HEOR at Kings College London as part of the International Federation of Association of Pharmaceutical Physicians.

Charles Barr, M.D., MPH, is Chief Science Officer for the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), a nonprofit scientific research organization convened by the Academy of Managed Care Pharmacy to monitor the safety and effectiveness of biosimilars and corresponding novel biologics.

Dr. Barr has extensive research experience across industry, academia and medicine. His prior leadership roles have centered on both clinical trial and observational research projects, and have included the use of large patient registries and real world data. Before joining the BBCIC, Dr. Barr was Group Medical Director and Head of Strategy & External Relationships in U.S. Medical Affairs, Evidence for Access at Genentech, Inc. He also has held leadership positions at Pfizer Inc. and Pharmacia in Global and US Medical Affairs, U.S. Outcomes Research, Managed Care and Disease Management. Prior to working in industry, Dr. Barr worked in healthcare for 15 years in both academic and community medical centers doing patient care, clinical teaching and research, implementation of electronic medical records, development and implementation of clinical guidelines, and clinical quality improvement. The driving passion of his career has been how to advance the frontiers of knowledge, leveraging science and technology to empower patients, physicians and policy makers with the best research to inform decisions and achieve the best outcomes.

Charlie received his M.D. and Master of Public Health from Loma Linda University and completed post-doctoral studies in biomedical computing, biostatistics, and health policy and management at Harvard University School of Public Health.

Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992.

In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology.

In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D;) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D; since 2010, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings. Rakesh is one of the most invited speakers in the biotechnology industry.

Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.

Dr. Joseph P. Fuhr, Jr. is a lecturer at College of Population Health Thomas Jefferson University and professor emeritus of economics at Widener University. He currently serves as a senior fellow with The American Consumer Institute and Ambassador for the Internet Innovation Alliance. Dr. Fuhr received his M.A. and Ph.D. from Temple University and his B.A. from LaSalle University. His primary research areas are antitrust, health economics, pharmacoeconomics, telecommunications and sports economics. In healthcare, he has written on ACOs, hospital mergers, specialty hospitals, exclusive arrangements, health insurance, bundling and doctor’s fees. In pharmacoeconomics, he has written on cost benefit analysis, biosimilars and predictive modeling. He has published more than 60 journal articles. He has taught graduate classes in health economics, pharmacoeconomics and pharmaceutical ethics. Dr. Fuhr has been an expert witness on numerous cases and has worked on various consulting projects.

John Garcia is the Global Commercial Excellence Lead at Alnylam, a pre-commercial rare disease company focused on the development and commercialization of RNAi based therapeutics. In addition, to building launch capabilities John spends much of his time at Alnylam supporting commercial and medical teams in trying to uncover new ways of finding patients through unifying data. Before Alnylam, John spent his time leading many different commercial teams in biopharma, starting a med device company, and consulting with a host of early stage ventures in life sciences. Prior to John’s life sciences career he was an active duty Marine Officer and retired as a Marine Infantry Major.

John is a father and husband first to his wife of 15 years, Elizabeth, and their four children, Zoe, JT, Gunnar, and Alex. In his free time he goes to work…

John holds degrees from Berkeley and the United States Naval Academy and has done coursework at Brown, Stanford, and University of North Carolina.

Dr. Chris Guinther has worked on a variety of initiatives for pharmacies, health plans and pharmacy benefit managers, including plan design, formulary management, and medical to pharmacy benefit conversions. He currently serves as System Director of Managed Care Pharmacy Services for Mercy Health, the largest health system in Ohio. His recent initiatives include orphan/biologic drug pricing and modeling the effects on plan spending. Prior to joining Mercy Health, he served as a Senior Clinical Consultant for Express Scripts working primarily in the Medicare Advantage space. He has been active at the national and regional level with various pharmacy associations including the Academy of Managed Care Pharmacy

Dr. Guinther received a Pharm.D. from the University of Florida and a B.S. of Pharmacy from the Ohio State University.

John Molenda is co-chair of Steptoe's Healthcare & Life Sciences Industry Practice, is head of the Intellectual Property Practice for the New York office, and has served on the firm's Executive Committee. He focuses on patent litigation at the district court and appellate levels, opinions of counsel, due diligence, and post-grant proceedings, including inter partesreviews (IPRs) and reexaminations. He represents clients across technologies, including biotherapeutics (biologics), pharmaceuticals (Hatch-Waxman), biochemical research tools, medical devices, semiconductors, and computer software.

Dr. Molenda's practice has a particular focus on biologics and biosimilars. He currently represents two pharmaceutical companies in a case involving blockbuster biologics to lower cholesterol and is coordinating pre-litigation strategy and counseling for a global biosimilars program involving high-value monoclonal antibody and cytokine products. Dr. Molenda has also led biologics teams conducting transaction-related diligence and pre-petition diligence in advance of IPR filings. He has spoken on recent developments involving biologics and biosimilars for ACI, Knowledge Group, BIOTECanada, Canaccord Genuity, and the Federal Circuit Bar Association (FCBA).

With respect to Dr. Molenda’s appellate practice, he litigates regularly in the U.S. Court of Appeals for the Federal Circuit, including briefing, oral argument, and complex motion practice. He has held substantial roles in 20 Federal Circuit appeals, including recently arguing one of the first pharmaceutical-related IPR appeals. Dr. Molenda is active in the Federal Circuit community, currently serving as a Vice Chair of the FCBA’s Bench & Bar Planning Committee. He has previously held leadership roles on the FCBA’s Patent Litigation, Legislation, and Rules Committees. Prior to private practice, he served as a Federal Circuit law clerk for the Honorable Alan D. Lourie.

With respect to Dr. Molenda’s district court practice, he litigates in district courts across the United States, including playing substantial roles in several trials, managing all aspects of pre-trial proceedings, assuming leading roles in mediations and Markman proceedings, and managing complex discovery. Dr. Molenda has served as co-chair of PLI’s Fundamentals of Patent Litigation program since 2014.

Morgan Molloy currently serves as the Head of U.S. Commercial at Spark Therapeutics. Prior to Spark, Mr. Molloy most recently was Vice President, Global Disease Lead Fabray Disease at Genzyme Corporation. While at Genzyme, he served in a variety of commercial leadership roles in three of the legacy Genzyme business units. Prior to Genzyme, Mr. Molloy spent ten years at Biogen Idec Inc. in positions of increasing responsibility within the commercial organization

Dr. Jose Ricardo Perez. Has served in leadership positions in academia, healthcare, and pharmaceuticals. Currently he is an Executive Medical Director of Medical Affairs at Exelixis, he created and lead the world’s largest expanded access protocol for patients with myelofibrosis usign innovative therapies in collaboration with clinicians in multiple centers of excellence within the US and in some European centers.

Previously, Dr.Perez was a Medical Doctor, Specialist in Internal Medicine and in Clinical Oncology in Venezuela taking care of patients with Cancer, ensuring that they received the most appropriate treatment for their disease together with a human touch. With an active participation in clinical trials he has contributed in the development of safe and more effective therapies to patients with diverse types of cancer Having lived in North America and Latin America and worked around the world, Dr. Perez has designed and implemented clinical studies involving thousands upon thousands of patients. His “real-world” research expertise allows him to combine medical knowledge with human compassion.

More recently, he moved to San Francisco to work in the biotechnology environment that is deeply rooted in the Bay Area, where he wishes to continue benefiting the lives of patients with Cancer, and to gain the west coast quality of life.

Dr. Pezalla in a leading innovator and consultant on payer strategy for pharmaceutical and device manufacturers. He focuses on unlocking the value of new products by developing industry-leading approaches to incorporating payer requirements into development programs, technology assessment plans, and value frameworks. He works with a variety of policy and industry groups on cutting edge coverage policy, innovations in value-based payments, and adaptive regulatory and market entry pathways. He is currently a Scholar-in-Residence at the Duke-Margolis Center for Health Policy in Washington.

Dr. Pezalla is the former Vice President for Pharmaceutical Policy and Strategy in the Office of the Chief Medical Officer at Aetna. In this position Dr. Pezalla developed and coordinated strategy for pharmaceutical evaluation and coverage across both the medical and pharmacy benefit, created Aetna’s framework for innovative contracts, and developed Aetna’s public policy positions on drug and device coverage.

Dr. Pezalla holds both BS and MD degrees from Georgetown University and an MPH from the University of California at Berkeley. He is a board certified pediatrician and was a Health Services Research Fellow at the University of Michigan.

Dr. Robert Popovian is Sr. Director, US Government Relations at Pfizer Inc. For the past 2 decades, Dr. Popovian has published and presented extensively on the impact of biopharmaceuticals and health policies on health care costs and clinical outcomes, including authorship in clinical and healthcare delivery journals and published expert source in Los Angeles Times, USA Today, Pink Sheet and Bloomberg News amongst many others. He also writes a monthly column published in Morning Consult regarding health policy and economic issues relevant to the biopharmaceutical industry. He currently serves as a board member for the Global Healthy Living Foundation.

Dr. Popovian is one of the few researchers who has studied and published both clinical and policy related economic analysis as well as one of a handful who have studied and published empirical data regarding emerging payment mechanisms in the US healthcare system. He was also one of the first to secure inclusion of health outcomes data regarding labeled indication of a biopharmaceutical.

Dr. Popovian completed his Doctorate in Pharmacy and Masters of Science in Pharmaceutical Economics and Policy degrees at the University of Southern California with honors. He has also completed a residency in Pharmacy Practice/Adult Internal Medicine and Infectious Diseases at the Los Angeles County – University of Southern California Hospital.

Grace-Marie Turner is president of the Galen Institute, a public policy research organization that she founded in 1995 to promote an informed debate over free-market ideas for health reform.

She has been instrumental in developing and promoting ideas for reform to transfer power over health care decisions to doctors and patients. She speaks and writes extensively about incentives to promote a more competitive, patient-centered marketplace in the health sector.

• She testifies regularly before Congress and advises senior government officials, governors, and state legislators on health policy.
• She was named by the Speaker of the House in 2013 to serve as a member of the Long Term Care Commission.
• Previously, Grace-Marie served for a three-year term on the National Advisory Board for the Agency for Healthcare Research and Quality, and she served as a member of the Medicaid Commission, making recommendations to modernize and improve Medicaid.

She has been published in hundreds of major newspapers, including The Wall Street Journal, The New York Times, and USA Today, and has appeared on ABC’s 20/20 and on hundreds of radio and television programs. She is a co-author of Why ObamaCare Is Wrong for America, published by HarperCollins in 2011, and editor of Empowering Health Care Consumers through Tax Reform. Grace-Marie speaks extensively in the U.S. and abroad, including at the London School of Economics, Oxford University, and the Gregorian University at the Vatican.

Grace-Marie is founder and facilitator of the Health Policy Consensus Group which serves as a forum for analysts from market-oriented think tanks around the country to analyze and develop policy recommendations.

She received the 2007 Outstanding Achievement Award for Promotion of Consumer Driven Health Care from Consumer Health World. In the mid-1990s, Grace-Marie served as executive director of the National Commission on Economic Growth and Tax Reform. For 12 years, she was president of Arnett & Co., a health policy analysis and communications firm. Her early career was in politics and journalism where she received numerous awards for her writings on politics and economics.

Reg Waldeck is the head of Market Access, Pricing, Health Economics and Payer Communications at Celldex Therapeutics Inc., a biotechnology company developing targeted therapeutics for patients with devastating diseases, with a current portfolio focused within immuno-oncology. He directs departmental efforts in support of successful access, evidence-generation, and commercialization of the Celldex portfolio. Dr. Waldeck received an MSc (Chemistry) from the University of Amsterdam, a PhD (Biochemistry) from the University of Sydney, and has completed post-graduate certificates in Health Economics (Monash University, Australia) and Marketing (University of Connecticut, USA).

Amber Walker, Director, Specialty Pharmacy Development. Amber is responsible for the development and ongoing management of Walgreens pharmacy programs, with a focus in the rare and orphan disease products and programs. In this position, she monitors the FDA pipeline of new products for specialty disease states to identify the unique needs of these products and determine how to best service the patients who receive them.

Amber joined Walgreens in 2009. She has provided superior customer service in her positions as a Referral Program Specialist, Physician Sales Representative, and National Account Manager over the course of her 13 years of experience in the specialty pharmacy field. Amber’s diligence, organizational skills and broad knowledge of specialty pharmacy is a valuable asset …

Gillian Woollett, M.A., D.Phil., SVP at Avalere, leads the FDA Policy and Regulatory Strategy Practice at Avalere, an advisory services firm of ~250 people that supports clients across the healthcare spectrum, from patients to biopharma companies and payers/providers. At Avalere she provides the “prequel” of scientific and technical expertise that supports drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful in the public and private reimbursement world. She launched the FDA Practice in 2012. Dr. Woollett and her Team translate into practical action all aspects of regulatory engagement strategy and policy development relevant to commercial success for multiple multi-national clients. Concurrently, she created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with ~30 now having used this stepping stone to transition their careers.

Previously, Dr. Woollett was Chief Scientist, and Administrator, at the law firm of Engel & Novitt, LLP – a boutique food and drug law firm that fully integrates sound science into all its services, and notably won an unreasonable delay suit against FDA during her tenure. Prior to that, she was VP, Science and Regulatory Affairs at BIO, where she established a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biologic medicines from a scientific, technical and policy perspectives. She joined BIO after serving as AVP at PhRMA, where her group led, for example, on the negotiation and creation with FDA of the comparability protocol in support of manufacturing changes to already licensed biologics (that became the conceptual basis of biosimilarity). At both trade associations, Dr. Woollett managed the interface between bio/pharma companies and the US Government in a manner that enabled their collective ability to expedite product development but without invoking any concerns of anticompetitive activity. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on biological weapons issues.

Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as domestic, regulatory and scientific issues and as an advocate. She has been an appointee on Federal Advisory Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She is currently represents biotechnology on the Material Technical Advisory Committee (MTAC) at the Department of Commerce (Secret Security clearance), and chairs the Biotech Work Group that addresses export controls and the Biological Weapons Convention, among other issues. She also provides a point of scientific interface with academic and professional organizations. She is an appointee to the Nomenclature and Labeling Expert Committee of the United States Pharmacopeia (USP), on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT), and on the Board of the Pharmaceutical Education Research Institute (PERI).

Gillian earned her B.A., M.A. in the Biochemistry from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford in the UK. She was a post-doc in the Department of Molecular Biology at the University of Edinburgh, and at the Biomedical Research Institute, Rockville, MD funded by USAID. She is well published in the peer reviewed literature.

Mr. Zweigenhaft is key industry thought leader and accomplished executive in the specialty-biotech pharmaceutical and oncology cancer care ecosystems.

Today Mr. Zweigenhaft is President of the National Association of Specialty Pharmacy, representing the industry on National Policy, Specialty Pharmacy Education and Government Relations based in Washington, DC. Mr. Zweigenhaft is also the Managing Partner of BioPharma Partners, LLC. a New York based Private Equity Company focused on incubating new healthcare delivery services, specialty bio-pharmaceuticals, genomics, precision medicine and digital health technologies into healthcare ecosystems. Mr. Zweigenhaft guidance has supported several key drug launch market strategies with industry leaders the likes of Genzyme, Pharmacyclics, Gilead, Janssen, Pfizer, Alexion, Bayer, GSK, Seattle Genetics, Monogram Science, Roche, Genentech, CureVax and Genomic Health.

Additionally Mr. Zweigenhaft is consultant and senior advisor to the shareholder group of Cancer Treatment Centers of America. In his role with the shareholders he is responsible for incubating growth and enterprise wide opportunities in the cancer care marketplace.

Previously Mr. Zweigenhaft held the office of CEO and Vice Chairman of Onco360 a national oncology pharmacy care management provider with corporate offices in New York City. The Onco360 model provided the full continuum of oncology pharmacy service solutions to over 3,000 community based Hematologists and Oncologists, Hospital Based Cancer Centers of Excellence in coordination with managed care providers insuring over 45 million people. Under Burt’s vision and leadership Onco360 created, developed and implemented the industry best practice oncology pharmacy model by incorporating the strengths of Board Certified Oncology Pharmacists and Oncology Patient Advocates to support the prospective and concurrent patient centered oncology medical home model. In 2014 PharMerica acquired controlling interest in Onco360 and relocated the company in 2015 to Louisville, KY.

Mr. Zweigenhaft previously served as Senior Vice President of Managed Care Sales and Marketing, Government Programs, Trade Relations and Business Development Strategies for Priority Healthcare Corporation, a publicly traded company in the specialty pharmacy sector with $2.3 billion in specialty drug revenues before being acquired by Express Scripts in 2005.

Prior to 2002, Mr. Zweigenhaft spent several years serving as a specialty pharmacy consultant to Medco, CuraScript, BioScrip and several Regional National Blue Cross Blue Shield and National Managed Care Payer programs.

Mr. Zweigenhaft holds a Bachelor of Science in Management and Economics from the University of Buffalo School of Management, where he also serves on the Dean’s Advisory Committee and remains active with the University of Buffalo schools of Pharmacy and Medicine including the Center of Excellence for Bioinformatics and Health Sciences. Mr. Zweigenhaft is a member of AMCP (American Managed Care Pharmacy), HOPA (Hematology Oncology Pharmacists Association) and ASCO (American Society of Consulting Oncologists). Mr. Zweigenhaft also serves on the Editorial Boards of several industry publications and is Editor and Chief of the Journal for Value Based Cancer Care. Mr. Zweigenhaft is also Co-Chairman and Co-Founder of the AVBCC (Association for Value Based Cancer Care) and serves as a Board Member of and President of NASP (National Association of Specialty Pharmacy) in Washington, DC.

Philanthropically Mr. Zweigenhaft serves on the National Board of Swim Across America for Cancer; a NFP organization that has raised $90 million to date to support cancer research laboratories. In 2015 Mr. Zweigenhaft was honored to be the recipient of the CancerCare “Help and Hope Award”.