Vice President, Patient and Health Impact Pfizer Essential Health Business Unit
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.
Mridula Iyer, Ph.D.
General Manager, Precision Medicine Quest Diagnostics
Mridula Iyer, Ph.D., currently serves as the General Manager, Precision Medicine at Quest Diagnostics leading the Precision Medicine business for all therapeutic areas.
Dr. Iyer’s professional experience spans the academic Pharma and biotechnology industry.
At Quest Diagnostics, she is responsible for providing strategic direction to the Precision Medicine/Companion Dx business, working closely with other teams to align with the market needs. Prior to joining Quest Diagnostics, Dr Iyer was at AZ as Director Diagnostics, at Molecular Health as Director of Product Marketing and with Qiagen Inc. leading their North American Molecular Diagnostics marketing and Global Product Management teams.
Chief Commercial Officer Enzyvant Therapeutics
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
Sophie Shen, PhD
Director Healthcare Quality Johnson & Johnson
Sophie Shen, PhD, is the Director, Healthcare Quality at Johnson & Johnson. In her role, Sophie ensures that Janssen Oncology strategies support the overarching movement to value-based care.
Previously, Sophie worked for J&J Worldwide Government Affairs and Policy team in Washington DC where she was responsible for Medicare coding and reimbursement analysis for J&J medical device and pharmaceutical sectors. Recently, she successfully requested for a new DRG for cardiac ablations. She began her career at United Health/Optum in 2006, where she led efforts to develop outpatient imaging efficiency measures that CMS later adopted for Hospital Outpatient Quality Reporting. She later spent two years at Brookings Institution where she worked with five private ACOs to set up their performance measurement system and provided technical assistance to 17 communities to develop HIT infrastructure to transform local healthcare systems. Additionally, Sophie worked with American Board of Medical Specialties to develop 22 cost and efficiency measures associated with 20 high-priority clinical conditions and tested in four different markets.
Sophie graduated from George Washington University and completed her Doctor of Public Health at University of North Carolina at Chapel Hill.
Scott Harold Shortenhaus
Director Lilly Oncology, US, PACE, Policy and Advocacy Eli Lilly
Scott is the director of Lilly Oncology’s public policy and advocacy efforts in the US. In this capacity, he is responsible for developing and implementing a patient-centered public policy agenda for Lilly Oncology – working closely with patient advocacy and professional organizations, legislators, think tanks, and other stakeholders on priorities of mutual interest. Before joining Eli Lilly, Scott was most recently a political appointee in the Bush administration, serving as the director of the Department of Labor Center for Faith-Based and Community Initiatives. While at the Department of Labor, Scott’s primary responsibilities included managing the President’s Prisoner Re-Entry Initiative and other prisoner re-entry demonstration projects. Prior to his work at the Department of Labor, Scott worked on the state level for Wisconsin Governor Scott McCallum and on Capitol Hill for Wisconsin Congressmen Mark Neumann and Paul Ryan. Scott is a native of Carmel, Indiana, and graduated from Taylor University in Upland, Indiana.
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).
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.
System Director, Managed Care Pharmacy Services Mercy Health
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.
Former Vice President, National Medical Director, Pharmaceutical Policy and Strategy Aetna
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.
Osama Rahma, MD
Assistant Professor of Medicine Center For Immuno-Oncology |Gastrointestinal Cancer Center
Dana-Farber Cancer Institute| Harvard Medical School
Bio: I participated in cancer immunotherapy drug development since I was a in training at the Vaccine Branch at the National Cancer Institute. The Vaccine Branch investigated variety of novel cancer vaccines and studied factors that could inhibit the immune response triggered by vaccine therapy, such as immune checkpoints. During my clinical oncology fellowship training at NCI I developed a great interest in gastrointestinal (GI) malignancies, focusing mainly on pancreatic cancer. My research efforts had led to the development of few clinical protocols using immunotherapy in pancreatic cancer that are currently open for enrollment at NCI and elsewhere. As the hepatobiliary and pancreatic cancer team co-leader at University of Virginia I had the opportunity to be the Principal Investigator of three pharma-sponsored multi-center clinical trials, two of which investigated the effects of three different cancer vaccines in pancreatic cancer. I am also the chair of tow investigator-initiated clinical trials using an immune checkpoint inhibitor (anti-PD-1) in combination with neoadjuvant chemoradiation therapy in pancreatic and rectal cancer. I recently joined the Center for Immuno-Oncology at Dana-Farber Cancer Institute to be part of national and international efforts to advance the field of cancer immunotherapy. In this exciting era of cancer immunotherapy we are currently investigating the combinations of variety of novel immunotherapeutic agents in multiple tumor types and working on identifying biomarkers that could determine clinical response.
Dr. Balch is the Chief Executive Officer of Patient Advocate Foundation and National Patient Advocate Foundation.
Dr. Balch has nearly fifteen years of executive leadership in the non-profit sector with an emphasis on consensus-building and collaboration. He has led numerous federal advocacy efforts on a range of issues both at the legislative and regulatory level over the years. He became the CEO of both PAF and NPAF in 2013. From 2006 - 2013, he served as the Vice President of the Preventive Health Partnership -- a national health promotion collaboration between the American Cancer Society, American Diabetes Association, and American Heart Association. Prior to his work with the Preventive Health Partnership, Dr. Balch was the Executive Director of Friends of Cancer Research.
Dr. Balch has served on the Executive Board of the Patient Advocate Foundation and National Patient Advocate Foundation since 2007. Dr. Balch also serves on numerous advisory boards and committees. He is a member of the External Advisory Board for the Hutchinson Institute for Cancer Outcomes Research (HICOR), a member of the Duke-Margolis Payment Reform Group, a member of the Robert Wood Johnson Foundation/Avalere Cost of Care Advisory Board, a member of the Quality and Outcomes Committee for the National Comprehensive Cancer Network (NCCN), and recently served as a member of the Guiding Committee for the Health Care Payment Learning and Action Network (LAN). Dr. Balch also serves on the Finance Committee and the Membership Committee for the National Health Council in Washington, DC, is a member of the National Committee for Quality Assurance’s Consumer Advisory Council, and sits on the inaugural board for The American Journal of Managed Care’s (AJMC) Institute for Value-Based Medicine (IVBM).
He earned his PhD in environmental studies with a concentration in political economy in 2003 from the University of California, Santa Cruz; his master’s degree in environmental sciences in 1997 from the University of Texas in San Antonio; his bachelor’s degree (cum laude) in biology in 1994 from Trinity University in San Antonio.
Dr. Balch is the Chief Executive Officer of Patient Advocate Foundation and National Patient Advocate Foundation.
Dr. Balch has a decade of executive leadership in the non-profit sector with an emphasis on consensus-building and collaboration. From 2006 - 2013, he served as the Vice President of the Preventive Health Partnership -- a national health promotion collaboration between the American Cancer Society, American Diabetes Association, and American Heart Association. Prior to his work with the Preventive Health Partnership, Dr. Balch was the Executive Director of Friends of Cancer Research.
He has led numerous federal advocacy efforts on a range of issues both at the legislative and regulatory level over the years. For example, he helped to organize and lead a coalition that successfully fought for improvements in the regulatory process for the review of cancer drugs at the Food and Drug Administration (FDA). He also contributed to the development of key federal policies related to the Affordable Care Act.
Dr. Balch serves on the Executive Board of the Patient Advocate Foundation and National Patient Advocate Foundation. Dr. Balch also serves on numerous advisory boards and committees. He is a member of the National Committee for Quality Assurance’s Wellness and Health Promotion Advisory Committee, a member of the Guiding Committee for the Health Care Payment Learning and Action Network (LAN), a member of the Advisory Board for the Patient Resource Cancer Guides, External Advisory Board member for the Hutchinson Institute for Cancer Outcomes Research (HICOR) and a member of the Robert Wood Johnson Foundation/Avalere Cost of Care Advisory Board. Dr. Balch also serves on the Finance Committee and the Membership Committee for the National Health Council in Washington, DC and recently accepted an invitation to join the inaugural board for The American Journal of Managed Care’s (AJMC) newest initiative, the Institute for Value-Based Medicine (IVBM). He is also a member of the 2017 Access to Innovation Forum Steering Committee for the Biotechnology Innovation Organization (BIO).
He earned his PhD in environmental studies in 2003 from the University of California, Santa Cruz; his master’s degree in environmental sciences in 1997 from the University of Texas in San Antonio; his bachelor’s degree (cum laude) in biology in 1994 from Trinity University in San Antonio.
STEPHANIE TRUNK is a partner in the Health Law Group at Arent Fox LLP in Washington, D.C. Ms. Trunk counsels pharmaceutical and device manufacturers, distributors and their customers, including pharmacy benefit managers, on regulatory, reimbursement and compliance matters. Her practice extends to counseling on drug pricing and government price reporting, HIPAA and privacy matters, counseling on Medicare Part D, developing corporate compliance programs, representing clients in contract negotiations and providing transactional support to her clients. Prior to joining Arent Fox LLP, Ms. Trunk was in-house counsel to a pharmacy benefit management company. Ms. Trunk is the author of numerous chapters on health law treatises including a chapter on Controlling Fraud, Waste and Abuse in the Medicare Part D Program in the ABA/BNA’s Health Care Fraud and Abuse: Practical Perspectives. She received a J.D. with Highest Honors from the George Washington University Law School in 2003 where she was elected to the Order of the Coif and a member of the George Washington Law Review. Ms. Trunk also has as a graduate certificate in health management from the George Washington University School of Public Health (2003) and she received a B.S. in Accounting Summa Cum Laude from the University of Maryland in 1997.
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.