Part II: Public Payers in the U.S. & Key International Markets

James Class leads IP, Value and Innovation policy for Gilead from its Washington, DC office. In this role, he manages cross-functional company efforts on Intellectual Property and Trade Policy, as well as Value Frameworks. James worked for almost a decade at PhRMA with responsibility for diverse public policy issues at the state, federal and international levels. He then spent seven years at Merck, where he held roles in Corporate Strategy, Regional and Country Commercial Operations and Global Public Policy in the US, Russia and Switzerland. James holds a PhD with distinction in Russian intellectual history from Georgetown University, has published original research in peer-reviewed journals, and has lived and traveled extensively throughout the world, promoting policies on science-based biologics regulation, pricing, and intellectual property among others. He also established the Board of the Partnership for Safe Medicines and launched the first direct-to-patient counterfeit drug alert system. He has participated in numerous stakeholder initiatives, including Interpol, WHO, and the USPTO Training Academy, as well as in trade associations like BIO, PhRMA, and IFPMA.

Alan Eisenberg is Vice President, Global Public Policy & Government Relations at Alnylam. In addition to global policy and government relations, he also leads US public payer engagement and reimbursement strategies, as well as government pricing. Prior to Alnylam, Eisenberg federal government relations for Celgene and was Executive Vice President at the Biotechnology Innovation Organization (BIO). He has served in a variety of senior staff and policy making roles on Capitol Hill and was a key member of staff teams that wrote several significant health laws including pediatric exclusivity, Medicare Part B reimbursement (Average Sales Price), and the creation of Medicare Part D. Eisenberg also worked at Ford Motor Company in Dearborn, MI, as an economist and finance manager. Eisenberg holds masters degrees from Harvard and George Washington Universities, and a Bachelor of Science from Union College.

Elizabeth has been with Biogen since 2012 and currently leads the US Market Access Strategy and Operations team. Her team is responsible for ensuring market access strategy for Biogen’s marketed products and late-stage pipeline align with corporate goals. Prior to joining the US team, Elizabeth lead the market access team for Multiple Sclerosis responsible for Europe and Canada. During this time, her team launched 4 products and lead over 40 reimbursement re-assessments in the region. She began her career at Biogen leading Health Economics and Outcomes Research for the Interferon portfolio. Prior to joining Biogen, Elizabeth’s early career was in both health economic consulting supporting health technology assessments and market access strategy. During this time, she worked on over 15 product launches. She also worked at the Centers for Medicare and Medicaid Services (CMS) during the implementation of the Medicare Modernization Act. Elizabeth eared a PhD in Health Economics and a Master’s in Health Policy from the Bloomberg School of Public Health at The Johns Hopkins University. She holds a dual BA from Smith College in Economics and German Literature and is fluent in German.

Erin Mistry brings 15 years experience in helping manufacturers evaluate their pricing, value and access portfolio strategies across global markets. She is currently Senior Managing Director, Head of Value, Access & HEOR at Syneos Health, a 23,000 + global organization that combines both clinical trial and commercial development services. Erin spent many years working with healthcare systems establishing quality metrics and leading clinical teams that feed into value-based care initiatives and patient engagement strategies while finding the pricing and access niche at Medimmune. She has worked extensively across a variety of therapeutic areas and global markets to build value messaging and demonstration, evidence requirements, pricing strategies, contracting opportunities, and stakeholder engagement plans across the commercial development spectrum. Erin enjoys the dynamic policy environment and the direct interaction with Payer decision makers that influence today’s access decisions.

Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs in Brussels and works as a lawyer in the healthcare boutique law firm NOVACOS in Düsseldorf. He advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Alexander has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Dr. Ulrich Everling. Alexander represents innovative life sciences companies at the EU institutions, before national authorities, HTA agencies, payers and courts. Alexander has a particular expertise in EU regulatory law such as GMP, lifecycle management, distribution and clinical trials, as well as in pricing and reimbursement procedures in Germany. He advises serveral US biotech and medtech companies in market access & government affairs related issues in Germany, offering strategic advice on value demonstration, pricing, tendering and other reimbursement matters. Alexander offers full-service legal support throughout all phases of the AMNOG-procedure, including drafting of dossier, G-BA benefit assessment, price negotiations with the GKV-Spitzenverband and arbitration board proceedings. He has a particular expertise in orphan drugs, medical devices as well as gene & cell therapies. His work also focuses on strategies for early value demonstration towards payers and national HTA bodies next to early patient engagement.

Jay Seemann is Vice President of Market Access Ex China for BeiGene. His current position includes responsibilities for the strategic and tactical execution plans for market access, reimbursement, distribution, and pricing, in support of the company's emerging product portfolio. He is an established industry executive leader in global commercialization, product launches, reimbursement and market access. His previous experience includes leading several US and Global commercialization organizations including building structure and new capabilities for start-up and mid-cap, large pharma, within both therapeutic and diagnostic commercial organizations. He has successfully launched numerous specialty products in the industry including a diverse and complex portfolio of diagnostic, physician-administered, and oral oncology products. Jay has held leadership roles with companies such as Sanofi Aventis, Bayer, Onyx Pharmaceuticals and Nanostring Technologies.