Dr. Leah Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s policy positions. Prior to joining Amgen, Dr. Christl served as the Director of the Therapeutic Biologics and Biosimilars Staff at the US FDA. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina.

Tiffany Fletcher, Head of Global Biosimilar Policy and Access, at Mylan, is responsible for the development and support of global policies to support biosimilars and increase patient access to high quality medicine. Tiffany has over twenty years of industry experience specializing in market access and reimbursement policy. An accomplished public policy leader, Tiffany has a talent for prepping the environment for complex product launches, including the successful development and execution of the government reimbursement strategy for the launch of the first biosimilar in the U.S. Prior to coming to Mylan, Tiffany spent five years at Sandoz Inc., A Novartis Division, leading in biosimilar and reimbursement policy development.

Denis Arsenault is a manager in the Office of Policy and International Collaboration within Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD). In this capacity, Mr. Arsenault leads policy development initiatives for BRDD on a number files including regulatory modernization and biosimilar biologic drugs.

Stan Mehr has over 30 years of experience in health care publishing and project management. He is the Content Director and Principal for Biosimilars Review & Report, a resource that has reported on the evolution of the US biosimilar industry since 2014. He is also the President of SM Health Communications, LLC, and has covered and consulted on the payer markets for more than 30 years.

Juliana been engaged in global biosimilar policy for over 15 years through her current position as well as her previous work for Hospira, Coherus BioSciences and as the President of the Biosimilars Forum. Ms. Reed has direct pre and post approval market experience in multiple countries across at least 9 biosimilars on the market today. In addition to her corporate positions, Ms. Reed has previously served on the board of the Generic Drug Association in the US, the board of Medicines for Europe, and was a co-founder of the US Biosimilars Forum where she is currently serving as the Forum’s Executive Director.

Dr. Stacey Ricci is the Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars at CDER. She has contributed to FDA guidance and standards for biotechnology-derived therapeutic proteins, particularly biosimilars. Dr. Ricci leads a multidisciplinary team overseeing the review of biosimilar and interchangeable products, advancing biosimilar policy, scientific research, and stakeholder engagement. Before joining the FDA in 2005, she completed post-doctoral research at the University of Pennsylvania and earned her Doctor of Science from Tulane University, along with a Master of Engineering and Bachelor of Science from Cornell University

BSc (Hons) in Biochemistry from University of Cape Town. Working in regulatory affairs and clinical development for over 30 years with focus on biological medicines and particular expertise in biosimilars. Joined PAREXEL in 2001 prior to which was with Novo Nordisk Ltd.

Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications including serving on executive governance committees and overseeing policy development on real world evidence, prescription drug promotion, clinical trial oversight and innovative trial design.

Rachel Turow is Associate General Counsel, Regulatory Law & Policy at Teva Pharmaceuticals and Head, U.S. Regulatory Policy. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses, and supports Teva’s drug-device combination products and digital health projects. Rachel also serves as head of regulatory policy for the U.S. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from

Dr. Hillel P. Cohen PhD is Executive Director of Scientific Affairs at Sandoz, helping explain the principles of biosimilars and biosimilar policies to the healthcare community, patient advocacy groups, and health authorities. He has published and given presentations in the areas of biosimilar education, switching, interchangeability, naming and safety. Dr. Cohen led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in both BsUFA 2 and BsUFA3 negotiations on behalf of industry. Hillel is active on the Education Committees including the Biosimilars Council and the Biosimilars Forum. Dr. Cohen received a BA from New York University and a PhD in Biology from Dartmouth.

A partner in King & Spalding's FDA and Life Sciences practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics and Biosimilar's, Eva draws upon her deep experience with these products at FDA to help clients navigate development, approval, post-market regulation and life-cycle management of drugs and biologics, biosimilars, and combination products.

Jennifer Graff, PharmD, is the Senior Director, Professional Affairs at the Academy of Managed Care Pharmacy (AMCP), where she oversees and leads strategic efforts for AMCP and collaborates with members and other stakeholders to advance medication management strategies, including formulary management, medication therapy management, quality, value-based care, patient outcomes, health information technology, and emerging professional practice issues. Previously, Dr. Graff served as Vice President, Policy Research at the National Pharmaceutical Council and HEOR roles at MedImmune and Pfizer. She holds a Doctorate of Pharmacy from the University of Nebraska Medical Center and completed a fellowship at the University of Michigan.

Since October 2015, Julie has been coordinating of the Biosimilar Medicines Group, a sector group of Medicines for Europe. Before that, Julie was part of Medicines for Europe’s regulatory and scientific affairs team for 8 years, with responsibilities in the areas of Quality, Compliance, Environment, Health & Safety as well as Bioequivalence. MSc in Pharmacology by background, she previously worked for the pharmaceutical industry. Her work consists in the coordination of Biosimilar policy related activities and external liaison with policy makers, EU institutions, Medicines Agencies, International organisations, industry and professional associations as well as a broad range of stakeholders.

Pharmacist graduated in Federal University Of Minas Gerais (UFMG), Brazil, Specialist in Health Surveillance. Started in Anvisa (National Health Surveillance Agency) in 2005 on the marketing authorizations office. From 2011 to 2013 performed as advisor in the Anvisa's Board Of Directors. In 2015 was the manager of the Cells, Tissues, Blood, Organs Office then moved in 2016 to the Anvisa inspectorate. Since August 2022 is the Head of Biological Products and Advanced Therapy Medicinal Products Office.

As Executive Director, Marketing for Amgen’s Biosimilars Business Unit, Chad Pettit leads the Global Biosimilars Commercial Team in developing global launch strategy for Amgen’s portfolio of 10 biosimilar medicines. He serves as a liaison with the biopharmaceutical industry on policy matters in biosimilars, a rapidly growing segment of the Amgen business. With his global experience, Chad has broad perspective and is recognized as an expert on biosimilar commercialization, market access for biosimilars, and the policy measures required to facilitate cost savings for patients and the health care system over the long-run.

Murray Aitken is a senior vice president of IQVIA and Executive Director of the IQVIA Institute for Human Data Science. The Institute undertakes independent research for publication, drawing upon the resources of IQVIA, and focuses on improving understanding of critical healthcare issues around the world, including the role of medicines in patient care, the disruptive impact of technology, productivity in research and development, and the value of information in improving decision-making. Murray directs the research agenda and co-authors reports, while also engaging externally with a broad range of healthcare decision-makers in the public and private sectors.

Thomas Herndon is a Senior Physician within the Office of Therapeutic Biologics and Biosimilars at the U.S. Food and Drug Administration. He has been at part of the Scientific Research Staff within OTBB for 3 years.

Amanda Major is the Director of Government Affairs and Policy at Coherus BioSciences. Coherus is a commercial stage biopharmaceutical company with the mission to increase patient access to cost-effective medicines that can have a major impact on their lives and to deliver significant savings to the U.S. health care system. Amanda has more than fifteen years in health policy experience at both the state and federal level. In her role, Amanda lobbies Congress and works with the administration to advance policies that boost biosimilars, promote American-made manufacturing and ensure a robust pharmaceutical pipeline. She leads the company’s legislative efforts around biosimilar incentivization and development.

Dr Balaji V. Prasad, is as a Director at Barclays Investment Bank covering U.S. Specialty Pharmaceuticals. Before joining Barclays, Balaji was a portfolio manager at Kieger AG, a dedicated Swiss healthcare asset management firm, responsible for global specialty pharma investments. Prior to that, he led Barclays' coverage of Indian Healthcare, Consumer Staples and Retail in Mumbai, following a stint at Goldman Sachs covering Indian Healthcare and Indian Software services. He earned his MD from Bangalore Medical College and MBA from IIM Ahmedabad.

Sarah Yim, M.D. has been the Director of the Office of Therapeutic Biologics and Biosimilars, in CDER's Office of New Drugs (OND), FDA since 2019. Prior to that, she spent 2 years as Director of the Division of Clinical Review in the Office of Generic Drugs, and 11 years in various roles in rheumatology drug review in OND. She received her undergraduate degree from Stanford University, her Doctor of Medicine degree from the Uniformed Services University of Health Sciences, and completed a postdoctoral fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at the National Institutes of Health.

Alex Brill is the founder and CEO of Matrix Global Advisors (MGA). In addition, Alex is a senior fellow at the American Enterprise Institute. Previously, Alex was the policy director and chief economist for the House Committee on Ways and Means, where he worked from 2002 to 2007. At Ways and Means, Alex directed policy development and led negotiations on a variety of tax, health, pension, and trade matters. Alex has testified numerous times before Congress on tax policy, labor markets, unemployment insurance, Social Security reform, fiscal stimulus, the manufacturing sector, and biological drug competition. He has served as an expert witness and litigation consultant in both tax and pharmaceutical patent litigations.

Dr. Pascal Crottet joined Swissmedic in 2009 as a Quality Assessor for Biologicals, and he has reviewed numerous CMC dossiers of Biosimilar Applications. He was involved in the stepwise updates of the Swiss Guidance document on Authorisation of Biosimilars. He is also engaged in discussions with other regulatory agencies on biosimilar related topics. Prior to that, he conducted basic research in the US and in Switzerland in the fields of glycobiology, immunology and intracellular protein trafficking. He received his degree in biochemistry and his PhD from the University of Fribourg, Switzerland.

Rachel Goode is Senior Vice President, Patents and Legal at Fresenius Kabi. She leads a global team of in-house attorneys and is responsible for the global patent and legal strategy of the biosimilars business. Prior to working for Fresenius Kabi, Rachel worked at the Teva where she acted as in-house counsel for the biosimilars business. Before joining Teva, Rachel worked as a patent attorney for the Merck Serono biosimilars unit where she was the Patents Lead for several biosimilar products. Rachel began her career in intellectual property as a patent attorney in a law firm in the UK. She is licensed as a Patent Attorney under European patent law and is a member of the UK chartered Institute of Patent Attorneys (CIPA).

Anna Hyde is the Vice President of Advocacy and Access at the Arthritis Foundation. She oversees both the federal and state legislative programs, in addition to grassroots engagement. Her focus is to raise the visibility of arthritis as a public health priority, build support for federal and state legislation that ensures access to affordable, high-quality health care, and enhance patient engagement in the policy-making process. Anna previously served as Senior Director of Advocacy and Access, managing the federal affairs portfolio and overseeing the state advocacy team. Prior to her time at the AF she was a Manager of Federal Affairs for the American Congress of Ob-Gyns and has worked in health policy since 2008.

Jim is President of JTKENNEY, LLC a managed care consulting practice in Waltham, MA. His current consulting activities include sales and marketing training, medical and pharmacy benefit design, formulary management, industry trend analyses, pipeline programs, rebate contracting, outcomes-based contracts, product and business development, and value assessments. Jim’s clients include pharmaceutical manufacturers, device companies, diagnostic suppliers, biologic/gene therapy companies as well as public and private health plans. Jim worked at Harvard Pilgrim Health Care for over 38 years in a number of management positions and he has been a member of AMCP for over 31 years, including a 3 year term as President of the organization.

Sonia T. Oskouei, PharmD, BCMAS, DPLA, is Vice President of Biosimilars for Cardinal Health, where she leads the national biosimilars strategy to enhance patient accessibility and affordability of critical therapies. A board-certified Medical Affairs Specialist, Dr. Oskouei was previously Vice President of Innovation and Digital Health at Premier Inc., where she also led their biosimilars strategy on behalf of 4,000 hospitals and 175,000 other provider types. She received her Doctor of Pharmacy from Belmont University and completed post-graduate residencies in Clinical Pharmacy and Health System Pharmacy Administration. She serves on the Board of Advisors for the Center of Biosimilars and is an established thought leader on biosimilars.

Dr. Jian Wang manages a team of scientific and clinical evaluators responsible for pre-market risk/benefit assessment. His division has regulatory responsibility for assessing non-clinical, pharmacology and clinical data for biological drugs for the treatment of haematological, oncological, and infectious diseases. At the moment, radiopharmaceuticals, gene therapies and biosimilars (regardless of their indications) are also regulated by the Division. Dr. Wang has broad regulatory experience in pre-market drug regulations for generics, biologics and biosimilars. He joined the Health Canada Pesticide Management Regulatory Agency in 1996.

Deborah Williams has more than 25 years of experience in private industry, trade association and government on government policies. Deborah was employed at three of the largest global pharmaceutical companies with key responsibilities for all aspects of Federal policy- payment coverage and coding, government drug pricing rules,value-based pricing and international reference pricing. She also advised on policies affecting potential new acquisitions, pipeline launches, new indications and preparation for LOE. Deborah spent 6 years as professional staff at the Ways and Means Committee developing and negotiating $2 -3 hundred billion in legislation. And, 7 years as a Senior Economist at Congressional Commissions and CMS

Senior consultant, Copenhagen Center for Arthritis Research (CopeCare), Copenhagen University Hospital Rigshospitalet, Glostrup, Denmark. Professor in Rheumatology at the University of Copenhagen. - >250 publications in peer-reviewed journals, H-index 50 - Head of the nationwide DANBIO research and quality database with >50,000 patients 2000-2022 - PI of several observational studies on biosimilar drugs - PI of several investigator-initiated trials of early rheumatoid arthritis, biological treatments and tapering - co-PI/steering group member of several IIT - Head of the Coordinating Center for the EuroSpA collaboration - Member of several Nordic/European collaborat regarding observational data on biological treatments

Margaret Rehayem is the Vice President of the National Alliance and in her role, provides leadership for national initiatives that support member collaboration, and drive health, equity and value for organizations and communities across the country. Her recent focus has included multi-stakeholder collaboratives and the development of strategies that support system & delivery reform. She has over 20 years' experience working with employers in various areas such as business performance & leadership, health benefits, advanced primary care, medical & pharmacy drugs, biosimilars, employee engagement, organizational culture, and the impact of health and wellbeing in organizations.

As the Co-founder and CEO of Patients Rising, Terry helps patients find their voice and become outspoken advocates for their health care. She manages all of the day to day operations and fundraising for the organization and is the visionary behind all of Patients Rising’s programs. A regular opinion writer on health policy and how it affects patients, she has been published in Chicago Tribune, Fortune, The Hill, the Boston Globe, Fierce Healthcare, MedCity News, Morning Consult, Crain's NY Business, Washington Times, Real Clear Health, American Thinker, The Federalist, and many more. She lives in the Washington D.C. area with her husband Jonathan and twin boys, Jackson and James.

Ms. Sarah Ikenberry is a Senior Communication Advisor at the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) in CDER, where she manages education and stakeholder engagement for biosimilars. She provides strategic communication support to senior leaders on biosimilar initiatives and priorities. With over 20 years of experience in public health and regulatory roles, Sarah has expertise in strategic communication planning, stakeholder outreach, campaign management, message development, and content creation for both web and traditional media. She holds a Master of Arts in Communication from Johns Hopkins University.

Martin Schiestl received his doctoral degree in chemistry with a specialization in bioanalysis from the University of Innsbruck in Austria in 1996. In the same year, he started his work on Biosimilar medicines at Sandoz where he built up the analytical and pharmaceutical development departments in charge of the biosimilar portfolio and other biological medicines of Sandoz. He moved into the regulatory and policy field in 2009, further fostering regulatory sciences for biosimilar medicines and supporting development and licensing of Sandoz’ biosimilar portfolio. In his current role, he is responsible for the Global Regulatory Affairs Policy at Sandoz Biopharmaceuticals.

Jim Carey is the Head of U.S. Policy and Government Affairs for Organon and Co. Organon is a global healthcare company, formed through a spinoff from Merck in June 2021, with a mission to deliver impactful medicines and solutions for a healthier every day. Organon’s vision is “A better and healthier every day for every woman.” In his role at Organon, Jim leads federal and state policy and government relations and is on the leadership team for Organon’s External Affairs and ESG group. Jim is based in Organon’s Washington, DC office. Jim also serves as the Treasurer of The Biosimilars Forum, an organization founded to inform and support public policies that encourage awareness, access, and adoption of biosimilars in the United States.

David’s is as a Subject Matter Expert (SME) on the CMC of Biological Medicinal Products and Regulatory Affairs and his role at Parexel involves guiding and advising clients on these aspects at the pre- and post-authorization stages of Clinical Trial and Marketing Authorization procedures. David also routinely interacts with the regulatory agencies on these projects. David worked for 6 years as a Pharmaceutical (CMC/Quality) Assessor of Biological Medicinal Products at the Health Products Regulatory Authority (HPRA) in Ireland. Prior to joining the HRPA, David developed a strong biomedical research career authoring / co-authoring 40 scientific publications covering a range of biomedical areas including tumour cell biology.

Peter Kiely joins Parexel from the Irish Health Products Regulatory Agency (HPRA), and has vast experience in Regulatory Affairs, including • assessment of clinical dossiers of MAA’s in a wide range of therapeutics • assessment of medicinal products in the treatment of Respiratory, Immunology and Inflammatory Bowel diseases, Rheumatology, Dermatology, general and vascular surgery • assessment of Clinical Trial Applications • technical advice, especially in Clinical Development, Marketing Authorization and Scientific Advice. In addition to 17.5 years’ experience in regulatory assessment, including parallel assessment with FDA, Peter was also an alternate member of the Committee for Medicinal Products for Human Use (CHMP) at the Europ