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.

As Amgen develops its biosimilars, Dr. Thomas Felix works to advance science and policy for a successful, patient-focused implementation. Dr. Felix partners with drug safety experts to characterize the ability to track and trace multisource therapeutic outcomes in various treatment settings and regions. He is committed to advancing pharmacovigilance systems to quickly and accurately identify adverse events and facilitate manufacturer accountability.

Suzette Kox is Senior Director International of the Biosimilar Medicines Group, a sector group of Medicines for Europe and the first Chairperson of the Biosimilars Committee of the International Generic and Biosimilar Medicines Association (IGBA). Suzette has been involved with biosimilar medicines since 2001 and is passionate about access to medicines around the world. Previously, she worked in regulatory affairs and management for ratiopharm (now Teva). She was also a visiting faculty member of the School for International Training in Geneva. Before joining the generic and biosimilar medicines industries in 1991, she followed a hospital and retail pharmacy career.

Laura McKinley is a Director of Regulatory Policy at Pfizer. Laura has been with Pfizer for over 10 years and has extensive experience working on biosimilars. Laura represents Pfizer on industry trade association biosimilar committees and was an industry representative during the initial BsUFA negotiations. Prior to joining the Global Regulatory Policy team at Pfizer, she was a Global Regulatory Lead on biosimilar development teams working to advance the development of Pfizer's portfolio of monoclonal antibody biosimilars. She received her Ph.D. in Pathology from University of Michigan in Ann Arbor, Michigan.

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.

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. Shacter regulated therapeutic proteins at the FDA for 18 years, serving as Chief of the Lab of Biochemistry in CDER’s Office of Biotechnology Products until leaving FDA in 2012. She supervised the regulatory review of a wide range of protein products & contributed to FDA policies & expectations for the manufacture, control, & analytical characterization of therapeutic proteins & biosimilars. She now consults on the science & regulation of protein products through her business ThinkFDA LLC.

Dr. Charles Barr is Chief Science Officer at AMCP Biologics and Biosimilars Collective Intelligence Consortium. He worked in academic medicine, industry and research (clinical trials, registries & RWD). He was Group Medical Director and Head, Strategy & External Relationships in US Medical Affairs, Evidence for Access at Genentech. His MD and MPH is from Loma Linda University and post-doctoral studies in biomedical computing, biostatistics, and health policy at Harvard School of Public Health.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Daniel Alvarez M.D. is a Senior Director at Pfizer. He works in the development of monoclonal antibody biosimilars. Dr. Alvarez interacts with regulatory agencies, clinicians and scientist to advance the knowledge of biosimilars development.

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.

Patrick Lynch is a product quality reviewer in the Office of Biotechnology Products at CDER. He has served in this position since 2014 where he reviews product quality information for therapeutic proteins, including analytical similarity information in biosimilar applications. Dr. Lynch first joined FDA in 2009 as a post-doctoral fellow and has worked for five years as a product quality reviewer in both CBER and CDER. Dr. Lynch received a Bachelor of Science in Biochemistry and Molecular Biology from the University of Georgia in Athens, Georgia. He received his Ph.D. in Biochemistry from Duke University in Durham, North Carolina.

KellieTaylor is currently the Associate Director of the Office of Medication Error Prevention and Analysis in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research’s (CDER) where she is responsible for the Center’s programs in risk management and medication error prevention. She provides oversight, coordination, and technical expertise for the pre- and post-marketing activities involving medication error prevention and analysis regulated drug and drug/device products, human factors studies, proprietary names, and the nonproprietary naming convention for biological products.

Dr. Cindy Cao oversees the Sandoz US regulatory affair biopharmaceutical department for all US regulatory activities to support the Sandoz Biosimilar development and commercialization. Her team is responsible for all filings of Sandoz biosimilar products to FDA. With 17 years of pharmaceutical R & D experience, Dr. Cao has played a number of leadership roles and accumulated extensive experience with clinical, nonclinical, CMC and device aspects of development projects as well as marketed products. Prior to joining the pharmaceutical industry, Dr. Cao was an Assistant Professor in University of Utah, conducting basic biological research in inflammation and cancer biology.

Mark J. Cziraky, PharmD, CLS, is a healthcare executive and entrepreneur with more than 25 years of experience in leading, designing and conducting research studies to improve quality, safety and affordability in healthcare, including randomized clinical trials and retrospective and prospective observational research designs. As the co-founder and Vice President of Research at HealthCore, Dr. Cziraky is currently responsible for the operational oversight of the Life Sciences Research business, and serves as key architect in creating unique, multi-stakeholder research collaborations within the healthcare industry. Dr. Cziraky has Fellowship status in the American Heart Association and the National Lipid Association.

Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals, Inc. Mr. Leicher has advised biotechnology companies for over 25 years. Mr. Leicher is a frequent lecturer on biotechnology law and is Chair of the Board of the Biosimilars Council, a Division of the Association for Accessible Medicines (AAM). In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale & Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the US District Court in DC after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.

Catherine Parker serves as Director General of the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch, Health Canada. She previously served as BGTD Acting Senior Executive Director and as Director of its Office of Policy and International Collaboration, playing a key role in major regulatory initiatives such as the Safety of Human Cells, Tissues and Organs for Transplantation Regulations, the new Blood Regulations, and the Global Pandemic Influenza Regulatory Preparedness Initiative. Catherine is Health Canada’s representative at the Assembly and Management Committee of the International Council on Harmonization, and the Steering Committee of the Pan-American Network for Drug Regulatory Harmonization.

Julie Rosenberg, MD is a Senior Director and Global Asset Leader at Pfizer, Inc. Julie is a pediatric oncologist who has worked in a variety of leadership roles in both academic medicine and the pharmaceutical industry. In her current role, she oversees the development of key oncology biosimilar programs from proof-of-concept through successful completion and product launch. Dr. Rosenberg is also a writer and the author of: Beyond the Mat: Achieve Focus, Presence, and Enlightened Leadership Through Principles and Practice of Yoga (Da Capo Press; Hachette Book Group; Dec. 2017).

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.

Dr. Worthing is a practicing rheumatologist at Arthritis & Rheumatism Associates in Washington DC, clinical assistant professor of medicine at Georgetown University Medical Center, and chair of the Government Affairs Committee of the American College of Rheumatology (ACR). He speaks regularly on behalf of the ACR regarding biosimilars policy and other issues of access to rheumatology care and treatment.

Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he stayed for medical training before going into industry to lead clinical research. He now oversees non-clinical and clinical activities across a portfolio of ten biosimilar products in multiple therapeutic areas.

Liz Pollitt is an independent consultant at BPCRCS, providing strategic and technical advice to clients on regulatory aspects of CMC for biological and biosimilar products. Formerly a senior pharmaceutical assessor in the Biologicals Unit at the MHRA involved in the assessment of all types of biological products, her focus on biosimilar products began as VP of CMC for Regulatory Affairs at CELLTRION, and she subsequently worked in the Biosimilars unit at Merck KGaA. Liz holds a PhD in Viral Immunology from the University of Leicester and completed postdoctoral studies at the Institute of Virology, University of Glasgow.

Tammy Powell has over 25 years of vocabulary experience at the National Library of Medicine. She manages RxNorm and has been involved in the RxNorm project since inception. In addition, she managers UMLS editing and DailyMed.

Dr. Sakurai is a reviewer in the Office of Cellular and Tissue-based Products of the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) since 2011. She is responsible for the pharmaceutical quality review of biotechnological/biological products and performing review of 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.

Chris Davis is Director of Government Affairs at Express Scripts, the nation’s largest independent pharmacy benefit manager and a strong advocate of biosimilars. He previously served as Senior Director of Federal Affairs at the Generic Pharmaceutical Association, where he advocated for the generic and biosimilars industries before Congress and worked on its Biosimilars Council. He was actively involved in Congressional passage of BSUFA I and educating Congress on the biosimilars approval pathway. Prior to joining GPhA, Chris was Legislative Director for former Congressman Rick Boucher, a member of the Energy and Commerce Committee, where he handled health care issues during the development of BPCIA.

Dr. Sue Lim is a Team Leader with the FDA, Office of New Drugs, Therapeutic Biologics and Biosimilars Staff. In this role, she provides review and oversight of therapeutic biologics and biosimilar products, as well as regulatory policy development for biosimilars. Dr. Lim was previously a Medical Officer with the FDA’s Division of Anti-Infective Products. Prior to the FDA, Dr. Lim served as an Infectious Diseases physician and Associate Hospital Epidemiologist at the University Health Network in Toronto, Canada. She received her MD from the University of Toronto where she also completed her residency in Internal Medicine and subspecialty training in Infectious Diseases. She has a MS in Health Policy from the University of Toronto.

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.

Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product Team Leader. Tania holds a PharmD, Pharmaceutical Sciences degree, and a post-graduate degree in Regulation and Evaluation of Medicines and Health Products from the Faculty of Pharmacy, University of Lisbon.