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.

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.

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.

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.

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.

Over the 18 years’ working experience in China National Regulatory Authority and National Control Lab and two years’ scientist/technical officer working experience in WHO HQ through international recruit process. Accumulated Chemical Manufacture and Control for biological products at both national and international level mainly covers: 1)technical review and assessment for biological products; 2)quality control assay and reference substances research and development including WHO international measurement standards; 3)technical leadership and professional input to regulatory science and regulation convergence for both CFDA and WHO written standards in the area of biologics standardization