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. Babbitt has 30 years of industry experience focusing primarily on biologics development. Over the past 8 years he has worked with many biosimilar developers on a broad array of products including filgrastim, infliximab, adalimumab, bevacizumab, trastuzumab, rituximab, and ranibizumab. One of his primary functions is to formulate clinical development plans and support client-FDA meetings. Dr. Babbitt has worked at PAREXEL for over 15 years and previously headed R&D at both LipoGen, Inc. and Cellcor, Inc. He has a PhD in Biochemistry (Univ. of Tennessee) and conducted post doc work in cellular immunology at Harvard and Washington University Medical Schools.

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.

Dr. Mike Muenzberg is VP Global Medical Director at the Merck Serono Biosimilar Unit. He was born in Austria and educated in Austria, Canada and Sweden. Dr. Muenzberg is licensed as Doctor of Nuclear Medicine and has more than 18 years’ experience in Pharmaceutical Industry, working as local as well as global Medical Manager/Director for Serono, Novartis, Amgen, Roche and Sandoz International Biopharmaceuticals. Since 2014 Dr. Muenzberg holds his position as VP Global Medical Director Biosimilars at the Merck Serono Biosimilar Unit, responsible for pipeline Biosimilars.

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

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).

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.

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

Steven Kozlowski is the Director of the Office of Biotechnology Products, Office of Pharmaceutical Quality, at the Center for Drugs Evaluation and Research (CDER), FDA. He received his medical degree from Northwestern University and trained in Pediatrics at the University of Illinois. OBP is responsible for the quality review of monoclonal antibodies and most therapeutic proteins at CDER. Dr. Kozlowski is involved in ongoing policy development for biosimilars and advanced approaches for the manufacture of biopharmaceutical products.

Dorothy (Dottie) McCabe, PhD FCP is currently the Executive Director of Clinical Development and Medical Affairs at Boehringer Ingelheim overseeing Immunology, both innovative and biosimilar, and Central Nervous System compounds. She received a PhD in Pharmacology from the University of Medicine and Dentistry of New Jersey and is a Fellow with the American Academy of Clinical Pharmacology. Dr. McCabe has thirty years of industry experience with broad multidisciplinary science and medicines expertise. She has held leadership positions in both medical affairs and new product development in a variety of medium and large pharma companies, including Amgen, Biogen, and Pfizer.

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. Rifkin received his MD from the University of Colorado. He completed his Residency in Internal Medicine and Hematology/Oncology Fellowship at the University of Arizona. Dr. Rifkin is currently in private practice at Rocky Mountain Cancer Centers. He is also a Clinical Associate Professor of Internal Medicine at the University of Colorado, Division of Medical Oncology and serves as an Associate Medical Director for the US Oncology Hematology Research Committee as the lead for Multiple Myeloma. Additionally, he serves as the Medical Director of Biosimilars for McKesson Specialty Health and US Oncology. He oversees clinical research in Biosimilars and participates in strategic development/introduction into the US marketplace.

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.

Lisa Bell Ph.D., Executive Vice President, Global Regulatory Affairs at Coherus, has close to twenty years of experience in global regulatory affairs and drug development across various therapeutic areas at leading biopharma companies. She has driven regulatory strategy of large and small molecule programs from pre-clinical through post-marketing phase, and has worked across several therapeutic areas from oncology to neurology/inflammation and rare diseases. Dr. Bell earned her Bachelor’s (Biology) and Masters (Biotechnology) degrees from Boston University, and a Ph.D. in Molecular and Cell Biology from the University of California, Berkeley.

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.

Paulo Moreira is a Clinical Development executive with 25+ years of experience in Clinical R&D. He has been with EMD Serono for the last 17 years. Presently serves as the Head of GCO External Innovation overseeing Clinical Innovation and Patient Centricity in Clinical Operations. He has had a preponderant role in establishing EMD Serono as an industry leader in patient centricity in clinical trials. Paulo is also a Visiting Scholar at Boston College. A member and leader of TransCelerate’s OC and CRA&A Workstream respectively. Recipient of PharmaVoice’s Top 100 in 2015 & 2017. CenterWatch’s Top Innovator 2018.

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.

Samantha Roberts is a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize drug development and review. Her portfolio includes patient-focused drug development, digital health, diversity and inclusion, and model-informed drug development. Prior to joining Roche/GNE, she worked at Friends of Cancer Research (FOCR) where she contributed to the genesis of the Breakthrough Therapy designation and initiatives to expand access to trials. Before FOCR, Dr. Roberts was a post-doctoral researcher at the FDA's Center for Biologics Evaluation and Research. She holds a Ph.D. in microbiology and molecular genetics from Emory University.

Professor, Depts. of Pharmaceutics, Pharmacotherapy and Outcomes Sciences, Medicinal Chemistry and Pharmacology and Toxicology, and Director of the PK/PD Laboratory at the School of Pharmacy of Virginia Commonwealth University (VCU), Richmond, VA. He has published and presented extensively to various scientific audiences in the area of quantitative pharmacology in early clinical drug development and optimal dose finding. He was and is serving on multiple university, AAPS, ACCP, ASCPT, NIH, and FDA committees.,He was awarded ACCP and AAPS fellowship status. He serves as expert consultant in clinical pharmacology with various pharmaceutical companies. He is currently chair of the Pharmaceutical Compounding Advisory Committee (PCAC).

M. Alan Brookhart is a Professor of Epidemiology at UNC Chapel Hill. His research is focused primarily on the development and application of statistical and epidemiologic methods for studies of prescription medications, vaccines, and other exposures using large clinical and healthcare utilization databases. In this area, he has made contributions to the development of quasi-experimental approaches that can be used to estimate causal effects in the presence of unmeasured or poorly recorded confounding variables. He has also been involved with the development of propensity score and marginal structural model methodology and has also developed new epidemiologic approaches for studying patterns of use medications and healthcare services.

Mary Jo Carden serves as Head of Policy at Sandoz, Inc. She previously served as Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities at the American Society of Consultant Pharmacists., and practiced as a retail pharmacist. For more than 20 years she has provided expertise and contributed to policy issues in the areas of Medicare Part D and B, Medicaid, the Affordable Care Act, Food and Drug Administration issues, and state policy issues.

John Carlsen, MHA Vice President, Covance Market Access Services John Carlsen has more than 16 years of experience as a reimbursement and health policy consultant. Mr. Carlsen specializes in assessing the impact of changes to Medicare and managed care payment systems on the reimbursement of drugs, biologics, and devices. He has closely followed developments related to biosimilars reimbursement since the enactment of the Affordable Care Act in 2010. Mr. Carlsen received an M.H.A. from the Ohio State University, and a B.A. in Economics from Duke University.

Dr. Grampp is Executive Director of Global Operations at Amgen, where he leads operations therapeutic area strategy. Previous to this role he was Director of Regulatory Policy and lead external affairs related to biosimilars in Latin America and other regions. In this capacity he has given invited presentations and authored peer reviewed publications concerning regulatory standards, pharmacovigilance, and manufacturing challenges for biotherapeutics. Dr. Grampp earned his bachelor’s degree in Chemical Engineering at the University of Wisconsin and a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology.

Viv Jenkins is a Clinical Operations Program Lead at Pfizer Ltd. She has over 20 years of drug development experience with running Phase I to IV and non-interventional clinical trials across many therapeutic areas including paediatric programmes. Current responsibilities are within Biosimilar development for small cell lung cancer.

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.

Dr. Weise is Head, Licensing Division 2, at the Federal Institute for Drugs and Medical Devices in Germany, alternate German member of the CHMP and Vice Chair of the Biosimilar Working Party at EMA. She has extensive experience in drafting biosimilar guidelines for EMA and WHO and in reviewing biosimilar applications. She is a trained pediatric endocrinologist with over 10 years of professional experience and has published scientific article on endocrinology and, more recently, biosimilars

Dr. Stanley Hong is now Senior Adviser of global marketing & sales and technical support at Celltrion Healthcare. He was President & CEO until December 2015. His team led the successful development of Infliximab, the world’s first mAb biosimilar, and gained approval for the product in Korea, Japan, Canada, across the European Union, and US. Dr. Hong was also responsible for other biosimilars’ development including Rituximab and Tratsuzumab biosimilars at Celltrion. Dr. Hong has 35 years industrial experience in the development of biopharmaceutical products and industrial enzymes. He received a PhD from Seoul National Univ in 1990. He spent two years at the University of Wisconsin as a Postdoctoral Fellow.

Dr. Lemery is a Lead Medical Officer (Team Leader) at the Food and Drug Administration within CDER’s Office of Hematology and Oncology Products. Dr. Lemery has been with the FDA for 10+ years and joined the FDA after completing his training in hematology and oncology at the National Institutes of Health.

Leigh Purvis is the director of health services research in AARP’s Public Policy Institute. She leads a team of policy analysts and researchers who work on health care issues and also heads the Institute’s work on prescription drug issues. Her primary areas of expertise are prescription drug pricing, biologic drugs, and prescription drug coverage. Leigh has a master’s degree in public administration with a concentration in health administration and policy from George Mason University and a bachelor’s degree in psychology from the University of Mary Washington. She also holds a certificate in gerontology from the University of Washington.

Cornelia is currently Head of Regulatory Affairs Biosimilars at Merck. She has over 20 years experience in the pharmaceutical industry. Prior to Merck, she served as Senior Director Regulatory Affairs – Biologics at Mylan, where she was responsible for all regulatory activities related to the development of Biosimilar products. Her pathway in Biosimilar development included positions at Apotex and Biopartners, where she built up the Regulatory Departments, supported drug development and led registration procedures for Biosimilar products. Cornelia has a degree in pharmacy from J.W. Goethe University of Frankfurt, Germany.

Hubert C. Chen is the Chief Medical Officer of Pfenex Inc., a clinical-stage biotechnology company developing biosimilars, therapeutic equivalent peptides and novel vaccines. In his current role, Dr. Chen oversees clinical research, regulatory affairs, and product development.