Hillel P Cohen, PhD
- Executive Director, Scientific Affairs
- Sandoz Inc., United States
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 BsUFA 2 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.
Cecil J. Nick, MS
- FTOPRA, Vice President (Technical)
- Parexel Consulting, United Kingdom
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.
Julie Marechal-Jamil, MSc
- Director, Biosimilar Policy & Science
- Medicines For Europe, Belgium
Since October 2015, Julie has become the coordinator 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.
Jian Wang, MD, PhD
- Division Manager, Clinical Review Division – Heamatology/Oncology
- Health Canada, Canada
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.
Leah Christl, PhD
- Executive Director, Global Regulatory and R&D Policy
- Amgen, United States
Dr. Christl is currently an Executive Director of Global Regulatory and R&D Policy at Amgen. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs in the U.S. FDA's Center for Drug Evaluation and Research and was also the director of the Therapeutic Biologics and Biosimilars Staff at FDA. Dr. Christl is a scientific, regulatory, and policy expert on biosimilar products and a strategist and lead for international activities related to biosimilars and other policy areas. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston.
Laura McKinley, PhD
- Director, Global Regulatory Policy and Intelligence
- Pfizer Inc, United States
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.
Sarah Yim, MD
- Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
- FDA, United States
Sarah Yim, M.D. is the Director of the Office of Therapeutic Biologics and Biosimilars, in CDER's Office of New Drugs (OND), FDA. 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.
Tiffany Fletcher, MA
- Head of Global Biosimilar Policy and Access
- Viatris, United States
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.
Anna Welch, MA
- Chief Editor, Biosimilar Development
- Life Science Connect, United States
Anna Rose Welch is the Chief Editor of Biosimilar Development, an online publication featuring executive interviews and thought leadership columns about global biosimilar industry trends and regulatory and commercialization challenges. In addition to speaking at several U.S. biosimilar conferences, she was also invited to Brazil in 2018 to address members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilars manufacturers about how to establish a national biosimilar policy. Her writing was included in the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development, published in 2018 by Springer.
Laura D. Wingate
- Senior Vice President, Education, Support, and Advocacy
- Crohn's & Colitis Foundation, United States
Laura Wingate began her career working at Memorial Sloan Kettering Cancer Center. During her tenure, she advised and implemented quality improvement initiatives including the redesign of the outpatient center focused on streamlining the patient’s experience. As the SVP, Education, Support, & Advocacy at the Crohn’s & Colitis Foundation, Ms. Wingate oversees patient, caregiver, and professional education, state and federal advocacy, and support programming for the Foundation. Ms. Wingate works in conjunction with National Scientific Advisory Committees, Board of Trustees, and patient volunteers on developing programs and resources. Laura serves on the American Board of Internal Medicine Gastroenterology Speciality Board.
Mary Jo Carden, JD, RPh
- Head, Policy
- Sandoz, Inc., United States
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.
Shubha Bhat, PharmD, MS
- Ambulatory Care Clinical Pharmacy Specialist - Gastroenterology
- Boston Medical Center, Center for Digestive Disorders & Crohn's and Colitis, United States
Dr. Shubha Bhat is a clinical pharmacist in the gastroenterology clinic at Boston Medical Center. As part of the Crohn’s & Colitis Program, she oversees the medication experience, including education, safety monitoring, and adverse effect management, of patients with inflammatory bowel disease. In addition to clinical practice, Dr. Bhat also partakes in research and teaching. She earned her Doctor of Pharmacy degree from Northeastern University in Boston, Massachusetts and Master’s degree in Clinical Sciences from University of Colorado.
Francis Farraye, MD, MS
- Director, Inflammatory Bowel Disease Center, Professor of Medicine
- Mayo Clinic Jacksonville, United States
Francis A. Farraye, MD, FASGE, is the Director of the Inflammatory Bowel Disease Center at the Mayo Clinic, Jacksonville, Fl and a Professor of Medicine at the Mayo Clinic College of Medicine. Dr. Farraye has an active clinical practice and his research is examining several aspects of the clinical management of patients with IBD, including vaccine optimization, eating disorders, diagnosis of C. difficile infection, stigma, and disclosure. A frequent speaker and invited lecturer on topics on the diagnosis and management of IBD, Dr. Farraye also has authored or co-authored over 450 original scientific manuscripts, reviews, book chapters, and abstracts and is the co-editor for several books on IBD.
Martin Schiestl, PhD
- Global Head Regulatory Policy and Intelligence
- Sandoz GmbH, Austria
Martin Schiestl received his PhD in chemistry with a specialization in bioanalysis from the University of Innsbruck. He started his work on Biosimilar medicines at Sandoz in 1996, where he built up the analytical and pharmaceutical development departments in charge of the biosimilar pipeline and other biological medicines of Sandoz. In 2009, he moved into the regulatory and policy field, and since 2015 he is working as Chief Science Officer for Sandoz Biopharmaceuticals. In addition, Martin has been serving as a member in the expert groups for biological products at the European and US Pharmacopoeia. He also represented the generic and biosimilar industry in the expert working groups for the ICH Q11 guideline and the ICH Q7 Q&A document.
Peter P. Stein, MD
- Director, Office of New Drugs, CDER
- FDA, United States
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.
John Michael O'Brien, PharmD, MPH
- Senior Fellow
- Usc-Schaeffer Center For Health Policy & Economics, United States
John Michael O’Brien is a pharmacist who served as Senior Advisor for drug pricing to HHS Secretary Alex Azar. He also served as Deputy Assistant Secretary for Health Policy, and a key advisor to the Secretary for health policy research, development, and analysis. Dr. O’Brien is a certified health insurance executive, has held senior policy positions in the life sciences and managed care industries, was a career official at CMS during the Obama Administration, and served as a health policy fellow in the U.S. Senate. He holds a number of academic appointments, an MPH from the Johns Hopkins Bloomberg School of Public Health, a PharmD from Nova Southeastern, and studied pharmacy and public policy at the University of Florida.
Ronny Gal, PhD
- Senior Research Analyst
- AllianceBernstein LP, United States
Ronny Gal is a senior research analyst with Sanford C. Bernstein, a Wall Street research firm. In this capacity he has been involved in the biosimilar field for the past 16 years.
Scott Gavura, MBA, RPh
- Director of Provincial Drug Reimbursement Programs
- Ontario Health (Cancer Care Ontario), Canada
Scott Gavura is Director, Provincial Drug Reimbursement Programs at Cancer Care Ontario (now part of Ontario Health), and has held this role since 2007. In this position Scott is responsible for the strategic management of CCO’s cancer drug reimbursement programs as well as patient access programs for cancer imaging and other services. Scott has been working for over 20 years to improve the use of medicines in roles ranging from front-line service as a community and hospital pharmacist to multiple roles in government and professional associations. Scott has a Bachelor of Science in Pharmacy degree, a hospital residency from London Health Sciences Centre, and an MBA from the University of Toronto.
Ryan Haumschild, PharmD, MBA, MS
- Director of Pharmaceutical Sciences
- Emory Healthcare, United States
Ryan Haumschild PharmD, MS, MBA is currently the Director of Pharmacy at Emory Healthcare in Atlanta, GA. Ryan completed his doctorate of pharmacy at the University of Florida and then went on to complete a PGY1/PGY2 residency in Health System Pharmacy Administration at The Ohio State University Wexner Medical Center while obtaining his Master’s Degree from The Ohio State University.Dr. Haumschild has oversight for oncology and infusion pharmacy services, retail and specialty pharmacies, finance and 340B program, and clinical pharmacy services. He has expertise biosimilar science and utilization Dr. Haumschild has oversight for oncology and infusion pharmacy services, retail and specialty pharmacies, finance and 340B program, ambulator
Andrea Laslop, MD
- Head of Scientific Office
- Austrian Medicines and Medical Devices Agency, Austria
Andrea Laslop joined the Austrian Medicines and Medical Devices Agency, a business unit of the Agency for Health and Food Safety (AGES), in 2006. She is head of the Scientific Office, which focusses on centralised European procedures during drug development, marketing authorisation and life-cycle management. Since 2003 she is a member of the EMA Scientific Advice Working Party and since 2007 of the Committee for Human Medicinal Products. Apart from covering all medicinal products to be licensed via EMA, her expertise specifically includes biosimilars, blood products and medicines for the treatment of osteoporosis. Prior to this Andrea Laslop worked as professor of pharmacology and toxicology at the Medical University of Innsbruck, Austria.
Sean McGowan, MBA
- Senior Director, Biosimilars
- AmerisourceBergen, United States
As the Senior Director of Biosimilars, Sean McGowan is responsible for leading strategy and business development initiatives for the Biosimilar product category at AmerisourceBergen. Sean partners with Biosimilar manufacturers in the pre-commercial, launch and post-launch phases to ensure the successful launch and growth of these products. Additionally, he leads the internal collaboration with AmerisourceBergen’s customer groups to guarantee open access to Biosimilar products for the organization’s customers and patients. Sean has over a decade of experience in the healthcare industry. Prior to joining AmerisourceBergen, he held strategy and business development positions at AstraZeneca, Endo Pharmaceuticals and Accolade Inc.
Michiel Ultee, PhD, MS
- Ulteemit Bioconsulting, United States
Dr. Michiel “Mike” Ultee has more than 35 years of experience in the development of biopharmaceuticals, from research through commercial manufacturing. Recognized as an industry expert on antibodies, fusion proteins and other recombinant proteins, he is a frequent speaker at international conferences and serves on the Editorial Advisory Boards of Biopharm International and Bioprocess International. He has been a regular panelist on the “Interphex Live” sessions on biosimilars and co-authored a book chapter on CMC aspects of biosimilars. As scientific co-founder, and CSO of Laureate Biopharma and its successor Gallus Biopharmaceuticals, he developed dozens of proteins into new biopharmaceuticals. He formed Ulteemit BioConsulting in 2013.
- Executive Director, Health Care Policy
- Pacific Business Group on Health , United States
- Patient Advocate, United States
A patient diagnosed with Ulcerative Colitis at the age of 19 with personal and professional experience in healthcare.
- Commercial Medicines Director
- NHS, England, United Kingdom
Barbara K Finck, MD, RN
- Coherus, United States
Dr. Finck is a seasoned biopharmaceutical professional with over 25 years of preclinical and clinical drug development experience in academic and biopharmaceutical settings. For the past 20 years she has served in senior positions within several companies, including several start-up companies, and has experience leading successful strategic drug development. She has expertise in all phases of global drug development across a broad range of therapeutic indications. She currently serves as the CMO for Coherus BioSciences, Inc. and is the founder, president and CEO of a start-up biotech focused on ischemic eye diseases.
Ali McBride, PharmD, MS
- Clinical Coordinator
- The University of Arizona Cancer Center, United States
Alexandra Moulson, MBA, MS
- VP Strategy, Programs and Portfolio
- Polpharma Biologics, Poland
Alex is an experienced leader and strategist with a broad background in marketing, product development, business development, portfolio management and launch with a focus in oncology. She has over 16 years experience in pharmaceuticals, 8 years originators, 6 years biosimilars, and 2 years generics. Alex is British, with Biochemistry and MBA degrees. Previously Alex was an Associate Principal at McKinsey, a Director for Business Development at MorphoSys and was responsible for bringing the Sandoz rituximab biosimilar to market in the EU, Japan, Australia, and Switzerland. Most recently she headed Strategy and Novartis Collaborations for Sandoz. She currently heads Strategy, Programs and Portfolio for PolPharma Biologics.
Chad Pettit, MBA
- Executive Director, Marketing, Global Biosimilars Commercial Lead
- Amgen Inc., United States
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.
Juliana Marguerite Reed, MS
- Vice President, Corporate Affairs, Global I & I and Biosimilars Lead
- Pfizer, Inc., United States
Juliana Reed is the Vice President, Corporate Affairs, for the Pfizer global Immunology, Inflammation and Biosimilars business. Ms. Reed has been engaged in global biosimilar policy for over 15 years through her current position as well as her previous work as Vice President of Global Government Affairs for Hospira, Inc. 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 President.
Eva Temkin, JD
- Acting Director of Policy, Office of Therapeutic Biologics and Biosimilars, CDER
- FDA, United States
Eva Temkin is the Acting Director for Policy in CDER’s Office of Therapeutics and Biologics, overseeing regulatory policy related to biosimilar, interchangeable, and other therapeutic biologic products. Ms. Temkin is also the lead for FDA’s Biosimilar Action Plan, which outlines the Administration’s plans for encouraging innovation and competition among biologics and biosimilars. Previously, Ms. Temkin was Associate Chief Counsel in FDA’s Office of Chief Counsel, where she counseled CDER on complex issues relevant to drug development and approval. She earned her J.D. from New York University School of Law and B.A. in economics, cum laude, from the University of Michigan.
- Senior Vice President
- American Cancer Society Cancer Action Network, United States
Pam Traxel serves as the Senior Vice President for ACS CAN, the advocacy affiliate of the America Cancer Society. Pam is responsible for helping ACS CAN develop relationships with companies and individuals to help further the fight against cancer through dynamic partnerships, events, and forums. Pam began her career with ACS CAN in 2007. She has been integrally involved in helping to establish ACS CAN as a nationwide advocacy organization that influences and shapes public policy at all levels of government to impact our mission and to represent the voices of all cancer patients and their families.
- Patient Advocate
- Ulcerative Colitis, United States
Alex Hochstrasser was diagnosed with Ulcerative Colitis in 2014 while pursuing a B.S. in Communications Media and a double concentration in Photography and Professional Communication at Fitchburg State Univerisity. Alex met Dr. Farraye in the fall of 2015 after losing 35lbs in a flare up and promptly started treatment with Remicade at Boston Medical Center. Alex has experienced excellent results from his treatments with Remicade, Inflectra, and Renflexis. He has made extensive lifestyle changes to ensure he does not relapse with Ulcerative Colitis and has been in remission for a few years now. Alex loves to learn about Crohn's and Colitis as well as the science and billing strategies behind today's modern biosimilar treatments.
- Head of Product Strategy & Insights
- Owen Mumford, Ltd, United Kingdom
George is currently Head of Product Strategy and Insights at Owen Mumford having worked for the former OEM and now Pharmaceutical Services division of the organisation since 2006. His current focus is on deciphering the rapidly changing pharmaceutical and biotech sectors in relation to their needs for combination products. In his previous roles in business development he worked closely alongside R&D to develop devices for a variety global pharmaceutical and diagnostic clients. Prior to Owen Mumford George worked for Abbott in EMEA marketing roles in Germany, focusing on their diabetes business.
Chrys Kokino, MBA
- Head of Global Biologics Commercial
- Mylan, United States
Chrys has engaged in specialty drugs for over 31 years. He has held multiple leadership roles in pharma and biotech. Currently he is the Global Commercial Head for Biologics & Insulins at Mylan. His broad experience spans multiple therapeutic areas such as oncology, immunology, endocrinology, etc. He has launched and commercialized specialty products in the U.S. and WW including EU, Asia, Africa, and MENA with products ranging in value from $100M to over $1B. He has represented top-tier pharma & biotech companies such as BMS, Amgen, Roche. In the recent 13 years, he has had a singular focus on advancing biosimilars in WW markets, first with Sandoz, and now with Mylan where the team has so far launched 6 biosimilars in various world markets.
Etienne Nedellec, PharmD, MSc
- French National Health Care Directorate
- Ministry of Social Affairs and Health, France
PharmD, working for the French National Health Care Directorate at the health products office in charge of the incentive scheme for biosimilars.
Stacey Ricci, DrSc
- Acting Director, Scientific Review Staff, OTBB, OND, CDER
- FDA, United States
Dr. Ricci is the Director of Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars within the Office of New Drugs/CDER/FDA. She leads a multidisciplinary team that provides oversight of biosimilar and interchangeable products at all stages of regulatory development. Dr. Ricci's work focuses on enhancing FDA's policy and procedures for the scientific review of these products. Prior to joining FDA in 2005, Dr. Ricci completed post-doctoral research at the Univ. of Pennsylvania, and received her Doctor of Science from Tulane Univ., and Master of Engineering and Bachelor of Science degrees from Cornell University.
Lisa LeGette, MBA, RPh
- Government Affairs Principal
- Cigna, United States
Lisa Le Gette, RPh, MBA, is a Government Affairs Principal for Cigna. In this role, she supports both Federal and State Regulatory policy, advocacy, and legislative matters. Lisa has more than 28 yrs. of professional pharmacist experience. After graduating from the University of Maryland, School of Pharmacy, Lisa spent her initial years in traditional practice settings. However, the last 17 yrs. have been in managed care at Express Scripts, a PBM acquired by Cigna. Prior to moving to Government Affairs in 2017, Lisa was Clinical Director for Express Scripts’ TRICARE Pharmacy Services contract, overseeing clinical programs and solutions for the Department of Defense (DoD). Lisa is an active member of the Academy of Managed Care Pharmacy.
Kevin Brian Knopf, MD, MPH
- Division Chief Hematology/Oncology
- Highland Hospital, United States
Dr. Knopf is currently Division Chief of Hematology and Oncology at Alameda Health Systems, a safety net medical system in Oakland, California and an assistant clinical professor of medicine at University of California, San Francisco. He is a member of the Institute for Health Policy at UCSF and an associate professor of pharmacoepidemiology at University of South Carolina School of Pharmacy.
Gillian Woollett, DrSc, MA
- Senior Vice President
- Avalere Health , United States
Gillian Woollett, MA, DPhil leads the Avalere FDA Practice. She provides the "prequel" of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate Centers for Medicare & Medicaid Services and healthcare policy/business world. Prior to joining Avalere, Gillian was chief scientist at Engel & Novitt, LLP, and was VP, Science and Regulatory Affairs at the Biotechnology Industry Organization. She joined BIO after being associate vice president at the Pharmaceutical Research and Manufacturers of America.
Mohannad Kusti, MD, MPH
- Regional Medical Director
- Pivot Onsite Innovations, United States
Dr. Mohannad Kusti is a global physician executive and healthcare consultant with unique expertise and experience related to corporate healthcare benefits serving a variety of employers as their consulting corporate medical director and chief medical officer through Optimal Workplace & Environmental Wellness. Most recently, Dr. Kusti joined Pivot Onsite-Innovations as the Regional Medical Director following a successful tenure as Corporate Medical Director at U. S. Steel Corporation at the Pittsburgh, PA location. Dr. Kusti is an Adjunct Assistant Professor in the Department of Occupational and Environmental Health Sciences at West Virginia University. He is also a board member for many employers coalitions such as PBGH, IBI, and NAHPC.