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 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.
Tiffany Fletcher, MA
- Head of Global Access Policy
- 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.
Leah Christl, PhD
- Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
- Amgen, United States
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.
Emanuela Lacana, PhD
- Deputy Director, OTBB, OND, CDER
- FDA, United States
Emanuela Lacana is currently the Deputy Director in the Office of Therapeutic Biologics and Biosimilars in CDER, as a research/reviewer. Emanuela joined the FDA Office of Biotechnology Products in 2001, as a research-reviewer. In that capacity, she was involved in the review of immunomodulators and tumor vaccines and conducted research on T cell development and molecular signaling. In 2006, Emanuela transitioned to a full-time reviewer position, reviewing therapeutic enzyme products, and in 2008, she became a Lead Interdisciplinary Scientist, overseeing the review and evaluation of therapeutic enzymes and enzyme replacement therapies. In 2013, Emanuela was promoted to Associate Director for Biosimilar and Biologics Policy in OBP, where she
Julie Marechal-Jamil, MSc
- Director, Biosimilar Policy and 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.
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.
Juliana Marguerite Reed, MS
- Pfizer, United States
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 President.
Laura D. Wingate
- Executive 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 EVP, 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.
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.
Lu-Ning Cui, MD, PhD
- Senior Clinical Evaluator, HPFB
- Health Canada, Canada
Dr. Lu-Ning Cui is a Senior Clinical Evaluator in Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics and is responsible for pre-market clinical evaluation of biotherapeutics and gene therapy products for the treatment of haematological diseases. Dr. Cui has broad scientific knowledge and regulatory experience in the assessment of clinical studies for generics and biosimilars. Dr. Cui has participated in the development of the guidance document for biosimilars in Health Canada. Other experience includes review of clinical trial information of biologics for the treatment of oncological, autoimmune, endocrine diseases. Dr. Cui joined Health Products and Food Branch, Health Canada in 2001.
- Director of Content
- Biosimilars Review & Report, United States
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, which has covered and consulted on the payer markets since 25 years.
Wyatt Gotbetter, MPA
- Health Advances, United States
Wyatt brings 20 years of life sciences experience to Health Advances, and joined the firm after a successful career leading teams in strategy development, product and portfolio management, and new product commercialization in the biopharma and medtech industries. Wyatt helps lead Health Advances’ Biopharma practice and focuses on commercial growth and business development strategies for therapeutics and their convergence with med tech in our Digital Health and Drug Delivery work. Wyatt earned his BS degree in Economics & Policy Analysis and an MPA degree, including a certificate from the Sloan Graduate Program in Health Services Management, at Cornell University, where he is currently on the faculty.
Patricia Aprea, MD
- Director, Evaluation and Control of Biológicals/Research
- ANMAT, Argentina
Director of Evaluation and Control of Biologic and Radiopharmaceutical Products-ANMAT. She studied biochemistry at the Buenos Aires University where she was assistant professor and researcher of the Biochemistry and Pharmaceutical Industries career. She has technical background for more than 25 years in regulatory science with emphasis in research, control and evaluation of biologic and radiopharmaceutical products. She coordinates the Sub-Committee for Biologic Products, Argentine Pharmacopeia. She is member of the Interministerial Commission on Advanced Therapies and she has participated as member of severals programs of the Ministry of Science Technology and Productive Innovation.
Anna Hyde, MA
- Vice President of Advocacy & Access
- Arthritis Foundation, United States
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.
Christian Schneider, DrMed
- Head of Biopharma Excellence and Chief Medical Officer (Biopharma)
- PharmaLex, Denmark
10+ years of Leadership and Management expertise at senior or very senior level in three separate Regulatory Authorities (MHRA – Medicines and Healthcare products Regulatory Agency, UK; Danish Medicines Agency, Denmark; PEI – Paul-Ehrlich-Institut, Germany). Memberships in Committees/Working Parties at the European Medicines Agency (EMA)
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.
- 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.
Sarah Crowley-Ikenberry, MA
- Senior Communication Advisor, OTBB, OND, CDER
- FDA, United States
Sarah Ikenberry is Senior Communication Advisor for the Office of Therapeutic Biologics and Biosimilars (OTBB), in the Food and Drug Administration’s, Office of New Drugs, where she provides communication advice and support to senior leaders and the agency about communicating strategic priorities, initiatives, and educational information about biosimilar and interchangeable products. Sarah also directs the development of patient and health care provider educational materials and manages stakeholder outreach for OTBB.
Erika Benke Emerson, MPA
- Chief Policy Officer
- Diabetes Leadership Council, United States
Erika B. Emerson is Chief Policy Officer of the Diabetes Leadership Council. She has more than 20 years of health policy and advocacy experience, including health care and pharmaceutical public policy, issues management, strategic communications and stakeholder relations. Her biopharmaceutical industry experience and understanding of the U.S. health care system lend unique insight to state and federal policies impacting access, quality and value of care and coverage for people with chronic conditions. Erika’s health policy and patient advocacy experience is rooted in behavioral and mental health. A serendipitous introduction to the diabetes community sparked a heart-and-mind connection that expanded her policy interests and personal passion
Luke Greenwalt, MBA
- Vice President, Market Access, Center of Excellence
- IQVIA, United States
Ted Okon, MBA
- Executive Director
- Community Oncology Alliance, United States
Ted Okon is a nationally recognized expert on the policy and politics of cancer care. He is quoted extensively in the press, including guest appearances on TV and radio news shows. Ted has testified before Congress on cancer issues and is frequently on Capitol Hill discussing the nation’s cancer care delivery system. Ted’s target areas of expertise include the cost of cancer treatment, health care reform, Medicare reimbursement, pharmacy benefit managers (PBMs), drug shortages, and the changing landscape of cancer care delivery in the United States.
Sundar Ramanan, PhD
- Vice President, Global Regulatory Affairs
- Biocon Biologics, India
At Biocon Biologics Dr. Sundar Ramanan is responsible for accelerating the pipeline toward successful registrations as well as advancing innovative regulatory policies, globally. He is a seasoned executive with expertise across biopharmaceutical drug development, operations, clinical & commercial strategy, policy and regulatory affairs. Prior to joining Biocon Biologics, he worked at Amgen and was responsible for its international regulatory strategy and policy for biologics & biosimilars, and helped shaped biosimilar standards globally. He has successfully led teams in the development of biopharmaceutical drug candidates from the early stages through commercialization, and life-cycle management across multiple therapeutic areas.
Eva Temkin, JD
- Partner, FDA and Life Sciences
- King & Spalding LLP, United States
A partner in our 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.
Paul Cornes, MD
- Bristol Oncology Centre, United Kingdom
Hye-Na Kang, DVM
- Access To Medicines and Health Products, World Health Organization, Switzerland
Dr Kang joined WHO HQ in January 2009 and has been in charge of development/implementation of WHO guidelines for regulatory evaluation of biologicals, particularly biotherapeutics including biosimilars. Prior to joining WHO, Dr Kang was a scientific officer for twelve years at Korea Ministry of Food and Drug Safety who was responsible for reviewing license applications, quality control, and inspection of biological products. In 2004, she worked on the project to develop HCV DNA vaccine at the Vaccine and Infectious Disease Organization-International Vaccine Center in the University of Saskatchewan in Canada.
James Kenney, MBA, RPh
- JTKenney, LLC, United States
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 30 years, most recently serving as Immediate Past-President of the organization.
Margaret Rehayem, MA
- Vice President
- National Alliance of Healthcare Purchaser Coalitions, United States
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.
Irene Z. Chan, PharmD
- Director (Acting), Division of Medication Error Prevention and Analysis 1, OSE,
- FDA, United States
CAPT Irene Z. Chan received a B.S. in Pharmacy and Doctor of Pharmacy degree from Rutgers University. CAPT Chan currently works at the Food and Drug Administration where she serves as Deputy Director in the Division of Medication Error Prevention and Analysis, responsible for leveraging her knowledge of regulations, human factors, and risk management to provide oversight of safety recommendations regarding drug nomenclature, labels, labeling, packaging, and product design.
Emily Gebbia, JD
- Policy Staff Director, OTBB, OND, CDER
- FDA, United States
Emily Gebbia is the Policy Staff Director in the Office of Therapeutic Biologics and Biosimilars (OTBB) within the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In this role, Emily oversees the development and implementation of regulatory policy related to biosimilar, interchangeable, and other therapeutic biologic products.
Stephanie L. Ho, PharmD
- Pharmacist Evidence Analyst and Strategist
- Kaiser Permanente, United States
Stephanie L. Ho, PharmD, BCPS, APh is a Pharmacist Evidence Analyst and Strategist with Kaiser Permanente National Drug Intelligence and Strategy. She specializes in drug information and provides evidence reviews, prepares pipeline drug forecasts, and develops formulary recommendations. Her focus and areas of expertise are hematology, oncology, and biosimilars, and she partners closely with clinicians and various stakeholders in strategic planning and formulary management within an integrated healthcare system. Dr. Ho earned her Doctor of Pharmacy degree from Western University of Health Sciences College of Pharmacy and completed both her PGY-1 pharmacy practice residency and PGY-2 drug information specialty residency at Kaiser Permanente.
- Executive Director
- Biosimilars Forum, United States
Meaghan Rose Smith is the first Executive Director of the Biosimilars Forum. She has spent her career in health care policy, with top roles in the U.S. Department of Health and Human Services, U.S. Senate, and U.S. House of Representatives. On the Senate Finance Committee, Meaghan worked on the landmark Affordable Care Act which enacted the Biologics Price Competition and Innovation Act (BPCIA), establishing the FDA’s pathway to review and approve biosimilars. Meaghan previously led the health care practice at SKDKnickerbocker, where she advised government leaders, CEOs, and started multi-party coalitions to achieve legislative and regulatory wins.
Steven Lucio, PharmD
- Senior Principal, Center for Pharmacy Practice Excellence
- Vizient Inc., United States
Steven Lucio leads the Center for Pharmacy Practice Excellence (CPPE), which provides Vizient members and the health care community with clinical and industry-related insights into pharmaceuticals and supports Vizient's mission to manage costs, improve quality of care and grow market performance. Steven is an industry leader and sought-after expert in the advancement and adoption of biosimilars as a key strategy in the management of drug price increases. He has been featured in multiple publications and broadcasts and is also the author of Biosimilars and Biologics: Implementation and Monitoring in a Healthcare Setting. Steven received his PharmD from Creighton University and his bachelors degree in pharmacy from the University of Texas.
Elena Wolff-Holz, MD, PhD
- Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor
- Paul-Ehrlich Institut, Germany
Dr Elena Wolff-Holz is a physician and regulator at the Paul-Ehrlich-Institut. She is Chair of the Biosimilar Medicinal Products Working Party (BMWP) and also serves as a Member of the Scientific Advice Working Party of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Previously, Elena worked for 14 years in the biotech industry in various senior clinical development and medical marketing functions at Centocor Inc (now J&J) and Amgen. She is a Lecturer at J.W. Goethe Universität, Frankfurt, DGRA, MEGRA and the FORUM Management Institute. Her work has resulted in several (co-) authorships in scientific journals and several presentations at (inter-)national conferences.
Preconference Short Courses
Biosimilars Resource Kit