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Biosimilars Conference


Speakers

  • Hillel  Cohen, PhD

    Hillel 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.

  • Mary Jo  Carden, JD, RPh

    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.

  • Laura  McKinley, PhD

    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.

  • Mark  Stewart, PhD

    Mark Stewart, PhD

    • Vice President, Science Policy
    • Friends of Cancer Research, United States

    Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments in the fastest and safest way possible. Mark leads the development and implementation of the organization's research and policy agenda as well as overseeing the conduct of research projects to inform ongoing policy discussions. He regularly participates in policy discussions and meetings throughout the year to help catalyze meaningful change for oncology healthcare.

  • Anna  Welch, MA

    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.

  • Sarah  Yim, MD

    Sarah Yim, MD

    • Acting Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER
    • FDA, United States

    Sarah Yim, M.D. is the acting 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.

  • Erika  Satterwhite

    Erika Satterwhite

    • Head of Global Biosimilars Policy
    • Mylan, United States

    Erika Satterwhite is a policy professional with expertise in international pharmaceutical market policy. Erika currently leads Global Biosimilars Policy for Mylan, a multinational health company with an industry-leading pipeline of biosimilar medicines, and serves as Chair of the Biosimilars Committee of the International Generic and Biosimilar medicines Association (IGBA).

  • Gillian  Woollett, MA

    Gillian Woollett, 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.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    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

  • Christopher J. Webster, DVM, PhD, MS, MSc

    Christopher J. Webster, DVM, PhD, MS, MSc

    • Principal
    • BioApprovals, United States

    Chris Webster runs his own consulting practice in biologics regulatory strategy specializing in maximizing development efficiency for biosimilars, biologics and vaccines. Chris formerly led biosimilars regulatory affairs at Baxalta and has also led biologics regulatory teams at Novartis Vaccines, Millennium and SmithKline Beecham Animal Health. Chris also has a strong interest in regulatory policy, and spent several years in Regulatory Policy and Intelligence at Pfizer, during which time he was also chair of the Genomics Technical Group at PhRMA. Chris graduated in veterinary medicine at the University of Edinburgh, and also holds a masters in immunology from the University of Birmingham and a doctorate from the University of London.

  • Janet  Woodcock, MD

    Janet Woodcock, MD

    • Director, Center for Drug Evaluation and Research (CDER)
    • FDA, United States

    Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations.

  • Jaclyn  Bosco, PhD, MPH

    Jaclyn Bosco, PhD, MPH

    • Senior Director, Global Scientific Head, Epidemiology and Biostatistics
    • IQVIA, United States

    Dr. Jaclyn Bosco is the Global Head of Epidemiology and Outcomes Research in Real World Solutions at IQVIA. With her practical experience leading observational and low-intervention research studies in North America, Europe, and Asia-Pacific regions, she provides scientific input and oversight for studies of biologics and biosimilars. As a thought leader in real world research of biosimilars, she has been invited to present at international congresses on the topic of generating real-world evidence for biosimilars with regulators and policy makers, is a Scientific Advisor for the U.S. BBCIC, and is the faculty lead for the ISPE biologic and biosimilars course.

  • Benjamin  Chandhok

    Benjamin Chandhok

    • Senior Director, State Legislative Affairs
    • Arthritis Foundation, United States

    Ben Chandhok is the Senior Director of State Legislative Affairs for the Arthritis Foundation, responsible for leading the state advocacy program. Before joining the Arthritis Foundation in 2016, Ben served as a Legislative Director in the Massachusetts House of Representatives and in the Rhode Island General Assembly as a Legislative Budget Analyst. He received his Juris Doctor from Boston College Law School and his Bachelor of Arts from Case Western Reserve University.

  • Sarah  Crowley-Ikenberry, MA

    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 (FDA), 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.

  • Juliana Marguerite Reed, MS

    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

    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.

  • Lauren  Vela

    Lauren Vela

    • Senior Director
    • Pacific Business Group on Health, United States

    Lauren Vela is a Senior Director at Pacific Business Group on Health. PBGH works to improve quality and affordability of healthcare by promoting more value-based measurement, payment and contracting. Lauren leads activities at PBGH to spread innovations in play by large self-insured employers and identifies opportunities in the healthcare delivery system where market pressure appropriately applied by large purchasers can have impact. Lauren convenes PBGH members around value-based projects for better healthcare.

  • Elena  Wolff-Holz, MD, PhD

    Elena Wolff-Holz, MD, PhD

    • Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP
    • European Medicines Agency, Netherlands

    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.

  • Murray  Aitken

    Murray Aitken

    • Senior Vice President and Executive Director
    • IQVIA, United States

    Murray Aitken is a senior vice president of IQVIA and Executive Director of the IQVIA Institute for Human Data Science. The Institute undertakes independent research for publication, drawing upon the resources of IQVIA, and focuses on improving understanding of critical healthcare issues around the world, including the role of medicines in patient care, the disruptive impact of technology, productivity in research and development, and the value of information in improving decision-making. In his role, Murray directs the research agenda and co-authors reports, while also engaging externally with a broad range of healthcare decision-makers in the public and private sectors as well as the media.

  • Hans  Ebbers, PhD

    Hans Ebbers, PhD

    • International Scientific Affairs
    • Biogen Netherlands B.V. , Netherlands

    Hans Ebbers, PhD, is at the International Scientific Affairs department of Biogen’s biosimilars business unit. Dr. Ebbers obtained his PhD at the department of Pharmaceutical Sciences from Utrecht University, the Netherlands. Since then he has worked on biosimilars in several academic, NGO, regulatory and medical affairs roles. He has a particular interest in biosimilars and has published several peer reviewed articles on this topic.

  • Emily  Griffiths, PhD

    Emily Griffiths, PhD

    • Subject Matter/Technical Specialist
    • Health Canada, Canada

    Dr. Emily Griffiths is a Subject Matter/Technical Specialist in the Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada. She leads the development of biosimilars policy. Since joining Health Canada in 2016, Dr. Griffiths has provided advice and developed policy and guidance documents to support the regulatory review of biosimilars. She participates in a number of Health Canada working groups related to biosimilars and contributes to international efforts to foster regulatory alignment. Dr. Griffiths has a PhD in Medical Biophysics and an Honours BSc in Immunology, both from the University of Toronto.

  • Cheryl  Koehn

    Cheryl Koehn

    • Founder and President
    • Arthritis Consumer Experts, Canada

    Ms. Cheryl Koehn is an arthritis advocate, community leader, published author and rheumatoid arthritis survivor for 31 years. Ms. Koehn has dedicated her life to helping others living with arthritis as well as people with other chronic diseases. She is the founder and president of Arthritis Consumer Experts, a national, patient-led organization that provides science-based information and education programs in both official languages to people with arthritis. She served as Co-Chair of the Summit on Standards for Arthritis Prevention and Care, Co-Founded the Best Medicines Coalition, and was two-time Chair of the Better Pharmacare Coalition.

  • Laura  Lasiter

    Laura Lasiter

    • Science Policy Analyst
    • Friends of Cancer Research, United States

    Laura Lasiter, Ph.D. is a Science Policy Analyst at Friends of Cancer Research (Friends) where she leads initiatives to explore evidence-based coverage and reimbursement policies supported by real-world evidence, including patient reported outcomes. She also directs the Friends’ Real-World Evidence Pilot Project to advance the regulatory use of real-world evidence. Prior to joining Friends, Laura was an American Association for the Advancement of Science Congressional Science Fellow for Senator Al Franken. She received her Ph.D. in Biomedical Sciences from the University of Tennessee Health Science Center for work conducted at St. Jude Children’s Research Hospital.

  • Nancy  Lin, DrSc, MS

    Nancy Lin, DrSc, MS

    • Senior Scientist, Epidemiology
    • Optum, United States

    Nancy Lin, ScD, is Senior Scientist, Epidemiology at Optum. A pharmacoepidemiologist, her primary research interests include applications for enriched electronic healthcare data systems to enhance surveillance and assessment of drug and biologics use, safety, and effectiveness. At Optum, Dr. Lin has led large-scale observational studies in the areas of rheumatoid arthritis, depression, and vaccines. Nancy received a Master of Science and Doctor of Science from Harvard School of Public Health.

  • Marjana  Marinac, PharmD

    Marjana Marinac, PharmD

    • Senior Director, Regulatory Affairs Drugs & Biologics
    • JDRF, United States

    Marjana Marinac is the Senior Director of Regulatory Affairs for Drugs and Biologics and is responsible for developing and implementing regulatory strategies to accelerate approval for priority JDRF therapies. In this role, she focuses on beta cell replacement and regeneration, immune therapies, biomarkers and pediatrics. Prior to joining JDRF in 2012, Dr. Marinac worked in regulatory affairs in the pharmaceutical industry working in both large and small molecule development in various therapeutic areas including sedation, oncology, vaccines and type 1 diabetes. Marjana received her doctor of pharmacy degree from Butler University in Indianapolis, IN.

  • Martin  Schiestl, PhD

    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.

  • Sameer  Awsare, MD

    Sameer Awsare, MD

    • FACP Associate Executive Director
    • Permanente Medicine, The Permanente Medical Group, United States

    DR. SAMEER AWSARE is an Associate Executive Director for The Permanente Medical Group in charge of Pharmacy, Adult and Family Medicine, Mental Health, Risk Adjusted Coding, Revenue Cycle, Outside Medical Services, Pain Management and the Opioid Initiative.Dr. Awsare joined the Permanente Medical Group in 1993. He is involved in resident teaching and was the Chair of the Hospital Ethics Committee. He has also been involved in Medicare coding and compliance at the medical center level. He was the Chief of medicine at our Campbell facility. He is currently the Secretary and Chair of the Governance Committee of the Mid-Atlantic Permanente Medical Group Board.

  • Elizabeth  Jex

    Elizabeth Jex

    • Attorney Advisor
    • Office of Policy Planning at Federal Trade Commission, United States

    Elizabeth Jex is an attorney advisor specializing in biopharmaceutical health policy in the Federal Trade Commission’s Office of Policy Planning. She is a career staff attorney with over 29 years of experience in public service. She is a frequent speaker for the FTC on the issues concerning biosimilar competition. Ms. Jex is a graduate of Williams College (1983) and obtained her Juris Doctor from Georgetown University Law Center (1987).

  • Edward  Li, PharmD, MPH

    Edward Li, PharmD, MPH

    • Associate Director, HEOR & RWE
    • Sandoz, United States

    Edward Li, PharmD, MPH, is Associate Director, Health Economics and Outcomes Research (HEOR) at Sandoz. He is responsible for the design and implementation of HEOR and Real-World Evidence studies for Sandoz products. Prior to joining Sandoz, he spent 15 years in academia as a professor, practicing oncology pharmacist, and outcomes researcher. In these prior roles, he performed health technology assessments to decide therapies for oncology clinical pathways and authored papers on biosimilars, pharmacoeconomics, and health outcomes.

  • Guido  Pante, PhD

    Guido Pante, PhD

    • Technical Officer
    • World Health Organization , Switzerland

    Guido worked 9 years for the Italian Medicine Agency (AIFA) having his main focus on the regulatory, quality and GMP aspects of biotherapeutic products in early phase of development as well as products submitted to the European Medicine Agency (EMA) for marketing authorization. Guido has also been deeply involved in several European Commission and EMA drafting groups and scientific advices. Guido took part to the planning, management and coordination of the WHO pilot project for prequalification of biotherapeutics products providing his quality, regulatory and GMP expertise since the very beginning of the project.

  • Ned  Pojskic

    Ned Pojskic

    • Leader, Pharmacy & Health Provider Relations
    • Green Shield Canada, Canada

    Ned Pojskic is Green Shield Canada’s Leader for Pharmacy and Health Provider Relations. In this role, he is responsible for setting GSC’s strategic direction with respect to provider and drug benefits management. Ned is responsible for overall drug formulary management, including pricing and policy as well as pharmaceutical industry partnerships.

  • Sundar  Ramanan

    Sundar Ramanan

    • Vice President, Global Regulatory Affairs
    • Biocon Research Limited-SEZ Unit, India

  • Angus  Worthing, MD

    Angus Worthing, MD

    • Chair, Government Affairs Committee
    • American College of Rheumatology, United States

    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.

  • Gianluca  Trifiro, MD, PhD

    Gianluca Trifiro, MD, PhD

    • Associate Professor of Pharmacology, Dept of Biomedical and Dental Sciences
    • University of Messina, Italy

    Gianluca Trifirò is MD, clinical pharmacologist and pharmacoepidemiologits working as Associate Professor of Pharmacology at the Academic Hospital of Messina with honorary position at Department of Medical informatics of Erasmus Medical Center of Rotterdam (NL). Scientific coordinator of an Academic Master program on “Use of Real-world data for evaluations in Pharmacovigilance, Pharmacoepidemiology ad Pharmacoeconomics” at University of Messina. Clinical pharmacologist of Phase I Clinical Trial Unit of Bambino Gesù Pediatric Hospital of Rome (Italy). Member of Steering Group of European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) at the European Medicine Agency.

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