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DoubleTree Bethesdan

Sep 23, 2019 7:00 AM - Sep 24, 2019 5:00 PM

8120 Wisconsin Avenue, , Bethesda, MD 20814 , USA

Biosimilars Conference


Hillel P Cohen, PhD

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.

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 and patients.

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

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

Sarah Yim, M.D. has been the Director of the Office of Therapeutic Biologics and Biosimilars, in CDER's Office of New Drugs (OND), FDA since 2019. 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, PhD, MA

Gillian Woollett, PhD, MA

Vice President, Head Regulatory Strategy and Policy, Samsung Bioepis, 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

Retired, Principal Deputy Commissioner, FDA , United States

Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER. In that position, she has led many of the FDA’s groundbreaking drug initiatives. In 2020 Dr. Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr. Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021-February 17, 2022. Dr. Woodcock is now the FDA's Principal Deputy Commissioner. In this role she works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and helps oversee the agency’s day-to-day functions.

Jaclyn  Bosco, PhD, MPH, FISPE

Jaclyn Bosco, PhD, MPH, FISPE

Vice President and Global Head of Epidemiology, IQVIA, United States

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

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, 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.

Juliana Marguerite Reed, MS

Juliana Marguerite Reed, MS

Executive Director, The Biosimilars Forum, 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 Executive Director.

Eva  Temkin, JD

Eva Temkin, JD

Partner, FDA and Life Sciences , King & Spalding LLP, United States

A partner in King & Spalding's 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.

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; 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.

Murray  Aitken, MBA

Murray Aitken, MBA

Executive Director, IQVIA Institute for Human Data Science, 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. 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.

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 Affairs Policy, Sandoz GmbH, Austria

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.

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, JD

Elizabeth Jex, JD

Attorney Advisor, Office of Policy Planning, 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, PhD

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.

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

Scientific Lead, INSPIRE; Professor, Pharmacology, Diagnostics and Public Health, University of Verona, 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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