United States Pharmacopeia

May 20, 2025 8:00 AM - May 21, 2025 5:00 PM

12601 Twinbrook Pkwy, , Rockville, MD 20852-1717 , USA

DIA/USP Evolution of Biosimilars Development Workshop

Evaluating what we have learned and where we are headed

Speakers

Hillel P Cohen, PhD

Hillel P Cohen, PhD

Biosimilars Expert, Retired, 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.

Jessica  Greenbaum

Jessica Greenbaum

Director, Regulatory Affairs Policy U.S., Sandoz Inc., United States

Diane  McCarthy

Diane McCarthy

Senior Director, Global Biologics, US Pharmacopeia, United States

Sonia Tadjalli Oskouei, PharmD

Sonia Tadjalli Oskouei, PharmD

Vice President & US Head, Biosimilars and Specialty, Sandoz, United States

Sonia T. Oskouei, PharmD, BCMAS, DPLA, is Vice President of Biosimilars for Cardinal Health, where she leads the national biosimilars strategy to enhance patient accessibility and affordability of critical therapies. A board-certified Medical Affairs Specialist, Dr. Oskouei was previously Vice President of Innovation and Digital Health at Premier Inc., where she also led their biosimilars strategy on behalf of 4,000 hospitals and 175,000 other provider types. She received her Doctor of Pharmacy from Belmont University and completed post-graduate residencies in Clinical Pharmacy and Health System Pharmacy Administration. She serves on the Board of Advisors for the Center of Biosimilars and is an established thought leader on biosimilars.

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.

Arlene  Wolny, DrMed

Arlene Wolny, DrMed

Global Head of Regulatory Affairs, Biocon, United States

Gillian  Woollett, PhD, MA

Gillian Woollett, PhD, MA

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

Dr. Gillian Woollett joined Samsung Bioepis in November 2021 as VP, Head Regulatory Strategy and Policy, US (SBUS), to stand up a U.S. presence for science-based regulatory strategy and policy in the leading global market for biologics. Previously, she was SVP and Principal Regulatory Scientist at Avalere Health and, prior to that, Chief Scientist and Administrator at Engel & Novitt, LLP. Dr. Woollett was VP of Science and Regulatory Affairs at BIO and AVP at PhRMA, where she worked on biosimilars policy. Dr. Woollett earned her B.A., M.A. in Biochemistry from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford. She was a post-doc at the University of Edinburgh and the Biomedical Research Institute.

Tamei  Elliott, MS

Tamei Elliott, MS

Associate Director, Scientific Programs, DIA, United States

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Diane  McCarthy

Diane McCarthy

Senior Director, Science and Standards ,Global Biologics Department , USP, United States

Dr. McCarthy is Senior Director, Science and Standards in the Global Biologics Department at the US Pharmacopeia. She leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports a diverse range of biological therapies, including monoclonal antibodies and other protein therapeutics, vaccines, peptides, and cell and gene therapy. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

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.

Kevin  Carrick, PhD

Kevin Carrick, PhD

Senior Director, Science and Standards, Biologics, United States Pharmacopei, United States

Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment. These standards include documentary (monographs and general chapters) and physical reference standards for varied products from oligonucleotides to gene therapies.

Anne  De Groot, MD

Anne De Groot, MD

CEO, EpiVax, United States

Dr. De Groot graduated with an M.D. from Pritzker School of Medicine / University of Chicago in 1983, with a specialty in Internal Medicine. In 2008, she became a faculty member at the University of Rhode Island. She established EpiVax, an immunoinformatics company, in May 1998

João  Tavares Neto

João Tavares Neto

, Brazilian Health Regulatory Agency (ANVISA), Brazil

Anna  Schwendeman

Anna Schwendeman

William I. Higuchi Collegiate Professor, Pharmaceutical Sciences, University of Michigan, United States

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