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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

Early Bird Ends

DAYS

HOURS

MINUTES

SECONDS

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

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.

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