Steve St. Onge | SVP - Corporate Development
Clarametyx Biosciences

Day 1 - World Orphan Drug Congress USA 2026 @ 15:10

Navigating the "New Normal" in Biotech: Addressing Uncertainties Around Funding, Regulatory Pathways and Partnering/Exit Strategies in a Challenging Macro Environment

In the evolving rare disease and orphan drug sector, companies face a “new normal” of constrained funding, complex regulatory pathways, and shifting partnership or exit strategies. This session explores how rare disease biotechs can navigate these uncertainties while advancing critical therapies for underserved patient populations. Experts will share practical approaches to de-risk development, engage regulators effectively, and build strategic alliances that support long-term success. 

Objectives 

• Examine the unique funding and regulatory challenges facing rare disease and orphan drug developers in today’s macro environment. 
• Discuss strategies for efficient capital use, early regulatory engagement, and designing programs to attract partnerships or successful exits. 
• Review case studies highlighting how rare disease biotechs maintain development momentum and patient impact despite market and regulatory uncertainties. 

Moderator: Steve St. Onge, SVP - Corporate Development, Clarametyx Biosciences

Neva West, CEO & Co-founder, Biotech Social, Inc

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Neva West / Navigating the "New Normal" in Biotech: Addressing Uncertainties Around Funding, Regulatory Pathways and Partnering/Exit Strategies in a Challenging Macro Environment

Neva West, CEO & Co-founder,
Biotech Social, Inc

Dr. Neva West has 20 years of pharmaceutical industry experience, including as a Global Medical Director at Biogen and as the owner of a medical communications and strategy firm working with many mid-size and startup pharmaceutical companies. She has worked in many therapeutic areas, spanning from...

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Maryam Mokhtarzadeh, Chief Medical Officer, Persephoni Bio