Bethesda North Marriott Hotel and Conference Center

Feb 03, 2025 7:45 AM - Feb 05, 2025 12:45 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 9, Track 4: Not Business as Usual: How to Modernize your Regulatory Operations for Today’s Venture Capital and AI-fueled Pharma Market

Session Chair(s)

Kunal  Lal, MBA

Kunal Lal, MBA

Consultant - Strategy & Change

Red Nucleus, United Kingdom

Over 70% of clinical trials are now led by small, venture-funded teams. These teams are using agile strategies and novel operating models to accelerate pipelines, maximize productivity with limited headcount, and successfully meet aggressive regulatory milestones. This session will distill these market trends into actionable takeaways for emerging and leading pharmaceutical organizations alike. Featuring expert speakers from various perspectives including Investor, Partner, Technology, and Sponsor, sessions will outline how smaller organizations can build and run a nimble regulatory function.

How New Technology and Investment Models Have Transformed Work in Emerging Companies - Toban Zolman, Kivo Inc.

How to Nimbly Lead the Regulatory Affairs Function at an Emerging Company - Alissa Minkoff, Third Harmonic Bio

How Emerging Pharma Teams are Accelerating Pipelines and Achieving Big Milestones - Sara Chan, SSI Strategy

Learning Objective :
  • Align their path-to-market strategy to today’s investor priorities and market dynamics
  • Develop and manage an agile operating model for their team and external partners
  • Effectively utilizese of technology and automation to maximize bandwidth, without sacrificing compliance

Speaker(s)

Toban  Zolman, MA

How New Technology and Investment Models Have Transformed Work in Emerging Companies

Toban Zolman, MA

Kivo, United States

Chief Executive Officer

Sara  Chan

How Emerging Pharma Teams are Accelerating Pipelines and Achieving Big Milestones

Sara Chan

SSI Strategy, United States

Vice President

Alissa  Minkoff, MS

How to Nimbly Lead the Regulatory Affairs Function at an Emerging Company

Alissa Minkoff, MS

Third Harmonic Bio, United States

Executive Director, Head of Regulatory Affairs

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