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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
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)
How New Technology and Investment Models Have Transformed Work in Emerging Companies
Toban Zolman, MA
Kivo, United States
Chief Executive Officer
How Emerging Pharma Teams are Accelerating Pipelines and Achieving Big Milestones
Sara Chan
SSI Strategy, United States
Vice President
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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