Session 1: From Concept to Blockbuster: Navigating the Challenges of Drug Development and Commercialization
2:00 PM – 2:45 PM | East Red Level, Suite 10
From Concept to Blockbuster: Navigating the Challenges of Drug Development and Commercialization
This session will examine the evolving challenges faced by biotech companies across different levels of company maturity: large-scale production, cell and gene therapy, and research and development. Understanding these challenges is crucial for industry stakeholders to navigate the complex landscape of drug development successfully. Biotech companies encounter distinct hurdles across developmental stages: early-stage limitations in resources and innovation scaling, mid-stage production and quality control complexities, and late-stage regulatory and commercialization hurdles. Consistent themes include funding constraints, regulatory navigation, and organizational adaptability. Moreover, the presentation will explore the strategic inflection points where biotech companies must critically evaluate their manufacturing approach, weighing the complex trade-offs between building internal production capabilities and leveraging external CDMO expertise. This presentation will offer insights from three different perspectives [a late stage industry veteran, a mid-stage company executive, and a startup founder]. These viewpoints will highlight the critical areas requiring attention as companies mature, providing a comprehensive overview of the dynamic biotech developmental landscape.
Speakers:
Darren Dasburg, CEO, Claus Biologics
Aaron Rice, Senior Director of Engineering & Facilities, Beam Therapeutics
Phani Sukhavasi, Head of Global Engineering, Vertex Pharmaceuticals
Biographies
Darren Dasburg, CEO, Claus Biologics
Darren Dasburg serves as the CEO of Clarus Biologics and brings over 43 years of experience in technical operations across small and large molecule manufacturing. Previously, he held leadership roles at AstraZeneca, including Vice President Global PMO & Strategy and Site GM for the Boulder Manufacturing Center. Darren has also worked on biosimilar development in Asia and led innovative capacity-sharing initiatives in bio-manufacturing. He holds a B.S. in Mechanical Engineering from Colorado State University, an MBA from Duke University’s Fuqua School of Business, and advanced biotechnology certifications from MIT.
Aaron Rice, Senior Director of Engineering & Facilities, Beam Therapeutics
Aaron Rice is the Senior Director of Engineering & Facilities at Beam Therapeutics. Known for his passion for innovation and operational excellence, he oversees critical infrastructure and engineering initiatives at Beam. Aaron holds a Mechanical Engineering degree and an MBA, Supply Chain Management from NC State.
Phani Sukhavasi, Head of Global Engineering, Vertex Pharmaceuticals
Phani Sukhavasi is the Head of Global Engineering at Vertex Pharmaceuticals, where he oversees global engineering strategy and operations for advanced pharmaceutical manufacturing. With extensive experience in engineering leadership at Vertex and previous roles at Lonza, Bristol-Myers Squibb and Genzyme, Phani specializes in developing innovative solutions for cell and gene therapy facilities and global quality control labs. He holds a Master’s in Management from Harvard Extension School and a Master’s in Chemical Engineering from the University of South Alabama, and is recognized for driving operational excellence and cross-functional collaboration in the biotech industry.
