In the rapidly evolving biotechnology sector, small and virtual companies play pivotal roles in innovation and development. However, these organizations face unique challenges that necessitate strategic navigation to ensure successful product development, partnership, collaborations, and commercialization. This session will address the key considerations when working in small and virtual biotech companies, focusing on analytical and process development challenges, CROs and CDMOs management, tech transfer, and supply chain issues, including raw materials.

Small and virtual biotech companies often encounter significant hurdles in analytical and process development due to limited internal resources and infrastructure. These companies must balance the need for robust analytical methods, process development, and quality oversight with the constraints of smaller budgets and personnel. Small companies frequently lack the extensive in-house capabilities required to develop methods and manufacturing processes for hands-on product understanding. They must carefully design and optimize analytical methods and processes to ensure that they are both efficient and compliant with regulatory requirements, all while managing the inherent risks of manufacturing.

CROs and CDMOs are essential partners for small and virtual biotech companies, providing critical expertise and infrastructure that these companies may lack. Effective CDMO management is crucial to the success of a biotech project. Small companies need to navigate complex agreements and ensure that CDMOs meet their specific needs, including timelines, quality standards, and cost constraints. Establishing clear communication channels, setting well-defined expectations, and maintaining rigorous oversight are vital for mitigating risks and ensuring alignment with project goals.

Supply chain management is another critical area where small and virtual biotech companies face unique challenges. Ensuring a reliable supply of raw materials and components is fundamental to maintaining uninterrupted development and manufacturing processes. Small companies may struggle with procurement issues, such as securing high-quality raw materials at competitive prices and managing supply chain disruptions. They must develop contingency plans to address potential shortages or delays, which can impact project timelines and costs.

This session will share learnings, offer practical guidance, and discuss strategies to address the critical issues or product development, out-sourcing management, and supply chain management while maintaining regulatory compliance.

Session Speakers:

Troublesome Issues Seen in Biologics Development in Academic Spaces and Small Startup Companies

Mark Levi, RTI International

Managing More With Less – the Power of Platforms

Isabelle Lequeux, BioPhorum

CMC Paths to Patients for Small & Virtual Biotechs

Stephen Sofen, Sofen Consulting LLC

Key Considerations for Startups (And Established Innovators) to Efficiently Engage and Partner With a Contract Development and Manufacturing Organization (CDMO)

Bruce Thompson, Kincell Bio

Additional Panelist:

Da Ren, Biotherapeutics Solutions

Cindy Riggins

Appearances