Leading or working in a biopharma startup environment is an exciting venture, but it can also be stressful. As an emerging company matures, it must transition from conducting benchtop research and creating small quantities of its own product to CMC/Manufacturing at scale to achieve a clinical enabling regulatory filing and conduct early stage clinical studies. There are a lot of options to consider and decisions to make. It’s never too early to plan!

In general, a small company cannot do everything required and may experience sticker shock when looking at human resources, outsourcing / partners, supply chain, and funding requirements. Going from research to CMC/ Manufacturing requires a different skill set. Processes that work on a bench do not necessarily scale, and the tech transfer processes with technical partners can be tricky. This panel will go into different approaches small companies can take and how to execute them well. We’ll also talk about new local initiatives to assist early stage companies with manufacturing.

This forum will cover the following:

• How to find the right partner to generate high quality GLP materials for tox studies
• Considerations for scaling small versus large molecule products
• How to set up quality clinical supply
• How to get the right service as soft skills are often lacking in partnerships

• Getting to a clinical enabling regulatory filing is expensive
• Plan ahead to enable manufacturing – personnel, partners, and funds
• Going from research to development/CMC is a different skill set
• Processes that work on a bench does not necessarily scale up