The Sprint to IND: Early De Risking Strategies That Enable Accelerated Development

Session details:

As development timelines compress, biotechs face a growing tension: moving quickly through IND-enabling milestones while generating data robust enough to stand up to regulatory, investor, and partner scrutiny. 
  
In this session, we share how early risk decisions, material availability, and execution choices shape speed to clinic. Drawing on decades of experience across molecule types, the discussion connects early de risking strategies to accelerate, yet reliable, IND readiness. 
  
Here, we will introduce three newly launched capabilities. First, a bundled early de risking approach to support selection of molecules with good manufacturability and safety profiles. Next, a new vector system for stringent, high expression of molecules to accelerate generation of pools and clonal cell lines. Finally, how these enabling technologies can be combined into an accelerated DNA to IND pathway while minimizing risk of rework or late-stage surprises. 
  
Together, these strategies illustrate a proactive framework for reducing technical uncertainty and supporting ambitious, yet achievable, IND readiness without compromising quality or patient safety. Attendees will hear first-hand from one of the experts directly involved in shaping these approaches.