The path to IND is no longer just about completing required studies, it’s about building a differentiated, investor-ready development strategy that maximizes probability of success. In today’s competitive environment, biotech companies must make smarter decisions earlier, leveraging modern regulatory flexibility, integrated evidence strategies, and predictive approaches to accelerate development while preserving capital.
This webinar explored how companies can strategically plan their journey to IND through strong commercial and development planning, Totality of Evidence (ToE) and Weight of Evidence (WoE) approaches, New Approach Methodologies (NAMs), and Model-Informed Drug Development (MIDD). Attendees will gain practical insights into building leaner, more efficient development programs, leveraging regulatory flexibility, and creating the evidence packages needed to support both regulatory and investor confidence.
Key learning objectives:
Discover how emerging biotech companies can build IND-ready and investor-ready development programs by integrating, scientific, regulatory, and commercial considerations early, reducing development risk, leveraging regulatory flexibility, and accelerating progress toward key value inflection points.
This webinar is ideal for:
- CEOs, Founders, and Co-Founders of emerging biotech companies
- Chief Scientific Officers (CSOs)
- Chief Medical Officers (CMOs)
- Chief Development Officers (CDOs)
- Heads of R&D and Translational Medicine
- Heads of Regulatory Affairs
- Clinical Pharmacology and Nonclinical Development Leaders
- Business Development and Strategy Leaders
- Venture Partners and Venture Builders
- Biotech Investors and Scientific Due Diligence Teams
- Program and Portfolio Leaders responsible for advancing assets toward IND
