A case-based, interactive workshop designed to equip participants with the tools needed to navigate the path to First-In-Human studies. Working in small groups, participants tackle a real-life development case while our experts provide guidance and answer all questions along the way.
What You'll Learn
- A proven framework to reduce development risk and fast‑track your asset to clinic
Strategic IND‑Enabling Thinking
- The importance of the Target Product Profiles (TPP) and the impact on drug development.
- Linking CMC, nonclinical, clinical and regulatory workstreams to create one cohesive plan
CMC, Nonclinical & Clinical Development Insights
- Manufacturing, stability, and analytical method considerations
- (GLP) tox, PK/ADME expectations
- Human dose prediction & early clinical trial design best practices and the importance of KOLs
Translational Laboratory Solutions
- End to end biomarker strategy from identification to clinical application
Who Should Attend
Built for founders, CSOs, COOs, and R&D leaders at:
- Startups and scale-ups
- Early to mid stage biotechs
- Companies preparing for Preclinical → First in Human
Why Attend
You’ll walk away with:
- Practical insights in common drug development issues and how to solve them
- A streamlined pathway toward IND submission
- Insights from experts who operate as an extension of biotech project teams
- A clear view on a roadmap that reduces risk, improves decision-making, and accelerates timelines
28
APR 2026
IND Enabling Workshop
What You'll Learn A proven framework to reduce development risk and fast‑track your asset to clinic Strategic ...
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29
OCT 2026
Target Product Profile (TPP) Workshop
An interactive session where we work hands-on with participating companies to structure their drug concept in a ...
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