The transition from preclinical development to first-in-human (FIH) studies is one of the most important milestones in drug development. In tranScrip’s Ask the Experts Live Q&A, Dr Jon Sisson and Christopher Floyd explored the strategic decisions that shape successful early development—from regulatory engagement and first-in-human study design to Target Product Profiles (TPPs), investment readiness and integrated development planning.
1. Regulatory engagement should be strategic
Scientific advice is most valuable when it helps resolve uncertainty, informs critical development decisions and builds constructive relationships with regulators—not simply to confirm existing guidance.
2. Build your development strategy around the Target Product Profile
A well-defined Target Product Profile should guide development from candidate selection through to commercialisation, helping align regulatory, clinical and commercial objectives from the outset.
3. First-in-human studies should create value
FIH studies should be designed to answer strategic questions and generate evidence that supports future development, regulatory interactions and investment decisions—not solely establish safety and pharmacokinetics.
4. Integrated planning reduces programme risk
Successful programmes combine regulatory, clinical, translational and commercial thinking within a coordinated development strategy, enabling better decision-making throughout development.
5. Strong strategy improves investment readiness
Investors increasingly look beyond promising science. Robust development plans, realistic regulatory strategies and experienced teams are key to building confidence and securing investment.
Download the full webinar Key Takeaways report
Access the complete expert summary, including:
- Five universal takeaways for successful early drug development
- Best practices for regulatory engagement and scientific advice
- Target Product Profile (TPP) strategy and implementation
- First-in-human study design considerations
- Integrated development planning and investment readiness insights
