Determine the safe dose for FIH study.
Preclinical development enables drug candidates to progress from research to development, by linking discovery in the laboratory to testing in humans. Analytical methodology and manufacturing processes are established and ramp up towards GMP compliance to support initial clinical trials. The product pharmacology, pharmacokinetic/ biodistribution, and toxicity profiles are explored, which ultimately aim to support the intended clinical trial design for first-in-human testing.
Understand the market potential
Identify the path to market and outline a high-level development plan.
Define optimal clinical indication
Outline a preliminary Target Product Profile (TPP), including commercial and clinical considerations.
Design and conduct preclinical studies, analytical and manufacturing process
Define pre-clinical data necessary to enter the clinic. Identify predictive models and alternatives to animal testing.
Set up the overall product development plan
Develop analytical methodology and manufacturing processes Identify product-related risks to be assessed and managed.
- For which indication to first develop the product?
- Is there an animal model and how relevant is it?
- Will the overall nonclinical program support the intended First-In-Man clinical trial?
- Is the manufacturing process adapted/able for future clinical development?
- Are all analytical methods necessary at this stage in place to assess quality?
- How realistic is the overall product development plan?
- What is the product time-to-launch?
- Are the unmet needs and therapeutic burdens from a patient perspective considered?