Between 85 and 90 percent of drug candidates entering clinical testing never reach approval, and much of that risk is set long before the first patient is dosed. A typical biotech spends US$6–8 million advancing a molecule to the clinic, leaving little margin for a failed good laboratory practice study or a starting dose that regulators will not accept. Successful investigational new drug (IND)-enabling programs integrate pharmacology, drug metabolism and pharmacokinetics (DMPK), formulation development, bioanalysis, safety pharmacology, toxicology, and regulatory strategy into a coordinated development plan.
This whitepaper outlines a practical framework for designing scientifically justified, regulatory-ready IND packages that reduce development risk, support first-in-human dose selection, and accelerate the path to the clinic.
Download this whitepaper to learn:
- Designing an integrated strategy that aligns pharmacology, DMPK, bioanalysis, formulation, chemistry, manufacturing, and controls, toxicology, and regulatory objectives
- Key differences between small-molecule and biologic programs, including species selection, genotoxicity, safety strategies, and regulatory expectations
- Justifying a first-in-human starting dose using evidence-based dose selection methods
- How safety pharmacology, toxicokinetics, genotoxicity, and toxicology studies build IND readiness
- Common causes of IND delays and strategies to mitigate them
