The transition from drug discovery to drug development is aptly termed the ‘valley of death’. Its earned this name due to the difficult journey, and high failure rate, between these two major activities. This journey can be exacerbated if there is a cultural divide between discovery, which often occurs in an academic environment, and development, which occurs in a commercial one; two workplaces which can speak different languages.

Part of the challenge is the broad array of different activities which need to occur in a coordinated, time efficient manner, often on a limited budget. This is further complicated by the multiple unknowns about the drug candidate. Consequently the results of each experiment has impact on the design of future studies which complicate the planning of future work.

Broadly the activities which need to occur include the following:

  • Preparation of a Development Plan including a Regulatory Strategy
  • Scale-up of the manufacturing process to generate sufficient product to conduct both the toxicology studies and early clinical studies (Ph I). Manufacture of the clinical trial material in accordance with GMP; often conducted by Contract Manufacturing Organisations (CMO)
  • Planning and executing non-clinical studies to support the initial clinical trials
  • Planning initial clinical studies and consideration of the overall clinical development program
  • Writing, compiling and submitting regulatory documentation to support the clinical trial

Each of these points raised multiple complications which can impact on the other aspects of the drug development path. For example: Ideally the product tested in the toxicology studies is the same batch as that intended for the initial clinical trial. In practice, the toxicology batch is often manufactured at a different scale and not under GMP. This presents a regulatory challenge in terms of providing data to justify the similarity of the products manufactured under different conditions. All part of the reason this zone is both hazardous and interesting.