Science is relatively lightly regulated, and not by FDA. Drug development is, rightfully, highly regulated. Many companies lose time, money, and opportunities by missing the transition from discovery to development. Preclinical operations concerns the preclinical stages of drug development, and the related regulatory considerations.
FDA has little interest in how you discovered your drug. Whether it was designed in a supercomputer or found in the Amazon rainforest, regulatory agencies are concerned with 1) safety, and 2) efficacy. There is a valid assumption that companies won’t spend time and money preclinically developing drugs that they know are ineffective, so regulators’ primary focus is on safety, and specifically, the risk/reward profile of the intervention (e.g. a vaccine given to millions of healthy children must have a spotless safety package, while a therapy designed to help a late-stage cancer patient may reasonably have more risk associated). If the end of the discovery stage is defined as lead identification, then ADMET, in vivo preclinical proof of concept (PoC), and dose ranging and timing studies, are the first steps in drug development. Understanding FDA guidances, recommendations, and requirements for IND-enabling studies, when and how to move to GLP studies, and how to record progress, are all required for success.
Because regulatory success is both central and required for drug development success, it’s never too early to have a solid regulatory plan, informed by domain-specific experts. As you approach the clinic, your spending on (what is typically external) expertise will climb significantly, ultimately yielding an IND submission package.
Ensuring a smooth transition from pre-clinical to clinical stage requires that your IND package and the data contained therein is sufficient for success. FDA is typically quite helpful – especially with smaller, highly innovative companies, but if your data are insufficient, you will not advance.
What data are required for a successful IND, where to find help (including FDA Guidances, external experts, and even NIH).