Setting up a commercial entity:
Proof of Concept

In the BioPharm Industry, Proof of Concept usually refers to early clinical drug development, conventionally divided into Phase 1 and Phase IIa. Phase 1 is typically carried out in a small group of healthy volunteers. However, in the Start Up environment, the prior proof of the concept phase typically requires the sequential performance of a series of prerequisite scientific studies that are executed in the laboratory. These complete scientific results are required before the Regulators will permit any “in man” Proof of Concept studies to proceed.

Our client contracted us to direct, design, and manage these early studies. First, our team familiarized themselves thoroughly with the technology, the proposed product candidates. An equally important consideration for us was to get a good read on who the anticipated customers were likely to be, and, what scientific support data they would be looking for to give them confidence to license or acquire our client’s product candidates in development. Accordingly, we designed a series of experiments that would deliver results that provided clear answers to the very select set of questions.

Based on the prior notion that good science was essential to ensure that the scientific results would be trusted, and provide clear answers, we used Good Laboratory Practice (GLP) right from the outset. Previously, we had been contracted by the same client to generate SOP’s covering all the routine scientific process and procedures they used in the course of their discovery research. Therefore, all these SOP’s were executed under GLP conditions. That is, careful attention was given to the prior calibration and validation of all laboratory equipment (using reference standards). The results showed that the SOP’s were consistently reproducible.

Ultimately, we summarized and packaged these in vitro scientific results, and used them to proceed with pilot production in accord with cGMP regulations, and we presented the data to the local Investigational Review Board (IRB) with the application to conduct our “first in man” studies. The same results were packaged to form part of the Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).