Streamline Early-Stage Development To Reach The Clinic Faster

By Srinivasan Shanmugam, Adare Pharma Solutions

Early-stage development is critical to establish a solid foundation for clinical trials. Success at this point in development means constructing a clear quality target product profile (QTPP) to drive positive proof of concept (PoC) results, all while considering scalability at each step to minimize development challenges downstream.

PoC can easily be conflated with early-stage development. In fact, PoC is a development element supported by early-stage development, whose aim is to produce initial evidence supporting the hypothesis that the drug works or has the potential to produce the desired therapeutic effect. While Phase 1 development sets out to prove safety/PK/PD in humans, it does not establish efficacy. PoC begins in earnest in Phase 2.

Early-stage development comprises a three-party agreement between sponsors, their CDMO partner(s), and regulatory authority. Regulatory agencies provide recommendations on project elements including preclinical testing, clinical trial design, safety monitoring, and data submission. Sponsors generally are responsible for designing and conducting preclinical/clinical studies: protocol, endpoints, population, etc. A CDMO partner can be invaluable toward helping the sponsor achieve those aims, as few organizations retain full-time, in-house expertise capable of making those critical decisions.