In the intricate realm of pharmaceutical development, First Human Dose (FHD) studies represent a pivotal juncture, replete with complexities yet essential for advancing patient safety and drug efficacy. These early-stage clinical trials aim to establish safety and refine the dose to minimise adverse events (AEs) with potentially some indication of efficacy. Traditional drug development pathways for solid oral formulations are often characterised by their transactional nature, contributing to prolonged timelines. Recognizing the critical balance between expediency and safety, PCI Pharma Services (PCI), a world leading CDMO, and CRO, Worldwide Clinical Trials provide an innovative end-to-end partnership designed to navigate the FHD process with unmatched efficiency from drug formulation, and clinical supply through to trial execution and study management.
In FHD development, formulating a drug is just the beginning. Other essential elements include executing Phase 1 trials with precise bioanalytical assessments, effective participant recruitment, and meticulously planned trial designs. These studies rely on healthy volunteers and expert teams to conduct detailed pharmacokinetic/pharmacodynamic (PK/PD) analyses, which are crucial for positioning the novel drug for success in subsequent phases. This article will cover the importance of the partnership between CROs and CDMOs and how their individual capabilities have the power to expedite clinical trials and increase efficiency.
Transforming FHD with Drug in Capsule Technology and Pristine Supply Management
CDMOs have the unique opportunity to proactively recognize areas of improvement in the development and manufacturing process and implement innovative solutions to combat hurdles. PCI identified a way to transform their client’s studies and expedite the pathway into the FHD study phase with their Supply Management and Readiness Team (SMART) of development, manufacturing, and supply management experts. SMART is not only an acronym but a reflection of its mission to guarantee the timely provision of solid oral medications for Phase 1 clinical studies. SMART FHD transcends conventional oral drug development and stability study delays by eliminating early-stage formulation development to deliver strategic operational advantages, including a managed operational package and pivotal distribution options. This approach can propel drugs into the early clinical phase months or even a year ahead of traditional methods.
With SMART FHD, all that is needed from the client is delivery of a sufficient volume of drug substance, and PCI can manage the rest. The critical difference is the streamlined drug-in-capsule (DiC) process that requires less back-and-forth on developing and optimising the drug formulation, moving a molecule to the clinical phase more quickly. In addition, there’s no need to add the potential for delays and higher costs from managing multiple vendors.
Comprehensive Solution Providing Time and Financial Savings
The SMART FHD plan offers a seamless package from the availability of the drug substance to delivery at the clinical site. The package provides a ready-made bundle of DiC development and flexible manufacturing, stability program management, packaging and labelling for clinical demand, regulatory dossier compilation, distribution, and clinical supply management.
The SMART approach is optimal for FHD studies as it provides the flexibility needed for dose-ranging studies. Eliminating time-consuming processes and delays over formulation options and having the drug product supply available before any regulatory and clinical site approvals enables an FHD trial to start months faster.
SMART FHD distinguishes itself by providing a white-glove partnership instead of standard transactional manufacturing services. The holistic oversight capabilities encompass material management and inventory planning enhanced by strategic distribution capabilities through Canada for North American studies. Access to this facility circumvents typical IND filing delays but also facilitates an expedited supply chain, significantly reducing time to trial. The predetermined package and unique supply chain remove delays that would otherwise add unnecessary time and increase costs.
