Early phase trials require highly flexible and reliable processes in clinical supply management, as the number of unknown variables is usually higher. Moving fast early in the study increases the likelihood of meeting the crucial milestone of first patient in dates. Guiding a compound swiftly through clinical trials provides priceless data to prioritise which drug candidates can be pursued.
PCI's speed-to-study services are designed to help drug sponsors quickly initiate phase-I and II trials. Its manufacturing processes and quality systems are purposefully designed to enable sponsors to obtain the necessary safety data as soon as possible, helping them bring forward drug candidates and, ultimately, accelerate product development timelines.
Early phase trials most often begin with limited supply of API. Following standard manufacturing processes often creates large amounts of waste as manufacturing quantities and doses have to be estimated and exaggerated to accommodate various dose strengths or participant numbers over several cohorts. This process often proves to be an expensive hurdle as manufacturing is a budget and timeconsuming process, and the cost of APIs are often expensive.
Just-in-time manufacturing offers the flexibility drug sponsors need to adjust dosages as safety and pharmacokinetics data is collected, removing the need for large amounts of drug wastage and overage. This solution maximises dosing flexibility by not committing the drug supply to finite dosing options.
A just-in-time manufacturing approach supports early phase adaptive clinical study designs by reducing API wastage down to only 5-10% of drug overage. Using traditional manufacturing methods, sponsors may see larger API usage, up to 50-100% wasted. Given the costs of API, this is a major issue for companies as they are working with limited funding.
Just-in-time manufacturing is also an effective method because it provides an ability to adjust and react quickly to clinical study demands, and allows maximisation of a compound's limited stability data.
Australia has become an emerging destination for phase-I trials due to the beneficial regulatory landscape, which supports and encourages accelerated and high-quality studies. Perhaps most importantly, data procured in Australia can be used for future IND applications for phase-II trials in the US. Many sponsor companies often choose to conduct just the phase-I trial in Australia to quickly get the study up and running, and then simply relocate the subsequent phases.
Many overseas clients with less than A$20 million ($13,801 million) in revenue take advantage of the research and development tax incentive - a generous 43.5% rebate for eligible companies. Australia also offers a short clinical trial notification scenario, offering approval in five to six weeks, and boasts a diverse patient population.
In Australia, patients can be dosed as quickly as six to eight weeks from submission, especially if clinical teams work with a clinical supply management partner that has the appropriate facilities and just-in-time manufacturing capabilities in Australia. In addition, multiple phase-I units in the country are co-located in tertiary teaching hospitals, providing convenience and flexibility.
A culture of speed, expertise, and flexibility is the key to ensuring phase-I and II trials start quickly and optimally. In the hands of the experts, who are well practised in the manufacture and coordination of early phase studies, the trial will start faster with the flexibility to adjust for unforeseen changes.