Innovative Just in Time Manufacturing (JTM) enables sponsors full late-stage customisation of their clinical trial materials
Almac Clinical Services has announced the launch of Almac Adapt, an innovative Just in Time Manufacturing (JTM) solution. This latest offering puts patients first and provides sponsors with a unique, adaptive supply strategy to ultimately meet the expanding challenges of clinical trials.
The drive to optimize the performance of clinical trials is increasing. Positive advancements, like the growth in development of targeted biopharmaceutical therapies and new trial designs, have had an impact on clinical development but have also brought new challenges to overcome.
These challenges have resulted in aggressive study timelines, rising costs, the need for supply chain flexibility and the necessity to supply smaller, yet more global, clinical studies for specifically targeted populations.
With Almac’s wealth of experience and understanding that time is a precious commodity for sponsors, its team of experts recognise the importance of having an agile clinical supply chain that meets the ever-changing needs of an evolving clinical trial landscape and it is with this in mind that Almac has redefined the supply chain experience and developed Almac Adapt.
The Almac Adapt solution offers the generation and delivery of kits to sites and patients worldwide in a matter of days, avoiding needless delays and over-production of sponsor’s high value drug product. By shifting the focus from what we do to why we do it, Almac Adapt™ embodies this understanding in a patient-centric culture by translating itself into an actionable and proactive manufacturing, packaging, labelling and distribution solution.
When necessary, Almac Adapt can be coupled with Almac’s dedicated supply chain experts who with precision thinking, aligns ‘speed’ with ‘need’’. This is offered by utilising its flexible forward planning and adaptive on-demand supply chain enabling the efficient resolution of mid-study protocol and patient demand changes whilst ensuring the quality and compliance of the product. This can also dramatically reduce overage of expensive IMP where wastage is not an option, in turn reducing costs for the sponsor.
This solution manipulates the global supply chain and bridges the gap between supply and demand, optimising on-time delivery for patients, inventory flexibility for sites whilst achieving key time-based milestones for the sponsor.
Natalie Balanovsky, Almac Clinical Services’ Just in Time Manufacturing (JTM) solutions manager comments: “The introduction of Almac Adapt further enhances Almac’s industry-leading capabilities within Clinical Trial Supply showcasing our commitment to advancing human health. We understand the challenges our clients are facing at a deeper level and we have the resource, experience and expertise to help by developing a robust Just in Time strategy.
“Working directly with sponsors we will deliver a flexible, adaptable and patient–centric supply solution. Because time is precious to both sponsors and patients nothing is more important to us than ensuring we deliver on this promise. I am delighted to announce the launch of Almac Adapt.”