Supply Chain Management for Global Clinical Trials

Transcription

1 Supply Chain Management for Global Clinical Trials Part 3 of the Clinical Supply Knowledge Share Series: Understanding and Delivering your Global Clinical Supply Chain Almac Clinical Services

2 Clinical Supply Chain Management ebook contents Share me

3 Section 1 The state of Clinical Supply Chain Management Resources The evolving role of Supply Chain Management What does a Supply Chain Manager (SCM) do? Luke Moyer State of the industry The age of biologics

4 Supply vs. demand led planning Stretching supply through drug pooling Technology and drug conservation Section 2 Market demands More for less Clinical trials are becoming increasingly complex in design, often including double or triple the primary end-points we would have seen just a decade ago. The numbers of participating countries is on the rise as competitive enrolment and the search for naïve subjects is taking us into new regions. In addition, investigational products have become more sophisticated and specialised, increasing manufacturing costs and timelines, while reducing available drug supply. With the estimated cost to bring a new product to market soaring, the ability to make smart and accurate supply chain decisions becomes more critical every day. As such, Supply Chain Managers are facing increasing pressure to conserve drug product and reduce overall IMP costs. Resources

5 Unpredictable demand Section 2 Market demands Minimising waste Drug product events We can never use less drug than is needed for patient demand. Overage is drug product that goes beyond patient demand and it comes from many different sources. Here are a few sources to consider when factoring overage: Logistical considerations Inaccurate assumptions

6 Incorporating actuals Section 2 Market demands Optimise supply Safety stock Forecast evolution Facing the unknown can be a daunting task. Supply Chain Managers are often tasked with making critical and costly decisions without all of the information they need. SCM s plan for what should happen and what could happen, while reacting to what is happening. During planning periods with high uncertainty, planners create incremental and iterative forecasts, shortening the planning horizon for packaging and depot re-supplies, so as not to over commit drug product and lose inventory because of expiry. The SCM will continually monitor forecast accuracy and adjust the planning horizon as confidence in the enrolment forecast grows. Flexibility by design Forecasts should account for high demand while using a planning horizon that reserves expiry for slower than expected enrolment. Overage vs. cost

7 Section 3 The challenges Key variables affecting clinical supply Resources Clinical enrolment The impact on larger clinical trials Luke Moyer Comparator purchase Temperature management

8 Section 4 The physical and digital Clinical Supply Chain Resources Expertise and consultancy Providing consultative expertise Luke Moyer The physical The digital

9 Section 5 Supporting technologies Resources IRT - Inventory management Packaging strategy Luke Moyer IRT - Expiry management

10 Section 6 Almac Supply Chain Management Solutions Navigating the complexities of the Clinical Supply Chain Forecast and simulation Clinical material forecasting, forecast management and simulation tools along with SCM expertise, matches clinical supply to patient demand, ensuring optimised strategies to meet your trial needs. Label development and regulatory vetting Almac can oversee label text development, regulatory review, translation and artwork, ensuring that IMP labels meet clinical, regulatory, drug product and country specific requirements. Inventory management Supply Chain Managers continually monitor trial supply globally, trending study activities and adjusting future campaigns and material transfers to ensure that the right IMP is at the right place at the right time to meet study demand. Temperature management solutions Almac s innovative software program, TempEZ, supports the full suite of Almac Temperature Services offerings, providing clients with a single central database to store temperature data while ensuring compliance to GxP and GDP regulations. IRT Medication management Supply Chain Managers consult on the medication management IRT design to meet study needs. They set, monitor and adjust inventory management levels and system expiry strategies to ensure optimisation of IMP while reducing distribution costs where possible. Other services Almac Supply Chain Managers can provide end to end management of investigator sponsored trials, provide pharmacy services and draft pharmacy manuals. They can also act as unblinded contacts for the site management of clinical supplies. Bulk drug management Supply Chain Managers convert finished good demand into upstream manufacturing and API requirements, working with capacity and lead time limitations to avoid downstream supply interruptions and reduce over production and bulk waste.

11 Section 7 The Clinical Supply Knowledge Share Series Look out for our future ebooks Download our Clinical Supply ebook This ebook takes an in-depth look at: The rise of biologics Challenges for biologic products Market pressures Consideration Checklists Coming soon Primary Packaging Coming soon Temperature Management Solutions Share me