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Clinical Supply Chain Platform

Worksteam Leader

Andy Dwyer, GSK

Work Stream Objectives                                                                                                                                     

Develop risk assessment tools tailored to support R&D supply chains and clinical supply delivery of medicines to patients

Deliver value to the industry through exploration of novel research areas e.g., analytics of public domain data sources to identify opportunities to tailor supply chains to the patient and product

A solution which enables supply chain information to increase velocity and agility but reduce waste and cost within clinical supply/trials

Develop and utilize decision making tools and/or methodologies to support delivery of novel medicines to the patient every day

The ability to integrate supply chains (R&D and commercial potentially) to improve quality of development and increase speed to market

Clinical Patient trial centric supply chains

Zero stock out (patient level) clinical supply chains with low waste and high velocity

Evaluate potential impact of new technologies that extend continuous supply beyond API and drug product

New technologies that assure quality for the patient and enable right first time supply delivery to the patient

Strands summary

 

STRAND 1 design clinical supply chain segmentation approaches that will deliver cost effective supply chains with built in flexibility/agility. Segmentation based on product type e.g. large/small molecule, formulation type, chemistry, stability etc), study design (complexity, shelf life, phase, speed), customer demand profiles , technologies and risk profile.

STRAND 2 to develop the approaches/ technologies for extending continuous manufacture to supply of patient pack (e.g. Just in time fulfilment, e-labelling)

STRAND 3 to develop risk profiling tools to identify and mitigate nodal risk failures (e.g. missing patient supply, single nodal sourcing in DS/DP/Packaging)

STRAND 4 to develop the business case for E2E clinical supply network re-design; Case for change; transformation requirements incl. responsive regulation, 21st century medicines (e.g., bioelectronics, cell/gene therapy, diagnostics and real time patient monitoring etc), the risks involved and the likely timescales.

STRAND 5 to develop tools which improve clinical supply forecasting and service delivery while reducing unnecessary waste.

STRAND 6 Develop zero defect clinical supply chains, based on emerging technologies, automation systems and processes, evolving regulatory expectations .  Scope from creation of the patient pack to reconciliation at the clinical investigator site.

STRAND 7 Develop e2e integrated digital supply chains in clinical supply to improve performance (e.g. efficiency, regulatory compliance, product security), with analytics and data visualisation

Partners

 

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