OxCD3: Oxford Centre for Drug Delivery Devices

The greatest challenge in oncological drug delivery is achieving successful penetration and distribution of the therapeutic agent throughout the tumour: billions of pounds have been spent to date in deploying biochemical approaches in an attempt to solve what is essentially an engineering problem, namely the transport of therapeutics from the blood stream to reach every cancer cell.

OxCD3 will seek to transform both clinical and industry practice in drug delivery by demonstrating the value and feasibility of engineering approaches, involving a combination of stimulus-responsive nanocarriers and medical devices already in clinical use, for improved tumour uptake and therapeutic outcome. The Programme Grant will enable the creation of a sustainable, world-unique multi-disciplinary environment for combinational engineering of biology, chemistry and medical devices to improve drug delivery under a single roof. It is also expected to create a unique training environment for the next generation of young scientists working on combination therapies and biomedical nanotechnology, by providing direct exposure to regulatory and manufacturing issues encountered when translating laboratory research into production and clinical practice.

A unique feature of the Centre is the capability to design both devices and drug delivery vehicles under a single roof. In the first 5 years, under EPSRC funding, up to 3 carefully selected "Device+Drug" exemplars will be manufactured to GMP, ready for Phase I clinical trials, to provide compelling evidence of feasibility to industrial partners and clinicians; in the next 5 years, a private-public partnership will be built to complete clinical trials of these exemplars using therapeutics of strategic significance to the pharmaceutical industry; beyond 10 years, full industrial sponsorship of the OXCD3 is anticipated, which will focus on addressing next-generation challenges in drug delivery (beyond cancer) in partnership with industry and clinicians. The transformative aim over 50 years is to position the UK as the world leader for multi-disciplinary drug delivery development, complementing its existing position as a drug discovery leader, from design to manufacture and clinical trials.

The proposed programme grant spans two of EPSRC's core strategic areas, "Healthcare Technologies" and "Manufacturing the Future" and will be key in providing the UK with a world-leading position in the exploding fields of targeted drug delivery and nanotechnology biomanufacturing. In addition to academic excellence in addressing the greatest challenge in oncological drug delivery (achieving tumour penetration), its aim is to provide the underlying science and manufacturing know-how that will enable successful delivery of existing and future anti-cancer agents, transforming both UK healthcare and UK industry.

True impact in biomedical engineering and drug delivery is achieved in one of three, often interlinked ways: translation from bench to bedside through clinical trials and demonstration of therapeutic efficacy; dissemination of transformative science and techniques through high-impact peer-reviewed publications for uptake by the academic and industrial communities; and commercialization of new advances, either through licensing to existing manufacturers or through the formation of new spin-out companies.
The impact of major advances in drug delivery has historically been limited by three factors:
(i) Scale-up: most innovative drug carrier manufacturing techniques developed in the laboratory are poorly suited to large-scale manufacturing, and often overlook the constraints of manufacturing to GMP as needed for clinical trials, thus requiring major and costly redevelopment before clinical trials and uptake by industry.
The OXCD3 difference: Involve the Clinical Biomanufacturing Facility from day one, so that laboratory techniques are selected from an early stage to be compatible with GMP scale-up.
(ii) Non-anticipation of regulatory hurdles, particularly for complex combinational products: the choice of drug vehicle materials and of the type of excitation required for device-triggered release will greatly affect the cost and complexity of experimentation and biocompatibility studies required for regulatory approval to enter the clinic.
The OXCD3 difference: Involve clinicians and a qualified pharmacist (QP) with direct experience of managing drug, device and combinational trials from day one,
(iii) Excessively long timescale to first-in-man trials:
The OXCD3 difference: Deliver not only transformative science but also three exemplars already manufactured to GMP ready for a clinical trial by the end of the funding period.