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MD-TEC Workshop: Drug & Device Discovery and Optimisation for Clinical Deve...

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Institute of Translational Medicine

Heritage Building (Old Queen Elizabeth Hospital)

Mindelsohn Way

Birmingham

B15 2TH

United Kingdom

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Drug Discovery and Optimisation for Clinical Development

Dr Richard Williams

Developing healthcare products in the lab and successfully translating them to the clinic not only requires a strong scientific basis for the underpinning technology, but also knowledge of how the finished product will be regulated and delivered at reasonable cost with robustly demonstrated benefit in the eyes of potential adopters. In reality, all of these aspects of product development are related to one another and must be considered as early on in order for potentially ground-breaking technologies to reach the clinic in a timely and cost-effective manner.

This workshop will give a holistic overview of key aspects of developing drug products and medical devices, including: building a network to triage and nurture ideas; the regulatory pathway; establishing safety; manufacturing at scale to clinical grade; and defining relevant measures of clinical success in trials. Key points to consider and questions to ask around a concept product will be discussed, along with their impact on reaching clinical trial or market from a project management perspective. Critically, the talk will highlight how considering the abovementioned aspects early on through relatively simple lab experiments and engagement with relevant regulatory bodies can help companies and academics innovate and get to market faster, at reduced cost and with less risk.

Dr Anthony Metcalfe

Developing a new device from an original concept at the laboratory bench through to the launch of a finished clinical product is a complicated process which can take many years and be very costly. The idea for a device application for the treatment of a medical issue can come from a variety of sources including academic and clinical research, and from industry. It can take many years to build up a body of supporting mechanistic, physical and pre-clinical evidence before selecting the finalised device technology for use in the clinic. Industrial companies, and more recently, some academic groups are identifying ways of streamlining a number of early processes to identify and test devices which possess suitable characteristics for use as medical treatments.

This workshop will consider the key stages of the medical device optimisation process, from the early identification of the medical application, disease identification and the multiple steps towards device development and validation for clinical trial. The importance of an early understanding of the novelty of the technology, its protection and the potential array
of uses for clinical application will be discussed. Finally, an overview of some of the commercial considerations of medical device development will be considered.



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Institute of Translational Medicine

Heritage Building (Old Queen Elizabeth Hospital)

Mindelsohn Way

Birmingham

B15 2TH

United Kingdom

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