Forum for Therapeutic Innovation Events

In June 2021, the Forum for Therapeutic Innovation at St Hilda’s held the online event, Enhancing Confidence in the Data Used to Make Decisions in First in Human Studies. We welcomed speakers, Professor Tim Higenbottam, President of the Faculty of Pharmaceutical Medicine; Professor Duncan Richards, Climax Professor of Clinical Therapeutics at the University of Oxford; Dr Martin-Immanuel Bittner, Co-Founder & CEO of Arctoris Ltd; and Professor Malcolm Macleod, Professor of Neurology and Translational Neuroscience and Academic Lead for Research Improvement and Research Integrity at the University of Edinburgh. They discussed the multiple aspects of reliability of data, focussing on one aspect in particular - reproducibility. Enhancing Confidence in the Data Used to Make Decisions in First in Human Studies is available to watch here

Our Hilary Term lecture in 2020 was Snakebite: the case for action and the need for innovation in treatment approaches, given by Dr Nick Cammack, Head of the Wellcome Trust’s Snakebite Team. 

Snakebite is arguably the world’s biggest hidden health crisis. It kills some 120,000 people every year, mostly from the world’s poorest communities in rural Africa, Asia and South America. The burden of death and disability is equivalent to that of prostate cancer or cervical cancer and greater than that of any other neglected tropical disease. Yet the problem is solvable – we need to bring snakebite treatment into the 21st century; we need innovative approaches to discovering and developing next generation snakebite treatments; and we need to build and importantly, sustain snakebite as a global health priority.

The Forum for Therapeutic Innovation at St Hilda’s launched on 11 June 2019 with an inaugural lecture by Professor Sir Michael Rawlins GBE, MD, FRCP, FMedSci. Sir Michael is the Chair of MHRA, the national regulator of all medicines and medical devices used in the UK. The lecture followed two workshops that discussed the following questions:

  • Are quality of life measures appropriate primary endpoints for pivotal (registration) clinical studies?
  • Should tangible evidence of Patient and Public Involvement be mandatory for regulatory approval of Clinical Trial Applications (CTAs)?

St Hilda's Principal 2014 - 2021, Professor Sir Gordon Duff, welcomed the full house and launched the new Forum. Professor Duncan Richards, Climax Professor of Clinical Therapeutics, introduced Sir Michael, who spoke on ‘Novel approaches to assessing the safety and efficacy of new medicines’. Sir Michael shared his thoughts on the field of clinical trials, how to integrate the patient’s voice into them, and the benefits of doing so. He considered traditional study designs, emerging study designs, alternative analytical approaches, and the use of biomarkers. Sir Michael concluded that approaches to trial designs and data analyses are changing. This could lead to the merging of experimental (deductive) and observational (inductive) techniques; a greater use of Bayesian methods, and the acceptance of biomarkers as a basis for marketing authorisation (licensing) under appropriate circumstances. The evening ended with a thought-provoking question and answer session.

 

Sir Michael Rawlins, Sir Gordon Duff and Professor Duncan Richards at the inaugural lecture for the Climax Centre for Clinical Therapeutics Research at St Hilda's College, OxfordThe inaugural lecture for the Forum for Therapeutic Innovation was given by Sir Michael Rawlins