The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) annual meeting held earlier this year have been published in the journal Frontiers in Pharmacology today [1].
It is a big deal for me that both our 2017 EUFEMED meeting and now this have been published while I have been Chairman of the AHPPI [2]. An important part of our fun event was that it was the 30th birthday of the world's oldest not-for-profit professional group for early-stage drug development. The AHPPI has been around since 1988 and is a place where people can keep learning about clinical pharmacology and the regulatory side of developing new drugs. The meeting was about how early-stage drug development is changing. Professor Alan Boyd, President of the Faculty of Pharmaceutical Medicine, gave the opening speech, which was about how the last 30 years have changed pharmaceutical medicine and how that has changed how patients are treated.
Our speakers talked about how translational pharmaceutics is being used to deal with the high failure rate of drug candidates and to speed up the process of getting drug candidates from the lab to clinical proof of concept. It was talked about how the European Medicines Agency updated its 2007 Risk Mitigation guideline for first-in-human clinical studies. The updated policy, which became law in February 2018, is mainly about lowering risks and promoting safety. It will help drug sponsors plan and carry out early clinical studies. It was talked about how to use integrated adaptive protocol designs in early clinical development in terms of the problems that come up when running early phase clinical trials on people. In their presentation, the Health Regulatory Authority laid out their plans to keep the UK an appealing place to do Phase I clinical studies after Brexit. The Medicines and Healthcare products Regulatory Agency said that it would be able to adopt and change many parts of the new European Clinical Trials Regulation if there is a ‘no deal’ Brexit.
The meeting gave people from a variety of fields—including drug development, clinical trials, research organisations, government science policy, and regulatory agencies—a chance to talk about how regulations are changing and what opportunities and challenges the UK will face after Brexit. At the end of the meeting, I summed up how the topics that were talked about showed that the pharmaceutical industry is working together to keep the UK as a desirable place to hold Phase I clinical studies.
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