Company insight
Transforming clinical landscapes
Precision Health Technologies Accelerator (PHTA), a Birmingham-based life sciences research facility is dedicated to the development of innovative therapies and technologies. We speak to Becky Bishop, industry trials hub lead at PHTA as she discusses how the company is working to change the relationship between clinical trials and the industry and its latest initiative Industry Trials Hub (ITH).
Can you please explain a little bit about Precision Health Technologies Accelerator for our readers? Everything we’re aiming to achieve within the PHTA is to accelerate the development of new treatments and technologies, and get them to patients faster. Essentially, we are the University of Birmingham’s flagship life sciences research facility, and the idea is that companies working with us can access the full spectrum of academic and clinical excellence in Birmingham – whether that’s multidisciplinary experts from across the University or clinical expertise based within some of the best hospitals in the UK. We’re co-located with the Queen Elizabeth Hospital and Birmingham Women’s and Children’s NHS Foundation Trust, for example, and an anchor tenant at PHTA is the Clinical Immunology Service which offers advanced and specialist diagnostic services. The environment that we are creating is a truly collaborative space where we can go from bench to bedside, and of course, a large part of that is being able to manage clinical trials at scale and pace.
Could you talk me through PHTA’s Industry Trials Hub (ITH)? How is PHTA working to change the relationship between clinical trials and the industry to generate the right data for drug labelling or regulatory approval of devices? How are pre-approval studies (Art. 62) submitted?
The idea for the ITH originated with the ACCELERATE platform, which brings together academia, industry and
Clinical Trials Insight /
www.worldpharmaceuticals.net
regulators to develop innovative therapies for children and adolescents with cancer. Through this group, we recognised that academic trials units like ours (the Birmingham Cancer Research UK Clinical Trials Unit (CRCTU)) were predominantly running academic trials rather than registration trials, which were not what we’d term ‘Fit for Filing’.
These trials are practice-changing, but
couldn’t inform a licencing authority, so pharma companies looking at our results would then have to replicate the study to registration levels either themselves or through a CRO. This significantly increases the time it takes for a drug to reach patients in the clinic. We realised we could work much more efficiently by setting up our academic trials to registration standards, but to do that we needed much more resource and a dedicated team to manage industry trials.
How important is it for you to change operating procedures to better meet the needs of the industry?
Although we’ve always had very strict operating procedures, the regulatory requirements are greater in terms of safety monitoring, risk-based monitoring and data verification. Our talent pool at the CRCTU is fantastic and they are very well-versed in trial management, but we have had to upskill in terms of adhering to ICHGCP guidelines. We’ve brought in more resource as these trials are more labour-intensive, particularly in terms of statisticians, and we’re working with specialist providers in areas like database provision and management.
Everything has increased in scale so that we can be more agile.
How does the new approach ‘fit for filing’ see ITH work with industry partners and regulators? In terms of regulators, a good example is Glo-BNHL, which is globally the largest platform trial in paediatric and adolescent relapsed and refractory B-cell non- Hodgkin Lymphoma. It’s a prospective early phase international multicentre platform clinical trial run in collaboration with various partners which has been approved by both the EMA and FDA, and what we’re seeing is that those regulators are now recommending our trial to companies who approach them with a potential solution for this disease. It’s much more efficient for industry to put their drug into our platform trial rather than trying to run multiple studies, as we have the eligible patients and the trials team structure in place to assess various drugs at the same time. If one isn’t successful, then the patients can be seamlessly moved on to another drug candidate which is better for them too. With industry, we’re maintaining the same levels of academic excellence we’ve always had, but through establishing a dedicated team, we’ve empowered ourselves to take ownership of registration-level trials and conduct them in a collaborative way with our industry partners. We’re avoiding duplication of effort, and reducing the time it takes to have a drug approved is good for our industry partners and fantastic for the patients waiting for treatment.●
www.phta.co.uk/ith 29
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