Morning, Wednesday, 9th September 2020
***Full-scale policy conference taking place online***
This conference will consider the future for advanced therapies in the UK.
Delegates will examine key issues for research and regulation - as the UK responds to the COVID-19 pandemic and at the same time prepares for possible regulatory and market changes at the end of the transition period.
Areas for discussion include:
- the impact COVID-19 on the sector and how it is adapting to meet need and changes in the supply chain, logistics and regulatory landscape,
- development of infrastructure and workforce needed to support the development of advanced therapies and the role and potential of the Advanced Therapy Treatment Centres (ATTC) network,
- key issues for the regulatory and approval process and the impact of possible regulatory divergence from the EU as the transition moves towards its conclusion,
- what more can be done to support innovation and research across the UK and what is being done to provide certainty over long term funding,
- improving adoption of advanced therapies in the NHS and patient involvement,
- learning from the expedited trial and approval processes in place during the pandemic in terms of supporting advanced therapies to market, and
- policy priorities for making the UK a global hub.
- Advanced therapies: power and potential for the UK - with Matthew Durdy, Chief Executive Officer, The Cell and Gene Therapy Catapult
- Key issues for research and development - investment, infrastructure, workforce and manufacturing
- Accelerating the process from research to treatment - assessment and approval of advanced therapies - with Professor Gillian Leng, Chief Executive, NICE
- Developing the regulatory structure - collaboration, innovation and managing the evolving landscape
- Improving adoption in the NHS - communication, access and spreading best practice - with Professor Fiona Thistlethwaite, Director, iMATCH
- Priorities for increasing patient involvement in advanced therapies
- Providing a platform for the development of advanced therapies - an international perspective
- Next steps for policy and making the UK a global advanced therapies hub.
Why this is relevant now - the context:
- The recent update to the Life Sciences Industrial Strategy which highlighted advanced therapies as a key area for growth and opportunity for the UK.
- Investment for development of a network of advanced therapy treatment centres across the country, as part of the leading-edge healthcare industrial strategy challenge fund.
- The UK’s trade negotiations with the EU, and with the PM outlining that any trade deal would not include regulatory alignment.
- The £200m government investment to scale up genome sequencing, as well as £70.6m additional funding for the Cell and Gene Therapy Catapult.
- Plans by the Accelerated Access Collaborative to develop detailed systems and processes across all UK health system partners to:
- support the adoption and supply of advanced therapies, and
- address the challenges of bringing products to patients.
- The Medicines Manufacturing Innovation Centre scheduled to open later this year.
- The £1.5m investment for the Advanced Therapies Apprenticeship Community.
The discussion in detail:
- The impact of COVID-19 on the research ecosystem for advanced therapies and what this means for the sector going forward, including;
- how best to recover and innovate supply chains following the shutdown of global transport systems for time-critical cell therapies,
- the impact of interruption of clinical trials during the pandemic and how best to ensure that patient involvement in advanced therapies clinical trials continues during and beyond the crisis,
- assessing initiatives within the sector to overcome evolving manufacturing challenges across life sciences, and
- what can be learnt from recent experiences to improve the resilience of the supply chain going forward.
- The Life Sciences Industrial Strategy and how to implement the plans it sets out - including in the areas of:
- innovation and adoption of advanced therapies - including:
- the ATTC network, which is already involved in the COVID-19 response with the first pandemic patients having been treated with cell therapy developed by an ATTC partner,
- realising the potential of gene therapies,
- how the COVID-19 pandemic has accelerated collaboration in health research; and what this means for future joint working,
- how the UK’s bioindustry is responding and adapting the way it works and streamlining processes to meet urgent need.
- infrastructure - and its development end‑to‑end to support innovation in advanced therapies - with discussion expected on priorities for:
- the new Medicines Manufacturing Innovation Centre in Glasgow, and
- the new dedicated Vaccines Manufacturing Innovation Centre based in Oxford which is being fast tracked as part of the COVID-19 response.
- manufacturing challenges for advanced therapies – with:
- the MHRA developing a framework for point-of-care manufacture by March 2021, and
- the Medicines Manufacturing Innovation Centre scheduled to open later this year.
- increasing the attractiveness of the UK, for:
- medicines development and manufacture, and
- investment, and how the UK will meet its targets for attracting research and development investment.
- the workforce - equipping them to deliver advanced therapies and address key skill gaps - including through the Advanced Therapies Apprenticeship Community.
- Supporting adoption, and improving patient involvement, drawing from presentations from international case studies and key UK bodies - looking at:
- the regulatory and reimbursement systems that need to be in place to support the adoption of advanced therapies by the NHS:
- from innovation and development, clinical trials and manufacture, and how COVID-19 has affected the research environment for these therapies, and
- to patient access and treatment.
- how to improve patient involvement throughout the process;
- the role of the third sector in facilitating this engagement, and
- the increased access to advanced therapies.
Policy officials attending:
Our forums are known for attracting strong interest from policymakers and stakeholders.
This conference looks no different. Places have been reserved by officials from the Department of Health and Social Care; the MHRA and the Department for International Trade.
This is a full-scale conference taking place online***
- full, four-hour programme including comfort breaks - you’ll also get a full recording to refer back to
- information-rich discussion involving key policymakers and stakeholders
- conference materials provided in advance, including speaker biographies
- speakers presenting via webcam, accompanied by slides if they wish, using the Cisco WebEx professional online conference platform (easy for delegates - we’ll provide full details)
- opportunities for live delegate questions and comments with all speakers
- a recording of the addresses, all slides cleared by speakers, and further materials, is made available to all delegates afterwards as a permanent record of the proceedings
- delegates are able to add their own written comments and articles following the conference, to be distributed to all attendees and more widely
- networking too - there will be opportunities for delegates to e-meet and interact - we’ll tell you how!
Full information and guidance on how to take part will be sent to delegates before the conference