RegMedNet at the 5th Annual European Advanced Therapies Investor Day

Written by Freya Leask

Discover the latest updates from industry leaders and investors in regenerative medicine with this conference report from the 5th Annual European Advanced Therapies Investor Day (9 November, London, UK).

On 9 November, 2017, 30 Euston Square played host to industry leaders in regenerative medicine and cell therapy from around the world to discuss the state of the industry and address the future outlook. RegMedNet attended to bring you up to date with the latest forecasts.

Alliance for Regenerative Medicine (DC, USA) CEO Janet Lambert Lynch began the meeting, welcoming attendees and highlighting milestones reached in 2017. With 934 clinical trials taking place in 2017, including the first CAR-T cell therapies from Novartis (Basel, Switzerland) and Gilead Sciences (UK), the mood throughout the day was largely optimistic.

Find out more: Discover why the FDA’s CAR-T approval sends strong signal to the cell therapy industry

In particular, Janet commented, “US regulators are very forward leaning in the space”, highlighting the new Regenerative Medicine Advanced Therapy Designation available for treatments demonstrated to be meeting an unmet need. This US support of developing therapies was also echoed by Paul Laikind, Viactye (CA, USA). Speaking to RegMedNet, Paul mentioned that the US, and to some extent Canada, was ahead of the EU “due to implementation of phase-appropriate regulation on, for example, manufacturing”.

The importance of engaging both regulators and patients early in the therapy development pipeline was a common theme across the meeting. In a panel on health technology assessment and access for ATMPs, chaired by Paolo Morgese (Alliance for Regenerative Medicine), speakers from regulators across Europe tackled questions on regulation, pricing and access.

“We look for closer collaboration, earlier engagement and creative thinking to be prepared for what is ahead in advanced therapies”, commented panellist Pilar Pinilla-Dominguez, Technical Adviser, National Institute for Health and Care Excellence (UK).

This sentiment was echoed by Sven Kili, VP, Head of Cell & Gene Therapy Development, GlaxoSmithKline (UK). It’s “critical” to engage regulators earlier, he explained to RegMedNet after hosting a panel on accelerated approval schemes and their impact on ATMP products at the event. He also revealed that “involving patients in the design and outcome of trials” was crucial in recruiting sufficient participants in Phase I and II, and first cohort trials for rare disease indications.

“From a GlaxoSmithKline perspective, cell therapy is a key to the future”, Sven continued. It will go “from strength to strength as we learn how to manufacture therapies more efficiently”, he explained, although “enormous amounts of targeted basic research” is still required to understand the pathopharmacology and bring down the cost of goods. He also cautioned against “research for research’s sake if we are to be targeted in our development”.

In conclusion, the 5th Annual European Advanced Therapies Investor Day was an illuminating look into the minds of regenerative medicine industry leaders. Despite the initial difficulties and enduring side-effects of some of these therapies, the outlook was very positive and we at RegMedNet look forward to seeing what 2018 has in store!