Phacilitate’s ATE Plenary: Celebrating Science and Stripes

Anna Osborne
2 September 2022
Cell Therapy
Collaborations, Mergers & Acquisitions
Finance & Investment
Gene Therapy
Patient Access & Engagement
Regulatory & Standards
In this blog, we round-up the opening Plenary from this weeks Advanced Therapies Europe as it made it’s in-person return.
What Has Happened Whilst We’ve Been Gone?

Three years have passed since Phacilitate’s Advanced Therapies Europe last opened its doors in 2019, and we are very pleased to welcome everyone back, and to welcome everyone to London – the home of Phacilitate, as the UK capital city plays host to the most exciting gathering in Europe for all things advanced therapies.

The meeting in London kicked off with the Plenary on Wednesday morning, chaired by Anthony Davies, Founder & CEO, Dark Horse Consulting, and later Jacqueline Barry, Chief Clinical Officer, Cell and Gene Therapy Catapult, who were joined by three panels of expert guests from across the cell and gene therapy field.

This opening talk was a chance to reflect upon the challenges and successes we have witnessed whilst in-person events such as Advanced Therapies Europe were out of action.

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It would be an understatement to say that a lot has happened since we last stepped into the European arena – the global Covid pandemic, the UK leaving the EU – it has been a lot for the ATMP space to get to grips with and navigate.

The implications of these external factors on the advanced therapies industry are still making themselves known, providing unique challenges to experts as they move forward.

In one panel Miguel Forte, CEO, Bone Therapeutics & President-Elect, ISCT and Kinnari Patel, COO, Rocket Pharma, explored the questions on everyone’s minds right now: How can we develop cell and gene therapy offerings in Europe to compete with the U.S., where is the ATMPs space in the EU and UK heading, how will we get there, and how can we get there faster?

Although there is a lot to unpack as the industry moves forward, it isn’t all questions and the unknown. There is also so much to celebrate from the last few years in the cell and gene therapy space that puts us in an exciting position moving forward, as Phacilitate’s Vice President of Europe Becky Johnson-Kent was keen to stress.

Since January 2020, there have been over 15 therapy approvals in mainland Europe and the UK including; Bristol-Myers Squibb’s Abecma, Orchard’s Libmeldy, Kite’s Tecartus and AveXis Zolgensma, to name a few, with more set to come in the next 12 months.

Although the pandemic brought delays, frustrations and unprecedented pressure, it did not stop the field from innovating and progressing forward with clinical pipelines, Becky continued to note.

Mergers, acquisitions and capital raisings over the last 12 months have seen more than 1100 deals across Europe, and since January 2020, there has been a staggering $8,150 billion put into the European advanced therapies market.

Patient Advocacy and CAR-T: The Beating Heart of CGT

The first Plenary panel looked to highlight these successes – and nothing epitomizes success in ATMPs as well as the story of CAR-T. More specifically the story of Emily whitehead.

Making up this panel was Tom Whitehead, Co-Founder & President, Emily Whitehead Foundation and Emily’s father, Dr. Stephan Grupp, Medical Director Cell & Gene Therapy Lab, Children’s Hospital of Philadelphia, Amir Hefni, Worldwide Commercial & Region Europe Head Cell & Gene, Novartis, and, James Miskin, CTO, Oxford Biomedica – all notable names to have shaped the CAR-T space we see today.

2022 marked a significant Milestone for CAR-T cell therapy. Rewind 10 years and Emily Whitehead was a seven-year-old with acute lymphoblastic leukemia that had become resistant to all current treatment options at the time, so Emily became the first pediatric patient to receive CAR-T. In May this year Emily celebrated 10 years’ cancer free.

This momentous occasion for a young woman and her family was also a meaningful milestone to so many in the cell and gene therapy, and, oncological spaces. The 10-year anniversary is a time to reflect on how far the industry has come, and how many lives have been changed, and saved, as a result of the innovation, determination and collaboration of those in this extraordinary industry.

It was especially moving to hear Tom Whitehead share that Emily was presently enjoying a trip sightseeing and shopping in London with her mum Kari. An extraordinary young women able to enjoy the ordinary things in life, due to the work and collaboration of exceptional scientists.

The time the whitehead family take to tirelessly share Emily’s story provides hope to so many. They are a leading example of the important role patient advocacy plays as the beating heart of this industry – they are why everyone in that Plenary room does what they do, and it is touching to see how this work saves lives and families be brought home by.

However, I liked a comment made by Anthony Davies, that in the future we hope to not be celebrating 10-year CAR-T anniversaries with the same enthusiasm as the industry has with Emily’s. Not because patients won’t be celebrating the curative nature of CAR-T and going on to lead cancer-free lives, but because reaching the 10-year mark will be the norm – all of those treated with CAR-T will be reaching this milestone and living ordinary lives beyond this decade point.

Navigating the European Landscape

Whilst CAR-T continues its reign in the UK and EU as much as in the rest of the world, other advanced therapies haven’t quite had the same success in the European market.

A tougher regulatory landscape and the complexities of a post-Brexit Europe prove to be barriers to many companies attempting to break into the UK and EU.

In the Plenary’s final panel Michael von Forstner, Global Head of Clinical Safety and Pharmacovigilance, Biogen, and, Niloofar Davoodi, Director Cell Therapy CMC, Takeda, and, Ian Rees, Inspectorate Strategy and Innovation, MHRA, highlighted the important considerations in regards to the regulatory climate in Europe: How do the different regulatory standards across jurisdictions impact the setting up and viability of clinical trials, how can the UK remain involved in European bioscience after its exit from the EU, and, what are the opportunities within Europe for growth and innovation to allow this space to be competitive against the U.S?

As the industry continues to move forward post-CAR-T’s 10-year anniversary, it is clear that there is a mix of apprehension and excitement over the potential of what ATMPs can achieve.

What these in-person events provide, amongst the sharing of knowledge and buzz of collaboration and future partnerships, is the clear sense that every aspect of consideration that goes into the complex development, and commercialization of advanced therapeutics strives, at its heart, to improve the future for patients today with diseases of un-met needs and all the patients to come.

CGT Earning its Stripes

Thinking about the difficulties in regards to cell and gene reimbursement in the European market, that every panellist was acutely aware of throughout the chats, I think Tom Whitehead commented on it perfectly. When asked ‘Why are these therapies so expensive?’ he simply responded: “Because they’re so damn good!”

We know that everyone at this meet is working to ensure everybody else – regulators, reimbursement bodies, investors, physicians, families and patients – can also see just how damn good these therapies are

I will leave you where the meeting started with an analogy to the Zebra – a term first coined in relation to business by entrepreneur Jennifer Brandel, and referenced by Becky in her opening address.

‘Zebra companies aim for sustainable growth and place value on coexistence with other players in the field,’ said Becky. ‘A zebra is both black and white and in this way a zebra company is both profitable and works to improve society. There is also a play on words in that zebras are known to move in groups, with zebra companies being characterised as mutualistic, tending to band together to support and preserve each other. Rather than butting heads and having a purely competitive relationship, zebra companies cooperate so that their individual inputs come together to produce a greater synergistic product. It struck me that these characteristics are similar to those values that I personally see within the CGT community, a collective drive, unity and ambition in order to advance the next pillar of medicine. So thank you for the very warm welcome and it’s a pleasure to be part of the herd,’ she concluded.

I’m sure we’re all excited to see what this herd will be achieving next!

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