Other than the opening night pub and pints, second day summer soiree, and the venue’s daily buffet offerings, which have all been notable feedback highlights, the event provided a fascinating and insightful agenda featuring many well-known and lesser well-known experts, advocates and titans from the cell and gene therapy industry.

After the first morning’s encaging opening Plenary (if you need a reminder and want to find out why everyone was referring to Zebra’s in their sessions, see an overview here), the event kicked off its four-track agenda, featuring talks, presentations, fireside chats and roundtables under the following focuses of the meet:

• Commercializing Exceptional Science
• Manufacturing, Supply Chain and Logistics
• Patient Access, Healthcare and People
• Automation

It was impossible to attend all of the sessions on offer, with all the panelists sharing invaluable insights, and experiences, and sparking useful audience discussions. However, we have summarized just a few of the moments that stood out over the 2 days of thought-provoking content.

The people

Attracting, Retaining and Developing Talent

As we see the cell and gene therapy industry expand in front of our eyes, with more and more innovative therapies being developed and taken from clinical stages through to commercialization, a more vast and more expert workforce is required. This need has created a workforce shortage across all areas of the industry.

Sponsored by Catapult the session, ‘Attracting & Retaining Talent to Develop the Workforce of the Future’, featured presentations highlighting methods of tackling the workforce shortage to build a robust community of CGT experts for the future.

Angela Justice, Chief People Officer, TCR² Therapeutics, explained how the speed of development we are seeing in the cell and gene therapy space is putting a strain on workforce capabilities, with this having the potential to become a limiting factor in the progress of advanced therapies. 

So how do we tackle this before it becomes a more prominent problem. First is the issue of attracting talent and second is the need to retain talent.

Angela stressed how crucial it is to build a company culture and embed that into the employee lifecycle. Culture refers to the values and behaviors of an origination. Defining what matters most to your company and ensuring this is central in the hiring processes and management techniques, attracts employees who align to this culture and are more likely to feel happier and more motivated in their work environment.

Managers are the companies ‘force multipliers’, and should embody the company values and culture to ensure these are consistent.

Workforce turnover is predicted to be 20% higher in 2022 than pre-pandemic numbers. So how do we go about retaining a strong CGT workforce?

Angela refers to the embeddedness theory – what keeps an individual connected to a company. The theory suggests retaining talent comes down to three aspects:

• Fit – How well and organizations culture fits with personal values and goals.
• Links – How well connected they feel to the organization.
• Sacrifice – How much leaving would disrupt their lives.

Paying attention to these three areas can have a huge impact in preventing employee turnover, which is disruptive, costly and time consuming.

Of course, another aspect to any workforce shortage is training. The complexities and specialties within the cell and gene therapy space mean we need an extremely expert workforce. Training initiatives, looking in similar fields for those with transferable skills, and investing in people early are all steps being taken to fill the gap the industry is currently facing.

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The Patients

Patients and Advocacy 

It has become apparent, now more than ever the importance patient advocates hold in maintaining and attracting interest to the potential curative benefit of advanced therapies. 

‘Patient Engagement: Driving Patient Advocacy to Inform Patient Centric Development’ chaired by Novartis’ Karin Blumer featured a number of speaker case studies looking at the role of patient advocacy in bringing engagement and awareness to the life-changing potential of cell and gene therapies, and the effect this has in shaping the developmental direction of therapies.

Sharing the experience of Novartis, Karin described how patient advocates have been instrumental to the rise of CAR-T.

Lifesciences Policy Analyst Anna Dickinson shared the importance of involving patients and advocates in policy making. After all, who’s better to advise upon what patients need than those who have experienced it first-hand themselves or witnessed a friend or family member go through it.

Rinri Therapeutics CEO Simon Chandler also described in this session, how Rinri’s first-in-class cell therapy for hearing loss benefited from early patient engagement to build credibility and support for its clinical development.

The Market Access Dilema

With all the progress we have seen in the European cell and gene therapy space the pitfalls that we have witnessed largely revolve around issues of reimbursement and market access. How do we tackle the barriers to market access in Europe?

This second and final day at ATE began with some real-life case study discussion in ‘Market Access & Reimbursement: Real World Evidence & Value Definition’, with chair Alexander Natz of EUCOPE, former bluebird UK GM Nicola Redfern, AviadoBio CEO Lisa Deschamps and Mark Trusheim, Strategic Director, NEWDIGS and Visiting Scientist, Massachusetts Institute of Technology (MIT).

How do we learn from the failure of reimbursement we witnessed with blurbird bio’s Zynteglo in Europe, and from the success seen in this same indication, and others, in the U.S.? The sharing of ideas, knowledge and experience between companies is key for the European market to evolve in support of a more flexible reimbursement plan to suit advanced therapies. It will take collaboration and advocation from all industry stakeholders to fix the current issues facing the European market. 

The Possibilities

It’s all about Automation

A key theme at this year’s Advanced Therapies Europe, as it is across the whole of the industry right now, is the takeover of automation in cell and gene therapy manufacturing.

The session, ‘European Expansion; Manufacturing High Quality, Low Cost & Large Volume Cell & Gene Therapies’, sponsored by Dark Horse Consulting and NHS Blood and Transplant, explored the methods being used to expand the cell and gene therapy manufacturing offering across Europe.

An example of what can be achieved with improved manufacturing is the development of off-the-shelf allogeneic human ventricular progenitor cells to treat heart failure by AstraZeneca, and the production of allogeneic red blood cells for blood transfusion and transplant by the NHS.

Implementing both current and future technologies can offer solutions to both common and niche challenges faced in cGMP manufacturing. Adopting standardized and systematic approaches could assist the struggles of taking therapies from clinical to commercial.

AstraZeneca Michael Delahaye, emphasised the importance of collaboration to bring automated systems into mainstream manufacturing. Outlining their current approach to automation of bioprocessing for ATMP development and production.

When it comes to implementing new and enabling technologies, Mark Kotter, CEO, Bit.Bio commented on the importance of collaborating with suppliers early on in the development process.

In the session ‘The Role of New & Enabling Technologies to Drive European CGT Commercialization Success’, Mark notes that investing extra effort into planning automated manufacturing methods and quality control processes in the early clinical stages, makes for an easier translation into commercial.

This is often easier said than done, particularly for a small company with limited resources. However educating those in early clinical and research phases on industry standards and the effect automation and digitalization can have on meeting these standards, can save time and money altering processes later down the line.

De-centralizing Manufacturing

There is lots of talk around the benefits of point-of-care (POC) and decentralized manufacturing, most notably on the impact this can have in ensuring patients receive treatment quicker.

Sponsored by Oribiotech and Adva Biotechnology ‘Exploring the Shift Towards Point of Care Automation & Decentralised Manufacturing’, was a chance to shout about the benefits and successes of automated point-of-care programs.

Advancement in artificial Intelligence, metabolic sensing and control have enabled decentralised manufacturing to offer an optimized manufacturing process.

Later on, in the session ‘Developing a commercially robust supply chain across the European continent’ chaired by Stephen Sullivan, Program Manager & International Liaison Officer, GAiT, we saw an interesting Q&A with the sessions panelist: Dorothea Ledergerber, Chief Technical Officer, Tigen Pharma, Andrea Zobel, Senior Director, Personalized Supply Chain, World Courier, Ludwig Camusot, Chief Corporate Development Officer, Cell-Matters. They highlighted how logistics and supply chain are just as much part of a patient’s treatment plan as the drug itself.

There is skepticism surrounding the possibilities of POC and de-centralized manufacturing, with many questionings how standard procedures can be maintained if manufacturing is spread out across hundreds of hospitals rather than one central location.

If you are manufacturing to GMP standards but your logistics are not, then it is back to square 1.

But the panelists are reassuring that with the levels of automation now featuring in the developmental processes decentralized standardization is a reality. Planning ahead and considering the unique needs of decentralized manufacturing early are crucial for its success.

Despite the large levels of risks and expenses a company can face moving from centralized to decentralized, at the end of the day it is all about patient access, and if this move in manufacturing norms can improve treatment for patients then, with support and honesty between companies, this move must be the way forward.

Investing in the Future

Sponsored by Catenion ‘Investing in Investment: The Long Term Strategy for CGT Growth in Europe’, was packed with industry experts including chairs, Ann-Hunter Van Kirk, Senior Equity Research Analyst Biopharmaceuticals, Bloomberg LP, Sven Kili, CEO, Antion Biosciences and Bryan Poltilove, Operating Partner, Broad Capital Partners, who lead fireside chats to take a dive into the cell and gene therapy investment landscape in Europe.

So what does this landscape, which is so fundamental to the advancement of innovative therapies, look like now and what do we need it to look like in the future if we are to see these advancements? The panelist’s explored the recent expansion in investment into European biotech’s as investors are realising the opportunity this industry offers, as well as stressing the need for this growth in financial support to speed up to allow therapies to be developed as fast as the science is.  

A Final Thank you…

Phacilitate would like to thank everyone who spoke and/or attended Advanced Therapies Europe, it was great to see faces old and new coming together in person to collaborate, share ideas and look at progressing this innovative and advanced industry forward!

You can continue or join these conversations in Miami at Phacilitate’s flagship event Advanced Therapies Week, taking place in January 2023, find out more here. See you all soon!

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