Hosted for the first time by Stevenage Bioscience Catalyst, Advanced Therapies Integrates had over 200 delegates from across the ATMP supply chain. Offering a day full of talks, panel sessions, tours and networking opportunities, this key industry event explores the challenges and opportunities facing the Advanced Therapies sector.

Dr Sally Ann Forsyth OBE, CEO, Stevenage Bioscience Catalyst (SBC), opened the event by setting out how Stevenage has quickly established itself as a life science cluster with a world leading specialism in cell and gene research. She outlined the essential components of this success, highlighting: the unique co-location of pharma and manufacturing; the wrap around targeted support at each growth stage, with access to specialist facilities from shared lab spaces offered free of charge for early-stage companies right through to later stage GMP facilities; training and mentoring; and access to finance. However, Sally Ann warned, “Although the UK produces some of the best research in the world there is still a major challenge to translate and commercialise these innovations.”

“Our aim is to build on our successful scale-up model by developing plans for a Centre for Commercialisation that could potentially reap further health benefits and deliver even greater economic return for the UK.”

Sally Ann finished her welcome talk by speaking of her goals for the future, “I am filled with immense optimism for the life sciences in the UK. As we support our companies from researched prototype to commercialisation it means that we can create greater economic benefit for research investment in UK science and that we can deliver profound health benefits to patients on a global scale.”

In the second fireside chat, ‘The Future of the ATMP CDMO Market: Challenges and Opportunities’ Matthew Durdy, CEO of the Cell and Gene Therapy Catapult interviewed Robert Panting, General Manager ATMP at Rentschler Biopharma about the current and future trends of the ATMP CDMO market and the best practises of developing ATMPs at scale.

When choosing a CDMO to partner with, Robert highlighted three things to look for: “One – Manufacturing is on the critical path so speed is a key aspect. Two – An organisation needs to be agile, not so well established, so it needs to be able to adjust because the technologies are moving. Three – Customer centricity, every project is different, and you want to be looking for partnership and flexibility.”

On competition, Matthew said “Ultimately competition is going to be fundamental to the growth of the industry, if we’re not seeing a thriving industry with choice, and products and driving new technology then we’re not going to achieve the dream”.  He then asked Robert about the basis of competition and competition between CDMOs. Robert answered “in an ideal world it would be clinical efficacy but we’re not there yet and unfortunately it is money that is the basis of competition.”

The interview ended with speculation on how the cost of ATMPs can be brought down through competition, increased productivity due to automation and digitalisation – and greater understanding of the processes of ATMPs.

Track 1, Session 1: ‘The right place at the right time’

Track 1, ‘Development, manufacture and implementation’ explored the challenges in the journey to widespread adoption of ATMPs, from efficient manufacturing to streamlined NHS implementation.

Facilitated by the opening speaker, Dr Sally Ann Forsyth OBE – Stevenage Bioscience Catalyst’s CEO, our panellists answered the question, ‘Does the UK system of science parks and innovation hubs support access to facilities and expertise?’ Featuring Katy Newton, Senior Vice President Immunology and Process Development at Achilles Therapeutics, Ketki Vispute, Associate Director CAR-T Manufacturing and Operations at Autolus, Ellie Junod, Investment Manager, Life Sciences at UBS, Philip Probert, Biologics Technology Lead at CPI and Tom Pike, Deputy Chief Executive Officer & Strategic Director at Stevenage Borough Council.

To start the panel, Sally Ann spoke about building a science cluster from her perspective at Stevenage. “To be a successful innovation supply chain which goes from research, to start up, to scale up to manufacturing, to patient – connectivity between these points is very important. There needs to be tailor made support for the right company at the right time.”

Ellie spoke from an investment perspective on building a connected life science cluster, “When we are making investment decisions, we look at a number of factors but the primary thing we look for is, is this a place where science can thrive?”

Tom spoke about the 3 P’s that local stakeholders can action to get support from a local authority to unlock growth clusters, “Pace: putting specialists in place to move quickly so that you can secure funding. People: Is there a pool of people and are there bodies that will help equip people with the right skills to train people in the right way. Passion: Is there a wide range of people absolutely committed to trying to help this global cluster grow? Because if it grows, it creates jobs, it created opportunity.”

Philip reflected on Tom’s points on a national level. Tom highlighted the strength of the UK’s rich innovation ecosystem with a high density of universities and research institutions and a strong supply chain. However he also referenced the weighting of science infrastructure around the UK. “It is not space that is the issue outside of the Northeast, it’s retaining the talent in these areas.”

Responding to an audience question about key decision-making factors, Ketki spoke about the importance of quick decision making: “changes are expensive and can we pivot quickly or is it going to be an extra 50 grand just for thinking about”. She also spoke about the importance of designing a process that you don’t have to re-engineer when you go to scale.

In response to another question about choosing the right home for a start-up with the right equipment required, the panels agreed that it was important to do your research and to consider and weigh up all available opportunities, as one place will not necessarily have everything you need. Based on her own experience Katy also emphasised considering, “it depends on the skillset you have already employed internally and whether they can do it themselves or whether you will need support.”

Session 3: You’re the Cell to my Gene

In ‘You’re the cell to my gene’, the panel focused on how to choose the right outsourcing partner for a productive partnership to help ensure ATMP quality and safety while overcoming financial and regulatory hurdles. Facilitated by James Fry, Partner and Head of Life Sciences at Mills & Reeve and featuring Kella Kapnisi, Project Manager, Senior Consultant at Team Consulting, Aimee Tyler, Clinical Account Manager at Miltenyi Biotec, Mark Cunningham, Head of Operations at NATA – Nucleic Acid Therapy Accelerator and Joe Healey, Chief Executive Officer and Co-Founder of NanoSyrinx.

James started the panel discussions with “ATMPs are a different, really complex technology and we are seeing CDMOs and CMOs clubbing together to provide support for biotechs”. As a consultant in the industry, Kella said “It comes down to time and money as a start-up to get that investment, and to spend time setting up your space can be a barrier – so having access to consultancies like us, that can provide a wealth of experience and access to facilities at a much faster pace – is a big driver”.

On selecting the right partner for a role Mark first outlined his belief, “I prefer to look at who the enablers are for your product and in time, building relationships with the right people.”

All of the panellists concurred that when selecting the right partner that the right culture and attitude towards a problem was key. Having the same vision: that it will be a long journey with the outcome of improved patient treatment will achieve the win-win goal.

On giving one piece of advice to creating effective partnerships, James mentioned to “Focus on the science, know the details and have the clarity”. Joe reiterated his previous point about first impressions and the right culture, “It really counts that you know you can work together.”

On bringing the right people on board Aimee said “Remember the vision that everyone is working towards, it is a long journey with many people on the same journey with different skills and expertise.”

Kella spoke about the need to build strong trusting relationships, “don’t be afraid to challenge or have the difficult conversations up front.”

To finish the panel James summarised all points. “Understand how the partnership fits into everything else and is it coherent with your broader strategy”.

Session 5: I got skills, they’re multiplying

The final Track 1 session, ‘I got skills, they’re multiplying’ was facilitated by Ian Parnham, Skills Programme Lead at Cell and Gene Therapy Catapult. This panel focused on the imperative need for comprehensive STEM education, with students at all levels being informed about the diverse career opportunities awaiting them post-course completion. This entails embedding skill development within undergraduate and postgraduate programs, placing a significant focus on practical training and fostering innovation.

The panel featured Bakul Gupta, Co-Founder of Deliver Biosciences, Dharmesh Vara, EMEA Field Application Specialist Leader at Cytiva, Rebecca Street, Head of Digital Operations at RoslinCT, James Kusena, Vice President of Operations at MicrofluidX, Anji Miller, Programme Director Translational Fellowships Skills Lead, Innovation hubs for Gene Therapies Senior Business Manager at LifeArc and Alessia Errico, Associate Director Search & Evaluation and Entrepreneurial Programmes Lead at Cancer Research Horizons.

Ian started the panel by addressing that while the need was universal across all of the companies represented by the panel, the method would have to be specific to the organisation. “There’s no one size fits all approach, there’s going to have to be a lot of different approaches and very specific interventions potentially based on location, based on cluster, based on challenge and based on the size of the organisation of course.”

On the challenges of recruiting trained scientists into her organisation Bakul said “educating people that entering the start-up world is not all bad, yes there are a lot of requirements and there is going to be long working hours and it’s going to be challenging – but it is fun and you’re creating therapies that are going to help patients down the line.”

James spoke about the challenges of recruiting as an organisation grows. “As we’ve scaled, it’s looking at the change and the type of talent that you need. At the beginning you need a unicorn, you need somebody that does everything.” He also spoke about when the resources are available, adapting to hiring for somebody with the right culture and mentality because the rest of the skills can be trained. “If you look at other industries, how many science graduates end up working at McKinsey or PWC or in financial industry, they don’t have that skillset to begin with, but they are picking a certain type of person who they can train and that is where we need to get to as an industry.”

Alessia followed this point by adding “a fast learner is more important than having someone that is ticking all of the boxes, but is not learning anything else as you go along that journey.”

Rebecca spoke about the need to incorporate knowledge and skills about the industry into the education system. “If students were coming out of their degrees with a basic level of understanding of GMO, understanding of aseptic techniques and an ability to work in a clean room that could cut our time to get them signed off as an operator by several months.”

Responding to a question from the audience about what the government or companies could be doing to support this education outreach, Dharmesh responded, “We see the gap and we are trying to fill it but it is going to take a lot of companies, a lot of working with governments and a lot more collaboration to make that happen.”

In a lead-up question focused on building business skills and awareness in not only students, but those working as scientists, Anji spoke about her experience of interacting with researchers who believe that there is a line where academic science should not mix with the business side. She also highlighted the practical skills deficit faced by students who studied during covid. “Covid meant that everything went virtual and half of courses have not switched back which means we have graduates coming through who have no practical skills and no concept of what you would do in a lab.”

The panel finished with more audience questions and ended with a quote from Rebecca “if there are skills that are core to your business, build them in house, invest in that and make sure you have longevity to have that knowledge in house”.

Track 2, Session 1: We used to have more fun

The first panel of track 2 was facilitated by Sam Goldsmith, Head of Commercialisation of Research and Investments at Cell and Gene Therapy Catapult and featuring panellists; Mustafa Munye, Vice President Operations at Complement Therapeutics, Karolina Zapadka, Investor at Parkwalk Advisors, Eric Halioua, President & Chief Executive Officer of PDC*line Pharma, David Venables, Chief Executive Officer at Laverock Therapeutics and Miguel Forte, Chief Executive Officer at Kiji Therapeutics.

In the context of the current economic environment the panellists discussed the availability of funding, where funding is coming from and if investors have confidence in the ATI field. Miguel emphasised “There is new money, it will be slower to access – but if you are good at what you do it will come”.

On getting investment David said, “Speak to a lot of investors, it is a volume game. Investors are swamped with information, so your history and personal relationships with people are important. Investors loathe to take binary risks, so you need to demonstrate adaptability and a management team that can adapt as necessary. The stronger experience and track record of your team, the easier it is.”

Sam added “Raising money shouldn’t be easy, you have to have a good plan”.

The conversation then moved onto the current market and the profile of deals happening. Mustafa said “at the time of our investment, American investors were cautious and retaining funds, as they had been burnt by the market. European investors at this point where able to invest more freely, as less leveraged by the market.” Eric followed this with “It is difficult to get US investment in Europe, but it is doable if you have a good European investor on board. All based on tight relationships of investment consortium.”

On investor confidence in the Advanced Therapies space, Karolina said “Cell and Gene therapy is a long process and is high risk. We need more investment in manufacturing to help scale up to increase confidence in our industry.” Miguel followed this up saying, “The field is getting to maturity but not mature enough yet. It takes time and costs money and maybe this is more complicated, but we all have a responsibility to adapt the models to the new reality”.

Advanced Therapies Integrates serves as a pivotal platform for industry leaders to collaborate and unlock the full potential of Advanced Therapies and Medicinal Products (ATMPs). The event highlighted the urgent need for a workforce equipped with adaptable and scalable skills that align with the dynamic nature of the cell and gene therapy sector. Emphasizing the fusion of scientific expertise with commercial acumen, the key takeaways underscored a call to action for intentional diversification in skills training. Collaborative efforts across the sector are needed to address common challenges and propel the industry forward.

The discussions further delved into the challenges and opportunities within the ATMP CDMO market, exploring ways to make therapies more accessible and cost-effective. Fundraising trends, especially for seed and growth stages, were highlighted, along with the heightened expectations for demonstrating the value of technologies in series A/B rounds. Panels covered topics such as: delivering therapies to those in need, working in partnerships across the industry, developing a strong ecosystem that builds pools of people with the right skills to support it, and how to access funding.

The significance of a supportive ecosystem, both on micro and macro levels, was emphasized. Bioscience clusters, exemplified by host and sponsor Stevenage Bioscience Catalyst, were recognized for accelerating treatment development and supporting UK-led innovation on a micro level. On a macro level, the event highlighted the critical juncture faced by the UK in addressing challenges related to the assessment and delivery of Advanced Therapies. From transforming clinical trials to navigating reimbursement mechanisms and addressing long-term data collection, the UK must take national-level action to ensure patient access to the evolving pipeline of Advanced Therapy treatments.

Samuel Thangiah, Co-Founder & Executive Director, Life Science Integrates, commented: “Today was a huge success. It was a really engaged audience from across the whole ATMP space and it cemented the potential to make this an annual event in Stevenage.”

A heartfelt thank you goes out to all our sponsors, partners, and speakers for their invaluable contributions that made our event possible. We appreciate your support and collaboration. Looking ahead, we eagerly anticipate having everyone back next year at Stevenage for another successful gathering.