Case Studies
Industry involvement in the ATTC programme
The challenge
Over the past five years, we have seen remarkable growth and clinical results in advanced therapy medical product (ATMP) development. The area of advanced therapies is relatively new; however, advances in technology have driven this industry to grow at a significant rate both in the number of clinical trials being run and companies developing products. The Advanced Therapy Treatment Centre (ATTC) programme spans academia, the NHS and private industry and is it the close partnership between these that allows these innovative treatments to be effectively delivered to patients. Currently, the ATMP industry is still in its infancy and members of the ecosystem need to work together, share knowledge and have opportunities to network with industry partners to develop the field.
The solution
The ATTC Industry Advisory Group (IAG), facilitated by Cell and Gene Therapy Catapult, brings together ATMP manufacturers operating in the UK from small biotech companies to multinational pharmaceutical companies including GSK, Novartis and Pfizer. The forum provides a safe place for industry to meet, discuss common issues and work towards solutions. The group also now counts representatives from NHS England and the MHRA amongst its membership, providing a space for companies to have discussions with the NHS on the clinical and regulatory requirements for the adoption of ATMPs.
The IAG also brings together a range of advanced therapy companies from pure manufacturing to support services. The companies involved with developing ATMPs face a myriad of challenges in supply chain, manufacturing, tracking and tracing of materials from and to hospitals, governance, clinical trials and adoption. Many of the small developers require expertise across the spectrum as they move their products through the regulatory pathway and establish methodology to support commercialisation and adoption by the NHS. Early discussions in the IAG can help prevent problems further along the development pathway.
The results
Industry partners across the ATMP space are working together in a collaborative, pre-competitive manner and now speaking with a single voice. This is especially valuable when working to develop standards, both nationally across the UK as well as working internationally with the Standards Coordinating Body on sector specific issues such as cell analysis QC, logistics and labelling.
Having the NHS partners involved in the IAG has resulted in a two-way dialogue that benefits both industry and the NHS. Industry now has a deeper understanding of the requirements for the adoption of ATMPs by the NHS. The NHS has an excellent view of what products are in development and can establish a dialogue with potential vendors in a neutral environment. With the NHS having this advanced view of products in development it can effectively plan what facilities will be required as these treatments move towards standard of care
The IAG has been a huge success from the ATTC programme, now having 39 partners involved and actively engaged in a positive manner to support and develop this industry in the UK.
Through the IAG we have also run a closed workshop with regulatory agencies and other specialists to help develop plans for approval, reimbursement and marketing
Making further impact
The IAG has already brought benefits to both industry and the NHS by allowing direct and open communication both ways. The next wave of benefits to both parties will be continuation of the development of standardised approaches to tissue & cell procurement, manufacturing, labelling and supply chain in the UK and beyond.
As the group continues to grow with new members from UK biotech SMEs and international companies looking to operate in the UK, there will be a focus on supporting the development of and implementing international standards. We will also be integrating hard-won knowledge from the ATTC activity to improve manufacturing, supply chain and adoption. The group will also be working to improve international links, to support both the export of UK products on the global market and the inward investment of international companies looking to expand into the UK.
