Themed “Enabling cell and gene therapies for Asia”, the inaugural Singapore Cell and Gene Therapy Conference 2023 was jointly organised by the Advanced Cell Therapy and Research Institute, Singapore (ACTRIS), Agency for Science, Technology and Research (A*STAR)’s Institute of Molecular and Cell Biology (IMCB) and SingHealth Duke-NUS Cell Therapy Centre (SDCT).

Held on 4-5 August 2023, this hybrid Conference was attended by more than 400 clinicians, researchers, manufacturing experts, and industry players who came together to showcase ground-breaking research and development (R&D) and share practical insights into the curative roles of cell and gene therapies (CGTs).

In conjunction with the conference, Guest-of-Honour Minister for Health Ong Ye Kung also officiated the launch of ACTRIS’ new 2,000 sqm cell therapy manufacturing facility, which is expected to play a pivotal role in shaping the next era of CGT manufacturing and making a positive impact on economic outcomes in Singapore and beyond.

Deloitte is proud to support this significant initiative as its Knowledge Partner. In this post-event report, we will provide a concise summary of the highlights at the Singapore Cell and Gene Therapy Conference 2023 and our observations regarding the conference proceedings.

Deloitte’s perspectives on the commercial delivery of CGTs in Asia

Having played a role in the commercial launch of every single CGT product that has been approved to date, Deloitte has had a front-row seat to the global CGT sector’s dynamic evolution over the last decade. Leveraging this experience, we have synthesised our cumulative learnings into six key areas that we believe industry and academia players alike should focus on in order to realise the promise of CGTs in Asia.
  • The primary challenge for CGT stakeholders lies not only in understanding and addressing each patient’s individualised requirements, but also constructing highly personalised manufacturing processes around a “market of one”.
  • As they embark on this journey, CGT stakeholders will need to begin by placing their patients at the heart of their value chains – not least by delineating specific details of the entire patient journey, including unique touchpoints, transitions, and the various stakeholders that are involved throughout the care pathway as patients receive their therapy and related care.
  • POC manufacturing – or the production of CGTs at or near the actual treatment site – is an innovative approach poised to revolutionise CGT manufacturing. Nevertheless, the exact definition of POC or “bed-side manufacturing” can vary significantly, and each interpretation comes with its own unique set of considerations and challenges.
  • To tackle these issues, CGT stakeholders could consider the adoption of several proactive strategies. These include, for example, engaging with clinical site providers to gauge their preferences and capabilities, fostering collaborative business models that bring together drug developers and POC developers, and considering the use of innovative approaches such as co-investments with contract development and manufacturing organisations (CDMOs), hub-and-spoke configurations, and mobile units.
  • One significant obstacle in the journey from scientific innovation to commercialisation in the field of CGTs is the inherently unpredictable and fluctuating nature of the production process.
  • To ensure that they are prepared to cope with any sudden and unforeseen circumstances in their value chains, CGT players must therefore learn to embrace the unexpected along five key dimensions: protocol and process standardisation, monitoring and traceability, resilience and flexibility, business continuity management, and patient-centricity.
  • Despite the inherent complexities of AI technologies, its emergence could potentially provide CGT stakeholders with the innovative solutions they need to overcome some of their most pressing issues.
  • Key use cases for AI include accelerating the wet-lab experimental process and analysis of complex biological data; integrating diverse sources of data to identify trends and insights; designing gene constructs; and boosting patient success rates through predictive modelling.
  • The underlying cause of the high prices of CGTs can be traced back to their extensive R&D expenses, high costs of delivering personalised treatments, high level of manufacturing intricacy, and landscape of escalating costs driven by emerging technologies.
  • To navigate these financial hurdles, a fundamental re-evaluation of traditional commercialisation models, including pricing and contracting strategies is needed. Examples of innovative models that stakeholders are exploring include value-based contracts, performance-based annuity approaches, as well as new regulatory and reimbursement strategies.
  • As the landscape of medical research continues to evolve, we are observing a growing call for greater collaboration between the pharmaceutical industry and academia – particularly at an earlier stage of product development.
  • By working together to develop cost-effective manufacturing methods and scalable production techniques, pharmaceutical companies and academic labs could help to increase the affordability and accessibility of CGT therapies for a broader patient population.