FASTNET FIRST-HAND: Cell & Gene Therapy Ireland

According to a recent report from McKinsey, we are heading into a Bio Revolution. Biological innovation has made R&D more precise, which will enable the spread of personalized medicine. A revolution in cell and gene therapies means that a rise in precision manufacturing in Ireland among life sciences and pharma players is setting Ireland up for a more bespoke future of drug manufacturing, where unique drugs for patients can be created and dispatched within 48 hours to anywhere in the world.

Ireland has a track record as a centre of excellence for pharmaceutical and biopharma manufacturing. In the last decade alone, more than €10 billion has been invested in biopharma manufacturing in this country with more than 30,000 people now employed in the sector, contributing more than €40 billion in exports annually.

Cell & Gene Therapy investment is growing four times as quickly as the rest of the pharmaceutical industry. While this is not the only area of growth in biopharma, it will be increasingly important in the coming years.

Research & Development

5. Over €11m of research funding awarded in Ireland in areas of gene therapy and cell therapy in the last 10 years by Science Foundation Ireland (SFI)
5. 4 Disruptive Technologies Innovation Fund’s (DTIF) awarded for cell and gene therapy amounting to €19m
5. Multiple cell & gene clinical trials ongoing in collaboration with Galway University Hospital and St James’s Hospital
5. There are seven clinical research facilitates and centres across Ireland within an integrated clinical research network known as HRB Clinical Research Coordination Ireland 
6. NIBRT is Partnering with REMEDI to deliver cell therapy manufacturing course in NIBRT (The Regenerative Medicine Institute (REMEDI) is a world-class biomedical research centre focusing on gene therapy and stem cell research)

Talent

Several of Fastnet’s clients are planning to develop in this area with potential investment in Irish operations and we have been doing some research to ensure we are well placed to support. For e.g AbbVie (formerly Allergan), are collaborating with NIBRT on the manufacture of gene therapies and APC, a Cell & Gene therapy CMO, announced a €10 million investment expanding the world-class research facilities at its global headquarters in Cherrywood, Dublin in 2018.  Also, Takeda has chosen Ireland to construct a commercial-scale cell therapy site. And Avectus is working to produce cell therapy products. 

From a talent perspective, specific experience in this area is still a rare commodity. The requirement will be primarily across three areas:

1. Process Development: experienced Process Development Scientists, Upstream and Downstream scientists and Senior Engineers
2. Manufacturing: cGMP Production, QA & QC, Supply Chain, Maintenance and Process Validation.
3. Senior Management: May need to attract leadership talent from other regions

The Irish Government provides funding to NIBRT (National Institute for Bioprocessing Research and Training), which can provide training to 4500 individuals a year. NIBRT offers practical based training for industry in cell and gene therapy development and manufacture. 2 new courses launched in 2020, Fundamentals of Stem Cell Therapy and, Advanced Cell Therapy Technology Course (in partnership with GE Healthcare)

Ireland is in a strong position to develop this pipeline of talent. Candidates already experienced in the manufacture of biological drugs, vaccines etc. can step into these roles with a relatively short learning curve therefore there are transferrable skills. Candidates with CMO experience would be particularly attractive as they will have expertise with multiple bioprocesses. 

We spoke to Niall Barron, Principal Investigator, Cell Engineering Lab at NIBRT and asked, What does Ireland need to do to become a hub for the global supply, management and manufacture of Cell & Gene Therapy treatments and what are the key challenges facing the sector?

Niall highlighted the following as necessary steps we need to take to ensure success.

1. Capability development: Commit to ensuring small and large companies can source highly trained CGT manufacturing staff.
2. Research excellence: Ensure availability of excellent scientific and engineering expertise in CGT manufacturing, including globally renowned leadership, within the Irish research system. Expand research funding to support this.
3. Infrastructure: Provide infrastructures to support CGT investment or development (e.g. testbeds, incubators, training facilities).
4. The role of government & state agencies: Develop CGT manufacturing as a national strategic priority across government departments and agencies.
5. Foster and support Innovation: Indigenous innovation will attract larger companies to Ireland through acquisition or proximity to talent.

According to Niall, the Challenges facing the sector in Ireland are as follows:

Complexity of the products: Modified cell therapies (e.g. CAR-T) are essentially a batch of one per patient. There are multiple supply chain/chain-of-custody challenges to get blood from patients, multi-step manufacturing process, and back to the patient with little time for QA/QC. Even gene therapies rely on ‘antiquated’ manufacturing processes – i.e. transient transfection of producer cells with GMP-grade plasmids.

Skills: Ireland has a huge existing base of operators in the Biopharma sector but they need to be supplemented with more CGT-specific (hands-on) training offerings from the HEI sector.

Opportunity

Ireland can now play a central role in this next evolution of Life Sciences. Brexit could lessen the UK’s attractiveness as a location for European Cell & Gene Therapy companies. With Ireland’s track record as a manufacturing location for highly complex biopharma products and the scale-up and batch production of new medicines as well as this country’s position as the only remaining English-speaking, Common Law EU member state it gives a compelling proposition for the next wave of Cell & Gene Therapy firms.

Also, the significant presence of the technology sector means Ireland is uniquely placed to deal with the complex data, quality, regulatory and supply chain issues associated with supporting the Cell & Gene Therapy sector.

References:

Special thanks to Niall Barron, Principal Investigator, Cell Engineering Lab at NIBRT

IDA; https://www.idaireland.com/newsroom/publications/why-ireland-for-cell-and-gene-therapy-development

EY: https://www.ey.com/en_gl/supply-chain/how-a-digital-ecosphere-helps-individualized-treatments-reach-patients

NIBRT: https://www.nibrt.ie/cell-and-gene-therapy-training-and-research-facility-at-nibrt/

McKinsey: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/covid-19-and-cell-and-gene-therapy-how-to-keep-innovation-on-track