Is cell and gene therapy the future of medicine?

18 Apr 2024

Hitech Health founder and MD Brian Harrison. Image: Hitech Health

For Future Health Week, Brian Harrison of Hitech Health discusses how cell and gene therapies focus on ‘the root cause of the problem’, the current regulatory challenges and the importance ‘being here now’ when leading a team.

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Researchers around the world are continuously seeking to improve humanity’s tools against illness and disease, with some novel concepts gaining traction.

With the support of technology such as AI, some experts claim it is becoming far easier to discover and develop novel drug entities. Meanwhile, concepts such as cell and gene therapy are showing success in research studies to treat various issues such as glaucoma.

There is also a growing need for more advanced medication, as research suggests autoimmune diseases are on the rise in many parts of the world. These diseases can range from debilitating to life threatening.

One person who believes cell and gene therapy holds the answers to improving healthcare is Brian Harrison, the founder and MD of Dublin-based Hitech Health. This manufacturing company focuses on helping client companies bring their novel medicines to patients – with a focus on cell and gene therapy.

Harrison has been in the biopharma industry for more than 30 years and spent a large portion of this with Bristol Myers Squibb as an “executive in the development of medicines”, before he set up HiTech Health roughly a decade ago.

He spoke highly of the potential of cell and gene therapy and said these treatments focus on “the root cause of the problem”.

“So, in cell therapy you’re giving sick patients healthy cells, so the cells are grown in a cleanroom environment and given back to the patient while you’re boosting their immune system and helping them to face whatever particular ailment they have,” Harrison said. “In gene therapy you’re actually repairing some damage, either replacing a gene or repairing a gene.

“These therapies really can be life changing for those with a genetic disorders and many of those rare disorders, genetic disorders can be life ending for kids when they’re born. So, if you can repair those, there’s been many stories in the last number of years where children have been fully cured, for example, by one genetic treatment.”

The rise of cell and gene therapy

Concepts like gene therapy are not exactly new, as studies showing the potential of this form of treatment took place in the 90s. But there were reports of difficulties in some of these early studies, which diminished interest in this sector until roughly 2008.

Harrison noted that it is likely “years down the line” before these types of advanced treatments make a huge impact in the market, but he remains hopeful and claimed advanced medicine is a rapidly growing field.

He also believes a massive boost came when the Human Genome Project created the first draft DNA sequence more than 20 years ago, laying the foundation for researchers to map the human genome.

“So, that was a huge help, you know, when you can update the human genome, then you can develop therapies, slowly,” Harrison said. “That’s been a real driver over the last 20 years.

“I do believe that these are the future of medicines, treating the root cause of the illness, you’re treating the cells, you’re treating the human tissue. So yeah, I firmly believe that this is the way forward. But there’s a lot of work to do to make them available to as far as mass markets and everyday treatments.”

In 2022, scientists claimed to publish the first complete sequence of the human genome, which will hopefully help scientists around the world to understand genetic contributions to diseases and improve clinical care in the future.

Challenges in the sector

Like any evolving market, Harrison notes that there are some challenges facing the growth of these advanced medicines, such as a slowdown in investment for new biotech companies for a couple of years “up until I think a few months ago”. He also feels there is a major challenge in Europe when it comes to regulation.

“Europe [has] kind of fallen behind, there’s a lot more clinical trials going on in the US and also in China,” he said.

“Europe is falling behind because I suppose each country is kind of treating how you deal with advanced medicines and clinical trials in this space differently, whereas well, it should be one EMA – European medicine authority. It really is country by country, and that’s a real challenge.

“And then, because advanced medicines is a rapidly growing field, obtaining and retaining expertise and staff, I think, is a challenge.”

Harrison believes there are ways to tackle these challenges and thinks there are discussions taking place between major regulatory organisations to “streamline the process”.

He also said education systems are “catching up” when it comes to advanced medicines which will lead to “more trained people”. Financial challenges will likely remain for companies in this sector, however.

“Money makes the world go around, I can’t solve that one,” he said. “But there certainly seems to be an increased investment in new biotech at the moment and hopefully that will continue.”

Being involved in the manufacturing and production side of medicines, Harrison also noted the differences in delivering cell and gene therapies compared to traditional pharmaceutical products.

“If you look at pharmaceuticals and the tablets you buy in the pharmacy, for example, these are made in very big factories, they can be stored and shipped around to the world’s patients. In many cases, for a cell or gene therapy, they might be taking a biopsy or tissue from a patient, purifying it in the cleanroom and giving it back to the patient.

“So, it’s very complex and very costly to do that. How do you scale that up for thousands or millions of patients?”

Leading the venture

Harrison has put his money where his mouth is when it comes to his belief in these advanced treatments, as he says the biggest risk he took career wise was leaving Bristol Myers Squibb to start his own company, while the second biggest was investing in the business.

“It’s a large investment in the future medicine space, but I firmly believe it is the future and we’re ambitious for success.”

HiTech Health has around 30 staff, with employees in Ireland and the UK. Harrison believes communication is key when it comes to leading a business, along with giving them the right skills and “responsibility and autonomy”.

“I’m not the expert in all these areas,” Harrison said. “We hire excellent people who have real skills and allowing them basically to demonstrate those skills.”

Harrison also believes it’s easy for people to be always “looking forward” and that so much can take place in a business environment that “you can be easily distracted”.

“But when you’re dealing with people, it’s really being available to them, listening to them, encouraging them, and good communication. So, being here now – as someone said to me once – it’s really important.

“I think the second thing is, you’ve got to make your own career, you’ve got to make it happen. So you don’t wait for someone else to make it happen for you. I think that’s a sound piece of advice.”

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Leigh Mc Gowran is a journalist with Silicon Republic

editorial@siliconrepublic.com