Founded by pharma veteran Brian Harrison, Dublin-based Hitech Health is helping companies propel their novel medicines from concept to launch.
While Ireland has carved a niche for itself as a pharmaceutical powerhouse, hosting the European offices of some of the world’s biggest pharma companies, it still lags behind other similar-sized European countries such as Denmark and Finland in attracting clinical trials.
As a result, Irish companies that are developing advanced medicines such as cell and gene therapies – many spin-outs from universities – find it hard to get to the clinical trials stage and scale their innovations.
This is where Hitech Health steps in. Founded by Brian Harrison in 2013, Hitech Health is a contract development and manufacturing organisation that focuses on helping client companies bring their novel medicines to patients.
Bringing expertise to the table
Based in Blackrock, Dublin, Hitech focuses on advanced therapeutic medicinal products such as cell and gene therapies – an emerging area of biomedical studies that aims to treat, prevent and even potentially cure diseases caused by genetic and acquired cellular defects.
“Most advanced medicines including cell and gene therapy products are developed by experts in universities who spin out companies with a focus on bringing their new medicines to patients,” said Harrison, a chemistry expert who serves as managing director of the company.
“In most cases, they do not have the expertise internally to understand the regulations and what it takes to bring a medicine initially into clinical trials through to being a marketed or approved medicine. These are the companies we partner with.”
Essentially, Hitech takes over the development and manufacturing of new medicines from client companies looking to outsource the process so that they can focus on drug discovery instead. Harrison said a typical medicine takes about 10 years to launch after being conceptualised.
“We help companies who do not have the expertise to bring products through this highly regulated development journey. This is really a very exciting time for the development of medicines and treatment of patients, especially in the field of personalised medicine.”
The first cell therapy product, Kymriah, was approved by the FDA in 2017 for the treatment of a specific type of blood leukaemia. Ever since, Harrison says there has been a surge in the development of cell and gene modified therapies focused on treating patients with rare diseases.
He said that as many as 10 to 15 of such advanced medicines are expected to be approved in the US to treat patients, and will make their way to Europe in the coming years.
“Our R&D and manufacturing facilities are state of the art for the development and manufacturing of these new medicines,” said Harrison, who has a PhD in chemistry from University College Dublin.
“We have all the analytical equipment required such as flow cytometry, cell counter, microscopy and sterility testing. We also have a good manufacturing practice facility which is validated for the manufacture of cell and gene therapy products.”
‘High inflation and lower growth’
Prior to founding Hitech Health, Harrison was a senior executive of development at Bristol Myers Squibb based in the US, responsible for the development of new medicines with a focus on product scale-up and launch. He then moved back to Dublin working for the same company.
“My career and expertise is in the operations side – taking therapies from laboratory scale through to full-scale manufacturing and supply should the medicines be successful through clinical trials,” Harrison explained.
“We have a team of experts who have deep technical knowledge where we can support our clients with analytical and process development expertise through to the manufacture of products to treat patients.”
In its 10-year run so far, Hitech has supported several clients to manufacture and get regulatory approval for products that have helped patients across Europe and the UK. The start-up opened its first R&D laboratory in 2020, followed by a manufacturing facility more recently.
Harrison believes that his business comes at an important time for the pharmaceutical industry, which is witnessing thousands of ongoing advanced medicine clinical trials in the US alone.
“Economic challenges such as high inflation and lower growth have led to lower levels of investment for these new products in development. There is also a major shortage of trained experts to enable development and manufacture of these complex products,” he explained.
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