Nexxus Scotland

Biopta Ltd

Biopta is a Contract Research Organisation (CRO) specialising in the use of fresh human tissues for the prediction of drug efficacy and safety during non-clinical drug development.

A spin-out company from Glasgow Caledonian University, Biopta was set up by Dr David Bunton and Professor Chris Hillier in 2002 to develop services and technology which could reduce the 90 per cent failure rate of drugs in clinical trials.

The company has won numerous awards for innovation for its patented technology, including a Scottish Enterprise Proof Of Concept Award, a regional John Logie Baird Award, a Scottish Executive SMART Award and the Nexxus Award for Innovation.

Biopta's inception in 2002 was the result of an innovative idea for testing drug candidates before they progressed to clinical trials. The company developed a unique method of testing compounds in vitro with great accuracy and now offers the technology (PM-1) as part of its range of human tissue research services.

Historically, relatively little human tissue-based research has been conducted using fresh human tissues because of the difficulties in sourcing and working with such tissues. In recent years however, the pharmaceutical industry has recognised that species differences and poorly predictive in vitro methods have contributed to the poor quality of lead candidates entering clinical trials. Of the drugs that fail in clinical trials, approximately 40% fail because of safety/tox issues and a further 40% fail because of lack of efficacy. Functional, intact human tissues and organs clearly represent one way in which more predictive data on safety and efficacy can be generated.

Biopta's aim is to make fresh, functional human tissue assays a routine part of the drug discovery process; in 2005 Biopta became the first company focussed on fresh human tissues to become members of the Good Laboratory Practice programme.

Dr David Bunton, Biopta's CEO, believes this is a key area for development and that human tissue assays will soon become the gold standard for safety testing. "The high failure rate of new drugs means that regulators worldwide are demanding new, relevant methods for the prediction of adverse effects; human tissue is increasingly being seen as the way forward," he said.

Naturally, conducting experiments on living human tissue is an emotive subject, which is why Biopta work closely with its tissue suppliers to ensure that all human tissue is ethically donated with fully-informed consent. This is a vital part of the process, and networks such as those available via the NHS and the life sciences community generally are a large part of what keeps Biopta in the West of Scotland. In addition, Scotland is home to a number of CROs employing highly skilled and committed groups of scientists.  Providing high quality services to the pharmaceutical and biotechnology industries is an area where Scotland has excelled and Biopta's staff has broad experience in the provision of research services.

To date, Biopta has investigated over 300 potential new drugs for over 60 clients, including 9 of the top 10 major pharma companies, in areas as diverse as asthma, diabetes, hypertension, cancer and migraine. To maintain its growth Biopta aims to stay at the forefront of human tissue research and, perhaps unusually for a CRO, has a dedicated internal R&D team headed by Dr Sarah Lynagh, which has created new assays in inflammation, drug absorption and cardiac safety. The team also regularly creates bespoke assays that meet the specific needs of clients.

Sarah said, "The field of human tissue research is moving rapidly and we are able to respond to market trends through the high number of enquiries we receive for new tests."

Biopta's Head of Operations, Dr Karen Macdonald, added, "Each project is unique, yet our experience in the area means that we are achieving turnaround times of 4-6 weeks for many projects. The tests are proving very popular with small biotech companies, who are able to add commercial value through early human proof of concept".

Biopta's next goal is to make human tissue testing part of the development of every drug, David Bunton commented, "Within 10 years we believe all drug development will focus on human test systems; as the leaders in functional human tissue assays we are well positioned to dominate this market".

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