A clinical performance

Dr Rabinder Buttar, one of the UK’s top entrepreneurial woman, tells BQ about her ambitious plans for ClinTec International and why there are plenty of hurdles in the way of success.

If First Minister Alex Salmond requires an exemplar for his vision of a more optimistic and progressive Scotland, then he should look no further than Dr Rabinder Buttar, president and chief executive officer of Glasgow-based ClinTec International.

This entrepreneurial scientist, born in the Punjab, raised by hard-working immigrant parents, educated at an inner-city state school in Glasgow before heading to the nearby university, is a perfect role model for much that is good about our small nation. She is building ClinTec International into an admirable global business, bristling with opportunity and employing local graduates in science and biomedicine.

In April, a pinnacle was becoming a recipient of the Queen’s Award for Enterprise in the Birthday Honours list. The company was the UK’s 27th fastest-growing, privately-owned technology company in last year’s Deloitte fast track listing. She has a string of awards, including Scottish Businesswoman of the Year in 2008. But there are no easy wins and guarantees of success. The sale of Scottish drug maker ProStrakan, one of the country’s biggest biotech companies, to Japanese firm Kyowa Hakko Kirin, highlights the profound difficulty of building a company of scale.

ClinTec International can’t hide from its own growing pains with its investors Elephant Capital recently forced to write down some of its investment because revenues are taking longer to come on stream and the markets are extremely tight. Elephant management says it believes in Rabinder’s business model and supports management efforts to achieve her highly ambitious business plans. Nevertheless, Rabinder Buttar is determined to create a much-needed Scottish-based success.

From the glass-fronted eyrie on the seventh floor of 133 Finnieston Street there is a wonderful urban panoramic view across the Clyde towards the Finnieston crane which once loaded steam trains made in Springburn on to ships that took the locomotives to India and beyond, to the rocket spires of academe at Gilmorehill. Although born in the Punjab, Buttar speaks with a wonderfully gentle Glaswegian burr.

“People recognise my Scottish accent,” she says. “I was at an Asian business event with David Cameron at 10 Downing Street. One of the guests was German and said I was speaking German with a Scottish accent, and another said I was speaking Punjabi with a Scottish accent. That was quite interesting.” Her mother and father, both teachers, placed great store in education, so they came to Scotland when she was five.

Buttar was educated at Woodside Secondary School, in the heart of Glasgow, whilst her two younger brothers and two younger sisters went to a school in Bishopbriggs, on the outskirts of Glasgow. She points northwards from the full-length office window.

“It was out there. It was just a normal Glasgow comprehensive. But it was closed a number of years ago. My parents wanted us to have the best education possible. It was an important factor – even today our parents are always telling us to do your best.” Her brother is ClinTec International’s senior director Bobby Bal, an MBA graduate and former Deloitte management consultant, while one of her sisters, Satinder, is a consultant in endocrinology at Raigmore hospital in Inverness, the other works in film and television, and her other brother is a property developer.

“Family is really important to me and we all get on well and we meet as often as we can,” she says. Rabinder Buttar was one of a handful from her school to go to Glasgow University, just across the Kelvingrove Park, and lapped up her science course.

“I was learning all about those complex biochemical pathways,” she says. “I really felt I wanted to do something that was much closer to medicine and helping patients.” She went on to University of Strathclyde where she undertook a PhD in immunology, developing novel methods for the production of human monoclonal antibodies and looking at their use to treat various diseases.

“At the time, this was a novel aspect of science,” she says. “Georges Kohler, Niels Jerne and Cesar Milstein shared the Nobel Prize for medicine in 1984 for the discovery of monoclonal antibody production. Milstein was working in Cambridge at the time and I was excited about working on such high profile technology at the time.” She worked with Professor Bill Stimson, her mentor, and her research involved the West of Scotland Blood Transfusion Service with her PhD being assessed by the Boots – Celltech.

“Professor Bill Stimson was very entrepreneurial and even today I’m amazed how he is still active in research with his own laboratories,” she says. “He’s set up several innovative companies and inspired me many years ago. I was fortunate to be his research assistant at that time.

“I felt I wanted to work in something closely related to medicine or pharmaceutical development, working with people and patients. I couldn’t describe the job at the time. Being a clinic research associate was a new kind of job. I was one of the first clinical researchers going into the industry. I saw how dynamic it was trying to get a product onto the market.” Running her own business wasn’t on her radar at this stage.

“I didn’t say I’m going to be an entrepreneur because it wasn’t something I knew about, but I had a vision of getting some kind of product – a drug, medicine or treatment – from the workbench through to the healthcare market as fast as possible. This meant moving into industry.” Her husband, Amrit, whom she met at university, was working as a dentist, and relished the prospect of working abroad, especially in Germany. Buttar joined him and wanted to use her immunology background to find a suitable job.

She had already gained commercial experience with Wellcome, now GSK, and Wyeth – now Pfizer and she followed another path in learning, spending a number of years working for a Japanese firm in Germany. She says: “I wanted to work with a Japanese company to experience a different culture and styles. I joined Fujisawa which was opening its European headquarters in Germany.” It complemented Buttar’s experience, giving her a chance to see the whole drug development process from start to finish.

“We took a drug from Phase I clinical trials to market launch. It was a novel immunosuppressive drug used for the prevention of rejection in liver, kidney and heart transplantations and I was very happy to be involved in a dynamic and growing company. They brought in scientists and researchers from all over the world. It was a mixture of the best talent from across Europe.

“It was a very ambitious and demanding thing to do, to take a drug from early clinical development through to its successful registration in Europe and US and onto the market. We had a core team of 18. We had to find solutions and that meant hiring in resources, even finding the latest technology to measure drug blood levels in patients. We did all this in the space of four years.

“If you got the dose too high when we were doing trials, you increased toxicity and the patient could die; if the dose was too low, the organ that was transplanted would be rejected, and the patient can die. So finding the correct ‘therapeutic window’ to be used in clinical trials was vital for us.” Buttar was responsible for designing and undertaking the first paediatric trial, which was often emotionally challenging dealing with young lives.

“My job was to hammer out protocols withthe best paediatric transplant surgeons in hospitals across Europe,” she says. It was massively successful and the result was Prograf, an immunosuppressant compound sold in 90 countries. Over the next ten years, Prograf became a “blockbuster” drug – essential for all organ transplants – and one that earns more than $1bn a year. This gave Buttar a brilliant insight and opportunity because she had to handle with all aspects of clinical drug development but the intellectual property remained with Fujisawa (now called Astellas).

“I learned a lot about the process and also working in a business environment,” she says. In 1994 to 1996, she took some time off to look after her two baby sons, and set up ClinTec International as a small clinical research organisation (CRO) and consultancy in her home in Dinslaken in Germany. But, with young children, having her extended family around her became important and she wanted to come back to Scotland. She came back to London in 2006 and then moved the base to Scotland in 2007.

“I already had a base in the UK and ClinTec International was registered in the UK in 1997. I had a German and a UK office but returning to Scotland was all to do with building a larger infrastructure for global growth.” For Rabinder Buttar, a successful CRO has to be prepared to adapt and enlarge its geographical coverage to suit the changing requirements of the clients, who are the major pharmaceutical firms or “Big Pharma”.

“The ongoing trend towards mergers and acquisitions among larger pharmaceutical and biotech companies shows no sign of abating in 2011,” she says.

“Going hand in hand with this trend is the super pharma strategy to be risk averse, leading to R&D budget being slashed.” “Everyone in Scotland is still involved in early stage drug development; we don’t have many products that are in the clinical phase yet. There is a huge gap because there is not enough funding in Scotland. We need to drive and push from early stage development to later stage development. It’s the later stage development that will create the blockbusters. Scotland is still a long way off from having blockbusters.” So ClinTec International has grown into a global CRO.

“Our clients are 11 of the top 25 pharma in the world, four or five of the top ten,” she says. “We also work with biotechnology companies, large ones and small start-ups. We have a mixture of clients.” With grant support from the Scottish Enterprise, the head office was set up in Glasgow where 45 people work as project managers, clinical research associates and in corporate, human resources, marketing and business development functions.

ClinTec undertakes Phase I to Phase IV clinical trials in 40 different countries in hospitals around the world and there are 15 regional country heads and six regional hub offices, including a large Indian office in Bangalore, where 50 people are employed.

“In Scotland it has been great to find a willingness of people to become involved in the company; they share the vision to grow this into a highly successful company. Almost everyone is a graduate or postgraduate from a Scottish university. Many have had working experience abroad and realise there is a company now operating in Scotland that can give them career opportunities. We’ve been very successful in bringing people back home. That’s good.” Another plus is that ClinTec has been able to offer active commercial research projects for the graduates of Glasgow and Strathclyde and other colleges in the West of Scotland.

“As a result, they are reconnecting with the universities and their research departments,” she says. “This brings closer links between industry and academia.” Her brother Bobby Bal joined, setting up financial systems, raising vital capital with investors, and looking at business development. “We are putting in management processes to act like a shadow plc, which gives us the option of going for a flotation in three to four years,” he says.

AIM-listed Elephant Capital, a private equity group specialising in companies interested in India, took a 28.6% stake in the company in August 2010 after injecting £8m.

Through this ClinTec has appointed three new directors to its board. Gaurav Burman, managing director of Elephant Capital; Anand Burman who is the chairman of Dabur, the world’s largest ayurvedic and natural health care company with around 350 branded products from toothpaste to fruit juices, and Jim Hauslein, ex-chairman of Sunglass Hut.

Gavin MacKenzie, the ACCA-trained ClinTec finance director, explains: “We have different revenue streams in multiple currencies. A large proposition is global clinical resourcing and that means we can identify and recruit clinical researchers from 80 countries worldwide and place them into client projects and programmes. This means steady income. We hire the experts and they get moved around within the pharmaceutical industry to work across product pipelines, depending on the needs.

We are in a strong partnership with Merck and other big pharma using this business model which is really effective.” ClinTec’s geographical diversity is one of its strengths, says Rabinder Buttar. And her Indiancultural heritage is a positive asset giving her a foothold into the sub-continent.

“I’ve always wanted to create good clinical research in places that have been neglected, such as India,” she says. “We’ve always gone where no-one else had been. I went to Eastern and Central Europe before the global players came, then we went to India before the global players, and now we’re in the Middle East and Africa, where the global players are still to come.” In 2010, ClinTec launched its own Academy of Clinical Excellence, which is training researchers in Dubai and Saudia Arabia to adopt best practices. The company is also working in China, Singapore and Thailand.

Buttar feels that the Big Pharma and the CROs must take more responsibility for training of its people and ensure the highest global ethical standards in research and testing. She is keen on doing oncology trials successfully in the emerging markets.

The issue is that regulations are not as well established in all the emerging markets, and this throws up the potential for abuses. Board forums and ethical committees are still in their infancy in some emerging countries and Rabinder wants the emerging nations to adopt the codes and regulations of the EMA, (European Medicines Agency), and US Food and Drug Administration. She is vociferous on the controversial issue of licensed proprietary drugs and generic drugs and how they can be used to help the sick and poor of the world.

“India has an abundance of generic drugs,” she says. “It is known for its generic drug manufacturing. If Indian and Western drug companies can collaborate, they can produce new chemical entities in ‘novel’ drugs. I’d like to see a lot more novel drugs produced in partnership between India and Western companies, actually originating out of India. We were involved with Dr Reddy’s laboratories to introduce India’s first novel and anti-cancer drug to the global market place. Partnerships like that should be more looked into and encouraged.” She adds that it is not just an Indian issue. She suggests that Scotland must have an enterprise programme that specifically looks at partnering emerging market scientists and Scottish-based scientists to produce novel drugs. New trials are looking at cancer therapies, with oncology one of the biggest challenges. She says there are different protocols for different types of cancer, while cardiovascular drug testing is still increasing, as is diabetes. Other more rare diseases such as Gauchers’s, a genetic disease, and Hepatitis C are prevalent in select populations and because of ClinTec’s vast geographical coverage extending into even remote regions it is one of the few CROs in the world to be able to support companies developing drugs for rare diseases. “India has the largest population of diabetics in the world,” says Buttar.

“The incidence is very high and it is also increasing in the Middle East, where there is a large number of diabetics and those liable to become diabetic. These are diseases that are common in Scotland and people should be collaborating in the area of testing. “There’s untapped market there. All the major prevalent diseases can be found in the Middle East and investigators are extremely interested in being involved in research.” So what is her ambition now for the business? “I never think of my business just in Scotland although we’ve got a committed and enthusiastic team here but we’re also really working closely with all our country managers who aspire to achieve global levels of excellence in every aspect of their work.” How does she define her business culture? “There’s open and transparent communication,” she says.

“It is about ensuring we have trust; we all want to do a good job and work together.” And how does this world-traveller, now in her late 40s, with a large number of speaking engagements and conferences to attend with a family in Glasgow, unwind and keep her mind fresh? “I’m very interested in Ayurvedic medicines and the Ayurvedic treatments,” she says.

“I value the weekends in Glasgow. My two sons who are 14 and 16 have been studying for their Intermediate grades and Highers. We have a lot of family get-togethers.” But she loves her work – and the daily challenges it brings.

“My vision is to continue to build the company across the globe,” she says. “Yes, it has been very tough and some of our contracts are taking longer to come to fruition, but this is a fact of life.

“I still see Clintec International becoming a £50m turnover company within the next three years.”