‘We need to focus on utilising technology to complete trials more cost-effectively’

ICON has been able to offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Dr Malcolm Burgess, Executive Vice President, Asia Pacific, ICON shares his views with Viveka Roychowdhury about the company’s growth trajectory in India and how it has performed in the last decade in the country

As ICON marks a decade of operations in India, what have been the key milestones of the company’s presence in India? 
As a leading Clinical Research Organisation (CRO), with its presence in India since 2002, ICON’s history has had many milestones in the past decade. We have expanded our service provision to become a full service CRO including Bioanalytical and Biomarker services as well as expanding our geographic coverage in India. ICON India now has more than 780 employees in four offices in Bangalore, Chennai, Gurgaon and Tiruvananthapuram. Additionally, we have successfully managed a central laboratory in Bangalore since November 2008 and associated investigator and logistical support requirements for clients in virtually every phase and therapeutic area of clinical development.

What is ICON’s USP compared to its peers?
The thing that sets ICON apart from other CRO’s is our culture. Since the formation of the company, we have been focused on being the best CRO, not necessarily the biggest one. Our focus on people, performance and clients has enabled us to grow from five people back in 1990 to over 8,300 staff (with over 1,200 of those based in Asia Pacific). For many years, ICON spent very little on advertising and simply relied on our reputation for business development. That approach has engendered a high degree of trust within our client base. Developing a drug is not a ‘quick hit.’ it requires a partner who can be relied upon for the duration, regardless of any obstacles or bumps that are encountered. While these may seem to be ‘soft’ attributes our desire to provide service of the highest standard to our clients permeates everything that we do and our clients know that their projects are in safe hands with ICON. I think these attributes are critical for all of our clients, but even more so for emerging biotech companies.

What changes have you observed in the CRO industry in India and how are these trends shaping the business environment?
The Indian government is making efforts to strengthen the regulatory framework for clinical research. Historically, the industry in India has been supported by thoughtful and well-drafted legislation. Unfortunately, the laws are not always implemented and can be interpreted differently by different parties. But with the introduction of new guidelines from India’s Central Drugs Standard Control Organisation, the industry is undergoing a dramatic change. As we get better clarity on the new regulations and its implementation, we expect to see an improvement for the better.
In the recent past we have also witnessed a consolidation of the CRO business through various acquisitions and mergers that will go a long way in reinforcing the clinical research industry in India.
I believe that adapting technology and tools to improve efficiencies in clinical development will go from strength to strength in the next few years. In fact, ICON has already made some great progress and we need to continue to harness the efficiencies that technology can bring to provide intelligent information to the study teams that will support better and faster decision making and make clinical development more cost effective for clients.
We also see the promise of personalised medicine moving forward over the next 10 years which may lead to a reduction in the size of studies but a compensating increase in the number of compounds being pursued. These studies will be conducted on a global basis and will require the sort of scale, depth of therapeutic experience and global footprint that ICON possesses.

What challenges are being faced by CROs, both globally and in India?
I think one of the challenges faced by CROs globally is how to manage clinical development in an effective and efficient manner by adapting technologies to address the issues of increasing research and development (R&D) costs, slow results, lack of funding, regulatory requirements, multiple databases, and shortage of qualified investigators and patient recruitment. As I mentioned above, the predicted trend is that more and more CROs will be turning to technology solutions to improve trial efficiencies and enhance the productivity of trial participants.
The challenges in India are the same as in all emerging markets, including staff recruitment, education of sites and other than that it suffers from the weakness and, in some cases, absence of important laws – although the government is working hard to address this. Limited sites and infrastructure for trials is also challenging. In addition there are challenges of covering the significant geography of the region and distance from global management teams, usually located in Europe and the US. However, the enthusiasm and dedication of the people on the ground more than makes up for these challenges.

The CRO industry in India is perceived as preying on patients, most often those belonging to the lower economic strata of society. How does ICON and the industry as a whole, address these concerns?
The Indian government has set up a team of inspectors to ensure the protection of volunteers, reliability of data and enforcement of proper checks and balances. Since October 2009, India has also taken steps to centralise the licensing of pharmaceutical products in order to streamline the regulatory process for pharma manufacturing. Regulations are also being considered in the areas of clinical ethics and patient safety.
ICON has an excellent track record of successful audits from regulatory bodies and clients quality is the cornerstone of ICON’s success and we have worked hard to establish a reputation for quality. ICON India has successfully completed several inspections by the US FDA and EMA. It is also one of the few ISO certified CROs in India. We are committed to maintaining, supporting, checking and improving our quality systems to exceed the quality standards demanded by our clients, patients and regulatory authorities consistently. The quality of our work is vital to our mission of bringing better medications to patients around the world.

What future business models do you see in this sector?
ICON recognises the importance of offering and delivering services where our clients need them, and has therefore devised a specific strategy to grow our regional presence in the Asia Pacific region significantly over the next few years. I think we need to focus on utilising technology to complete trials more cost-effectively and in more innovative ways so that the spiralling cost of increasing development can be curtailed. We need to start challenging some of the ‘norms’ and continue to innovate in our industry. We have great experts in all areas of drug development and we need to get these people more involved in changing the way we develop drugs.

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