The $3-billion clinical research organisation, Quintiles, which has worked on over 4,700 studies involving over 2.7 million patients, has set up its fourth phase I facility in Hyderabad after London, Kansas and Uppsala (Sweden). Eddie Caffrey, senior vice-president and head of global phase I, Quintiles, explains to BV Mahalakshmi the company?s plans for India.
Built on the principles of clinical, commercial, consulting and capital, how does the company look at the Indian market in terms of growth for clinical development services?
With Asia playing an increasingly important role in the global drug development, the demand for clinical development services in India will continue to grow.
Quintiles started its operations in India in 1997 and has sequentially introduced most of its global services in India over the years to meet the growing needs. Quintiles? phase I unit in Hyderabad represents a significant expansion of Quintiles? global capacity to meet increasing demand for phase I services, while maintaining the highest quality standards. It complements Quintiles? existing services in India, including the electrocardiogram unit, data management, clinical development and central laboratory.
What is the market potential for clinical services in the country and globally? How much is your market share and how do you plan to grow your revenues here?
The global pharmaceutical market will continue to grow and India as one of the key economies of the region will emerge as a significant market for the global biopharmaceutical industry.
As a private company, we do not disclose our financial data. At the Hyderabad centre, we hope to break even in the second year of our operations. Quintiles has a strong presence in India employing more than 1,500 employees across five locations Mumbai, Ahmedabad, Delhi, Bangalore and Hyderabad.
Having proven experience in clinical trials, how do you look at the regulatory system in India? Do you think there are challenges which have to be plugged in?
Evolution of the regulatory framework is imperative to support India?s growth into a significant biopharmaceutical hub in the region. Significant progress has been made in this area over the years.
To safeguard patients and bring up the quality of clinical research in India, the government has laid the groundwork for increased oversight of clinical trials and implemented harsher penalties for companies/investigators that violate GCP guidelines. As a company which always works with an unwavering commitment to quality, patient safety and ethics.
How are phase I units helping the global pharmaceutical industry? How many molecules have you screened till date and in which areas?
Making the right decisions in early development is critical to the success of a biopharma portfolio.
As an ally to biopharma, Quintiles? phase I programme provides the information and perspective needed to make key decisions earlier than ever before. Combining the novel approaches and advanced techniques, grounded in deep scientific expertise and real-world experience in handling complex phase I/IIa trials, Quintiles offers data-driven insights that can help speed up a clinical development programme, bringing new and more effective medicine earlier to patients.
With 25 years of proven experience in complex phase I/IIa trials, Quintiles has conducted trials across 18 therapeutic areas including oncology, CNS, infectious disease, and cardiovascular disease.
Hyderabad is Quintlies? fifth location in the country. Do you plan to have more centres in the country similar to the relationship with the Apollo group?
We have no immediate plans but we constantly monitor what facilities we need to meet our customer demand across multiple service lines and multiple geographies.