"Kendle plans to increase its clinical development activities within India"

-Bharat Doshi, Country Manager, Kendle India

Kendle India was incorporated in December 2004. With a staff of 18 clinical research professionals, Kendle India is a global clinical research organization (CRO) that provides phase I-IV clinical development, regulatory affairs, biometrics and late phase services to help the world's biopharmaceutical companies maximize product life cycles and grow market share.

Kendle's team in India possesses clinical research and project management experience, plus broad therapeutic expertise. Bharat Doshi, Country Manager, Kendle India, shares with BioSpectrum the company's India plans and achievements.

What have been your key achievements in 2006-07?

Kendle India grew at more than 100 percent in terms of head-count and revenue. We increased our exposure to research sites by approximately 200 percent. And we have started covering neighboring countries, such as Sri Lanka, Pakistan, Bangladesh and have placed a contract CRA in Thailand.

What are the different services that have been introduced?

Kendle competes and has competitive advantages in the following core competencies:

• Global clinical development, which provides Phase I-III clinical research services to biopharmaceutical companies across a broad spectrum of therapeutic areas

• Regulatory affairs, which provides consulting and submissions and pharmacovigilance/safety services to help guide customers through the regulatory maze to avoid pitfalls, obtain approvals faster and maintain compliance

• Biometrics, which provides clinical data management, biostatistics and scientific programming services that expedite the clinical development process

• Late Phase, which provides proactive and innovative designs for Phase IIIB/IV studies and value-added pre- and post-launch services to leverage study result

What were the company's revenues?

Kendle reports revenue by geographic area. Net service revenues for the first quarter of 2007 were $95.4 million, of which 50 percent were in North America, 43 percent in Europe, 4 percent in Latin America and 3 percent in the Asia Pacific region.

What are the new partnerships and alliances that the company entered into in the previous year?

Worldwide, Kendle International acquired the Phase II-IV business of Charles River Laboratories last year. Locally, Kendle India increased its usage of research sites (hospitals) by 200 percent more than the previous year. This included all big sites such as All India Institute of Medical Sciences, Post Graduate Institute of Medical Education and Research, Christian Medical College and King Edward Memorial Hospital. We trained five new sites last year on ICH-GCP standards and gave them an opportunity to participate in international clinical research.

What are the investments in terms of infrastructure, new plans and projects and the studies undertaken?

Kendle has expanded the capacity of its office based in Gurgaon from 12 to 50 associates.

From this office, Kendle plans to increase its clinical development activities within India and also in the region. This will mean more clinical studies being done in India. Simultaneously, we will expand our headcount at this new office and when it approaches capacity, we plan to move to another office location within India. We will consider offering other services also from the same office. In terms of more number of clinical trials, we intend to work with more sites and train more new resources for clinical research activities.

What are the key challenges? And how do you plan to overcome them?

Attracting appropriate talent is a challenge, and it is complicated by the fact that many employees change jobs quite often. We are overcoming these challenges by offering an aggressive compensation and benefits package and by providing an environment that strikes a work-life balance. In addition, we try to "grow our talent" by encouraging associates to gain additional knowledge and skills, leading to additional career options within Kendle. A key to this is Kendle College, our proprietary, industry-leading training and educational organization that provides a wide variety of interactive learning opportunities including self-paced courses and live collaborative experiences.

Shalini Gupta