Outsourcing to India
Productivity in the pharma industry is down and costs are up. “The numbers are pretty scary,” said James Taylor, worldwide head of contracting and outsourcing at Pfizer (www.pfizer.com). Taylor spoke about the steps Pfizer has taken to improve speed, quality, and cost in drug development. With studies ongoing in 11 therapeutic areas, contracts with as many as 50 different CROs at one time, and a host of niche service providers, managing and leveraging global resources and standardizing procedures are significant challenges for big pharma companies such as Pfizer.
More than two years ago, Pfizer changed its sourcing strategy. The company no longer outsources by compound; it is now aligned functionally (rather than by project teams), with functional groups working with local sites to pursue lower-cost regional models. This has pared Pfizer’s sourcing partners to 16 providers/CROs and allowed it to leverage economies-of-scale and to take advantage of more cost-efficient local sources.
Taylor presented on Pfizer’s experience in India, describing the country in general as having moderate maturity in operational and technical skills, with an improving learning curve. High demand for talented and experienced labor makes turnover a huge challenge in this emerging market. He urged companies to maintain a buffer of pooled labor and resources.
Risk management is another important consideration. Although access to technology is much improved in India, companies should anticipate and plan for service interruptions such as those caused by floods and railway explosions.
Describing Onconova Therapeutics’ (www.onconova.com) rationale for offshoring trials, Ramesh Kumar, Ph.D., co-founder, president, and CEO of the company, identified rate of enrollment as the primary driver. Slow recruitment is the biggest barrier to successful trial completion.
Onconova has core competencies in discovery to early development, with a focus on cell protection and cancer therapeutics. Offshoring allows Onconova to diversify its subject pool to include a variety of cancer types, prior therapies, and standards of care. In Mumbai, India, as in the U.S., lung and breast cancer occur with the highest incidence in men and women respectively. However, the rank order then differs, with higher rates of cancer of the esophagus, cervix, larynx, and ovaries in the Indian population compared to the U.S., offering companies such as Onconova access to larger patient pools for these types of cancer.
Onconova’s strategy is to work only with offshore investigators that attend the American Society of Clinical Oncology’s annual meetings, which gives them common ground and facilitates integration with U.S. development efforts.
Dr. Kumar described the cost advantage of offshoring as an “incidental benefit, not a driver. Don’t bother going offshore to lower costs; it’s not worth it.”
What brought India into the clinical trial equation? Dr. Kumar pointed to the World Trade Organization as the biggest driver, by mandating changes in the business environment that require India to respect patents. Other key factors include emerging private-public partnerships, such as the Bill and Melinda Gates Foundation; a shift in the focus of the Indian pharma industry from process to product; and the evolving Indian economy, which is changing from a largely agricultural to a more high-value base.
Dr. Kumar outlined several factors to consider when exploring the option of offshore trials: physician training, which may be minimal, with no or limited experience in clinical studies; logistical concerns, such as global transport connections for central lab shipments and availability of dry ice; differences in how Investigational Review Boards function; the need to invest in monitoring and to hire monitors that are independent of the hospital or CROs; data and sample transfer issues; and the importance of establishing influential contacts in the country of interest to help navigate the regulatory process.