RESEARCH TRIANGLE PARK, N.C. – June 11, 2009 – Quintiles Consulting today released the first in a three-part series of white papers addressing how best to navigate risk in drug development. The first paper, “On the Re-Balancing of Risk to Transform Cost and Productivity in Drug Development,” focuses on operational risk. It is available for download at

Biopharmaceutical companies are facing unprecedented challenges in their efforts to bring new medicines to market to meet the needs of patients. Drug development costs are soaring – requiring on average nearly $1 billion and 17 years to bring a compound to market. It is well recognized in the industry that traditional cost-cutting and methods to improve productivity have been exhausted.

“This new environment calls for novel risk-based solutions,” said Adrian McKemey, Quintiles Consulting practice leader for product development and commercialization. “We are applying new business models to help companies rebalance, share and hedge their risk – transforming the traditional approach to development.

The new risk-based approaches focus on ways to circumscribe, share, rebalance and hedge drug development risk to transform cost and productivity.

“We are seeing risk being evaluated through three distinct lenses – operational risk, portfolio risk and resource risk,” McKemey said.

The models outlined in the paper challenge and redistribute the traditional boundaries of the pharmaceutical business model, i.e., what a pharmaceutical company must own to capture competitive advantage and to grow, and what can be factored out and hedged by partnering with external sources.

The next paper in this series will focus on portfolio risk mitigation. To receive this paper or to learn more about Quintiles Consulting visit our website at

The authors:

Adrian McKemey is a Managing Director with Quintiles Global Consulting (QGC) and leads the Product Development and Commercialization Practice.

Badhri Srinivasan leads the Enterprise Transformation Unit – an organization dedicated to mining the experiences accumulated over 10,000 clinical trials to identify systematic issues and solutions increased speed and reduce cost and variance in clinical development.

Peter Payne leads efforts on assessing, mitigating and pricing asset and clinical development risk to support risk sharing initiatives at the portfolio, operational and resource level.

About Quintiles Consulting

Quintiles Consulting works with pharmaceutical, biotech and medical device companies to maximize potential and minimize risk, from discovery through development and commercialization by providing expert strategic, operational, and technical advice. Building on the global reach and expertise of Quintiles Transnational, Quintiles Consulting practice areas include Product Development and Commercialization, Regulatory and Quality, and Market Access, and Eidetics. Quintiles Consulting has full-time consultants based across the U.S. and Europe to serve its global clients. For more information, please visit

About Quintiles

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit