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September 29, 2010

Endo Pharmaceuticals Embraces Virtual R&D to Expand Drug Pipeline


The traditional pharmaceutical model for drug development, testing, approval and commercialization is being challenged on all sides. Recent regulatory actions to suspend sales of the GlaxoSmithKline diabetes drug Avandia in Europe and to severely restrict access in the U.S. provide a sense of the tougher review and approval environment facing the pharma industry. Add the inexorable rise of generics, the squeeze on reimbursements for high-priced prescription drugs, and stricter controls on marketing to physicians and to consumers and there seem to be few reasons for optimism by the leading pharmaceutical companies.

However, this same landscape provides an opportunity for launching innovative new drug discovery and commercialization models. Endo Pharmaceuticals, after more than a decade as a specialty pharmaceutical company focusing on branded and generic prescription medicines for pain, is re-inventing itself to become a leader in new modes of treatment research, drug development and commercialization that its leaders believe will thrive in the new, tougher reality for pharmaceuticals.

MedHealthWorld interviewed Ivan Gergel, M.D. the Executive Vice President for Research and Development at Endo Pharmaceuticals to find out more about the Endo strategy for innovation and growth.

MedHealthWorld (MHW): Why is Endo Pharmaceuticals changing its model and how will this impact your product offerings?

Ivan Gergel, M.D. (IG): First, it’s important to note that some organizational fundamentals remain in place. Endo Pharmaceutical’s core business is developing and commercializing pharmaceutical products to manage pain. We have achieved success since 1997 through developing strong partnerships – our product offerings grew primarily through in-licensing and acquiring pharmaceutical assets with the intent to complete development (as needed) and ultimately commercialize pain treatments. Those products and relationships provide a strong platform for us to build on as we address current pharma challenges and develop innovative and even more flexible models.

Our priorities are to expand and grow our drug development and drug approval pipeline to include both near and long-term assets that give us the ability to address multiple disease conditions and markets. But we are not following the traditional path for drug discovery. We are expanding our R&D capabilities for early and later stage development by investing in semi-virtual forms of discovery in a way that combines consistent quality and strong expert oversight with leveraging the capabilities of scientists and researchers around the world.

MHW: Could you explain how this virtual R&D model works in practice?

IG:  Our Virtual Discovery Program now combines in-house experts in multiple research fields with using the know-how of research partners in India and in other countries that have strong drug discovery development track records. Our in-house team provides the essential oversight and direction and using multiple remote research teams allows us to take “more shots on goal,” to increase the likelihood of producing viable products in a shorter period of time.

Virtual R&D allows Endo to take on multiple development opportunities without investing in in-house facilities and specific capabilities that can be handled by contracting with experts. So Endo has biochemists and other scientists working in our U.S. location, but we use research labs in India and have up to 80 people working there full time under contract, plus dozens more providing support services in their labs. This model saves us development time as well as significant capital costs – it would cost almost 4 times as much to operate an equivalent R&D program entirely in the U.S

We plan to have more than 10 of these virtual R&D programs operating by the end of 2010. Not only does this increase our chances of achieving commercialization of new drug treatments, it give us the option of shutting down programs that are not able to advance to the next level, and quickly shifting resources to accelerating the programs that are demonstrating the most promising results.

MHW: What are the long-term goals of Endo Pharmaceuticals?

IG: We are focusing our efforts on filling gaps within the healthcare continuum. Despite the range of drug therapies on the market today, huge unmet medical needs remain. Drug discovery and new treatment development is a painstaking process that often takes years, but the excitement and fulfillment come when a discovery leads to a treatment that improves patients’ lives as well as providing new commercial opportunities. Endo aims to implement innovative drug discovery strategies that use our resources more effectively and increase the chances of success. We are not putting all our efforts into bringing just one blockbuster drug to market. Our goal is to develop multiple highly effective and different drugs and drug-device combinations in a cost-effective way that makes it rewarding to provide treatments for a number of patient populations.

We are moving to offer an array of solutions across several therapeutic areas to our customers. Our virtual R&D model allows us to expand beyond pain treatments to take on conditions in oncology, urology and more. In the next several years, Endo is poised to offer highly innovative devices and implants that combine with drugs to provide new types of therapeutic solutions – at price points that will serve the needs of different markets.

Ivan Gergel, M.D., was appointed executive vice president of research and development for Endo Pharmaceuticals in April 2008. Prior to joining Endo, Dr. Gergel was senior vice president of scientific affairs and president of the Forest Research Institute of Forest Laboratories Inc . Prior to that, Dr. Gergel served as vice president and chief medical officer at Forest and executive vice president of the Forest Research Institute. He joined Forest in 1998 as executive director of clinical research following nine years at SmithKline Beecham, and was named vice president of clinical development and clinical affairs in 1999. Dr. Gergel received his M.D. from the Royal Free Medical School of the University of London and an MBA from the Wharton School.


Dr. Cronin is a Professor of Management in the Information Systems Department at Boston College. To read more of her articles, please visit her columnist page.

Edited by Erin Monda
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