Advances in Biopharmaceutical Technology in India
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Chapter 19:   Outsourcing R&D to India

Outsourcing is the delegation of non-core operations or jobs from internal production within a business to an external entity that specializes in that operation with the main objective of reducing costs. Its main advantages include that of saving capital resources for core activities and also allowing a company to concentrate on its core competencies. However the industry is not without its share of problems. They range form loss of jobs to security concerns about sensitive data being transferred. This Chapter seeks to address some of the issues related to offshore outsourcing with respect to India in the biopharma industry. With the developed countries becoming increasingly conversant with the socio-economic, political and legal environment of the countries where offshoring is done, the volume and quantity of work outsourced has largely increased. Experts have classified offshoring into three phases-that of entry, consolidation and finally integration. From labor centric offshoring to white collar offshoring, a paradigm shift has occurred. Outsourcing in the biopharma industry has grown since the 90ís and continues to grow with greater complexity in drug discovery and regulatory process. However there are many legal issues connected with this industry including the all important management of biological wastes and currently many hospitals lack the required infrastructure to deal with the same. It is however, heartening to know that India has the largest number of US FDA approved drug manufacturing facilities outside the US. Some key advantages to the biopharma industry through outsourcing include reduction of costs from drug development, improved manufacturing efficiencies, improved net earnings etc. India has become one of the most preferred destinations for collaborative R&D, contract research and clinical research as a result of compliance with international standards.

About the Authors:

Probir Roy Chowdhury
J. Sagar Associates
Bangalor, India

Sajai Singh
Resident Partner
J. Sagar Associates
Bangalor, India

Uri Reichman, Ph.D., M.B.A. -- Dr. Reichman is the chief of the Infectious Diseases and Medical Engineering Branch at the Office of Technology Transfer, NIH. He joined OTT in December 1999. Prior to joining the NIH, Dr. Reichman worked for twenty years (1980-1999) in the biotechnology industry, specializing in the field of medical diagnostics. From 1973 to 1980, Dr. Reichman conducted academic research at Sloan Kettering Institute for Cancer Research in New York. Dr. Reichman is an author of 26 scientific papers and an inventor on several patents. Dr. Reichman received his Ph.D. in Medicinal Chemistry from the Hebrew University in Jerusalem, Israel, and obtained an M.B.A. degree from Iona College in New York.

Bharat Khurana, D.V.M., Ph.D. -- Dr. Khurana has over ten years of scientific research experience in the fields of virology, cell and molecular biology, and biochemistry. Prior to joining the Uniformed Services University of the Health Sciences (USUHS), he was a postdoctoral fellow in the Laboratory of Viral Diseases at National Institute of Allergy and Infectious Diseases, National Institutes of Health. He received his Ph.D. from University of Cologne, Germany and his D.V.M. from Haryana Agricultural University, India. Dr. Khurana is also currently pursuing a part-time dual degree MS-MBA program at the Johns Hopkins University to expand on his knowledge and skills in regulatory affairs and biopharma business development. Dr. Khurana has authored or co-authored several research and review articles in peer reviewed scientific journals. Additionally, he has reviewed grant proposals for the Advanced Technology Program (ATP) of the National Institute of Standards and Technology (NIST).

Steven M. Ferguson currently serves as the Director of the Division of Technology Development and Transfer. Prior to joining NIH Office of Technology Transfer in 1990, Mr. Ferguson served in marketing and management positions in biomedical firms subsequent to being a scientist at the National Cancer Institute. His healthcare experience has also included work as Director of Marketing and Public Relations for a rural 70-bed hospital. Registered to practice before the USPTO, Mr. Ferguson also holds Masterís Degrees in Business Administration (George Washington University) and Chemistry (University of Cincinnati) as well as Bachelorís Degree in Chemistry (Case Western Reserve University). Mr. Ferguson has been an economic reviewer for Maryland Industrial Partnerships (MIPS) as well as the Advanced Technology Program (ATP) grant programs and is an instructor for both the USDA Graduate School and the NIH FAES Graduate School where he also the department chair for the new Certificate in Technology Transfer Program. Mr. Ferguson was also the Susan T. and Charles E. Harris Visiting Lecturer at the Watson School of Biological Sciences at the Cold Spring Harbor Laboratory and has published articles on licensing and technology transfer issues. He has received the NIH Directorís Award and seven NIH Merit Awards in recognition of his activities in the management and negotiation of technology licensing agreements from the National Institutes of Health.

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Eric Langer
BioPlan Associates, Inc.
2275 Research Blvd, Suite 500
Rockville, MD 20850
Phone: 301-921-5979; Fax: 301-926-2455