Declining Productivity, Ever Increasing Cost and Lengthening Timelines for Pharmaceutical Innovation: Can India Provide a Solution?

This meeting will be held at the MBC Offices, located on the ninth floor of One Cambridge Center, Cambridge, MA 02142.

The success of India's generic pharmaceutical industry is primarily attributed to its world-class competency in the chemistry and low cost for product development. India is expected to maintain its leadership role in providing cost-effective generic medicines to the developed as well as developing countries. With the success in the generic area, some Indian pharmaceutical companies are also making transition into innovation-driven R & D. The timing is just right - India's emergence in the knowledge-based industry on one hand and on the other hand established pharmaceutical and biotech companies exploring options to address R & D productivity, cost and timelines issues.

In spite of exponential increase in R & D spending, productivity (as judged by NDA approvals) has remained rather flat over the last decade. The current model of spending in excess of $ 1 billion to convert a molecule into medicine may not be sustainable. Failure is norm in the pharma R & D business and the cost of failures partly reflects high cost of bringing new drugs to the market. Inability and/or lack of will to prioritize projects also lengthen timelines for discovery and development of new drugs.

Indian Pharma companies can partly address issues related to productivity, cost of innovation and ever increasing timelines for discovering and developing new drug. Availability of talent pool and low cost for pharma innovation in India provide unique options for converting cost-effectiveness advantage into opportunities - more shots at the goal for a given budget. India also offers opportunities for productivity enhancement and efficiency by allowing parallel tracks. India's vast patient pool and talented clinicians play a critical role in expediting proof of concept (POC) trials for go/no-go decisions and for pivotal Phase II and III clinical trials. India is also an ideal location for exploring Pharmacogenomics applications for personalized medicine.

Diverse business models of different Indian companies provide various options to leverage the India advantage for pharmaceutical innovation. Medicinal Chemistry contract services are offered by a number of Indian companies for those looking just to expand efforts in the chemistry area - this is a rather well established model. On the other hand, a handful of innovation-driven companies have also embarked on risk/reward sharing alliances for drug discovery on novel targets. This is a high risk option for an Indian company but an ideal scenario to explore validation of novel targets first in a non-clinical and then in the clinical settings.

India's transition to high risk innovation-driven approaches will require appetite for risk taking, transition to short term to long term strategies and new models for funding and partnership. The presentation will briefly cover the above mentioned topics with case studies.

Speaker

Rashmi H. Barbhaiya, Advinus Therapeutics , India

Rashmi H. Barbhaiya, Ph.D. is a Pharmaceutical Executive with 27 years of experience in Pharmaceutical R&D. He has a unique blend of management experience in Drug Discovery and Development, Novel Drug Delivery, Herbal and Generic products. He is one of the founders, CEO and Managing Director of Advinus Therapeutics, a research-based pharma company located in Bangalore and Poona, India.

Dr. Barbhaiya started his industrial pharmaceutical career in 1980 with Bristol-Myers Company in the United States where he spent next 21 years. The diversity of his background and experience has played a key role in speedy and successful development of a number of drugs for the treatment of a variety of diseases such as, AIDS and other infectious diseases, cancer, depression, anxiety, hypertension, CHF, diabetes and mild to moderate pain, including migraine. In the capacity of Vice President in the Pharmaceutical Research Institute of Bristol-Myers Squibb, he also played a key role, working with the drug discovery organization, in introducing "developability" as a key criterion in lead optimization, selection of drug candidates for development and to reduce timelines for discovery to development transition as well as for IND filings.

In the year 2002, he returned to India to join Ranbaxy as the President of R & D and led a team of over 900 professionals involved in generic, drug delivery, herbal and innovation-driven new drug research and development activities. During his tenure at Ranbaxy, he developed strategies and played a key role in improving the commercial potential of ANDA submissions by focusing on Para IV and Fist-to-File applications while increasing the quantity of submissions for the US FDA and rest of the world. He is also credited for attracting world-class experienced scientists from overseas and for enhancing an innovation-driven culture to create one of the leading pharmaceutical R & D organizations in India. He was instrumental in creating an R & D alliance between Ranbaxy and GSK, the first of its kind for an Indian company. He is also credited for creating an alliance between Medicine for Malaria Venture (MMV) and Ranbaxy for developing a novel antimalarial which under currently undergoing Phase I clinical trials.

He obtained the Ph.D. degree in Clinical Pharmacology from the St. Bartholomew's Hospital Medical College, University of London. He continued his education through post-doctoral training at the University of Florida and University of Wisconsin. His scientific contributions have resulted in over 150 publications. He has helped to organize a number of scientific symposiums around the world. He is a member of several professional societies, among them are AAPS, ASCPT and ISSX. He has served on the Editorial Boards of Antimicrobial Agents and Chemotherapy and Biopharmaceutics and Drug Disposition journals. Dr. Barbhaiya has received a number of awards for his scientific contributions. Some of these include AAPS Fellow, AAPS Meritorious Manuscript Award, AAPS Outstanding Achievement Award, Ranbaxy Award for Excellence in Pharmaceutical Research and India Life Sciences Person of the Year 2007 by Burrill & Company.