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Speaker Biography

Patrick P. DeLuca, Ph.D. Hon Dott, RPh
Professor of Pharmacy and Sullivan Medalist
University of Kentucky College of Pharmacy

Patrick P. DeLuca is Professor in the Faculty of Pharmaceutical Sciences at the University of Kentucky College of Pharmacy and a Sullivan Medallist at the University. His primary teaching and research responsibilities and interests are in novel drug delivery, formulation and process development of proteins and peptides, and freeze-drying. Dr. DeLuca has mentored over 75 graduate students and post doctoral fellows and is the author or co-author of over 220 articles and book chapters. Fourteen of his students have received graduate student outstanding manuscripts awards from the Parenteral Drug Association and the AAPS. Professor DeLuca is the recipient of several AAPS research achievement awards, including the first Research Achievement Award in Pharmaceutical Technology, the first AAPS Outstanding Educator Award and the Dale Wurster Research Achievement Award in Pharmaceutics. Recognition from the University of Kentucky include the William B. Sturgill Award for outstanding contributions to graduate education and research, the Sullivan Medal for his humanitarian efforts, and a Distinguished Lecturer at the College of Pharmacy. He was named Pharmacist of the Year (2002) by the Kentucky Pharmacists Association. Professor DeLuca is a Distinguished Alumnus of Temple University, but most noteworthy is his receiving an Honorary Doctorate from the University of Perugia in Italy in 2006. He is the Editor-in-Chief for the online journal, AAPS PharmSciTech, and formerly was the Chief Editor of Pharmaceutical Development and Technology. Dr. DeLuca is a Fellow and founding member of AAPS, an elected member-at-large of the Executive Committee and recently was elected President of AAPS; a Fellow of AAiPS; Past President, Fellow and member of the APHA Academy of Pharmaceutical Sciences; a senior Fellow of the Institute for Advanced Biotechnology; and holds membership in the American Pharmaceutical Association, the Controlled Release Society, Parenteral Drug Association, the New York Academy of Sciences, the American Association of Colleges of Pharmacy, and the American Society of Health Systems Pharmacists. He serves on the editorial board of several scientific journals and is a consultant to the F.D.A. and the pharmaceutical industry.

Dr. Prakash Amrut Mody
Chairman & Managing Director
Unichem Laboratories Limited

Dr. Mody is the Chairman and Managing Director of Unichem Laboratories Limited, a leading national pharmaceutical company with global presence. Unichem is engaged in the business of synthesis, development, manufacturing, marketing and export of pharmaceutical bulk drugs and formulations. Unichem is headquartered in Mumbai and has a host of manufacturing facilities approved by World regulatory agencies. It is also involved in new process and biotech research.

Dr. Mody is a doctorate (Ph.D) in Organic Chemistry from the University of Bombay. He has done his Marketing Management from Jamnalal Bajaj Institute of Management Studies, University of Bombay.

Dr. Mody is a Graduate Alumni of Harvard Business School having undergone the Owner Presidents' Management Program.

He is associated with various bodies, both in the industry and academics.

• Ex-Vice President of the Indian Pharmaceutical Association (I.P.A.)
• He is a Member of the National Committee on Drugs & Pharmaceuticals of the Confederation of Indian Industry.
• Member of the Managing Committee at the Indian Merchant Chambers
• Dr. Mody is also on the Executive Committee of the industry association viz. Indian Drug Manufacturers Association (I.D.M.A.)
• He was also the Chairman of the Industrial Pharmacy Division of the Indian Pharmaceutical Association for the year 1999-2000.
• Trustee at the Bombay College of Pharmacy
• Member of the World Presidents' Organisation Inc. - An international organization for Chief Executives worldwide.
• Dr. Mody is a member of the Senate - SNDT Women's University.
• Dr. Mody is a member of the Rotary Club of Bombay Mid-Town and is involved in many other social activities.

Talk Abstract
Abstract: Growth of Indian Pharmaceutical Industry in R & D and Outsourcing by Dr. Prakash Mody

Scope of presentation:

The phenomenal opportunity of Indian Pharmaceutical sector both in R & D and outsourcing will be examined in the context of:

• Global R & D productivity scenario
• Major challenges in Innovation
• Innovation and outsourcing opportunity for India
• Unichem's contribution

Global Scenario

Globally there is a decline in the R & D productivity. NCE's pipeline has not kept pace with increasing R & D expenditure. Only 3 out of 10 drugs produce revenues greater than their R & D costs. In this scenario, Pharmaceutical companies in developing world can offer lower R & D costs and improved R & D productivity.

Indian Pharmaceutical Market

As per IMS / Mckinsey report, by 2015, India is projected to be the 10th largest pharmaceutical market with a turnover of US$ 20 Billion. The rising GDP growth is raising income levels leading to higher per-capita healthcare expenditure. Access to medicines and healthcare to over 1 billion are sub optimized, especially in rural areas. All these factors are offering tremendous growth potential.

NCE development is at nascent stage in India. There are 54 molecules at different stages of development. NCE Research is focused in various areas, including, anti-infectives, metabolic disorders, respiratory and pain management. At the same time, a ten thousand strong Indian pharma industry has become highly fragmented due to excessive competition. Domestic medicines price control affects profitability and is an impediment to R & D. Indian companies are therefore concentrating on collaborative R& D, Contract manufacturing and clinical research through CRAMS with companies in USA, Europe and Japan.

India's Pharmaceutical potential

India is on the threshold of creating R & D innovation in the pharmaceutical industry of the 21st century. It has emerged as leading manufacturer of world class pharmaceuticals. There is a paradigm shift in thinking from business driven to R&D focused approach. The new initiatives encompass entire spectrum of research activities, eg NCEs, NDDS, Bio-similars and specialty generics. India's cost structure is a key competitive advantage. In addition to the cost, huge talent pool of skilled scientists is driving strong local industry. Indian companies offer wide variety of services in R & D, custom synthesis, contract manufacturing and clinical research etc. through either service model or collaborative partnership or both. A US$ 20 billion contract manufacturing and US$ 4 billion research outsourcing are proving to be great opportunities. Taking advantage of India's advantageous position, leading global pharmaceutical companies have setup their manufacturing base or R & D centres and even USFDA is in the process of establishing its office in India.

How Unichem has positioned itself to capture Global Opportunities?

Unichem Laboratories Limited is a leading Indian Pharmaceutical company with International operations. It has 65 years of goodwill in serving medical fraternity. Built on strong foundation of quality and reliability, it has made considerable investments in world class API and dosage forms manufacturing facilities approved by international regulators.

Unichem's R & D facilities with over 150 scientists is dedicated to pharma and process research, NDDS, ANDA development for leading markets in USA, EU and Japan. Its biotech facility focuses on innovative and competitive bio-similar products.