India - An Emerging Pharmaceutical Powerhouse
by Dr. Ajit Dangi
Director General, Organisation of Pharmaceutical Producers of India (OPPI)
As the Indian economy begins to globalise and enters the second phase of economic reforms, radical changes are taking place in the business environment. Globalisation, privatization and liberalization have become the new "mantra" for survival and growth.
Two industries which have effectively weathered the globalisation wave and taken it as an opportunity and not as a threat are Information Technology (IT) Industry and the Pharmaceutical Industry. Both are knowledge based industries and have tremendous potential to make a major impact not only on the economy but also on the quality of life of the Indian people. Pharmaceutical Industry in India, in particular is increasingly being recognized as a reliable source of quality medicines at affordable price and is now moving from "imitation" to innovation" phase. It is likely to become globally dominant in few years' time; replicating the success of India's I.T. Industry.
The presentation will give a perspective on present status, future trends as well as impact of Intellectual Property Rights (IPRs) on Pharmaceutical Industry. The McKinsey study has projected pharmaceutical sales of U.S. $ 25 Bn. by the year 2010. Various strategic options as well as key enablers to achieve this objective will be presented.
Clinical Development: Scopes & Challenges
by Dr. Mohan Beltangady
vice president, Pfizer Global R&D, Pfizer Inc
"During the 1990s, clinical development times were a major source of the growth in drug development costs. From the 1980s to the 1990s, clinical period out-of-pocket costs grew five times as fast as preclinical period costs," according to the Tufts Center for the Study of Drug Development (TCSDD). These findings resonate well not just within Pfizer, but also the pharmaceutical industry worldwide. Significant advances made over the past few decades have enhanced our understanding of basic biology, pharmaceutical sciences, medicinal chemistry, pharmacology, and major multi-disciplinary approaches. These advances have enabled pharmaceutical companies to bring to market new drugs that are safer and better tolerated than those of yesteryear - but not without cost. The current estimated price tag for fully capitalized costs to develop a new drug, including studies conducted post-approval, averages $897 million (Press Release, May 13, 2003, TCSDD).
Productivity challenges remain enormous for the pharma industry where a large proportion of compounds never make the full successful transition from the laboratory to the market. Efforts to increase productivity by implementing process improvements employing technological advances that increase speed and quality while reducing costs have been ongoing for the past few years. However, these dramatic trends appear to have reached a plateau. The pharmacogenomics promise is still some years away from being able to deliver. In addition, some underlying issues relating to the conduct of clinical research are still not satisfactorily resolved. These issues include access to qualified investigators, appropriate patient populations to meet trial needs, and a well-trained workforce to manage the logistics and operational components of clinical trails for timely project execution.
Advancement in Pharmaceutical Technology
by Hari Fluora
President of Operations, Applied Containment Engineering, USA
A significant per cent of current pharmaceutical processes involve the handling of potent compounds. We will describe the available technologies for handling these potent compounds, in addition we will also discuss:-
- Containment Best Practices
- Protection offered by Personal Protection Equipment
- Contamination Sources
- Available Containment Technologies
- Containment facility design guidelines
- Qualification and Validation of Containment Systems
cGMPs for 21st Century
by Vinod P. Shah, Ph D.
AAPS - President, USA
FDA has launched two new initiatives (1) Process Analytical Technologies (PAT) and (2) Pharmaceutical cGMPs for 21st Century: A risk-based approach to modernise the Agency's regulations of pharmaceutical manufacturing and product quality. The goal is to evaluate the currency of Agency's drug product quality regulation system - CMC review and cGMP inspections - and to ensure that the most up-to-date concepts of risk management and quality system approaches are incorporated. Progress made in the last year along with the outcome of the scientific workshop (A drug quality system for the 21st century, April 22-24, 2003) with the stakeholders will be presented and discussed. It is anticipated that modernization of the cGMP regulations will facilitate introduction of PAT tools, concepts and innovations in pharmaceutical manufacturing to improving drug product quality. cGMPs for 21st century regulations will provide the medicines of highest quality and will ensure that various GMP and CMC programmes are well integrated, systematized and strengthened, and risk-based orientation is adopted.