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Advances in genomics transforming drug development and delivery

Knowledge of specific genes underlying diseases and differences in individuals' genetic makeup that cause them to react differently to drugs are changing the face of drug development and delivery, says Anthony J. Sinskey, professor of microbiology and co-director of the Sloan School's Program on the Pharmaceutical Industry (POPI).

Advances brought about by cutting-edge genomics technology are just some of the promises and pressures faced by the pharmaceutical industry. A symposium at MIT Dec. 9 and 10 outlined an industry in transition, facing myriad challenges in the coming years to make money and get new drugs to patients quickly and effectively.

The Future of the Pharmaceutical Industry Symposium, co-sponsored by POPI and MIT's Industrial Liaison Program, brought together representatives from industry, science, government and academia to explore the major revolution under way in the world of health care.

The pharmaceutical industry had $337 billion in worldwide sales in 1999 and is expected to reach $506 billion next year. Yet across the industry, despite unprecedented highs in spending, research and development productivity is falling, Sinskey said. Average product launches are 0.5 per year, and clinical trials have gotten longer and less successful overall. The good news is that advances in technology have brought about an unprecedented number of new chemical entities to investigate; the bad news is that better models are needed--such as a more "human-like" mouse--to see which of these will pan out as useful drugs.

Sinskey believes the industry needs to form a new paradigm, with the help of academic partners, based on the trends in science and technology. "The easy drugs have been done," he said. "The new drugs require new technologies and new approaches." In the future, treatments for diseases such as cancer, diabetes, infectious diseases, sepsis and multiple sclerosis will be tailored to individuals, taking into account each person's genetic makeup, the specifics of their case of the disease and their likelihood to respond to a particular treatment.

These kinds of custom-made treatments will reduce mistakes in dosages, potentially lower drug development costs and possibly revive failed drug candidates that wouldn't work in the general population but may help specific sub-populations, but this will represent a paradigm shift in how the health care system works. "I think it's going to take a lot of hard work and a lot of praying, because it is a challenge to do this," Sinskey said.

In addition to Sinskey, MIT speakers at the symposium included David E. Housman, the Ludwig Professor of Biology at the Center for Cancer Research, who spoke about the use of pharmacogenetics in cancer treatment; Douglas A. Lauffenberger, the Whitaker Professor of Biological Engineering, Biology and Chemical Engineering and director of the Biological Engineering Division, and Peter K. Sorger, associate professor of biology and biological engineering and co-chair of the MIT Computational and Systems Biology Initiative, spoke on systems biology; Martha L. Gray, the Edward Hood Taplin Professor of Medical and Electrical Engineering and director of the Harvard-MIT Division of Health Sciences and Technology, spoke on noninvasive imaging techniques; Linda G. Griffith, professor of chemical engineering and bioengineering and director of the Biotechnology Process Engineering Center, spoke on biomaterials and devices for tissue and organ regeneration.

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