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Innovation in Bio-Safety Testing from Pre-Clinical to Product Launch
(Part Four)

Moderator: Steven R. Tannenbaum '58, PhD '62
Noubar Afeyan PhD '87 Joseph V. Bonventre Linda G. Griffith James Green: August 18, 2005; Running Time: 1:27:47

About the Lecture

About the Lecture

“To me, systems biology is the religion you switch to when target-based drug discovery doesn’t work,” Noubar Afeyan states boldly. He claims that after losing billions of dollars, the pharmaceutical industry and academia are beginning to see the value in testing drugs by measuring outcomes in biological networks. He calls this systems pharmacology, where you “measure in living systems multiple analytes in the same organism, perturbing the state and taking thousands of measurements per sample.” Researchers use computer images to visualize the differences and similarities in drug response across many networks, and then try to correlate these responses statistically.

The inability to predict toxicity early in drug development cost the pharmaceutical industry an astonishing $8 billion in 2003, says Joseph Bonventre, approximately one-third the cost of all drug failures. “We generally can’t pick up toxicity until it’s too late,” he says, so key challenges are developing better preclinical studies with useful biomarkers, improved animal models, and high throughput techniques; and on the clinical side, coming up with a “safe harbor approach to amass kidney and other toxicity data,” developing consortia to validate biomarkers, dealing with IP issues and building “an improved bedside to bench flow of information.”

Linda Griffith's vision is “building a human body on a chip.” She’s not talking about an individual’s genome or health history, but “a living, 3D interconnected set of tissues on a chip. If you perturb it, you make it develop a disease.” Such a device would enable researchers to predict negative drug interactions and even to build models of disease. Griffiths’ version of liver tissue, built on a silicon scaffold, may prove especially useful for drug toxicity tests.

At Biogen, “the holy grail for any justification of a new approach or technology is that we’re going to chop a significant amount off the time it takes to move a new product from bench to bedside,” says James Green. He believes that “drugs and paradigms are orders of magnitude more complicated than 24 years ago.” He hopes that new techniques “that take us into the genome, interpreting data as patterns” offer some promise.

Lecture Details

Location: Wong Auditorium

About the Speakers

Moderator: Steven R. Tannenbaum '58, PhD '62

Underwood-Prescott Professor of Toxicology and Chemistry
MIT Biological Engineering Division and Chemistry Department

Tannenbaum earned his Ph.D at MIT in 1962 and has continued as a faculty member up to the present time. An early career in Food Chemistry and Nutritional Biochemistry led to many research papers and books on food proteins and to several awards from the Institute of Food Technologists. Tannenbaum was promoted to Full Professor in 1974.

For the past 35 years Tannenbaum's research has been in the area of chemical toxicity and carcinogenesis. His laboratory was the first to discover the endogenous synthesis of nitrogen oxides, its mammalian origin, and its stimulation by the immune system. His laboratory has also pioneered the development and application of proteins as biomarkers of human exposure to environmental and endogenous compounds.

Tannenbaum is the author or coauthor of approximately 350 scientific papers, 15 patents, and has edited seven books. He was elected to the Institute of Medicine of the National Academy of Sciences in 1996.

Noubar Afeyan PhD '87

Managing Partner and CEO, Flagship Ventures

Joseph V. Bonventre

Robert H. Ebert Professor of Medicine and Health Sciences and Technology, Harvard Medical School, Brigham and Women's Hospital Co-Director of the Harvard-MIT Division of Health Sciences and Technology

Linda G. Griffith

Professor, Biological Engineering and Mechanical Engineering Director, Biotechnology Process Engineering Center

Griffith received a degree in chemical engineering from Georgia Tech in 1982, and a Ph.D. in the same field from the University of California, Berkeley in 1988. She received a National Science Foundation Young Investigator Award in 1991, was named a fellow of the American Institute of Medical and Biological Engineers in 1998, and was selected as one of the "Brilliant 10" byPopular Science in 2002.