Deriving Drug Discovery Value from Large-Scale Genetic Bioresources Proceedings of a Workshop (2016) / Chapter Skim
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3 Discovery Activities Related to Genetic Bioresources
3 Discovery Activities Related to Genetic Bioresources
Pages 25-38
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(John) The development of effective and safe new drugs requires a more complete understanding of the molecular, cellular, and or ganismal mechanisms underlying potential drug targets and pathways.
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This chapter also introduces ideas for incorporating patient perspectives and data in genomics-enabled drug development collaborations. INFORMATICS APPROACHES TO UNDERSTANDING PHARMACOGENOMICS The Pharmacogenomics Knowledge Base (PharmGKB)
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For example, a statistical model was used to recognize two drugs that adversely altered blood glucose levels based on the adverse event signature reported through the U.S. Food and Drug Administration's Adverse Event Reporting System, a database that contains information on adverse events and medication errors.
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The third point Altman emphasized is that drugs, like genes, have vastly underestimated pleiotropic effects that need to be considered during drug development. Drugs can cause unintended adverse effects when they bind to "off-target" proteins (Karczewski et al., 2012)
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Data from 23andMe also confirmed that the SIK2 SNP carried an increased risk of immune phenotypes and a decreased risk of cardiovascular disease, John said. Examining data from multiple genetic bioresources was extremely important, she said, because they supported the idea that the inhibition of SIK2 may be beneficial for immune-mediated disease, but the data also pointed out potential safety concerns.
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STEPPING STONES TO UNDERSTANDING THE UNDERLYING BIOLOGY OF DRUG TARGETS Understanding the biology of drug targets can increase the likelihood of successful drug discovery and development, said Tim Rolph, the vice president of program value enhancement at Pfizer Inc. It takes considerable time to understand molecular targets and disease mechanisms well enough to devise effective treatments, he said.
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A PUBLIC–PRIVATE COLLABORATIVE APPROACH TO TARGET VALIDATION The translation of 21st-century genetics into diagnostics, prognostics, and treatments has had many successes, especially in the areas of oncology, rare diseases, and drug safety, said Lon Cardon, the senior vice president of alternative discovery and development and head of target sciences at GlaxoSmithKline (GSK)
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Pharmaceutical companies compete in other areas, such as chemistry, clinical trials, and linking targets to relevant phenotypes. But in the precompetitive realm, companies can share research results without losing their competitive advantage, he said.
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"The PMI will follow from these drug discovery target validation activities just about perfectly," Cardon said, "and we need to find a way [to make] the PMI data equally accessible to all so that we can benefit all parties." COLLECTING AND SHARING DATA TO TREAT A NEUROLOGICAL DISORDER The Michael J
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Instead it should be viewed as a cycle, she said, and it is important to look for biomarkers in addition to drug targets because there is a critical need to measure the progression of the disease in actual patients. The members of the foundation believe that achieving this perspective requires breaking down the siloes that exist between basic science, drug development, clinical research, and biomarker studies, Chowdury said.
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Patients who are living with a disease can be a valuable resource, she added, because they are often more willing to share their data than members of the general population, because they are in a position to benefit directly by doing so. EXPLORING THE DEFINITION OF THE PRECOMPETITIVE RESEARCH SPACE As discussed in previous sections in this chapter, one issue to be considered in a discussion of genomics-enabled drug discovery using data from large bioresources is the role of precompetitive research.
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It's more efficient from a societal and from a patient perspective to think of that part of the game as something we could share." As part of the Industry Partnership for Human Genetics, John said, companies submitted a number of genes of interest to academic researchers. All of the participants saw the full list of genes, but they did not know which company had submitted which gene.
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commercial health care system, and with direct-to-consumer genetics companies, he said, and it is worth exploring the precompetitive space in each of these models. INDUSTRY–UNIVERSITY RELATIONS Another area related to the precompetitive space that can present challenges is the relationship between industry and university researchers, said John Carulli, director of precision medicine at Biogen.
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