Drug Repurposing and Repositioning Workshop Summary (2014) / Chapter Skim
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6 Increasing the Efficiency and Success of Repurposing
6 Increasing the Efficiency and Success of Repurposing
Pages 49-56
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From page 49... ...
Initial drug discovery and repurposing are not very different from each other in the sense that they share some of the same challenges encountered during the drug development process, Cardon said. When thinking about drug development, the initial approach may be to focus on the drug itself, but with drug repurposing in rare diseases the thought process is different and the approach typically begins with a focus on the disease pathology, and clinical insights remain critical, Cardon said.
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From page 50... ...
• A centralized system of technology transfer offices that work with uni versities on a contractual basis to provide specialization in technology and negotiation may be an alternative way to facilitate academia– industry partnerships by providing expertise.
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From page 51... ...
With diseases such as cancer, for example, immense quantities of data are being generated that can foster innovation, both in the kinds of compounds that are being developed and in the specific treatments used for molecularly profiled diseases. Genomics can be used throughout the repurposing process to identify therapeutic approaches and disease pathways, said Ronald Bartek, president of Friedreich's Ataxia Research Alliance.
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From page 52... ...
The most promising approach, individual participants observed, is an integrated one that combines genomics, clinical observations, basic research, animal models, and clinical trials. However, Power reminded the group, all approaches need to culminate in human experiments if drugs are to be used in patients.
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From page 53... ...
A number of barriers to repurposing exist. One is that companies may decline to release information out of a fear that a blockbuster drug will be tarnished if a repurposing program uncovers safety or efficacy issues, said Michael Pacanowski, acting associate director for genomics of the Center for Drug Evaluation and Research at FDA.
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From page 54... ...
Technology transfer officers have different levels of expertise in negotiating complex arrangements with private companies and government, and they are often overburdened at their jobs, Rai said. An alternative model that has been discussed is to centralize the technology transfer process so that a smaller number of technology transfer officers with expertise in particular areas represent a number of universities.
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From page 55... ...
Researchers will need to work with patient organizations to make sure that patients feel comfortable and that privacy concerns are adequately understood. Data quality is also a consideration, but simple measures, such as an app that asks patients to report on their pain level, can offer good ways of collecting information, even if not all data will be useful in, for example, securing a label change from FDA.
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From page 56... ...
Finally, individual workshop participants who spoke stated that the ultimate measure of success is improved health. As Ringel put it, by creating value for patients, repositioning can change people's lives.
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