Improving and Accelerating Therapeutic Development for Nervous System Disorders Workshop Summary (2014) / Chapter Skim
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6 Perspectives on Next Steps
6 Perspectives on Next Steps
Pages 73-78
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From page 73... ...
Current Therapeutic Development Practices David Michelson, vice president of clinical neuroscience and ophthalmology at Merck Research Laboratories, observed several key themes throughout the first session and identified next steps to aid in drug discovery. Michelson said several participants indicated that companies do not have confidence in choosing nervous system disorder targets and as a result choose to work in areas where the science is further along.
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From page 74... ...
Several participants noted that the use of multiple models may be beneficial to discover and validate targets; there is no simple "yes" or "no" as to whether a specific animal model will be useful, but little is gained by continuing to pursue a target when data suggest it may be futile. Increasing reagents for novel targets in laboratories and establishing better biomarkers by considering the patient group in which the mechanism of the disease is likely to be homogeneous (patient stratification)
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From page 75... ...
Michelson noted that the focus should not be to accelerate the drug discovery process, but rather to make it better and more efficient. The Regulatory Pathway William Potter, senior advisor in the Office of the Director of the National Institute of Mental Health, highlighted how many basic scientists are unfamiliar with Food and Drug Administration approval procedures and resources at NCATS that may potentially resolve these issues.
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From page 76... ...
During the session, participants discussed an array of topics, including the use of human data for target identification; the willingness of researchers to conduct rigorous experiments both in preclinical models and in an experimental medicine setting; and opportunities to accelerate the pathway to first-in-human trials when the severity of the disease warrants it. However, participants mainly focused their discussions on the investment portfolio in the neuroscience field and where there are opportunities for nonprofits, NIH, and pharmaceutical companies to reconsider their portfolios.
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From page 77... ...
In addition, Haas noted that there is a strong need to consider the use of new tools such as proteomics, transcriptomics, and computational modeling approaches. Optimizing Therapeutic Development Collaboration and the precompetitive space were two key themes in the workshop discussions, noted Daniel Burch, vice president and global therapeutic area head for central nervous system diseases at Pharmaceutical Product Development, Inc.
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From page 78... ...
Finally, several speakers and participants advocated for open data sharing among researchers and a centralized database for all preclinical trials to increase collaborative efforts and decrease replication in the field.
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