Informatics
Figure 4 Supporting study monitoring
through visualisation of clinical pathology, clinical
observations, body weights and micropathology data
References 1 CDISC-SEND.
https://www.cdisc.org/standard s/foundational/send. 2 Scope is INDs and NDAs Requirements are listed in the FDA data standards catalog, which can be found at:
https://www.fda.gov/forindustr y/datastandards/studydatastand ards/
default.htm. 3 Innovation in the pharmaceutical industry: New estimates of R&D costs. Journal of Health Economics 47 (2016) 20-33
https://dukespace.lib.duke.edu/ dspace/bitstream/handle/10161 /12742/DiMasi-Grabowski- Hansen-RnD-JHE-2016.pdf? sequence=1&isAllowed=y. 4 Figures 1-4 provided by Xybion Corporation. 5The eTRANSAFE project (
www.imi.europa.eu) has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777365. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
60
pathologies and determine reference ranges for clinical pathology. Drilling down further into this data can identify the impact of study duration, species specificity and gender differences on the findings observed.
Conclusion Sponsors are now required to submit data from preclinical
reduce the burden of in vivo testing and help iden- tify/validate novel targets. Ultimately, these efforts will complement sys-
tems biology approaches and serve to improve the drug development process, leading to better medicines being available for patients in a timelier fashion.
DDW toxicology studies started after
December 17, 2016 to the FDA in SEND format for Investigational New Drug (IND) applications and New Drug Applications (NDAs). The SEND format creates a structured terminology and con- sistency for regulatory submissions and allows for concise communication between the FDA, CROs and sponsors. Moving beyond the objective of regulatory com-
pliance, the SEND format standardisation repre- sents a significant opportunity for drug developers to extract valuable scientific and operational insights from preclinical data. From enhanced study monitoring and visualisation of operational metrics to reducing drug failure rates and improv- ing safety outcomes, the potential is significant at a time when risk and complexity of drug develop- ment continues to rise. Eventually these data sets can be leveraged to build predictive models that
Katherine Briggs is Research Leader at Lhasa Limited. Bob Friedman is Chief Technologist at Xybion Medical Systems. Kristen Ferrara is Director, Global R&D IT Programs, at Takeda Pharmaceuticals. Mark Pinches is Senior Principal Scientist at Lhasa Limited. Will Drewe is Principal Global Alliance Manager at Lhasa Limited. Cheryl Riel is Head, Nonclinical Writing and Document Management, at Alnylam Pharmaceuticals. Melody Thompson is Manager, Nonclinical Writing, at Alnylam Pharmaceuticals. Antoinette Hayes is Lead Associate Scientist, Toxicology Study Manager at Alnylam Pharmaceuticals. Jason Gratt is Principal Software Engineer at Takeda (formerly Millennium) Pharmaceuticals. Shylah Wyllie is Manager II, Drug Safety Research & Evaluation at Takeda Pharmaceuticals. MaryBeth Walsh is a consultant with the Pistoia Alliance.
Drug Discovery World Winter 2018/19
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