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Improving cancer drug development

Improving cancer drug development

Improving cancer drug development

Veterinary Cancer Society
Veterinary Cancer Society
on behalf of Missouri Veterinary Medical Association


$25.00 $ 25.00 $ 25.00

25.00 $ 25.00 25.00 25.00
Normal Price: FREE $25.00


Launch date: 14 Jan 2016
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Last updated: 20 Apr 2016

Reference: 161838

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Improving Cancer Drug Development One approach to improving the timeliness of cancer drug development is to focus on producing "clinically ready", qualified assays to assess engagement of the drug target under study early in preclinical testing; these assays can then be applied during first-in-human clinical trials. Definitive correlation of drug efficacy with inhibition of the agent’s presumed target, as well as correlation of tumor target inhibition with that in normal tissue surrogates, should be developed from in vivo studies in preclinical model systems utilizing procedures that can be transferred directly to the clinic. This approach could significantly improve the level of information developed from first-in-human studies; and although such a model shifts resource utilization earlier in the development process, it allows for the evaluation of molecular proof-of-mechanism during the initial clinical trials of the drug and the ability to correlate target effects in pre-clinical systems and patients simultaneously. The addition of molecular tumor characterization studies by next generation sequencing approaches to define DNA driver mutations further expands the range of “precision” medicine clinical trials; these assays enhance the speed with which mechanism of action studies can be developed and used to validate drug targets in the clinic. The availability of molecular target validation assays that have been employed in the clinic during phase I trials also permits more definitive assessment of target inhibition in tumor and surrogate tissues during phase II studies, potentially shortening the drug development life cycle.


Learning objectives
• Attendees will be able to discuss how pre-clinical trials and assays focusing on proof of mechanism will shorten drug development time and reduce cost of bringing a new drug to market.
• Attendees will be able to discuss how biomarker development is key to shortening drug development time.
• Attendees will be able to list the numerous drugs currently in use in cancer patients that lack either proof of mechanism data and also lack biomarkers.
Veterinary Cancer Society

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Veterinary Cancer Society
on behalf of Missouri Veterinary Medical Association

Dr. James H. Doroshow has been the Deputy Director for Clinical and Translational Research of the National Cancer Institute since 2011, and the Director of NCI’s Division of Cancer Treatment and Diagnosis since 2004. He continues to pursue his own research program as a Senior Investigator in the Developmental Therapeutics Branch of the NCI’s intramural Center for Cancer Research. He is the author of over 400 full-length publications in the areas of molecular pharmacology, the role of oxidant stress in tumor cell signal transduction, and novel therapeutic approaches to solid tumors. From 1983 to 2004, Dr. Doroshow was the Chairman of the City of Hope Comprehensive Cancer Center’s Department of Medical Oncology and Therapeutics Research, and Associate Cancer Center Director for Clinical Investigation. He is currently a member of both the Forum on Drug Discovery, Development, and Translation and the National Cancer Policy Forum of the Institute of Medicine of the National Academies of Science and the Associate Editor for Oncology of the 25th Edition of the Cecil Textbook of Medicine. He received his A.B. degree from Harvard College in 1969 and graduated from Harvard Medical School in 1973. Following an Internal Medicine residency at the Massachusetts General Hospital, he completed a fellowship in Medical Oncology at the Medicine and Clinical Pharmacology Branches of the National Cancer Institute, NIH.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Missouri Veterinary Medical Association
  • 0.25 Hours -
    Exam Attempts: 3
    Exam Pass Rate: 60

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