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Name of Submitter:
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Daria Mochly-Rosen
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Title of proposed idea:
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Centers for the Study of Drug Attrition In Vivo
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What is the major obstacle/challenge in the biomedical research field? What is needed to overcome this obstacle/challenge?
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In the field of biomedical research related to drug discovery, attrition is the major obstacle to translation and delivery. Nine out of 10 drugs entering human trials will fail. This loss is “attrition.”
• Each failure costs $1-2 billion dollars; the cumulative cost of failed compounds for each success makes attrition the major cost of drug discovery.
• Attrition translates into major societal and public health impacts, including: long wait times; lack of availability; high cost of drugs for patients; and a lack of drug development for underserved patient populations (including those with orphan diseases, hidden disorders, and patients who are under-insured).
A partnership between industry and academia, which through research, education and outreach, focuses on:
• The innovation and development of new technologies including biomarker based animal models. |
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What emerging scientific opportunity is ripe for investment by the Common Fund?
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The cost of attrition to the health care system is at its tipping point. There is a burgeoning acknowledgment, particularly in industry and funding organizations, that false positives in traditional animal model based drug discovery are the major source of failures in translational research and thus of attrition.
The proposed Attrition Study Centers in academia would establish a new discipline for the academic study of the science and philosophy of biomarker based animal modeling, and the development of alternative, refined and STANDARD methodologies in animal research with the explicit goal of solving attrition.
Pharma and biotech are highly motivated to find a solution to attrition, but to do so they need the kind of freedom to innovate and take on high risk projects that characterizes an academic research environment. |
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What are the potential Common Fund investments that could accelerate scientific progress in this field?
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About $10M/Academic Center is need to launch so that it can:
• Support research projects addressing the development of biomarker-based animal models and alternative systems that generate predictive, validated testing systems aimed at reducing attrition.
• Support education through seminar series, workshops, support of trainees focusing on attrition.
• Support outreach through web presence, social media and networking, quarterly newsletters and an online journal.
• Support a yearly meeting with key stakeholders including Pharma and biotech, NIH and FDA, and patient advocacy groups.
A total of 5-10 grants should be awarded. Each academic center can focus on particular clinical indications or it could be that this will not be restricted, but yearly reports and inter-institutional collaboration will be established. |
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If a Common Fund program on this topic achieved its objectives, what would be the impact?
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• The Centers will produce and deliver new biomarker based animal models and new alternative drug testing methods that are predictive, fast and reliable.
• Over a 5 year period, each Center would support approximately 10 projects, which focus on finding solutions to the problem of attrition.
• Trainees, students and fellows will be trained in new methods in an emerging field that will position them to be leaders in transforming drug discovery.
• New jobs will be immediately created in the research laboratories supported by the Centers. It has long been recognized that we no longer train students in animal physiology an pharmacology, which impact the pharma industry. These centers will provide much needed training for jobs.
• The Centers will be creating technologies and innovations to produce effective new drugs discovered in record time. |
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