Rewiring Drug Research and Development through Human Data-Driven Discovery (HD3)

Author:

Jackson David B.1ORCID,Racz Rebecca2,Kim Sarah3ORCID,Brock Stephan1,Burkhart Keith2

Affiliation:

1. Molecular Health GmbH, 69115 Heidelberg, Germany

2. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA

3. Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, College of Pharmacy, University of Florida, Orlando, FL 32827, USA

Abstract

In an era of unparalleled technical advancement, the pharmaceutical industry is struggling to transform data into increased research and development efficiency, and, as a corollary, new drugs for patients. Here, we briefly review some of the commonly discussed issues around this counterintuitive innovation crisis. Looking at both industry- and science-related factors, we posit that traditional preclinical research is front-loading the development pipeline with data and drug candidates that are unlikely to succeed in patients. Applying a first principles analysis, we highlight the critical culprits and provide suggestions as to how these issues can be rectified through the pursuit of a Human Data-driven Discovery (HD3) paradigm. Consistent with other examples of disruptive innovation, we propose that new levels of success are not dependent on new inventions, but rather on the strategic integration of existing data and technology assets. In support of these suggestions, we highlight the power of HD3, through recently published proof-of-concept applications in the areas of drug safety analysis and prediction, drug repositioning, the rational design of combination therapies and the global response to the COVID-19 pandemic. We conclude that innovators must play a key role in expediting the path to a largely human-focused, systems-based approach to drug discovery and research.

Publisher

MDPI AG

Subject

Pharmaceutical Science

Reference100 articles.

1. High drug attrition rates—Where are we going wrong?;Hutchinson;Nat. Rev. Clin. Oncol.,2011

2. A new paradigm for navigating compound property related drug attrition;Barton;Drug Discov. Today,2016

3. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009–2018;Wouters;JAMA,2020

4. Innovation in the pharmaceutical industry: New estimates of R&D costs;DiMasi;J. Health Econ.,2016

5. Evaluate Ltd. (2023, January 15). Evaluate Vantage 2020 Preview. Available online: https://www.evaluate.com/thought-leadership/vantage/evaluate-vantage-2020-preview#download.

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