How Well Are We Applying Quantitative Methods to Reverse Translation to Inform Early Clinical Development?

If we are to improve our low success rate and rising costs in the pharmaceutical industry, we need to use every tool available. Reverse translation can particularly inform discovery and early clinical development via appropriate quantitative integration of relevant data. This commentary reports on a crowd‐sourced survey (2017) that sought to evaluate the integration of reverse translation in pharma. The results indicate that these methods are being applied, to varying degrees, across most respondents.

[1]  CJ Musante,et al.  Quantitative Systems Pharmacology: A Case for Disease Models , 2016, Clinical pharmacology and therapeutics.

[2]  S. Marshall,et al.  Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation , 2016, CPT: pharmacometrics & systems pharmacology.

[3]  K Kretsos,et al.  Model-Based Optimal Design and Execution of the First-Inpatient Trial of the Anti-IL-6, Olokizumab , 2014, CPT: pharmacometrics & systems pharmacology.

[4]  Hugues Dolgos,et al.  Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: strategic considerations. , 2009, Drug discovery today.

[5]  P. H. van der Graaf,et al.  Integrated Pharmacometrics and Systems Pharmacology Model-Based Analyses to Guide GnRH Receptor Modulator Development for Management of Endometriosis , 2012, CPT: pharmacometrics & systems pharmacology.

[6]  B. '. ’t Hart,et al.  Reverse Translation for Assessment of Confidence in Animal Models of Multiple Sclerosis for Drug Discovery , 2018, Clinical pharmacology and therapeutics.

[7]  S. P. Gibert,et al.  Strategic Considerations , 2001 .

[8]  Heidi Ledford,et al.  Translational Research: The full cycle , 2008, Nature.

[9]  H. Derendorf,et al.  Prediction of in vivo and in vitro infection model results using a semimechanistic model of avibactam and aztreonam combination against multidrug resistant organisms , 2017, CPT: pharmacometrics & systems pharmacology.