Journal of Pharmacokinetics and Pharmacodynamics

, Volume 41, Issue 6, pp 545–552 | Cite as

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop

  • Klaus Romero
  • Vikram Sinha
  • Sandra Allerheiligen
  • Meindert Danhof
  • Jose Pinheiro
  • Naomi Kruhlak
  • Yaning Wang
  • Sue-Jane Wang
  • John-Michael Sauer
  • J. F. Marier
  • Brian Corrigan
  • James Rogers
  • H. J. Lambers Heerspink
  • Tawanda Gumbo
  • Peter Vis
  • Paul Watkins
  • Tina Morrison
  • William Gillespie
  • Mark Forrest Gordon
  • Diane Stephenson
  • Debra Hanna
  • Marc Pfister
  • Richard Lalonde
  • Thomas Colatsky
Short Report

Abstract

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics [www.go-isop.org] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.

Keywords

Regulatory science Modeling and simulation Quantitative drug development Pre-competitive research (Q)SAR Pharmacometrics Biostatistics 

References

  1. 1.
    Food and Drug Administration (2004) Innovation or stagnation: challenges and opportunity on the critical path to new medical products, Accessed online 26 Feb 2013: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm
  2. 2.
    Kruhlak NL, Benz RD, Zhou H, Colatsky TJ (2012) (Q)SAR modeling and safety assessment in regulatory review. Clin Pharmacol Ther 91:529–534PubMedCrossRefGoogle Scholar
  3. 3.
    Wang SJ, Hung HM (2013) Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations. Contemp Clin Trials 36:673–681PubMedCrossRefGoogle Scholar
  4. 4.
  5. 5.
    Food and Drug Administration (2010) Guidance for Industry: qualification process for drug development tools. Accessed online 3 Apr 2013 at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf
  6. 6.
    Smink PA, Miao Y, Eijkemans MJ, Bakker SJ, Raz I et al (2014) The importance of short-term off-target effects in estimating the long-term renal and cardiovascular protection of Angiotensin receptor blockers. Clin Pharmacol Ther 95:208–215PubMedCrossRefGoogle Scholar
  7. 7.
    Gumbo T, Dona CS, Meek C, Leff R (2009) Pharmacokinetics-pharmacodynamics of pyrazinamide in a novel in vitro model of tuberculosis for sterilizing effect: a paradigm for faster assessment of new antituberculosis drugs. Antimicrob Agents Chemother 53:3197–3204PubMedCentralPubMedCrossRefGoogle Scholar
  8. 8.
    Pasipanodya J, Gumbo T (2011) An oracle: antituberculosis pharmacokinetics-pharmacodynamics, clinical correlation, and clinical trial simulations to predict the future. Antimicrob Agents Chemother 55:24–34PubMedCentralPubMedCrossRefGoogle Scholar
  9. 9.
    Marino S, Kirschner DE (2004) The human immune response to Mycobacterium tuberculosis in lung and lymph node. J Theor Biol 227:463–486PubMedCrossRefGoogle Scholar
  10. 10.
    Marino S, El-Kebir M, Kirschner D (2011) A hybrid multi-compartment model of granuloma formation and T cell priming in tuberculosis. J Theor Biol 280:50–62PubMedCentralPubMedCrossRefGoogle Scholar
  11. 11.
    Jacqmin P, McFadyen L, Wade JR (2010) Basic PK/PD principles of drug effects in circular/proliferative systems for disease modelling. J Pharmacokinet Pharmacodyn 37:157–177PubMedCentralPubMedCrossRefGoogle Scholar
  12. 12.

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Klaus Romero
    • 1
  • Vikram Sinha
    • 2
  • Sandra Allerheiligen
    • 3
  • Meindert Danhof
    • 4
  • Jose Pinheiro
    • 5
  • Naomi Kruhlak
    • 2
  • Yaning Wang
    • 2
  • Sue-Jane Wang
    • 2
  • John-Michael Sauer
    • 6
  • J. F. Marier
    • 7
  • Brian Corrigan
    • 8
  • James Rogers
    • 9
  • H. J. Lambers Heerspink
    • 10
  • Tawanda Gumbo
    • 11
  • Peter Vis
    • 12
  • Paul Watkins
    • 13
  • Tina Morrison
    • 2
  • William Gillespie
    • 9
  • Mark Forrest Gordon
    • 14
  • Diane Stephenson
    • 6
  • Debra Hanna
    • 6
  • Marc Pfister
    • 15
  • Richard Lalonde
    • 8
  • Thomas Colatsky
    • 2
  1. 1.Clinical PharmacologyCritical Path InstituteTucsonUSA
  2. 2.US Food and Drug Administration (FDA)Silver SpringUSA
  3. 3.Merck Sharp & Dohme Corp. Pharmaceutical CompanyWhitehouse StationUSA
  4. 4.Faculty of Science, Leiden Academic Centre for Drug Research, PharmacologyGorlaeus LaboratoriesLeidenThe Netherlands
  5. 5.JanssenRaritanUSA
  6. 6.Critical Path InstituteTucsonUSA
  7. 7.CertaraSt LouisUSA
  8. 8.PfizerGrotonUSA
  9. 9.Metrum Research GroupTariffvilleUSA
  10. 10.University Medical Center GroningenGroningenThe Netherlands
  11. 11.University of Texas Southwestern Medical CenterDallasUSA
  12. 12.Lap & P Consultants BVLeidenThe Netherlands
  13. 13.The Hamner Institutes for Health SciencesResearch Triangle ParkUSA
  14. 14.Boehringer Ingelheim Pharmaceuticals, Inc.RidgefieldUSA
  15. 15.University of BaselBaselSwitzerland

Personalised recommendations