ROLE OF EFFECTIVE PROJECT MANAGEMENT IN REDUCING DRUG DEVELOPMENT COST

Authors

  • Faisal BA Zaidi
  • Salma Ahmed
  • Munish Makkad

DOI:

https://doi.org/10.22159/ajpcr.2017.v10i3.16186

Abstract

ABSTRACT
Pharmaceuticals are passing through the difficult phase due to increasing numbers of patents expiry along with increasing cost of drug development.
Protocol design, regulatory cycle time, site selection, patient enrollment and monitoring are some of the cost contributing elements for late phase
clinical trials. This paper applies the principles of project management and suggests means to reduce the cost of late phase drug development. It also
throws light on the critical role that a project manager can play in overall drug development process.
Keywords: Cost of drug development, Effective project management, Reduction in cost of drug development.

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References

REFERENCES

Sertkaya A, Birkenbach A, Berlind A, Eyraud J. Examination of Clinical Trial Costs and Barriers for Drug Development. July; 2014. Available from: http://www.aspe.hhs.gov. [Last accessed on 2016 Jun 07].

Kureishi A. Asia: A New Frontier in Strategic Drug Development; 2011. Available from: http://www.quintiles.com. [Last accessed on 2016 Jun 07].

Slater T, Bouton C, Huang ES. Beyond data integration. Drug Discov Today 2008;13(13-14):584-9.

Battelle Technology Partnership Practice. Biopharmaceutical Industry-Sponsored Clinical Trials: Impact on State Economies. March; 2015. Available from: http://www.phrma.org. [Last accessed on 2016 Jun 07].

Schultz H. Closing the Variance Gap: The Challenges with Clinical Trial Budget Management and Forecasting. May; 2015. Available from: http://www.appliedclinicaltrialsonline.com. [Last accessed on 2016 Jun 07].

Quintiles White Paper. Improving Clinical Development in Emerging Biopharma Settings: How Model Based Drug Development Leads to Smarter, More Predictable Trials. Available from: http://www.quintiles.com. [Last accessed on 2016 Jun 07].

Morrison BW, Cochranb CJ, Whitec JG, Harleyd J, Kleppingere CF, Liu A, et al. Monitoring the quality of conduct of clinical trials: A survey of current practices. SAGE J 2011. Available from: http://www.ctj.sagepub.com.

Getz K. Clinical Trial Complexity. USA: Tufts CSDD, Tufts University School of Medicine; 2012. Available from: http://www.nationalacademies.org/hmd/~/media/34D1A23404A8492998AD2DF0CB6CD4D1.ashx.

Johnson J. Clinical Protocols: Improve Your Designs and Reduce Costs. Feb; 2016. Available from: http://www.intilaris.com. [Last accessed on 2016Jun 07].

El-Assi Z. Cost forecasting for clinical trial management. Am Pharm Rev Suppl 2015;18-21. Available from: http://www.niceinsight.com/Userfiles/Articles/PDFs/APR_Supplement_0415_Merge.pdf.

Covance, Addressing Operational Challenges in Conducting Clinical Trials. July; 2015. Available from: http://www.covance.com. [Last accessed on 2016 Jun 07].

Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012. JAMA 2014;311(4):378-84.

Lyle Fitzsimmons. Clinical Trial Site Selection: Research Reality Check. January, 2010. Available from: http://www.iconplc.com. [Last accessed on 2016 Jun 07].

Clinipace. Trends in Clinical Trial Site Selection & Patient Recruitment. Available from: http://www.clinipace.com. [Last accessed on 2016 Jun 07].

Cutting Edge Information. Clinical Trial Budgets Decreased Among Surveyed Companies by Implementing Risk-Based Monitoring Approaches, According to Cutting Edge Information. February, 2016. Available from: http://www.marketwired.com. [Last accessed on 2016 Jun 07].

Quintiles White Paper. Transform Clinical Development Through Advances in Risk-Based Monitoring; 2015. [Last accessed on 2016 Jun 07].

Bhowmik D, Chandira M, Chiranjib B. Emerging trends of scope and opportunities clinical trials In India. Int J Pharm Pharm Sci 2010;2 Supp 1:7-20.

Farfel G, Neuer A. Faster Study Start-Up and Reduced Costs through the Use of Clinical Document Exchange Portals; 2009. Available from: http://www.intralinks.com.

Umashankar V, Gurunathan S. Drug discovery: An appraisal. Int J Pharm Pharm Sci 2015;7(4):59-66.

Published

01-03-2017

How to Cite

Zaidi, F. B., S. Ahmed, and M. Makkad. “ROLE OF EFFECTIVE PROJECT MANAGEMENT IN REDUCING DRUG DEVELOPMENT COST”. Asian Journal of Pharmaceutical and Clinical Research, vol. 10, no. 3, Mar. 2017, pp. 53-56, doi:10.22159/ajpcr.2017.v10i3.16186.

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Review Article(s)