Abstract
In a global environment where health care costs are soaring, R&D efforts are flatlining. Meanwhile, payers are demanding more value for their money. In this environment, the traditional siloed drug development model is not sustainable. Yet innovations such as adaptive trial designs, real-world data collection, precision medicine, and patient-centric trials that have been proven to streamline clinical trials, enrich the data they produce, and facilitate reimbursement have not been widely adopted. Why? Because the medicines ecosystem currently lacks 3 key prerequisites for innovative and sustainable change: (1) a highly trained workforce that can handle and interpret high volumes of fragmented data; (2) a dependable process for judging what constitutes value in medical innovation; and (3) corporate cultures that learn fast from failure and mine the competitive riches offered by a diverse workforce. Cultivating the right people, processes, and culture will require a concerted effort by industry, academia, governments, and nongovernmental organizations (NGOs) to devise efficient, effective solutions.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
The Economist Intelligence Unit. The Innovation Imperative: The Future Of Drug Development. London: The Economist Intelligence Unit; 2018. https://druginnovation.eiu.com. Accessed September 23, 2018.
Kolata G. New cancer treatments lie hidden under mountains of paperwork. The New York Times. https://www.nytimes.com/2018/05/21/health/medical-records-cancer.html. Published 2018. Accessed September 23, 2018.
UK Bioindustry Association and Medicines Discovery Catapult. State of the Discovery Nation 2018 and the Role of the Medicines Discovery Catapult. Alderley Edge, Cheshire, UK: UK Bioindustry Association and Medicines Discovery Catapult; 2018. https://s3-eu-west-1.amazonaws.com/media.newmd.catapult/wp-content/uploads/2018/01/16220811/MDC10529-Thought-Leader_v10_Interactive_v1.pdf. Accessed September 23, 2018.
Duke University’s Center for Actionable Health Data Science. Duke Forge. https://forge.duke.edu. Published 2018. Accessed September 23, 2018.
Verily Life Sciences, LLC. https://verily.com. Accessed September 23, 2018.
World Economic Forum. The Future of Jobs: Employment, Skills and Workforce Strategy for the Fourth Industrial Revolution. Cologny, Switzerland: World Economic Forum; 2016. http://www3.weforum.org/docs/WEF_Future_of_Jobs.pdf. Accessed September 23, 2018.
PAREXEL International Corporation. PAREXEL and Kyoto Pharmaceutical University Strengthen Commitment to Japan’s Biopharmaceutical Workforce. 2015. https://www.parexel.com/company/news-events/press-releases/2015/parexel-and-kyoto-pharmaceutical-university-strengthen-commitment-japans-biopharmaceutical-workforce. Accessed September 23, 2018.
PAREXEL International Corporation. PAREXEL and Meiji Pharmaceutical University Announce Academic Program to Develop Japan’s Biopharmaceutical Workforce. 2018. https://www.parexel.com/company/news-events/press-releases/2018/parexel-and-meiji-pharmaceutical-university-announce-academic-program-develop-japans-biopharmaceutical-workforce. Accessed September 23, 2018.
Further training Bundesagentur für Arbeit. arbeitsagentur.de. https://www.arbeitsagentur.de/en/further-training/. Published 2018. Accessed September 23, 2018.
Weiturbildung Clinical Monitoring/Clinical Trial Management. parexel-academy.com. https://parexel-academy.com/en/fortbildungen/weiterbildung-clinical-monitoring-clinical-trial-management/. Published 2018. Accessed September 23, 2018.
Harmonized Core Competency Framework. sclinicaltrialcompetency.org. https://www.clinicaltrialcompetency.org/framework-1/. Published 2014. Accessed September 23, 2018.
IQVIA Institute for Human Data Science. Global Oncology Trends 2018: Innovation, Expansion and Disruption. Danbury, CT: IQVIA Institute for Human Data Science; 2018. https://www.iqvia.com/institute/reports/global-oncology-trends-2018. Accessed September 23, 2018.
Summary of Decisions. nice.org. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/summary-of-decisions. Published 2018. Accessed September 23, 2018.
Hwang T, Darrow J, Kesselheim A. The FDA’s expedited programs and clinical development times for novel therapeutics, 2012-2016. JAMA. 2017;318(21):2137.
Center for Drug Evaluation and Research. Advancing Health Through Innovation: 2017 New Drug Therapy Approvals. Rockville, MD: US Food and Drug Administration; 2018. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf. Accessed September 23, 2018.
Parallel consultation with regulators and health technology assessment bodies. ema.europa.eu. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001857.jsp&mid=WC0b01ac0580a11c96. Published 2018. Accessed September 23, 2018.
European Network for Health Technology Assessment. eunethta.eu. Published 2018. https://www.eunethta.eu. Accessed September 23, 2018.
US Food and Drug Administration. Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers: Guidance for Industry and Review Staff. Rockville, MD: US Food and Drug Administration; 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf. Accessed September 23, 2018.
Calabrò G, La Torre G, de Waure C, et al. Disinvestment in healthcare: an overview of HTA agencies and organizations activities at European level. BMC Health Serv Res. 2018;18(1).
Hay M, Thomas D, Craighead J, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32(1):40–51.
Edmondson A. Teaming: How Organizations Learn, Innovate, And Compete In The Knowledge Economy. 1st ed. San Francisco: Jossey-Bass; 2013:164–183.
Hewlett S, Marshall M, Sherbin L. How diversity can drive innovation. Harvard Business Review. 2013.
Mayer R, Warr RS, Zhao J. Do pro-diversity policies improve corporate innovation? Financ Manage. 2018;47(3):617–650.
International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use. ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2). Geneva, Switzerland: ICH; 2009. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf. Accessed September 23, 2018.
ICH M2 Expert Working Group. Electronic Common Technical Document Specification. Geneva, Switzerland: International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use; 2008. http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf. Accessed September 23, 2018.
MedDRA Work Products. ich.org. https://www.ich.org/products/meddra.html. Accessed September 23, 2018.
Quality Guidelines. ich.org. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html. Accessed September 23, 2018.
International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use. ICH Harmonised Tripartite Guideline: Pharmacovigilance Planning E2E. Geneva, Switzerland: International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use; 2004. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf. Accessed September 23, 2018.
Mota C, Barbosa J, Liberti L, Bonamici D, Grignolo A. Expedited regulatory pathways in established and emerging markets. DIA Global Forum. 2018;10(9). https://globalforum.diaglobal.org/issue/september-2018/expedited-regulatory-pathways-in-established-and-emerging-markets/. Accessed October 1, 2018.
Gladwell M. The tipping point: How little things can make a big difference. Boston: Little, Brown; 2000.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
About this article
Cite this article
Grignolo, A., Siu, A. Improving Drug Development and Patient Access With the Right People, Processes, and Culture: What Needs to Happen Right Now to Bring Better Medicines to the Patients Who Need Them. Ther Innov Regul Sci 53, 398–402 (2019). https://doi.org/10.1177/2168479018814224
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479018814224