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Updated: Jan 27, 2026

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
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Are Regulation and Innovation Priorities Serving Public Health Needs?

Christopher-Paul Milne1, Kenneth I Kaitin1

  • 1Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, United States.

Frontiers in Pharmacology
|March 26, 2019
PubMed
Summary
This summary is machine-generated.

Healthcare faces challenges in developing new medicines for diseases like cardiovascular and central nervous system disorders due to high costs and risks. Current drug development priorities, like oncology, misalign with global health needs.

Keywords:
drug developmentinnovationnew active substance (NAS)pharmaceutical R & Dregulatory agency

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Area of Science:

  • Pharmaceuticals and Health Economics
  • Drug Development and Regulatory Science

Background:

  • Global healthcare systems face increasing demands for innovative medicines and cost containment.
  • Significant unmet medical needs exist in areas such as cardiovascular diseases and central nervous system disorders.
  • High development costs and commercial risks deter investment in these critical therapeutic areas.

Purpose of the Study:

  • To analyze the misalignment between current drug development focuses and global healthcare needs.
  • To identify the origins of this disparity in pharmaceutical research and development.
  • To propose strategies for addressing unmet medical needs in underserved therapeutic areas.

Main Methods:

  • Review of current trends in pharmaceutical research and development investment.
  • Analysis of healthcare priorities and economic impact of various disease areas.
  • Examination of regulatory and commercial factors influencing drug sponsorship.

Main Results:

  • Drug development disproportionately focuses on oncology, neglecting other areas with high medical need.
  • Cardiovascular and central nervous system diseases represent significant unmet needs with limited new drug approvals.
  • The current development landscape is misaligned with broader public health requirements.

Conclusions:

  • Realigning drug development priorities with global health needs is crucial.
  • Innovative approaches are required to incentivize development in high-need, high-risk therapeutic areas.
  • Addressing the identified misalignment will improve access to essential medicines worldwide.