A new paper published in the science journal Nature reviews drug discovery (“Delivering regulatory impact from consortium-based projects”) highlights how to maximize the regulatory impact of consortium-based projects. This is based on the concept of ‘regulatory science’.
Regulatory science is an emerging field focused on developing the scientific tools, standards, and approaches needed to assess the safety, efficacy, quality, and performance of products regulated by government agencies like the U.S. Food and Drug Administration. It aims to improve the development, review, and oversight of products like drugs, biologics, and medical devices.
Regulatory science also plays a crucial role in ensuring public trust in these products and facilitating the translation of scientific advancements into safe and effective treatments. The concept requires a multidisciplinary field.
The paper, by authors from IHI and the Critical Path Institute, highlights the importance of a structured, strategic approach to regulatory issues from the beginning.
The Innovative Health Initiative (IHI) and Critical Path Institute® (C-Path) have provided insights from multistakeholder global consortia launched over the past two decades to address barriers in drug development.
The review is titled “Delivering regulatory impact from consortium-based projects,” and the paper presents a joint approach to addressing key challenges in developing tools to support regulatory decision-making.
As an example, the output of such regulatory science can help to develop technical and scientific standards for preclinical assessment, product development, and post-market surveillance.
Drawing on the experience of cross-sector partnerships, the authors stress that collaboration alone is not enough to achieve meaningful impact on accelerating drug development. Key aspects to maximize regulatory impact include early regulatory engagement, clear evidentiary standards, and long-term planning for data access and sustainability.
“This work emphasizes the urgency—and feasibility—of building globally coordinated, cross-sector efforts to drive innovation for patients who have long been underserved,” said C-Path Vice President of Global Affairs Cécile Ollivier in a statement sent to Digital Journal.
“By aligning stakeholders and lowering technical and regulatory barriers, we can reshape the drug development landscape.”
As regulatory science becomes more central to translating innovation into patient benefit, the authors highlight the importance of taking a structured, strategic approach to regulatory issues, starting from the earliest stages of project planning and running right through to the post-project stage.
