New C-Path Article in Nature Reviews Drug Discovery Highlights Regulatory Impact of Consortium Projects
In a recent publication in Nature Reviews Drug Discovery, the Critical Path Institute (C-Path) presents critical insights into maximizing the regulatory impact of consortium-based projects. This collaborative initiative, led by Innovative Health Initiative (IHI) and C-Path, explores the outcomes of international multilateral consortia formed over the last two decades to tackle barriers in drug development. The article titled "Ensuring Regulatory Impact Through Consortium Projects" outlines a collective approach for addressing pivotal challenges in developing tools that support regulatory decision-making.
The authors underscore that mere collaboration is insufficient for fostering real progress in accelerating drug development; instead, they emphasize the importance of early engagement with regulatory authorities. By establishing clear criteria for the evidence submitted and integrating long-term planning concerning data access and sustainability, projects can significantly boost their regulatory effectiveness.
Cécile Ollivier, Vice President of International Affairs at C-Path, stated, “This work highlights the urgent and feasible need for building globally coordinated and interdisciplinary initiatives that can deliver innovations to often overlooked patients.” By uniting key stakeholders and dismantling technical and regulatory barriers, the environment for drug development can be profoundly transformed.
As the role of regulatory science increasingly grows in translating innovations into real benefits for patients, a systematic and strategic approach to regulatory issues is vital. This approach should commence from the earliest planning phases of a project and persist through its post-completion stages. Nathalie Seigneuret, Chief Scientific Project Manager at IHI, remarked, “Together we strive to turn promising advancements in health research and innovation into tangible benefits for individuals and patients.” Regulatory science plays a fundamental role in this endeavor, and the authors express hope that the insights shared in this article will assist projects in meeting regulatory demands.
Aligned with IHI guidelines for applicants and consortia regarding regulatory aspects of IMI and IHI projects, the article delineates key priorities for practical implementation:
This publication reflects a growing support for innovative and sustainable research aiming to accelerate drug development and facilitate informed regulatory decision-making. To read the complete article and access supplementary materials, visit here.
About IHI:
The Innovative Health Initiative (IHI) is dedicated to transforming health research and innovation into real benefits for patients and society while ensuring Europe maintains its leadership position in interdisciplinary and sustainable patient-centered research. Today's healthcare and research increasingly intersect various sectors. By supporting projects that connect these sectors, IHI paves the way for a more integrated approach to healthcare—from prevention to diagnosis, treatment, and disease management. IHI is a partnership between the European Union and European industry associations representing the pharmaceutical industry, medical technologies, biotechnology, digital health, and vaccine manufacturing, specifically COCIR, EFPIA, EuropaBio, MedTech Europe, and Vaccines Europe. The IHI's budget totals €2.4 billion, with half of that amount sourced from the EU’s Horizon Europe research and innovation program. Industrial partners have committed €1 billion to the initiative, with an additional €200 million potentially contributed by other organizations that choose to become Contributing Partners.
IHI builds upon the successes of the Innovative Medicines Initiative (IMI), with the program office continuing to manage the IMI project portfolio. For additional information, visit ihi.europa.eu or follow IHI on LinkedIn, Bluesky, and Mastodon.
About the Critical Path Institute:
Founded in 2005, the Critical Path Institute (C-Path) emerged as a public-private partnership in response to the U.S. FDA's Critical Path Initiative. This year, C-Path celebrates 20 years as a vital independent nonprofit organization whose mission is to lead collaborations that facilitate the development of more effective treatments for patients worldwide. C-Path is recognized as a pioneer globally in accelerating drug development, establishing numerous international consortia, programs, and initiatives involving over 1,600 scientists and representatives from government and regulatory agencies, academic institutions, patient organizations, disease-specific foundations, and pharmaceutical and biotechnology companies. C-Path's global headquarters is situated in Tucson, Arizona, while its European branch operates in Amsterdam, Netherlands, with engaged collaborators in various countries. For more information, visit c-path.org and follow us on LinkedIn, X, Facebook, Instagram, BlueSky, and YouTube.
The authors underscore that mere collaboration is insufficient for fostering real progress in accelerating drug development; instead, they emphasize the importance of early engagement with regulatory authorities. By establishing clear criteria for the evidence submitted and integrating long-term planning concerning data access and sustainability, projects can significantly boost their regulatory effectiveness.
Cécile Ollivier, Vice President of International Affairs at C-Path, stated, “This work highlights the urgent and feasible need for building globally coordinated and interdisciplinary initiatives that can deliver innovations to often overlooked patients.” By uniting key stakeholders and dismantling technical and regulatory barriers, the environment for drug development can be profoundly transformed.
As the role of regulatory science increasingly grows in translating innovations into real benefits for patients, a systematic and strategic approach to regulatory issues is vital. This approach should commence from the earliest planning phases of a project and persist through its post-completion stages. Nathalie Seigneuret, Chief Scientific Project Manager at IHI, remarked, “Together we strive to turn promising advancements in health research and innovation into tangible benefits for individuals and patients.” Regulatory science plays a fundamental role in this endeavor, and the authors express hope that the insights shared in this article will assist projects in meeting regulatory demands.
Aligned with IHI guidelines for applicants and consortia regarding regulatory aspects of IMI and IHI projects, the article delineates key priorities for practical implementation:
- - A clearly defined regulatory strategy established at the project's outset
- - A data management plan tailored to regulatory goals
- - A sustainability blueprint ensuring data accessibility post-project
- - Early engagement with regulatory bodies, coordinated by seasoned partners
This publication reflects a growing support for innovative and sustainable research aiming to accelerate drug development and facilitate informed regulatory decision-making. To read the complete article and access supplementary materials, visit here.
About IHI:
The Innovative Health Initiative (IHI) is dedicated to transforming health research and innovation into real benefits for patients and society while ensuring Europe maintains its leadership position in interdisciplinary and sustainable patient-centered research. Today's healthcare and research increasingly intersect various sectors. By supporting projects that connect these sectors, IHI paves the way for a more integrated approach to healthcare—from prevention to diagnosis, treatment, and disease management. IHI is a partnership between the European Union and European industry associations representing the pharmaceutical industry, medical technologies, biotechnology, digital health, and vaccine manufacturing, specifically COCIR, EFPIA, EuropaBio, MedTech Europe, and Vaccines Europe. The IHI's budget totals €2.4 billion, with half of that amount sourced from the EU’s Horizon Europe research and innovation program. Industrial partners have committed €1 billion to the initiative, with an additional €200 million potentially contributed by other organizations that choose to become Contributing Partners.
IHI builds upon the successes of the Innovative Medicines Initiative (IMI), with the program office continuing to manage the IMI project portfolio. For additional information, visit ihi.europa.eu or follow IHI on LinkedIn, Bluesky, and Mastodon.
About the Critical Path Institute:
Founded in 2005, the Critical Path Institute (C-Path) emerged as a public-private partnership in response to the U.S. FDA's Critical Path Initiative. This year, C-Path celebrates 20 years as a vital independent nonprofit organization whose mission is to lead collaborations that facilitate the development of more effective treatments for patients worldwide. C-Path is recognized as a pioneer globally in accelerating drug development, establishing numerous international consortia, programs, and initiatives involving over 1,600 scientists and representatives from government and regulatory agencies, academic institutions, patient organizations, disease-specific foundations, and pharmaceutical and biotechnology companies. C-Path's global headquarters is situated in Tucson, Arizona, while its European branch operates in Amsterdam, Netherlands, with engaged collaborators in various countries. For more information, visit c-path.org and follow us on LinkedIn, X, Facebook, Instagram, BlueSky, and YouTube.
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