Critical Path Institute

Critical Path Institute The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005.

Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the Food and Drug Administration (FDA) created under the auspices of the FDA’s Critical Path Initiative program in 2005. C-Path’s aim is to accelerate the pace and reduce the costs of medical product development through the creation of new data standards, measurement standards, and methods standards that aid in the scientific evaluation of the efficacy and safety of new therapies. These pre-competitive standards and approaches have been termed “drug development tools” (DDTs) by the FDA, which established a process for official review and confirmation of their validity for a given context of use. C-Path orchestrates the development of DDTs through an innovative, collaborative approach to the sharing of data and expertise. We build consensus among participating scientists from industry and academia with FDA participation and iterative feedback. The process culminates in a formal application to FDA for official “qualification” of the DDT for a given use in product development. Qualified DDTs then become open standards for the scientific community which, in turn, may be assured both of the scientific rigor under which they were developed and of the FDA’s understanding and acceptance of their validity.

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Gl...
09/17/2025

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Global Impact Conference (CGIC), taking place September 9–11 at the Washington Marriott at Metro Center in downtown Washington, D.C.
This year’s event will bring together leaders and innovators from across the life sciences ecosystem to explore how C-Path’s collaborative programs are driving progress in neurology, rare diseases, pediatrics, and beyond.

As C-Path celebrates its 20th anniversary, CGIC 2025 stands out as a milestone event—bringing together a global community dedicated to advancing medical innovation and improving patient outcomes.

Whether you're joining us from industry, regulatory agencies, academia, patient organizations, or as someone with lived experience, you’ll find valuable insights, thought-provoking discussions, and meaningful opportunities to collaborate.

What to Expect:
• Cross-sector networking opportunities
• Sessions focused on today’s most pressing challenges in drug development
• A celebration of two decades of global impact

Dates: September 9–11, 2025
Location: Washington Marriott at Metro Center

Register now: https://f.mtr.cool/zrzrizhcdm

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for P...
09/16/2025

Celebrating 20 Years of the Critical Path Institute: Accelerating Drug Development and Advancing Better Treatments for People Worldwide. This year marks a special milestone for C-Path- 20 years of growth, innovation, and an unwavering commitment to our mission. As we celebrate this journey, we reflect on the moments, people, and breakthroughs that have shaped our of success.

2011: C-Path launches the Electronic Patient-Reported Outcomes Consortium, collaborates with Europe’s Innovative Medicines Initiative, develops first-ever therapeutic area data standards for Alzheimer’s in partnership with CDISC, and is named in NIMH’s “Top 10 Research Advances of 2011."

Your donation today will inspire hope and advance C-Path’s life-changing efforts to accelerate drug development. Help transform the next generation of medical breakthroughs with your contribution. Support C-Path today!

Keep Us going for 20 more by donating to C-Path: https://f.mtr.cool/zprkybfycm

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Gl...
09/15/2025

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Global Impact Conference (CGIC), taking place September 9–11 at the Washington Marriott at Metro Center in downtown Washington, D.C.
This year’s event will bring together leaders and innovators from across the life sciences ecosystem to explore how C-Path’s collaborative programs are driving progress in neurology, rare diseases, pediatrics, and beyond.

As C-Path celebrates its 20th anniversary, CGIC 2025 stands out as a milestone event—bringing together a global community dedicated to advancing medical innovation and improving patient outcomes.

Whether you're joining us from industry, regulatory agencies, academia, patient organizations, or as someone with lived experience, you’ll find valuable insights, thought-provoking discussions, and meaningful opportunities to collaborate.

What to Expect:
• Cross-sector networking opportunities
• Sessions focused on today’s most pressing challenges in drug development
• A celebration of two decades of global impact

Dates: September 9–11, 2025
Location: Washington Marriott at Metro Center

Register now: https://f.mtr.cool/ukjsnrdvcc

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Gl...
09/14/2025

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Global Impact Conference (CGIC), taking place September 9–11 at the Washington Marriott at Metro Center in downtown Washington, D.C.
This year’s event will bring together leaders and innovators from across the life sciences ecosystem to explore how C-Path’s collaborative programs are driving progress in neurology, rare diseases, pediatrics, and beyond.

As C-Path celebrates its 20th anniversary, CGIC 2025 stands out as a milestone event—bringing together a global community dedicated to advancing medical innovation and improving patient outcomes.

Whether you're joining us from industry, regulatory agencies, academia, patient organizations, or as someone with lived experience, you’ll find valuable insights, thought-provoking discussions, and meaningful opportunities to collaborate.

What to Expect:
• Cross-sector networking opportunities
• Sessions focused on today’s most pressing challenges in drug development
• A celebration of two decades of global impact

Dates: September 9–11, 2025
Location: Washington Marriott at Metro Center

Register now: https://f.mtr.cool/hunodueqaz

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-dema...
09/14/2025

Dive into the world of solutions for Drug Development with C-Path's YouTube channel! Subscribe now for access to on-demand content including meetings, webinars, interviews, and more. Stay informed, stay inspired!

SUBSCRIBE to C-Path's YouTube Channel Now ►► https://f.mtr.cool/rhzsnazhzh

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/rpjvucvryf For 20 years, C-Path has been provid...
09/13/2025

Interested in C-Path updates? Be sure to subscribe at https://f.mtr.cool/rpjvucvryf For 20 years, C-Path has been providing vital infrastructure to generate a neutral environment for everyone working in drug development to collaborate, not compete. Let's improve lives, together.

09/13/2025

Relive the best moments of the 2025 C-Path Clinical Outcomes Assessment Program Annual Meeting.

Rare Disease Clinical Outcome Assessment Consortium Update
Lindsey Murray, PhD, MPH — Executive Director of the Rare Disease Clinical Outcome Assessment Consortium at Critical Path Institute — shared updates on this collaborative initiative, launched in 2022 to address critical challenges in rare disease drug development.

With approximately half of all rare diseases affecting children and few approved treatments available, the Consortium is working to advance the use of meaningful clinical outcome assessments to accelerate the development of therapies for these underserved populations.

Learn more about our COA program here: https://f.mtr.cool/znunjcpuey

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Gl...
09/13/2025

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Global Impact Conference (CGIC), taking place September 9–11 at the Washington Marriott at Metro Center in downtown Washington, D.C.
This year’s event will bring together leaders and innovators from across the life sciences ecosystem to explore how C-Path’s collaborative programs are driving progress in neurology, rare diseases, pediatrics, and beyond.

As C-Path celebrates its 20th anniversary, CGIC 2025 stands out as a milestone event—bringing together a global community dedicated to advancing medical innovation and improving patient outcomes.

Whether you're joining us from industry, regulatory agencies, academia, patient organizations, or as someone with lived experience, you’ll find valuable insights, thought-provoking discussions, and meaningful opportunities to collaborate.

What to Expect:
• Cross-sector networking opportunities
• Sessions focused on today’s most pressing challenges in drug development
• A celebration of two decades of global impact

Dates: September 9–11, 2025
Location: Washington Marriott at Metro Center

Register now: https://f.mtr.cool/jaikytehem

09/12/2025

Watch the interviews from the 2024 C-Path Global Impact Conference on our YouTube!

In this video, Cheryl C**n, Vice President of the Clinical Outcome Assessment program, discusses the various consortia within the program that are focused on improving clinical trial methodologies. The three primary consortia include the Patient Reported Outcome Consortium, the Rare Disease COA Consortium, and the Electronic COA Consortium. Each consortium has specific objectives: the PRO aims to develop and modify measurement tools for regulatory qualification; the RD-COA is creating an online resource for measuring outcomes in rare diseases; and the eCOA is focused on the technological aspects of data collection in clinical trials.

Cheryl elaborates on the significant progress made in qualifying numerous instruments for clinical trials across different therapeutic areas and highlights the collaborative efforts between sponsors and regulatory bodies, which have led to a greater understanding of evidence generation and expedited drug development.

Watch here: https://f.mtr.cool/qsmqrxgebm

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Gl...
09/12/2025

Register NOW! We’re excited to announce that registration is now open for the 2025 Critical Path Institute® (C-Path) Global Impact Conference (CGIC), taking place September 9–11 at the Washington Marriott at Metro Center in downtown Washington, D.C.
This year’s event will bring together leaders and innovators from across the life sciences ecosystem to explore how C-Path’s collaborative programs are driving progress in neurology, rare diseases, pediatrics, and beyond.

As C-Path celebrates its 20th anniversary, CGIC 2025 stands out as a milestone event—bringing together a global community dedicated to advancing medical innovation and improving patient outcomes.

Whether you're joining us from industry, regulatory agencies, academia, patient organizations, or as someone with lived experience, you’ll find valuable insights, thought-provoking discussions, and meaningful opportunities to collaborate.

What to Expect:
• Cross-sector networking opportunities
• Sessions focused on today’s most pressing challenges in drug development
• A celebration of two decades of global impact

Dates: September 9–11, 2025
Location: Washington Marriott at Metro Center

Register now: https://f.mtr.cool/xfpftwomds

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1840 E River Road Ste 100
Tucson, AZ
85718

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Monday 8am - 5pm
Tuesday 8am - 5pm
Wednesday 8am - 5pm
Thursday 8am - 5pm
Friday 8am - 5pm

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