C-Path’s Kristen Swingle Named President

Swingle joined C-Path in 2019 and was named interim president in 2021

TUCSON, Ariz., Sept. 8, 2022 — Critical Path Institute (C-Path) today announced that its Chief Operating Officer (COO) and Interim President, Kristen Swingle, M.S., has been named COO and President, effective immediately. Swingle has filled the interim President role since 2021, stewarding C-Path through growth and innovation, including the establishment of multiple national and global programs, a new European entity, a 50% staff increase, and a 90% increase in revenue.

Swingle, a leading voice in the Arizona bioscience community with two decades of experience in the medical and molecular sciences, has served as COO since July 2019, leading C-Path’s daily operations along with the development and implementation of its global strategy. Furthermore, she has served as Chairwoman for the AZ Bio Board of Directors for nearly five years and is a member of Women Business Leaders of the U.S. Health Care Industry Foundation.

“The Board recognizes the importance of this decision, as it represents its commitment to make deeper investments in C-Path’s leadership knowing that we are moving into very exciting times,” said C-Path Board Chairman Wainwright Fishburn. “The phenomenal momentum and traction over this last period of high growth for C-Path has a lot to do with the role Kristen has played. We have every confidence in her, and our incredible C-Path staff, as we take on the complex work ahead to support the great opportunities before us.”

“I thank the Board for this opportunity. I am incredibly honored to serve as President during a time of important and significant expansion of C-Path’s programs,” Swingle said. “My commitment to C-Path is always amplified by working with our dedicated and experienced executive leaders and staff — they are the driving force for C-Path’s success. I look forward to continuing to build on C-Path’s strengths and core competencies alongside my talented team.”

“Kristen has proven to shine in times of growth and change, and is a recognized leader with broad life science experience who has done a tremendous job leading C-Path operations,” said founding Board Member and Vice-Chairman Jeffery E. Jacob, SM. “The Board continues to work closely with Kristen, Chief Science Officer, Dr. Klaus Romero, Chief Financial Officer Kevin Perkins, and the Executive Team, to advance C-Path’s mission to improve the medical product development and regulatory process to benefit patients worldwide.”

The Institute and its Board have carefully deliberated its most advantageous steps forward to sustain the exponential growth it has undergone in the last three years, and anticipates announcing a new Chief Executive Officer this fall. “I look forward to partnering with our new CEO as we pursue C-Path’s ambitious agenda ahead,” Swingle said.

About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. For more information, visit c-path.org.

Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government source(s), totaling $11,196,634. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.


Kissy Black

ERA4TB Update

NEWSLETTER: The ERA4TB (European Regimen Accelerator for Tuberculosis) project, a public-private initiative devoted to accelerating the development of new treatment regimens for tuberculosis, issued its first newsletter this month which includes updates on the project thus far. Read the full communication and subscribe, here: https://era4tb.org/newsletter.

ePRO Consortium Announces Open Access Article



In collaboration with the DIA Study Endpoints Community, C-Path’s ePRO Consortium is pleased to announce the open access article “Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials” is available online in the April 1, 2020 issue of Contemporary Clinical Trials. This article provides recommendations for the structure and content of an evidence dossier aimed at supporting a clinical trial endpoint derived from mobile sensor data as fit-for-purpose in regulatory decision making.

Link to article: https://www.contemporaryclinicaltrials.com/article/S1551-7144(20)30040-9/fulltext



Collaborating for Cures Leveraging Global Public-Private Partnerships to Accelerate Biopharmaceuticals Development

Event Date: 03/07/2013

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) and Critical Path Institute (C-Path) held a joint event in Brussels, Belgium on the challenges and opportunities of public-private partnerships (PPPs). More than 120 participants attended the conference and many more followed the live webcast.

This first ever public conference co-sponsored by IMI and C-Path featured cross-sector participants discussing challenges and opportunities in the rapidly-evolving PPP space. The lively discussion focused on identifying mechanisms for enhancing the productivity of PPPs, coordinating individual PPP efforts to avoid duplication, and adopting best practices on data sharing, intellectual property, patient involvement in research, and other cross-cutting issues in order to streamline biopharmaceuticals development world-wide.

  • Download the agenda
  • Watch the entire conference online here
  • Read the highlights of the event on twitter at #CollaboratingForCures



Innovative solutions to shared challenges

Introduction: Collaborating for Cures – Leveraging Global Public-Private Partnerships to Accelerate Biopharmaceuticals Development
Michel Goldman, Executive Director, IMI Martha Brumfield, President and CEO, C-Path

Harnessing the Discovery Engine of NIH to Maximize Translation
Maria Freire, President, Foundation for the National Institutes of Health (FNIH)

How Technology Transfer and other IP Agreements can Spur Bench to Bedside Translation
Tania Bubela, Associate Professor, School of Public Health, University of Alberta

How patients supply more than a voice in Accelerating Medical Product development
Alastair Benbow, Chief Executive, The Age of the Brain

How FDA Promotes Partnerships to Accelerate Medical Product Development
ShaAvhree Buckman-Garner, Director, Office of Translational Sciences, CDER, FDA


IMI and C-Path collaboration on Alzheimer’s disease

Prediction and Faster Assessment of Functional Properties of New Drug Candidates for Alzheimer’s Disease in Early Clinical Development: The IMI PharmaCog project
Jill Richardson, EFPIA coordinator IMI PharmaCog / Director, External Alliances and Development, GSK R&D China

European Medical Informatics Framework (EMIF)
Simon Lovestone, Director Biomedical Research Centre for Mental Health and Dementia, King’s College London

Coalition Against Major Diseases: Regulatory Science can Accelerate Drug Development for Neurodegeneration
Diane Stephenson, Executive Director, Coalition Against Major Diseases, Critical Path Institute

The Regulator’s View
Maria Isaac, Scientific Advisor, European Medicines Agency


IMI and C-Path collaboration on tuberculosis

PreDiCT-TB Model-based preclinical development of antituberculosis drug combinations
Gerry Davies, Senior Lecturer in Infection pharmacology, University of Liverpool

CPTR Mission, Structure & Goals for Innovation
Debra Hanna, Executive Director, Critical Path to TB Drug Regimens