Global Biopharmaceutical Leader to Usher C-Path in Next Phase of Growth and Innovation

Board names Dr. Daniel Jorgensen as Chief Executive Officer

TUCSON, Ariz., Sept. 27, 2022 — Critical Path Institute (C-Path) today named Daniel M. Jorgensen, M.D., MPH, MBA, its Chief Executive Officer (CEO). An experienced leader in drug development, healthcare and business, Jorgensen will continue C-Path’s distinguished reputation of collaboration with global stakeholders, including patient groups, academic institutions, the pharmaceutical industry and regulatory agencies, to set a vision for C-Path’s next phase of growth and innovation. Jorgensen’s tenure as CEO will commence on the first of October.

“Dr. Jorgensen has long been a visionary in drug development, applying his vast insight, experience and passion for healthcare to advancing every organization he has been a part of,” said Kristen Swingle, M.S., C-Path’s COO and President. “We’re excited to welcome him to C-Path and to be able to benefit from his leadership and expertise.”

Jorgensen is an accomplished physician executive with more than 24 years of experience in the biopharmaceutical industry, in both small and large companies, public and private, including C-level positions for the past 11 years. Before C-Path, he was CEO at AxoProtego, guiding the neuroscience startup through funding and partnership activities. AxoProtego has an exclusive worldwide license from Johns Hopkins University for a biotechnology platform addressing neurodegeneration in areas of high unmet need.

Jorgensen began his career as a pediatrician with a deep interest in vaccines and public health. He worked at the Centers for Disease Control & Prevention (CDC) and other public health organizations before taking his first job in the industry, developing vaccines for Pasteur Merieux Connaught. During his 10 years at Pfizer, Jorgensen was the Global Clinical Leader for azithromycin and was named Pfizer’s first Vaccine Development Team Leader, playing a key role in multiple FDA meetings, submissions and approvals. Thereafter, he served as Chief Medical Officer at several biotechnology companies, developing drugs across multiple therapeutic areas.

“Dan’s deep pharmaceutical and regulatory expertise makes him the perfect choice to drive C-Path into the future,” said Wainwright Fishburn, C-Path Board Chair. “We were searching for a bold leader with an outstanding background to execute our strategic roadmap for continued organizational growth globally, and we’re thrilled that he’ll be leading the organization.”

“C-Path has an excellent reputation in advancing medical innovation and global health in a way that is uniquely collaborative, and I am thrilled to be part of its mission,” Jorgensen said. “We have a lot of exciting goals for the years ahead and I’m looking forward to hitting the ground running, with the support of C-Path’s outstanding staff and extended stakeholders.”

Jorgensen holds a B.S. from Yale University, an M.D. from the University of Wisconsin Medical School and a Master of Public Health from the University of Washington School of Public Health. He also holds an MBA from the Yale School of Management, as a member of the charter class for Yale’s MBA for Executives: Leadership in Healthcare.

“We look forward to building new C-Path partnerships within the national and international scientific, industry and regulatory communities, with the goal of improving the health of patients and populations,” Jorgensen added.


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.

Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

C-Path Awarded FDA Grant to Establish Public-Private Partnership to Advance Treatments for Rare Neurodegenerative Diseases

TUCSON, Ariz., Sept. 14, 2022 — Critical Path Institute (C-Path) has announced it will serve as the convener of the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a new public-private partnership (PPP) to benefit people across multiple rare neurodegenerative diseases, supported by a grant from the U.S. Food and Drug Administration (FDA). The Agency announced the PPP today in a press release.

“These innovative and collaborative approaches are needed to accelerate medical product development for the benefit of individuals living with these rare diseases, and their families,” said Wainwright Fishburn, C-Path Board Chair. “I am thrilled about this partnership that will strengthen collaborations between C-Path, FDA and NIH, and bring together a diverse group of stakeholders.”

C-Path’s proven proficiencies will be leveraged to ensure the success of this effort, specifically the organization’s track record in generating tangible solutions that have accelerated drug development in numerous diseases. This, together with the capabilities of its Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP ®) to integrate multiple patient-level data sources across rare diseases, will provide the foundation for leveraging advances in basic and clinical sciences, supported by NIH, and innovative regulatory science, supported by FDA.

In June, the FDA unveiled its Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) — a five-year strategy for improving and extending the lives of people with rare neurodegenerative diseases, including ALS, by advancing the development of safe and effective medical products and facilitating patient access to novel treatments. The plan was developed in accordance with the provisions of the Accelerating Access to Critical Therapies for ALS Act, including the requirement to establish a public-private partnership this fiscal year.

“It is an honor for C-Path to be part of this transformative partnership with FDA and NIH. CP-RND will leverage all five of C-Path’s core competencies — data management and standards, quantitative analytics and modeling, biomarkers, clinical outcome assessments and regulatory science — as well as C-Path’s concentration areas from its neuroscience/neurology, pediatrics, and rare disease programs,” explained Klaus Romero, M.D., M.S., F.C.P., C-Path’s Chief Science Officer and Executive Director of Clinical Pharmacology. “This partnership with FDA and NIH will positively transform medical product development and make CP-RND a template for comprehensive and meaningful collaborative science.”

As with previous PPPs at C-Path, CP-RND will provide a neutral environment for pre-competitive collaboration including, but not limited to industry, patients, advocacy groups, academia, non-profit organizations, and others, to come together and actively contribute to advance promising solutions for the benefit of these communities. To learn more about C-Path’s CP-RND, visit https://c-path.org/programs/cp-rnd and contact the team at CP-RND@c-path.org.

 


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.

Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

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.

Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

C-Path European Nonprofit Established in Amsterdam

C-Path in Europe works seamlessly with its U.S. counterpart to advance the development of novel regulatory-endorsed methodologies to accelerate medical product development

AMSTERDAM and TUCSON, Ariz., March 23, 2022 — In support of Critical Path Institute’s (C-Path) mission to catalyze innovation that accelerates the path to a healthier world, C-Path is excited to announce the opening of its EU nonprofit headquarters in the Netherlands, which will focus on the development of existing and future activities in Europe.

C-Path is recognized globally as a leader in regulatory science, with extensive knowledge and experience in seeking and obtaining regulatory endorsement of drug development tools (DDTs) or novel methodologies in cooperation with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). All C-Path regulatory-endorsed tools and methodologies are freely available to the broader scientific community.

The nonprofit’s headquarters in Amsterdam will extend and complement C-Path’s activities to improve public health, as well as share expertise, data, risks and costs to expedite advancements in global regulatory science by facilitating public-private partnerships with members from the biopharmaceutical industry, government regulatory agencies, academic institutions and patient groups in Europe.

“C-Path already has an established and longstanding presence in Europe,” said C-Path Board Member, Tomas Salmonson, Ph.D., M.S., and former Chair of the EMA Committee for Medicinal Products for Human Use (CHMP). “We look forward to facilitating existing and new collaborations to productively support European Regulatory Science research programs and also contribute to the delivery of the EMA Regulatory Science Strategy to 2025.”

Since its inception in 2005, C-Path has worked to forge relationships and collaborations in Europe in tandem with U.S. efforts to facilitate global collaboration. Since then, C-Path has received a significant number of Qualification Opinions and Letters of Support from EMA and has a substantial track record of successful DDT and novel methodology endorsements by FDA, EMA and PMDA. These regulatory milestones have contributed to addressing different unmet needs in medical product development, which have transformed drug development in different areas (among others, tuberculosis, polycystic kidney disease, Alzheimer’s, Parkinson’s, and irritable bowel syndrome).

“Advances in drug development are rapidly playing out on a global stage, and C-Path’s extensive background in accelerating the drug development and regulatory processes will fuel innovation for the development of novel approaches that can be endorsed by regulators in many countries,” said C-Path Chief Science Officer Klaus Romero, M.D., M.S., F.C.P. “Working together with European organizations remains a key C-Path priority. We’re excited to have an office in Amsterdam, which we know will serve to enhance our collaborative efforts and speed the development of treatments for some of the world’s most complex health issues.”

An informative webinar, C-Path in Europe: Moving Global Regulatory Science Forward, is scheduled for April 20, 2022. Register here.

To learn more, visit: https://c-path.org/c-path-in-europe.


 

About C-Path

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.

In the U.S., Critical Path Institute is supported by the Food and Drug Administration (FDA) of the 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.

 

Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

C-Path and the European Joint Programme on Rare Diseases to Expand Global Impact and Partnership

PARIS, France and TUCSON, Ariz., U.S., February 1, 2022 — Critical Path Institute (C-Path), an independent global nonprofit organization, and the European Joint Programme on Rare Diseases (EJP RD), an initiative that has received funding from the European Union’s Horizon 2020 research and innovation programme, have announced a collaboration to advance technologies and methodologies that are fit for regulatory purposes to further global rare disease research and drug development.

C-Path has a proven track record in establishing public-private-partnerships that positively impact the process of medical product development in rare diseases. EJP RD promotes integration, efficacy, production and social impact of research in rare diseases. In this context, EJP RD and C-Path have successfully established a collaboration using a shared data model to demonstrate that key datasets from both efforts can be queried simultaneously.

“Collaboration is a foundational principle of success to address unmet needs in medical product development in rare diseases,” said C-Path Chief Science Officer Klaus Romero, M.D., M.S., F.C.P. “As novel approaches are vital to address these unmet needs, our partnership with EJP RD will expand our global capabilities in collaborating for methodologies and technologies to accelerate research with tangible impact for individuals and their families living with rare disease.”

Building on the experience from the past year , both organizations will support the creation of an interoperable global data ecosystem for rare disease to expedite effective development of new therapies. The partnership will benefit patients, regulators, advocacy stakeholders, researchers and industry.

“The cooperation between EJP RD and C-Path not only allows us to bring our unique expertise together, but also sets the foundation for future joint actions in the data, regulatory and clinical methodology space strengthening capacities of the research and development community in EU and on a global scale,” said EJP RD Coordinator Daria Julkowska, Ph.D., Assistant Director, Thematic Institute of Genetics, Genomics & Bioinformatics, INSERM.


 

About C-Path

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 dozens of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

 

About EJP RD
The European Joint Programme on Rare Diseases (EJP RD) is a programme aiming to create an effective rare diseases research ecosystem for progress, innovation and for the benefit of everyone with a rare disease. EJP RD supports rare diseases stakeholders by funding research, bringing together data resources & tools, providing dedicated training courses, and translating high quality research into effective treatments.

For more information, please contact info@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.

The European Joint Programme on Rare Diseases is an initiative that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N°825575.

 

Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

Launch of UNITE4TB Partnership Marks a New Era in Tuberculosis Treatment Development

The partnership will accelerate the development of new Tuberculosis (TB) drug regimens as part of the Innovative Medicines Initiative (IMI), a public-private European Research & Development Consortium

TUCSON, Ariz., July 15, 2021 — To advance anti-tuberculosis (TB) science and enable the progression of new, safe, and affordable treatment solutions for TB patients worldwide, a new consortium of 30 partners from 13 countries has officially launched. The 7-year, €185 million project called UNITE4TB, aims to accelerate and improve the clinical evaluation of combinations of existing and novel drugs, with the goal of developing new and highly active TB treatment regimens for drug-resistant and -sensitive TB.

UNITE4TB is the newest project of the IMI AMR Accelerator, a public-private collaboration with the shared goal of progressing the development of new medicines to treat or prevent resistant bacterial infections.

“Tuberculosis is a major threat to public health worldwide. By bringing together leading experts from the public and private sectors in Europe and beyond, UNITE4TB is well placed to deliver results that will accelerate the development of better treatment regimens to tackle this disease,” says Dr. Pierre Meulien, Executive Director of IMI.

Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). The growing emergence of multidrug-resistant TB is well-recognised as a public health challenge and has sparked new interest and investment in anti-TB drug development. Despite increased activity in the field, an integrated approach to TB drug development is still limited.

With European Federation of Pharmaceutical Industries and Associations (EFPIA) and Associated Partners on board, UNITE4TB has access to the majority of the most innovative TB compounds, currently in late pre-clinical, clinical phase 1, and early phase 2 stage. The consortium will deliver an efficient, global clinical trials network equipped to conduct phase 2 trials. State-of-the-art adaptive trial designs will be implemented, and advanced modelling, artificial intelligence and machine learning techniques will be employed. All of this will allow for the selection and testing of novel combination regimens with a high probability of success in subsequent phase 3 clinical trials.

Anja Karliczek, Germany’s Federal Minister of Education and Research, says: “Europe’s UNITE4TB project creates an important new platform for research to combat tuberculosis. Science and industry will jointly test their clinical candidates and share research results. The objective is to develop effective combinations for new, urgently needed solutions to treat tuberculosis. This public-private partnership will set a new standard in the fight against global diseases such as TB. UNITE4TB is a remarkable example of international research collaboration. I am delighted that Germany is supporting the consortium with funding of around 25 million euros to the two German partners. I am confident that UNITE4TB will contribute towards achieving the goal of ending tuberculosis by 2030 that was adopted by the G20 Heads of State and Government at the UN General Assembly.”

Critical Path Institute, Ltd. (Ireland) is a wholly owned subsidiary of Critical Path Institute, an independent, nonprofit established as a public-private partnership. C-Path, Ltd. will lead the data sharing workgroup for UNITE4TB and will be assisting with machine learning and artificial intelligence efforts. 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. C-Path, Ltd. EU is in Dublin, Ireland, and C-Path U.S. is in Tucson, Arizona. Learn more at c-path.eu and c-path.org.

UNITE4TB is the largest public-private collaboration on clinical TB drug development in the history of the EU. It will set a new standard for anti-TB regimen development, enhancing the efficiency with which new treatments are delivered to TB patients across the world.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute to 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.

For more information and interview requests, please contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org



UNITE4TB is a public-private partnership with representation from academic institutions, small- and medium-sized enterprises (SMEs), public organisations, and pharmaceutical companies. Over the next 7 years, the consortium will be active in approximately 40 trial sites on four continents (Europe, Asia, Africa and South America), with the goal of delivering novel phase 2 clinical trials that will accelerate the development of new TB drugs and regimens. Achieving this goal will facilitate fulfilment of one of the main unmet needs in the TB field: better-tolerated drug regimens of shorter duration that can be deployed to tackle tuberculosis across various drug-resistance patterns and co-morbidities. For more information, visit the Consortium website: www.unite4TB.org

Consortium partners

Academic/SME partners

  • Stichting Radboud Universitair Medisch Centrum (Radboudumc) (The Netherlands)
  • London School for Hygiene and Tropical Medicine (LSHTM) (United Kingdom)
  • University of Oxford (United Kingdom)
  • Forschungszentrum Borstel, Leibniz Lungenzentrum (Germany)
  • Lygature (The Netherlands)
  • Lancaster University (United Kingdom)
  • University College London (United Kingdom)
  • TASK (South Africa)
  • Vita-Salute San Raffaele University (UniSR) (Italy)
  • Helmholtz Zentrum München (Germany)
  • KNCV Tuberculosis Foundation (KNCV) (The Netherlands)
  • Critical Path Institute, Limited (Ireland) 
  • European Lung Foundation (United Kingdom)
  • Instituto de Saude Publica da Universidade do Porto (ISPUP) (Portugal)
  • University of Liverpool (United Kingdom)
  • Institut de Recherche Pour le Developpement (France)
  • University of Hamburg (Germany)
  • University of California San Francisco (UCSF) (USA)
  • TB Alliance (USA)
  • FIND (Switzerland)
  • University of Milano (UMIL) (Italy)
  • University St Andrews (United Kingdom)
  • Uppsala University (Sweden)
  • European Respiratory Society (Switzerland)
  • TBnet (Germany)

EFPIA/Associated Partners

  • GlaxoSmithKline Investigación y Desarrollo S L (GSK) (Spain)
  • Janssen Pharmaceutical (Belgium)
  • Otsuka Novel Products GmbH (Germany)
  • Deutsches Zentrum für Infektionsforschung (Germany)
  • LMU University Hospital Munich (Germany)

View a detailed overview of all partner information on the UNITE4TB website

C-Path Announces Health Care Leader Appointment to Board of Directors

TUCSON, Ariz., July 8, 2021 — Critical Path Institute (C-Path) today announced the appointment of health care industry leader and active civic involvement pioneer Mara G. Aspinall, MBA, to its Board of Directors.

Aspinall is Managing Director and Co-Founder of BlueStone Venture Partners, LLC, a venture fund investing in life sciences technology companies in the U.S. Southwest. She also serves as CEO of Health Catalysts Group, a consulting firm dedicated to the growth of health information technology and diagnostics firms and publisher of the popular Health Catalysts Diagnostics Year in Review. During the pandemic, Aspinall served as an advisor to The Rockefeller Foundation on COVID testing.

“Mara is a long-time supporter of C-Path’s work and we’re thrilled to have her join the Board at this exciting and important new phase of evolution for C-Path,” said Board Chairman Wainwright Fishburn. “The addition of Mara complements our Board’s skills and experiences, and we are confident she will provide valuable industry perspective. We look forward to her engagement in guiding our strategic initiatives and being the catalyst for innovation that accelerates the path to healthier world.”

Aspinall has extensive experience in the risk-based capital industry. In addition to BlueStone, she has served as advisor on life sciences transactions for private equity firms. At Blue Cross Blue Shield Arizona, Aspinall chaired the Board for its strategic corporate venture fund, Trinnovate Ventures.

As President and CEO of Tucson-based Ventana Medical Systems, now Roche Tissue Diagnostics, Aspinall led her world-class team to new financial success, more than two dozen major instrument and assay launches as well as global leadership in companion diagnostics. Previously, she served as President of Genzyme Genetics and Genzyme Pharmaceuticals. Genzyme Genetics grew into one of the country’s leading diagnostic testing companies and was sold to LabCorp for $1 billion.

“I believe C-Path’s leading-edge approach to medical product development creates profound contributions that impact patients’ lives,” said Aspinall. “Their development of actionable solutions through an innovative, collaborative approach in the sharing of data and expertise is a major driver of change. I look forward to working with the Board to create value, drive consensus and generate the confidence necessary to support the adoption of solutions by sponsors and regulators.”

A leader in educating payers and policymakers on personalized medicine, Aspinall served on the Health and Human Services Secretary’s Advisory Council on Genetics, Health & Society (SACGHS) in the Bush and Obama administrations. With a passion for education about the importance of diagnostics in health care, Aspinall co-founded the School of Biomedical Diagnostics at Arizona State University, the first and only program dedicated to diagnostics as an independent discipline.

Aspinall was named Arizona Bioscience Leader of the Year by the Arizona Biotechnology Association in 2016, one of “100 Most Inspiring People in Life Sciences” by PharmaVOICE magazine and one of Women Inc’s Most Influential Corporate Board Directors. She started her business career at the strategic consulting firm Bain & Company. Aspinall holds an MBA from Harvard Business School and a BA from Tufts University.

Aspinall’s Board appointment begins immediately. She is also a Board of Directors member on Abcam, Allscripts, Castle Biosciences, OraSure, AZBio and Blue Cross Blue Shield Arizona.

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 56.5% funded by FDA/HHS, totaling $16,749,891, and 43.5% funded by non-government source(s), totaling $12,895,366. 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. For more information, please visit FDA.gov.


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 dozens of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and  c-path.eu.

Contact:
Kissy Black
C-Path
615.310.1894
kblack@c-path.org

C-Path Welcomes Alphabet Clinical Policy and Strategy Head, Former FDA Commissioner to Board

TUCSON, Ariz., May 19, 2021 — Critical Path Institute today announced the appointment of Robert M. Califf, MD, MACC, head of Clinical Policy and Strategy for Google parent company Alphabet’s Verily Life Sciences and Google Health divisions, to C-Path’s Board of Directors. Califf served as the U.S. Food and Drug Administration (FDA) Commissioner under President Barack Obama’s administration from 2016-2017.

A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.

“It’s an honor to join C-Path’s Board, as its organizational mission and vision align with my conviction that collaborative science is a key component of translating computing and technology into better health and health care,” said Califf. “My roles at Verily and Google Health support this, and I know I will draw from my experience to help C-Path continue to innovate and accelerate the path to drug development and approval.”

Califf has a long history with Duke University and, until November 2019, was founding director of Forge, Duke’s center for actionable health data science and Vice Chancellor for Health Data Science. Included in his tenure at Duke are the Donald F. Fortin, M.D., Professor of Cardiology in the School of Medicine, Vice Chancellor for Clinical and Translational Research and founding director of the Duke Clinical Research Institute, which he helped grow into the nation’s largest academic clinical research organization.

Within the FDA, Califf served as Deputy Commissioner for Medical Products and Tobacco where he provided executive leadership to the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health and Center for Tobacco Products. He also oversaw the Office of Special Medical Programs and provided direction for cross-cutting clinical, scientific and regulatory initiatives, including personalized medicine, orphan drugs, pediatric science and the advisory committee system. He was appointed Commissioner in February 2016 where he was committed to strengthening programs and policies that enabled the agency to carry out its mission to protect and promote the public health.

“We are excited to welcome Dr. Califf to C-Path’s Board. For decades, Rob has been an influential voice in stressing the importance of, and driving, public-private partnerships in the health industry,” said Board Chairman Timothy R. Franson, M.D. “Partnerships and collaboration are the foundation of C-Path’s work, and we know his contributions will make a significant difference in C-Path’s aim to transform the medical product development process.”

Califf has led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH Health Care Systems Research Collaboratory – Coordinating Center and was co-PI of the Patient-Centered Outcomes Research Institute Network.

He is a member of the National Academy of Medicine (formerly known as the Institute of Medicine (IOM)), one of the highest honors in the fields of health and medicine, and has served on numerous IOM committees and as a member of the FDA Cardiorenal Advisory Panel and FDA Science Board’s Subcommittee on Science and Technology. Califf has also served on the Board of Scientific Counselors for the National Library of Medicine, as well as on advisory committees for the National Cancer Institute, the National Heart, Lung, and Blood Institute, the National Institute of Environmental Health Sciences and the Council of the National Institute on Aging. He remains an Adjunct Professor at Duke and Stanford University.

“Rob’s deep expertise and passionate commitment to breaking down research and data silos have been transformational in creating technical, scientific and regulatory alliances in life sciences and health care,” said C-Path President and COO Kristen Swingle, M.S. “The Board and I look forward to working closely with Rob as we advance C-Path’s comprehensive approach to seeking solutions for unmet needs in the treatment of various diseases and conditions.”

Califf’s Board appointment begins immediately.

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 55% funded by FDA/HHS, totaling $14,575,306, and 45% funded by non-government source(s), totaling $11,916,747. 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. For more information, please visit FDA.gov.

 


 

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 dozens of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and  c-path.eu.

Contact:
Kissy Black
C-Path
615.310.1894
kblack@c-path.org

C-Path Program and Consortia Leaders Selected to Serve in Sr. Vice President and Vice President Roles

Inish O’Doherty and Sudhir Sivakumaran will lead new programs;
Stephen Joel Coons and John-Michael Sauer move into Sr. VP roles.

 

TUCSON, Ariz., March 10, 2021 — Critical Path Institute (C-Path) today announced it has promoted Inish O’Doherty, Ph.D., to Vice President of the organization’s newly formed Immunology and Hematology Program and Sudhir Sivakumaran, Ph.D., to Vice President for its Neuroscience Program, effective immediately. Both Drs. O’Doherty and Sivakumaran currently serve as Executive Directors of multiple C-Path consortia. Additionally, current Program Officer Stephen Joel Coons, Ph.D., will now serve as Senior Vice President of the Clinical Outcome Assessment (COA) Program and John-Michael Sauer, Ph.D., as Senior Vice President of Translational and Safety Sciences Program.

The promotions and new program groups stem from a reorganization and optimization within C-Path after a year of strategic development planning.

As Vice Presidents, and in partnership with senior leadership, Dr. O’Doherty and Dr. Sivakumaran will guide all operational and scientific activities for the Immunology and Hematology and Neuroscience Programs, respectively. These activities will include supporting and implementing strategic priorities for the various consortia in these programs, and individual working groups within them. Each will also work with key individuals at regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA).

Dr. O’Doherty, a clinical development scientist, has been with C-Path for more than four years, as Executive Director of C-Path’s Type 1 Diabetes (T1D) Consortium and Transplant Therapeutic Consortium (TTC). His work focuses on the pre-competitive development of biomarkers and quantitative tools, which aim to optimize clinical trial design and minimize risk in regulatory decision-making.

Dr. Sivakumaran, a neuroscientist and research and development professional, has nearly 20 years combined experience in academic, pre-clinical and early clinical research and development, and business development. He has been with C-Path since July 2019 and serves as Executive Director of the Critical Path for Alzheimer’s Disease (CPAD) consortium and Interim Executive Director for the Huntington’s Disease Regulatory Science Consortium (HD-RSC).

The Immunology and Hematology Program will include T1D, TTC and the Critical Path for Sickle Cell Disease (CP-SCD) Consortium. The Neuroscience Program will consist of CPAD, HD-RSC, Critical Path for Parkinson’s (CPP) Consortium, Duchenne Regulatory Science Consortium (D-RSC) and the Critical Path to Therapeutics for the Ataxias (CPTA) Consortium.

“Inish and Sudhir are natural selections for these new leadership roles within C-Path,” said C-Path President and CEO Joseph Scheeren, Pharm. D. “They bring deep and insightful experience to the programs and will continue to drive the organization’s strategic leadership and business development initiatives in support of C-Path as the premier advisor to academia, industry, regulators and other partners in the ever-evolving medical product development and regulatory ecosystem.”

The Translational and Safety Sciences Program will focus on drug safety, nephrology, inflammatory bowel disease (IBD), drug repurposing and translational therapeutics, where the COA Program will continue its work on patient-reported outcome measures and other COAs, with an added emphasis on rare diseases.

For three decades, Dr. Coons has focused on incorporating the patient’s voice into the assessment of health and health care. Prior to C-Path, he was a professor in the College of Pharmacy and the Mel & Enid Zuckerman College of Public Health at the University of Arizona. Dr. Coons is a fellow in the American Association of Pharmaceutical Scientists and Professor Emeritus at the University of Arizona.

Dr. John-Michael Sauer is a toxicologist by training with more than 15 years’ experience in drug discovery and development. He has led multiple functional areas across pharmaceutical companies and is dedicated to bringing quantitative translational science approaches to safety assessment, as well as transforming the way we use nonclinical safety data to drive clinical study design and data interpretation. Dr. Sauer is a Research Professor, Department of Pharmacology, College of Medicine, Professor of Practice, James E. Rogers College of Law and Designated Campus Colleague, University of Arizona.

“John-Michael and Stephen are accomplished experts in their respective fields, and we’re honored to have them continue to lead these areas for C-Path,” said Scheeren. “As longstanding members of our leadership team, they have made significant contributions to the growth and success of the organization.”

Reporting directly to Dr. Scheeren, O’Doherty, Sivakumaran, Coons and Sauer will continue to serve on C-Path’s leadership team, “helping to shape the innovative and regulatory pathways to accelerate delivery of therapies for patients in need,” Scheeren said.

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 55% funded by FDA/HHS, totaling $14,575,306, and 45% funded by non-government source(s), totaling $11,916,747. 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. For more information, please visit FDA.gov.


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 dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

Media Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

 

C-Path, Ltd. Announces New Contract with Innovative Medicines Initiative

 

DUBLIN, Ireland, December 3, 2020 — Critical Path Institute, Ltd. (C-Path, Ltd.) announced today a new contract with the Innovative Medicines Initiative 2 Joint Undertaking (IMI2 JU). The new project will leverage C-Path’s global expertise in developing novel product development tools.

“The mission of IMI, to improve health by speeding up the development of, and patient access to, innovative medicines, is carried out through collaborative projects, and each project has taken large steps forward towards reaching this goal,” said Pierre Meulien, IMI2 JU’s Executive Director. “IMI’s new contract with C-Path, Ltd. will identify opportunities to expand the impact of these projects for patients across Europe.”

Novel methodologies, including biomarkers, clinical outcome assessments and disease progression models, are tools that inform regulatory decision-making during the product development process. These tools can decrease clinical trial size and/or duration, inform endpoint selection, increase the patient voice, improve safety monitoring and more, depending on the tool. As a result, product developers have a more efficient process, bringing therapies to patients faster.

“C-Path’s expertise lies beyond leading collaborations that gather consensus among its member organizations,” said Acting Chief Executive of C-Path, Ltd. Graham Higson, M.Sc. “We’ve been uniquely successful in using these collaborations to identify key product development needs, assessing available data, then using that data to develop novel drug development tools.”

Often, these tools can be submitted for endorsement at the regulatory agencies, such as the European Medicines Agency. By doing so, product developers have increased confidence in the tool and are more likely to incorporate it into their development programs. Regulatory endorsed tools are also publicly available on agency websites.


Critical Path Institute, Ltd. (C-Path, Ltd.) is a wholly owned subsidiary of Critical Path Institute (C-Path), 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 dozens of pharmaceutical and biotech companies. C-Path, Ltd. EU is headquartered in Dublin, Ireland, and C-Path US is headquartered in Tucson, Arizona, with additional staff in multiple other locations. For more information, visit www.c-path.org and  c-path.eu.

 

Media Contact:
Kissy Black
C-Path
615.310.1894
kblack@c-path.org