C-Path Appoints Dr. Klaus Romero as Chief Science Officer

 

 

TUCSON, Ariz., March 12, 2020 — The Critical Path Institute (C-Path) today announced the appointment of Klaus Romero, M.D., M.S., F.C.P., as its new Chief Science Officer (CSO) effective April 1, 2020. Dr. Romero, a clinical pharmacologist and epidemiologist with more than 17 years combined experience in academic and pharmaceutical clinical research, translational sciences, pharmacometrics, modeling and simulation and pharmacoepidemiology, has been with C-Path since December 2007. His most recent role has been as Executive Director of Clinical Pharmacology and Quantitative Medicine. He will continue in dual roles as CSO and head of the Quantitative Medicine Program.

As CSO, Dr. Romero will spearhead innovations in research and science by delivering strategic and operational leadership of C-Path’s data-driven nationally and internationally recognized programs in medical product development solutions. In collaboration with senior leadership, he will set the vision for C-Path’s scientific endeavors and ensure that the focus of C-Path’s public-private partnerships stay closely aligned with its mission to accelerate the pace and reduce the costs of medical product development, through innovation in data science, model-informed drug development, patient-centric drug development and precision medicine to optimize the scientific evaluation of the efficacy and safety of new therapies. This will be achieved through strengthening C-Path’s pillars in quantitative medicine, data science, biomarkers, clinical outcome assessment tools and regulatory science.

“With more than 15 years of diverse experience in the drug development space, including demonstrated leadership abilities in heading large programs and cross-functional teams, there are few people who would be equally suited to lead C-Path’s scientific initiatives than Klaus,” said C-Path President and CEO Joseph Scheeren, Pharm. D. “His combination of clinical pharmacology, epidemiology and model and simulation experience, plus his business development expertise and history of fostering meaningful interactions between regulatory agencies, industry, academia and patient groups will be key in enhancing signature C-Path consortia initiatives, while bringing strategic focus to data analytics to drive research and create efficiencies across all stages of drug development.”

During his tenure with C-Path, he has helped lead clinical pharmacology, pharmacoepidemiology and modeling and simulation projects in Alzheimer’s disease, polycystic kidney disease (PKD), tuberculosis, type 1 diabetes, Parkinson’s disease, Duchenne muscular dystrophy, kidney transplantation, Huntington’s disease and cardiovascular drug safety. His work has helped to achieve major milestones, including the first regulatory endorsement by the U.S. Food and Drug Administration and European Medicines Agency of a clinical trial simulation tool for mild and moderate Alzheimer’s disease and the regulatory qualification of the first imaging biomarker for PKD. Dr. Romero’s scientific production with C-Path has resulted in more than 60 peer-reviewed publications related to his work with the Institute.

Reporting directly to Scheeren, Dr. Romero will serve as the Institute’s spokesperson on all scientific matters.

“I am incredibly excited and honored to have been given the opportunity to further serve C-Path in this role. I am proud of our 15-year history, as we have grown from a small group of pioneers into a mature organization of innovators in solutions to expedite medical product development,” said Dr. Romero. “I look forward to advancing and growing our pipeline of collaborative pre-competitive efforts. The era of knowledge management, decision science and personalized medicine represents the right time for C-Path to grow its leadership in transforming smart data into actionable cutting-edge knowledge to de-risk and expedite medical product development.”

Dr. Romero is a fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics, and the International Society for Pharmacoepidemiology. In addition to his duties at C-Path, he serves as Chairman of the Board of Directors for CredibleMeds®. He is fluent in English, Spanish, German and Portuguese, and has a passion for music, designing and playing innovative electric guitars. Dr. Romero is also a Research Associate Professor at the University of Arizona College of Medicine, Adjunct Professor at the College of Health Solutions at Arizona State University, Adjunct Professor at the University of Southern California’s School of Pharmacy and serves on the Scientific Board of Pharos Dx. Dr. Romero received his medical degree from Pontifical Xavierian University, completed his training in Clinical Pharmacology at Columbia National University and holds an MS degree in Epidemiology from the Columbia School of Medicine.

Dr. Romero succeeds C-Path CSO Lynn Hudson, Ph.D., who will retire at the end of March; a position she has held since 2011. Under Hudson’s leadership, C-Path’s scientific consortia and programs have more than doubled.

“It has been an honor to serve as C-Path’s scientific leader for the past decade,” Hudson said. “C-Path continues to reach important milestones and achieve great progress in creating drug development efficiencies that have changed the time and expense it takes to get safe medical products to those who need them. I am incredibly proud of the work done here and I know Klaus will be a key player in C-Path’s future success.”


 

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 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.

 

Contact:

Kissy Black
615.310.1894
kissyblack@c-path.org

C-Path Selects Experienced Neuroscientist to Lead Alzheimer’s Consortium

 

 

TUCSON, Ariz., March 12, 2020 — The Critical Path Institute (C-Path) today announced it has named Sudhir Sivakumaran, Ph.D., as Executive Director of its Critical Path for Alzheimer’s Disease (CPAD) consortium effective immediately. 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, phase 1 and phase 2 clinical study design, data analysis and diligence and business development. He has been with C-Path since July 2019 as Associate Director for CPAD.

As Executive Director of CPAD, Dr. Sivakumaran will guide all operational and scientific input for the CPAD Consortium and develop and implement the strategic plan and priorities for individual working groups within CPAD. He will work with key individuals at global regulatory agencies including the U.S. Food and Drug Administration, European Medicines Agency and the Pharmaceuticals and Medical Devices Agency. Dr. Sivakumaran will also provide scientific leadership and oversee projects dealing with neuroscience, biomarker qualification, clinical outcome assessment development, data sharing and aggregation related to utility of modeling and simulation in Alzheimer’s disease (AD).

“We are thrilled that Sudhir has accepted the role of Executive Director of our long-standing Alzheimer’s consortium, CPAD,” said C-Path President and CEO Joseph Scheeren, Pharm. D. “He brings a wealth of experience to the program and in the short time Sudhir has been with C-Path, he has stepped up to continue to drive CPAD’s initiatives to create new tools and methods to increase the efficiency in the development process of new treatments for AD and related neurodegenerative disorders. With Sudhir leading CPAD, I know we’ll continue to enhance our already ample collaborative efforts with our agency, industry and patient organization partners in this area.”

Dr. Sivakumaran previously held positions as Associate Director, Research Management at Aptinyx, Inc. in Greater Chicago and Senior Manager, External Partnerships & Alliances, Neuroscience at Pfizer, Inc. in Cambridge, Mass. He has published more than a dozen peer-reviewed publications and was the recipient of multiple research grants and awards including the Epilepsy Foundation & American Epilepsy Society Post-doctoral Training Fellowship, Integrated Pilot Award from BU-CTSI, Academy of Finland Research Grant and the CURE Young Investigator Travel Award among others. He speaks English, Tamil, and Italian and his interests include traveling the world, long road trips and exploring and enjoying world cuisine. Dr. Sivakumaran holds a doctorate in neuroscience from SISSA/ISAS in Trieste, Italy and an M.Sc. and B.Sc. in microbiology from Univ. of Madras in India.

“I am very excited to be at C-Path and for the opportunity to lead the CPAD consortium,” said Dr. Sivakumaran. “Alzheimer’s disease is globally one of the most devastating diseases for millions of people and their loved ones. We are at a game changing moment in finding meaningful and effective therapeutic options in AD. An organization like C-Path, and its consortium CPAD, provides a great opportunity for us to come together within a neutral, pre-competitive environment in partnership with industry experts, regulatory agencies and patient organizations and work towards finding effective solutions for the most pressing needs and de-risk the drug development process in AD. I look forward to continuing to work with everyone at C-Path and beyond, towards refining and redefining our future course of action in AD drug development.”

Reporting directly to Scheeren, Dr. Sivakumaran will serve on C-Path’s leadership team, which is responsible for the overall strategic direction of the Institute.


 

About CPAD
CPAD’s mission is to accelerate the drug development process for patients with chronic neurodegenerative disease leading to dementia. Its primary focus is on AD. CPAD works with industry, regulatory authorities, and patient advocacy organizations to advance Drug Development Tools for evaluating drug efficacy and safety, to optimize novel clinical trial designs, and aggregating anonymized patient-level data using CDISC consensus standards to facilitate the regulatory review process.

CPAD has the following areas of pre-competitive focus: (1) regulatory qualification of biomarkers (2) development of CDISC data standards for AD endpoint assessments, (3) creation of integrated databases for observational and clinical trials data, and (4) development of quantitative model-based tools for drug development.

 

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 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.

 

Contact:

Kissy Black
615.310.1894
kissyblack@c-path.org

ERA4TB, an International Consortium to Accelerate the Development of Comprehensive Treatments Against Tuberculosis

C-Path, Ltd. and more than 30 partners from 13 countries participate in the ERA4TB project.

The ERA4TB (European Regimen Accelerator for Tuberculosis) project is a public-private initiative dedicated to the development of drugs against tuberculosis. With a team of more than thirty organizations and a budget of over 200 million euros ERA4TB will focus on developing a new, improved tuberculosis treatment. The partners will share their expertise, knowledge and resources to rapidly progress new candidate drugs into clinical trials.

Tuberculosis is the leading cause of death by an infectious disease worldwide. According to the World Health Organization (WHO), an estimated 10 million people became ill with tuberculosis in 2018, and 1.6 million died. Even though the incidence of tuberculosis is declining, the drug-resistant form constitutes a growing threat to the safety of the world population. It is in this spirit that the UN has pledged to end the tuberculosis epidemic by 2030 through joint action of its member states.

David Barros-Aguirre, Project Lead for ERA4TB and VP and Head of Tuberculosis Research, Global Health R&D, GSK said: “On behalf of the ERA4TB partners, we are very excited about the start of this unique collaborative project in the field of tuberculosis where the expertise from public partners and a pipeline of promising preclinical candidates from pharmaceutical companies merge to accelerate the development of novel clinical candidates. The goal is to deliver an innovative and differentiated combination regimen for the treatment of TB, which can play a key role in the elimination agenda.”

Standard tuberculosis treatment is based on a combination regimen of four drugs that were all developed more than 60 years ago. Treatment lasts for at least six months and, in the case of resistance to the standard drugs, can be as long as two years. The current drugs are inefficient by today’s standards and a new, faster-acting and safer treatment is required to reduce the length of therapy and to overcome the menace of drug-resistant strains. Until now, the development of new drugs has been slow and their incorporation into tuberculosis treatment regimens conducted in a sequential manner.

Stewart Cole, Scientific leader of ERA4TB and President of the Institut Pasteur, said “ERA4TB has assembled an impressive array of resources to seamlessly harness the agility and innovation of academia with the pragmatism and scientific expertise of pharma. I am confident that this powerful European initiative will speed the path to TB elimination.”

ERA4TB is set to change the paradigm of tuberculosis treatment development by abandoning the sequential approach in favor of a parallel pathway, which will allow the simultaneous investigation of more than a dozen drug candidates. By implementing a standardized approach to tuberculosis drug development, that is well coordinated with the collaborations outside Europe, ERA4TB has the potential to optimize, and, more importantly, greatly reduce the development times of the new regimens needed to eliminate this epidemic.

According to Juan José Vaquero, project coordinator from UC3M (University Carlos III Madrid) and leader of the imaging team, “ERA4TB will change the paradigm for the development of new TB drugs by adopting a flexible and modular collaboration scheme in which research efforts can be rapidly mobilized to where they are most needed allowing several molecules to be investigated simultaneously. This will save both time and money.”

ERA4TB is sponsored by the European Union’s Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking and part of the AMR Accelerator umbrella.

About the Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, EFPIA. More information can be found at www.imi.europa.eu.

Acknowledgement

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853989. The JU receives support from the European Union’s Horizon 2020 research and innovation programme, and in-kind support from EFPIA, TB Alliance, Bill & Melinda Gates Foundation and University Of Dundee.

 

Disclaimer

This communication reflects the views of the ERA4TB Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.

 

CONTACTS:

Project Leader: David Barros-Aguirre
Project Coordinator: Juan Jose Vaquero Lopez
Scientific Leader: Stewart Cole

Funded by FDA, C-Path and NORD to Launch Rare Disease Data and Analytics Platform

 

 

The collaborative project between the organizations will kick off at a launch meeting in September and will aim to reduce barriers for the development of new treatments and cures for rare diseases

 

TUCSON, Ariz. and WASHINGTON, August 7, 2019 — The Critical Path Institute (C-Path) and the National Organization for Rare Disorders® (NORD) will host a meeting on Tuesday, September 17 in Bethesda, MD to formally launch development of a new rare disease data and analytics platform. Funded by a cooperative agreement through the Food and Drug Administration, [Critical Path Public-Private Partnerships Grant Number U18 FD005320  from the US Food and Drug Administration] the goal of the platform is to accelerate the movement of therapies from bench to bedside for rare diseases. The platform will provide the infrastructure for a sustainable, cooperative scientific approach to clinical trial readiness in rare diseases by addressing vast knowledge gaps about the natural course of disease, the clinical evaluation of new treatments, and patients’ perspective on disease and treatment.

The Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP) will provide a centralized and standardized infrastructure to support and accelerate rare disease characterization with the goal of accelerating therapy development. The robust integrated platform will include integrated rare disease data from various sources such as clinical trials, observational studies, real world data and patient registries — including those within NORD’s IAMRARE registry platform — and an analytics platform that will allow efficient and effective interrogation of that data to generate solutions to inform clinical trial design and regulatory review.

“For people living with rare diseases, time is of the essence,” said Joseph Scheeren, PharmD, C-Path President and Chief Executive Officer. “By leveraging the rare disease community access and data of NORD and the data curation, aggregation, governance and advanced analytics expertise of C-Path, we are poised to make a significant impact on rare disease drug development by providing quality data that will inform clinical trial design and accelerate the development of therapies.”

“Currently, more than 25 million people in the United States are affected by one or more of the over 7,000 rare diseases,” stated Peter L. Saltonstall, NORD President and Chief Executive Officer. “Drug development for these diseases is often impeded due to the low affected patient numbers and a limited understanding of how rare diseases progress or how to measure clinical improvements. FDA-approved treatments exist for only 10% of rare diseases; with this collaboration we can change that statistic for the better for our rare community.”

Meeting attendees will include representatives from across the community including regulators, patient organizations, clinicians, researchers and pharmaceutical companies interested in rare disease drug development. Attendees will have the opportunity to learn about the goals of the RDCA-DAP and how to engage in the early stages of this effort.

Register for the meeting here; https://bit.ly/2YOj3jl

 


 

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 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.

 

About the National Organization for Rare Disorders (NORD)®
The National Organization for Rare Disorders (NORD)  is the leading independent advocacy organization representing all patients and families affected by rare diseases. NORD is committed to the identification, treatment and cure of the more than 7,000 rare diseases, of which approximately 90% are still without an FDA-approved treatment or therapy. NORD began as a small group of patient advocates that formed a coalition to unify and mobilize support to pass the Orphan Drug Act of 1983. For more than 35 years, NORD has led the way in voicing the needs of the rare disease community, driving supportive policies and education, advancing medical research and providing patient and family services for those who need them most.  NORD is made strong together with over 275 disease-specific member organizations and their communities and collaborates with many other organizations on specific causes of importance to the rare disease community. For more information, visit rarediseases.org.

 

Media Contacts:

Kissy Black
C-Path
615.310.1894
kissyblack@lotosnile.com

Laura Mullen
NORD
203.304.7258
lmullen@rarediseases.org

C-Path Taps Medical Science Operations Executive Kristen Swingle as Chief Operating Officer

 

 

TUCSON, Ariz., July 2, 2019 — The Critical Path Institute (C-Path) is pleased to announce that after an extensive search, it has appointed Kristen Swingle as its new Chief Operating Officer, effective July 1, 2019.

Swingle, who previously served as Vice President of Stem Cell Operations for Cord Blood Registry (CBR), a part of California Cryobank Life Sciences, specialized in newborn stem cell collection, processing and cryopreservation, brings nearly two decades’ worth of experience in the medical and molecular sciences industry to bear in her new role as she leads the daily operations of the organization and development and implementation of C-Path’s global strategy and goals.

“We are excited to welcome Kristen to C-Path,” said C-Path President and CEO Joseph Scheeren, PharmD. “She is joining C-Path at an important time for our organization, when we are growing and making incredible progress in numerous areas of critical unmet medical need. I look forward to working with her as we continue to push the boundaries of research in order to bring about innovative tools to expedite the development of treatments and cures for some of the world’s most relentless, rare and devastating diseases and medical conditions.”

Selected as one of the top 500 Arizona Business Leaders for 2017 by Arizona Business Leader publication, one of only five leaders named in the Bioscience category, Swingle began her career as a research and development specialist, but quickly moved into operations roles which highlighted her skills in product development and manufacturing, quality and regulatory affairs management, project and fiscal management, and team leadership.

“The strength of C-Path’s work is in the way multidisciplinary teams from across the pharmaceutical industry, patient organizations, disease foundations, academia and regulatory agencies come together in a neutral environment to achieve a common goal,” said Swingle. “I am equally honored and excited to bring my leadership experience to C-Path as it develops new approaches to advance medical innovation and regulatory science, and I look forward to working with our staff and collaborators in accelerating the path to a healthier world.”

In 2005, Swingle moved to Cord Blood Registry (CBR), in Tucson, Arizona, where she held a variety of positions, culminating in her appointment in 2018 as Vice President, Stem Cell Operations and Tucson Facility. In this role, she oversaw stem cell manufacturing and quality operations and served as the site head for the Tucson facility which houses a stem cell laboratory, cryobank and call center operations. There she led nearly 200 employees across varying business units, including Laboratory and Quality Operations, Inside Sales, Customer Service, Technology, Human Resources and Finance.

Among Swingle’s long list of accomplishments is being named Chairwoman of AZBio Board of Directors in 2018 and serving as the 2017 Chair of the AMAG Women’s Network Steering Committee, with a mission to support the professional development of women within the healthcare industry.

Swingle holds a BS in Biology from Northern Arizona University and Master of Science (MS), Medical Sciences from Texas A&M University.

Swingle succeeds COO Steve Broadbent, MBA, who has held the position since 2012. Under Broadbent’s strategic leadership, C-Path’s revenue, number of employees, and the number of consortia it operates have more than doubled. Broadbent will continue to serve as a C-Path Special Operations Advisor until September to ensure a seamless transition.

 


 

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 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 remote locations. For more information, visit c-path.org and c-path.eu.

 

Media Contact:

Kissy Black
615.298.1144
kissyblack@lotosnile.com

C-Path, CDISC Develop Therapeutic Area Standard to Foster More Efficient and Meaningful Research for HIV

 

 

TUCSON, Ariz. and AUSTIN, April 16, 2019 — The Critical Path Institute (C-Path) and CDISC are pleased to announce the release of a global Therapeutic Area Standard that specifies how to structure commonly collected data and outcome measurements in clinical trials for HIV. The standard, released in the form of User Guide for data managers, statisticians, programmers and study managers, covers the areas of prevention, vaccines and treatment and is freely available on the CDISC website.

CDISC Therapeutic Area User Guides (TAUG) provide examples and guidance on implementing CDISC standards to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

HIV, the virus that causes AIDS, is one of the world’s most serious health and development challenges. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), there were approximately 36.9 million people worldwide living with HIV/AIDS at the end of 2017. Of these, 1.8 million were children (<15 years old).

Implementing this standard will allow HIV data to be structured effectively and easily analyzed, leaving more time for researchers to focus on discoveries that will have invaluable impact on clinical research and global public health. This standard will also promote data harmonization across a wide range of studies in HIV, which will facilitate collaboration and cross-study analyses to ensure the highest return on research investments.

“We were honored to be a part of the amazing team working on the development and publication of the new Therapeutic Area User Guide for HIV clinical trials,” said C-Path President and CEO Martha Brumfield, Ph.D. “The importance of these standards cannot be underscored enough. We encourage the research community to rapidly adopt this information in their studies, as structuring data in a common format is key to supporting the development of additional drug development tools and therapies for HIV/AIDS.”

“Collaboration and inclusivity have always been bedrocks of CDISC’s culture. It’s why we convene a global community of experts from across the research spectrum and facilitate the development of standards that are open and available to all, enabling data sharing around the world,” said David R. Bobbitt, CDISC President and CEO. “The development of this important standard has benefitted from the input of a diverse set of collaborators to tackle a critical public health issue.”

This CDISC Therapeutic Area standard for HIV was developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), the U.S. Food and Drug Administration (FDA), TransCelerate, the Japan Pharmaceutical and Medical Devices Agency (PMDA) and additional stakeholders. The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) was a major partner in the development of this User Guide. The goal of the CFAST initiative is to accelerate clinical research and medical product development by creating and maintaining data standards, tools and methods for conducting research in therapeutic areas that are important to public health. This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201700078C and the US FDA through grant 1U01FD005876.

CDISC standards have been adopted and used in more than 90 countries. To date, TA standards have been developed for over 30 disease areas.

 


 

About C-Path

C-Path (Critical Path Institute) 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 over 1,500 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path is headquartered in Tucson, Arizona, with additional staff in multiple remote locations. For more information, visit www.c-path.org.

 

ABOUT CDISC

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world. www.cdisc.org.

 

Contacts:

Kissy Black
615.298.1144
kissyblack@lotosnile.com

Ann P. White
+1.512.363.5826
awhite@cdisc.org

C-Path Selects Global Regulatory Affairs Leader as New President and CEO

TUCSON, Ariz., March 21, 2019 — After a worldwide search, the Critical Path Institute (C-Path) today announced it has appointed Joseph Scheeren, Pharm. D., as its new President and Chief Executive Officer. Scheeren previously served as Senior Advisor Research and Development for Bayer AG and has had a distinguished 36-year career in the pharmaceutical industry having held positions domestically and internationally in drug development and regulatory approval on three continents.

“Dr. Scheeren exemplifies the in-depth knowledge and inspiring leadership that C-Path, and every organization we collaborate with, deserve in a chief executive officer,” said C-Path Board Chairman Timothy R. Franson, M.D. “His global experience with drug development and the regulatory process is evidenced by a long list of first cycle approvals for new therapies and we couldn’t be more thrilled to welcome him to C-Path.”

Scheeren joined Bayer Pharmaceuticals as Senior Vice President, Head of Global Regulatory Affairs, in 2004, responsible for development in the US and in 2009 became Site Head US in Montville, NJ. In 2012, he assumed the position of Head of Global Development Asia in Beijing and in 2015, was appointed Head of Global Regulatory Affairs Pharma and Consumer Care of Bayer Healthcare, Basel, Switzerland. In January 2018, he was appointed Senior Advisor R&D, Bayer AG. Scheeren’s experience with global regulatory affairs will help C-Path expand its mission worldwide.

“C-Path and its partners define the type of innovation and solutions that healthcare needs now and into the future to provide patients hope and access to new treatments and cures by accelerating innovation in the development and approval pathway,” Scheeren said. “I am committed to continuing C-Path’s success by making new science happen through collaborations and continuing to be a change agent in healthcare.”

Scheeren succeeds C-Path President and CEO Martha Brumfield, Ph.D., who has led the organization since 2013 and is initiating a phased retirement. Under Brumfield’s leadership, C-Path’s funding and staff have doubled, the organization has established a Data Collaboration Center and a center of excellence in quantitative medicine, plus expanded its profile in Europe. Brumfield will serve as a special advisor to Scheeren for six months and will oversee select projects already in progress to ensure a seamless transition.

“C-Path has had outstanding growth since its founding in 2005, when it responded to the call of the FDA’s Critical Path Initiative program,” Brumfield said. “We are confident that this transition under Dr. Scheeren’s leadership will mark yet another key milestone toward our future success. I look forward to supporting him in the coming months.”

Scheeren has an established network of connections across the globe and holds many memberships and designations. He serves on the advisory boards at the Center for Innovation in Regulatory Science, the Center of Regulatory Excellence Singapore, the Research & Development-based Pharmaceutical Association in China, and the China Core Research and Development Committee. He is currently serving as Board chair of the Drug Information Association (DIA) and has served as Chairman of the DIA Regional Advisory Council for Europe, the Middle East and Africa; he is also a foreign member of the Academie Nationale de Pharmacie, France, a lecturer at Yale University and an adjunct Professor at Peking University.

His start date is April 15, 2019 and he and his family will be living in Tucson, Arizona.

 


 

About C-Path:

C-Path (Critical Path Institute) 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 over 1,500 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path is headquartered in Tucson, Arizona, with additional staff in multiple remote locations. For more information, visit www.c-path.org.

 

Media Contact:

Kissy Black
615.298.1144
kissyblack@lotosnile.com

Critical Path Institute Celebrates Expanded Operations with Opening of European Headquarters

 

C-Path in the EU will work to accelerate the development of new therapies through innovative methodologies for endorsement by regulators of pharmaceutical products

TUCSON, Ariz., January 17, 2019 — Critical Path Institute (C-Path) is excited to announce the launch of Critical Path Institute, Ltd. (C-Path, Ltd.) in Ireland, a fully-owned subsidiary that will enable C-Path to increase its activity in the European Union and broaden its global operations as it works to accelerate the development of therapies in a wide range of diseases and medical conditions. As a nonprofit that builds consensus among its stakeholders from around the world to improve public health, the organization shares expertise, data, risks and costs to move regulatory science forward.

As its U.S. counterpart does, C-Path, Ltd. will form consortia of scientists and clinicians from the biopharmaceutical industry, government regulatory agencies, academic institutions and patient groups. These consortia will collaborate to develop novel methodologies — such as biomarkers, clinical outcome assessment instruments, models and clinical trial simulation tools and databases — and will submit evidence packages to European regulatory agencies (as well as agencies in the U.S. and Japan) for review. The novel tools and methodologies will be made freely available to the broader scientific community.

“After our initial startup phase, we anticipate increasing C-Path activities in the European Union,” said C-Path Executive Director, European Office, Graham Higson, M.Sc. “We look forward to bringing our expertise to bear on European Research Infrastructure programmes sponsored by the European Commission, such as those led by the Innovative Medicines Initiative.”

Shortly after it was founded in 2005, C-Path began forging relationships with European entities. In 2007, C-Path’s Predictive Safety Testing Consortium (PSTC) was the first collaboration to submit through the pilot qualification procedures an evidence package for seven kidney safety biomarkers to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In May 2008, EMA issued a qualification statement for these nephrotoxicity biomarkers.

Over the ensuing 10 years, C-Path has received a number of positive qualification opinions from EMA including those for an Alzheimer’s disease imaging biomarker, a disease model of mild to moderate Alzheimer’s, kidney safety biomarkers, the Hollow Fiber System model of tuberculosis, a polycystic kidney disease imaging biomarker, and a Parkinson’s disease imaging biomarker, as well as EMA Letters of Support for skeletal muscle and liver safety biomarkers, and a proposed model-based clinical trial enrichment tool for clinical trials in Amnestic Mild Cognitive Impairment (aMCI).

“Advances in drug development are rapidly playing out on a global stage, and C-Path’s expertise in applying regulatory science fuels innovation and the development of novel methodologies that can be endorsed by regulators in multiple countries like Europe, the U.S. and Asia,” said C-Path President and CEO Martha Brumfield, Ph.D. “C-Path began working together with European organizations early on, and our commitment to Europe remains solid. We’re excited to begin this new chapter, which we know will only serve to enhance our collaborative efforts and speed the achievement of our shared goals.”

 

About C-Path, Ltd., Board of Directors

The C-Path, Ltd. Board of Directors brings a wealth of experience in medical research and innovation, academic leadership, regulatory science and the pharmaceutical and biotech industries.

Enda Connolly, B.A., has held leadership roles in economic development, science and innovation in Ireland for more than 35 years. As chief executive of the Health Research Board, he helped reposition Irish health research by introducing innovative funding initiatives that place emphasis on patient-oriented research. He previously served as a member of the executive team of IDA Ireland. Connolly has worked as a strategic advisor on economic development projects for the governments of Qatar and Saudi Arabia. He currently is chairman of the Board of Beaumont Hospital, and he serves on the boards for RCSI Hospital Group and the Health Information and Quality Authority.

 

John Hegarty, Ph.D., D.Sc., has more than 40 years of experience in research, education, and university leadership. He was a professor of laser physics at Trinity College Dublin, where he served as president/provost from 2001 to 2011. More recently, Hegarty co-founded Innovation Advisory Partners, which focuses on education, research, and innovation policy. He is chair of the Irish Times Trust and a member of the Irish Times Board. He also is a member of the Fulbright Ireland Board and the Hugh Lane Gallery Board, and he chairs the Translational Medicine Institute based in St. James’s Hospital.

 

Graham Higson, M.Sc., has spent more than 35 years in the pharmaceutical industry. He is managing director and owner of GCH Pharma Consulting Ltd, which specializes in the provision of strategic regulatory advice, drug development, regulatory outsourcing and organizational development. He has been a member of both the EFPIA and PhRMA regulatory affairs committees, the CMR Regulations Advisory Board, and the TOPRA Regulatory Advisory Council. Higson will continue to serve as the Executive Director, European Office, for C-Path.

 

Caitriona O’Driscoll, Ph.D., B.Sc. Pharm., is a pharmacist, and professor and chair of pharmaceutics at the School of Pharmacy, University College Cork (UCC), Ireland. O’Driscoll’s research is focused on the design, formulation and characterization of biomimetic drug delivery systems, incorporating the products of the pharmaceutical biotechnology industry such as peptide/protein-type drugs and nucleic acids. She is a board member of the Irish Health Products Regulatory Authority and a founding member and chair of Regulatory Science Ireland.

 

Mary Teeling, M.D. Pharm., is a specialist pharmaceutical physician with more than 30 years’ experience in the areas of pharmacology and pharmaceutical medicine. She developed the Master of Science (MSc) in Pharmaceutical Medicine programme in 2004, while working in Trinity College Dublin, and was course director up until 2018. Currently, she is adjunct professor of pharmaceutical medicine within the department of pharmacology and Therapeutics. She has also worked, or held roles, with the National Medicines Information Centre, the Irish Medicines Board, the EU Committee for Human Medicinal Products, the Royal College of Physicians, the NDA Regulatory Advisory Board and the WHO Uppsala Monitoring Centre.

Visit the Critical Path, Ltd. website at: https://c-path.eu/.

 

 


About Critical Path Institute

C-Path (Critical Path Institute) 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 over 1,500 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path is headquartered in Tucson, Arizona, with additional staff in multiple remote locations. For more information, visit www.c-path.org.

Contact:

Kissy Black
615.298.1144
kissyblack@lotosnile.com
 

Conference Highlights Public Private Partnership Role in Medical Product Development

December 3, 2014 | Download PDF

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Conference Highlights Public Private Partnership Role in Medical Product Development

Global organizations convene cross-sector thought leaders to discuss public-private partnerships


BETHESDA, MD, December 3, 2014—Today, the Critical Path Institute (C-Path) and Innovative Medicines Initiative (IMI) are convening an international group of thought leaders to identify new ways to collaborate and achieve a common goal of a robust regulatory science infrastructure that better supports efficient and productive medical product development. Accelerating the Development of Drugs, Diagnostics and Devices: Partnerships to Expand the Precompetitive Space is the second annual meeting of C-Path and IMI, and will explore key topics around partnerships to advance regulatory science, data-sharing and patient safety biomarkers.

“We are proud to partner with our colleagues at IMI to host a discussion on the role of public-private partnerships,” said Martha Brumfield, Ph.D., president and chief executive officer of C-Path. “No single entity has adequate resources, experience and data to tackle the complex issues in disease areas such as Alzheimer’s, Parkinson’s, schizophrenia, and diabetes. Global, collaborative efforts, along with the early engagement of regulatory authorities, advance innovation in these and other areas of unmet need.”

Public-private partnerships (PPPs) are at the forefront of a cross-sector effort to transform the expensive, time-consuming, high-risk and complicated process that delivers new treatment options. In its second annual conference, the two organizations will explore lessons learned with the PPP model and identify additional ways to leverage resources and avoid duplication of efforts.

“Collaboration is essential if we are to solve the biggest challenges in medicines development and to ensure patients gain rapid access to innovative therapies,” said Michel Goldman, M.D., Ph.D., executive director of IMI. “IMI and C-Path have been working together and sharing best practices for many years now, and this event represents an excellent opportunity to discuss how open collaboration models can contribute to solving medicine’s greatest challenges.”

Three separate panel discussions, moderated by C-Path and IMI, will draw on the perspective of government officials, researchers, regulators, and pharmaceutical industry representatives. The sessions include:

  • Partnerships to Advance Regulatory Science and Leverage Global Biopharmaceutical Development will feature a discussion between Janet Woodcock of the U.S. Food and Drug Administration (FDA), Dalvir Gill of TransCelerate BioPharma, William Chin of Pharmaceutical Research and Manufacturers of America (PhRMA) and David Wholley of the Foundation for the National Institutes of Health (FNIH).
  • In session two, Safety Biomarkers: The Predictive Safety Testing Consortium (PSTC) and Safer and Faster Evidence-based Translation (SAFE-T) Collaboration conversation, John-Michael Sauer of C-Path and Michael Merz of Novartis will moderate a discussion with representatives from Merck, Sanofi, the FDA and European Medicines Agency.
  • The third panel, Maximizing the Value of Data Shared by Multiple Organizations, brings together representatives from non-profit organizations and government to discuss ways to maximize the research utility of data.

PPPs have been successfully used to create new data standards and to identify biomarkers in several therapeutic areas, including pressing public health concerns such as Alzheimer’s disease, tuberculosis and kidney safety. “These models are the future of drug development and while significant progress has been made, today’s conversations will certainly push us forward,” said Brumfield.

Michel Goldman added, “Public-private partnerships are now an established feature of the drug development landscape. Today’s meeting will allow us to review what PPPs can do and how we can do even more to contribute to the development of the medicines of the future, for the benefit of patients and society.”



Notes to Editors

The event will be held at the Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. It will also be possible to view the slides and hear the event audio via WebEx: https://pstcevent.webex.com/pstcevent/onstage/g.php?MTID=e6c6c0956270c0c4b7c3cc2d0f8ee970e

Password: Cpath

About the Critical Path Institute

The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA).  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 seven global, public-private partnerships that currently include over 1,300 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies.  C-Path is headquartered in Tucson, Arizona.  For more information, visit www.c-path.org and at @cpathinstitute.

About the Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators.

IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU’s research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources. For more information, visit www.imi.europa.eu and at @IMI_JU.

Contact
C-Path: Catherine Brady at (617) 945-9316
IMI:  Alessandra Paccamiccio at (32) 2 221 8183