Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions

C-Path’s Crohn’s Disease Biomarkers Pre-Consortium funded by The Helmsley Charitable Trust is proud to announce its first publication in the journal Inflammatory Bowel Diseases titled, “Biomarkers of Crohn’s Disease to Support the Development of New Therapeutic Interventions.” The result of collaboration among experts in Crohn’s disease, including academia, health care institutes, foundations, public advocacy groups, industry and regulatory bodies, this work has identified biomarkers that can be used as drug development tools to advance clinical trials in IBD and potentially improve patient care.

Free access: https://academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izaa215/5896885?guestAccessKey=70d1e3c0-2aaf-4d65-b1bb-292f7df3b625

C-Path and Lundbeck Announce a Data Sharing Collaboration to Enable Development of Advanced Drug Development Tools in Alzheimer’s Disease

 

 

TUCSON, Ariz., March 18, 2020 — The Critical Path Institute (C-Path) and H. Lundbeck A/S (Lundbeck) are proud to announce that they will work together to significantly improve the scientific community’s insight in Alzheimer’s disease (AD) through Lundbeck’s contribution of a unique set of clinical trial data from more than 2,500 AD patients to the Critical Path for Alzheimer’s Disease (CPAD) consortium’s integrated database for qualified researchers across the globe to access.

The Data Contribution Agreement (DCA) between Lundbeck and C-Path, with support from Gates Ventures, will allow for these clinical data to be integrated and managed by CPAD, with support from C-Path’s Data Collaboration Center (DCC) adding to the CPAD patient-level database in AD, which presently contains data from more than 14,500 patients. CPAD is currently exploring acquisition of contemporary datasets from other sources with an expected growth of the CPAD database to include more than 40,000 patient-level records in the coming months.

This contribution of patient-level data from Lundbeck embodies Lundbeck’s continued support to increase pre-competitive collaborations between pharmaceutical companies and academia, and to advance effective public-private partnerships. Generous contributions such as these ensure that CPAD can continue its mission to develop innovative quantitative tools and methods to de-risk and speed up the drug development process in AD.

These data stem from Lundbeck’s Phase II and III studies that evaluated the compound idalopirdine in AD and include relevant information about disease progression, drug effects and clinical trial design. The shared data are highly valuable and the contribution of this type of data is vitally important to CPAD’s work in developing a disease progression model across the entire continuum of AD, from the earliest to late stages of the disease. CPAD aims to provide advanced drug development tools that will aid in optimizing clinical trial designs and execution and facilitating the regulatory review process.

“Lundbeck and C-Path recognize the hard work to generate these data and contributions of the many patients with Alzheimer disease, their relatives and caregivers, and the investigators who took part in these trials,” said C-Path President and CEO Joseph Scheeren, Pharm.D. “We look forward to continuing to work together to advance and expedite the development of new therapies.”

“We are delighted with this opportunity to share data with CPAD, ensuring that researchers can get the most out of them in advancing the understanding of Alzheimer’s and how to best develop new treatments. We are proud to contribute to this work, not only through our own drug development activities, but also in this unique collaboration,” said Mads Dalsgaard, Senior Vice President, Experimental Medicine & Clinical Development at Lundbeck.

 


 

About Critical Path Institute
C-Path is an independent, nonprofit organization established in 2005 as a public-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’s US headquarters is located 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 H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,500 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centres in Denmark and California and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18,1 billion in 2018 (EUR 2,4 billion; USD 2,8 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.

 

Contact:

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

C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem

 

TUCSON, Ariz., March 17, 2020 — The Critical Path Institute (C-Path) today announced it has been awarded a grant to conduct stakeholder engagement to garner insights, feedback and refinement of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) proposed framework to enhance the pediatric medical device ecosystem and to develop a strategic plan for implementation. Funded by a cooperative agreement through the FDA, C-Path will work in collaboration with CDRH and other stakeholders to organize a workshop to brainstorm on the framework and strategic plan for building a viable ecosystem.

“We are thrilled to be part of this effort and honored to have been selected to work with CDRH to optimize the ecosystem,” said C-Path President and CEO Joseph Scheeren, Pharm.D. “This initiative has our full support and fits in well with our ongoing efforts in the pediatric and neonatal space.”

Currently, there are challenges to advancing promising new pediatric devices from ideation to clinical studies, to regulatory approval, to use for pediatric patients, including:

  • The small numbers of children with any one condition, and their dispersion across the world, making it difficult to conduct clinical trials;
  • The need to consider children’s growth and variably influenced disease mechanisms;
  • The lengthy development timeline and associated high costs;
  • Lack of funding for small inventors and companies;
  • Difficulty in identifying expert resources across the development-to-commercialization continuum.

Modernized regulatory programs and processes developed by CDRH during the past few years have supported a growing number of novel technologies available to improve patient care. In the pediatric area, CDRH has led a public meeting where challenges to innovation were verified and aspects of a supportive ecosystem were discussed. Additionally, CDRH has finalized guidance documents clarifying regulatory issues relevant to pediatric populations and provided millions of dollars to fund pediatric device consortia across the U.S. However, over the past decade, fewer than 10% of high-risk and high-benefit medical devices have been designed, evaluated and labelled for children below the age of 18.

“Today’s health care system has yet to engender a solution to the complex public health issue of medical device development for children and small populations,” said CDRH Chief Medical Officer and Director for Pediatrics and Special Populations Vasum Peiris, M.D., M.P.H. “Novel regulatory options and public-private sector collaboration informed by patient and caregiver perspectives are necessary components to create a sustainable national environment for safe technology innovation that serves the unique needs of children. We welcome input from all stakeholders as we clarify and build on the framework CDRH has proposed to transform traditional thinking around engaging, sustaining and innovating in the pediatric medical device ecosystem.”

Stakeholder groups including the Advanced Medical Technology Association (AdvaMed), the American Academy of Pediatrics (AAP), the Milken Institute, and clinicians, researchers, innovators, payors and patient groups will review and refine the high-level proposed framework developed by CDRH. The framework lays out a vision for an ecosystem that would facilitate the design, development and commercialization of medical devices for children. Through stakeholder input and feedback the framework will be iterated and refined, and goals for the yet to-be-formed multi-stakeholder workgroup – whose objective would be to optimize and complete the design of the ecosystem – will be established.

“There is an opportunity for the FDA, patient advocacy groups, academia and industry to collaborate and optimize design — with the guidance and support of C-Path — of this much needed ecosystem,” said AdvaMed Vice President for Technology and Regulatory Affairs Tara Federici. “Stakeholders will review and evaluate the proposed framework to ensure it could be effective in de-risking and accelerating pediatric medical device development while maintaining existing safety and effectiveness requirements.”

“Children are not small adults — their biology is different. Even so, every day across the nation, the care of children requires the use of many medical devices that were not specifically designed for them,” said Kurt Newman, M.D., President and CEO of Children’s National Hospital and immediate past Chair of the Board of Trustees of Children’s Hospital Association. “Children should be a priority when it comes to healthcare innovation because entire lifetimes are at stake. We commend and support the FDA’s leadership in this effort to create a system that supports innovation for children.”

“Pediatricians often find themselves without the medical or surgical devices they need to care for their patients because medical devices for children can lag five to ten years behind those for adults,” said American Academy of Pediatrics CEO and Executive Vice President Mark Del Monte, J.D. “That time frame is most of an entire childhood. We must do more to get children the devices they need sooner, and innovation is essential to enhance safe and effective options. We applaud those who have come together with that goal in mind and look forward to working with the FDA, C-Path, and other stakeholders to advance device development for children.”

“It is essential to shift the balance of device innovation toward fulfilling the vast unmet needs of children,” said Christopher Lee, former Director of the Milken Institute Center for Financial Markets and co-chair of the FasterCures BRIDGE Initiative, a recently launched program that develops novel models for driving biomedical innovation. “This proposed framework seeks to take this challenge head on by realigning incentives across the system, and we look forward to contributing to that process.”

The project’s initial deliverable, to bring together interested stakeholders to share insights and further refine and develop the proposed framework at the workshop, will occur in the latter part of this year. Specific dates, location, and registration information for the meeting will be released soon. Meeting proceedings and a strategic development plan to enhance the pediatric medical device ecosystem will be developed within six months of the workshop.

This grant is funded by a cooperative agreement through the FDA [Critical Path to Public Private Partnerships Grant Number U18 FD005320]; the grant is administered by the Center for Drug Evaluation and Research (CDER); this project is funded by the Center for Devices and Radiological Health (CDRH). Views expressed in written materials or publications do not necessarily reflect the official policies of the U.S. Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.


 

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 AdvaMed
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit advamed.org.

 


 

About the American Academy of Pediatrics
The American Academy of Pediatrics (AAP) is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit aap.org and follow us on Twitter @AmerAcadPeds

 


 

About Milken Institute
The Milken Institute is a nonprofit, nonpartisan think tank that helps people build meaningful lives, in which they can experience health and well-being, pursue effective education and gainful employment, and access the resources required to create ever-expanding opportunities for themselves and their broader communities. FasterCures is a center of the Milken Institute, with a mission to put patients in the center of the healthcare system, and break down the unnecessary barriers to innovation. For more information, visit milkeninstitute.org.


 

About FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

Contact:

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

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

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
 

CPTR Newsletter – April 2018

 

CPTR Newsletter – April 2018

In this issue:

  1. ReSeqTB to be Adopted for WHO Surveillance of Drug-Resistant TB
  2. New Collaborations Expand TB-PACTS Database and Leverage Data for Analyses
  3. CPTR Workgroup Works to Advance Regulatory Qualification of LAM, a Promising New Biomarker
  4. TB-PBPK Model Progresses Toward EMA and FDA Qualification
  5. TB-ReFLECT Update: A Collaborative Effort to Enhance TB Clinical Research
  6. New Project Launched to Evaluate Adaptive TB Clinical Trial Designs
  7. C-Path Partners with Catalysis Foundation for Health to Establish Database with Visualization and Analytic capabilities

ReSeqTB to be Adopted for WHO Surveillance of Drug-Resistant TB

The Relational Sequencing TB Data Platform (ReSeqTB), a global TB knowledge base for predicting TB drug resistance, will be adopted as the World Health Organization (WHO) bioinformatics platform for sequence-based surveillance of drug-resistant TB (DR-TB). In this new project phase, ReSeqTB will support surveillance and global policy development for sequencing-based clinical diagnosis of DR-TB. It could also serve as a model for the broader goals of establishing global antimicrobial resistance surveillance and clinical diagnosis networks for WHO high-priority pathogens. The development of ReSeqTB has been made possible through the collaboration of WHO, Foundation for Innovative New Diagnostics (FIND), and Critical Path Institute (C-Path) through their participation in the CPTR Initiative. 

“Genetic sequencing is the future of surveillance and diagnosis of DR-TB,” said Dr. Tereza Kasaeva, Director of the WHO Global TB Programme. “With ReSeqTB, sequencing can be used to rapidly and accurately estimate prevalence of resistance to anti-TB drugs. This platform has the potential to expand our understanding of the genetic basis of drug resistance and open the way for the use of sequencing for effective clinical management of patients with DR-TB, saving millions of lives.”

“ReSeqTB is actively collecting, standardizing, and aggregating genomic, phenotypic and, when available, clinical data to support the development of global policy for use of sequencing-based diagnostics in high-burden settings” said Dr. Debra Hanna, Executive Director of C-Path’s Critical Path to TB Drug Regimens (CPTR) initiative. “Together with our partners, we are working with the US FDA to pursue regulatory clearance of ReSeqTB to support patient management decisions.”

ReSeqTB is changing the DR-TB landscape. “ReSeqTB is already informing the development of commercial TB molecular diagnostic solutions, and the confidence-graded mutations list is becoming a standard for interpretation of existing and future molecular diagnostics,” said Dr. Catharina Boehme, CEO of FIND. “Building genetic sequencing into global diagnostics policy is an exciting advance. Enhanced diagnostics mean that patients can get a diagnosis earlier, which means they can access the right treatment more quickly – and the transmission of DR-TB is curtailed.”

Read full press release here: https://c-path.org/global-health-partners-accelerate-uptake-of-genetic-sequencing-for-surveillance-and-diagnosis-of-drug-resistant-tuberculosis/

New Collaborations Expand TB-PACTS Database and Leverage Data for Analyses

The TB PACTS Steering, including representatives from C-Path, the Special Programme for Research and Training in Tropical Diseases (TDR) at WHO, TB Alliance, St. George’s University of London, University of California, San Francisco, and the Innovative Medicines Initiative (IMI), were enthusiastically in favor of integrating datasets previously consolidated by the IMI PreDiCT-TB consortium into the TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS). The consolidated IMI PreDiCT-TB consortium database currently contains 32 clinical data sets, most mapped to the CDISC TB 1.0 standard.  To-date, TB-PACTS has received data transfers for thirteen of these datasets. An additional eight datasets are expected to be integrated into the platform within the year.

This collaboration will expand the aggregated Phase 3 TB clinical trial data in the TB-PACTS data platform that is publicly available to qualified researchers. Within CPTR, the data will be used to expand the ongoing modeling and simulation efforts (e.g., refine quantitative models linking dynamic changes in time to liquid culture positivity (TTP) to clinically relevant endpoints for Phase 3 trials such as culture conversion and durable cure).

“When we established TB-PACTS we did it not only to make data from TDR-sponsored studies available, but also (and mostly) to create a trusted system where others too would be confident to share the data they generated,” said Dr. Piero Olliaro, head of intervention and implementation research at TDR. “This is happening now with the IMI PreDiCT-TB datasets, and we look forward for others to follow, so that researchers can have as many data as possible to investigate and fill critical knowledge gaps in tuberculosis.”

CPTR Advances Regulatory Discussions on Promising Tools and Methodologies to Inform and Enhance Decision-making in TB Drug Development

CPTR Workgroup Works to Advance Regulatory Qualification of LAM, a Promising New Biomarker

CPTR’s Biomarker and Clinical Endpoint Workgroup continues to progress the investigation of lipoarabinomannan (LAM) as a non-culture based pharmacodynamic biomarker to assess treatment response in clinical trials evaluating novel TB drug candidates.

LAM is a major component of mycobacterium cell wall, comprising up to 1.5% of total bacterial weight. A new immunoassay (LAM-ELISA) has been developed by Otsuka Pharmaceutical Co, Ltd (Otsuka)., which uses monoclonal antibodies against novel, unique LAM epitopes with high sensitivity and specificity to quantify sputum LAM concentration. Under the proposed context of use, sputum LAM could serve as a potential real-time decision-making tool in adaptive clinical designs of new TB treatment regimens. 

Building off a successful Critical Path Innovation Meeting with the FDA earlier in the year, CPTR received a positive response from FDA to the Letter of Intent submission, formally accepting the biomarker into FDA’s Qualification Program on October 31, 2017. The team has been advancing discussions with the EMA in parallel, with plans to submit documentation on the biomarker to both agencies in 2Q 2018.

TB-PBPK Model Progresses Toward EMA and FDA Qualification

CPTR and Simcyp have successfully developed a physiologically-based pharmacokinetic model for tuberculosis (TB-PBPK).  This model incorporates relevant pathophysiological changes that occur in TB-infected individuals to describe drug distribution from the systemic circulation into the different lung compartments and tissues, including granulomas. It may be utilized for simulations with a variety of virtual populations, including a virtual South African population. This model is complete and fully deployed within the Simcyp® simulator environment.  When applied to a library of standard of care (SOC) or emerging data for new compounds, this model may be used to inform early clinical development through predictions of drug distribution to the target tissues.

CPTR and Simcyp submitted a Letter of Intent and a briefing package to the EMA on November 22, 2017 to start the formal scientific advice qualification process for the PBPK model as a TB drug development tool. CPTR received formal feedback from EMA prior to a scheduled meeting with EMA’s Scientific Advice Working Party (SAWP) to discuss qualification on February 7, 2018. The EMA endorsed the updated context of use statement, to focus on the application of the PBPK platform to inform the design healthy volunteer studies for drugs that are not P-gp substrates, administered as monotherapy, for which plasma concentrations are known.  Further refinements to the model are being investigated which will serve as the basis for a final qualification decision by EMA.

CPTR held an informal meeting with the FDA on December 1, 2017 to discuss next steps for regulatory interaction for the potential endorsement of the PBPK platform. Per FDA’s request, CPTR will initiate a Fit-For-Purpose submission to FDA, with a Letter of Intent and Briefing Book, incorporating the scientific advice from EMA. 

Application of novel tools and methodologies can inform drug development decisions throughout the process:

TB-ReFLECT Update: A Collaborative Effort to Enhance TB Clinical Research

In 2016, C-Path and the Global TB Programme of the World Health Organization (WHO) partnered with researchers from the University of California, San Francisco (UCSF), to develop leading-edge quantitative analyses of data from the TB-Platform for Aggregation of Clinical TB Studies (TB-PACTS) database. The objective of this collaboration, called TB reanalysis of fluoroquinolone clinical trials (TB-ReFLECT), is to extract from these analyses key lessons from the TB-PACTS platform, and then package such lessons as tools to optimize future TB trial design.

The TB-ReFLECT team completed sensitivity analyses in November 2017, which included different classifications of unfavorable outcomes, and efficacy analyses that examined random effects of pharmacokinetic (PK) imputations and parametric survival models. UCSF recently presented on TB-ReFLECT efficacy analyses at a WHO workshop on clinical design, and a manuscript detailing these analyses has been submitted for peer review.   

The final stage of the project, safety analysis, is in progress and will analyze proportionality approaches to identify specific adverse events or clusters of adverse events, to inform benchmarking of the HRZE regimen in terms of safety.

CPTR will hold a face-to-face Steering Committee meeting to discuss how to message major learnings from TB-ReFLECT findings and discuss extensions to the project and/or integrations of the analyses into other CPTR projects.

New Project Launched to Evaluate Adaptive TB Clinical Trial Designs

CPTR’s Biomarker and Clinical Endpoint Workgroup (BCE-WG) launched a new effort to evaluate adaptive TB clinical trial designs, via simulation.  This project aims to evaluate a set of Phase 2 and 3 clinical development strategies and compare their overall efficiency and performance in selecting potential pan-TB regimens. A Steering Committee, consisting of experts in the field from academia, NGOs, and industry, was created to develop the scope, metrics and quantitative work for this project. Quantitative analyses simulation work is scheduled to commence in 2018. 

“Adaptive clinical trial designs using biomarkers to rapidly select the most promising treatments have been used with much success in other disease areas,” said Dr. Patrick Phillips, Professor, UCSF. “We need to be using the most efficient tools to rapidly develop safer and more efficacious TB regimens that can bring real patient benefit. In this project, we will develop and critically appraise some of the most promising biomarker-driven clinical development strategies, providing guidance to help developers speed novel regimens to market.”

C-Path Partners with Catalysis Foundation for Health to Establish Database with Visualization and Analytic capabilities

C-Path and Catalysis Foundation for Health (CFH) have partnered to share data from the clinical study “Mycobacterium tuberculosis (Mtb) Biomarkers for Diagnosis and Cure.” The collaboration seeks to identify biomarkers that correspond to detailed PET/CT information collected in this study, and to ultimately identify blood, urine, or saliva biomarker(s) that could replace sputum as a means of both diagnosing a patient and tracking their treatment progress.

Read more about the corresponding transcriptomics data for this study here:

https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE89403.

Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers

January 12, 2015

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Critical Path Institute Secures Additional Regulatory Support For Kidney Safety Biomarkers

EMA Letter of Support Opens Door for Clinical Qualification

TUCSON, Ariz., January 12, 2015 – The Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) issued a first-of-its kind Biomarker Letter of Support for two essential kidney safety biomarkers identified and evaluated by the Predictive Safety Testing Consortium (PSTC)’s Nephrotoxicity Working Group.

The kidney safety biomarkers, osteopontin (OPN) and neutrophil gelatinase-associated lipocalin (NGAL), are proteins that can be measured in urine. Higher levels of OPN and NGAL could indicate that the kidneys are being damaged, which may result in a loss of kidney function. The Letter of Support intends to encourage scientists to collect data from nonclinical and exploratory clinical studies, which may lead to qualification of these biomarkers.

“We are pleased to continue working collaboratively with the EMA, academia, and industry to identify tools, processes, and methods to improve the drug development process,” said Martha Brumfield, Ph.D., president and chief executive officer of C-Path. “With this Letter of Support, the EMA has opened doors that encourage the generation of necessary, rigorous clinical data to determine if these biomarkers hold clinical utility.”

The EMA’s Letter of Support indicates that these biomarkers have strong potential for use in humans and warrant additional exploration and data gathering. The EMA granted the Letter of Support for OPN and NGAL to encourage their use in both nonclinical and exploratory clinical studies as markers of proximal renal tubule degeneration/necrosis. With this milestone, work will continue in earnest on the qualification of OPN and NGAL for use in clinical trials.

“We are all incredibly excited about our collaborative interactions with EMA and the creation of the Letter of Support, enabling us to further define the path to clinical biomarker qualification,” said John Michael Sauer, Ph.D., Executive Director, Predictive Safety Testing Consortium, Critical Path Institute.

The Letter of Support is posted on the EMA website and can also be accessed via the C-Path PSTC website under the Regulatory Successes tab, along with a summary data package describing the studies that support the use of these kidney safety biomarkers.

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 1,000 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 http://www.c-path.org.