Critical Path Institute

January 2012 - Reinventing clinical trials

As R&D costs spiral for drug developers, disruptive approaches to clinical trial design and management are gaining traction. Get ready for electronic data capture, precompetitive data sharing, virtual trials and a variety of bold new paradigms.

November 2011 - CPTR Yields Progress: New Five-Way Agreement Among Pharmas and NGOs will Speed Development of TB Drug Combinations

The Critical Path to TB Drug Regimens (CPTR) today announced an innovative agreement between AstraZeneca, Sanofi, Tibotec, TB Alliance, and the World Health Organization to share information on tuberculosis (TB) compounds within their respective drug pipelines to quickly identify and work together to develop the most promising TB drug regimen, regardless of sponsor. Previously, development of new TB regimens could take decades.

November 2011 - C-Path's Avilés Discusses Importance of Data Standards in FDA Week Article

FDA is encouraging industry to use newly crafted therapeutic data standards -- such as utilization of qualified biomarkers-- in submissions and could start requiring companies to use the standardized data elements in the future,sources said following the release of the first set of standardized therapeutic data elements for Alzheimer's disease that they said could make reviews and approvals faster and more efficient.

November 2011 - C-Path Joins Leading Voices and Organizations in Alzheimer's Research, Drug Discovery and Care to Call for Dramatic New Strategy to Stop Alzheimer's Disease in Report Out Today

Leaders Engaged on Alzheimer's Disease (LEAD) was created in February 2008 as an open network of Alzheimer's-serving organizations to link key stakeholders from the government, business, and civic sectors to increase attention to and awareness of Alzheimer's disease, its care, treatment, prevention, research, and eventual cure.

October 2011 - C-Path's K. Romero Co-Authors Special Report- Striving for an Integrated Drug-Development Process for Neurodegeneration: the Coalition Against Major Diseases

Alzheimer's and Parkinson's diseases are the two main neurodegenerative disorders and despite the public health need, drug development for these conditions has been plagued by a high attrition rate in the late phases of evaluation.

October 2011 - Critical Path Institute and Clinical Data Interchange Standards Consortium Announce Release of Data Standards for Alzheimer's Disease Research

Critical Path Institute(C-Path)and Clinical Data Interchange Standards Consortium(CDISC) today announced the release of version 1.0 of the Alzheimer's disease (AD) Therapeutic Area Standard(SDTM AD/Mild Cognitive Impairment User Guide). This was developed for the clinical research community to facilitate analysis and learning from clinical studies for treatment or prevention of AD.

September 2011 - Critical Path Institute Launches New iTunes App

Critical Path Institute, in cooperation with app co-developer, Scientific Technologies Corporation (STC), has just launched MyMedsList, which is available on iTunes for iPhone, iPad, and iPod Touch.

September 2011 - Critical Path Institute Announces Launch of Critical Path Foundation

Foundation to foster a global community of philanthropists to improve health and save lives

September 2011 - Pharsight to Work with Critical Path Institute's Polycystic Kidney Disease Consortium on Disease Progression Modeling

Pharsight, a market-leading provider of software and scientific consulting services to improve productivity and decisionmaking in clinical drug development, has announced they will be working with Critical Path Institute's Polycystic Kidney Disease (PKD) Consortium to create and study quantitative models of disease progression in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD).

June 2011 - Critical Path Institute and Innovative Medicines Initiative Announce Formal Collaboration

Internationally renowned organizations share common commitment to advancing science that improves medical product development. Critical Path Institute and the Innovative Medicines Initiative (IMI) announced today that they have signed a Memorandum of Understanding to further the missions of both organizations.

June 2011 - Critical Path Institute Establishes Electronic Patient-Reported Outcome Consortium

Critical Path Institute has established the Electronic Patient-Reported Outcome (ePRO) Consortium comprising five member firms that provide innovative electronic data collection technologies for capturing patient-reported outcome (PRO) endpoints in clinical trials.

May 2011 - Critical Path Institute Joins Community Partners In Dispose-A-Med Program

Critical Path Institute (C-Path) announced that it has become a proud partner in Dispose-A-Med, a joint, community-based initiative focused on the safe disposal of outdated and unneeded medicines, especially narcotics.

April 2011 - Critical Path Institute Announces Expansion of Regulatory Science Consortium For Tuberculosis

Critical Path Institute is proud to announce that the Regulatory Science Consortium, an arm of the Critical Path to TB Drug Regimens (CPTR), has added ten new member organizations that include over 100 participants in five workgroups.

February 2011 - Critical Path Institute President and CEO Plans To Retire in 2012

Critical Path Institute's Board of Directors today announced that President, CEO, and Chairman of the Board, Raymond L. Woosley, MD, PhD, has informed them of his plan to retire as President effective January 31, 2012.

February 2011 - Critical Path Institute and Clinical Data Interchange Standards Consortium Host International Program At New Training Facility

Joint efort to advance data standards and create public databases as means o accelerate medical product development

January 2011 - Critical Path Institute And Clinical Data Interchange Standards Consortium Announce Innovative Partnership To Address Major Diseases

Global leaders join forces to establish data standards and create public data bases as new means to accelerate medical product development

December 2010 - Executive director of Critical Path Institute's Coalition Against Major Diseases testifies before congress on Alzheimer's disease progress.

Marc Cantillon, MD, presents the critical role of public/private partnerships in creating innovative tools to advance the development of new Alzheimer's disease therapies.

December 2010 - Alfred M. Cohen, MD, FACS, FASCRS, Joins as Director, Cancer Biosignature Programs

Tucson, Arizona, December 9, 2010 - Alfred M. Cohen, MD, FACS, FASCRS, has joined Critical Path Institute (C-Path) as Director of its Cancer Biosignature Programs.

December 2010 - Martha Brumfield, PhD, Hired as Director, International Programs

Tucson, Arizona, December 9, 2010 - Martha Brumfield, PhD, has joined Critical Path Institute (C-Path) as Director of International Programs.

November 2010 - Leading Neuroscientist Joins Critical Path Institute

Marc Cantillon, MD, has joined Critical Path Institute as Executive Director of one of its major consortia, the Coalition Against Major Diseases (CAMD). Dr.Cantillon has a 15+year background in government,academic and pharmaceutical industry translational research, drug development and clinical research.

November 2010 - Leading Pharmacologist and Pharmaceutical Scientist Joins Critical Path Institute

Thorir D. Bjornsson, MD, PhD, has joined Critical Path Institute as a member of its Board of Directors, and will also lead one of its major consortia, the Critical Path to TB Drug Regimens, Regulatory Science Consortium (CPTR).

October 2010 - Governor Brewer Awards $2.2 Million in Stimulus Dollars Towards Creation of New Biomedical Research Resource in Arizona

Science Foundation Arizona selects Tucson based Critical Path Institute and collaborator, Roche's Ventana Medical Systems, to develop innovative national resource for clinical research standardization

October 2010 - Raymond Woosley, MD, PhD, C-Path President/CEO to present keynote address at CDISC North American Exchange November 1-5, 2010 in Baltimore, MD

The CDISC Board of Directors and Dr. Rebecca Kush, President & CEO are pleased to announce three exceptional keynote speakers to introduce this year's event: Dr. Doug Fridsma, acting director of the Office of Interoperability and Standards in the Office of the National Coordinator for Health Information Technology; Dr. Theresa M. Mullin, Ph.D., Director, Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) and Dr. Raymond L. Woosley, Founder and Chief Executive Officer of the Critical Path Institute (C-Path).

October 2010 - Manuscript on Current State of Pharmacometrics in Special Issue of Journal of Clinical Pharmacology Co-authored by C-Path's Klaus Romero, MS, MD Recently Released

Pharmacometrics as a Discipline Is Entering the "Industrialization" Phase: Standards, Automation, Knowledge Sharing, and Training Are Critical for Future Success

June 2010 - Critical Path Institute's Predictive Safety Testing Consortium Announces First-Ever Qualification Decision by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

For the first time, new biomarker tests to detect drug-induced kidney injury have been accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

June 2010 - Coalition Against Major Diseases Introduces the First Combined Pharmaceutical Trial Data on Neuro-degenerative Diseases

A new database of more than 4,000 Alzheimer's disease patients who have participated in 11 industry-sponsored clinical trials will be released today by the Coalition Against Major Diseases (CAMD).

May 2010 - Critical Path Institute's Predictive Safety Testing Consortium Announces Special Issue of Nature Biotechnology Dedicated to Newly Qualified Kidney Safety Biomarkers

A special May 10, 2010 issue of Nature Biotechnology (NBT) includes ten scientific publications from Critical Path Institute's Predictive Safety Testing Consortium's evaluation of seven kidney biomarkers for use in drug safety assessment.

April 2010 - Critical Path Institute President/CEO Receives Award of Excellence

Raymond L. Woosley, MD, PhD, President/CEO of Tucson-based Critical Path Institute (CPI), was recently presented with the prestigious 2010 PhRMA Foundation Award in Excellence in Clinical Pharmacology at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT).

March 2010 - Critical Path Institute Continues to Expand