Here you will find recent C-Path news events. Please feel free to browse the documents and news releases below to learn more about what we are doing at Critical Path Institute. Click here to download a Press Kit.
Critical Path Institute's (C-Path) leaders announced today that John-Michael Sauer, PhD, has joined the organization as Executive Director of the Predictive Safety Testing Consortium (PSTC), C-Path's longest standing consortium.
The Predictive Safety Testing Consortium (PSTC) led by the Critical Path Institute (C-Path) and the Safer and Faster Evidence-based Translation (SAFE-T) consortium sponsored by the Innovative Medicines Initiative (IMI), announced today the signature of an agreement to work together in their efforts to improve drug safety.
Critical Path Institute's (C-Path) Polycystic Kidney Disease Outcomes Consortium (PKDOC), the Clinical Data Interchange Standards Consortium (CDISC), and the PKD Foundation announced today the launch of version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, a clinical data standard that provides guidance on the implementation of the CDISC Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions.
The Board of Directors of the Critical Path Institute (C-Path) announced today that Martha Brumfield, Ph.D., has been named interim president and chief executive officer of the organization. Brumfield, C-Path's former director of International & Regulatory Programs, takes over immediately for Carolyn Compton, M.D., Ph.D., who will be assuming a new position at Arizona State University (ASU).
The National Multiple Sclerosis Society and Critical Path Institute (C-Path) announced today that they have joined forces to launch the Multiple Sclerosis Outcome Assessments Consortium (MSOAC). This coalition of industry, academia, patient representatives, regulatory agencies, and the National MS Society will develop new standards for assessing outcomes in clinical trials of MS therapies. The MSOAC will collect, standardize, and analyze data from MS studies with the goal of qualifying a new clinician-reported outcome measure of disability as a primary endpoint for future MS trials.
Dr Carolyn Compton served as planning committee co-chair for the recent Institute of Medicine workshop, "Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Accelerations Network" on Nov 16. To download a free PDF of the report (or to purchase your own copy of the paperback), click here.
On Tuesday October 23, 2012 the stars were shining inside the Phoenix Convention Center at the AZBio Awards as our community came together to celebrate the companies and individuals who are moving us forward faster.
Critical Path Institute (C-Path) announces that it has received a Bronze Bicycle Friendly Business (BFB) award from the League of American Bicyclists in recognition for its commitment to promoting bicycling and a healthy lifestyle in the workplace.
Clarification, November 5, 2012: CFAST is a joint initiative of CDISC and the Critical Path Institute. The FDA and TransCelerate Biopharma, Inc. are partnering with CFAST in its Therapeutic Area Standards Program.
If you felt as if you needed a little more muscle to lift this week's printed issue of Inside Tucson Business, you can thank a woman — make that lots of women.
Included this week is the annual special section announcing the 2012 Women of Influence in Southern Arizona as nominated by you, readers of Inside Tucson Business. This year, the number of honorees has doubled to 20.
C-Path and CDISC featured at the October 19th Data Standards Forum at the National Institutes of Health
Ten of the world's largest pharmaceutical companies said on Wednesday that they would cooperate on research aimed at accelerating drug development, starting with streamlining clinical trials.
The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the launch of the Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year. The official launch of CFAST will take place at the CDISC 2012 International Interchange in Baltimore, Maryland (24-26 October 2012).
Officials with the Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path), two organizations strongly affiliated with the US Food and Drug Administration (FDA), have announced the release of a new "breakthrough tool" used to help combine and report data from multiple studies.
A "breakthrough" tool that standardises reporting of research data in the development of drug regimens to combat tuberculosis (TB) has been launched by the US-based Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC).
The inclusion of C-Path in the Star's centennial "100 Days of Science" series is a most welcome honor.
What needs to be highlighted is the pivotal role that Science Foundation Arizona (SFAz) has played in C-Path's success. SFAz provided over $14 million, a sum guaranteeing C-Path's independence and allowing C-Path to become the trusted, neutral partner of the FDA and the pharmaceutical industry.
When I'll Have Another won the Kentucky Derby in May, no one talked about the hundreds of millions of dollars each year that is lost by the owners of the thousands of horses that lose countless races. Now, imagine a horse race impossibly longer and riskier than the derby, not a mile and a half long and completed in just under two minutes and two seconds, but a race stretching from New York to Los Angeles, not run on a groomed track but on a mere path and taking even the best horse about 10 years to complete at a cost to the owner of about a billion dollars.
That's right: 10 years and a billion dollars.
Fewer new prescription drugs will get approved in the U.S. this year than the 30 approved in 2011, a ratings agency forecasts, adding to the many stresses on the pharmaceutical industry. The Food and Drug Administration approved only 14 innovative drugs in the first half of this year, down from 18 in the first half of 2011, says a report released Wednesday by Fitch Ratings.
Tucson's Critical Path Institute recently got some good news - and some noteworthy recognition - when the U.S. Senate gave final approval to a budget reauthorization bill including the Food and Drug Administration partnership program that helps fund the institute.
The Clinical Data Interchange Standards Consortium (CDISC) and the Critical Path Institute (C-Path) announce the signing of a partnership sagreement to establish the Coalition For Accelerating Standards and Therapies, or CFAST, an initiative 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.
The Coalition Against Major Diseases is pooling clinical data to build disease and drug models.
FDA approved rifampin for the treatment of tuberculosis (TB) in 1971, the same year Intel Corporation invented the first microprocessor. Since then, advances in computer technology have revolutionized the way people live and work. But no additional medications have been approved by FDA for the treatment of Mycobacterium tuberculosis infectionâ€”a problem that federal officials and others want to fix.
Re: the April 19 article "Vast study advances breast cancer fight."
C-Path's work was positively acknowledged by Dr. Janet Woodcock during the April 18 House Energy and Commerce Committee Hearing. Congressman Engel (NY) posed a question about C-Path and the Critical Path Partnerships.
The Association of Clinical Research Organizations (ACRO) today provided the FDA with a number of suggestions to improve the drug development process, highlighted by a call to appoint a Chief Innovation Officer within the agency. ACRO's recommendations were included in testimony presented by Executive Director Doug Peddicord, Ph.D., at a public hearing titled "Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice."
The Critical path Institute (C-Path), the US Food and Drug Administration (FDA)-supported public-private initiative working to advance personalized medicine, is advancing quickly and is bearing results, reports The Arizona Star.
Your doctor may soon - perhaps in a year - be able to order up a test to map out your entire genome, or genetic blueprint, and get it in about eight hours for about $100.
That's stunning news, considering the same test took up to a year and $100 million a decade ago, and now takes 24 hours and costs about $1,000.
Gene-based, "personalized medicine" is coming - the trick is how to use that information to create safe, effective drugs that can navigate a regulatory path to market that now typically takes an average of 12 years and $1.6 billion.
I saw a presentation yesterday by Carolyn Compton, the new head of C-PATH, the critical path institute located in Tucson, AZ. This group has the goal of accelerating the development of new medicines by working at the interface between pharmaceutical companies, academic researchers and clinicians, the FDA, and the public.
Critical Path Institute (C-Path) has announced that Steven T. Broadbent has been chosen as the next chief operating officer of C-Path. Mr. Broadbent takes over for Rick Myers, who recently stepped down from C-Path in order to focus on his role as Chairman of the Arizona Board of Regents. Mr. Myers will continue to serve C-Path as a member of its board of directors.
In a large-scale study and an upcoming clinical trial, scientists supported by the National Institutes of Health address one of the trickiest issues in prescribing medicine—how to quickly optimize each patient's dosage of the common blood-thinning drug warfarin.
Critical Path Institute (C-Path) is proud to welcome four new board members who were recently elected to serve three-year terms (2012-2015). Joining the board are D. Craig Brater, MD, Dean, Indiana University School of Medicine; Samuel Broder, MD, Executive Vice President and Chief Medical Officer, Celera Genomics; James C. Greenwood, President and CEO of the Biotechnology Industry Organization (BIO); and Richard T. Myers, Jr., Regent, Arizona Board of Regents. Current board member, Peter B. Corr, PhD, General Partner, Celtic Therapeutics, LLLP, was named as the new Chairman of the Board.
Tuberculosis (TB) is often thought to be a disease of the past. The reality: Because no new therapies for TB have been developed in the past 50 years and treatment is long and complex, TB continues to kill 1.4 million people a year- someone every 20 seconds. Additionally, drug resistant forms of TB are an imminent public health concern. Critical Path Institute (C-Path) joins in acknowledgment of this global threat as it is commemorated on World TB Day 2012 - March 24th - to highlight its impact and acknowledge the work being done to eradicate the disease.
Critical Path Institute (C-Path) announced today that Dr. Carolyn Compton has joined the organization as its new president and chief executive officer. Dr. Compton takes over for Dr. Raymond L. Woosley, C-Path's founder, who last year announced his intention to step down as President/CEO, and asked the Board of Directors to begin a search for his successor.
Based on a request for regulatory review by Critical Path Institute's (C-Path) Coalition Against Major Diseases (CAMD), the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has issued a positive opinion on the use of magnetic resonance imaging (MRI) to measure hippocampal volume as a tool to enrich recruitment into regulated clinical trials in the pre-dementia stage of Alzheimer's disease (AD). This is the first imaging-based biomarker for AD to be granted a positive opinion by a regulatory agency.
Critical Path Institute(C-Path)and The Hamner Institutes for Health Sciences (The Hamner) announced today that they have signed a Memorandum of Understanding (MOU) to develop innovative, collaborative activities in the areas of regulatory science research
for predicting, detecting and monitoring liver safety issues during the development of new medicines.
December 2011 - C-Path's Creating Consensus Science Conference Keynote Addresses by Dr. Margaret Hamburg, Commissioner, FDA and Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy, NIH
View confernece slides and videos from Critical Path Institute's Creating Consensus Science: Tools and Tactics for Next-Gen Drug
Hundreds of leaders from cross-sector arenas in government, academia, the biotechnology and pharmaceutical industry, and patient advocacy organizations gathered over the past two days at Critical Path Institute's Creating Consensus Science: Tools and Tactics for Next-Gen Drug Development conference to articulate a common commitment to the future of global collaborative efforts that develop innovative tools to accelerate medical product development.
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.
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.
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.
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.
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.
Foundation to foster a global community of philanthropists to improve health and save lives
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).
The CDISC International Interchange this fall in Baltimore will highlight "Standards for Patients". The Conference on 12-13 October features three prominent keynote speakers, presentations from CDISC leaders and volunteers from around the globe and interactive panels on streamlining clinical research and using EHRs for research.
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.
Critical Path Institute has established the Electronic Patient-Reported Outcome (ePRO) Consortiumcomprising five member firms that provide innovative electronic data collection technologies for capturing patient-reported outcome (PRO) endpoints in clinical trials.
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.
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.
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.
Joint efort to advance data standards and create public databases as means o accelerate medical product development