Critical Path Institute

“Mike kasser and jeff jacob have a business relationship. Peter hutt and jeff jacob have a business relationship. Wain fishburn and jeff jacob have a business relationship.”

“Form 990 is prepared by an external cpa firm using information provided by the organization. The form is reviewed by the organization's comptroller, coo, president/ceo, an outside cpa, the board audit, finance, and risk committee, and the board of directors prior to being finalized.”

“All members of the board of directors and all officers of the organization are required to fill out a conflict of interest form annually. The results are compiled and reviewed by the board's audit, finance, and risk committee. Any actual or perceived conflicts that have the potential to bias any discussions or decisions by the board are discussed by the board. Any director with a real or potential conflict will recuse themselves from any discussion or decision where the conflict has a bearing.”

“A board of directors compensation committee meets and reviews executive compensation annually. Every few years the committee seeks an independent compensation consulting organization. After the consulting organization has been retained, the compensation committee receives the consultant's executive compensation reviews and recommendations. This information is then used as a basis for the compensation committee's recommendation to the board of directors. The last independent compensation survey was conducted for the ceo in august 2011. The ceo's salary has remained constant since the time of her hire. An overall salary program for employees, which is developed based on salary survey information, must be approved by the board of directors compensation committee before implementation. All employee salary increases must be approved by the president/ceo.”

“Articles of incorporation can be found on the arizona corporation commission website. The conflict of interest policy and the financial statements (via the annual report) are posted on the institute's website.”

“The critical path institute (c-path) is an independent, non-profit organization uniquely dedicated to implementing the fda's critical path initiative by creating collaborations among regulators (scientists from the fda and ema), the regulated medical product industry, academia, patient groups, and other organizations that advance medical innovation through the development of tools and methods based upon sound, consensus-based science. The accomplishments for this fiscal year report include: the coalition against major diseases develops tools and novel methodologies to accelerate progress in the prevention, treatment and cure of major neurodegenerative diseases focusing on alzheimer's disease. This year's accomplishments include: developed an addendum to the informed consent form developed last year that will enable broader sharing of patient data and specimens for future research; obtained regulatory agreement for the statistical analysis approach for the hippocampal volume biomarker qualification effort. The full qualification package should be submitted in early 2018. Held workshops on the use of biometric monitoring devices in clinical trials and associated data standards. Published two journal articles. The coalition for accelerating standards and therapies is 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. Cfast is a partnership between the clinical data interchange standards consortium (cdisc) and the critical path institute (c-path). This year the consortium received three fda grants and began work to develop data standards for hiv, clostridium difficile-associated diarrhea, and one for medical countermeasure studies under the animal rule; published cdisc standards on kidney transplant, rheumatoid arthritis, major depressive disorder, ebola, diabetic kidney disease and malaria standards, and cardiovascular imaging; posted a standard for duchene muscular dystrophy for public review. The critical path for parkinson's goals are to develop quantitative model-based tools to accelerate the treatment of parkinson's disease, especially for those individuals experiencing the first clinical signs of motor symptom onset. Their accomplishments this year include: four new parkinson's clinical trial datasets have been added to the database; submitted a letter of intent and full qualification package to ema for the qualification of molecular neuroimaging of the dopamine transporter(dat) as a prognostic biomarker for enrichment in trials for early parkinson's disease; received a letter of support from the ema for the use of dat imaging as an enrichment biomarker for pd clinical trials. The mission of the critical path to tb drug regimens initiative is to accelerate the development of novel tb drug regimens that are safer, shorter, and more efficacious than the current standard of care. Their mission expanded to accelerate the development of a clinically useful in vitro rapid drug susceptibility assay to support tb regimen development and deployment. Their accomplishments this year include: submitted input to the fda draft guidance on infectious disease next generation sequencing based diagnostic devices; met with the ema about cptr's physiologically based tb-infected lung model; formed a new partnership with tgen north/nau to develop an az-based sequencing and data platform coe for whole genome sequencing of m. Tuberculosis and contribute to the reseqtb platform. This work is supported by the bmgf sequencing supplement grant awarded to c-path. Cptr is in discussion with imi-predict-tb to transfer and host their clinical trial data repository as their program sunsets in early 2018. Cptr is partnering with commonwealth informatics to collaborate on a commonwealth clinical data analytics (ccda) pilot project. Cptr had a critical path innovation meeting on cptr's lipo”

“The patient-reported outcome consortium has a goal to establish and maintain a collaborative framework with appropriate stakeholders for the qualification of patient-reported outcome (pro) instruments and other clinical outcome assessment (coa) tools that will be made available for use in clinical trials where coa-based endpoints are used to support product labeling claims. The non-small cell lung cancer working group completed its quantitative pilot study and submitted the report to the fda. With positive feedback from the fda, proc is working on a performance outcome instrument to assess cognitive impairment in clinical trials for mild cognitive impairment due to alzheimer's disease; submitted the depression quantitative pilot study report and data to fda for review; initiated an effort to develop a patient-reported measure to assess fatigue in patients with rheumatoid arthritis; submitted the asthma quantitative pilot study report and study data to fda; published eight articles; qualification briefing packages were submitted for depression and non-small cell lung cancer for fda review. The predictive safety testing consortium has a goal to bring together pharmaceutical companies to share and validate innovative safety testing methods under advisement of the u.s. Food and drug administration (fda), european medicines agency (ema), and japan's pharmaceuticals and medical devices agency (pmda). Currently pstc is focused on developing and obtaining regulatory qualification of improved clinical safety biomarkers for use in drug development. This year the consortium: co-hosted the drug induced liver injury workshop; received letters of support for liver, kidney, and vascular injury safety biomarkers from the fda and ema; held a series of webinars on bile salt export pump inhibition; submitted a qualification briefing package of glutamate dehydrogenase as a specific biomarker of drug-induced liver injury, and held an advice and consultation meeting with the fda; held a critical path innovation meeting with the fda to discuss a research plan for the qualification of translational drug-induced pancreatic injury safety biomarkers. The pediatric trials consortium accomplished its goal of establishing a new, independent non-profit organization to support and advance research and education on innovative pediatric treatments. The new institute for advanced clinical trials for children serves as a neutral forum for public-private collaboration in addressing common challenges in pediatric trials to help demystify the studies. It will also assist in optimizing study designs, protocols, best practices, training, and engagement of patients and parents. Two new consortia were initiated this year. The first is focusing on qualifying islet autoimmunity antibodies as prognostic biomarkers to be used in the development of therapies for the treatment, and ultimately, the prevention, of type 1 diabetes. The second is working to identify mechanisms and drug development tools to accelerate drug discovery for transplant patients, through the collaborative involvement of key stakeholders in the field. The consortium is initially focusing on kidney transplant, but may expand to other solid organ transplants in the future.”

“Research support services: program service expenses 1,924,899. Management and general expenses 0. Fundraising expenses 0. Total expenses 1,924,899. Consulting: program service expenses 665,528. Management and general expenses 23,996. Fundraising expenses 0. Total expenses 689,524. Other professional fees: program service expenses 655,085. Management and general expenses 27,232. Fundraising expenses 0. Total expenses 682,317.”