Critical Path Institute

“Peter hutt and jeff jacob have a business relationship. Wain fishburn and jeff jacob have a business relationship. Jeff jacob and shaun kirkpatrick 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 director of finance, coo, president/ceo, 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. In connection with the hiring of our new ceo in april 2019, the search firm utilized for recruitment conducted a bench-marking analysis to determine an appropriate salary. An overall salary program for employees 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 advancing multiple aspects of 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: critical path for alzheimer's disease (cpad) develops tools and novel methodologies to accelerate progress in the development of prevention and treatment strategies for alzheimer's disease. This year's accomplishments include: (1) launching the c-path industry data sharing initiative, based on close collaboration with fda and industry membership. (2) expansion of the consortium through the execution of additional data sharing agreements and enrollment of new industry members. The critical path for parkinson's (cpp) consortium'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: (1) receiving feedback from the fda endorsing the cpp modeling analysis plan with advice to acquire parkinson's disease randomized clinical trials. (2) aggregating a total of 11 clinical trial datasets to enrich the cpp database and further the development of a parkinson's disease-drug-trial model. (3) launching the digital drug development tools (3dt) project which has held three high-impact regulatory meetings in 2019. (4) launching two new task forces to aid in supporting future regulatory engagement for pd digital device measures. The mission of the critical path to tb drug regimens (cptr) 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: (1) completed the graphical user interface (gui) for the longitudinal ttp dynamics model linking time-to-positivity to clinical outcomes. (2) deployed the reseqtb website (www.reseqtb.org), a "one-stop" source for curated, aggregated, and clinically relevant genetic drug resistance data, to support the tuberculosis drug resistance surveillance program at the world health organization, expanding accessibility (beyond researcher-level use) to the reseqtb data platform and available bioinformatics and visualization tools. (3) reanalyzed data in the reseqtb platform to generate the annual updated drug resistance report and performed an analysis of new drug resistance mutations identified in comparison to last year's report. (4) completed sequencing collaboration project with translational genomics research institute (tgen) to sequence over 8,800 mtb. Isolates. (5) automated the reseqtb bioinformatics pipeline, redesigned the relational database infrastructure to optimize data analytics, and deployed a scalable instance of this platform to the world health organization to support their global tb drug resistance surveillance effort. (6) completed the hollow fiber system stage ii work in which tb monotherapy and combination drug therapies were compared head-to-head to identify the most promising regimen combinations and dosing schedules. (7) deployed tb-pacts 2.0 enhanced search and query tool for internal testing. The data collaboration center (dcc) is a center within c-path to enable multiple organizations to work together in a neutral setting and share clinical data in order to optimize its value in creating new insights and tools that accelerate drug development in areas with unmet medical needs. The dcc supports data sharing”

“The multiple sclerosis outcome assessments consortium (msoac) has a goal to obtain regulatory qualification of an improved clinical outcome assessment instrument as a primary or secondary endpoint in clinical trials of multiple sclerosis (ms) therapies. Their accomplishments this year include: (1) completed analysis on the curated, remapped, and aggregated control and treatment arms of 16 clinical trial datasets. (2) received a draft positive qualification opinion from the chmp/ema. The polycystic kidney disease outcomes consortium (pkdoc) has developed and obtained regulatory qualification from the u.s. Food and drug administration (fda) and the european medicines agency (ema) of total kidney volume (tkv) as a prognostic biomarker for use in clinical trials for new therapies for autosomal dominant polycystic kidney disease (adpkd). The consortium continues to explore alternate clinical endpoints, including a composite endpoint, innovative clinical trial designs, and regulatory pathways to help expedite new therapies in pkd. The fda has communicated that tkv is a "reasonably likely surrogate," which makes it eligible for an accelerated approval process at the fda. Six new companies are now working to develop therapies for this disease. The fda approved otsuka's drug (jynarquetm). This is the first-ever fda-approved treatment for pkd. Although it was not a direct output of pkdoc, the consortium's work positively contributed to advances in the field consistent with this success story. There is renewed interest from industry members to further expand the efforts of the pkdoc. The patient-reported outcome consortium (proc) 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. Their accomplishments this year include: (1) two pro measures were qualified by fda for exploratory use, for the asthma daytime symptom diary (adsd) and the asthma nighttime symptom diary (ansd). (2) fda indicated that the consensus-based harmonized myelofibrosis symptom assessment measure, the myelofibrosis symptom assessment form (mfsaf) v4.0 diary, would be added to fda's coa compendium. (3) the pro consortium has issued a total of 22 licenses for use of pro consortium measures including the smdds, the nsclcsaq, and the myelofibrosis symptom assessment form v4.0 (mfsaf v4.0). (4) the following coas are in various stages of the development and/or qualification process: ucsd performance-based skills assessment for mild cognitive impairment (upsa-mci), diary for irritable bowel syndrome symptoms-c (dibss-c) for constipation predominant ibs, diary for irritable bowel syndrome symptoms-d (dibss-d) for diarrhea predominant ibs, diary for irritable bowel syndrome symptoms-m (dibss-m) for mixed ibs, an optimized promis physical function short form for ms patients, pediatric asthma diary - observer (pad-o), pediatric asthma diary - child (pad-c), rheumatoid arthritis wg - promis short form v1.0 - fatigue 10a. 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. Their accomplishments this year include: (1) in cooperation with mt. Sinai and fda, initiated the predictox pre-consortium focused on the development of quantitative tools to better predict clinical safety for preclinical data. (2) met with pmda to update on status of kidney clinical qualification and request initiating qualificatio”

“Research support services: program service expenses 1,325,218. Management and general expenses 594. Fundraising expenses 0. Total expenses 1,325,812. Consulting: program service expenses 651,056. Management and general expenses 20,513. Fundraising expenses 0. Total expenses 671,569. Other professional fees: program service expenses 31,674. Management and general expenses 3,402. Fundraising expenses 0. Total expenses 35,076.”