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. Periodically, the committee requests a compensation analysis to determine if employee compensation has remained within market range or if adjustments are required. This information is then used as a basis for the compensation committee's recommendation to the board of directors. 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 (cpi), by establishing 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 critical path for alzheimer's disease (cpad) consortium develops tools and novel methodologies to accelerate progress in the development of prevention and treatment strategies for alzheimer's disease (ad). This year's accomplishments include: (1) spear-heading an industry data-sharing initiative to expand the acquisition of contemporary patient-level clinical trial data that will be incorporated into a comprehensive disease progression model across the ad continuum. (2) expanding the ad clinical trial data repository to 41 studies with 20,549 individual anonymized patient records. It has been utilized by 456 approved applicants from around the globe, covering over 150 distinct organizations from pharmaceutical industry, government agencies, nonprofit organizations, academia, and independent researchers, from more than 40 different countries. (3) convening a quantitative modeling working group to support the generation of actionable ad drug development tools. The critical path for parkinson's consortium's (cpp) goals are to develop quantitative model-based tools to accelerate the treatment of parkinson's disease (pd), especially for those individuals experiencing the first clinical signs of motor symptom onset. Accomplishments this year include:(1) launched stage 2 of the digital drug development tools (3dt) project with a goal to acquire data from digital devices to better understand how to manage, distribute, standardize, and apply these data to optimize pd clinical trials. (2) expanded the pd integrated database to over 12,000 subjects from five observational studies and 13 clinical trials in pd. 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. Accomplishments this year include: (1) enriched the tb platform for aggregation of clinical trials (tb-pacts), by incorporating 17 clinical trial datasets; (2) submitted documentation package for a pre-submission meeting with fda cdrh to update the agency on the relational sequencing for tb (reseqtb) database progress, gain a letter of support from cdrh, and define a regulatory path forward; and (3) completed the adaptive trial design project and finalized a quantitative platform to determine the utility of adaptive trial designs as novel clinical development strategies. The critical path for sickle cell disease (cp-scd) consortium was launched in april of 2020. It is a collaboration set up to develop community consensus on how to optimize and accelerate drug development for this rare disease. The mission of the cp-scd is to support collaborative development and regulatory endorsement of novel medical product development tools. These tools will help to optimize and de-risk clinical trials to increase the efficiency in developing and delivering safe, effective treatments for people living with sickle cell disease. The cure drug repurposing collaboratory (cdrc) is a public-private partnership initiated in june of 2020 by c-path and the u.s. Food and drug administration (fda) in partnership with the national center for advancing translational sciences (ncats), part of the national institutes of health (nih). Cdrc, in partnership with the fda-ncats”

“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) received final positive qualification opinion adopted by the chmp/ema; and (2) received positive determination letter from fda coa qualification program accepting the qualification plan for use of symbol digit modalities test to assess cognition in trials of ms therapies. The polycystic kidney disease outcomes consortium (pkd-oc) 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 solutions to accelerate the development of novel medical products for individuals living with pkd, which include quantitative disease progression models, 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. A new tkv modeling proposal has been initiated this year; this effort will result in the development of tools to optimize clinical trial design for pkd therapies. 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. Accomplishments this year include: (1) received advice letter from fda in response to the initial briefing package submitted by the multiple sclerosis working group for qualification of the promis short form v1.0-fatigue-multiple sclerosis 8a (promis fatiguems-8a); (2) the small cell lung cancer working group submitted a letter of intent (loi) to fda for a new measure derived from the nsclc-saq v1.0 and received a reviewability memorandum from fda; (3) received the ok from fda to move forward with development of a qualification plan for the symptoms of major depressive disorder diary (smddd); and (4) in collaboration with the eproc, developed the presentation titled "coronavirus disease 2019 (covid-19): risk assessment and mitigation strategies for the collection of patient-reported outcome (pro) data through clinical sites." the predictive safety testing consortium (pstc) 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's accomplishments include: (1) initiated the predictox project, focused on the development of quantitative tools to better predict clinical safety for preclinical data, in cooperation with the icahn school of medicine at mt. Sinai and fda; (2) a letter of intent for qualification of drug-induced muscle injury biomarkers advanced to the stage two review at fda; and (3) the qualification plan for glutamate dehydrogenase (gldh) as a biomarker to detect drug-induced liver injury advanced to the stage two review at fda. The work of the quantitative medicine program (quantmed) focuses on the development and innovation of quantitative solutions for medical product development and clinical needs, with”