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. 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 comptroller, 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. 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 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: the coalition against major diseases was rebranded as the critical path for alzheimer's disease. It 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) receiving a letter of support from the ema encouraging industry sponsors to share with cpad the patient-level data from completed phase ii and iii clinical trials, including active and control arms, allowing cpad to complete development and validation of a proposed quantitative model for implementation by sponsors actively designing clinical trials in amnestic mild cognitive impairment (amci). (2) generated graphical user interface-based updates to the ad mild-to-moderate clinical trial simulation tool and mild cognitive impairment (mci) clinical trial simulation tool - the hippocampal neuroimaging-informed amnestic mci clinical trial simulator. (3) increased use of the database and models. The critical path for parkinson's 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) submission to ema and fda of the first modeling tool for parkinson's- "model-based clinical trial enrichment tool for parkinson disease clinical trials". (2) received fda's formal response to cpp's letter of intent outlining recommendations for what should be submitted in the modeling briefing document. (3) ema qualification advice letter received for the model-based clinical trial enrichment tool for parkinson's disease 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: (1) eleven new tb clinical datasets were acquired, curated, and integrated into the tb platform for aggregation of clinical tb studies (tb-pacts) platform and made accessible to qualified researchers. To date, over 55 applications have been submitted and 42 have been approved to support tb research. (2) completed the stage 2 analysis of tb re-analysis of fluoroquinolone executed clinical trials (tb-reflect), which focused on isoniazid resistant sub-cohort and examination of safety findings for standard of care regimens which contain a fluoroquinolone. (3) completed or significantly advanced the following modeling and simulation projects: population pk/pd, liquid culture, quantitative systems pharmacology, and cardiac risk assessment algorithm. Additionally, hfs-tb experiments characterizing the pk/pd attributes of three drugs and regimens for tb have been completed, with four experiments ongoing. Other model-based analyses are ongoing to identify preferred methods for the translation of data from in vitro and in vivo (animal) models to predict clinical outcomes for anti-tb drugs and regimens. (4) expanded analyses to support pbpk qualification efforts based on feedback from ema's scientific advice working party (sawp). Further analyses designed to verify pbpk granuloma model performance are in progress. The data collaboration center is”

“At the request of the fda, c-path formed an international neonatal consortium (inc). The purpose of the consortium is to accelerate the development of safe and effective therapies for neonates. Inc engages the global neonatal community - families, neonatal nurses, academic scientists, regulators, pharmaceutical investigators, advocacy organizations, and funders - to focus on the needs of the neonate. This past year inc's clinical pharmacology workgroup developed a white paper to assist regulators in preparing guidance on the clinical pharmacology considerations for neonates, including recommendations for safer formulations encompassing ease of administration. Inc's bronchopulmonary dysplasia (bpd) workgroup described potential endpoints for trials to evaluate treatments for chronic pulmonary insufficiency of prematurity (cpip). Inc's seizure workgroup developed recommendations for use in a master protocol to evaluate medications to treat neonatal seizures. Inc's data workgroup reviewed the value and needs for sharing neonatal data and proposed a global approach to collecting, standardizing, and sharing data. Inc's clinical pharmacology adverse event subgroup completed development of the neonatal adverse event severity grading scale (naess) and have incorporated the new ae terminology into the national cancer institute - enterprise vocabulary services (nci-evs) online thesaurus. Inc submitted comments on the notice of proposed rulemaking (nprm) "federal policy for the protection of human subjects" to u.s. Health and human services' office for human research protections and also supplied input on drugs and therapeutic areas that require further study in neonates, in response to national institute of child health and development's request for information on the best pharmaceuticals for children act priorities in pediatric therapeutics 2017. The multiple sclerosis outcome assessments consortium 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) executed the statistical analysis plan (for a single measure) developed for fda and submitted the final qualification package. (2) executed the statistical analysis plan (including four measures) developed for ema and the "voice of the patient" methodology and submitted the final qualification package to the ema. The polycystic kidney disease outcomes consortium 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. 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. Two pro measures were qualified by fda for exploratory use, the symptoms of major depressive disorder scale (smdds) and the non-small c”

“Research support services: program service expenses 1,404,700. Management and general expenses 0. Fundraising expenses 0. Total expenses 1,404,700. Consulting: program service expenses 836,851. Management and general expenses 68,397. Fundraising expenses 0. Total expenses 905,248. Other professional fees: program service expenses 118,245. Management and general expenses 7,976. Fundraising expenses 0. Total expenses 126,221.”