2011-01-10T13:01:44-06:00 2010-06-30 BeachFleischman PC PO Box 64130 Tucson AZ 857284130 990 2009-07-01 201991334 Critical Path Institute CRIT 5205473440 1730 East River Road No 200 Tucson AZ 857185898 Raymond L Woosley MD PHD 5205473440 2010-12-16 1 Karen K McCloskey CPA MST 5203214600 2009 2016-02-24 21:20:13Z Raymond L Woosley MD PhD 1730 East River Road No 200 Tucson AZ 857185898 7321919 0 X WWW.C-Path.Org X 2004 AZ Foster and conduct research and educational programs that will lead to safer medical products. 15 12 33 1 0 0 5746728 7249111 0 25670 18941 17970 53647 5790368 7321699 0 0 3339747 3786257 0 2904 2117922 2567001 5457669 6353258 332699 968441 3725919 5226330 1374926 1906896 2350993 3319434 To create innovative collaborations in regulatory science that enable the most efficient and safe medical product development. 0 0 4739827 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 the regulated (medical product industry) that result in accelerated development of safe, new medical products. The accomplishments for this fiscal year report include:The Coalition Against Major Diseases (CAMD) was created to develop tools and processes to accelerate progress in the prevention, treatment and cure of major neurodegenerative diseases, initially focusing on Alzheimer's and Parkinson's Diseases. Accomplishments include: 1) an Alzheimer's disease data standard has been developed in conjunction with CDISC that includes all of the high priority data elements. A secure online database has been designed, built, and tested. Data from eleven clinical trials of member companies comprising over 4,000 patients have been remapped into the new data standard and loaded into the database. At an international press conference on June 11th, the database was made available to qualified researchers. In the first week since the announcement, over 30 individuals have applied for access to the data; 2) an initial Alzheimer's disease progression model has been created using data from the ADNI studies. It will be further tested and a placebo effect added using member clinical data; and 3) a series of Cerebral Spinal Fluid (CSF) and imaging biomarkers have been identified as potentially useful in identifying early symptomatic patients with a high likelihood of conversion to full dementia in a short period of time for inclusion in clinical trials. A research plan has been written and is in review.The Patient-Reported Outcomes Consortium (PRO) was created to identify and prioritize the medical product development areas where PRO instruments are needed, establish an overarching framework for collaboration and infrastructure for a PRO Consortium, and submit qualification dossiers to regulatory agencies for qualification of PRO instruments for use in regulatory and developmental decision making. The following Working Groups have been established and are working from their scoping summary documents: Cognition, Irritable Bowel Syndrome, Asthma, Depression and Non-small Cell Lung Cancer.The Predictive Safety Testing Consortium (PSTC) compiles, generates, and submits for regulatory review data on new safety biomarkers to be used in drug development, thus advancing the drug safety assessment process. The following Working Groups have had successes this year: Hepatotoxicity, Nephrotoxicity, and Skeletal Muscle. The Hepatotoxicity Working Group has completed all 46 planned studies and the data will be uploaded into the data base in July 2010. The Nephrotoxicity Working Group has completed all 12 planned studies and the data were to be loaded into the database by the end of July 2010. The Skeletal Muscle Working Group has completed all 31 planned studies and the data should be completely uploaded by August 25, 2010. The Critical Path to TB Regimens (CPTR) is a new collaboration with the Bill and Melinda Gates Foundation and the Global Alliance for TB Drug Development. The goal of this collaboration is to significantly speed development of innovative treatments for tuberculosis. 0 w 0 4739827 1 1 0 1 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 1 0 0 0 0 1 0 0 0 1 25 0 1 33 1 0 0 0 0 0 0 0 0 0 15 12 0 0 1 0 0 0 0 1 0 0 0 0 1 1 1 1 1 1 1 0 AZ X X Allison Alberts 5206478380 1730 East River Road Suite 200 Tucson AZ 857185898 J Lyle Bootman PhD 1.00 X 0 0 0 John Carter 1.00 X 0 0 0 Peter B Corr MD 1.00 X 0 0 0 M Wainwright Fishburn Jr 1.00 X 0 0 0 Jeffrey Jacob 1.00 X 0 0 0 Shaun A Kirkpatrick 1.00 X 0 0 0 James T Kolbe 1.00 X 0 0 0 Walter H Moos PhD 1.00 X 0 0 0 Cindy Parseghian 1.00 X 0 0 0 Leslie P Tolbert PhD 1.00 X 0 0 0 Alastair JJ Wood MD 1.00 X 0 0 0 Raymond L Woosley MD PhD 60.00 X 372407 0 43534 Joseph R Assenzo PhD 20.00 X 64890 0 5191 Celinda Johnson 50.00 X 109868 0 16593 Richard T Myers 60.00 X 248255 0 29052 Jeffrey Cossman MD 40.00 X 179747 0 24860 Steven Broadbent MBA 50.00 X 115202 0 18240 Ralph Martel PhD 40.00 X 172072 0 29350 Marietta Anthony PhD 50.00 X 131674 0 16209 Klaus Romero MD 40.00 X 127432 0 13397 Maryellen Culotta PhD 40.00 X 124072 0 24318 1645619 0 220744 12 0 1 0 University of Arizona PO Box 3520 Tucson AZ 85722 Sub-Award CERT grant 519444 United BioSource Corporation PO BOX 758641 Baltimore MD 21275 Research 250000 Ephibian 3180 N Swan Rd Tucson AZ 85712 Database Development 177816 Tucson Pharma Ventures 3830 N Webster Rd Tucson AZ 85750 Consulting 120451 American Capitol Group 122 C Street NW Ste 500 Washington DC 20001 Government Relations 108342 5 1632061 2359479 3257571 25479 7249111 18561 18561 12404 12404 12404 12404 600 220 380 380 380 Reimbursed Expenses 541700 41243 41243 41243 7321699 41243 0 31345 974729 323146 649882 1701 2225206 1669683 555311 212 150222 148451 1740 31 232858 205169 27592 97 203242 161136 41984 122 104631 88906 15699 26 77660 52547 25071 42 1079375 1071448 7914 13 40945 39287 1655 3 198368 157758 40543 67 123004 105487 17488 29 292412 170635 121610 167 227117 196826 30241 50 103645 91217 12188 240 92658 66525 26089 44 39053 27684 11350 19 Government Relations 108342 108342 Dues and Subscriptions 45257 33427 11810 20 Miscellaneous 17956 11548 6397 11 Bad Debt 15057 9632 5416 9 Taxes and Licenses 1521 973 547 1 6353258 4739827 1610527 2904 1951804 469124 1366141 2100765 108062 373633 11670 140145 50754 19959 684785 318777 237488 366008 1729555 0 27141 3725919 5226330 308149 355254 1066777 1551642 1374926 1906896 X 1048008 3319434 1302985 0 2350993 3319434 3725919 5226330 X 0 1 1 X 1 1 X 2095375 3191066 4151021 5746728 7249111 22433301 2095375 3191066 4151021 5746728 7249111 22433301 795319 21637982 37510 65306 73625 34114 30965 241520 17970 41243 59213 22734034 0.95180 X Schedule A, Part II, Line 10, Explanation of Other Income: Reimbursed Expenses RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 108342 108342 6244916 6353258 467663 116916 0 0 325961 362038 422883 467663 1578545 2367818 144000 147033 108811 108342 508186 81423 90510 105721 116916 394570 591855 136608 54453 82155 165673 107808 57865 382504 156516 225988 366008 7321699 6353258 968441 0 968441 7331134 9435 9435 7321699 0 7321699 6362693 9435 9435 6353258 0 6353258 X 1 1 X X X X X 0 0 0 0 0 0 0 0 0 Raymond L Woosley MD PhD 372407 0 0 0 0 0 23850 0 19684 0 415941 0 0 0 Richard T Myers 248255 0 0 0 0 0 18333 0 10719 0 277307 0 0 0 Jeffrey Cossman MD 179747 0 0 0 0 0 14574 0 10286 0 204607 0 0 0 Ralph Martel PhD 172072 0 0 0 0 0 14000 0 15350 0 201422 0 0 0 Tucson Pharma Ventures Jeffrey Jacob, Board Member, is a member of Tucson Pharma Ventures. 120451 Consulting 0 0 X 1 24930 Comparable sales X Furniture 1 549 Comparable sales 0 0 0 Form 990, Part VI, Section A, line 4 The organization amended its corporate bylaws in the prior year to define the roll of the Chief Operating Officer, to change the principal place of business listed on the bylaws, and to remove the powers and duties of the advisory board. The principal place of business was changed to: 1730 E. River Road, Suite 200 Tucson, Arizona 85718 The Chief Operating Officer's position was defined as follows: The Chief Operating Officer shall be responsible for managing the operations of the organization, including Human Resources, marketing, facilities, finances, information technology, and other duties as assigned by the President/CEO. Form 990, Part VI, Section A, line 8b There are no committees with authority to act on behalf of the governing body. Form 990, Part VI, Section B, line 11 Form 990 is prepared by an independent CPA using information provided by the organization. The form is reviewed by the Accounting Specialist, Treasurer, COO, President/CEO, and another outside CPA prior to being finalized. Form 990, Part VI, Section B, line 12c Officers, Directors, and employees must fill out conflict of interest disclosures annually. These disclosures are reviewed by the President/CEO. The COO reviews the President/CEO's disclosures. Conflict of interest disclosures are publicly available on the Institute's website. Form 990, Part VI, Section B, line 15 A Board of Director's Compensation Committee meets and reviews executive compensation periodically. The committee seeks an independent compensation consulting organization and reviews that organization's qualifications. 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. An overall salary program must be approved by the board of directors before implementation. All employee salary increases must be approved by the President/ CEO. The last independent compensation survey was conducted for the CEO on January 14th, 2009. Form 990, Part VI, Section C, line 19 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 Foundation 1730 East River Road Suite 200 Tucson AZ 85718 204780896 Raising and contributing funds to Critical Path Institute AZ 501(C)3 11 N/A 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0