Civic Intelligence

Transcelerate Biopharma Inc

990 • Fiscal year 2017 • EIN 46-0886344

Jan 01, 2017 to Dec 31, 2017 • Filed on May 04, 2018

100 Four Falls Corp Center No 655West Conshohocken, PA 19428

(484) 539-1230

Siviq Scores

Precomputed percentiles for this filing year versus similar nonprofits in the same peer cohort.

Liabilities / Assets

85th percentile

0.70x

Higher debt load relative to assets than 85% of similar nonprofits.

2017 filings • 501(c)6 • $25M-$50M nonprofits • Source year 2017

Liabilities / Revenue

86th percentile

1.18x

Higher debt load relative to revenue than 86% of similar nonprofits.

2017 filings • 501(c)6 • $25M-$50M nonprofits • Source year 2017

Net Margin

10th percentile

-12%

Higher net margin than 10% of similar nonprofits.

2017 filings • 501(c)6 • $25M-$50M nonprofits • Source year 2017

Top Officer Pay

94th percentile

$1,669,588

Higher top officer pay than 94% of similar nonprofits.

Top officer pay equals 6.4% of source-year revenue.

2017 filings • 501(c)6 • $25M-$50M nonprofits • Source year 2017

Asset Growth

16th percentile

-1.7%

Faster asset growth than 16% of similar nonprofits.

2017 filings • 501(c)6 • $25M-$50M nonprofits • Annualized from 2016 to 2017

Revenue Growth

85th percentile

27%

Faster revenue growth than 85% of similar nonprofits.

2017 filings • 501(c)6 • $25M-$50M nonprofits • Annualized from 2016 to 2017

Assets

Down

$43,979,845

Down $741,968 (-1.7%) from 2016

Net Assets

Down

$13,147,972

Down $3,105,431 (-19%) from 2016

Liabilities

Up

$30,831,873

Up $2,363,463 (+8.3%) from 2016

Revenue

Up

$26,172,580

Up $5,493,396 (+27%) from 2016

Expenses

Up

$29,275,313

Up $5,541,609 (+23%) from 2016

Net Income

Down

-$3,102,733

Down $48,213 (-1.6%) from 2016

Historical Trend

Balance Sheet Trend

The highlighted filing sits inside the broader history for assets, liabilities, and net assets.

$60M$40M$20M$0Assets 2012: $5,857,436Liabilities 2012: $5,678,804Net Assets 2012: $178,6322012Assets 2013: $9,075,300Liabilities 2013: $1,902,607Net Assets 2013: $7,172,6932013Assets 2014: $34,898,547Liabilities 2014: $24,786,391Net Assets 2014: $10,112,1562014Assets 2015: $43,370,074Liabilities 2015: $24,062,150Net Assets 2015: $19,307,9242015Assets 2016: $44,721,813Liabilities 2016: $28,468,410Net Assets 2016: $16,253,4032016Assets 2017: $43,979,845Liabilities 2017: $30,831,873Net Assets 2017: $13,147,9722017Assets 2018: $38,632,750Liabilities 2018: $31,059,509Net Assets 2018: $7,573,2412018Assets 2019: $45,613,199Liabilities 2019: $36,755,773Net Assets 2019: $8,857,4262019Assets 2020: $49,374,410Liabilities 2020: $36,650,129Net Assets 2020: $12,724,2812020Assets 2021: $50,373,384Liabilities 2021: $39,738,784Net Assets 2021: $10,634,6002021Assets 2022: $48,482,660Liabilities 2022: $38,508,812Net Assets 2022: $9,973,8482022Assets 2023: $48,107,662Liabilities 2023: $36,490,338Net Assets 2023: $11,617,3242023

Highlighted filing

2017

Assets$43,979,845
Liabilities$30,831,873
Net Assets$13,147,972

Operations Trend

Revenue, expenses, and net income across loaded years, with this filing highlighted.

$40M$30M$20M$10M$0-$10MRevenue 2012: $5,672,849Expenses 2012: $5,494,217Net Income 2012: $178,6322012Revenue 2013: $13,643,765Expenses 2013: $6,823,303Net Income 2013: $6,820,4622013Revenue 2014: $15,293,388Expenses 2014: $11,780,323Net Income 2014: $3,513,0652014Revenue 2015: $25,465,264Expenses 2015: $16,269,496Net Income 2015: $9,195,7682015Revenue 2016: $20,679,184Expenses 2016: $23,733,704Net Income 2016: -$3,054,5202016Revenue 2017: $26,172,580Expenses 2017: $29,275,313Net Income 2017: -$3,102,7332017Revenue 2018: $25,318,445Expenses 2018: $30,891,037Net Income 2018: -$5,572,5922018Revenue 2019: $27,979,345Expenses 2019: $26,700,072Net Income 2019: $1,279,2732019Revenue 2020: $31,974,894Expenses 2020: $28,107,965Net Income 2020: $3,866,9292020Revenue 2021: $31,090,660Expenses 2021: $33,180,341Net Income 2021: -$2,089,6812021Revenue 2022: $33,600,302Expenses 2022: $34,262,372Net Income 2022: -$662,0702022Revenue 2023: $34,168,812Expenses 2023: $32,521,149Net Income 2023: $1,647,6632023

Highlighted filing

2017

Revenue$26,172,580
Expenses$29,275,313
Net Income-$3,102,733
Jump To
Filing Snapshot
Filing Period
Jan 1, 2017 to Dec 31, 2017
Signed
May 4, 2018
Return Version
2017v2.2
Gross Receipts
$26,172,580
Mission and Program Overview

Mission

Transcelerate biopharma inc. Is dedicated to improving the health of people around the world by accelerating and enhancing the research and development (r&d) of innovative new therapies.the organization's mission is to collaborate across the global biopharmaceutical r&d community to identify, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines. Transcelerate evolved from conversations at various forums for executive r&d leadership to discuss current issues facing the industry, and examine solutions for addressing common challenges.membership in transcelerate is open to biopharmaceutical companies with research & development operations.

Improve the health of people in the world by enhancing the r&d of innovative therapies.transcelerate biopharma inc. Is a non-profit organization dedicated to improving the health of people around the world by accelerating and enhancing the research and development (r&d) of innovative new therapies. The organization's mission is to collaborate across the global biopharmaceutical r&d community to identify, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of new medicines.membership in transcelerate is open to biopharmaceutical companies with research & development operations.

Balance Sheet Detail
LineBeginningEndChange
Assets
Accounts Receivable$20,833,333$23,100,000▲ $2,266,667
Savings and Temporary Cash Investments$21,694,408$12,842,533▼ $8,851,875
Investments in Publicly Traded Securities-$4,997,301-
Cash and Non-Interest-Bearing Accounts$2,026,630$2,926,545▲ $899,915
Prepaid Expenses and Deferred Charges$153,031$101,107▼ $51,924
Land, Buildings, and Equipment, Net$2,564$512▼ $2,052
Total Assets$44,721,813$43,979,845▼ $741,968
Other Assets Total$11,847$11,847→ $0
Liabilities
Deferred Revenue$23,333,333$25,100,000▲ $1,766,667
Accounts Payable and Accrued Expenses$5,135,077$5,731,873▲ $596,796
Total Liabilities$28,468,410$30,831,873▲ $2,363,463
Net Assets / Fund Balance
Unrestricted Net Assets$16,253,403$13,147,972▼ $3,105,431
Total Net Assets Fund Balance$16,253,403$13,147,972▼ $3,105,431
Total Liabilities and Net Assets / Fund Balance$44,721,813$43,979,845▼ $741,968

Asset Categories

AssetBook ValueDepreciationBasis
Other Land Buildings$512$9,744$10,256
Equipment$0$4,202$4,202
Compensation and Service Providers

Employees

NameTitleFull / Part TimeBaseOtherTotal
Dalvir GillChief Executive OfficerFT$572,372$1,097,216$1,669,588
Janice ChangSenior Vice President of Global OperationsFT$449,932$36,349$486,281
Janice ChangSenior Vice President of Global Oper-$361,446$124,835$486,281
Jennifer a BurgessExecutive Director of Communications & EngagementFT$283,235$36,913$320,148
Jennifer a BurgessExecutive Director of Communications-$228,897$91,251$320,148
Cara L RinaldiSenior Director of Portfolio ManagementFT$231,401$40,831$272,232
Cara L RinaldiSenior Director of Portfolio Managem-$193,401$78,831$272,232
Anthony GargesHead of Finance and ContractsFT$148,256$57,990$206,246
Jeneen DonadeoDirector, Program ManagementFT$166,788$28,947$195,735
Denise ReyesAssociate Director, Program ManagementFT$176,418$16,795$193,213
Denise ReyesAssociate Director, Program Manageme-$139,668$53,545$193,213

Board Members and Trustees

NameTitle
Elliott LevyChair of Board of Director
David NicholsonVice Chair of Board of Director
Alise ReicinBoard Member
Badhri SrinivasanBoard Member
Bernhardt ZeiherBoard Member
Christopher CorsicoBoard Member
Elias ZerhouniBoard Member
Iris Loew-friedrichBoard Member
Jan LundbergBoard Member
Kate OwenBoard Member
Kathy RouanBoard Member
Michelle RohrerBoard Member
Paul StoffelsBoard Member
Peter KristensenBoard Member
Rob ScottBoard Member
Rod MackenzieBoard Member
Roy BaynesBoard Member
Sean BohenBoard Member
Takuko Yamada-sawadaBoard Member
Ulo PalmCorporate Secretary
Andrew LeeTreasurer

Highest Paid Contractors

ContractorServicesLocationCompensation
Accenture LLPConsulting & It Services161 N CLARK STREET, Chicago, IL 60601, Uk$6,781,394
CognizantIt Services211 QUALITY CIRCLE, College Station, TX 77845$5,867,259
Kilpatrick TownsendLegal Services601 14TH STREET NW SUITE 900, Washington, DC 20005$2,363,669
Kinapse LimitedConsultingPO BOX 654068, Dallas, TX 75265$1,013,141
Yoh Services LLCConsulting-$998,050
Revenue and Support

Revenue Composition

Contributions and Grants
$0
Program Service Revenue
$26,133,333
Investment Income
$39,247
Other Revenue
$0
Change in Net Assets
$-3,102,733
Expenses and Functional Allocation

Major Expense Lines

Line ItemAmount
Other Expenses$24,485,225
Salaries, Compensation, and Employee Benefits$4,790,088
Grants and Similar Amounts Paid$0
Professional Fundraising Fees$0
Total Fundraising Expense$0

Functional Expense Allocation

Line ItemProgramManagementFundraisingTotal
Fees for Services Other$17,032,691$894,518-$17,927,209
Information Technology$2,616,310$124,533-$2,740,843
Fees for Services Legal$1,863,649$525,507-$2,389,156
Current Officers, Directors, Trustees, and Key Employees-$2,155,870-$2,155,870
Other Salaries and Wages$1,069,766$1,071,896-$2,141,662
Travel$203,405$200,328-$403,733
Conferences and Meetings$135,892$172,101-$307,993
Other Employee Benefits$10,914$245,982-$256,896
Office Expenses$446$166,981-$167,427
Payroll Taxes$58,598$106,127-$164,725
Occupancy-$137,550-$137,550
Fees for Services Accounting-$117,074-$117,074
Insurance-$109,419-$109,419
Advertising$30,100$54,538-$84,638
Pension Plan Contributions$32,756$38,179-$70,935
Depreciation Depletion-$2,051-$2,051
Other Expenses$85$2,050-$2,050
All Other Expenses-$75-$75
Total Functional Expenses$23,091,852$6,183,461$0$29,275,313
Fundraising, Events, and Gaming
Fundraising activities
No
Gaming activities
No
Professional fundraiser used
No

Fundraising and Gaming Totals

Line ItemAmount
Professional Fundraising Fees$0
Political and Lobbying Activity
Political campaign activity
No
In-house lobbying only
Yes
Subject to proxy tax
Yes
Governance and Compliance

Governance Checklist

Compiled or reviewed by an accountant
No
Annual disclosure for covered persons
No
Backup withholding compliance
Yes
Business relationship with family members
No
Business relationship with organization members
No
Material changes to governing documents
Yes
Compensation from other sources disclosed
No
CEO compensation reviewed
Yes
Other officer compensation reviewed
Yes
Conflict-of-interest policy
Yes
Audited financial statements prepared
No
Key decisions subject to board approval
No
Management duties delegated
No

Governance Explanations

Form 990, Part VI, Section A, Line 4

During 2017, the board of directors and members of the corporation approved amending and restating the certificate of incorporation of the corporation, in order to update the purpose clause to more accurately encompass the corporation's current and planned activities. The corporation's amended and restated certificate of incorporation was filed in delaware effective as of december 5, 2017. Prior to this amendment, the first paragraph of article iii of the corporation's certificate of incorporation previously read as follows: "the corporation is organized exclusively for the purpose of promoting a common business interest within the meaning of section 501(c)(6) of the internal revenue code of 1986, as amended (the "code"), and, in particular, for the purpose of providing leadership, project management, and governance designed to improve the quality of, and reduce costs in, clinical trial execution by pharmaceutical and biotechnology companies within the life sciences industry, and consistent with that purpose, to engage in any lawful act or activity for which non-stock, nonprofit corporations may be organized under the general corporation law of the state of delaware (the "dgcl"). The corporation shall be a nonprofit corporation." following this amendment, the first paragraph of article iii of the corporation's amended and restated certificate of incorporation now reads as follows: "the corporation is organized exclusively for the purpose of promoting a common business interest within the meaning of section 501(c)(6) of the internal revenue code of 1986, as amended (the "code"), and, in particular, for the purpose of providing leadership, project management, and governance relating to industry collaborations designed to improve the efficiency of research and development initiatives and activities in the areas of preclinical research, clinical trial execution, and pharmacovigilance, undertaken by pharmaceutical and biotechnology companies within the life sciences industry, and consistent with that purpose, to engage in any lawful act or activity for which non-stock, nonprofit corporations may be organized under the general corporation law of the state of delaware (the "dgcl"). The corporation shall be a nonprofit corporation." amendment of bylaws: during 2017, the board of directors of the corporation approved amending the bylaws of the corporation to increase the number of at-large tier i directors from 2 to 3, and to increase the maximum number of members of the board of directors from 20 to 21. Section 3.02 of the bylaws now reads as follows: "section 3.02 number and composition of directors. The number of directors shall be determined by resolution of the board of directors adopted by the affirmative vote of directors constituting a majority of the total number of directors in office at the time of such vote. The board of directors shall be comprised of up to twenty-one (21) members; provided that: (i) ten (10) seats are filled by directors who are representatives of the charter members (and each charter member has discretion to appoint its own representative to the board of directors ("charter member directors"); (ii) up to three (3) additional seats shall be filled by directors who are representatives of the tier i members who are not charter members ("at large tier i directors") (charter member directors and at large tier i directors collectively shall be referred to as "tier i directors"); (iii) up to six (6) seats shall be filled by directors who are representatives of the tier ii members ("tier ii directors"); (iii) one (1) seat shall be filled by a director who is a representative of the associate members ("associate member director"); and (iv) one (1) seat shall be filled by the chief executive officer of the corporation ("ceo director"). The board seats reserved for the tier i members, including the charter members, shall at all times represent at least 55% of the total number of directors of the board. In the event

Form 990, Part VI, Section A, Line 6

The members of the corporation consist of such firms and corporations that are approved for membership from time to time by the board of directors or its designees in accordance with the policies and procedures of the corporation. The corporation has the following categories of members: a. Tier i members - to be eligible for tier i membership, a firm or corporation must be a pharmaceutical or biotechnology company with an annual budget for research and development in excess of $2.5 billion. Eligibility for tier i membership is established based upon a company's publically available research and development expenditures over the three (3) year period preceding the date the company applies to join the corporation. The initial tier i members are further defined as the "charter members." b. Tier ii members - to be eligible for tier ii membership, a firm or corporation must be a pharmaceutical or biotechnology company with an annual budget for research and development that is less than $2.5 billion but more than $100 million. Eligibility for tier ii membership will be established based upon a company's publically available research and development expenditures over the three (3) year period preceding the date the company applies to join the corporation. C. Associate members - to be eligible for associate membership, a firm or corporation must be a pharmaceutical or biotechnology company with an annual budget for research and development that is less than $100 million.

Form 990, Part VI, Section A, Line 7A

The board of directors shall be comprised of up to twenty-one (21) members; provided that: (i) ten (10) seats are filled by directors who are representatives of the charter members; (ii) up to three (3) additional seats shall be filled by directors who are representatives of the tier i members who are not charter members; (iii) up to six (6) seats shall be filled by directors who are representatives of the tier ii members; (iv) one (1) seat shall be filled by a director who is a representative of the associate members; and (v) one (1) seat shall be filled by the chief executive officer of the corporation. The corporation's bylaws state that directors shall be elected or appointed, as applicable, annually at the annual meeting of members and shall serve until the following annual meeting of members and until their successors are elected or appointed, as applicable, and qualified. Each charter member shall have the right to appoint a representative of the charter member to serve as a charter member director. Tier i at-large directors shall be elected by a plurality vote of the tier i members, which include the charter members. Tier ii directors shall be elected by a plurality vote of the tier ii members. The associate member director shall be elected by a plurality vote of the associate members. The ceo director shall serve ex-officio, for so long as he or she shall hold the office of chief executive officer. Transcelerate does not presently have any assoicate members therefore, the assoicate member board seat is currently vacant. Each tier i member shall be entitled to three (3) votes at every meeting of members on matters which tier 1 members are entitled to vote. Each tier ii member shall be entitled to one (1) vote at every meeting of members on matters which tier ii members are entitled to vote. Associate members shall be entitled to notice of and to attend meetings of the members but shall not be entitled to vote at such meetings, provided however, associate members shall have the right to cast one (1) vote each with respect to the election of the nominee to fill the associate member board position. Notwithstanding the above, in order to be eligible to vote, a member must be in good standing and its dues and assessments paid in full.

Form 990, Part VI, Section B, Line 11B

The finance committee and management review and approve the form 990. The form is then distributed to all members of the board for their review before filing with the internal revenue service.

Form 990, Part VI, Section B, Line 15

For 2017, the transcelerate executive committee prepared and approved the compensation package for the ceo. However, the transcelerate executive committee has been disbanded effective as of january 1, 2018; thus, for 2018 and going forward, the board chair, with input from other directors or a subcommittee of the board, will review and recommend the ceo's compensation package for approval by the full board. The ceo approves the compensation for the senior vice president of global operations, along with all other key employees.

Form 990, Part VI, Section C, Line 19

The organization's governing documents, financial statements, and conflict of interest policy and other corporate policies are available upon request.

Filing and Contact Details

Filer

Filer Name
Transcelerate Biopharma Inc
EIN
46-0886344
Phone
4845391230
Address
100 FOUR FALLS CORP CENTER NO 655, WEST CONSHOHOCKEN, PA 19428

Signing Officer

Name
Dalvir Gill Phd
Title
CEO
Phone
4845391230
Signed
2018-05-04
Discuss with paid preparer
Yes

Organization Details

Principal Officer
Dalvir Gill Phd
Formed
2012
Legal Domicile
De
Voting Board Members
20
Independent Board Members
19
Employees
14
Volunteers
0

Preparer

Firm
Eisneramper Llp
Address
130 NORTH 18TH STREET SUITE 3000, PHILADELPHIA, PA 19103-2757
Preparer
Helen M Martin
Phone
2158818800
Supplemental Narrative

Additional Explanations

Form 990, Part IX, Line 11G

External contractor support: program service expenses 9,957,568. Management and general expenses 56,165. Fundraising expenses 0. Total expenses 10,013,733. Project management fees: program service expenses 6,581,082. Management and general expenses 402,875. Fundraising expenses 0. Total expenses 6,983,957. Communications fees: program service expenses 494,041. Management and general expenses 435,478. Fundraising expenses 0. Total expenses 929,519.

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IRS990/ActivityOrMissionDesc0IMPROVE THE HEALTH OF PEOPLE IN THE WORLD BY ENHANCING THE R&D OF INNOVATIVE THERAPIES.TRANSCELERATE BIOPHARMA INC. IS A NON-PROFIT ORGANIZATION DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES. THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS.
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IRS990/Desc0IN 2017, TRANSCELERATE DELIVERED THE FOLLOWING ACCOMPLISHMENTS:CLINICAL DATA STANDARDS: CONTINUED TO PARTNER WITH THE STANDARD-SETTING ORGANIZATION CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC. TO DELIVER INDUSTRY-WIDE THERAPEUTIC AREA STANDARDS IN THE AREAS OF SCHIZOPHRENIA AND INFLUENZA.CLINICAL DATA TRANSPARENCY: PUBLISHED 3 NEW RESEARCH PUBLICATIONS AND IMPLEMENTATION TOOLS, ALL PUBLICLY AVAILABLE ON THE TRANSCELERATE WEBSITE. CLINICAL RESEARCH ACCESS & INFORMATION EXCHANGE: PUBLISHED TWO PAPERS IN DIA'S TIRS JOURNAL (IMPROVING INVESTIGATIVE SITE CONTACT OPTIONS ON CLINICAL TRIAL REGISTRIES, AND IMPROVING INFORMATION EXCHANGE WITH CLINICAL TRIAL PARTICIPANTS) AND LAUNCHED A REGISTRY OF THE FUTURE PROPOSAL, ALL PUBLICLY AVAILABLE ON THE TRANSCELERATE WEBSITE. COMMON PROTOCOL TEMPLATE: ACHIEVED ALIGNMENT WITH FDA/NIH, DELIVERED PROOF OF CONCEPT FOR AUTOMATION, AND DELIVERED RELEASE 5.0 OF THE COMMON PROTOCOL TEMPLATE WHICH INCLUDES ENHANCED FEATURES, AND ADDITIONAL TA LIBRARIES.ECONSENT: DELIVERY OF ECONSENT ASSETS TO INDUSTRY (INCLUDING IMPLEMENTATION GUIDANCE AND LANDSCAPE ASSESSMENT) PUBLICLY AVAILABLE ON THE TRANSCELERATE WEBSITE. ELABELS: DEVLIERED CONCEPTUAL WIREFRAME AND IMPLEMENTATION GUIDANCE, PUBLICLY AVAILABLE ON THE TRANSCELERATE WEBSITE. ELABEL PILOTS COMMENCED AT 4 MEMBER COMPANIES.ESOURCE: ESOURCE PUBLISHED TECHNOLOGY LANDSCAPE PAPER, COMPLETED A CONNECTATHON (THROUGH HL7) & ROUNDTABLE WITH HEALTH AUTHORITIES, ACADEMIA AND INVESTIGATOR SITES.INTERPRETATION OF PHARMACOVIGILANCE REGULATIONS: DEVELOPED PERSPECTIVE FOR INTERPRETATION OF AMBIGUOUS IND SAFETY REGULATIONS.INVESTIGATOR REGISTRY: 11 TRANSCELERATE MEMBERS PARTICIPATING, AND ACTIVELY SHARING INVESTIGATOR BACKGROUND INFORMATION.PLACEBO STANDARD OF CARE: CONTINUED DELIVERY OF CONVERTED DATA (109 TRIALS CURRENTLY) WITH MORE THAN 78,000 PATIENTS ACROSS 13 DISEASE AREAS.RISK BASED MONITORING: LAUNCHED THE RBM INTERACTIVE GUIDE.SHARED INVESTIGATOR PLATFORM: LAUNCHED 4 ADDITIONAL RELEASES TO ENHANCE SITE CAPABILITIES.VALUE OF SAFETY INFORMATION DATA SOURCES: DEVELOPED HIERARCHY OF VALUE HYPOTHESIS AND COLLECTED DATA TO SUPPORT THEIR HYPOTHESIS AND COMMENCED DISCUSSION WITH HEALTH AUTHORITIES REGARDING SAME.ADDITIONALLY, IN DECEMBER 2017 THE TRANSCELERATE BOARD OF DIRECTORS APPROVED THE FOLLOWING NEW WORK AREAS: - ADVANCING SAFETY ANALYTICS: THIS PROJECT WILL FOCUS ON DEVELOPING BEST PRACTICES AND GUIDANCE AROUND THE APPLICATION OF INTERROGATIVE METHODS TOWARDS VARIOUS SAFETY DATA SOURCES. - COMMON REGISTRY DATA PACKET: GUIDANCE ON AUTHORING AND PROCEDURAL BEST PRACTICES FOR SPONSORS TO ENSURE THE AVAILABILITY OF COMPLETE, ACCURATE, TIMELY, AND LAY AUDIENCE-FRIENDLY ("QUALITY") INFORMATION AND TO IMPROVE DATA RE-USABILITY. - COMMON SAP TEMPLATE: A COMMON STATISTICAL ANALYSIS PLAN (SAP) TEMPLATE WOULD PROVIDE A MODEL LAYOUT AND CONTENT FOR SAP DOCUMENTATION AND WOULD LINK DIRECTLY TO TRANSCELERATE'S COMMON PROTOCOL TEMPLATE (CPT). - DATA MONITORING COMMITTEE: DEVELOP A FRAMEWORK/TOOLKIT FOR SPONSORS TO USE TO INCREASE THE POPULATION OF PEOPLE WITH REQUISITE SKILLS TO SERVE ON A DATA MONITORING COMMITTEE. - INTELLIGENT AUTOMATION OPPORTUNITIES: THIS PROJECT WILL FOCUS ON IDENTIFYING HOW INTELLIGENT AUTOMATION TECHNOLOGIES CAN BE USED TO SUPPORT EXECUTION OF PV ACTIVITIES/PROCESSES. BY CONDUCTING AN IMPACT ASSESSMENT AND WORKING WITH GLOBAL HEALTH AUTHORITIES TO VERIFY RISKS/ISSUES WITH THEIR USE, THIS INITIATIVE WILL PROVIDE GUIDANCE ON APPROPRIATE APPLICATIONS OF NEW TECHNOLOGY IN PV PRACTICE. - MODERNIZATION OF DIGITAL DATA FLOW: TO RECOGNIZE THE BENEFITS OF TRUE END-TO-END DATA FLOW THE FOLLOWING STEPS MUST BE COMPLETED: A RE-ENGINEERED PROCESS AND ACCOMPANYING METHODOLOGY; DIGITIZATION OF PRIORITIZED PROCEDURES. - PROTOCOL DEVIATIONS : CREATE AND OBTAIN FEEDBACK FROM HEALTH AUTHORITIES ON A FLEXIBLE BEST PRACTICE TOOLKIT AND FRAMEWORK FOR THE COLLECTION, MANAGEMENT AND REPORTING OF PROTOCOL DEVIATIONS.
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IRS990/MissionDesc0TRANSCELERATE BIOPHARMA INC. IS DEDICATED TO IMPROVING THE HEALTH OF PEOPLE AROUND THE WORLD BY ACCELERATING AND ENHANCING THE RESEARCH AND DEVELOPMENT (R&D) OF INNOVATIVE NEW THERAPIES.THE ORGANIZATION'S MISSION IS TO COLLABORATE ACROSS THE GLOBAL BIOPHARMACEUTICAL R&D COMMUNITY TO IDENTIFY, DESIGN AND FACILITATE IMPLEMENTATION OF SOLUTIONS DESIGNED TO DRIVE THE EFFICIENT, EFFECTIVE AND HIGH QUALITY DELIVERY OF NEW MEDICINES. TRANSCELERATE EVOLVED FROM CONVERSATIONS AT VARIOUS FORUMS FOR EXECUTIVE R&D LEADERSHIP TO DISCUSS CURRENT ISSUES FACING THE INDUSTRY, AND EXAMINE SOLUTIONS FOR ADDRESSING COMMON CHALLENGES.MEMBERSHIP IN TRANSCELERATE IS OPEN TO BIOPHARMACEUTICAL COMPANIES WITH RESEARCH & DEVELOPMENT OPERATIONS.
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