| Return Reference | Explanation |
|---|---|
| FORM 990, PAGE 1, PART I, LINE 6 | OFFICERS AND BOARD DIRECTORS |
| FORM 990, PAGE 2, PART III, LINE 4A | A.PATIENT PREFERENCE & EXPERIENCE: COMPLETED THE DESIGN AND DEVELOPMENT OF THE CONJOINT TOOL AND SURVEY ON PATIENT PREFERENCE FOR SUBCUTANEOUS DRUG DELIVERY; FIELDING IS COMPLETE WITH OVER 500 RESPONSES RECORDED FROM THE US, EU, AND JAPAN, AND ANALYSIS IS UNDERWAY. B.HIGH DOSE HIGH VOLUME: COMPLETED AN INDUSTRY-WIDE SURVEY ON "HARMONIZATION OF PAIN METHODOLOGIES FOR SC ADMINISTRATION-; DRAFT MANUSCRIPT "INTEGRATED CMC ROAD MAP FOR DEVELOPMENT OF HDHV PRODUCTS- AND THE "HDHV SELECTION CRITERIA MATRIX" ARE EXPECTED TO BE PUBLISHED IN 2026 FOLLOWING INTERNAL SC CONSORTIUM REVIEW. C.CLINICAL DESIGN & REGULATORY STRATEGY: PUBLISHED A CROSS-COMPANY SURVEY MANUSCRIPT ON CLINICAL AND REGULATORY STRATEGY IN THE JOURNAL OF CONTROLLED RELEASE AND CONDUCTED A WORKSHOP ON "DEVELOPMENT PATHWAYS AND CONSIDERATIONS FOR SUBCUTANEOUS BIOLOGIC FORMULATIONS" AT THE CRS 2025 ANNUAL MEETING & EXPOSITION IN PHILADELPHIA. D.SUSTAINABILITY: COMPLETED AND PRESENTED RESULTS OF THE INDUSTRY BENCHMARKING SURVEY AT MULTIPLE CONFERENCES THROUGHOUT THE YEAR, INCLUDING A POSTER PRESENTATION AT THE PDA UPS CONFERENCE IN VIENNA, AND SUBMITTED A MANUSCRIPT FOR PUBLICATION IN THE ON-DRUG DELIVERY JOURNAL. E.IMMUNOGENICITY: ENHANCED SC CONSORTIUM AWARENESS BY HIGHLIGHTING IMMUNOGENICITY SUB-TEAM ACTIVITIES AT THE IMMUNOGENICITY AND BIOASSAY SUMMIT, AUTHORED THE IMMUNOGENICITY PORTION OF "DEBUNKING THE MYTHS OF SC DELIVERY,- AND EXPECTS MANUSCRIPT SUBMISSION BEFORE YEAR-END. F.BIOAVAILABILITY: SUBMISSION OF "DEBUNKING THE MYTHS OF SC DELIVERY," DESCRIBING ADVANCEMENTS AND OPPORTUNITIES IN SC BIOAVAILABILITY, TO THE JOURNAL OF CONTROLLED RELEASE; A SECOND PUBLICATION, "PREDICTING HUMAN SUBCUTANEOUS BIOAVAILABILITY OF MONOCLONAL ANTIBODIES USING A NOVEL OPEN FLOW MICROPERFUSION (OFM) PORCINE MODEL," IS UNDER REVIEW. |
| FORM 990, PAGE 6, PART VI, LINE 3 | THE ORGANIZATION DELEGATES THE MAJORITY OF OPERATIONS SECRETARIAT DUTIES TO THE MANAGEMENT COMPANY, VITAL TECHNICAL MARKETING, INC. INCLUDING BUT NOT LIMITED TO ADMINISTRATION OF THE MAJORITY OF MEETINGS, ASSISTANCE WITH MEMBERSHIP DUTIES AND ALL FINANCIAL DUTIES. |
| FORM 990, PAGE 6, PART VI, LINE 6 | GOVERNING BOARD MEMBERS: INDUSTRY EXPERTS IN SUBCUTANEOUS DRUG DEVELOPMENT & DELIVERY WHO GUIDE THE OVERALL DIRECTION OF THE SC CONSORTIUM THROUGH VOTING RIGHTS AND SERVING AS SUB-TEAM LEADS AND/OR PARTICIPANTS. SUB-TEAM COLLABORATORS: INDIVIDUALS WHO ARE NOT ON THE GOVERNING BOARD BUT WHO ACTIVELY CONTRIBUTE TO SUB-TEAM WORKSTREAMS. THESE COLLABORATORS MAY BELONG TO AN ORGANIZATION CONTRIBUTING TO THE GOVERNING BOARD OR BE ANOTHER STAKEHOLDER IN THE SC ECOSYSTEM AND ARE DIRECTLY INVOLVED IN DRIVING FORWARD SC CONSORTIUM WORKSTREAMS. |
| FORM 990, PAGE 6, PART VI, LINE 7A | MEMBERS ELECT MEMBERS OF THE GOVERNING BODY. |
| FORM 990, PAGE 6, PART VI, LINE 7B | YES, MAJOR DECISIONS OF THE GOVERNING BODY ARE APPROVED BY THE GOVERNING BOARD MEMBERS THROUGH A VOTING PROCESS, AS WRITTEN IN THE CONSORTIUM'S BYLAWS. |
| FORM 990, PAGE 6, PART VI, LINE 11B | NO REVIEW WAS OR WILL BE CONDUCTED. |
| FORM 990, PAGE 6, PART VI, LINE 12C | THE CONSORTIUM REGULARLY MONITORS AND ENFORCES COMPLIANCE BY REQUIRING ALL ORGANIZATIONAL REPRESENTATIVES (INCLUDING BOARD MEMBERS AND COMMITTEE MEMBERS) TO: ANNUALLY SIGN AN AFFIRMATION OF CONFLICT OF INTEREST POLICY AND DISCLOSURE FORM CONFIRMING THEIR UNDERSTANDING AND AGREEMENT TO COMPLY. DISCLOSE ANY POTENTIAL CONFLICTS, WHICH ARE REVIEWED BY THE BOARD. RECUSE THEMSELVES FROM DISCUSSIONS AND VOTES WHERE A CONFLICT EXISTS. UNDERGO PERIODIC REVIEWS TO ENSURE COMPLIANCE WITH TAX-EXEMPT REQUIREMENTS AND ETHICAL STANDARDS. |
| FORM 990, PAGE 6, PART VI, LINE 19 | THE ORGANIZATION MAKES ITS GOVERNING DOCUMENTS AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC UPON WRITTEN REQUEST. |
| FORM 990, PART IX, LINE 11G | RESEARCH SERVICES 37,177 0 0 SUSTAINABILITY 278,083 0 0 TOTAL 315,260 0 0 |
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