Attach to Form 990 or 990-EZ.
Information about Schedule O (Form 990 or 990-EZ) and its instructions is at| Return Reference | Explanation |
|---|---|
| FORM 990 - ORGANIZATION'S MISSION | THE ALLIANCE FOR REGENERATIVE MEDICINE (ARM) IS THE PREEMINENT GLOBAL ADVOCATE FOR REGENERATIVE AND ADVANCED THERAPIES. ARM FOSTERS RESEARCH, DEVELOPMENT, INVESTMENT AND COMMERCIALIZATION OF TRANSFORMATIONAL TREATMENTS AND CURES FOR PATIENTS WORLDWIDE. BY LEVERAGING THE EXPERTISE OF ITS MEMBERSHIP, ARM EMPOWERS MULTIPLE STAKEHOLDERS TO PROMOTE LEGISLATIVE, REGULATORY AND PUBLIC UNDERSTANDING OF, AND SUPPORT FOR, THIS EXPANDING FIELD. |
| FORM 990, PAGE 2, PART III, LINE 4A | CHALLENGE; SUBMITTED COMMENTS TO FDA AND EMEA RE: SEVERAL REGULATORY PROPOSALS; WROTE PAPER REGARDING FUTURE ROLE OF THE RAC LEADING TO NIH POLICY CHANGES; HOSTED WORKSHOP ON INTERNATIONAL REGULATORY HARMONIZATION AND PUBLISHED PAPER IN STEM CELL TRANSLATIONAL MEDICINE, JULY 2014; SUBMITTED PROPOSALS FOR CONGRESSIONAL 21ST CENTURY CURES INITIATIVE RE: STATUTORY AND REGULATORY CHANGES NEEDED TO SUPPORT RM AND ADVANCED THERAPY PRODUCT DEVELOPMENT; FOLLOW-UP TO RECOMMENDATIONS MADE IN EUROPEAN ATMP REGULATION REPORT TO IMPROVE REGULATORY ENVIRONMENT FOR ATMPS IN EU (HOSPITAL EXEMPTION, FEE REDUCTIONS, PROPORTIONATE REGULATION OF MANUFACTURING INCLUDING CLOSED DEVICES, STREAMLINED ROUTE TO MAA, CENTRALIZED CLASSIFICATION). C. REIMBURSEMENT: MEETINGS WITH CMS OFFICIALS TO DISCUSS REIMBURSEMENT ISSUES; HOSTING REIMBURSEMENT "HANDS ON" WORKSHOP FOR MEMBERS FEATURING EXPERTS; DRAFTING AND PROVIDING COMMENTS TO CMS REGARDING PROPOSED PAYMENT RULE; MEETINGS WITH CONGRESS REGARDING NEEDED REIMBURSEMENT POLICY CHANGES. |
| FORM 990, PAGE 2, PART III, LINE 4B | MONTHLY MEMBER NEWSLETTER AND BI-WEEKLY INDUSTRY NEWSLETTER. B. CAPITAL FORMATION: HELD 2ND ANNUAL REGEN MED INVESTOR DAY ATTRACTING OVER 300 ATTENDEES, 48% OF WHICH WERE INVESTORS, STRATEGIC PARTNERS, GOVERNMENT FUNDING AGENCIES AND RESEARCH ANALYSTS; HELD STEM CELL MEETING ON THE MESA ATTRACTING 730 UNIQUE ATTENDEES OVER THREE DAYS, WITH 465 OF THOSE ATTENDEES BEING AT THE PARTNERING FORUM SPECIFICALLY, WHICH WAS 21% HIGHER THAN 2013; HELD EU ADVANCED THERAPIES INVESTOR DAY IN LONDON, ATTRACTING OVER 175 ATTENDEES, 51% OF WHICH WERE INVESTORS, STRATEGIC PARTNERS, GOVERNMENT FUNDING AGENCIES AND RESEARCH ANALYSTS. C. OPERATIONS AND GOVERNANCE: EXPANDING MEMBERSHIP BY 31%, INCLUDING RECRUITMENT OF TWO LARGE PHARMA / BIOTECH MEMBERS AND 21 MEMBER ORGANIZATIONS WORKING ON GENE THERAPIES TO GROW SECTION; MEMBERSHIP MERGER WITH ALLIANCE FOR ADVANCED THERAPIES (AAT) AND ESTABLISHMENT OF EUROPEAN SECTION; OPERATING THREE TECHNOLOGY SECTIONS - CELL THERAPY, TISSUE ENGINEERING AND BIOMATERIALS, GENE AND GENETICALLY-MODIFIED CELL THERAPY; EXPLORATION OF PARTNERSHIPS AND MEMBER RELATIONSHIPS IN ASIA; OPERATING NUMEROUS CONFERENCES AND EVENTS, INCLUDING BUT NOT LIMITED TO: STEM CELL MEETING ON THE MESA; 2ND ANNUAL REGEN MED INVESTOR DAY; REGEN MED STATE OF THE INDUSTRY BRIEFING; ANNUAL DINNER AND LEGISLATIVE FLY-IN; REGEN MED RECEPTION AT BIO INTERNATIONAL CONVENTION; EUROPEAN ADVANCED THERAPIES INVESTOR DAY; BOARD, EXECUTIVE COMMITTEE AND STRATEGIC PLANNING MEETINGS. |
| FORM 990, PAGE 2, PART III, LINE 4C | "CRITICAL ELEMENTS IN THE DEVELOPMENT OF CELL THERAPY POTENCY ASSAYS FOR ISCHEMIC CONDITIONS." |
| FORM 990, PAGE 2, PART III, LINE 4D | OTHER ACTIVITIES INCLUDING, BUT NOT LIMITED TO: DISCUSSIONS WITH HEALTHCARE PROVIDERS TO ENSURE ADEQUATE COVERAGE OF REGENERATIVE MEDICINE PRODUCTS; PRESENTING INFORMATION AT PUBLIC MEETINGS CONVENED BY FDA, NIH AND OTHER GOVERNMENT AGENCIES. |
| FORM 990, PAGE 6, PART VI, LINE 7A | THE GOVERNING BODY IS ELECTED BY THE MEMBERS AT THE ANNUAL MEETING THAT TAKES PLACE IN THE FALL EACH YEAR |
| FORM 990, PAGE 6, PART VI, LINE 11B | THE TREASURER AND FINANCE COMMITTEE REVIEW THE TAX RETURN PRIOR TO FILING |
| FORM 990, PAGE 6, PART VI, LINE 12C | THE CONFLICT OF INTEREST POLICY COVERS ANY DIRECTOR, PRINCIPAL OFFICER, OR MEMBER OF A COMMITTEE WITH GOVERNING BOARD DELEGATED POWERS. DISCLOSURE IS TO DIRECTORS AND MEMBERS OF COMMITTEES WITH GOVERNING BOARD DELEGATED POWERS. DISCLOSURES ARE REVIEWED AND MAINTAINED BY THE REMAINING MEMBERS OF THE GOVERNING BOARD OR COMMITTEE. THE GOVERNING BOARD OR COMMITTEE REVIEWS EACH TRANSACTION TO COME BEFORE THE BOARD FOR POTENTIAL OR ACTUAL CONFLICTS OF INTEREST. IF POTENTIAL OR ACTUAL CONFLICTS (PAST, PRESENT OR FUTURE) ARE IDENTIFIED, THE CHAIRPERSON OF THE GOVERNING BOARD OR COMMITTEE SHALL, IF APPROPRIATE, APPOINT A DISINTERESTED PERSON OR COMMITTEE TO INVESTIGATE ALTERNATIVES TO THE PROPOSED TRANSACTION OR ARRANGEMENT. AFTER EXERCISING DUE DILIGENCE, THE GOVERNING BOARD OR COMMITTEE SHALL DETERMINE WHETHER THE ORGANIZATION CAN OBTAIN WITH REASONABLE EFFORTS A MORE ADVANTAGEOUS TRANSACTION OR ARRANGEMENT FROM A PERSON OR ENTITY THAT WOULD NOT GIVE RISE TO A CONFLICT OF INTEREST. THE IDENTIFIED CONFLICTS OF INTEREST AND APPROPRIATE RECUSALS ARE DOCUMENTED IN THE MINUTES OF EACH BOARD OR COMMITTEE MEETING. |
| FORM 990, PAGE 6, PART VI, LINE 19 | THE ORGANIZATION DOES NOT MAKE ITS GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS AVAILABLE TO THE PUBLIC. |
| FORM 990, PART IX, LINE 11G | CONFERENCE & EVENT PLANNING 202,386 0 0 PUBLIC RELATIONS & COMMUNICAT 9,446 9,446 0 CONSULTANT FEES 12,296 5,269 0 |
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