Corporate & Industry 
Engagement Policy

Shwachman-Diamond Syndrome Alliance Corporate & Industry Engagement Policy: Sponsorship, Promotion, and Clinical Trial Support

 

Last reviewed and adopted: May 2022

Thank you for your interest in supporting the mission of the Shwachman-Diamond Syndrome Alliance, Inc., a 501(c)(3) nonprofit organization dedicated to driving research for therapies and cures for Shwachman-Diamond Syndrome (SDS). The terms “Shwachman-Diamond Syndrome Alliance”, “SDS Alliance,” “SDSA” “we,” “us” or “our“ may be used interchangeably. 

 

The SDS Alliance will enter into corporate engagement for the sole purpose of providing mission-related benefits to its members and the SDS community.  The SDS Alliance will not accept any corporate donation or enter into any corporate relationship or engagement that would create a conflict of interest, or even its appearance, with the SDS Alliance’s mission, sound science, or board-approved policies.  All procedures and formal agreements with corporate donors will be designed to prevent any undue influence upon the SDS Alliance.

The SDS Alliance will perform appropriate and adequate due diligence, with respect to all corporate donors, to ensure that the company’s activities, affiliations and business practices do not compromise the SDS Alliance’s mission.

In all relations with external organizations, the SDS Alliance will act in ways that will only enhance the credibility and professional recognition of the SDS Alliance. In order to ensure that all corporate donations are in alignment with the SDS Alliance’s mission and are always for the sole benefit of the SDS community, the SDS Alliance’s Board of Directors has approved the following guidelines and principles in regard to corporate support.

Types of Corporate Support

  • Financial and/or in-kind support in the form of grants and/or sponsorships for educational and communications vehicles (i.e., conferences, videos, podcasts, publications) and/or for fundraising purposes

  • Strategic alliances that provide improved services for constituents and cause-related marketing

  • Professional support and/or grants for clinical trials and research

 
Vested Corporate Interactions to Avoid

 

A vested corporation is one that either makes or offers products/services used by an individual with SDS.

  • SDS Alliance will not

    • endorse any other corporation’s product, service, or program

    • lend its name to license products, services, or programs of other organizations

    • recognize or certify the quality or standards of a particular company, including its products and services

  • SDS Alliance’s name and logo should not be associated with a specific branded product of an external company.  References to the SDS Alliance website, phone number, and address for the purposes of referral information are an exception to the above

 
General Principles

  • Revenue generated through corporations will be used to advance the mission of the SDS Alliance in accordance with the strategic plan

  • The SDS Alliance will maintain complete control of the development and implementation of all content and materials related to educational conferences and materials and all research and clinical trials conducted by the SDS Alliance. Corporations providing sponsorships for advocacy and research conferences or symposia will not influence conference content or the selection of speakers

  • SDS Alliance will maintain control and discretion over all corporate funds received and will ensure compliance with related grant agreements

  • In exchange for contributions, the SDS Alliance will allow standard recognition to include, but not be limited to, items such as signage and acknowledgment in SDS Alliance publications.  Additional types of recognition will be considered on a case-by-case basis, based on the type of funding or opportunity presented. SDS Alliance will not endorse any corporation or product nor will it allow a corporation’s interest to factor into its decision-making process.  All unrestricted educational grants received by the SDS Alliance will acknowledge and recognize the contributing corporate donor, not the company’s product (i.e. specific drug)

  • SDS Alliance will not accept grants that may adversely affect its nonprofit status

 
SDS Alliance Policy on Organizational Participation in Food and Drug Administration (and other regulatory agency) Hearings and Meetings

 

The following information details the SDS Alliance official policy on organizational participation in Food and Drug Administration (FDA) ad other regulatory agency hearings and meetings regarding the regulatory approval of drugs, biological products, and medical devices in accordance with its Corporate Relations Policy:

  • The SDS Alliance will not generally provide testimony or submissions in its name in direct support for or against any drug, biological product, or medical device approval application. However, the SDS Alliance may on occasion provide testimony, submissions, or participate in open or closed FDA meetings in its name to provide information about, or relevant to, tuberous sclerosis complex (SDS) or related diseases, including information (e.g. evidence of community need, what constitutes evidence of clinical benefit, endpoints, etc.), which may be relevant to regulatory decisions regarding an application under FDA review or a product under development.

  • Any request for the SDS Alliance to provide testimony, statements, or opinions either supporting or opposing specific drugs, biological products, or devices in FDA or regulatory approval proceedings shall be reviewed by the Science and Medical Committee, the Government Relations Committee, and the Executive Committee of the SDS Alliance Board of Directors.  These Committees shall make a recommendation to the Board of Directors regarding whether the SDS Alliance should testify or take similar action.  In the event that the Committees recommend that the SDS Alliance should provide testimony, statements, or opinions either supporting or opposing specific drugs, biological products, or devices in FDA or regulatory approval proceedings, final determination of the course of action to be taken by the SDS Alliance in an official capacity shall be made by the Board of Directors.  If a representative of the SDS Alliance testifies before the FDA, that person will clearly disclose any conflict of interest prior to testimony or submission as is required at all FDA meetings and hearings.  Nothing in this section prohibits the CEO or Chief Science Officer or other senior executes from representing the interests of the SDS community in a manner that is non-specific to individual drugs, biological products, or medical devices.

  • SDS Alliance staff will monitor the development of drugs, biological products and devices relevant to SDS, including the pendency of applications for FDA or other regulatory approval of such treatments, and provide this information to its members and the general public.

  • In the dissemination of information concerning the development of treatments, officers and staff of the SDS Alliance will comply with the Corporate Relations Policy and refrain from taking any action that can be seen as endorsing any corporation’s product, service, or program, except as provided above.

  • The Chief Executive Officer, together with the SDS Alliance Board of Directors, will maintain complete control of the development and use of all content and materials produced or used by the SDS Alliance related to the dissemination of information concerning the development and regulatory approval of drugs, biological products, medical devices, or programs for the treatment of individuals with SDS.

  • Nothing in this policy impedes or discourages individual members of the SDS Alliance, or its Advisory Boards from participating in or testifying before the FDA or other regulatory panels, provided they make clear that they are not acting as a representative of the SDS Alliance.