Responsibility

Global Medical Affairs

Certified Continuing Medical Education Program Grants (U.S.)

Amicus Therapeutics supports programs and activities that foster excellence in patient care and provide valuable scientific, medical, and educational information to the medical and scientific communities. Grant funding for an accredited Continuing Medical Education (CME) program (i.e., ACCME, AMA, AAFP, ADA, or AOA) or continuing education for other allied health professions (e.g., nurses, pharmacists), from U.S.-based continuing education entities (e.g., academic institutions, education program vendors) will be considered.

Since available grant funding is limited, selection priority is given to exceptional high quality, impactful educational activities (Moore’s Outcome Level 4 or higher) which serve to maintain, develop, or increase the knowledge, skills, and professional performance that an HCP uses to provide services to patients, the public, or the profession. An assessment of program participant outcomes is a requirement for funding.

Amicus Therapeutics will not influence the content nor have control over those educational programs funded through Global Medical Affairs as independent medical education grants.


Overview

  • Amicus Therapeutics support for eligible IME programs is compliant with federal and state laws, as well as guidelines that govern such activities. Amicus Therapeutics commercial staff, including field staff, are not involved in decisions to fund IME programs.
  • Responsibility and control over the selection, content, faculty, educational methods, materials, and venue for an independent medical education event belongs solely to the organizers of the event in accordance with the accredited provider's guidelines.
  • Amicus Therapeutics will not provide any advice or guidance to the accredited independent medical education provider (including, if requested) regarding program content or faculty for any Independent Medical Education program.
  • Amicus Therapeutics requires that a fully-executed Letter of Agreement (LOA), in the form provided by Amicus Therapeutics, be signed by the requesting Continuing Education Provider and Amicus Therapeutics Global Medical Affairs Independent Medical Education prior to the commencement of the Continuing Education program. Continuing education programs that have commenced in the past will not be approved nor funded by Amicus Therapeutics.
  • For those funding requests approved by Amicus Therapeutics, the IME funding recipient is required to confirm the completion of the activity and to provide documentation of how the funds were used within 90 days after the completion of the independent medical education activity. Documentation should be sent to GMA_IME@amicusrx.com for reconciliation.
  • Funds provided by Amicus Therapeutics in support of an IME program and not spent in the execution of the program must be returned to Amicus Therapeutics.

Please note that Amicus Therapeutics will not provide educational grant funding for the following:

  • Individuals
  • Requests for payments to Individuals
  • Fellowships
  • Overhead Expenses
  • General Operating Expenses
  • Entertainment Expenses
  • Awards / Travel Awards
  • Costs of travel, lodging, or other personal expenses of non-faculty individuals attending IME, either directly to the individuals participating in the event or indirectly to the event's provider.
  • Funding used to compensate participants for time spent at the IME event.
  • Debarred institutions or groups, including organizations or their employees on probation with the ACCME or other organizations, or on the OIG exclusion list; as well as faculty debarred from a federal healthcare program or on the OIG exclusion list.
  • While Amicus Therapeutics does not prohibit organizers from serving meals at IME events, funds provided by Amicus Therapeutics to support IME events shall not be used to subsidize meals or beverages for attendees at these programs.

Therapeutic / Disease State Areas of Interest

Amicus Therapeutics will consider funding certified educational grants for programs that address the following rare disease states:

  • Fabry Disease
  • Pompe Disease

Certified CME funding requests are accepted for review on an ongoing basis and can be submitted at any time. Requests must be received no later than 90 days before the activity start date. Under no circumstances will CME funding requests be considered for programs that have taken place or started in the past.

Amicus Therapeutics, Inc., reserves the right to modify, revise or delete therapeutic areas of interest, and other terms and conditions of its CME funding program, at any time and without notice.

Request for Proposals (RFPs)

Request for Proposals may be published by Amicus Therapeutics periodically in therapeutic or disease state areas of interest based on educational gaps that are identified.

For further information concerning an open RFP, please email GMA_IME@amicusrx.com


Grant Submission Process

Required Materials for Grant Consideration
  • Letter of Request (LOR), provided on the requesting organization's letterhead (pdf), which includes the following information:
    • Document addressed to GMA IME.
    • Program title, date(s), and location(s).
    • Description of the proposed activity.
    • Identification of the target audience and projected number of attendees.
    • Name of accrediting body and accredited provider, including type and number of medical education credits offered for the proposed activity (program must be certified).
    • If applicable, identification of co-requesting organization(s), medical education partner(s), and/or logistical partner, including contact information for these organizations.
    • Whether or not the requestor is seeking co-funding support from other companies or entities.
    • Amount of funding requested from Amicus Therapeutics.
    • Signed and dated by authorized representative.
  • Needs or educational gap assessment (separate document or can be included in the LOR).
  • Educational objectives (separate document or can be included in the LOR).
  • Proposed agenda (draft acceptable).
  • Proposed program outcomes assessment (e.g., pre- and post-test scores for the participants, participant survey with respect to the quality and / or utility of the educational program).
  • Full, itemized program budget (must use Amicus budget spreadsheet).
  • If applicable, a copy of the organization's non-profit determination letter from the IRS.
  • Current IRS W-9 form or equivalent foreign documentation (must be signed and dated within the last 12 months).

Required application and budget spreadsheet forms can be requested from Amicus Therapeutics by sending an email to the following address: GMA_IME@amicusrx.com.

Application Process

  • Complete Funding Request Application (must request Grant Application Form).
  • Draft Letter of Request (LOR) clearly specifying how the funding will be used (attach as PDF).
  • Draft program description and rationale; e.g., unmet medical educational need (attach as PDF).
  • Submit Budget Proposal (must complete and send Amicus Therapeutics budget spreadsheet).
  • If applicable, a copy of the organization's non-profit determination letter from the IRS.
  • Submit signed W-9 by Payee Organization (attach as PDF).
  • The above information should be emailed to the following address: GMA_IME@amicusrx.com.
  • The grant applicant will receive a confirmation email when the grant application and supporting documents are received.
  • The grant applicant will be contacted if the submission packet is considered to be incomplete.

Notification of Decision

  • A confirmation email with an identification number will be sent to the requestor within three (3) business days of grant submission.
  • Once the review process is complete, email notification with the decision will be sent to the Requester.
  • If grant request is approved, a separate email with the Letter of Agreement will be sent to the Requester. Amicus Therapeutics requires that its form of agreement is fully executed prior to the start date of the program content development or activity.

Reconciliation

  • A completed reconciled budget form must be provided to Amicus Therapeutics within ninety (90) days of the program end date via email to GMA_IME@amicusrx.com.
  • If the completed reconciled budget, or any other requested documentation are not received within the specified timeframes, the recipient will be precluded from receiving additional education funding.
  • All unused funds must be returned to Amicus Therapeutics.
  • The provision of outcome data (e.g., number of participants, participant areas of specialty, pre- and post-test scores, participant surveys) that measures effectiveness, value, benefit, or impact of a completed (live and/or enduring) CME program or event is required as a condition of funding.

Welcome to the Amicus Therapeutics, Global Medical Affairs Investigator-Initiated Program (IIP) Site. Amicus welcomes submission of high-quality investigator-sponsored research.

Suitable types of research proposals:

Preclinical, and Clinical Studies, Observational studies, Epidemiological Studies and Outcomes studies will be considered.

Amicus IIP Research Areas of Interest (2017)*:

Fabry Disease:

Investigator-Initiated Research Areas of Interest:

  1. Early use of migalastat in the progression of Fabry disease, inclusive of early interventions in Fabry disease and the consequences of delaying diagnosis, treatment, or management of disease
  2. Studies that elucidate the burden of Fabry Disease and associated treatments- including phenotypes, cardiovascular, GI, pain, neurological, cerebrovascular, renal, skin, respiratory and ocular
  3. Studies of migalastat in models that demonstrate the potential clinical utility of migalastat in Fabry disease
  4. Studies that evaluate the relationship of genotype and/or phenotype, pathogenicity, or disease progression
  5. Examining migalastat efficacy in Fabry mutations and special populations
  6. Explore migalastat value to patients, physicians, and payers; such as, PROs, HEOR, QOL, compliance and adherence

*Amicus Therapeutics, Inc., reserves the right to modify, revise or delete investigator-initiated research areas of interest, and other terms and conditions of its IIP program at any time and without notice.

Application Process:

Please speak with your Amicus Global Medical Affairs contact (Medical Director or Medical Science Liaison) for submission templates and additional information. You may also contact the Investigator Initiated Program Administrator at Investigator-InitiatedProgram@amicusrx.com for additional questions or assistance in contacting your local Amicus Medical Affairs representative.

Additional Details:

Brief Concept:

The Amicus IIP is accepting proposals for review either as a brief concept “letter of intent” outlining the proposed research and a proposed budget, or a full protocol with an itemized budget.

The IIP Review Committee will review and provide feedback on the brief concept of the proposed research. If the application is of interest, the investigator may then be asked to submit a full protocol and an itemized protocol budget for further review.

Full Protocol:

A full proposal and itemized budget must be submitted for review by the investigator prior to final determination or recommendation by the IIP Committee. A signed and dated CV from the investigator will also be required. The Amicus IIP committee meets regularly and will review a completed submissions at the next Committee meeting.

The investigators may submit a full protocol and itemized budget, if they wish to forgo the Brief Concept step.

Thank you for your interest in the Amicus Therapeutics, Global Medical Affairs Investigator-Initiated Program. Please email the Investigator Initiated Program Administrator at Investigator-InitiatedProgram@amicusrx.com for additional questions or to receive submission and budget forms for the IIP program.