Global Medical Affairs | Amicus Therapeutics

Global Medical Affairs

Important Information for Physicians About SD-101 for Epidermolysis Bullosa

 

Independent Medical Education

Accredited 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 close gaps in health care provider(HCP) knowledge, skills, and professional performance used to provide services to patients, the public, or the profession. Amicus Therapeutics will not influence the content nor have control over those educational programs funded through Global Medical Affairs as independent medical education grants. An assessment plan of participant outcomes is a requirement for funding.

Non-Accredited Medical Education Program Grants

Amicus Therapeutics applies the same standards of independence to non-accredited continuing education (CE) grants with respect to content, influence, faculty selection, educational methods, materials, venues and attendees as it does to accredited CE grants. Examples of non-certified CE educational programs that Amicus Therapeutics can potentially support include, but are not limited to, the following:

  • Lectures or other educational activities
  • Managed care-sponsored educational activities
  • Grants to support healthcare-related public policy initiatives
  • Disease state and treatment education and awareness

Overview

  • Amicus Therapeutics 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. Reconciliation documentation should be uploaded to the grant application through the Amicus IME Grant Portal
  • 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

Submit an application through our secure online portal, where you can track the status of your request and communicate with Amicus. The application captures the following information:

  • Unmet needs or educational gap assessment
  • Educational objectives
  • Program details
    • 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 accredited)
    • 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
  • 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)

If you are applying for the first time, Register Here. To continue an online application, or to check on the status of an application, Login Here. If you have additional questions, email us at GMA_IME@amicusrx.com.


UNACCREDITED MEDICAL EDUCATION

Amicus funds unaccredited activities aimed at educating health care professionals, researchers, scientists, or patients, such as health-related public conferences, symposia, or community awareness campaigns where the program includes topics relating to disease management, therapy options and treatment. If you are applying for the first time, Register Here. To continue an online application, or to check on the status of an application, Login Here. If you have additional questions, email us at GMA_IME@amicusrx.com.


Notification of Decision

The online portal allows you to track the progression of your grant request, and communicate with Amicus

  • A confirmation email with an identification number is sent to the Requestor immediately following a submission
  • Requests for additional information are managed directly through the online portal
  • Once the review process is complete, an email notification with the decision is sent to the Requester
  • If grant request is approved, a 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 uploaded onto the approved grant via the online portal within ninety (90) days of the program end date
  • 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

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INVESTIGATOR-INITIATED PROGRAMS

Amicus provides support for interventional and non-interventional research across multiple phases of development. We welcome the scientific and academic research community to submit high-quality investigator-sponsored research applications through our IIP portal.

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 *:

Amicus has a competitive research grant review process with specific requirements that must be met in order for your application to be evaluated. Applications that best align with our Research Areas of Interest will be considered.

Fabry Disease:

2018 Investigator-Initiated Research Areas of Interest:

  • Early use of migalastat in progression of Fabry disease, inclusive of early interventions in Fabry disease and consequences of delaying diagnosis, treatment, and/or management of disease
  • Studies that elucidate burden of Fabry disease and associated treatments, including phenotypes, cardiovascular, GI, pain, neurological, cerebrovascular, renal, skin, respiratory, ocular, and hearing
  • Studies that lead to better understanding of central and peripheral neurologic manifestations of Fabry disease and explore the use of migalastat in management and prevention of neurologic complications (e.g. stroke, TIA, MRI changes, neuropathic pain, etc.)
  • Studies of migalastat in model systems that demonstrate potential clinical utility of migalastat in Fabry disease
  • Studies evaluating the relationship of genotype and/or phenotype, to pathogenicity or Fabry disease progression
  • Studies examining migalastat efficacy in Fabry mutations and special populations
  • Studies that explore migalastat value to patients, physicians, and payers; such as:
    • Patient Reported Outcomes
    • Health Economics and Outcomes Research
    • Quality of Life
    • Compliance and adherence

Pompe Disease:

2019 Investigator-Initiated Research Areas of Interest:

  • Diagnosis of Pompe Disease
  • Treatment and Management of Pompe Disease
  • Epidemiology of Pompe Disease
  • Genetics of Pompe Disease
  • Systemic involvement in patients with Pompe Disease (e.g. pulmonary, cardiac, rheumatologic, orthopaedic, CNS)

*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:

The IIP process is facilitated through an online portal that allows a Brief Concept application or Full Protocol to be submitted through our user-friendly website. You can track your application through the review process, as your application is reviewed for scientific merit, alignment with our areas of interest, budget availability, and other considerations. If you are returning to the Amicus IIP portal, or would like to check on the status of an application, Click Here.

Brief Concept:

Amicus will review and provide feedback on a Brief Concept of the proposed research. If the Brief Concept (41 KB .docx)  is endorsed, the investigator is asked to submit a Full Protocol and an Itemized Budget for further review. Register Here to begin the Brief Concept application process.

Note: Submission of a Brief Concept does not guarantee endorsement. Any support from Amicus is contingent on the review and approval of a Full Protocol and an executed agreement.


Full Protocol:

A well-designed Full Protocol (97 KB .doc) and itemized Budget (22 KB .xlsx) must be submitted for review prior to final determination or recommendation by Amicus. A signed and dated CV from the investigator is also required. Investigators may submit a Full Protocol and Itemized Budget, if they wish to forgo the Brief Concept step. Click Here if you would like to skip the Brief Concept step, and move straight to a Full Protocol submission.

Note: Amicus standard rate of overhead on direct study costs is not to exceed 30%.

Amicus strives to provide a response to your application within 60 days of submission to the portal.

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 with additional questions.

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