Alzheimer’s Disease Regulatory Science Fellowship
The Reagan-Udall Foundation for the FDA (RUF), in partnership with the Alzheimer’s Association and the U.S. FDA, Division of Neurology Products (DNP), is offering a two-year Regulatory Science Fellowship focused in the area of Alzheimer’s Disease. The fellow will have an unparalleled opportunity to receive training in regulatory science at the FDA, gaining valuable experience and knowledge working with the DNP.
Watch Nancy Beck, PhD, Program Development Manager, discuss the fellowship during RUF’s annual open public meeting on May 14, 2014.
Background and Goals:
There are currently no drugs available to prevent Alzheimer’s Disease (AD) or even slow its course. A recent series of high-profile late stage drug failures have led those in Alzheimer’s research to begin to rethink many of the underlying hypotheses related to drug development including therapeutic targets, trial design, appropriate patient populations, biomarkers, and clinical outcome measures. Patient groups, academic researchers, pharmaceutical manufacturers, and other stakeholders have formed a wide array of consortia and initiatives to examine many of these issues. A primary goal of this fellowship is to facilitate communication and collaboration between DNP and the various AD stakeholders and to help identify opportunities for DNP participation in relevant partnerships and activities to address critical issues in AD research and product development.
The fellow will work with DNP to identify opportunities advance the development of treatments for Alzheimer’s and related diseases. Activities will include:
- Develop a comprehensive understanding of the regulatory review process.
- Learn current challenges facing Alzheimer’s drug development and regulation.
- Develop an awareness of DNP practices, thinking, and approach to various aspects of AD drug development, data and other relevant scientific resources (e.g. trial design, therapeutic targets).
- Develop a comprehensive summary of the current landscape of Alzheimer’s drug development activities – including all relevant consortia, initiatives and other stakeholder activities.
- Facilitate dialogue among FDA and stakeholders with regard to activities in AD drug development and create a system to maintain an on-going dialog with Alzheimer’s stakeholders.
- Work with DNP to determine areas of mutual interest and identify mutually beneficial initiatives between DNP stakeholder groups.
- Create a strategy and implementation plan for DNP’s participation in public-private partnerships, initiatives, and other activities with Alzheimer’s stakeholders.
- Receive training in regulatory science, clinical trial design/conduct, statistical analysis, and drug/ biologics law.
- Attend CDER educational briefings, scientific rounds, and other relevant seminars.
- Attend scientific meetings related to Alzheimer’s disease on behalf of the FDA (at times in combination with the members of the FDA Division of Neurology Products) and summarize the process and outcomes of any meetings attended.
- Present, when appropriate, the FDA perspective on selected topics related to AD orally at meetings or in a written format.
Applicants should have a strong commitment to improving the health of individuals with AD. The ideal candidate should also possess:
- a medical degree (MD, DO)
- several years of clinical experience working with patients with AD and/or other dementias
- a basic understanding of the design and conduct of clinical trials
- knowledge of the AD research landscape
- the ability to write and communicate clearly as well as thoughtfully summarize and convey complex information to varied audiences
- experience with academic presentation and publication
- high degree of comfort level working independently and collaboratively
- experience with multi-stakeholder partnerships or relationship building between diverse stakeholders is recommended
How to apply:
Applicants must submit the following items:
- Personal statement (~500 words) describing your background, interest in this fellowship, and how the fellowship fits into your long-term goals.
- Two writing samples
- Medical/osteopathic school transcript
Application materials should be sent to the following: email@example.com. Please tell us how you heard about the fellowship!
Applications are reviewed on a rolling basis. The deadline to apply is August 31, 2014.
The fellow will work on a full-time basis at the Food and Drug Administration headquarters in Silver Spring, Maryland.
Two years with a flexible start date between July and November of 2014.
- Stipend from $120,000-150,000 annually, commensurate with experience
- Allowance for health insurance
- Funds for relocation are available
- Funds for travel to professional conferences, at the discretion of the DNP supervisor, are available
This fellowship is funded by the Alzheimer’s Association and administered by the Reagan-Udall Foundation for the FDA. The fellow will be a contractor of RUF and will not enter into an employee/employer relationship with the FDA, RUF, or the Alzheimer’s Association.
Upon appointment, RUF will require Fellows to complete annual disclosure forms listing financial and other interests that they, their spouses or minor children, or organizations in which they are involved (as a partner, employee, board member, etc.), have a financial interest that may give rise to real or apparent conflicts with the work of the fellowship.
New Fellows will be required to complete additional paperwork by the FDA as a condition of their appointment including a Commitment to Protect Non-Public Information, a Liability Release, and forms required to complete a formal Conflict of Interest screening conducted by FDA’s Ethics Office.
The fellow will be permitted to practice in a clinical setting 1 day per week, if desired. The work must be conducted during FDA work hours and may consist of up to, but not more than, 8 hours per week. This work must be uncompensated. For work outside of FDA work hours, fellows may be permitted to receive compensation. In this case, the fellow must file an Outside Activities request and receive approval from the FDA Ethics Office.
- The Reagan-Udall Foundation for the FDA (RUF) is an independent 501(c)(3) not-for-profit organization created by Congress to support the mission of the FDA by advancing regulatory science and research. RUF provides a unique opportunity to bring all parties to the table (FDA, Patient Groups, Academia, other Government entities, and Industry) to work together in a transparent way to create exciting new regulatory science. One of RUF’s statutory mandates is to establish academic training fellowships for scientists, doctors, and other professionals to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice. To learn more: http://www.reaganudall.org/
- The Food and Drug Administration (FDA), Division of Neurology Products (CDER/OND/ODEI/DNP) is responsible for review of investigational and marketing applications for drug and biologic treatments intended for neurological indications. To learn more: http://goo.gl/c7jWke
- The Alzheimer’s Association is the leading, global voluntary health organization in Alzheimer’s care and support, and the largest private, nonprofit funder of Alzheimer’s research. To learn more: http://www.alz.org/
For questions, please contact firstname.lastname@example.org.