Research Project Description
Division of Clinical Pharmacology III
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
A fellowship opportunity is currently available in the Division of Clinical Pharmacology III within the Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).
OCP’s mission is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER’s Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.
Microneedles represent an innovative way to delivery to the skin, or to systemic circulation, molecules that would otherwise, due to their chemistry, not penetrate at a sufficient rate or extent to be useable in a clinical fashion. Microneedles are a dosage form that currently exists in the laboratory and are available from a number of suppliers. This pathway would represent a viable route to deliver antidotes, opiates, pre-treatment agents, or any other drug or biologic that can be formulated into the system. While various microneedle systems are commercially available, the problem is that they are primarily passive systems – an undesirable characteristic when speed is of the essence. 3M has produced a powered microneedle delivery system, but it is bulky and depends upon a battery to exert pressure to force the drug through hollow microneedles.
The objective of this project is to assess the feasibility of the proposed mechanism and fabrication potential of an innovative, self-contained, delivery system. The project in this stage would include a literature review of the current state-of-the-art in microneedle fabrication and commercially available delivery systems, along with an evaluation of various materials available to assist in a “go”/ “no-go” decision for future funding.
The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for four months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.
- A Doctoral degree in pharmaceutics or chemical engineering received within the last five years.
- Students currently pursuing a Doctoral degree in pharmaceutics or chemical engineering are also encouraged to apply. Proof of enrollment will need to be provided each semester.
- Experience/emphasis on transdermal drug delivery (preferably with microneedles), microdialysis techniques and system optimization, or developing disposable medical devices and plastics is desirable.
- Experience in publications/presentations is preferred.
How to Apply:
To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0045 in all communications.