Subject: Position available at FDA for a research associate

Food and Drug Administration (FDA)
Center for Devices and Radiological Health
Office of Science and Engineering Laboratories
Division of Biology, Chemistry and Materials Science
Subject: Position available at FDA for a research associate to study
relationships between coating processing, properties and drug release from
drug eluting balloons (DEBs)

Background: Angioplasty balloons are inserted into blood vessels blocked by
plaque and expanded to remove the blockage. Restenosis (reblockage) occurs at
rates of 40-50% due to cell proliferation within 3-6 months after a balloon
angioplasty. The drug eluting balloon (DEB) is an angioplasty balloon that
also delivers drugs to the blood vessel lumen to minimize cell proliferation
and restenosis. The problem with DEBs that this project will address is the
need for data and test methods essential for determining the amount of drug
lost prior to and during DEB inflation in the vessel. This information will
improve FDA evaluation of DEBs that deliver a wrong dosage which leads to
either toxicity and destruction of the vessel or insufficient drug,
myocardial infarction and heart attack.
Methods: This project will study effects of coating processing variables on
coating properties and the amount of drug transfer to the blood vessel using
Quality by Design (QbD) science methodology. QbD evaluates risks and key
steps in the manufacturing process to improve product quality and to evaluate
how the processing affects the coating properties and performance. The
distribution of the drug in the balloon coating, drug crystallinity and the
coating structure will be evaluated by x-ray analysis, DSC and microscopy of
the coating. The coating loss will be simulated by insertion/inflation of the
DEB in a simulated blood vessel, followed by measurements of coating loss by
HPLC. We have completed a similar QbD study in 2013 to be published this year
for drug eluting stents (DES).

Qualifications (in order of priority):
1. graduate or senior undergraduate student studying science or engineering
2. experienced and confident working in the lab, dexterous at handling tools
and setups
3. adept at independently solving problems, performing experiments and
analyzing data
4. present at FDA a minimum of 50 hours/month during school and 160
hours/month during summer and committed to a minimum of 1 full summer and 1
full semester.
5. begin at as soon as possible, no later than Jan 19, 2015.
6. interested in medical devices, a career in science or engineering and in
reading books/journals related to methods/materials concerning this study.

Additional Information:
   Depending on the applicant’s skill level and experience, this would begin
either as a volunteer position or as a paid position at a rate based on
degree of education.
   We will work with your school so you may receive research credit.
   We provide training on specific instruments and techniques.
   All contributing to the results are coauthors in future publications.

Contact Dr. Martin McDermott
Email: [log in to unmask]
Phone: (301) 796-2621; Fax: (301) 796-9924
Address 10903 New Hampshire Avenue, Silver Spring MD, 20993

Contact Person: Dortch, Anjelica
Contact Email: [log in to unmask]