1. Rapid Response Team Nakissa Sadrieh, Ph.D. Associate Director for Research Policy and Implementation, OPS

2. Overview of the Rapid Response Team (RRT) The RRT is a research-based mechanism: –To provide research support to review divisions and ultimately drug approvals. –To respond to literature reports of drug inefficacy or toxicity. –To evaluate suspected causes of therapeutic inequivalence. –To provide data for counterterrorism initiatives.

3. Background on Rapid Response Team (RRT) Created in November 2000 Function: to provide timely and specific research support (laboratory-based or literature-based) for designated regulatory issues that require further Agency study. Goal: to provide review divisions with sound scientific data which may be used in regulatory process.

4. Composition of RRT Group of multidisciplinary scientists from –OTR –ONDC –OCPB –OGD Initially part of OTR, however now part of OPS immediate office

5. RRT projects are: High priority Have short turnaround time (maximum 6 months) Expected to have direct regulatory impact: –support reviewer recommendations (OND and OGD) –support labeling changes –support for advisory committee issues

6. Examples of past projects Palatability of doxycycline and potassium iodide tablets in human subjects to identify dosing regimens that would be appropriate for pediatric populations in the event of a bioterrorism incident. Permeability study of commercially available gloves to a lotion and shampoo used for treatment of lice.

7. Examples of past projects (cont’d) Determination of dissolution properties of select drugs. Determination of BCS classification of select drugs. Determination of neurotoxicity of ketamine in juvenile animal models.

8. Resources OTR laboratories: –Laboratory of Clinical Pharmacology (LCP) –Division of Pharmaceutical Analysis (DPA in Saint Louis) –Division of Product Quality Research (DPQR) –Division of Applied Pharmacology Research (DAPR) Contracts (Univ. of Tennessee, USHUS)

9. Ongoing projects Palatability study of ciprofloxacin tablets in human subjects, to identify appropriate dosing regimens for pediatric populations in the event of a bioterrorism incident. Research support for the Therapeutic Inequivalence Action Coordinating Committee (TIACC).

10. Ongoing studies (cont’d) Data mining projects with the Office of Drug Safety (ODS) to characterize adverse event profiles for generic drugs, as compared to innovators. Providing laboratory support for select RSR projects.

11. Accomplishments of RRT Generated data for publication on the FDA website, of “Home Preparation Procedure for Emergency Administration of Potassium Iodide Tablets to Infants and Small Children” (http://www.fda.gov/cder/drugprepare/kiprep.htm) Generated data to update drug label information.

12. Future directions To provide sound scientific data which may contribute to policy decisions by regulators. Identify new areas of regulatory research which might help policy development. Collaborate with scientists outside of FDA to identify new technologies which might be incorporated in drug development.