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Biomed/Biotech SIG: Nano Drug Products  

Where
Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland  20855

When
Oct 19, 2017    6:00 pm - 8:45 pm (GMT -5:00) EST

“The Evolving Landscape of Drug Products
Containing Nanomaterials”

To be presented by

Katherine Tyner, PhD
Acting Associate Director of Science
Office of Product Quality (OPQ)
Center for Drug Evaluation and Research (CDER), US FDA

       Thursday, October 19, 2017

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:45 PM – Program 
8:45 – 8:55 PM – Door-prizes drawing; Networking
Online Registration site: http://www.asq509.org/ht/d/DoSurvey/i/35817
Open to Public – 
$5: non-ASQ members to cover pizza/drink cost; 
Free: ASQ members, veterans, senior citizens, past speakers, US PHS Commissioned Corp officers, teachers, students, interns, residents, postdocs, FDA Commissioner’s Fellows, MJ-DC members, NTUAADC members, CAPA members, NTMUADC members, CKUAADC members, NTHUAADC members, NJTUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, NCARSQA members, OCA-DC members, AAMB members, ACAP members, DC Leaders Club members, BioTrain volunteers, current job-seekers, Tai-Chi classes students in Metropolitan DC.

Location: Kelly’s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855
Registration Deadline: Please register by Thursday noon, October 19, 2017.  
Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; gchang2008@yahoo.com or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb’s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor of 7529 Building with its external entrance opposite to the left side of 7519 building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from “Calhoun Place” stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary 
The Center for Drug Evaluation and Research (CDER) within the US FDA maintains a technical profile of drug products containing nanomaterials that have been submitted to the Agency for review. A review of drug products over the past 50 years highlights the diversity and changing landscape for these products. This talk will discuss several trends observed in the development of drug products containing nanomaterials, including the relative rate of approvals for these products.

Speaker’s Bio: 
Dr. Katherine Tyner is the Associate Director of Science (acting) in the immediate office of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research at the United States Food and Drug Administration (FDA). As Associate Director, Dr. Tyner leads the OPQ Science Staff in coordinating the intersection between science, review and policy in OPQ as well as facilitating interactions between other CDER offices and FDA Centers. 

Dr. Tyner received her PhD in Chemistry from Cornell University and joined the Food and Drug Administration in 2007 as a chemist specializing in nanotechnology. While at the FDA, Dr. Tyner has investigated the quality, safety, and efficacy of drug products containing nanomaterials, and she currently leads the CDER nanotechnology working group and is active in other CDER and FDA nanotechnology initiatives. Dr. Tyner is the author of multiple book chapters and journal articles concerning the appropriate characterization and biological impact of nanoparticle therapeutics. 

This event is cosponsored by NTU Alumni Association DC Chapter (www.ntuaadc.org) and Chinese American Professional Association DC Chapter (www.capadc.org).