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Biomed/Biotech SIG: Generic Drug Regulatory Science  

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

When
Jul 13, 2017    6:00 pm - 8:45 pm (GMT -5:00) EST

“Evolving Regulatory Science for Generic Drugs” 
 
To be presented by

Wenlei Jiang, PhD
Senior Science Advisor 
Office of Research and Standards
Office of Generic Drugs (OGD)
Center for Drug Review and Research (CDER), US FDA

       Thursday, July 13, 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: https://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, and current job-seekers

Location: Kelly’s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855
Registration Deadline: Please register by Thursday noon, July 13, 2017.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] 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 
Generic drugs account for 89% of prescriptions dispensed in the United States and saved the US healthy system more than 1 trillion dollars in the past decade. Yet, there are scientific challenges that limit the availability of certain complex generic drugs, and some physicians and patients are not fully convinced about the substitutability of generic drugs.  

Intensive FDA intramural and extramural research efforts, as well as cross-office/center collaborations, were undertaken to promote the science related to generic drugs. This presentation will highlight significant advancements in understanding the science of equivalence and developing new tools for generic drug development and review, as well as efforts in enhancing public confidence on generic drugs. 

Speaker’s Bio
Dr. Wenlei Jiang is an expert pharmacologist and currently serves as a Senior Science Advisor in the Office of Research and Standards (ORS)/Office of Generic Drugs (OGD)/Center for Drug Evaluation and Research (CDER). She is mainly responsible for coordinating post-market generic drug safety investigation, representing ORS on OGD’s new international harmonization activities, and developing opportunities for scientific outreach. Previously she served as the Acting Deputy Director of ORS, where she provided oversight on Generic Drug User Fee Act (GDUFA) regulatory science research programs. 
Her research interest has been focused on bioequivalence standard development for generic complex drug products containing nanomaterials, solid oral modified release drug products, narrow therapeutic index drugs, as well as post-market surveillance of generic drugs. She used to work in the Division of Chemistry, OGD to review the chemistry and manufacturing control (CMC) sections of ANDAs. 
Prior to joining FDA, she was at Novartis Pharmaceutical Corporation where her responsibilities included formulation development of conventional liquid and solid dosage forms, as well as advanced parenteral drug delivery systems. She received her PhD in Pharmaceutics and Pharmaceutical Chemistry from The Ohio State University in 2001.

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