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Biomed/Biotech Special Interest Group  

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

When
Feb 25, 2016    6:00 pm - 8:45 pm (GMT -5:00) EST

“The Role of Clinical Pharmacology 
in Biological Drug Development”

          To be presented by

Yow-Ming Wang, PhD
Biologics Team Leader
Office of Clinical Pharmacology Division III
Office of Translational Sciences
Center for Drug Evaluation and Research (CDER), FDA

       Thursday, February 25, 2016

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:45 PM – Program 
8:45 – 9:00 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, CKUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, NCARSQA members, OCA-DC members, 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, February, 25, 2016.  
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 
This presentation provides a high level understanding of the basic principles of clinical pharmacology and its role in drug development from phase 1 through phase 3 which ultimately leads to product approval by FDA.  I will introduce how the clinical pharmacology data are captured during drug development and then communicated to patients, physicians, and the healthcare community at the time of product approval.  

Among the FDA regulated biological products, the focus of this presentation is on the protein therapeutic agents reviewed in Center for Drug Evaluation and Research (CDER).  I will cover briefly the FDA’s definition of biological products and the FDA approved biological products.  I will also use case examples to illustrate the application of clinical pharmacology principles in support of regulatory submission and product approval and additional clinical pharmacology considerations for biological products.  

Speaker’s Bio: 
Dr. Yow-Ming Wang is the biologics team leader in the Division III of the Office of Clinical Pharmacology at FDA.  The biologics team at DCP III is responsible for reviewing submissions of biologic products in three clinical divisions. Dr. Wang joined FDA in March 2011. 

Prior to the FDA, she spent many years in the pharmaceutical industry with experience in the discovery research, preclinical development, and clinical development of small molecules and large molecules. From 2004 to 2011, she worked at Amgen where she supported multiple biologic products in clinical development, in registration phase, and in post-marketing phase.  Prior to that, Dr. Wang supported small molecule drug discovery and development for 11 years at Vertex Pharmaceuticals and at Parke-Davis Pharmaceutical Research.  She received her PhD degree from The Ohio State University College of Pharmacy with a research focus on Pharmacokinetics and Biopharmaceutics.