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Biomed/Biotech SIG: Life-Cycle Management of Biologics Products  

Where
9366 Gaither Rd. 1st Fl Music Room, Gaithersburg, MD 20877

When
Apr 04    6:00 pm - 8:45 pm (GMT -5:00) EST

“Life-Cycle Management of Biologic Products”
and A Successful Scientist-Entrepreneur Story
                        
                          To be presented by

Audrey Jia, MD, MS, PhD
President & Principle CMC/Regulatory Lead
Datarevive, LLC  

       Thursday, April 4, 2019

Venue: 9366 Gaither Rd. “1st Floor Music Room”, Gaithersburg, MD 20877 (CCACC)
6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:50 PM – Program 
8:50 – 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, current job-seekers, CCACC volunteers/employees/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, FAPAC members, CBA members, AAGEN members, NCARSQA members, OCA-DC members, AAMB members, ACAP members, DC Leaders Club members, BioTrain volunteers, all Tai-Chi classes students in Metropolitan DC, and L4FA Community Members.

Registration Deadline: Please register by Thursday noon, April 4, 2019.  
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 8 onto Shady Grove Dr. Drive toward east and turn left onto Gaither Rd. The building is on your left after passing a stop sign. By Metro rail: Exit at the Red Line Shady Grove Station. 

Summary 
Life cycle management is an important part of drug development especially after the marketing approval. This talk will use biological products as examples and combine with ICH guidelines and FDA guidances to discuss the life cycle management from the regulatory perspective.

Our speaker will also share her excitements, achievements, and challenges with a career transition from an R/D scientist and a regulatory review scientist to a successful regulatory entrepreneur.

Speakers 
Dr. Audrey Jia, MD, MS, PhD, holds a Master degree in Bioscience Regulatory Affairs from Johns Hopkins University, and a PhD degree in Microbiology and Molecular Genetics from Emory University. Prior to that, Dr. Jia obtained her Bachelor degree of Medicine from Peking University. Dr. Jia has 18 years of combined experience in biologic drug development and regulatory review. She spent 10 years from 1999 to 2009 in the biopharmaceutical companies working on monoclonal antibody engineering, humanization, affinity maturation, expression, and purification. 

During her time in US FDA from 2009 to 2015, Dr. Jia was a full time CMC reviewer for IND/BLA review applications of biological products including antibody fragments, fusion proteins, antibody drug conjugate, combination products, and radiolabeled antibodies. She performed numerous IND reviews and BLAs (including post approval reviews), and conducted several US and international cGMP pre-approval inspections (PAIs). She is specialized in both novel proteins/antibodies and biosimilar products reviews. 

Dr. Jia currently leads a regulatory consulting firm for drug and biologic products and serves as the principle CMC and regulatory lead. She has helped many foreign companies and filed their US INDs/BLAs successfully.  

This event is cosponsored by Chinese Culture and Community Service Center, Inc. (CCACC, www.ccacc-dc.org), NTU Alumni Association DC Chapter (www.ntuaadc.org), and Chinese American Professionals Association of Metropolitan Washington, DC (www.capadc.org).