2016-2017 CBA Workshop Series 1

Strategy of Drug Research, Development, and Marketing Approval

9:30AM – 1:00PM, Saturday, August 27, 2016, 9318 Gaither Road, Gaithersburg, MD 20877


The Biopharma Development & Production (BDP) Week Asia Pacific in Singapore on Nov.1-3, 2016
Biologics Innovation and Frontier Technology (BIFT) China Summit 2016 on Sept 20-21 in Shanghai
Bio Partnering APAC 2016 Summit on Sept. 20-21, 2016 in Shanghai
CBA Leadership Team and Distinguished Speakers at the 2016 Annual Conference
Dr. Ge Li, CEO and Chairman of Board of WuXi AppTec and Dr. Bahija Jallal, EVP of AstraZeneca & Head of MedImmune, received the 2016 Brilliant Achievement Award at CBA 2016 Annual Conference
CBA, in collaboration with MedImmune, successfully organized the 2016 Annual Conference on June 11, 2016

CBA's 20th Anniversary: 1995-2015

About us

The Chinese Biopharmaceutical Association – USA (CBA) is one of the largest Chinese American professional associations in the US (www.cba-usa.org). Founded in 1995, CBA is an independent, non-political, not-for-profit professional organization led by its elected board of...

Latest News

  • The Biopharma Development & Production (BDP) Week Asia Pacific

    November 1-3, 2016

    Grant Copthrone Waterfront Hotel, Singapore

    Register at: www.biopharmaproduction-asia.com

    CBA members could claim 20% off the regular registration rates

  • Bio Partnering APAC 2016 Summit

    September 20-21, 2016 | Shanghai, China

    -Learn global pharma industry trends to set your own business strategy

    -Discover the best collaboration model to improve deal making

    -Understand and overcome alliance management challenges with essential and effective practices

    -Listen to leading biotechs to find new opportunities

    -Meet directly with potential partners to make big deals in your handshake



2016-2017 CBA Workshop Series 1

Strategy of Drug Research, Development, and Marketing Approval


9:30 am-1:00 pm | August 27, 2016
Room 226, Chinese Culture and Community Service Center (CCACC)

9318 Gaither Road, Gaithersburg, MD 20877


Admission Cost: $5.00 for public

FREE for active members of CBA, CCACC, NIH-CSSA, or ASQ509



CBA-USA is organizing this series of workshops,co-sponsored by CCACCwith the goalof providing opportunities for professionals in the bioscience research field to gain a deeper understanding ofdrug development and marketing approval. Our speakers are experts in this field with hands-on experience in biopharmaceutical industry or Regulatory Authoritywho will share their expertise with all participants. Come join us on 27 August, 2016 to learn more and meet professionals!


  • CCACC (Chinese Culture and Community Service Center)
  • ASQ509: American Society for Quality (www.asq.org) – Washington DC and Maryland Metro, Section 509 (www.asq509.org)
  • NIH-CSSA (Chinese Students and Scholars Association of the National Institute of Health)



Section 1 9:30-10:30am: Introduction and the 1st Topic


9:30-10:00 Introduction (CBA, CCACC, ASQ509, NIH-CSSA, and Participants)
10:00-10:30 Strategy of Drug Research, Development, and Marketing Approval
Speaker: Lisa Pitt, PharmD, Vice President, Global Regulatory Affairs, Premier Research


Section 2    10:31-11:20am: Cross-Function Staffing in Supporting Drug Development

10:31-10:55 Industry Perspective: Cassandra Hoffman, BS, PMP, GPM Manager, AstraZeneca
10:56-11:20 FDA Perspective: Ke Zhang, PhD, Office of New Drugs, CDER, FDA


Section 3 11:21-11:50am: Q&A and Panel discussion


Section 4 11:51-1:00pm: Door-prizing drawing, Pizza Lunch and Network


Biography of Speakers

Cassandra Hoffman, BS, PMP, Global Project Manager, AstraZeneca

Mrs. Hoffman has more than 10 years of experience in the biotech and pharmaceutical industry. She has worked across multiple therapeutic areas and has experience managing projects from preclinical to late stage drug development. Mrs. Hoffman oversees projects from cooperate perspective.


Lisa Pitt, PharmD, Vice President, Global Regulatory Affairs, Premier Research
Dr. Pitt was trained as a Pharmacist and received her PharmD from University of Maryland. Dr. Pitt has more than 20 years of experience in the biopharmaceutical industry including Novartis and MedImmune, and FDA. At her current position, Dr. Pitt oversees Regulatory Affair in Primer Research.



Ke Zhang, PhD, Senior Pharmacologist, Office of New Drugs (OND), CDER, FDA

Dr. Ke Zhang was trained as a cardiovascular pharmacologist and received his Ph.D. from Ohio State University. He joined the FDA in 1994 in the Division of Gastrointestinal and Inborn Errors Products in the Office of New Drugs, CDER, FDA. He is currently a senior pharmacologist reviewer.




CBA workshop organizing committee c/o Frank Li
Chinese Biopharmaceutical Association (CBA-USA)
PO Box 61362, Potomac, MD 20859-1362
Email: contact@cba-usa.org

Website: www.cba-usa.org


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