CBA 28th Annual Conference
Date: September 30, 2023
Location: Marriott Washingtonian Center (9751 Washingtonian Blvd, Gaithersburg, MD 20878)
The long-awaited Chinese Biopharmaceutical Association (CBA) 28th Annual Conference is scheduled to convene on September 30, 2023, Saturday at Marriott Washingtonian Center (9751 Washingtonian Blvd, Gaithersburg, MD 20878). The conference will be held both in-person and online simultaneously.
The theme of the conference is “Accelerate Drug Development through Scientific Innovation, Regulatory Convergence, and Global Partnership“, including eight forums:
- Regulatory and Scientific Innovations in Global Drug Development
- Acceleration of Drug Development and Artificial Intelligence
- cGMP Inspection
- ADC and RDC for Targeted Therapy: Development and Practical Considerations
- Sustainable Drug Development
- RNA Vaccine and Therapeutics Development
- Improve the Efficiency of Drug Development
- Lessons Across Borders: CBA’s Entrepreneurship in the U.S. and China
Many outstanding speakers from academia, government, and industry have been confirmed on-site presentations. They are Dr. Lawrence Yu, Director of the Office of New Drug Products (ONDP), OPQ, CDER, FDA; Dr. Eleftherios(Terry) Papoutsakis, Unidel Eugene DuPont Professor, University of Delaware, A Member of National Academy of Engineering, Dr. Luigi Ferrucci, Scientific Director of the National Institute of Aging (NIA), NIH; Dr. Patricia Keegan, CMO of Shanghai Junshi Biosciences and TopAlliance Biosciences; Dr. Shein-Chung Chow, Professor at Duke University School of Medicine; Dr. Hao Zhu, Division Director, OCP, OTS, CDER, FDA; Dr. Joga Gobburu, Director of Translational Science, School of Pharmacy, University of Maryland, etc.
The speakers include clinical and research professors, as well as founders and executives of biotech companies, and FDA drug review experts. The conference covers cutting-edge achievements in basic research, the latest drug developments of different fields in pharmaceutical industry, in-depth discussions on government regulatory policies and approval, and conversations about the challenges and opportunities of biotech investment.
CBA sincerely invites you to attend the 28th Annual Conference! We look forward to meeting you in person (Marriott Washingtonian Center in Maryland) or online on September 30th, 2023. We will discuss hot topics in medical and pharmaceutical fields in China and the United States, and the latest advancements in translational research, drug development and regulatory policies. Do not miss out on this wonderful opportunity!
The spots for on-site attendance are limited. Please click the button below to register for the conference as soon as possible!
Confirmed Speakers
Lawrence Yu, PhD
Director
Office of New Drug Products
FDA/CDER/OPQ
Eleftherios (Terry) Papoutsakis, PhD
Unidel Eugene DuPont Professor
University of Delaware
A Member of National Academy of Engineering
Luigi Ferrucci, MD, PhD
Scientific Director
National Institute of Aging
NIH
Patricia Keegan, MD
Chief Medical Officer
Shanghai Junshi biosciences and TopAlliance Biosciences
Shein-Chung Chow, PhD
Professor
School of Medicine
Duke University
Hao Zhu, PhD
Division Director
Division of Pharmacometrics
FDA/CDER/OTS/OCP
Joga Gobburu, PhD
Director of Translational Science
School of Pharmacy
University of Maryland
Bo Chi, PhD
Microbiologist
FDA/CDER/OPQ/OPMA
Jennifer Eck, MS
Senior Director
CMC Regulatory Affairs just
AstraZeneca
Jie He, PhD
Lead Consumer Safety Officer
FDA/CBER/OCBQ/DMPQ
Ziping Wei, PhD
Chairman, Co-founder and CEO
Bliss Biopharmaceutical
Qing Liang, PhD, DABR
CEO
Neulink pharma
Meijuan Li, PhD
Vice President
Head of Translational Science and Biostatistics
Eisai Inc, Oncology
Min Park, PhD
Chief Business Officer
Henlius
Jingke Weng, PhD
Director, Professor
Institute for Plant-Human interface
Northeastern University
Daozhan Yu, PhD
CEO
AAVnerGene Inc.
Ammar Ahmed Chaudhry, MD
Global Head of Clinical Imaging
AstraZeneca
Yuling Li, PhD
Co-founder and President
Innoforce Pharmaceuticals
Patrick Lu, PhD
President & CEO
Sirnaomics
Baoshan Zhang, PhD
Staff Scientist
NIH
Shaily Arora, PharmD
Executive Regulatory Science Director
Oncology Regulatory Affairs
AstraZeneca
Vishnu Dutt Sharma, PhD
Staff Fellow
FDA/CDER/OTS/OCP/DPM
Ning Xia, PhD
CEO
Chemical.AI
Feng Gu, BS
CEO
Chanshow Biotechnology Inc.
Edmund Wang, MS, MBA
Founder and CEO
Kactus Biosystems
Yanping Li, PhD
Executive Director of Regulatory Affairs
Clin-nov Medical
Jingyu (Julia) Luan, PhD, RAC
Senior Director of Global Regulatory Affairs
AstraZeneca
CBA President
Song Wu, PhD
Head of Translational Oncology
Hansoh Bio
CBA Immediate Past President
You Li, PhD
Vice President, Program Executive
EQRx
CBA President-Elect
Agenda
Saturday, September 30, 2023, 07:45 am – 5:30 pm
Washingtonian Ballroom & Lakeside Ballroom
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7:45 – 8:30 8:30 – 8:40 am |
Registration Opening Remarks Jingyu (Julia) Luan, PhD, CBA President, Senior Director, Global Regulatory Affairs, AstraZeneca
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Keynote Session 1: Regulatory and Scientific Innovations in Global Drug Development
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8:40 – 10:20 am
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Washingtonian Ballroom
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Session Moderators: Jingyu (Julia) Luan, PhD; You Li, PhD
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| 08:40 – 09:05 am |
Regulatory Assessment and Submission of New Drugs in the Age of Digitalization Lawrence Yu, PhD, Director, Office of New Drug Products, FDA/CDER/OPQ
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| 09:05 – 09:30 am |
Geroscience: the New Frontier of Medicine Luigi Ferrucci, MD, PhD, Scientific Director of National Institute of Aging, NIH
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| 09:30 – 9:55 am |
Engineered Megakaryocytic Extracellular Vesicles for Hematological Cell and Gene Therapies Eleftherios (Terry) Papoutsakis, PhD, Professor, University of Delaware, A member of National Academy of Engineering
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| 9:55 – 10:20 am |
Q&A and Panel Discussion (all speakers)
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10:20 – 10:40 am Coffee Break and Group Photos
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Keynote Session 2: Acceleration of Drug Development and Artificial Intelligence
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| 10:40 am – 12:15 pm |
Washingtonian Ballroom
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Session Moderators: Angela Men, MD, PhD; Wei Zhang, PhD
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| 10:40 – 11:00 am |
Multinational Clinical Development – Continuing Challenges and Opportunities for Efficiencies Patricia Keegan MD, Chief Medical Officer, TopAlliance Biosciences
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| 11:00 – 11:20 am |
Current Regulatory Critical Clinical Initiatives in Pharmaceutical Development Shein-Chung Chow, PhD, Professor, Duke University School of Medicine
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| 11:20 – 11:40 pm |
Use of Artificial Intelligence and Machine Learning to Support New Drug Development and Enhance Patient Care Hao Zhu, PhD, Division Director, Division of Pharmacometrics, FDA/CDER/OTS/OCP
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| 11:40 – 12:00 |
Artificial Intelligence and Machine Learning (AI/ML) for Drug Development: Applications, Opportunities and Challenges Joga Gobburu, PhD, Director of Translational Science, School of Pharmacy, University of Maryland
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| 12:00 – 12:15 pm |
Q&A and Panel Discussion(all speakers)
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12:15 – 12:30 pm |
Group photos and picking up lunch |
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12:30 – 1:30 pm Parallel Lunch Sessions
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| Lunch Session A |
Washingtonian Ballroom(Salons A-C)
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Session Moderator: Gengcheng (Jack) Yang, MS
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| 12: 30 – 12:50 pm |
Exploring Low Protein Adsorption and DNA Adsorption in Consumables Selection Feng Gu, BS, CEO, Chanshow Biotechnology
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| 12:50 – 1:30 pm |
CBA and Partners’ Show
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| Lunch Session B |
Washingtonian Ballroom (Salons D-G)
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Session Moderator: Xuyang Song, PhD, MBA
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| 12: 30 – 12:50 pm |
Kactusbio company introduction Edmund Wang, MBA, MS, Founder & CEO, Kactus Biosystems
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| 12:50 – 1:30 pm |
CBA and Partners’ Show
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| Lunch Session C | Lakeside Ballroom |
| Session Moderator: Yixing Han, PhD | |
| 12:30 – 12:50 pm |
Haichang Biotech Company Introduction Nandita Shetty, clinical operation manager, HaiChang Biotech |
| 12:50 – 1:10 pm |
Clinical Research Trends in China Angela Wang, MBA, China Commercial Director, Novotech |
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1:30 – 3:00 pm Parallel Sessions 3A, 3B and 3C
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Parallel Session 3A: cGMP Inspection Washingtonian Ballroom
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Session Moderators: Hao Li, PhD; Feiyan Jin, PhD
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| 1:30 – 1:50 pm |
FDA Facility Inspection for CDER Biological Product Approval Bo Chi, PhD, Microbiologist, FDA/CDER/OPQ/OPMA
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| 1:50 – 2:10 pm |
TBD Jennifer Eck, MS, Senior Director, CMC Regulatory Affairs, AstraZeneca
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| 2:10 – 2:30 pm |
FDA/CBER inspection of Manufacturing Facilities for Cell and Gene Therapy Products Jie He, PhD, Lead Consumer Safety Officer, FDA/CBER/OCBQ/DMPQ
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| 2:30 – 3:00 pm | Q&A and Panel Discussion (all speakers) |
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Parallel Session 3B: ADC and RDC for Targeted Therapy: Development and Practical Considerations Washingtonian Ballroom (Salons D-G)
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Session Moderators: Chunhong Liu, PhD; Yingxi Chen, MD, PhD
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| 1:30 – 1:50 pm |
Challenges and Opportunities in Antibody-Drug Conjugate Development Ziping Wei, PhD, Co-founder, Chairman, and CEO of Bliss Biopharmaceutical (Hangzhou) Co., Ltd.
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| 1:50 – 2:10 pm |
RDC: Imaging and therapeutic potentials Qing Liang, PhD, DABR, CEO of Neulink Pharma
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| 2:10 – 2:30 pm |
Developing Monitoring Biomarker for ADC Drug Adverse Events Meijuan Li, PhD, VP, Head of Translational Science and Biostatistics, Eisai Inc, Oncology
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| 2:30 – 3:00 pm |
Q&A and Panel Discussion (all speakers and Min Park, PhD, CBO, Henlius)
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Parallel Session 3C: Sustainable Drug Development Lakeside Ballroom
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Session Moderators: Qing Li, PhD; Tongqing Zhou, PhD
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| 1:30 – 1:50 pm |
Harnessing Plants for Medicines with Modern Approaches Jingke Weng, PhD, Director, Professor, Institute for Plant-Human Interface, Northeastern University
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| 1:50 – 2:10 pm |
Enhance AAV Gene Therapy Efficiency Daozhan Yu, PhD, CEO, AAVnerGene Inc.
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| 2:10 – 2:30 pm |
TBD Ammar Ahmed Chaudhry, MD, Global Head of Clinical Imaging, AstraZeneca
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| 2:30 – 3:00 pm |
Q&A and Panel Discussion (all speakers)
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3:00 – 3:30 pm 3:15 – 3:30 pm
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Coffee Break and Group Photos Lucky Draw Washingtonian Ballroom (Salons D-G) |
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3:30 – 5:00 pm Parallel Sessions 4A, 4B and 4C
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Parallel Session 4A: RNA Vaccine and Therapeutics Development Washingtonian Ballroom (Salons A-C)
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Session Moderators: Chao Wang, PhD; Yuling Li, PhD
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| 3:30 – 3:50 pm |
CMC Development and Commercialization of mRNA Therapeutics and Vaccines Yuling Li, PhD, President and Co-founder, Innoforce Pharmaceuticals
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| 3:50 – 4:10 pm |
TBD Patrick Lu, PhD, President & CEO, Sirnaomics
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| 4:10 – 4:30 pm |
Structure-Based Immunogen Design for Effective mRNA Vaccines Baoshan Zhang, PhD, Staff Scientist, NIH
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| 4:30 – 5:00 pm |
Q&A and Panel Discussion (all speakers)
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Parallel Session 4B: Improve the Efficiency of Drug Development Washingtonian Ballroom (Salons D-G)
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Session Moderators: Joe Wang, MD PhD; Helen Fu, PhD
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| 3:30 – 3:50 pm |
RWD/RWE: Oncology Case Studies Shaily Arora, PharmD, Executive Regulatory Science Director, AstraZeneca
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| 3:50 – 4:10 pm |
The Role of Model-Informed Drug Development Approaches in Drug Development and Vishnu Dutt Sharma, PhD, Staff Fellow, FDA/CDER/OTS/OCP
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| 4:10 – 4:30 pm |
Accelerating Drug Discovery Through AI-Driven Automation Ning Xia, PhD, CEO, Chemical.AI
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| 4:30 – 5:00 pm |
Q&A and Panel Discussion (all speakers)
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Parallel Session 4C: Lessons Across Borders: CBA’s Entrepreneurship in the U.S. and China Lakeside Ballroom
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Session Moderators: Song Wu, PhD; Hang Lu, MD
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3:30 – 5:00 pm Panelists: |
Q&A and Panel Discussion Patrick Lu, PhD, President & CEO, Sirnaomics Ziping Wei, PhD, Co-founder, Chairman, and CEO, Bliss Biopharmaceutical (Hangzhou) Co., Ltd. TBD TBD
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5:00 – 5:15 pm
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Concluding Remarks and Group Photos
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You Li, PhD, CBA President-Elect Washingtonian Ballroom (Salons A-C) Jingyu (Julia) Luan, PhD, CBA President Washingtonian Ballroom (Salons D-G) Song Wu, PhD, CBA Immediate Past President Lakeside Ballroom
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