The Theme
Empowering Healthcare with Cutting-Edge Biopharma Technologies and Leading Global Partnerships
8 sessions:
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The Future of Global Drug Development
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From the Discovery of Novel Science to Epic Molecule Development
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Clinical Development in Novel Checkpoint Inhibitors and Cell Therapy
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CMC and Emerging Bioprocess Technologies
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Recent Advances in Innovative Therapeutic Modalities: siRNA and ADC
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Drug Development in the Era of Precision Medicine
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Challenges and Opportunities in the New Era of Biotech Investment
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27-Years of Bridging Innovations and Entrepreneurship Between US and China
Keynote Speakers
Peter Marks, M.D., Ph.D.
Director, Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)
Title: “FDA’s Perspective on the Future of Cell and Gene Therapy”
Peter Stein, M.D.
Director, Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Title: “Clinical trial diversity and Global MRCT”
Patricia Keegan, M.D.
Chief Medical Officer, TopAlliance Bioscience
Title: “Multi-regional Trials: Opportunities and Challenges”
Gregg Semenza, M.D., Ph.D.
Director, Vascular Program, Institute for Cell Engineering
Professor of Genetic Medicine, Pediatrics, Radiation Oncology, and Molecular Radiation Sciences, Biological Chemistry, Medicine, and Oncology
Johns Hopkins University School of Medicine
Dr. Semenza was awarded the Nobel Prize in Physiology or Medicine in 2019, for his ground-breaking discovery of the HIF-1 (hypoxia-inducible factor 1) protein, which controls changes in gene expression in response to changes in oxygen availability.
Sunil Verma, M.D.
SVP, Global Head of Oncology, Medical AstraZeneca, Gaithersburg, MD
Mark Lanasa, M.D., Ph.D.
SVP, Chief Medical Officer (CMO), Solid Tumors BeiGene
Other Distinguished Speakers
Yang Liu, Ph.D.
Founder, Chairman, CEO and Chief Scientific Officer OncoC4
Ke Liu, M.D., Ph.D.
Chief Development Officer, Marengo Therapeutics, Boston
Rafiq Islam, M.S.
Vice President-Bioanalysis and Biomarker, Amador Bioscience
Baolin Zhang, Ph.D.
Senior Investigator, CMC Review Leader
Office of Biotechnology Products
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)
Raghavan Venkat, Ph.D.
Senior Vice President, Head of Biopharmaceutical Development, AstraZeneca
Xu-Rong Jiang, M.D., Ph.D.
Senior Vice President, Cellular Biomedicine Group Inc.
Title: “Overcoming the Challenges of CMC in Cell and Gene Therapy”
Min Park, B.S., B.A.M.
Chief Business Officer, Henlius (Aton Biotech)
Title: “Smart Platform Strategies: Accelerate Molecule to Market”
Patrick Lu, Ph.D.
Founder, Chairman and CEO, Sirnaomics, Inc.
Fiona Yu, MBA
CEO, Unogen Biotech Ltd.
Lai-Xi Wang, Ph.D.
Professor of Chemistry and Biochemistry University of Maryland, College Park
Tentative Title: “Antibody Glycosylation and Site-Specific ADC Conjugation”
Helen Zhong, Ph.D.
Senior Vice President, Preclinical Research, BiOneCure
Title: “An anti-HER2/Trop-2 Bispecific Antibody-Drug Conjugate with a New DNA Toposisomerase I Inhibitor Exerts Potent and Broad Antitumor Activity in Preclinical Tumor Models”
Jane Fang, M.D., M.S.
CEO & Founder, Polaris Strategic Partners, Inc.
Title: “Reimaging Clinical Trials: New Path, New Possibilities for Early Phase Clinical Development from Chine to Global”
Matt Britz, M.S., MBA
Chief Operating Officer, AffyImmune Therapeutics
Title: “Affinity-tuning and Tracking CAR T cells for Solid Tumors”
Nektarios (Aris) Oraiopoulos, Ph.D.
Professor, University of Cambridge
Yieyie Yang, Ph.D., J.D.
Associate, Finnegan, Henderson, Farabow, Garrett & Dunner LLP
Title: “IP Strategies for Valuable and Enforceable Patents”
Catherine Pan
Partner, Corporate Group Head of New York Office, Co-Chair of US-China Practice Group, DORSEY & WHITNEY LLP
Agenda
Saturday, December 17, 2022, 08:30 am – 5:30 pm
Washingtonian Ballroom & Lakeside Ballroom
| 8:30 – 8:40 am |
Opening Remarks Song Wu, PhD, CBA President, 2022-2023, Head of Translational Oncology, Hansoh Bio/Hansoh Pharm
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Plenary Keynote Session 1: The Future of Global Drug Development
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8:40 – 10:40 am
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Washingtonian Ballroom
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Session Moderators: Jingyu (Julia) Luan, PhD, Angela Yuxin Men, MD, PhD
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| 08:40 – 09:05 am |
Taking Gene Therapy to the Next Level Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA) Member of the National Academy of Medicine
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| 09:05 – 09:30 am |
Clinical Trial Diversity/Global Multi-Regional Clinical Trials (MRCT) Peter Stein, MD, Director, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
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| 09:30 – 9:55 am |
Multi-regional Trials: Opportunities and Challenges Patricia Keegan MD, Chief Medical Officer, Shanghai Junshi Biosciences and TopAlliance Biosciences
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| 9:55 – 10:30 am |
Q&A and Panel Discussion: Panelist: Peter Stein, MD Peter Marks, MD, PhD Patricia Keegan MD Sunil Verma, MD Mark Lanasa, MD, PhD
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10:30 – 10:50 am Coffee Break and Group Photos
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Plenary Keynote Session 2: From the Discovery of Novel Science to Epic Molecule Development
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10:50 am – 12:20 pm |
Washingtonian Ballroom
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Session Moderators: Angela Zeng, MD, PhD, Yingxi Chen, MD, PhD
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10:50 – 11:15 am |
HIF Inhibitors for Cancer Therapy Gregg Semenza, MD, PhD, Professor, Johns Hopkins University School of Medicine, 2019 Nobel Laureate in Physiology or Medicine
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11:15 – 11:40 am |
TBD Sunil Verma, MD, SVP, Global Head of Oncology, Medical, AstraZeneca
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11:40 – 12:05 pm |
New Generation of Global Biotech Mark Lanasa, MD, PhD, SVP, Chief Medical Officer, Solid Tumors, BeiGene
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12:05 – 12:20 pm |
Q&A
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12:20 – 12:30 pm |
Lucky Draw Session Washingtonian Ballroom |
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12:30 – 1:30 pm Parallel Lunch Sessions
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| Lunch Session A |
Washingtonian Ballroom
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Session Moderator: Xuyang Song, PhD
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| 12: 40 – 1:00 pm |
SMART PLATFORM STRATEGIES: Accelerate Molecule to Market Min Park, Chief Business Officer, Aton Biotech
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| 1:00 – 1:30 pm |
CBA and Partners’ Show
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| Lunch Session B |
Lakeside Ballroom
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Session Moderator: Jack Yang, MSc
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| 12: 40 – 1:00 pm |
IP Strategies for Valuable and Enforceable Patents Yieyie Yang, PhD, JD, Associate, Finnegan, Henderson, Farabow, Garrett & Dunner LLP
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| 1:00 – 1:30 pm |
CBA and Partners’ Show
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1:30 – 2:50 pm Parallel Sessions 3A and 3B
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Parallel Session 3A: Recent Clinical Development in Novel Checkpoint Inhibitors Washingtonian Ballroom
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Session Moderators: Helen Fu, PhD, Tongqing Zhou, PhD
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1:30 – 1:50 pm |
Preserving Immune Tolerance Checkpoints for Safer and More Effective Immunotherapy Yang Liu, PhD., Founder, Chairman, CEO and Chief Scientific Officer, OncoC4
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1:50 – 2:10 pm |
Hot Topics in Cancer Immunotherapy Ke Liu, MD, PhD, Chief Development Officer, Marengo Therapeutics
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2:10 – 2:30 pm |
Immunogenicity Assessment in the Age of New Drug Modalities Rafiq Islam, VP, Amador Bioscience
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2:30 – 2:50 pm |
Q&A |
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Parallel Session 3B: CMC and Emerging Bioprocess Technologies Lakeside Ballroom
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Session Moderators: Xu-Rong Jiang, MD, PhD, Hao Li, PhD
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| 1:30 – 1:50 pm |
The Evolving Landscape of Anti-PD-1/PD-L1 Antibody Development Baolin Zhang, PhD, SBRBPAS Expert, FDA/CDER/OBP
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| 1:50 – 2:10 pm |
Next Generation Biologics: Moving beyond mAbs Raghavan Venkat, PhD, Senior Vice President, Head of Biopharmaceutical Development, AstraZeneca
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| 2:10 – 2:30 pm |
Overcoming the Challenges of CMC in Cell and Gene Therapy Xu-Rong Jiang, MD, PhD, Senior Vice President, Cellular Biomedicine Group
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| 2:30 – 2:50 pm |
Q&A
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2:50 – 3:10 pm |
Coffee Break and Group Photos |
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3:10 – 4:30 pm Parallel Sessions 4A and 4B
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Parallel Session 4A: Recent Advances in Innovative Therapeutic Modalities: siRNA and ADC Washingtonian Ballroom
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Session Moderators: Qing Li, PhD, Chunhong Liu, PhD
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3:10 – 3:30 pm |
Advancing RNAi Therapeutics for Cancer Treatment Patrick Lu, PhD, President, and CEO, Sirnaomics
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3:30 – 3:50 pm |
Antibody Glycosylation and Site-Specific Antibody-Drug Conjugation Lai-Xi Wang, PhD, Professor of Chemistry and Biochemistry, University of Maryland
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3:50 – 4:10 pm |
An Anti-HER2/Trop-2 Bispecific Antibody-Drug Conjugate with a New DNA Topoisomerase Inhibitor Exerts Potent and Broad Antitumor Activity in Preclinical Tumor Models Helen Zhong, PhD, Senior Vice President, Preclinical Research, BiOneCure
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4:10 – 4:30 pm |
Q&A
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Parallel Session 4B: Drug Development in the Era of Precision Medicine Lakeside Ballroom
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Session Moderators: You Li, PhD, Hongjun Yang, PhD
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3:10 – 3:30 pm |
Reimagining Clinical Trials: New Path, New Possibilities for Early Phase Clinical Development from China to Global Jane Fang, MD, CEO & Founder, Polaris Strategic Partners
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3:30 – 3:50 pm |
Affinity-Tuning and Tracking CAR T Cells for Solid Tumors Matt Britz, COO, AffyImmune Therapeutics
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3:50 – 4:10 pm |
Bringing the Promise of Precision Medicine for Cancer Care within Reach for All Rami Zahr, Sr. Director of Product Strategy, Personal Genome Diagnostics, Labcorp |
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4:10 – 4:30 pm |
Q&A
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4:30 – 5:15 pm
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Parallel Session 5A: Round Table Discussion: Challenges and Opportunities in the New Era of Biotech Investment Lakeside Ballroom
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Session Moderators: Frank Li, PhD, Fiona Yu, MBA
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Panelists: Frank Li, PhD, Founder and Senior Consultant, BLA Regulatory, Past CBA President Changshou Gao, PhD, SVP & CTO, Innovent Biologics Inc Nektarios (Aris) Oraiopoulos, PhD, Professor, University of Cambridge Ting Feng, PhD, Partner, Sirona Capital Catherine Pan, Partner, Co-Chair of US-China Practice Group, DORSEY & WHITNEY LLP
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4:30 – 5:15 pm
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Parallel Session 5B: Round Table Discussion: 27-Years of Bridging Innovations and Entrepreneurship Between US and China Washingtonian Ballroom
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Session Moderators: Richard Y. Zhao, PhD
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Panelists: Richard Y. Zhao, PhD, Professor & Div Head, Mol Path, Director, Mol Diagnostics, Fellow, American Academy Microbiology, Univ. Maryland Med Ctr, Past CBA President Patrick Lu, PhD, President, and CEO, Sirnaomics, Past CBA President Yifan Zhai, MD, PhD, CMO, Ascentage Pharma, Past CBA President Lin Sun-Hoffman, JD, PhD, Founding Partner, Ambiz Law Group, Past CBA President |
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5:15 – 5:25 pm |
Lucky Draw Session Washingtonian Ballroom |
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5:25 – 5:30 pm |
Conclusion Remarks and Group Photos Washingtonian Ballroom
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Jingyu (Julia) Luan, PhD, CBA President-Elect (2023-2024)
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6:00 – 8:30 pm |
CBA Annual Conference Dinner
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Hosts: Angela Yuxin Men, MD, PhD, Xuyang Song, PhD
Dinner tickets are not included in the general registration for the conference, and it should be purchased separately in advance. Dinner tickets are required to attend the CBA Annual Conference Dinner |
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Sponsors and Partners
