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Roundtable

TL18-25 Roundtable Discussions

Thu, Sep 25, 11:45 AM - 1:00 PM Room Glen Echo Bethesda North Marriott Hotel & Conference Center

8 Presentations

TL18: Unlocking the Power of External Data and Data Fusion in Regulatory Decision-Making

11:45 AM - 1:00 PM

Lei Nie (The US FDA)

Co-authors: Mark Van Der Laan (UC Berkeley)

External Real-World Data Data Fusion Data Integration External Controls Real World Evidence Historical Controls

TL19: Use of Real-world Data in Drug Approval for Hematological and Rare Disease Clinical Trials

11:45 AM - 1:00 PM

Co-authors: Lola Luo (FDA)

real world evidence/real world data rare hematological disease external control causal methods intercurrent events and missing data confounders

TL20: Adaptive Pooling Strategies for Surrogate Endpoint Validation in Cell Therapy: A Dynamic Information Borrowing Framework

11:45 AM - 1:00 PM

Jinjie Chen (BMS)

Co-authors: Wencong Chen (Bristol Myers Squibb)

Surrogate Endpoint Cell Therapy Dynamic Information Borrowing Pooling Strategy

TL21: Navigating Safety Reporting Requirements and Safety Assessment for IND: Insights and Discussions on FDA 2021 Guidance

11:45 AM - 1:00 PM

Viviana Rodriguez (Merck)

Co-authors: Parul Bhargava (Merck)

IND safety reporting Aggregate analysis FDA Final rule

TL22: Bridging the Gap: Navigating the Transition from Academia to the Pharmaceutical Industry

11:45 AM - 1:00 PM

Yan Lin (Eli Lilly and Company)

Co-authors: Yanhong Zhou (Eli Lilly and Company)

Job searching Transition from academia to Pharmaceutical Industry Networking Transferrable skills

TL23: Discussion on Changes to the US Federal Government and its Effects on Statisticians Working on Drug Development Across Industry and Government

11:45 AM - 1:00 PM

Co-authors: Disa Yu (Sanofi)

Federal government Changes Drug development collaboration Job opportunities and/or job security Regulatory agencies Current Events

TL24: Interpretable Deep Learning-Based Multi-Omics and Clinical Data Integration in Clinical Trial Development: Opportunities and Challenges

11:45 AM - 1:00 PM

wenting wang (Sanofi)

Co-authors: Hong Wang (Sanofi)

Multi-Omics Interpretable Deep Learning Decision Making in Clinical Trial Development Intergration

TL25: Am I a Data Scientist or a Statistician? Or Am I Cool Enough to Juggle Both Hats?

11:45 AM - 1:00 PM

Co-authors: Ji Lin (Sanofi)

artificial intelligence machine learning biostatistician data scientist

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