About BBSW MEETUPS

 

MEETUP SERIES FOCUS

Changes in Scientific Paradigm and Technological Advances of the 21st Century Drug Development: Role and Impact of Statistics and Data Science

EXPECTATIONS AROUND THE MEETUPS

For Attendees

  • Playground/brewing ground for open dialogue

  • Meet cross industry and academia colleagues 

  • Technical discussions on selected topics

  • Explore potential collaborations with partners/colleagues in related fields

  • Career path/ leadership discussions

For BBSW Organizing Committee

  • Understand better the interests from the community

RANGE OF POTENTIAL TECHNICAL TOPICS THEMES

  • Use of modern data infrastructures and technologies to optimize clinical data collection, aggregation, access, monitoring, and analysis

    • Analysis solutions: 

      • adaption of R and Python in pharma

      • interactive analyses via RMarkdown, RShiny, iPython

    • Data warehouse solutions (AWS Athena, Redshift)

    • Choice of cloud computing (e.g., AWS, Azure, Google cloud)

    • Data processing and ETL (AWS GLue, Matillion)

    • Data aggregation: new data types, processes and systems

  • Understanding challenges and opportunities in drug development 

    • Patient selection and utilization

    • Development of novel endpoints

    • Monitoring and understanding safety data collection, analysis and interpretation

    • Impact of orphan disease status on planning for efficacy and safety targets and analyses

    • Clinical development for pediatrics indications

  • Considerations and examples in utilizing real world data 

    • The use of RWD in regulatory submissions

    • Challenges and opportunities in utilizing RWD: the use of standards and curation, etc.

  • Regulatory trends and guidances with impact on data collection, analysis and interpretation

    • non-SAS based submission

    • Interactive tools for submission

    • Rolling submissions

    • Expedited approvals

    • RWD/RWE

    • CDISC

    • Software as device/therapy

  • Challenges and opportunities in new digital healthcare solutions

    • Wearables

    • Mobile health

    • Data privacy

    • Data ownership

  • Understanding novel diagnostics, and their impact to clinical trials and clinical practice

    • ctDNA

    • Digital pathology/CT

    • Liquid biopsies

  • COVID 19

    • Missing data and statistical challenges

    • Operational challenges

    • Regulatory challenges

    • Manuscript review

MEETUP ORGANIZERS

 

Ning Leng, Anqi Zhu, Aarthi Balasubramanyam, Jeni Zhou, Qinshu Lian and Yinqi Zhao

Alumni: Julia Varshavsky and Sofia Mosesova