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Tuesday, June 18 • 10:00am - 11:00am
#222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-573-L04-P; CME 1.00; RN 1.00

The speakers will discuss how to enable external control arms (ECAs) at scale. The session will shed light on how to overcome the scalability and quality challenges of real-world data preparation to scale up ECAs from ad hoc projects to enterprise-level machinery for pharmaceutical clinical development function. It will also include ongoing work to create enterprise infrastructure for high-quality evidence generation using ECAs, including selected results from multicenter ECAs in several therapeutic areas.

Learning Objectives

Explore strategies to address the inherent challenges of real-world data (RWD) preparation at scale for external control arms (ECAs), including data scalability and quality; Describe how to transition from ad hoc ECA projects to an enterprise-level approach that ensures data quality, processing efficiency, and trustworthiness in analytical results for pharma clinical development.

Chair

Mayur Saxena, PhD

Speaker

Industry Update
Jussi Leinonen

Industry Update
Victoria Chia, PhD, MPH

Industry Update
Hongwei Wang

Industry Update
Jingyu (Julia) Luan, PhD


Speakers
avatar for Mayur Saxena

Mayur Saxena

Chief Executive Officer, Droice Labs, United States
As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and... Read More →
avatar for Victoria Chia

Victoria Chia

Executive Director, Center for Observational Research, Amgen Inc, United States
Victoria Chia has 15+ years of experience at Amgen Inc as a pharmacoepidemiologist. She currently leads the oncology therapeutic area in the Center for Observational Research. She has worked on oncology and neurology products, supporting multiple products through the product lifecycle... Read More →
JL

Jussi Leinonen

Strategic Project Lead, Bayer , Finland
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →
avatar for Hongwei Wang

Hongwei Wang

Director/ Senior Research Fellow, AbbVie, United States

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Forum