Getting real with real-world evidence: A discussion on building successful programs

The signing of the Cures Act in 2016 marked a major milestone in signaling regulatory acceptance of real-world evidence (RWE). As recently as November 2021, the FDA issued additional guidance on the adoption of RWE further strengthening their support. As a result, the BioPharma industry has invested heavily in RWE programs and early adopters have seen promise in areas such as label expansion, safety studies, and clinical trial design. However, most organizations still wrestle with challenges like: 

  • How do we integrate large volumes of real-world data, including unstructured and semi-structured, and make it available to the teams that need it the most?
  • How do we ensure reproducibility in RWE studies?
  • How do we scale analytics across teams in an open and secure way?

Join this webinar to hear from regulatory affairs professionals, pharmaceutical company executives and leaders in data and AI as they discuss the challenges and opportunities for RWE across the drug lifecycle and lessons learned building successful RWE analytics programs.

Featured Speaker

Harini Gopalakrishnan
Executive Director
Syneos Health

Harini is an executive director at Syneos Health with the Real World/Medical Affairs technology group. Previously, she led Real World Evidence and Insights - Technology Product at Sanofi and oversaw the implementation of Sanofi’s RWE Strategy into an end to end big data analytics platform on the cloud. She has a diverse experience that combines research informatics, Real world evidence analytics and big data technologies and has worked across several life science customers in her past life. She has a Master’s in Bioinformatics and an engineering in Computer Science. She is passionate about driving innovation and accelerating tech adoption for different problems in the life sciences and health care space

Susan Eaton
Director, Observational Data Sciences


Susan Eaton is an epidemiologist and data scientist with over 20 years of experience working in CRO’s, government, and pharmaceutical/biotech industry settings. She is experienced in the preparation, design, and analysis of real world data, including insurance claims, electronic health records, registries, phenotype data associated with Biobanks, etc. to rapidly answer a range of key research questions and to meet regulatory requirements. Most recently, she has grown the portfolio of RWD assets from a single claims data source to a variety of claims, EHR, and registry data; creating a team central to the ingestion and analyses of many kinds of data; building partnerships across organizations, and designing and implementing a high speed, integrated analytics platforms in a cloud environment, all providing significant return on the initial investment.

Michael Sanky
Global Healthcare and Life Sciences Leader

Mike is the Global Industry Lead for Healthcare & Life Sciences at Databricks, where he focuses on translating the immense potential of data & AI to specific use cases and applications in the healthcare industry.

Mike joined Databricks from Optum, where he was the General Manager of the Real World Data & Analytics business, which included responsibility for building and licensing Optum's commercial data products. Mike's team served a wide range of healthcare companies including nearly all of top 40 pharma, other UnitedHealth Group business units, and the US government. Prior to Optum, Mike worked in consulting, specializing in data-driven analytics in the healthcare industry. Mike has deep experience with claims and clinical data, patient-level analytics, and, most importantly, how these assets and capabilities translate to value in the healthcare ecosystem.

Date:  Thursday, January 27, 2022
Time:  12 pm ET / 9am PT
Duration:  1 Hour

Register now for this webinar

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