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Biopharma companies are increasingly adopting RWE to drive efficiencies in drug research and development. From informing early stage planning to supporting label expansions, RWE research methods are enabling R&D teams to make more informed decisions, faster.

In this webinar, hear from global biopharma leaders and Aetion about how and where RWE can enable more agile research approaches to accelerate drug development.

You will also hear about:

    Updates on the state of RWE in 2021, including trends in regulatory approvals and anticipated guidances this year

    Examples of how biopharma can use RWE to inform trial feasibility and design, to test lab-developed hypotheses, and to support label expansion
    How global biopharma companies are integrating RWE across their R&D teams, with insight into trends and best practices for operationalizing adoption


Speakers:

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Nicolle Gatto, Ph.D., M.P.H.

Senior Vice President, Scientific Research

Aetion


Nicolle is an epidemiologist with 20 years of industry experience, and she is the Senior Vice President of Scientific Research at Aetion. She serves as a senior scientific voice ensuring appropriate and principled use of real-world data/evidence, designing and communicating scientific frameworks, standards and methodologies, and collaborating with stakeholders globally. Prior to Aetion, Nicolle was the Group Head for Vaccines and Oncology with the Epidemiology Group at Pfizer, providing strategic leadership, oversight of comprehensive epidemiology strategies to examine the safety of medicines, consultation on design of pragmatic trials and hybrid studies, and expertise on methods-related epidemiologic issues. She has designed and implemented primary and secondary data collection observational studies and pragmatic trials, and has presented to and negotiated these studies with FDA and EMA. Nicolle is Fellow of the International Society for Pharmacoepidemiology and an Adjunct Assistant Professor of Epidemiology at Columbia University and Tulane, teaching courses in pharmacoepidemiology, causal inference and confounding control methods.

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Julie Schiffman

Senior Vice President of Scientific Engagement and Delivery

Aetion


Julie is the Senior Vice President of Scientific Engagement and Delivery at Aetion. Previously, she spent 17 years at Pfizer working on both the commercial and R&D sides of the business to improve overall R&D productivity and get treatments to patients faster, and at a lower cost. Most recently, Julie was the Vice President, Global Business Analytics, where she led a 350-person data and analytics team as they ran analyses to drive Pfizer’s business and portfolio forward. Prior to Pfizer, Julie spent time consulting at Deloitte. She received her B.A. from Brown University, and her M.B.A. from the Wharton School.

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Bob LoCasale, Ph.D.

Head of RWE

Sanofi


Dr. Robert J. LoCasale Jr. is the Head of Real-World Evidence within Sanofi’s Digital Office. In his role, Bob leads a team of real-world investigators, biostatisticians, and literature synthesis experts responsible for the design and execution of RWE studies, post-hoc analysis of RCTs, and quantitative analysis of the scientific literature. Bob is an epidemiologist by training with a Ph.D. in Pharmacoepidemiology and a M.S. in Epidemiology and Preventive Medicine from the University of Maryland, Baltimore. He has worked in various scientific and managerial roles building and delivering RWE in the pharmaceutical industry for 15+ years. Bob is also a certified coach, has a green belt in Lean Six Sigma, is a Philadelphia sports enthusiast, and is a father of two boys (8 and 4).

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Najat Khan, Ph.D.

Chief Data Science Officer

Janssen R&D


As the Chief Data Science Officer, Najat is responsible for the overall Data Science strategy and vision for Janssen R&D, and for ensuring a seamless integration of Science and Data Science as Janssen R&D executes on high value programs for its pipeline. She is continually advancing critical Data Science foundations, including creating a best-in-class R&D data science organization by selecting the highest priority questions to pursue across Discovery and Development, fueled by data and platforms that allow the execution and deployment at scale. She has also built a strong and growing team of bilingual Data Science talent, fluent in both Data Science and Science, while also being a key catalyst in strategically curating external partnerships to accelerate ongoing efforts and to expand access to relevant real-world data. Najat is also the Co-chair of the Johnson & Johnson Data Science Council that drives adoption of Data Science across the three three sectors (Pharma, Medical Devices, and Consumer) and Global Corporate Functions across the company.


Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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