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Thursday, June 20 • 8:00am - 9:00am
#406: More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-682-L04-P; CME 1.00; RN 1.00

Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?

Learning Objectives

Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.

Chair

Nancy A Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Christina Mack, PhD, MPH

Panelist
Paul Strijbos, PhD

Panelist
Jeffrey Nahum Siegel, DrMed, MD

Panelist
Martha Azer, PharmD, RPh


Speakers
avatar for Nancy Dreyer

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States
Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing... Read More →
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
avatar for Paul Strijbos

Paul Strijbos

Senior Principal Neurotech Innovation Leader, F. Hoffmann-La Roche Ltd, Switzerland
Paul is a PhD neuroscientist with over 25 years of clinical development experience across the product lifecycle. He works as Neurotechnology Innovation Leader in the late stage Neuroscience organization of F. Hoffmann-La Roche in Basel and focusses on the development, validation and... Read More →
avatar for Martha Azer

Martha Azer

Associate Director, Global Regulatory Policy & Intelligence, Johnson & Johnson, United States
Martha Azer is an Associate Director of Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the US policy work on Digital Health and Artificial Intelligence & Machine Learning as well as Precision Medicine to help shape the regulatory policy landscape to provide... Read More →
avatar for Jeffrey Siegel

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States
Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum