Revolutionizing Clinical Trials: The Impact of Technology and Innovation on Regulatory Landscape

Discover an informative webinar delving into the transformative impact of technology and innovation in clinical trials and the related regulatory challenges and adaptations. The landscape of clinical trials is undergoing a significant transformation, driven by advancements in technology and innovation. This webinar aims to explore the profound impact of these developments on the regulatory framework governing clinical trials. In recent years, technology has revolutionized various aspects of clinical trials, including patient recruitment, data collection, monitoring and analysis. The integration of electronic health records, wearable devices and mobile applications has streamlined the recruitment process, enabling researchers to reach a larger and more diverse pool of participants. Moreover, these technological advancements have facilitated real-time data collection, enhancing the accuracy and efficiency of clinical trial outcomes.

The emergence of innovative methodologies, such as adaptive trial designs and virtual trials, has also challenged traditional regulatory approaches.

This webinar will:

• Delve into the regulatory implications of these technological and innovative advancements
• Explore how regulatory bodies are adapting to these changes, ensuring patient safety and data integrity while ethical considerations are upheld
• Uncover challenges faced by regulators in keeping pace with rapidly evolving technologies while maintaining robust oversight and compliance.

Join this webinar to gain valuable insights from industry experts and regulatory authorities and discover strategies to navigate the evolving regulatory environment successfully.

Speakers

Trang Gisler, Senior Director, Strategy, Government and Public Health Services, PPD clinical research business, Thermo Fisher Scientific

Trang Gisler has over 20 years of scientific/technical, IT and business management experience in both the public and private sectors with a key emphasis on digital health, clinical trials, vaccine and program management.

Prior to joining the PPD clinical research business, Trang was the Chief Digital Officer at My Own Med, Inc., a digital health company that works to support community-based clinical research to diverse under-served and under-presented communities using patient-centric digital solutions focusing on patient-reported outcome instrument development and validation.

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Previously, Trang worked at The Food and Drug Administration (FDA) as the Director of Program Management and Operation in the Office of the Commissioner/Office of Chief Scientist focusing on the advancing regulatory science initiatives as well as the critical path programs. Prior to The FDA, she worked at the department of health and human services (BARDA) and the Department of Defense (DoD) as the Project Officer managing multimillion-dollar vaccine programs.

Preceding this, she served as Associate Director for the Tolerance Assay Group at the Immune Tolerance Network (ITN), a non-profit consortium of researchers seeking new treatments for diseases of the immune system. At ITN, she managed the operations of over 20 centralized laboratory facilities and the execution of biomarker discovery studies for over 25 Phase II clinical trials.

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Carlos Peña, PhD, MS, Chief Regulatory Officer and Chief Quality Officer, Jacobs Institute

Carlos Peña, PhD, MS, is Chief Regulatory Officer and Chief Quality Officer, leading the newly established Offices of Regulatory Services and Office of Quality Services at the Jacobs Institute (JI). Carlos served 20+ years as a public servant in the federal government. Prior to the JI, Carlos served as the Director of the Office of Neurological and Physical Medicine Devices, at the Center for Devices and Radiological Health (CDRH), at the US Food and Drug Administration (FDA).

He was responsible for providing leadership in the development of safe and effective neurological and physical medicine devices to support The FDA’s mission. Carlos provided oversight over several cross-functional teams and was the lead contact for the agency’s strategic plans and implementation efforts for neuro devices.

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Before his FDA Director role, Carlos served as Assistant Director of Emerging Technologies in the White House Office of Science & Technology Policy (OSTP) in the Executive Office of President Obama for two years (2012-2014). Prior to the White House, Carlos began his career ascension at The FDA, starting as a Lead Reviewer, Team Leader and Acting Branch Chief for CDRH, before moving into the role of Science Policy Analyst and, finally, the Director of Emerging Technology Programs in The FDA Commissioner’s Office.

Carlos holds a PhD in Neuroscience from Case Western Reserve University and a master’s degree in comparative physiology from the University of Connecticut. He holds an Emergency Medical Technician license in West Virginia and currently volunteers as a firefighter and for Emergency Medical Services in both New York and West Virginia.

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