Unlocking Potential and Navigating Limitations of Using Real-World Evidence in Safety

The utilization of real-world evidence (RWE) for safety assessment has become an integral component of healthcare decision-making. How have regulatory agencies evolved to incorporate RWE into safety evaluations and to leverage RWE for post-market surveillance, signal detection, and decision-making in regulatory processes? How can technology enable healthcare stakeholders to harness the full potential of RWE in real-time safety monitoring?

Register Free: https://www.pharmexec.com/pe/navigating-limitations

Event Overview:

Clinical trial protocols often focus on the clinical objectives of the trial without considering the implications of the design on the patients participating in the trial from a practical and emotional impact perspective, as well as outcomes and endpoints that matter most to patients. This can contribute to lower trial participation, increased drop-out rates, and reduced operational efficiency.
Could incorporating the patient voice in clinical trial design and execution address these issues?

In this webcast, experts discuss the challenge and importance of including patients as partners in research and the potential for more consistency in patient inclusion, including research methods and approaches designed to ensure patients have authentically shaped trial designs.

Key Learning Objectives:

• Understand the impact of trial design on participants and why a patient-centric approach can lead to more successful clinical trials.
• Learn about structured approaches to incorporating patient voices to optimize clinical trial design.
• Learn about a patient engagement use case that resulted in a health authority positive decision.

Who Should Attend:

This webinar is applicable to:

• Clinical researchers, clinical decision teams, and patient engagement leads responsible for:
  • Clinical development planning and study design
  • Management of patients and measurement of clinical outcomes
  • Clinical data management, collecting and evaluating trial metrics
  • Project management of studies, process optimization, and operational excellence

Speakers:

FABIAN SANDOVAL
President & CEO
Emerson Clinical

Dr Fabian Sandoval, president & CEO of Emerson Clinical Research Institute, has over 25 years of bench-to-bedside research experience. His diversified research career has been in academia, healthcare systems, and the public sector. He received his Bachelor of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine.
Before opening the doors to Emerson Clinical Research Institute (ECRI), Dr Sandoval’s research activities included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS), where he focused his work on early onset Alzheimer’s disease and Creutzfeldt-Jakob disease. He previously conducted research in the outpatient Oncology unit at the NIH Clinical Center and successfully supported an NIH RO1 grant for the prevention of epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center and Children’s National Medical Center.
He has since started the Emerson Community Clinic to support un-insured patients across the Washington DC metro area and the Emerson Diversity Health Foundation, whose mission is to educate patients and providers on the importance of participating in clinical research and access to care.


EMUELLA FLOOD
Director, Patient Reported Outcomes
AstraZeneca

Emuella Flood is Director of Patient Centered Science at AstraZeneca in Immunology. In this role, she designs and implements patient-centered evidence generation strategies for Immunology drug development to ensure that evidence important to patients is captured and can inform regulatory, payer, HCP, and patient decision-making.


SCOTT SCHLIEBNER
Principal
Rare Clinical, LLC

Scott Schliebner a strategic, innovative, and commercially-oriented life sciences executive with 30 years’ experience across the biopharma, CRO, MedTech, and non-profit sectors. With a strategic and consultative approach to building and growing life science businesses, Scott has developed relationships, partnerships, and collaborations that have driven commercial success. Scott’s thought leadership efforts include leveraging RWE/RWD, technological innovation, and patient-focused paradigms to accelerate clinical drug development. Active as a commercial officer, strategic advisor, board member, and mentor, he is passionate about infusing data and innovation into life sciences organizations.


CARLA RODRIGUEZ-WATSON, PhD, MPH
Director of Research
Reagan-Udall Foundation for the Food and Drug Administration (FDA)

Dr Carla Rodriguez-Watson is the director of research for the Reagan-Udall Foundation for the FDA. She is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies. Projects include those focused on developing and advancing frameworks and tools to systematically describe data sources and methods for use in pre- and post-market studies of product safety and effectiveness, as well as the Innovation in Medical Evidence, Development and Surveillance (IMEDS) Program, where such tools can be leveraged. IMEDS leverages a distributed network and tools developed by the FDA’s Sentinel initiative to design and execute post-market drug safety studies in a network of 9 healthcare systems representing over 111 million persons. Carla brings her extensive background in public health surveillance and health outcomes research to this work.
She earned her PhD in epidemiology from the University of Washington School of Public Health (dissertation: Accuracy of emergency department chief-complaint to identify pediatric influenza from Emergency Department Visits), her MPH from Columbia University Mailman School of Public Health, and her BA from Rutgers University.


REBECCA NASH
Principal, Real-World Evidence
Oracle

Rebecca has worked for over 25 years in research consultancy and evidence-based strategy. At Oracle Life Sciences she leads a team of RWE qualitative and quantitative research professionals. Prior to joining Oracle, Rebecca worked as the head of evidence at Macmillan Cancer Support, UK, where her team funded academic health outcomes studies, partnered with cancer registries across the UK, and led cancer patient experience research programs. She is trained in cultural anthropology.


KATHY BEUSTERIEN
Senior Research Scientist
Oracle

Kathy has over 25 years of experience performing health outcomes research. She has consulted on several communications with the FDA and EMA regarding patient-reported outcomes (PRO) endpoints in clinical trials and developed PRO measures and dossiers for regulatory review. Kathy regularly leads workshops and presentations at scientific and industry conferences on these areas. She is a founding member of the International Academy of Health Preference Research (IAHPR).

Register Free: https://www.pharmexec.com/pe/navigating-limitations