Creating the Future in Clinical Research with CROs Using Real-World Data
Advances in data management technology and analytics have raised the expectation of sponsors to work with CRO partners who can help them maximize the value derived from RWD.
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Real-world data (RWD) plays an increasingly important role in clinical research and healthcare decision making. By using more readily available data from a wider population, clinical researchers can potentially deepen their understanding of disease behavior within the body, and treatment responses from different patient populations. Optimization of this data will enable researchers to design and conduct clinical trials more efficiently, both from a cost and timeline perspective.
However, accessing and analyzing large amounts of data can be unwieldy and resource intensive. Advances in data management technology and analytics have raised the expectation of sponsors to work with CRO partners who can help them maximize the value derived from RWD.
Key Learning Objectives:
- How CROs are leveraging technology to maximize the value derived from RWD
- What issues need to be considered to produce robust and meaningful data
- How CROs are using technology to gain deeper insights from the RWD
- Some of the challenges CROs have encountered with the abundance of RWD
- What the industry and regulators can do to support greater usage of RWD
Who Should Attend:
Sponsor and CRO roles who are responsible for:
- Clinical development planning
- Study designs
- Country and site identification, feasibility assessment, selection, and activation
- Clinical data management, collecting and evaluating trial metrics
- Project management of studies, process optimization, and operational excellence
VP Information Technology
Raghu Chintala has over 40 years of experience in a variety of industries including healthcare, financial services, and enterprise software. He has been in ICON PLC for the past 12 years and heads up the specialty functions including Labs, medical safety, and imaging. Prior to taking a role in the IT group in ICON, Raghu headed up project management in the clinical research services group of ICON. Raghu has also worked in other healthcare services organizations as a CIO and a COO.
With over 10 years’ experience across business development, marketing and clinical development, Chems generates a high-performance culture that attracts top talent and partners. As a growth-oriented strategist, Chems can effectively manage and lead cross-cultural and cross-functional teams in complex situations that engage internal and external stakeholders in times of change and challenging environments. His additional core specialties include RWE clinical trials, market access and medical writing.
Executive VP, Clinical Development Services
Scott is a clinical strategist with nearly 30 years of clinical drug development experienced focused on rare diseases, orphan drugs, and advanced therapeutics. Scott’s focus is on patient-centered approaches to drug development; reducing the burden of clinical trial participation; and leveraging novel and disruptive technologies to bring new therapies to patients faster. Committed to collaborative efforts to further drug development, Scott has developed active partnerships with rare disease patient-focused organizations, patient advocacy groups, drug development institutes, and academic research centers. Scott serves on Board of Uplifting Athletes and Angel Aid, and also regularly speaks on novel strategies to accelerate rare disease drug development. Scott holds a master’s degree in Public Health (MPH) from the University of Utah School of Medicine and completed a Graduate Research Fellowship at The National Institutes of Health.
Director of Research
Reagan-Udall Foundation for the FDA
Carla Rodriguez-Watson, PhD, MPH is the Director of Research for the Reagan-Udall Foundation for the FDA, Carla 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 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 M 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.
Chief Strategy Officer, Head of Real-World Evidence & Safety Data Analytics
ZEG – Zentrum für Epidemiologie und Gesundheitsforschung Berlin GmbH
Marc has more than 20 years of experience in the pharmaceutical and CRO business, serving as Director of Real-World Evidence, and global consulting at Kantar Health, as Director at Kendle, now Syneos Health, and working on Diagnostic Imaging and Medical Device studies at Amersham Health and GE Healthcare.
As Chief Strategy Officer, he is establishing a strong secondary data stream to complement and combine with ZEG Berlin’s long-established primary data business. Real-World Evidence and services bridge the growing need for leading-edge secondary data collection with ZEG Berlin’s classical studies for post-authorization, safety, and effectiveness.
Before moving to clinical research, Marc worked with Aventis Pharmaceutical’s global research center focusing on functional genomics and proteomics.
Marc Pignot holds a PhD in Bio-Organic Chemistry from the Max Planck Institute of Molecular Physiology and completed postdoctoral training in nucleic acid chemistry at the University of Frankfurt/Scripps Research Institute (La Jolla).
VP and Head PPAS & RWE Specialized Solutions
Mariah Baltezegar is a member of Peri- and Post-Approval Studies (PPAS) executive team and is responsible for the performance, growth and development of consumer health and specialized real-world evidence (RWE) study solutions. In her current role, she has developed innovative solutions for hundreds of consumer health and RWE studies including strategies like digital enablement, decentralized studies (DCT), central principal investigator models and other approaches that aim to reduce patient and caregiver burden. Over the last 20 years, she has held various positions of increasing responsibility across the PPD enterprise all with a strategic eye for efficiency through process or technology, maximizing the study participant and site experience while ensuring high quality customer results. Mariah completed her Master of Business Administration at the University of North Carolina, Wilmington and holds a bachelor’s degree in psychology with a minor in statistics from Winona State University.
Global VP, Product Strategy, Experience, and Enablement
Ryan Kennedy is the Global VP of Product Strategy, Experience, and Enablement for Oracle Health and AI. Ryan has 22 years of clinical research experience ranging from direct site and patient management at University of Pittsburgh’s Cancer Center to eCOA and eClinical technology development. He has a bachelor’s in philosophy and Neuroscience from Allegheny College and an MBA from the Katz School of Business, University of Pittsburgh.
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