Substantial changes are emerging in traditional clinical research catalyzed by the COVID-19 pandemic, driving the increased implementation of patient-centric approaches like decentralized clinical trials (DCTs) to test and deploy new medicines to the market. How can these developments advance pediatric clinical research?
PRA’s Center for Pediatric Clinical Development would like to invite you to register for this webinar to hear experts address some of the challenges that exist in pediatric clinical research and how they may be overcome by implementing decentralized clinical trials. Following an overview of regulatory, operational, scientific, medical, digital health technology and legal aspects for pediatric DCTs in diverse therapeutic areas and medical devices, the panelists will cover important considerations for sponsors. They will discuss how to ensure proper preparedness for pediatric DCTs and the impact of DCTs on sites. Pediatric trials engage and involve the entire family. Participants will hear a presentation of a parent/family perspective on participation in a pediatric DCT.
Dr. Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc, Sr. Vice President, Scientific & Clinical Affairs, Global Center of Excellence Strategy for DCTs, PRA Health Sciences, Raleigh, NC, USA
Dr. Isaac R. Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. He is a Senior Vice President for Scientific & Clinical Affairs, leading the Strategy of the Global Center of Excellence for Decentralized Clinical Trials, PRA Health Sciences. Past positions in the last 32 years include: FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Decentralized Clinical Trials enabled by Digital Health Technologies; CEO/Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs, NIH; Senior Clinical Scientist, Schering Plough Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research; and a B.S. in Biology.
Shelly Barnes, Global Clinical Innovations Lead; UCB Biosciences, Raleigh, NC, USA
Accelerating innovative strategies leading UCB into the era of Decentralized Clinical Trials and solutions driving the improvement of the patient experience within the conduct of our clinical trials. Delivering solutions using novel technologies, transforming from traditional clinical trials to patient preferred clinical trials while maintaining quality, compliance and stakeholder commitments. Actively represents UCB on several industry consortiums including DTRA, CTTI, TransCelerate and IMI.
Terry Jo V. Bichell, PhD, MPH, Founder/Director, COMBINEDBrain Consortium for Outcome Measures and Biomarkers for Neurodevelopmental Disorders Brentwood, TN, USA
Terry Jo Vetters Bichell worked primarily as a public health nurse-midwife until her youngest child, Lou, was diagnosed with Angelman syndrome in 2000. She quickly switched focus to move bench research into the first clinical trials for Angelman syndrome and design natural history studies. Dr. Bichell earned a PhD in neuroscience from Vanderbilt University in 2016, studying gene-environment interactions in Huntington’s disease rodent models. She was the founding director of the A-BOM Alliance from 2016-2018. In 2019, Dr. Bichell launched COMBINEDBrain, a pre-competitive consortium of patient advocacy organizations, working to identify outcome measures and biomarkers for rare genetic neurodevelopmental disorders. She is the Vice Chair of the Tennessee Rare Disease Advisory Council and leads a course in Translational Neuroscience at Vanderbilt University. As a parent, Terry Jo has been with her son Lou many times, as he has participated in clinical trials in the search for a treatment for Angelman syndrome.
Christoph P. Hornik, MD, PhD, MPH, Associate Professor of Pediatrics with Tenure, Duke University and Duke Clinical Research Institute (DCRI), Durham, NC, USA
Dr. Hornik dedicates his professional life to the development of safe and effective therapeutics for children, including those with critical illness and congenital cardiac disease. He led and continues to lead innovative clinical trials and real-world-evidence research projects including traditional multicenter trials, prospective registries, electronic health record integration efforts, and novel direct-to-family trials in children. Dr. Hornik is Chief of the Division of Quantitative Sciences and Director of the DCRI Pharmacometrics Center and Small Trials Program. His scholarly accomplishments include >180 peer reviewed publications.
Who Should Attend?
- Research and Development
- Clinical Research
- Medical Affairs
- Scientific Affairs
- Regulatory Affairs
- Clinical Affairs
- Project Management
- Clinical Operations
- Risk Management
- Health Care Professionals
- Patient Advocacy Groups and Their Members
- Anyone Interested in Pediatric Research
What You Will Learn
In this webinar, participants will learn about:
- Challenges in pediatric clinical research overcome by implementation of DCTs
- Regulatory, operational, scientific, medical, digital health technology and legal aspects for pediatric DCTs
- How sponsors can plan and prepare for a pediatric DCT
- The importance of the sites in preparing and conducting pediatric DCTs
- Important considerations for parent/patient for pediatric trials and how DCTs can be beneficial
PRA Health Sciences
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.
With 19,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.
At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.