A Holistic Approach to Parkinson’s Disease Endpoint Data Collection: Efficacy, Safety and Quality of Life

Life Sciences, Clinical Trials, Medical Device, Drug Safety, Biomarkers, Digital Health,
  • Thursday, May 16, 2024 | 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
  • 60 min

In this webinar, the expert speakers will comprehensively explore Parkinson’s disease endpoint data collection, where they will delve into the crucial elements of efficacy, safety and quality of life. The webinar will highlight the revolutionary Opal wearable solution and its important role in providing quantitative gait assessments, thus offering a better understanding of disease progression.

The speakers will present compelling evidence underscoring the heightened sensitivity of digital measures in monitoring Parkinson’s disease progression compared to conventional clinical scales. Furthermore, they will dissect the efficacy and quality of life evaluations by leveraging clinical rating scales, patient-reported outcomes and the distinctive utility of the on/off dyskinesia diary.

They will also review the significance of imaging features in accurately characterizing Parkinson’s disease biologically, paving the way for biomarker-guided drug development. Neuroimaging reveals striatal dopaminergic neuronal loss and the structure, function and integrity of motor circuitry throughout the brain. These circuits represent crucial targets for assessing patient eligibility, safety and therapeutic efficacy in the development of disease-modifying therapies.

Delving into safety considerations, the speakers will explore the impact of autonomic dysfunction associated with Parkinson’s disease, and the role for high-quality blood pressure data and heart rate variability analysis to characterize this. In addition, they will review QT interval monitoring strategies and some practical insights into implementing cardiac safety monitoring in this unique population.

Register to attend this webinar to learn about the complexities of Parkinson’s disease endpoint data collection and obtain invaluable insights for improving patient outcomes and advancing therapeutic interventions.

Speakers

Todd Rudo, Clario

(Moderator) Todd Rudo, MD, Chief Medical Officer, Clario

Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high-quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.

Message Presenter
Dr. Vrutangkumar V. Shah, PhD, Clario

Dr. Vrutangkumar V. Shah, PhD, Director, Data Science & Biostatistics, Precision Motion, Clario

Dr. Vrutangkumar V. Shah is a scientist with over 13 years of experience in clinical research. He is currently working as a Director, Data Science and Biostatistics at Clario, a global data and technology company that helps with decentralized clinical trials. He consults with sponsors and CROs in developing the Statistical Analysis Plan (SAP) package for Phase I-IV clinical studies. His expertise includes but is not limited to data analytics, biostatistics, machine learning and time-series analysis to develop digital biomarkers for clinical trials.

Message Presenter
Laura Khurana, Clario

Laura Khurana, MPH, Principal Scientific Advisor, Clario

Laura Khurana is an experienced public health and clinical research professional with a special interest in electronic clinical outcome assessments (eCOAs) for clinical trials. Laura has 17 years of experience in the clinical research industry, initially working in web-based data collection for patient registries and post-approval safety studies. Laura has been at Clario for 10 years, and in her current role as Principal Scientific Advisor she is responsible for leading the scientific direction for eCOA services, including directing data collection design strategy based on best practices, knowledge of the literature, patient and site preferences and applicable regulations. She has experience supporting trials across a wide range of clinical indications, including multiple sclerosis, headache and migraine, dermatology and diabetes. Laura earned her MPH from Boston University School of Public Health, and her BA from the University of Georgia.

Message Presenter
Dave Scott, Clario

Dave Scott, PhD, Vice President, Medical & Scientific Affairs, Neuroscience, Clario

Dr. David Scott, PhD, is Vice President, Medical and Scientific Affairs at Clario. His aim is to facilitate drug development through standardized measurement of the neural correlates of neurodegenerative and other centrally mediated diseases. As a student at Johns Hopkins University and the University of Michigan, he employed multi-modal imaging approaches, including dynamic PET and functional MRI to study the neurobiology of placebo analgesia. At Omneuron, he developed real-time fMRI applications aimed at treating chronic pain, depression and addiction. Since joining Clario in 2012, David’s focus has been to enable MRI and molecular imaging solutions toward safety, eligibility and therapeutic efficacy endpoints. He works with radiologists, physicists, software engineers and operational specialists on the design, execution, analysis and interpretation of neuroscience clinical trial imaging data. His motivation is to enable neuroimaging to accelerate the delivery of therapeutic benefits to patients around the world.

Message Presenter
Jeff Heilbraun, Clario

Jeff Heilbraun, MS, Vice President, Medical Affairs, Cardiac Safety, Clario

Jeff Heilbraun is the Vice President of Medical and Scientific Affairs, Cardiac Safety at Clario. He completed his Bachelor of Science degree in Biology at Tufts University with a focus on physiology and his Master of Science in Health Promotion and Disease Management studies at the American University in Washington DC where he continued as an adjunct professor in the Health Promotion program. Throughout his career, Jeff has maintained his focus on the science, technology, trial design and regulatory considerations surrounding cardiac safety within pharmaceutical development. With his 30 years of experience with the Clario cardiac safety services team, Jeff has had the opportunity to support solutions for both safety and efficacy endpoints across a wide range of therapeutic indications. He has been fortunate to support both internal white papers and publications from a scientific and regulatory perspective in the area of blood pressure monitoring and endpoints.

Message Presenter

Who Should Attend?

This webinar will appeal to

  • CEOs
  • Chief Medical Officers
  • Chief Scientific Officers
  • Clinical Data Managers
  • Clinical IT
  • Clinical Monitoring
  • Clinical Operations (early phase)
  • Clinical Operations, Clinical Development, Clinical Research
  • Clinical Pharmacologists
  • Clinical Scientists
  • Data Science
  • Digital Health/Innovation/Operations
  • Health Economics and Outcomes Research
  • Imaging Scientists
  • Medical Affairs
  • Medical Monitor / Head of Development for Program
  • Protocol Managers
  • Regulatory Affairs
  • Sr. Managers, Trial Initiation
  • TA Experts (oncology)

What You Will Learn

Attendees will learn about:

  • Quantitative gait assessments for precision motion and evidence of digital measurement sensitivity for tracking progression in PD rather than the clinical scale
  • Efficacy and QOL assessments for eCOA including clinical rating scales, patient reported-outcomes and the unique role of the on/off dyskinesia diary
  • Imaging features that are essential for the accurate biological characterization of PD and enable biomarker-guided drug development
  • Using BP and HR variability to assess efficacy in PD and safety considerations, including QT risks and BP; insight into the impact of autonomic dysfunction associated with PD related to blood pressure and cardiac rhythm endpoints and approaches to implementing BP and ECG monitoring within a PD-focused clinical trial

Xtalks Partner

Clario

Clario is a leading healthcare research and technology company that generates the highest quality clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Clario’s science, technology, and operational experts have helped deliver over 26,000 trials and contributed to over 800 regulatory approvals in more than 100 countries. For more than 50 years, we have provided deep scientific expertise and the broadest endpoint technologies to help transform lives around the world.

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