Optimize Obesity Development: Endpoint Strategies for Early-phase Innovation to Late-phase Differentiation
Join the featured experts in eCOA, cardiac safety and medical imaging to learn how phase-appropriate endpoint solutions that generate high-quality, informative data can support critical decisions. From detecting early safety and efficacy signals informing dose selection, go/no-go and study design decisions, to characterizing treatment benefit and risk building a differentiated, regulator-ready evidence package, implementing the right endpoint strategy and technologies is paramount.
Register to learn how an integrated, phase-appropriate endpoint strategy can help teams identify meaningful signals earlier, reduce development uncertainty and generate stronger evidence for regulatory review and product differentiation.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EDT (NA-East)
- 04:00 p.m. – 05:00 p.m. BST (UK)
- 05:00 p.m. – 06:00 p.m. CEST (EU-Central)
Attendees will learn how to:
- Build a phase-appropriate endpoint strategy that integrates patient-reported outcomes, glucose monitoring technologies (BGM & CGM), cardiac and imaging data to support the critical decisions required across the development cycle
- Connect the subjective patient experience with objective glucose data by studying symptoms, medication timing, fasting status, rescue actions and connected glucose readings. Attendees will also learn how this data can reveal early safety, tolerability and efficacy signals, inform dose selection and study design and strengthen the late-phase treatment-benefit narrative
- Evolve cardiac safety assessments across development, from focused QTc and heart-rate evaluation in early safety trials to consistent, scalable collection of 12-lead ECG and blood-pressure data in later development
- Select the right imaging strategy for Phase II and Phase III trials evaluating obesity, body composition analysis, impact on fatty liver disease and the broader physiological effects of weight-loss therapies
- Generate differentiating evidence beyond the standard body weight and glycemic control measures leveraging innovation modalities such as MRI-PDFF, MR elastography, organ volumetry, visceral and subcutaneous adipose tissue analysis and functional MRI
Moderator
Todd Rudo, M.D.
EVP, Chief Medical Officer at 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.
Speakers
Vic Patel, M.D., Ph.D.
V.P., Chief Medical Officer, Cardiology at Clario
Dr. Vic Patel is board-certified in Cardiology with a PhD in Biophysics and has done extensive research on arrhythmia mechanisms. For 11 years, he served as a Faculty Member at U. Penn. School of Medicine, where he directed the Molecular Arrhythmia Research program and practiced clinical electrophysiology.
Dr. Patel spent the next eight years in drug development and cardiac safety as a Clinical Development Leader and therapy area head across all phases. At Clario, Dr. Patel oversees Cardiology Consulting, ECG/Holter core lab services and leads the Biostatistics and Medical writing groups.
Brian K. Rundle, Ph.D.
Scientific Advisor at Clario
Brian Rundle is a Neuropsychologist and Scientific Advisor within Clario’s eCOA Science & Consulting team, where he helps pharmaceutical and biotechnology sponsors optimize the collection of patient-centered and cognitive outcomes data in clinical trials. His work focuses on the design and implementation of research technology that balances regulatory compliance, scientific rigor and intuitive user experiences to maximize data quality and participant engagement.
With expertise spanning neuroscience, cognitive assessment, metabolic disorders and connected devices, Brian works closely with sponsors to develop fit-for-purpose solutions for complex clinical research programs. Leveraging a unique blend of scientific, technical and project management experience, he provides strategic guidance on study design, endpoint selection and clinical trial technologies that support successful drug development.
Mark W. Tengowski, D.V.M., M.S., Ph.D.
Director, Medical & Scientific Affairs, Medical Imaging at Clario
Dr. Mark W. Tengowski’s current responsibilities include Clinical Development and Trial Experiences in SLD/MASH (formerly NAFLD/NASH) and biliary cholangitis; Crohn’s disease, perianal fistula, ulcerative colitis; osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, spondyloarthritis, psoriatic arthritis and bone age; and women’s health including endometriosis, uterine fibroids, endometrial thickness and breast volume and density using various MRI, XR and CT imaging and clinical response assessments.
Dr. Tengowski began his industry career with Pfizer (1999-2007) working in Drug Safety Evaluation (Groton) and Global Clinical Technologies (Ann Arbor). In 2007, he began his imaging core lab service starting at VirtualScopics (2007-2013) and Clario (formerly Bioclinica/ERT, 2016 to present).
Dr. Tengowski is a 1992 graduate of the University of Wisconsin School of Veterinary Medicine with graduate training in Pharmacology (MS, 1994) and Endocrinology & Reproductive Physiology (PhD, 1997), both from the UW-Madison Graduate School. Dr. Tengowski holds veterinary medical licenses in WI and NY and is USDA-accredited (Category II). He is a member of the AASLD.