Advances in biomarker testing are revolutionizing strategies for diagnosing and managing neurological disorders and shifting the current treatment paradigm to a more personalized approach. Testing has always played a role in the management of mild cognitive impairment or early-stage Alzheimer’s disease (AD) patients. With the availability of disease-modifying therapies (DMTs), removing barriers to testing now has become an even more critical need to ensure that all eligible patients are tested to identify those that could benefit from therapy. However, the testing paradigm in AD is a complex one – multiple biomarkers and several different modalities including imaging and clinical lab testing exist.
This expert panel will discuss the current AD biomarker testing landscape including opportunities and some key barriers such as test awareness, availability, and reimbursement. The discussion will also highlight ways to address some of these challenges, including building evidence to demonstrate and communicate the value of testing in the management of AD.
Register here for this webinar to learn how to identify and overcome challenges in Alzheimer’s disease biomarker testing.
Pete Riccelli, PhD, Senior Director, Precision Medicine, Commercial Strategy and Market Access, Veranex
Dr. Pete Riccelli has over 25 years of experience in the clinical molecular diagnostics and precision medicine industry. At Veranex, Dr. Riccelli is a senior leader in the precision medicine practice, supporting clients in market access landscapes, commercial launch strategies, portfolio prioritization and opportunity assessments. Dr. Riccelli’s prior precision medicine strategic consulting experience was serving as a Senior Director at Diaceutics where he led and delivered projects providing biomarker testing insights and commercial launch & go-to-market strategies and tactics for Dx/CDx tests to leverage opportunities and mitigate challenges to launch and drive patient testing to enable pharma targeted therapy diagnostic strategy in US and global markets. Other relevant clinical diagnostics experience includes serving roles in R&D, business development, medical affairs and pharma/Dx scientific liaison that includes IVD assay development, biomarker and molecular Dx/CDx technology assessment, CDx partnership alliance management and medical & technical education communication at Nanosphere, Abbott, Ventana, and HTG Diagnostics. Dr. Riccelli has a PhD and MS in Chemistry from the University of Illinois Chicago and a BS in Biochemistry from Michigan State University.
Catheline Plaideau, PhD, Sr. Manager, Precision Medicine, Commercial Strategy and Market Access, Veranex
Dr. Catheline Plaideau is part of the precision medicine practice at Veranex. She has experience working with biopharmaceuticals and diagnostics within biotech, mid-size pharma and big pharma, both in Europe and in the US, where she held different positions across R&D, Clinical Operations, Marketing and Market Access & Pricing. Her experience spans from drug design to market access and commercial strategy and operations across various therapeutical areas. Implementing precision medicine within the Alzheimer’s disease continuum has been an important focus for her over the last few years. Dr. Plaideau completed a PhD in Pharmaceutical and Biomedical Sciences at the Catholic University of Louvain and the de Duve Institute in Belgium. She has also certifications in Health Economics and a double Master’s degree in Bioengineering and Business Management from the Catholic University of Louvain and the Brussels Management School (ICHEC), respectively.
Charles A. Stemple, D.O., M.B.A., Medical Director, Dream Big Health LLC
Dr. Charles Stemple is a medical director with 20 years of managed care experience in clinical, managerial, and administrative areas. His knowledge of genetic testing in clinical policy includes assays, validation, panels, clinical validity and clinical utility, and his expertise includes integration of clinical, pharmaceutical, and operational health plan activities including Medicare claims policy, ICD-10, and regulatory/compliance. As the national medical director for bariatric, and transplant services for commercial and Medicare lines of business, Dr. Stemple currently oversees utilization management for inpatient, outpatient, and physician activities, analysis of cost trend drivers, and implementation of clinical initiatives to address both unit cost and resource utilization. Additionally, Dr. Stemple is a chairman of national medical technology assessment committee, a chairman of medical pipeline committee, and co-chair of the pharmacy and therapeutics committee.
Rahul D. Singal, MD, President, RS Health Innovations LLC
Dr. Rahul Singal has 20+ years of health care experience as a CMO, CEO, scientist, practicing internist and health care information technology entrepreneur. He is currently engaged as an advisor to HCIT companies that are focused on developing and marketing solutions to health plans that drive the Triple Aim of improved health outcomes, lower costs and increased member experience.
Dr. Singal recently led product innovation and clinical oversight as CMO at Avalon Healthcare Solutions, a laboratory benefit manager organization. Prior to Avalon, Dr. Singal held CMO positions at ZeOmega and DST Health. DST Health provided pharmacy, medical claims processing and analytics for over 100 health plan customers covering over 50 million beneficiaries. From 2000 to 2015, Dr. Singal was founder and co-founder in several health care technology companies focused on improving health outcomes for patients, physicians and payers. Two of these companies were recognized by Inc 500 as the fastest growing companies in the U.S. ranking #25 in 2008 and #103 in 2013, respectively.
Dr. Singal is a graduate of Stanford Medical School and completed his residency in Internal Medicine at the Washington University School of Medicine.
James E. Galvin, M.D., M.P.H., Professor of Neurology and Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine
Dr. James Galvin is a Professor of Neurology and Psychiatry & Behavioral Sciences at the University of Miami Miller School of Medicine. He is the Founding Director of the Comprehensive Center for Brain Health, Director and Principal Investigator of the Lewy Body Dementia Research Center of Excellence, and Chief of Cognitive Neurology for Palm Beach and Broward County leading brain health and neurodegenerative disease research and clinical programs. Dr. Galvin has authored over 300 scientific publications and 3 textbooks on healthy brain aging, cognitive health, Alzheimer’s disease, Lewy Body dementia, and related disorders.
Dr. Galvin has received over $100 Million in research funding from the National Institutes of Health, Alzheimer’s Association, Michael J Fox Foundation, American Federation for Aging Research, Lewy Body Dementia Association, Association for Frontotemporal Degeneration, Missouri, New York, and Florida Departments of Health, and numerous Private and Family Foundations.
Who Should Attend?
- Pharma/biopharma (translational medicine, medical affairs and scientific affairs with job titles such as Director of CDx, Diagnostic Strategic Planning, Commercial PM and Dx, CDx/Dx Market Access, Clinical Affairs Directors) with Alzheimer’s disease therapy portfolios
- Dx manufacturers (medical affairs and scientific affairs with job titles such as Director of CDx Development, Marketing and Planning Managers and Directors, Directors of Assay Development, Director of Business Development and Partnerships) with specific assays or applicable technology platforms for testing Alzheimer’s disease patients
- Neurology Healthcare Providers (HCPs) specialized in treating and managing Alzheimer’s disease patients
- Lab Directors
What You Will Learn
- Understand the current landscape for MCI and early AD-related biomarker testing in terms of clinical practice, evidence context, and payer coverage and reimbursement
- Review key barriers to clinical adoption of MCI and early AD-related biomarker testing
- Understand what steps can be taken to overcome these testing barriers and optimize availability and access to testing
Veranex is a global medical device solution provider that brings expertise in design and engineering, human factors, regulatory affairs, quality systems, preclinical studies, clinical trial strategy/execution, data management, commercialization strategy, reimbursement, and market access together with integrated support across your entire product life cycle. By uniting these industry-leading service organizations — IMMR, Experien Group, Ximedica, Worrell, Boston Healthcare Associates, Quartesian, Fusion Biotec, Devicia, and Medidee — Veranex delivers expert guidance that accelerates your speed to market, controls development costs, mitigates development risk, and accelerates market viability assessment. From concept-to-commercialization, Veranex customers realize efficiencies in cost and time through integrated and comprehensive solutions that unify your entire development process.
Veranex Precision Medicine Commercial Strategy Market Access team provides strategic planning and implementation support to pharma/Dx innovators for development and commercial launch of their Dx product (Screening, diagnostic, therapy monitoring, CDx) to ensure optimal biomarker testing for beneficial patient management, and targeted therapy outcomes. Focus areas include (but are not limited to) market assessment, market access, reimbursement, launch readiness, go-to-market, real world data strategy, and Dx Center of Excellence. Our team of SMEs have hands-on experience in development and commercial launch of Dx tests globally.