Increasing aging populations have contributed to a rise in diagnosis of diseases of the central nervous system (CNS), such as Alzheimer’s and Parkinson’s Disease.
Increasing aging populations have contributed to a rise in diagnosis of diseases of the central nervous system (CNS), such as Alzheimer ’s and Parkinson’s Disease. In fact, the WHO estimates that dementia alone affects 5-8% of all individuals over 60 years of age and that cases will increase by 10 million per year rising to 82 million cases in 2030 and 152 million in 2050.
The burdens of these diseases for individuals, families and society, as a whole, has led to great investment from the drug development industry. Yet, the complexity of the CNS has caused low success rates in novel drug development for this therapeutic area.
In this webinar, attendees will learn about:
- Recent advances in biomarker research, both wet lab and imaging
- Why these solutions are essential for higher quality clinical study designs
- The importance of objective and clinically accurate biomarkers as a means of studying the effect of study drugs on homogenous populations
“It will be extremely helpful to understand the extent to which the suggested clinical benefit of aducanumab, donanemab and other amyloid-plaque reducing treatments are associated with reductions downstream biomarker measurements like CSF p-tau and NfL. It would be even more helpful to extend these relationships to blood-based biomarkers like plasma p-tau and NfL, since blood samples are commonly collected at multiple time-points in all of the trial participants. If the field could find relationships between a treatment’s clinical benefit and these or other downstream biomarker effects, it could have a major impact on the development and potential approval of all Alzheimer’s disease-modifying treatments. Indeed, it might help to find and support the approval of an Alzheimer’s disease prevention therapy sooner than otherwise possible.”
Eric M. Reiman, M.D.
Executive Director, Banner Alzheimer’s Institute
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Andrew Roche, PhD
Senior Director, Scientific Affairs at ICON Central Laboratories
Andrew, a PhD with in depth knowledge of the intricacies of analytical methods and their applications within clinical trials, oversees the Scientific Affairs and Global Validations functions of ICON Central Laboratories.
Andrew has a Degree and PhD from Trinity College Dublin and has since accumulated 20 years of experience within the clinical trials industry with particular focus on the intricacies of biomarkers, associated laboratory methods and their ability to facilitate an efficient and accurate assessment of the clinical safety and efficacy of therapeutics moving through clinical trials.
Anu Bansal, MD, MHCM
Director of Medical and Scientific Affairs, ICON
Anu obtained his undergraduate degree in biochemistry at Harvard College and his medical degree at the Albert Einstein College of Medicine. After completing his radiology residency at Harvard Medical School, he trained in both diagnostic and interventional neuroradiology at the Mallinckrodt Institute of Radiology. Additionally, he has a Masters in Healthcare Management from the Harvard School of Public Health and is board certified in Radiology and Clinical Informatics.
Anu has worked for more than 15 years in clinical and academic settings as a neuroradiologist, and has extensive experience with clinical trials, imaging biomarker design, advanced and quantitative neuroimaging, neurodegenerative disease, and adult and pediatric neuro-oncology.
Peter Schueler, MD
Senior Vice President Drug Development Services - CNS, Ageing and Pain, ICON
Peter Schueler, is board certified in Neurology and in Pharmaceutical Medicine (Swiss Medical Association). After his medical education he worked in the pharmaceutical industry and since 2000 in the CRO world, being with ICON since 2007. He issued over 40 publications as first author on drug development and drug safety. In 2015 his book “Re-engineering clinical trials'' was published by Elsevier.
Peter continues to lecture in Pharmaceutical Medicine at the University of Duisburg-Essen and at the European Center Pharmaceutical Medicine (ECPM), Basel, Switzerland.