Patient Centricity in Neurodegenerative Diseases

Neurodegenerative diseases are one of the most challenging conditions not only for the patients but also for caregivers, healthcare providers and the healthcare systems. Over the past few decades, there has been a major focus to drive the science and research in the field, leading to better and more precise treatment options for patients.

However, there is a stronger need to incorporate patients’ and carers’ voices to inform each stage of value creation, from scientific discovery to providing access to new treatment options. This webinar brings experienced voices across the pharma industry and patient organizations to put a spotlight on patient-centric approaches in clinical research for neurodegenerative disorders.

The expert speakers will explore the latest advancements in patient-centric precision medicine, focusing on the use of fluid and imaging biomarkers for identifying patients, stratifying them and monitoring their treatment responses.

It will delve into the treatments for neurodegenerative disorders and the critical role that biomarkers play in these processes, discussing why extensive patient participation is necessary. Moreover, the importance of incorporating patient and caregiver input into the design and execution of clinical trials for neurodegenerative diseases will be emphasized, highlighting how such integration can enhance trial effectiveness and patient outcomes.

Register for this webinar today to understand how to integrate patient-centric approaches in clinical research for neurodegenerative diseases.

Speakers

Vikas Mohan Sharma, MD, Global Head of Neuroscience and Ophthalmology, Fortrea (Moderator)

Dr. Vikas Mohan Sharma, MD, joined Fortrea in December 2023 and serves as its Global Head of Neuroscience and Ophthalmology therapeutic areas. He is a recognized industry leader with more than 24 years of experience in healthcare, clinical development, and medical affairs, known for his expertise in research ethics and patient safety.

Dr. Sharma has held various leadership roles in healthcare, CROs, and the biopharmaceutical industry and is considered a key opinion leader in the field of drug development. He leads and collaborates on various industry, consortia, and non-governmental efforts to advance progress in precision psychiatry, digital biomarkers, and the use of technologies to address healthcare access and “last mile” challenges.

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In his most recent role with large pharma, Dr. Sharma was responsible for the end-to-end clinical development strategy and execution of early and late-stage products, as well as leading global clinical development, medical affairs, and scientific relations teams spanning multiple therapeutic areas. With 16 years of clinical experience in Psychiatry and as an Investigator in CNS trials, Dr. Sharma has a track record of success in developing and executing first-in-class, “blue ocean” and “beyond the pill” product strategies for pharmacological as well as digital assets. He is known to champion early investment in biomarker development and has a passion for bringing the right stakeholders together.

Dr. Sharma also serves as an independent ethics expert with the European Research Council and other non-governmental organizations. He is passionate about helping children with special needs and volunteers for this cause by sharing his time and expertise. He earned his MD in Psychological Medicine from Seth Gordhandas Sunderdas Medical College (GSMC) and the King Edward Memorial (KEM) Hospital in Mumbai, India.

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William Potter, MD, PhD, Independent expert (retired from NIMH, Lilly, and Merck)

Dr. Bill Potter’s professional training began with an early MD/PhD program at Indiana University in the late 1960’s where he obtained his MD. His PhD dissertation was based on research carried out at the NIH as a fellow in the laboratory of B. B. Brodie who was viewed as one of the fathers of psychopharmacology. Upon completion of the fellowship, he remained in the Public Health Service (PHS) under a joint residency program in psychiatry with two years devoted to clinical training and a third to clinical research. This formed the foundation for two decades of translational psychopharmacology research in NIH intramural programs until his retirement from the PHS in 1996.

There, his research centered on exploring whether specific biochemical mechanisms could be linked to specific therapeutic effects, especially in depression and manic-depressive illness. Bill began with exploring concentration/clinical effect relationships and then differential effects on brain biochemistry (with studies of fluid compartments including CSF) ultimately over-seeing a diverse research group involving both preclinical and clinical studies on molecular mechanisms of action of a variety of compounds.  His team’s research became well known with Bill involved at multiple levels in national and international psychopharmacology efforts with former trainees from his lab holding senior positions both in academia and industry in the US, Europe, Asia and South America.  As methods for exploring brain function in humans advanced, he has become even more interested in translation from the bench to bedside of novel molecular targets on components of psychiatric illness. It became apparent by the mid 1990’s that this line of research exceeded the scope of what was possible within an independent intramural research group and required the kind of team science being carried out in industry.

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In 1996 Bill joined Eli Lilly to be lead early clinical development of CNS compounds championing incorporation of emerging biomarkers to establish doses and reduce the need for purely empirical dose ranging studies in Phase 2 and Phase 3 studies. At the same time, he led precompetitive efforts to build shared databases to better understand placebo response and how to increase signal detection in clinical trials – activities in which he continues to the present working across organizations such as ISCTM and ASCP to bodies such as the Foundation of the NIH Biomarker’s Consortium and the Neuroforum of the National Academy of Sciences where representatives from government (NIH, FDA, VA and DOD), industry, academia and advocacy interact.

In 2004 he became head of CNS early development at Merck and then of “translational neuroscience” with a focus on even more extensive incorporation of biomarkers into novel drug development. Because of intense interest in beta amyloid formation as a target for Alzheimer’s, much focus was devoted to biomarker research in AD which continues to this day in his chairing of precompetitive efforts managed through the FNIH. Following Bill’s retirement from industry at the age of 65 in 2010 he has devoted even more time to how to accelerate improving signal detection in clinical trials and applying biomarkers to increase the yield from studies of compounds acting on still-to-be-validated molecular targets. Until recently, much of his time was to bring this message to the NIMH in the role of a senior advisor. Bill continues to view working together across public and private stakeholders as the surest way to accelerate the identification of novel treatments for CNS disorders.

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Hartmuth Kolb, PhD, CSO, Enigma Biomedical Group (EBG), USA

Dr. Hartmuth Kolb received his PhD in Organic Chemistry in 1991 at Imperial College of Science, Technology and Medicine, London. He joined Ciba-Geigy in 1993 and in 1997 became VP of Chemistry at Coelacanth Corporation to work with K. Barry Sharpless on pioneering Click Chemistry (2022 Chemistry Nobel Prize for KBS).

He then became the Head of Siemens Biomarker Research, where he and his team developed PET tracers using Click Chemistry. The PHF-Tau PET tracer [18F]-T807 (aka “Flortaucipir”, “Tauvid”) was recently approved by the FDA to image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. Dr. Kolb joined Janssen in January 2014. His research interests include the development of PET tracers for all therapeutic areas, and the development of precision medicine approaches in Neuroscience.

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His lab developed a p217Tau blood test that detects the presence of Alzheimer’s pathology in patients. In March 2024, he joined EBG as their CSO to focus on the development of CNS imaging tracers. Dr. Kolb served as the Co-Chair of the Neuroscience Steering Committee of the Foundation of NIH Biomarkers consortium. He has over 100 peer-reviewed scientific papers and over 70 patents.

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Shana Dodge, PhD, Director of Research Engagement at the Association for Frontotemporal Degeneration (AFTD)

Dr. Shana Dodge, PhD, is the Director of Research Engagement at the Association for Frontotemporal Degeneration (AFTD). A licensed clinical psychologist, she holds a PhD in Clinical Psychology from the University of Hawaii, an MA in Psychology from the New School and a BA in Psychology from George Washington University.

Shana works to ensure clinical researchers and regulatory bodies understand the needs, priorities and values of people directly impacted by FTD and that people with FTD and their loved ones can make informed decisions about research participation.

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