Speakers

The DxA is pleased to welcome leading experts in the field from biotech, pharma, academia, and venture capital sectors to discuss the future of Alzheimer’s diagnostics.

Please find speaker information and participation details below.

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Cecilia S. Lee, MD, MS

Cecilia S. Lee, MD, MS

Professor and Klorfine Family Chair of Ophthalmology at University of Washington

Dr. Cecilia Lee is a Professor and Klorfine Family Chair of Ophthalmology at University of Washington in Seattle, WA. She specializes in medical retina and uveitis serves as the Director of Clinical Research at the Department of Ophthalmology. Dr. Lee’s research interests include Big Data, clinical epidemiology, ophthalmic imaging, and retinal biomarkers of Alzheimer’s disease. She co-leads UW Computational Ophthalmology Lab with primary focus on machine learning/Big Data research in transdisciplinary fields such as ophthalmic imaging, neuroradiology, and neuropathology.  

Dr. Lee received NIH/NEI K23 Career Development Award and has several NIH funded grants. She serves as the principal investigator of Eye Adult Changes in Thought (ACT) study, a prospective, longitudinal community-based cohort that is followed with visual function tests and multiple retinal imaging biennially until the development of dementia. She has received funding from the Alzheimer’s Drug Discovery Foundation’s (ADDF) Diagnostic Accelerator (DxA) program. In addition, Dr. Lee serves as the Program Director of Artificial Intelligence Ready and Equitable Atlas for Diabetes Insights (AI-READI) project with the goal of generating a flagship AI-ready dataset to support future AI-driven discoveries in Type 2 diabetes as part of the NIH Bridge2AI Program. Dr. Lee aspires to leverage large datasets to study and gain novel insights of prevalent health conditions through next generation Big Data and machine learning approaches.

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Lightning Round: Searching for Ophthalmic Biomarkers of Alzheimer's Disease
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Nicklas Linz, PhD

Nicklas Linz, PhD

CEO and Co-Founder at ki:elements

Dr. Nicklas Linz is the CEO and co-founder of ki:elements, a company pioneering in the development of speech biomarkers for various pathologies, including Alzheimer's disease and Parkinson’s disease. He leads an interdisciplinary team of data scientists, software developers, psychologists and medical doctors with in-depth understanding of these therapeutic areas. ki:elements stands out for its innovative approach in utilizing speech analysis as a non-invasive, cost-effective tool for remote early detection and monitoring of cognitive and motor impairments. Following the DiME V3 framework, Dr. Linz and his team have been able to analytically and clinically validate ki:elements’ speech biomarker for cognition (SB-C) and speech biomarker for motor function (SB-M).

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Validation of the ki:elements Speech Biomarker for Cognition (SB-C) in Alzheimer’s Disease
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Laura Nisenbaum, PhD, MS

Laura Nisenbaum, PhD, MS

Executive Director of Drug Development at the Alzheimer’s Drug Discovery Foundation (ADDF)

Dr. Laura Nisenbaum is a proven scientific leader with 30 years of biotechnology industry and academia experience. At the ADDF, she oversees the Scientific Affairs, Biomarker Development, and Aging and Alzheimer’s Prevention teams.

Most recently, Dr. Nisenbaum served as Senior Director of Aducanumab Biomarkers and Diagnostic Pathways at Biogen, where she led the biomarker strategy for Aducanumab, as well as the Diagnostics Pathway group within the Biomarker Organization.

Her time at Biogen followed 20 years of experience at Eli Lilly and Company where she served as Asset Manager for Chorus, an autonomous early-phase clinical development organization within Lilly. Dr. Nisenbaum also served as Research Fellow and neuroscience lead in tailored therapeutics, translational medicine, and preclinical drug discovery.

Prior to joining the biotechnology field, Dr. Nisenbaum received a Fulbright Scholarship to study in Cologne, Germany. She then completed her PhD in neuroscience in 1991 at the University of Pittsburgh and transitioned to industry after completing postdoctoral training at the National Institutes of Health (NIH), the University of Tennessee College of Medicine, and a faculty position in Physiology and Neurobiology at the University of Connecticut.

Throughout her career, Dr. Nisenbaum has contributed to the discovery and development of more than 15 novel therapeutics, bringing three molecules for FDA approval. She has also authored over 35 publications in peer-reviewed scientific journals.

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Overview of DxA Portfolio
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Mark Roithmayr

Mark Roithmayr

CEO of the Alzheimer’s Drug Discovery Foundation (ADDF)

Mark Roithmayr is an admired nonprofit leader with four decades of experience in both start-ups and mature organizations. At the ADDF, Mr. Roithmayr is responsible for steering the Foundation’s overall strategy, focus, and business operations. Since joining the ADDF in 2017, the organization has transformed dramatically in impact, scale, presence, and brand. Under his leadership, the ADDF’s revenue has increased five-fold from $17M to an excess of $90M and mission related investing has grown over 100%.

As such, Mr. Roithmayr sets the strategic vision of the ADDF and works in partnership with the Co-Founder and CSO, Howard Fillit, MD, Executive Leadership, and the Board of Governors and Overseers to advance and execute the Foundation’s mission of accelerating the discovery of drugs to prevent, treat, and cure Alzeimer’s disease and related dementias. His areas of expertise and focus include venture philanthropy, strategic planning, volunteer development, and brand-building. One of Mr. Roithmayr’s milestone accomplishments was securing Bill Gates, as well as Jeff Bezos and MacKenzie Scott, as donors to further the Foundation’s venture philanthropy efforts. Additionally, he secured a 10-figure gift from the families of Leonard and Ronald Lauder, ensuring all overhead costs will be covered at the ADDF for the next two decades.

Prior to joining the ADDF, Mr. Roithmayr was Chief Relationship Officer at the Leukemia and Lymphoma Society. There, he helped launch its venture philanthropy initiative, directed its 56 national chapters, and led annual fundraising of over $200 million. Prior his time at the Leukemia and Lymphoma Society, he served for seven years as president of Autism Speaks. As that organization’s first president, he shepherded its growth from a start-up into the world’s largest autism research and advocacy organization. Earlier in his career, Mr. Roithmayr held several executive positions, spanning two decades, with the March of Dimes. He earned a bachelor’s degree in communications at Rowan University.

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Opening Remarks
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Ioannis Tarnanas, PhD

Ioannis Tarnanas, PhD

Founder and Chief Scientific Officer at Altoida, and Expert Evaluator for Brain & Mental Health and Digital Biomarkers at EIT Health

Dr. Ioannis Tarnanas received his PhD in Neuroscience from Aristotle University in Thessaloniki, Greece. Ioannis has pioneered virtual and augmented reality environments for everyday function monitoring since 2000. In 2005, he became involved in the first digital biomarker project in the world from Novartis AG, the smart exelon patch, approved by the FDA in 2013. He recently created an accurate predictive tool based on cognitive and non-cognitive digital biomarkers of early onset dementia. He currently serves as the Principal Investigator of the Alzheimer's Drug Discovery Foundation (ADDF) project entitled, “Digitally-enhanced personalized medicine: accurate selection of subjective cognitive decline and measuring progression of mild cognitive impairment" (reference # GDADB-201906-2018897), which specifically addresses the validation of Altoida’s Software as a Medical Device (SaMD) for the accurate selection of subjective cognitive decline and measuring progression of mild cognitive impairment in individuals at risk of Alzheimer’s disease and related dementias from the community. In addition, he has been a Principal Investigator for the Research & Development and validation studies of Altoida’s SaMD to date, totaling $4.3 million in public funding & $24 million in private funding. Ioannis has been the founder and Chief Scientific Officer of Altoida since 2016 and is responsible for the interactions with the FDA, which has awarded the breakthrough designation to Altoida’s predictive SaMD system. Finally, he is part of the expert evaluators for the European Institute for Innovation and Technology, Health sector (EIT Health) for Brain & Mental Health and Digital Biomarkers, where Ioannis continues to pursue his development of computational biomarkers of Alzheimer’s disease.

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Digitally-Driven Precision Medicine: Accurate Identification of Preclinical and Prodromal Alzheimer’s & Measuring the Progression of MCI
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Charlotte Teunissen, PhD

Charlotte Teunissen, PhD

Professor of Neurochemistry and Chair of the Neurochemistry Lab at Amsterdam UMC

Dr. Charlotte Teunissen’s drive is to improve care of patients with neurological diseases by developing body fluid biomarkers for diagnosis, stratification, prognosis and monitoring treatment responses. Studies of her research group span the entire spectrum of biomarker development, starting with biomarker identification, often by –omics methods, followed by biomarker assay development and analytical validation, and lastly, extensive clinical validation and implementation of novel biomarkers in clinical practice.  

She has extensive expertise with assay development on state of the art technologies, such as mass spectrometry and antibody-based arrays for biomarker discovery, ultrasensitive immunoassays, and in implementation of vitro diagnostic technologies for clinical routine lab analysis. She is responsible for the large well-characterised biobank of the Amsterdam Dementia cohort, containing >10,000 paired CSF and serum samples of individuals visiting the memory clinic of the Alzheimer Center Amsterdam  (a.o. controls, patients with Alzheimer’s, Frontotemporal, Lewy Bodies). To ensure the quality of the biosamples, the group studies pre-analytical effects, which are key to implementation. Charlotte is leading several collaborative international biomarker networks, such as the Society for Neurochemistry and Routine CSF Analysis and the Alzheimer’s Association-Global Biomarker Standardization and Blood Based Biomarkers and the Body Fluid Biomarkers PIA, and the recently founded Coral proteomics consortium. She is the coordinator of the Marie Curie MIRIADE project, aiming to train 15 novel researchers into innovative strategies to develop dementia biomarkers (10 academic centers + 10 non-academic centers), and the JPND bPRIDE project, that aims to develop targeted blood based biomarker panels for early differential diagnoses of specific dementias and is a collaborative project between 7 European and 1 Australian centers.  

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Methods of Standardization
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Manu Vandijck

Manu Vandijck

Product Development Manager at Fujirebio Europe NV

Manu Vandijck is Product Development Manager at Fujirebio Europe NV.  He obtained an Industrial Engineer degree at Karel de Grote Hogeschool (Antwerp, Belgium) in 1996 and started immediately thereafter working at Fujirebio Europe (formerly Innogenetics) in the R&D Product Development group.

Since 2010, his focus and main responsibilities are linked to the Fujirebio Europe Neurodegeneration product portfolio.  He leads a team that develops new and relevant biomarker assays from defining the raw materials to full verification and validation for introduction into the market, and supports Alzheimer’s disease (AD) related market activities. Over the last few years, a successful release of Fujirebio’s fully automated platform in Europe, the LUMIPULSE G series, was achieved. On this platform, the team made Alzheimer’s CSF and plasma biomarker assays available that are globally implemented in general clinical testing labs and research institutes. As a representative for IVD-assay manufacturers, Manu is involved in several international working groups to increase standardization and use of biomarkers in the diagnosis of Alzheimer’s.

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To pTau217, or (Not) to pTau181, That Is the Question
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Joseph M. Volpe, PhD

Joseph M. Volpe, PhD

Business Segment and Discipline Director of Neurology at Labcorp

Dr. Joseph Volpe graduated from Duke University in 2008 with a PhD in computational immunology. He received the American Association of Immunologists-Huang Foundation Young Investigator Award in 2007 for his work in anti-HIV antibody composition. Upon graduating, Dr. Volpe worked as a Medical Science Liaison at Monogram Biosciences, which is now a Labcorp company. In early 2016, he became Labcorp’s Director of Scientific Outreach, helping to build the foundations for Medical Science Liaison team.

In early 2018, Dr. Volpe began putting together the pieces of what is now Labcorp’s Neurology program, for which he is both the Business Segment Director and Scientific Discipline Director. Under his direction, the Neurology program has grown to offer a fully competitive portfolio, as well as establishing Labcorp as the leader in neuro blood biomarkers, such as NfL. He is an author of several peer-reviewed articles and conference posters. He is a two-time Labcorp Chairman’s Award winner, getting the recognition in 2011 and 2022. He is a member of the American Academy of Neurology (AAN).

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The Future of Alzheimer’s Diagnostics in Clinical Care
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Svenja Wacker, PhD

Svenja Wacker, PhD

Science Director of Neuropsychology Business Development at Cogstate

Dr. Svenja Wacker is a bilingual (German/English), licensed clinical neuropsychologist with expertise in global clinical trial management and consultation, as well as extensive experience in hospital-based rehabilitation neuropsychology, neuropsychological assessment and intervention, program development, and medical staff training. She currently serves as Science Director on Cogstate’s Business Development team. Dr. Wacker graduated from George Mason University with a PhD in clinical psychology and a fellowship in clinical neuropsychology at Yale University School of Medicine. She completed a postdoctoral residency at Harvard Medical School in neuropsychological assessment.

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Smartphone-Based Learning and Memory Assessment: Assessing Community Engagement in the Lila App
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Henrik Zetterberg, MD, PhD

Henrik Zetterberg, MD, PhD

Professor of Neurochemistry at the University of Gothenburg (Sweden) and University College London (UK), and a Clinical Chemist at Sahlgrenska University Hospital (Sweden)

Dr. Henrik Zetterberg is a Professor of Neurochemistry at the University of Gothenburg (Sweden), and University College London (UK), and a Clinical Chemist at Sahlgrenska University Hospital in Gothenburg (Sweden). He is Head of the Department of Psychiatry and Neurochemistry at the University of Gothenburg, leads the UK DRI Fluid Biomarker Laboratory at UCL, and is a Key Member of the Hong Kong Center for Neurodegenerative Diseases and a Visiting Professor in the University of Wisconsin Department of Medicine, School of Medicine and Public Health (Madison, WI). His main research focus and clinical interest are fluid biomarkers for brain diseases, focusing on neurodegenerative diseases in particular.

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Update on Blood-Based Biomarkers for Alzheimer's Disease
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Methods of Standardization
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