Panel Discussion - Advancing Adaptive Pathways and Real-World Evidence for Orphan Drugs: A Policy Debate

Panel Discussion – Advancing Adaptive Pathways and Real-World Evidence for Orphan Drugs: A Policy Debate

Event Timeslots (1)

DAY ONE (Salles des Arches)
12:00 - 12:45

10:00 - 11:15 - BREAKOUT SESSION
—
Creative interventions at the interface of neuroscience and artificial intelligence

In 2017, more than 300 million people worldwide were estimated to suffer from brain disorders, imposing an economic burden of nearly 900 billion EUR in patient care. Therefore, the urgent need of the hour is to identify creative interventions to heal the brain and cure the mind. The goal of this breakout session is to bring together a world-leading group of panelists to discuss creative interventions and the interface of neuroscience and artificial intelligence to identify therapeutic treatments for brain disorders.

Srikanth Ramaswamy is an assistant professor at Newcastle University where he directs the Neural Circuits Laboratory. His laboratory employs multidisciplinary approaches at the interface of theory and experiments to understand how neuromodulatorry systems shape learning and cognition in neocortical circuits. He aims to identify the organising principles underlying the functional logic of neuromodulatory systems to inform deep learning models. He is also a Picower Visiting Professor, Marie Curie Fellow and Fulbright Scholar at MIT. He is a passionate advocate of diversity, equity and inclusion and is the chair of the promotion of diversity task force in the ALBA network.

Zeljka Krsnik is an Associate Professor of Neuroscience at the School of Medicine University of Zagreb at the Scientific Centre of Excellence for Basic, Clinical and Translational Neuroscience, Zagreb, Head of the Laboratory for Neurogenomics, Head of the Laboratory for Digitalization of the Zagreb Human Neuroembryological Collection, as well as Assistant Director of the Croatian Institute for Brain Research. Her main research focus is to understand the molecular and cellular mechanisms, as well as cortical connectivity development of the human cerebral cortex. Previously, she was a postdoctoral associate at Yale University and, in addition, a member of BrainSpan Consortium. In 2013 she was awarded with the International Brain Research Organization (IBRO) Return Home Fellowship Award. In 2018 she was appointed as a Chair of the IBRO Alumni Committee and currently she is the Chair of the Young IBRO (International Brain Research Organization) and a member of IBRO Executive Committee. In addition, she is a Board member for Neuroscience and Brain Disease at the Croatian Academy of Sciences and Arts. Since 2018 Zeljka Krsnik is a member of an ALBA Network Board of Directors, with the mission to foster equity, diversity and inclusion in brain sciences across the world.

Marcus Kaiser is a Professor of Neuroinformatics in the University of Nottingham, working on computational approaches to inform diagnosis and interventions for brain network or connectome disorders. His research interest is to develop novel ways for brain stimulation, informed by neuroimaging and computer models, to improve cognition in health and disease. He actively promotes the use of simulations and models in the areas of computational neurology and computational psychiatry. His current work is focused on predicting the effects of brain stimulation, either invasive approaches such as optogenetics or stimulation through implanted electrodes or non-invasive approaches such as focused ultrasound stimulation. For this, he uses a combination of techniques from machine learning and network analysis to computer simulations. The aim is to improve the treatment of brain disorders and mental health conditions.

Javier DeFelipe is the director of the Laboratorio Cajal de Circuitos Corticales, Universidad Politecnica de Madrid and of the Laboratorio de Microorganización de la Corteza Cerebral, Instituto Cajal, CSIC. His laboratory is involved in the development of a variety of software tools to classify neuronal cell types and to examine the anatomical design (neuronal morphology and synaptic organization) of brain circuits. His interests are to study the history of our current understanding of cortical organization and function. In particular, he is interested in the roots of cortical histology and circuitry. He is also fascinated by the link between the study of the brain and art and has been involved in organizing and curating numerous exhibitions around the world. He has written several articles, chapters and books on both this subject and the influence of Santiago Ramón y Cajal in modern neuroscience.

15:40 - 16:55 - BREAKOUT ROOM

Build brains better Brain capital focused policies and investments

Our session will explore four components of brain capital focused policy and investment innovations.

First, Dr. Harris Eyre will introduce brain capital. Brains are indispensable drivers of human progress. Why not invest more heavily in them? Dr. Eyre will talk about efforts to place brain capital at the center of a new narrative to fuel economic and societal recovery and resilience, along with efforts from the OECD Neuroscience-inspired Policy Initiative.

Second, Erin Smith will discuss women’s brain health innovations. The COVID-19 pandemic has exacerbated global mental health and gender inequalities. To improve women’s brain capital, we must incorporate new data: namely, the perspective and experience of women. Erin will discuss how solutions that consider the experience of women are more likely to create structural change across sectors, from neuroscience and health care to racial equality, public policy, and workplace norms.

Third, Dr. Caroline Montojo will talk about opportunities for public-private partnerships to advance neuroscience within society. Major national investments are being made into neuroscience research and neurotechnology development. New tools and technologies that carry strong ethical, legal, and social implications are rapidly touching upon the public sphere. Increased attention and investment into issues at the intersection of neuroscience and society will be critical. Dr. Montojo will discuss models for partnership between the public and private sectors to strengthen neuroscience’s role within society.

Fourth, Dr. Karen Rommelfanger will explore the competitive edge of neuroethics for neurotech innovators. The world is mobilizing around the allure of unlocking the mysteries of the brain from universities to healthcare and industry start-ups. Neurotechnology is rapidly developing to be applied in wide-ranging contexts. These advances in neuroscience continue to surface thorny ethical issues further complicated by diverse cultural assumptions about brain and mind. In this talk, Dr. Rommelfanger will discuss how neuroethics can be a creative tool to advance and accelerate the most societally impactful global neuroscience innovation.

Caroline Montojo, Ph.D., is the President and CEO of the Dana Foundation, a private philanthropic organization in New York City dedicated to advancing understanding about the brain. Dr. Montojo leads the Foundation into its next chapter which focuses on neuroscience within society, how neuroscience both reflects and informs society. This includes fields where neuroscience interfaces with the world, such as ethics, law, humanities, medicine, arts, social sciences, policy, education, and public engagement. Dr. Montojo was previously the Director of Life Sciences and the Director of Brain Initiatives at The Kavli Foundation where she worked closely with the Kavli Institutes to advance science. Dr. Montojo has been deeply involved in catalytic efforts to advance neuroscience, including the U.S Brain Initiative and the International Brain Initiative (IBI). She served as an elected spokesperson for the IBI, giving talks at multiple scientific conferences such as the International Conference on Learning and Memory, the US National Institutes of Health Advisory Committee to the Director of NIH Working Group on BRAIN Initiative 2.0, and the UC Irvine Brain Initiative Launch. She also contributes to publications on international neuroscience and neuroethics in editorials, articles, and perspectives. Dr. Montojo completed postdoctoral research in the Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles (UCLA). Her research at UCLA focused on investigating neural biomarkers for psychiatric illness using functional magnetic resonance imaging and behavioral techniques, for which she was awarded the Arnold Scheibel Distinguished Postdoctoral Fellow in Neuroscience Award and the Stephen R. Mallory Schizophrenia Research Award. Dr. Montojo received her B.A. from the University of California, Berkeley, and completed her M.A. and Ph.D. at Johns Hopkins University. She holds a Women in Leadership Certificate from the Cornell SC Johnson School of Business and was an invited member of the World Economic Forum Global Future Council on Neurotechnology and the National Academy of Sciences’ Forum on Neuroscience and Nervous System Disorders.

Dr. Karen S. Rommelfanger is a neuroethics strategist and researcher. She received her PhD in neuroscience and received postdoctoral training in neuroscience and neuroethics. Her research explores how evolving neuroscience and neurotechnologies challenge societal definitions of disease and medicine. Dr. Rommelfanger is an Associate Professor in the Departments of Neurology and Psychiatry and Behavioral Sciences. She also Directs the Neuroethics and Neurotech Innovation Collaboratory and the Neuroethics Program Director at Emory University’s Center for Ethics. She holds editorial positions as Senior Associate Editor at the American Journal of Bioethics Neuroscience and is first neuroethicist to be called to the editorial advisory board of Neuron. She is dedicated to cross-cultural work in neuroethics is co-chair of the Neuroethics Workgroup of the International Brain Initiative and collaborates with the Organization for Economic Cooperation and Development on implementing responsible neurotechnology recommendations. For the NIH, she is an appointed member to the NIH BRAIN Initiative Neuroethics Working Group and served as Neuroethics Subgroup member of the Advisory Committee to the Director at NIH for designing a roadmap for BRAIN 2025. Dr. Rommelfanger’s engages in cross-sectoral work as a member of the Global Futures Council of the World Economic Forum and neuroethics advisor with BrainMind a community of entrepreneurs and investors. A key part of her work is fostering dialogue across multiple stakeholders in neuroscience. As such she is a frequent contributor and commentator in popular media such as NPR, The New York Times, USA Today and The Huffington Post. She is founder of the newly formed international neuroethics think tank-Institute of Neuroethics (IoNx) and run a first-of-its kind neuroethics consulting firm (Neuroethics Co-Lab).

Erin is a technologist and brain health executive focused on building the future of brain health. She is an Atlantic Fellow for Brain Equity at the Global Brain Health Institute at UC San Francisco (UCSF) and a Thiel Fellow at Stanford focused on neuroscience and computer science. Erin has experience in building and applying deep technologies such as digital phenotyping, sensors, and imaging to brain health. She priorly ran a company that developed affective computing tools for Parkinson’s and Alzheimer’s disease. Her publications have been featured in leading journals including Neuron, Molecular Psychiatry, and American Journal of Geriatric Psychiatry. Erin is the director of the PRODEO Institute, a think-tank focused on radical approaches to advancing brain health, and Vice President of PRODEO, a group of brain-health focused executives. She has had academic collaborations with Stanford University School of Medicine, Harvard Medical School, Weizmann Institute of Science, and the Michael J. Fox Foundation. Erin is a Y Combinator and Forbes 30 under 30 alumni and an AAAS IF/THEN Ambassador.

After growing up in Northern Queensland, Harris Eyre, MBBS PhD, originally trained in clinical medicine and neuroscience. He is now based in the US and is a global executive working to address the brain health pandemic. He is President of PRODEO, which propels forward novel brain health technology companies – supporting their business development, capital raising and product strategy. He is Co-Founder of the PRODEO Institute, which incubates and funds radical approaches to the global brain pandemic. For example, he is co-lead of the OECD-PRODEO Institute Neuroscience-inspired Policy Initiative which has been developed in collaboration with colleagues from the Meadows Mental Health Policy Institute, Gates Ventures, the Milken Institute, Johnson & Johnson, PWC and Fondation Fondamental. This initiative seeks to incubate new approaches to brain-based investing, economics and policy. His work is driven by breaking down disciplinary siloes to unlock unexpected advances. He is lead editor of the new book Convergence Mental Health with Oxford University Press. He maintains advisory or adjunct roles with the Healthy Brains Global Initiative, the American Psychological Association, the American Association of Geriatric Psychiatry and Deakin University. He is an alumnus of Forbes 30 Under 30 and the Fulbright Scholar program. He has authored 100+ papers and chapters in outlets such as Lancet Neurology, World Psychiatry and The RSA Journal.

11:45 - 13:00 - BREAKOUT SESSION
—
Daily EEG for People with a Brain Disorder

This breakout session will give an in-depth look at the current state and future developments of EEG technology for daily use. Speakers from different backgrounds will present their (consumer) wearable EEG, clinical-grade wearable EEG and implantable EEG, augmented by an overview of the wealth of possibilities daily EEG would bring to people living with a brain disorder. In the first half of the session, each speaker will present the latest development in their field in about 10 minutes. Next, the session will continue with a moderated debate on the future of daily EEG and how this can impact people with a brain disorder.

Daily EEG for People with a Brain Disorder

A social and innovative digital business leader with a critical and empathetic mindset, a lot of sense for responsibility and humor. And a touch of non-conformism. Loves the journey towards truly disruptive experiences by smart innovation and agility.

Julie is a fast-learning, engaging and team-minded Neuroscientist. During my PhD and postdoc (VIB), she became an expert in molecular neuroscience and brain plasticity. Internationally, she worked abroad in a top-level neuroscience lab in Montréal. She loves to deploy my endless scientific curiosity, passion and collaborative spirit to make a difference in society. After 2 years of experience in product development, she is currently taking on the role of Medical Stakeholder Ambassador at Byteflies. She is positioned at the interface between product & sales teams and medical experts, the pharma industry and top-notch hospitals to set up wearable health solutions for Epilepsy. Ultimately, Byteflies’s mission is to make health care more personal, proactive, accessible, affordable and equitable, especially for people with chronic conditions.

More info: https://www.linkedin.com/in/alvinchantw/

Isabelle François has a passion for healthcare and a sweet spot for science. As managing director of Health House she can combine these two passions because on a daily basis she deals with future technological innovations, which is a nice bonus for a bio-engineer. The Health House is a unique and world-class experience center where the future of healthcare is showcased to medical professionals and the general public in an innovative and highly technological way. Before her position at Health House, François was active as Intellectual Property (IP) Officer at KU Leuven Research & Development. Here she was responsible for writing patents and negotiating contracts between the university and other institutions. Before her function as IP Officer, she was Coordinator Clinical Trials at Fugeia, a company active in the food sector. François has a degree of bio-engineer in cell and gene biotechnology and a PhD in Applied Biological Sciences.

15:45 - 16:05 - AGORA SESSION
—
MindBot: a cobot platform to look after workers’ mental health

The workplace environment has a great impact on workers’ mental health and well-being, even more if considering the time people spend at work. A good psychosocial work environment can be very beneficial for workers’ mental health, whilst a poor one can have significant negative effects, including experiencing work-related stress, burnout, problems at home,drug and alcohol abuse. The negative effects impact the organizations too, that experience poor overall business performance, increased absenteeism, presenteeism and higher accident and injury rates.
This is the second most frequently reported work-related health problem in Europe, after musculoskeletal disorders.In the context of Industry 4.0, where robots, sensors and automated work are pervasive, conditions are potentially more harmful for workers’ mental health, as they could be exposed either to monotonous and alienating tasks or to very challenging tasks. The progressive adoption of collaborative robots (cobots) in manufacturing SMEs opens the way to a radical organizational and technological transformation, where by design the whole workplace environment could contribute to promote workers’ mental health.
The aim of our session is to show how an enhanced multi-stakeholder engagement takes into account manifold facets affecting mental health and intervenes on technological, relational and organizational aspects of the cobot-based work, fostering investment in research and innovation and facilitating SME business development.The objective is to design workplaces where level of challenge and difficulty of job tasks match with the workers’ abilities, in order to support their motivation and engagement by interacting with cobots in a flexible and personalized way. This will facilitate workers’ positive attitude, promoting good mental health and preventing negative experiences of anxiety or boredom and apathy that eventually lead to mental illnesses. Expected results are the definition of guidelines for the design of a “mental health friendly” manufacturing workplace and a new generation of cobots, the Mindbots.

Received her bachelor degree in Social Sciences in 2011 at University of Augsburg which qualified her for a DAAD (German Academic Exchange Service) full scholarship to study the Master’s degree “International Financial and Political Relations” in Loughborough, UK. In December 2012, she graduated with a distinction, while she had already started working at the Chief Innovation Office at KUKA AG in November 2012. In September 2015 Nadine joined the Project Office of KUKA’s Corporate Research department; first as support for the RockEU and RockEU2 projects and since 2017 as analyst of social impacts of robotics. Here she has been actively contributing to the integrated technology development process and written analyses for both European and national research projects like REFILLS, MURAB and RoSylerNT. Her research interests lie in the ethical and psycho-social impacts of robots in human-robot interaction.

MD specialized in Clinical Psychology, is professor of Psychology at the Medical School of the University of Milano. Her research work is devoted to the study of mental health indicators and daily experience fluctuation models across activity domains and cultural contexts, as well as among individuals experiencing chronic disease or social maladjustment. During three decades of intensive research work she has built the largest international databank on the psychological structure and phenomenology of flow (aka optimal experience) across cultures and activities. Her scientific production includes papers in international peer-reviewed journals, as well as authored and edited books. Especially relevant to the present project are The Wiley Blackwell Handbook of the Psychology of Positivity and Strengths-Based Approaches at Work (edited with L.Oades, M. Steger and J. Passmore, 2017) and Flow at work: Measurement and implications (edited with C. Fullagar, Routledge, 2017). Since 2010 she is Editor in Chief of the Journal of Happiness Studies.

Alberto holds a MSc in Physics and Physics Technology from the University of Cantabria (Spain) and joined BioRICS in 2019 as a Project Engineer in R&D. Within BioRICS Alberto is taking care of algorithm development. His main interests and experiences are within the field of data analysis of biological signals to monitor the physical condition and well-being of animals and humans. Alberto also takes interest in collecting the relevant information from the data analysis and translating it in a comprehensive way for the different types of users.

Graduated from the Faculty of Humanities and Social Sciences of the University of Zagreb. She used to work more than 20 years in the biggest national newspapers as a columnist, a redactor and an editor. Besides the experience in the private sector, she also has an experience in the public sector working in the Government Office for Social Partnership, the Agency for Mobility and European Programmes, the Institute for Occupational Safety Improvement and the Ministry of Labour. She has a wide range of experience as a project manager (writing project proposals, controlling the implementation of projects and implementing projects) and as an OSH expert she took part in the TAIEX mission. On behalf of the Croatian Government she is a member of the EU Advisory Committee on Safety and Health at Work.

10:50 - 11:15 - AGORA SESSION
—
Relevance of gender issues in Neurology

Prior to the COVID-19 pandemic, the European Academy of Neurology had already decided to launch a taskforce on Gender and Diversity in Neurology, with the overall mission to increase awareness and improve knowledge about sex, gender, ethnic and racial differences and disparities in neurological disorders. Indeed, there are several biological, genetic, and epigenetic differences between men and women that can impact epidemiology, clinical manifestation, and treatment of many neurological disorders. Global burden ofneurological diseases affects much more women than men at any age.

Risk factors of stroke differs in women compare to men. Motor and non-motor fluctuations in Parkinson’s disease are not the same between men and women. Precision medicine in neurology needs neurologists to be aware of these differences to improve care and outcome of neurological patients. This session will provide new insights about this new expanding field of medicine applied to neurology.

Elena Moro graduated in Medicine at the University of Trieste (Italy), and completed her residency in Neurology at the Rome Catholic University (Italy). She did her fellowship in surgery for movement disorders in Grenoble, France, under the supervision of Pr. Pollak and Pr. Benabid. After receiving her PhD in Neurosciences, she joined the Division of Neurology at the Toronto Western Hospital (Canada) as medical Director of the surgical program for Movement Disorders. She worked with Pr. AE Lang and Pr. AM Lozano. In 2012 she moved to Grenoble, France, as full Professor of Neurology at the Grenoble Alpes University. Currently, she is the Director of the Movement Disorders Center, and the Head of the Department of Psychiatry, Neurology, Neurological Rehabilitation and Forensic Medicine at the CHUGA. To date, she has published more than 200 papers based on clinical research in movements disorders. Her main research has been focused on restoring brain function, especially with deep brain stimulation. Pr. Moro has trained many medical students, PhD students and neurology fellows. She is actively involved in several international academic societies. She is currently the Secretary General of the European Academy of Neurology and the Treasurer of the International Association of Parkinson and Related Disorders.

Joke Jaarsma is EBC Treasurer and President of the European Federation of Neurological Associations (EFNA). In 2009 she started the European Alliance for Restless Legs Syndrome, an organization which now represents all major European patient groups for RLS. She still works with them as Director of External Relations. Furthermore, she also is a member of several scientific panels at the European Academy of Neurology. In her working life, Joke Jaarsma was senior publisher at one of the major science publishers. She joined the Dutch Restless Legs Syndrome (RLS) patient association in 1999, and she is still active as Vice President of the Dutch group. Having finished full-time paid employment, she decided to spend her retirement in helping give neurology patients a strong and collective voice.

Frances-Catherine Quevenco is an accomplished neuroscientist with a passion for enabling dementia patients to access timely and accurate diagnoses to receive the proper care they need. Frances completed a BSc at UCL London in Psychology, followed by an MSc at Imperial College London before joining the National University of Singapore as an Associate Cognitive Neuroscientist. After 2 years of research at NUS, she joined Prof. Roger Nitsch’s group at the University of Zurich, dedicating her PhD and Postdoc to exploring preclinical Alzheimer’s disease biomarkers using neuroimaging techniques to enable earlier detection of the disease when an intervention is most effective and where she first became aware of the stark sex differences between the manifestation of the disease. She has since then broadened her field of expertise, taking on an International Medical Manager position at Roche Diagnostics to educate and establish the value of a timely biomarker-based diagnosis in the field Alzheimer’s disease. In parallel, she is also a strong advocate of advancing research into sex- and gender-specific differences in brain and mental disease and a core team member of the Women's Brain Project and the Communications Chair of the Sex & Gender Alzheimer’s Association PIA.

15:00 - 15:20 - AGORA SESSION
—
Shifting the paradigm with Adaptive/Responsive Cranialized Brain Pacemaker to treat neurodegenerative diseases by cutting DBS surgery time in half!

What it takes to make Brain Pacemakers as routine as heart pacemakers and shifting the paradigm for Deep Brain Stimulation surgeries?

Similar to heart pacemakers, DBS is the gold standard for late-stage Parkinson’s treatment with world-wide regulatory approval, but adoption remains limited to ~5% due to patient access, procedure complexity, and cost, delaying and depriving eligible candidates. Diseases of cerebrovascular origins such as refractory hypertension, stroke, Alzheimer’s and vascular dementia rank alongside cancer as one of the greatest healthcare challenges faced by humanity, affecting one in three in later life.

Bioinduction has developed the first miniaturized precisely targeted, adaptive/responsive AI enabled, ‘brain-pacemaker’ called Picostim™, designed to be implanted directly into the skull and making it cosmetically invisible. Being a third of the size of conventional devices, it eliminates the need for tunneling extension wires (that need revision surgeries due to fractures) through neck tissue to a chest incision for the larger conventional batteries.

The elegant streamlined single-stage intra-operative skull integrated implantation workflow enables a safer, simpler, less traumatic, and less painful single-stage surgery, in less than half the time of conventional multi-stage, multi-day intervention, as well as doubling surgical productivity bringing cost savings for the health system, with lower life-cycle cost compared to conventional technologies. The procedure innovation harnesses convergence of state-of-the-art precise image guided planning and navigation enabling improved patient comfort with asleep surgery, an integrated surgical robot assistance, together delivering the future of brain pacemaker interventions.

Smart Picostim™ cranialized DBS platform innovation introduces a patient-centric brain pacemaker innovation together with an elegant single-stage procedure solution that enables paradigm change and introduces the future of brain pacemaker implantation to treat large unmet needs in chronic brain disorders via improved patient experience, increasing patient access, and improving overall outcomes for all the stakeholders.

Mr. Nik Patel has been practising Consultant Neurosurgeon and Honorary Senior Clinical Lecturer at the Institute of Clinical Neurosciences (University of Bristol) since his appointment in 2005. He trained in medicine at Charing Cross & Westminster Medical School, and in neurosciences at University College London. In 1991 he gained a First-Class Honours Degree in Neurosciences and in 1994 graduated in Medicine with Distinction in Pathology from University of London. His basic surgical training was completed at Oxford University. His neurosurgical training was completed at Frenchay hospital, University of Bristol, where he was appointed Consultant Neurosurgeon in 2005. Nik has developed a special interest in the treatment of functional brain disorders. His surgical and research interests have focused on developing innovations, and in advancing less-invasive and stream-lined procedural solutions. He has been recognised for his neurosurgical research excellence with a Medical Research Council fellowship; awards from both the American and the European Associations of Neurological Surgeons; and a Hunterian Professorship from the Royal College of Surgeons of England.

Former general manager of Neuromodulation international at Boston Scientific, former CEO Pixium Vision, Entrepreneur Brain-Machine innovations. Global business leader passionate about meaningful MedTech/NeuroTech innovations and transhumanism that makes a difference in improving lives. Interfacing the knowledge and technologies at the frontier of innovations with over 25 years of building and leading high-performance winning teams executing in high growth start-up ventures and multi-disciplinary environments. Spanning international general management and strategic responsibilities in Neuromodulation / Bioelectronics, brain-machine interface arena.

10:25 - 10:40 - BRAIN TALK
—
Dr Viktor Jirsa, Virtual Epileptic Patient technology

Over the past decade we have demonstrated that the fusion of a patient’s own brain imaging data with computational dynamic models allows building personalized virtual brain models with diagnostic and prognostic performance. Our hybrid approach fuses data-driven with mechanistic modeling techniques and has been successfully applied in aging and stroke research and to clinical applications in epilepsy. Here we illustrate the workflow called Virtual Epileptic Patient (VEP) along the example of drug resistant epilepsy, where the application of machine learning and AI allows the estimation of the epileptogenic zone. A large multisite randomized clinical trial is testing VEP technology in epilepsy surgery patients. The workflow of end-to-end modeling is an integral part of the European neuroinformatics platform EBRAINS and enables neuroscientists worldwide to build and estimate personalized virtual brains. Virtual Brain Technologies (VB-Tech) has recently been created as a spin-off from AMU to exploit virtual brain technology with the mission of commercializing the VEP medical device as a trailblazer of TVB technology and the long-term vision of transversal extension to other diseases including Parkinson, multiple sclerosis, and Alzheimer. VB-Tech will address the market access challenge, for this technology and its future developments, transitioning from an academic prototype to an industrialized and certified medical device, allowing for the patients to benefit from it. VB-Tech will also be committed to adding a strong focus on medical education on top of the commercial objectives, placing the clinician in the center of the project.

Viktor Jirsa is Director of the Inserm Institut de Neurosciences des Systèmes at Aix-Marseille-Université and Director of Research at the Centre National de la Recherche Scientifique (CNRS) in Marseille, France. Dr. Jirsa received his PhD in 1996 in Theoretical Physics and Applied Mathematics and has since then contributed to the field of Theoretical Neuroscience, in particular through the development of large-scale brain network models based on realistic connectivity, linking network dynamics to brain function, behavior and imaging. His work has been foundational for network science in medicine with clinical translation to epilepsy. Dr. Jirsa is lead of the brain simulation platform The Virtual Brain (www.thevirtualbrain.org) and lead scientist (WP1) of the European flagship Human Brain Project (https://www.humanbrainproject.eu/). Dr. Jirsa has been awarded several international and national awards for his research including the 1st Human Brain Project Innovation Prize (2021), Grand Prix Départemental de Recherche en Provence (2018), Early Career Distinguished Scholar Award (NASPSPA, 2004) and Francois Erbsmann Prize (2001). Dr. Jirsa serves on various Editorial and Scientific Advisory Boards and has published more than 160 scientific articles and book chapters, as well as co-edited several books including the Handbook of Brain Connectivity.

12:25 - 12:40 - AGORA SESSION
—
DYRK1A, a novel therapeutic target for Down syndrome and Alzheimer's disease

Our objective is a drug correcting cognitive deficits in Alzheimer’s disease (AD). Our strategy is to use Down syndrome (DS) as a ‘back door’ to enter the AD therapeutic field. Cognitive deficits in AD and in DS can indeed be attributed to an excessive production/activity of the DYRK1A protein kinase (gene located on chromosome 21). Consequently, genetic and pharmacological inhibition of DYRK1A correct cognitive deficits in various animal models of AD and DS. These results have encouraged us to screen for, develop and optimize pharmacological inhibitors of DYRK1A for over 15 years. We discovered that Leucettamine B, a natural product extracted from the marine sponge Leucetta microraphis, inhibits DYRK1A with relatively good selectively. Inspired by this initial hit, we first synthesized, optimized and extensively characterized >500 analogues, the Leucettines. Improving the pharmacological properties of these compounds led us to Leucettinibs, a second-generation family of DYRK1A inhibitors (0.5-20 nM IC50, orally available, >560 compounds synthesized, 4 patents filed). Leucettines (ip) and Leucettinibs (p.o.) correct spatial and learning memory deficits observed in various animal models of AD and DS. This strong proof of concept (and data from other groups) supports the idea that pharmacological inhibition of DYRK1A might correct memory deficits in AD and DS patients. Our final clinical drug candidate, Leucettinib-21, was selected following a stringent GO/NO GO decision tree based on multiple in vitro and in vivo safety, pharmacology (ADMET) and IP parameters, strengthening our chance to develop a solid therapeutic drug candidate for the correction of cognitive deficits. The synthesis of a 1.5 kg, GLP batch of Leucettinib-21 is being carried for the regulatory preclinical studies which will start in January 2022.

Laurent Meijer obtained Doctorate degrees from the Universities of Lille and Paris VI, did a post-doc at the Stanford University Hopkins Marine Laboratory, Pacific Grove (1978-’79), obtained a CNRS position in 1979, did a sabbatical in 1985-’86 at the University of Washington (Department of Biochemistry, Seattle) and was a Visiting Professor for 3 years (2001-2004) at the Rockefeller University in New York. As a CNRS Research Director he was heading a team of 21 co-workers (‘Protein Phosphorylation & Human Disease’ group), at the ‘Station Biologique de Roscoff’, till June 2011. He is now Chairman and Chief Scientific Officer of ManRos Therapeutics (2011) and of Perha Pharmaceuticals (2019), two small biotech companies focused on the development of kinase inhibitors targeting cystic fibrosis (CF) (ManRos), cognitive deficits associated with Alzheimer’s disease (AD) and Down syndrome (DS), prevention of Hearing Loss (HL) induced by ototoxic products or acoustic trauma, and polycystic kidney disease (PKD) (Perha Pharma). Aged 68, he is author of more than 360 scientific articles and co-inventor in 43 patents. His major work and expertise are focused on the search for, optimization and characterization of pharmacological chemical inhibitors, inspired by marine natural products, of disease-relevant protein kinases and their development as innovative therapeutic drug candidates.

11:45 - 12:05 - AGORA SESSION
—
Teleneurorehabilitation: new therapeutic approaches in acquired brain injury

The recent advances in Information and Communication Technologies (ICTs) enabled a growing amount of people worldwide to remotely interact at affordable costs, embracing the possibility to join in complex human activities like neurorehabilitation. During the last decades telemedicine tools have been implemented, which have proven to be a solution for continuity of care in patients at risk of isolation (e.g. people living in remote areas worldwide) and in several clinical conditions (e.g. immunocompromised individuals) showing good adherence and also a positive impact in terms of efficacy in different areas of intervention. Additionally, telerehabilitation can be adapted to multiple clinical conditions and allows individualization of treatment to suit the needs of the patient and the pathology.

The health pandemic caused by SARS-CoV-2 (COVID-19) has limited the access of a large number of patients with acquired brain damage to neurorehabilitation programs [1]. The activities of the rehabilitative team were limited to those strictly necessary: the out-patients’ treatments or those delivered at home by therapists were suspended ante most of in-patients were confined to patient’s room. Noteworthy, beyond physical distancing measures, also changes in healthcare services access regulation are negatively affecting the access to rehabilitative services during the current pandemic [2].

Ensuring the continuity of cure, an adequate treatment intensity and repetition over time are major challenges in neurorehabilitation. Telerehabilitation can potentially enable continuum of care in situations of physical distancing, so it could be an effective alternative to physical intervention and mitigate some negative effects caused by the pandemic. As far as neurorehabilitation is concerned, most of the programmes developed have focused on specific aspects, especially motor aspects such as balance or upper limb, but not on a multi-specialist approach or within a more global framework. Moreover, most of these studies have used selected samples with restricted inclusion criteria (excluding cognitive problems, language, major dependencies…).

The objective of this study was to determine the effectiveness, adherence and usability of a teleneurorehabilitation tool aimed at providing patients with acquired brain injury with clinical assistance during the pandemic.

Methods

All patients older than 18 years old who participated in a face-to-face neurorehabilitation program at the time of confinement were candidates to participate in a teleneurorehabilitation program. An individual intervention was planned for all the participants who accepted to participate in the teleneurorehabilitation program to replicate their face-to-face program, reproducing the contents, duration and frequency of the sessions, as well as their previously assigned therapists. This planning was reviewed weekly. The effectiveness of the program was determined from the change in functional independence, determined with the extended version of the Barthel Index, once the face-to-face activity was resumed. The adherence to the program was assessed by the responsible therapist using a 10-point Likert scale. The usability of the teleneurorehabilitation tool was determined by the participants using an “ad-hoc” questionnaire.

Conclusions

The teleneurorehabilitation intervention was effective at improving the independence of patients with acquired brain injury, and promoted high adherence and usability. These data could be seen as an opportunity to rethink current neurorehabilitative routines, envisioning mixed procedures in which face-to-face sessions are integrated and combined with telerehabilitation.

Dr. Joan Ferri serves as General Director of Vithas Hospitals Neurorehabilitation Network (www.neurorhb.com), which includes different rehabilitation facilities located in Spain. He is also an active member of the National Medical Advisory Committee of Vithas Hospitals.He is currently the President of the Spanish Society of Neurorehabilitation and member of the scientific committee of neurorehabilitation in the European Academy of Neurology. Dr. Ferri is an expert in Neurorehabilitation, clinical Neuropsychologist and PhD at the University of Valencia. He has served in the Board of Governors of the Spanish Neurorehabilitation Society from 2000 and is the actual President of this institution. Dr. Ferri is also a member of the Stroke Strategy Committee (Spanish National Health System), and collaborates as associate member with the National Commission of Brain Injury due to traffic accidents. From an academic perspective, he collaborates with the University of Valencia and coordinates a Master's Degree in Neurosciences and Neurorehabilitation at CEU University. Dr. Ferri, participates as a member in numerous national and international societies, including the International Brain Injury Association (IBIA) and the International Society of Neurorehabilitation and Brain Damage. He is the author of more than 100 peer-review scientific articles and book chapters on neurosciences and most importantly he is a recognised collaborator of national brain injury family associations.

09:40 - 11:30 - PANEL DISCUSSION
—
Business Development in Neurology, Psychiatry and Unmet Needs

An interactive panel discussion where senior representatives from pharmaceutical companies will discuss their organizations areas of interest in neurology and psychiatry, their priorities for sponsored research, collaboration and partnering, criteria, and the approach to relationship development and collaboration. Special attention will be paid to challenges in the sector and addressing unmet medical needs. Questions from the audience will be encouraged.

Christian is a business and innovation advisor in the biotech, health and pharma sectors, with 20 years strategic advisory, business creation, development and operational experience. His focus is business strategy, financing and business development for start-up and growth companies, and innovation policy for governments, university networks, and health systems. He founded the leading international biotech and health focused platform for connecting technology transfer, licensing and innovation office directors with serial entrepreneurs, industry and investors, over 10 years chairing more than 30 international summits on 5 continents, designed to the build expertise and capacity of tech transfer officers and startup and spinout CEOs to engage effectively with industry and investors. These summits were attended regularly by representatives of over 300 leading medical and life sciences universities and institutes world-wide and hosted by organizations such as the NIH, Wellcome Trust and Institut Pasteur. He was the lead rapporteur for the EC’s 3 year innovation in healthcare initiative, led a successful turn-around of a near bankrupt European biotechnology federation, coordinated the first European level entrepreneur training bootcamp for biotech founders/CEOs, developed the first pan-European biotech investment conference for start-ups in collaboration with the EC and EASDAQ (now Euronext), and convened the working group which led to some of the first formal collaborations and LP investments by large industrial biotechnology companies into venture capital funds. He has served as advisor and board member to private companies, associations, and patient organizations, and through Broadreach Global’s Confluence Innovation network, provides innovation stakeholders from research, healthcare and startup companies by-invitation access to and partnering with a global network of investment and industry KOLs.

Norman Putzki, M.D., Ph.D., based in Basel, Switzerland, is the Novartis Global Development Head Neuroscience. He studied Human Medicine in Germany, the United Kingdom and Switzerland and graduated from Essen University (Essen, Germany) as M.D. He earned his PhD ‘magna cum laude’ for investigating the NDMA pathway in Parkinson’s Disease. He performed residency training in Internal Medicine and Neurology in Essen, University College London (Institute of Neurology Queen’s Square) and University of Berne (Switzerland). During his academic career, his focus was on inflammatory disorders of the CNS. He led clinical and research groups in two academic centers before joining pharma industry in 2010 (Medical Research, Biogen Idec, Cambridge, MA, US). In 2013, Norman joined Novartis and consecutively held leadership roles of increasing seniority in development. Later-on, he led the US Neuroscience Medical organization before returning as Global Head of Development Neuroscience. Norman has a strong background in neuroimmunology with work in the areas of regulatory T cell function and many clinical aspects of MS. He authored/co-authored >50 peer reviewed publications and 4 books. He is a fellow of the American Academy of Neurology.

John Isaac joined Johnson & Johnson in September 2016 as Senior Director, identifying and advancing collaborative opportunities in Alzheimer’s Disease and mood disorders. Prior to this John was Head of Neuroscience and Mental Health at the Wellcome Trust (2014-2016). Previous to that he worked at Eli Lilly in the UK leading a team of labs dedicated to identifying new treatments for Alzheimer’s disease and schizophrenia. John obtained a BSc in Pharmacology and Biochemistry at the University of Southampton in 1990. His postdoctoral training was with Rob Malenka and Roger Nicol at UCSF. He has held tenured academic positions at University of Bristol and at the National Institutes of Health, USA. John has published > 80 peer-reviewed research papers with >10,000 citations and holds an honorary position at at University of Oxford.

10:30 - 11:20 - PANEL DISCUSSION
—
Business Development: Imaging, AI and Digital

An interactive panel discussion with senior representatives from large healthcare, technology and pharmaceutical companies. Discussion will focus on their application of imaging, Artificial Intelligence and digital technologies in the brain health space, their strategies and research and partnering interests. What are they developing internally and what are the priorities for external R&D and innovation partnering? In what areas are they keen to engage with partners, at what stage, and under what criteria? What areas are considered of greatest potential, and where are the most important challenges? Questions from the audience will be encouraged.

Jan Vandenneucker is an experienced project lead, strategist, and technology architect for digital health projects in the field of neurology. Driven by a passion for solving complex problems, he takes pride in developing solutions that have the potential to make a transformational difference in improving care for people living with a neurological condition. As a Digital Care Transformation Project lead at UCB Biopharma, his remit includes Epilepsy, Myasthenia Gravis and Progressive Supranuclear Palsy. In addition to his primary job functions, Jan is a mentor to the UCB’s young professionals employee resource group. He holds a MSc in Applied Sciences & Engineering from the Free University of Brussels and currently resides in Belgium.

Zsolt Lenkei graduated in 1992 from Semmelweis University's Faculty of Medicine in Budapest, Hungary. He obtained a PhD in Neurosciences from the University Pierre and Marie Curie in Paris in 1998, while working at the Chaire de Médecine Experimentale of the College de France, Paris. After a post-doc at the Montreal Neurological Institute of McGill University, Canada, he established an independent research team at ESPCI Paris. He was recently recruited as senior team leader to the new Institute of Psychiatry and Neurosciences of Paris at INSERM. He is an internationally recognized specialist in the neuronal cell biology of cannabinoid receptors, as shown by his election as co-chair of the Gordon Research Conference on Cannabinoid Function in the CNS, 2019. He has a proven track record of success in contributing to interdisciplinary projects that include renowned physicists and chemists, collaborations that have yielded several important publications and patents. Finally, he is still the fastest Hungarian sailor, by holding the national World Sailing Speed Record Council (WSSRC) record, made in 2010 in Lüderitz, Namibia.

11:45 - 12:25 - PANEL DISCUSSION
—
Financing Brain Innovation

A discussion panel with leading European venture capital investors focused on or actively investing in CNS, neurology, psychiatry and brain related innovations, including both bio-pharma and imaging, AI, medtech and digital technologies. What are their specific investment interests, and why? What are their criteria, and at what stage do they engage and invest? How does this vary according to indication and approach? What data do they want to see and what other factors paly a key role in the decision to invest? How is risk assessed and managed, and are there greater barriers to investment in some areas of brain health than others, and why? Questions from the audience will be encouraged.

Prof. dr. Philip Scheltens studied at the VU University Amsterdam, Netherlands, gaining his MD in 1984, and PhD in 1993. Clinical residencies in neurosurgery and neurology supported his academic development. He is Professor of Cognitive Neurology and Director of the Alzheimer Center at Amsterdam University Medical Centers. His main interests are early diagnosis, biomarkers, clinical trials and drug development. He has been the (inter)national PI for over 35 studies, including phase 1-3 multicenter clinical trials. He supervised >75 PhD theses since 2000. He founded the Dutch national plan against dementia and served as chair of the board. He is co-editor-in-chief of Alzheimer’s Research & Therapy and co-leads various EU projects. He authored over 1100 peer reviewed papers and > 75 book chapters and co-edited several major text books. He is member of the Royal Dutch Academy of Arts and Sciences (KNAW) and served as Secretary General until 2020. In 2016 he was awarded the European Grand Prix for Alzheimer’s Research. In 2020 he was Knighted in the Order of the Netherlands Lion by the King. Since 2020 he is also managing partner of the LSP Dementia Fund. In September 2021 he was elected chair of the World Dementia Council.

Raúl Martín-Ruiz is a Partner in Ysios Capital, a leading Spanish independent venture capital firm that provides private equity financing to early- and mid-stage human healthcare and life science companies. Prior to joining Ysios in 2008 he developed his career in Laboratorios Almirall, initially working in corporate business development (Licensing In and Licensing Out) and then as responsible for developing and managing the business of the company in the Americas and Africa through licensees and distributors. Initially he was trained as a researcher in the areas of Central Nervous System pharmacology in the Department of Pharmacology of the UPV-EHU (University of the Basque Country), and in neurochemistry in the Department of Neurochemistry of the IIBB-CSIC (Institute for Biomedical Research of Barcelona-Spanish National Research Council). He is a Board member of Synendos Therapeutics and CorWave, Chairman of Anaconda Biomed and former Board member of STAT-Dx (acquired by Qiagen), Prexton Therapeutics (acquired by Lundbeck) and MedLumics. He has a B.Sc. in Biological Sciences by the UPV-EHU and holds a Ph.D. in Neurosciences by the same university and the CSIC.

Laia joined Sanofi Ventures in 2018 with a background in biotech investing primarily in Europe. Prior to Sanofi, Laia served as Investment Director for Ysios Capital where she led investments and served on the Boards for OxThera, Minoryx Therapeutics and Inbiomotion, and as an observer for AM-Pharma. Earlier in her career, Laia was part of the European New Business Development team of Janssen-Cilag, a pharmaceutical company of the Johnson & Johnson group, where she assessed commercial and scientific licensing-in opportunities. Previously she worked as a researcher in the UK in companies such as Spirogen (now AstraZeneca), Medivir and UCB-Celltech. Laia currently serves on the Board of Directors for Muna Therapeutics and is a board observer for Nodthera. Previous investments and board roles include Lava Therapeutics (LVTX). Laia graduated in Chemistry from the University of Barcelona, where she also completed a Master in Science and a Ph.D. with honors. Laia holds an M.B.A. from Cambridge Judge Business School, University of Cambridge, where she focused on biotechnology, healthcare and finance.

14:20 - 14:35 - INNOVATION SHOWCASE
—
NIMOCHIP: a microfluidic lab-on-a-chip for better diagnostIcs of nerurodegenerative diseases

Amyotrophic lateral sclerosis (ALS) is a severe and fatal neurodegenerative disease characterized by an asymptomatic phase of undetermined duration while it takes on average about nine to 12 months for someone to be diagnosed with ALS. The time from the asymptomatic phase to the first notice of symptoms could last for years. However, there is no specific biomarker in the presympomatic phase, and there is no specific test for precise diagnostics in the symptomatic phase. At the early stages, ALS shows high clinical variability in presentation and prognosis and overlapping symptoms with other neurological disorders, so clinicians at that stage tend not to make such diagnosis. All of this leads to a diagnostic delay from several months to years causing progression of the disease that lead to complete patient disability and death without the possibility of successful treatment. Early, precise and more specific diagnosis is needed for adequate and personalized treatment.

We base our approach on decades of our pre-clinical research of ALS patient sera that led us to identify a set of novel biomarkers and a detection technology for early-stage ALS progression. We are developing a portable stand-alone clinical “lab on a chip”, NIMOCHIP^® for disruptive in vitro diagnostics of ALS that could be further developed to diagnose other neurological disorders with an inflammatory component (e.g. multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, Huntington’s disease,). NIMOCHIP^® contains multiple chambers with seeded living cells (of animal or human – cell line origin) labeled with fluorescent probes, that are treated with nanoliter volumes of patient’s samples (purified immunoglobulins G – IgGs from patient sera).

NIMOCHIP is using “optics on a chip” technology that could measure a set of physiological fluorescence molecular biomarker signatures (intracellular calcium, reactive oxygen species – ROS, pH, ion channel responses). The acquired optical signals are analyzed using specialized software to obtain a personalized biomarker signature and to generate a detailed diagnostic report for the clinician.

Full professor, Founder and head of Center for laser microscopy, Faculty of Biology University of Belgrade. Coordinated the first FP project in biomedicine in Serbia - FP6 project “NEUROIMAGE”, and now coordinates a H2020 MSCA RISE project “AUTOIGG” aiming to design a lab & optics-on-a-chip device using fluorescence signaling for the diagnostics of neurodegenerative diseases. President of the Serbian Brain Council the member of the European Brain Council (EBC) and liaison of the National Councils to the EBC, European Society for Molecular Imaging Board member, Association of Italian and Serbian Scientists Steering committee member, Former president of the Biophysical Society of Serbia, Founding member of the Optical Society of Serbia, Member of University Graduate Studies Council; Founded PhD programmes in Biophotonics and Biophysics at the University of Belgrade; Expertise: neurobiophysics of ion channels and cellular mechanisms in neurodegenerative diseases and use of advanced microscopy in bioimaging.

14:00 - 15:15 - BREAKOUT SESSION
—
Cannabis and the Brain

Session sponsored by Cannabinoid Education 360

Professor Dr Eugen Trinka FRCP is Chairman of the Department of Neurology at the Christian-Doppler-Klinik (CDK), Paracelsus Medical University Salzburg, and Chair of the Neuroscience Institute, Salzburg, Austria. He received his MD from the University of Vienna and an MSc in Public Health Sciences and Technology from the UMIT Hall in Tirol. After a research fellowship at the Montreal Neurological Institute, McGill, Canada, he built up the comprehensive epilepsy centre at the Department of Neurology, Innsbruck Medical University, Austria. In 2010, Professor Trinka was appointed Chairman of Neurology at Paracelsus University, where he continued building epilepsy services of excellence and participated actively in the European Reference Network EpiCARE. He is currently Chair of the International League Against Epilepsy (ILAE) Europe and member of the ILAE Executive Committee. He served as President for the Austrian Chapter of the ILAE and as President of the Austrian Society of Neurology from 2018 to 2020. Professor Trinka’s research interests include cortical dysplasia, status epilepticus and drug development, cognitive neurosciences and neurophysiology, and public health. He has authored over 530 peer-reviewed publications and is an active member of various task forces for the ILAE.

Dr Amir Englund PhD is a research fellow at the Department of Addictions and the Department of Psychosis studies at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London. He completed his PhD on the psychopharmacology of cannabis constituents including their acute, cognitive and electrophysiological effects. He has carried out research in cannabinoid psychopharmacology and has conducted several experimental cannabis studies involving healthy volunteers. He has also worked on clinical trials of cannabidiol (CBD, a non-intoxicating cannabinoid) as an adjunct treatment of patients with a psychotic disorder. He is currently running a study in healthy volunteers where he aims to find the optimum ratio between THC and CBD in cannabis that is least related to cognitive impairment and paranoia. Dr Englund has advised both UK and European bodies on cannabinoid science.

Chandni Hindocha PhD is Associate Director, Scientific Advisor for Cannabinoid Science at GW Pharmaceuticals (part of Jazz Pharmaceuticals). She received her PhD from University College London (UCL) in the neuropsychopharmacology of cannabinoids and their implications in neuropsychiatric disorder and conducted post-doctoral research at UCL and Yale University on the genetics of the endocannabinoid system in addiction and psychosis. She has a background in clinical trials on cannabidiol and the psychopharmacology of addictive disorders. She has been awarded several prestigious awards from academic societies including the 2020 Senior Public Communication Award from the British Association of Psychopharmacology and the 2020 Rafaelsen Young Investigator Award from the International College of Neuropsychopharmacology. She has published over 50 papers in high-impact neuroscientific journals, of which 17 are first/joint first authorship.