Key Opinion Leaders

A recognized global leader in stroke therapy, Dr. Lyden led a landmark 1995 clinical study that resulted in approval of the first treatment for stroke, which involves the intravenous delivery of an engineered protein that breaks down blood clots. His research bridges the lab and the clinic, with a focus on translating discoveries into new therapies that can eventually be tested in the type of large, multi-institutional clinical trials that he helms.

Dr. Lyden also played an important role in refining the National Institute of Health Stroke Scale, a widely used tool for evaluating the severity of a stroke. He produced and directed training and certification videos about the scale that have been viewed almost 2 million times by health care providers around the world.

The co-author of over 350 peer-reviewed papers and book chapters, Dr. Lyden has received research funding from federal agencies continuously for more than 30 years. He is advancing a new approach to stroke treatment using agents that target multiple biochemical pathways at the same time. His studies delve into the toxic effect on brain cells of thrombin, an enzyme that helps blood clot, as well as the therapeutic possibilities of blocking that enzyme. Another research interest centers on lowering the body temperature as a potential stroke treatment.

Dr. Lyden is no stranger to USC. He pursues active collaborations with faculty in the Zilkha Neurogenetic Institute and in the Laboratory of NeuroImaging (LONI) to develop therapies for stroke. Even closer connections are likely to speed the progress of complicated trials, such as an ongoing three-year, multicenter preclinical study.

In addition to the allure of facilitating his research partnerships, Dr. Lyden is excited by the academic atmosphere at the Keck School of Medicine.

“I’m very grateful for my 10 years at Cedars-Sinai. It’s been great,” he said. “Here at the final chapter of my long career, I’m very much looking forward to returning to an academic milieu full of challenging graduate students, postdoctoral scholars and research faculty who are fully invested in basic science.”

Dr. Lyden is board-certified in vascular neurology and has been ranked as one of the “Best Doctors in America” continuously since 2009. He will see patients at the LAC+USC Medical Center and the Keck Medicine of USC clinic in Beverly Hills.

At Cedars-Sinai, Dr. Lyden founded the Department of Neurology, the Comprehensive Stroke Center, the Neurology Residency Program and the Vascular Neurology Fellowship. Before that, he was professor and vice chair of clinical neurology at the University of California, San Diego, and clinical chief of neurology and director of the Comprehensive Stroke Center at UCSD Medical Center. He also served as staff physician at the Veteran’s Affairs Medical Center.

Dr. Lyden completed his medical training at the Baylor College of Medicine in Houston, followed by an internship at Mercy Hospital and Medical Center in San Diego and a neurology residency and stroke fellowship at UCSD Medical Center.

He has earned such honors as the American Stroke Association’s William M. Feinberg Award for Excellence in Clinical Stroke, as well as election to the American Academy of Neurology, the American Neurological Association, the American Heart Association, and the European Stroke Organization.

He is a member of the editorial board of the journals Stroke and Therapeutic Hypothermia and Temperature Management, an associate editor of The International Journal of Stroke and a peer reviewer for Lancet and Science Translational Medicine.

Jeffrey Saver, MD, works at the University of California at Los Angeles (UCLA), where he is medical director of the Stroke Unit at the UCLA Medical Center, an associate professor of neurology at the School of Medicine, and codirector of the Stroke Center. He has published more than 80 original articles, more than 15 book chapters, and two edited volumes. His research focuses on stroke prevention, acute stroke treatment, stroke diagnosis, and cognitive and behavioral consequences of stroke.

Saver is a fellow of the Stroke Council of the American Heart Association and the American Academy of Neurology. He received both his undergraduate and medical degrees from Harvard University and trained in internal medicine at Brigham and Women’s Hospital in Boston and in neurology at the Harvard-Longwood Neurological Training Program. Saver performed additional subspecialty fellowship training in cognitive neuroscience at the University of Iowa and in cerebrovascular disease at Brown University.

Kennedy Lees is Professor of Cerebrovascular Medicine at the University of Glasgow, UK, and Director of the Acute Stroke Unit in the Western Infirmary in Glasgow 1990-2015. His research interests include acute neuroprotection and thrombolysis for stroke, stroke trial design and secondary prevention, including blood pressure manipulation and AF detection. He has extensive experience with translational medicine in relation to stroke treatment. Recent research has concerned choice of outcome measures for stroke trials, the training of investigators in their use (such as the Rankin training programme) and the optimal analysis approaches.

Professor Lees has helped coordinate multicentre stroke trials including PROGRESS, ASSIST, MAST-E and CARESS, and acted as chief investigator for the GAIN-International, IMAGES, SAINT I and MACSI trials. He leads the Virtual International Stroke Trial Archive (VISTA) group, chaired the SAINT and CHANT Trials’ Steering Committee, is a past chairman of the European Stroke Council and is President of the European Stroke Organisation. He has chaired data monitoring committees for acute stroke trials including ICTUS, DIAS, ASSIST, mRECT trials, ECASS 3 and NEST-3. He chairs the outcomes committees for trials including the NIH-funded CLEAR-3 and MISTIE-3 trials, EU FP7-funded EuroHyp-1 and PRECIOUS trials, SITS-OPEN and CREGS-S. He is European associate Editor for Stroke. He is a member of the Scientific Steering committee and UK Coordinator for the Safe Implementation of Thrombolysis in Stroke (SITS) collaboration, and helps lead pooled individual patient analysis of iv thrombolysis trials and thrombectomy trials in stroke.

As President of the European Stroke Organisation, Professor Lees was chairman of the first ESO Conference, held in Glasgow in April 2015 and will lead the second ESO Conference to be held in Barcelona in May 2016.

Liz leads the advisory and consulting services for the Wool Consulting Group and the Wool Training Institute.  She has over 30 years of clinical research experience, and 23 years in education and training, and is a recognized thought leader (workforce development, workforce resource management, training and clinical research), trainer, and international speaker with a focus on solutions and added value results for the research community and clients.  She is a certified instructional designer, virtual training instructional designer, training manager and master trainer. Serves as the Chief Learning Strategist for Wool Consulting Group and Wool Training Institute.  Her expertise produces results in both organizational effectiveness and efficiencies (design, re-design, modifications for growing companies, and post-mergers and acquisitions) in support of the organization’s goals.

Liz has provided consulting and training services to Academic Institutions, NIH, global NGOs, CROs, biotechnology and pharmaceutical organizations, that includes six of the TransCelerate Biopharma, Inc. companies during her consulting tenure in the areas of department level strategic support, workforce development and engagement strategies and methods, enterprise wide training strategy, and framework gap analyses, training course design, development and  delivery, and metrics,  SOPs and performance management  and vendor program gap analyses and framework development.

As a distinguished author with both ACRP and SoCRA professional associations, Liz has published articles on Workforce Development and Workforce Resource Management, Professionalization of the Clinical Research Coordinator, Education and Training, Metrics, and Quality Management Systems, to name a few. She was the Guest Editor, for the ACRP Journal Titled – Focus on the Learner: Education and Training in the 21^st Century – Paradigm Shift to Performance.

Further, Liz has presented at both the ACRP and SoCRA annual meetings on Workforce Development and Workforce Resource Management since 2018 that reflects her 20 years’ experience and thought leadership in developing and equipping the workforce for the present and the future.

Wool Consulting Group is a Champion Member for the Partners in Workforce Advancement initiative led by Association of Clinical Research Professional with representation on the Diversity in Clinical Research Professionals Steering Committee and Career Development Committee. Liz also served on the Harvard MRCT committee for the Clinical Research Competency Model Framework.

As the Chief Learning Strategist at Wool Consulting Group, Liz leads the workforce development and Wool Training Institute advisory and consulting services as she is passionate about developing the workforce to their personal and professional potential and performance and supporting the organizations to accomplish this goal! Equipping the learning and development team to accomplish these goals is critical to organizational success.  As part of the Wool Training Institute’s philanthropic initiatives, Liz and colleagues provide mentoring to clinical research professionals in Nashville, TN – in the Saturday Series Future Notes to My Self  – that will be launched later in 2021. Additional philanthropic initiatives include supporting instructional designers and trainers to various learning modalities (in-person, virtual, eLearning, microlearning) that is free to a global audience for upskilling their expertise (see Wool Consulting Group website).

Dr. Steven C. Cramer is a Professor of Neurology at the University of California, Los Angeles. He is also the Director of Research at California Rehabilitation Institute, and co-PI of the NIH StrokeNet clinical trials network. Dr. Cramer graduated with Highest Honors from University of California, Berkeley; received his medical degree from University of Southern California; did a residency in internal medicine at UCLA; and did a residency in neurology plus and a fellowship in cerebrovascular disease at Massachusetts General Hospital. He also earned a Masters Degree in Clinical Investigation from Harvard Medical School.

His research focuses on neural repair after central nervous system injury in humans, with an emphasis on stroke and on recovery of movement. Treatments examined include robotic, stem cell, monoclonal antibody, brain stimulation, drug, and telehealth methods. A major emphasis is on translating new drugs and devices to reduce disability after stroke, and on individualizing therapy for each person’s needs. Dr. Cramer has been awarded the Stroke Rehabilitation Award from the American Heart Association and the Barbro B. Johansson Award in Stroke Recovery from the World Stroke Organization, co-edited the book “Brain Repair after Stroke”, and is the author of over 250 manuscripts.

A list of Dr. Cramer’s publications can be found at
https://www.ncbi.nlm.nih.gov/myncbi/1rSsCRxdbzpAQ/bibliography/public/

Dr. Posner is a Professor of Psychiatry at Columbia University and her work is saving lives all over the globe across 6 continents. The President of the American Psychiatric Association noted her work with the Columbia Protocol could be “like the introduction of antibiotics.” The U.S. Department of Defense said that her work is “nothing short of a miracle” and stated “her effective model of improving the world will help propel us closer to a world without suicide.” The CDC noted that her work is “changing the paradigm in suicide risk assessment in the US and worldwide.”

Dr. Posner’s work has been noted in a keynote speech at the White House and in Congressional hearings, and she gave the lead presentation in a forum on school safety at the U.S. Senate in her partnership with the Parkland community. Through her advocacy she has changed local, national and international policy, which in turn has helped achieve reductions in suicide across all sectors of society. Israeli government officials said her work “is not only saving millions of lives but in Israel it is literally changing the way we live our lives.”

She gave the invited presentation on tackling depression and suicide at the first European Union high level conference on mental health, was recognized as the Most Distinguished Alumna of her graduate school at Yeshiva University in the past 50 years, and received the New York State Suicide Prevention Award. She was also named one of New York Magazine’s “Most Influential.”

The Columbia Protocol is policy across all 50 states, many national agencies, and most countries. Dr. Posner was commissioned by the FDA to develop a scientific approach that has become the gold standard for suicide monitoring and is ubiquitous across the U.S. and worldwide. The FDA has characterized her work as “setting a standard in the field” and a lead article in The New York Times called it “one of the most profound changes of the past sixteen years to regulations governing drug development.” Her scholarly work has been included in the compendium of the most important research in the history of the study of suicide.

In 2018, Dr. Posner was awarded The Secretary of Defense Medal for Exceptional Public Service.

Kim draws on her broad-based industry experience to offer a wide variety of services to meet the diverse needs of clients. A member of the CNS (Collaborating for Novel Solutions) Summit Leadership Council, shaping the future of clinical development, she is actively involved in providing innovative solutions to make it easier and more efficient for sites and patients to participate in clinical trials. Dr. Bishop developed the initial executive function test battery (a novel collection of validated cognitive tests) utilized in global phase III dementia (Parkinson’s disease) trials, with several tasks now routinely incorporated across many indications. Educational & Research Background: pharma medicine, cognitive psychopharmacology, experimental psychology, and lean 6 sigma healthcare. +25y Clinical Research, Global Clinical Operations, Cognitive Drug Research, Drug Safety, and a consultant/service provider/trainer working with many powerhouses across the industry.

With Kim’s versatile skill set and varied experiences, she is recognized as a valuable contributor in:
• Global Clinical Operations
• Cognitive & Executive Function Testing in Clinical Trials – continued strategic advancement in Alzheimer’s, Parkinson’s, Epilepsy, Psychiatric, Autism/ADHD, Oncology, etc.
• Training Materials & Tools – providing standardized and customized programs
• Innovative Global Training Technology (+1.5 million) – empowering healthcare professionals and sites to connect with sponsors, CROs, IRBs and other industry stakeholders to share and exchange info for business and regulatory purposes
• Clinical Outcome Assessments – developing innovative strategies for COA instrument selection
• Artificial Intelligence (AI) – unlocking hidden data patterns to help discover new opportunities for compounds in development
• Operations Transformation – maximizing efficiency, reducing costs, enhancing quality, improving customer experience
• Collaboration Initiatives – driving radical change across the industry

Dr. Ramirez provides Rater Training for CNS Clinical Trials, Protocol Consultation, Neuropsychology (Cognition), Psychopathology, Psychopharmacology

Dr. Paul Michael Ramirez is Professor and a former Chair of Psychology. He completed his doctoral degree in Psychology at The City College of the City University of New York (CUNY) with a specialization in Clinical Neuropsychology and a subspecialization in Clinical Psychopathology, while on a National Science Foundation Fellowship. He later completed a Postdoctoral Program in Psychopharmacology at Fairleigh Dickerson University.  Dr. Ramirez also earned an M.Phil. in Psychology (Concentration in Neuropsychology) from the Graduate School & University Center, CUNY, an M.A. Degree in Psychology from the City College of New York and an M.A. Degree in Reading Disabilities with a postgraduate year studying Learning Disabilities at New York University. His clinical experience includes having served as Treatment Team Leader of the Geriatric and Neuropsychiatry Units and Acting Chief of the Research Unit of an Albert Einstein College of Medicine affiliated hospital in New York City where he also served as Director of Education for AECOM/BPC Psychopharmacology CME. He was also Senior Neuropsychologist and Assistant Professor of Psychiatry at the Columbia University College of Physicians and Surgeons. Dr. Ramirez currently serves on the Board of Advisors at the Center for Advanced Studies in India (CASII-Bhuj, Kutch; also called Kachchh in the District of Gujarat) as a clinical trial expert and has been appointed to a second 5-year term on the State Psychology Board by the New York State Board of Regents, currently serving as its Chair. He has also recently completed a term as Vice President of the New York Academy of Traumatic Brain Injury. Dr. Ramirez has made over 200 professional presentations and, over the past 20 years, has provided rater training for pharmaceutical efficacy and side effects scales across CNS indications as well as for the assessment of cognitive disorders throughout North America, South America, Central America, Asia, Eastern and Western Europe, Scandinavia and South Africa. Dr. Ramirez has published papers on schizophrenia, other major mental disorders, health psychology and has been Principal Investigator and Co-Investigator on grants from the National Institute of Health (NIH), National Cancer Institute (NCI), The National Institute of General Medical Sciences (NIGMS) and pharmaceutical industry sponsors. Dr. Ramirez is also listed as a contributing author of the Positive and Negative Syndrome Scale (PANSS), a co-author of the Informant Questionnaire for the PANSS (IQ-PANSS) and a co-author of the official Japanese translation of the PANSS.

Dr. Quinn holds the post of Senior Clinical Lecturer and Honorary Consultant Physician in Stroke. He has a broad research portfolio, his principal research interests are around trial methodology, functional assessment and neuropsychological consequences of cardiovascular disease.

Dr. Quinn has published extensively on topics relating to stroke, cognition and test accuracy and has authored original research, opinion pieces and editorials for journals such as British Medical Journal; Journal of the American Medical Association and New England Journal of Medicine.

He is Principal Investigator for a number of studies and holds the inaugural CSO/Stroke Association priority program grant for his research into cognitive outcomes following stroke. Recent notable outputs include co-authoring best practice guidance for test accuracy studies in dementia; creating online training for stroke trials and developing short form assessment scales that are being used in various research studies and clinical sites.

Dr. Quinn is passionate about evidence based practice and has worked to raise standards in clinical research involving older adults. He holds editorial board positions with various journals including Stroke (American Stroke Association); Frontiers in Neurology (Frontiers) and PLOS (Public Library of Science). He is coordinating editor for the Cochrane Dementia Group; member of the Dementia Platforms UK vascular theme and part of the NIHR Complex Reviews Support Unit. Previous roles include the guideline writing group for the European Stroke Organisation; Question Writing Group for the Royal College of Physicians and Scientific Committee of the British Association of Stroke Physicians.

Within the University, Terry has a number of supportive roles. He leads the Glasgow Academic Training Environment, mentoring the next generation of clinic al academics. He is also vice chair of the MVLS ethics committee, advisor of studies for undergraduate medical students and part of the Athena Swan Self-Assessment Team. Beyond the University his academic citizenship includes chairing Trial Steering Committees and Data Safety Monitoring Board; examining for higher degrees and sitting on grant and fellowship review boards for various research funders.

Communicating science is a particular strength and in his role working with patient, caregivers and lay public, as lead for the Scottish Stroke Research Network he has initiated a number of schemes around research dissemination and involvement. As clinical member of the Scottish Parliament Cross Party Group on Heart Disease and Stroke and advisor to Healthcare Improvement Scotland, Terry has ensured that research results inform policy. A recent example is his role as medical advisor to the National report on atrial fibrillation.

Identifying, researching, writing and editing evidence-based case studies to highlight the non-academic impacts of research conducted in the College of Medical, Veterinary and Life Sciences as a key component of the 2021 Research Excellence Framework (REF) submission.

Editor and writer with substantial experience in biomedical publishing and research.

Professional skills include:
• Developmental editing of original research papers, opinion articles, reviews and funding applications
• Writing news stories, features, editorials, reports, research impact case studies, article synopses, e-learning course material and other online content
• Commissioning, peer review, sourcing artwork and proofreading
• Use of electronic systems to manage copyflow and layout
• Planning and execution of time-sensitive projects
• Use of social media to promote content and communicate key messages
• Ability to deal with a varied workload and meet strict deadlines
• Ability to work effectively with a diverse range of internal and external contacts
• Ability to use initiative to take decisions, solve problems and work under minimal supervision
• Considerable experience of the higher education sector, the academic research environment and impact-driven research

Co-creator and Educator for the free online course Research Impact: Making a Difference, which was developed by the University of Glasgow and is hosted by FutureLearn.