In the November 2020 issue of Movement Disorders, Dommershuijsen and his fellow researchers in the Netherlands wrote an excellent editorial on the ethical considerations of screening for rapid eye movement sleep behavior disorder (RBD) in the healthy general population. I wanted to use this blog to discuss why this question is such an important one to consider as discoveries in the alpha-synucleinopathies continue to advance.
The identification of a reliable biomarker in neurodegenerative diseases such as Parkinson’s disease and Alzheimer’s…
Neurodegenerative diseases like Parkinson’s and dementias continue to represent some of the most significant threats to human health and the healthcare system at large.
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Dr. Roy Freeman, one of CND Life Sciences’ three founders and a senior scientific advisor, is Professor of Neurology at Harvard Medical School and director of the Center for Autonomic and Peripheral Nerve Disorders in the Department of Neurology at Beth Israel Deaconess Medical Center in Boston, Massachusetts. Dr. Freeman is former chairman of the World Federation of Neurology research group on the autonomic nervous system, former president of the American Autonomic Society, and former chairman of the Autonomic Section of the American Academy of Neurology. He serves on the Executive Committee and the Steering Committee of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the FDA. His research and clinical interests are the physiology and pathophysiology of the small nerve fibers and the autonomic nervous system. He has a special interest in biomarker development in neurodegenerative disease. He is the principal investigator on National Institutes of Health-funded studies on the neurological complications of diabetes, the neurobiology of stress, and biomarker development in alpha-synucleinopathies. He is Editor-in-Chief of Autonomic Neuroscience: Basic and Clinical and on the editorial boards of The Clinical Journal of Pain, Pain: Clinical Updates, and Clinical Autonomic Research.
Dr. Paler joined CND Life Sciences in July 2022 as Chief Pathologist and Laboratory Medical Director, responsible for leading the Pathology department, performing slide interpretation in support of the Syn-One Test® and other cutaneous neurodiagnostic tools, and ensuring CND meets and exceeds all laboratory quality standards. Dr. Paler is also a key contributor to CND’s research and development projects, continuous improvement initiatives, and collaborations with the biopharma industry. An anatomic and cytopathology board-certified pathologist, he attended Wayne State University School of Medicine in Detroit, MI and performed residency training at Los Angeles County + USC Medical Center in Los Angeles. He has practiced pathology in the commercial reference laboratory setting for 22 years. Prior to starting at CND, he worked as Medical Director and Surgical Pathologist at Labcorp Oncology (formerly Impath and Genzyme Genetics) for 21 years, the last eight years as Medical Director in Phoenix, AZ. His accomplishments include verification and implementation of PD-L1 companion diagnostic testing, HPV mRNA ISH testing, digital pathology, novel IHC markers, EGFR, KRAS, and NRAS molecular testing, and the launch of new LIS systems. He has served on various committees within the College of American Pathologists, including the 15189 Committee and the CAP Personalized Healthcare Committee. He is a member of the College of American Pathologists, American Society for Clinical Pathology, United States and Canadian Academy of Pathology, and the American Medical Association. Dr. Paler is an ardent champion of laboratory quality and ISO 15189 principles, and he advocates as a leader in Diversity, Equity, and Inclusion initiatives.
Mackenzie joined CND Life Sciences as Senior Manager, Clinical Services in March 2021. In her role, Mackenzie provides personalized support to both clinicians and patients, drives the development of new programs and processes to ensure customer satisfaction, and works closely with the laboratory and other departments to establish cross functional success. Mackenzie studied Biomedical Engineering at the University of Arizona and received her Master of Engineering in Bioengineering at the University of California, Berkeley. Prior to joining the team, Mackenzie managed over 100 neuroscience clinical research trials at HonorHealth Research Institute and was a key player in the development and management of their COVID-19 clinical research program. Mackenzie has also spent time in academic research studying Alzheimer’s disease at Fred Hutchinson Cancer Research Center. Personally impacted by the devastating reality of neurodegenerative diseases, Mackenzie has a passion for patient care and support.
Dr. Feng joined CND Life Sciences in November 2021 as a Senior Pathologist and Laboratory Medical Director, responsible for performing slide interpretation in support of the Syn-One Test™ and other cutaneous neurodiagnostic tools and ensuring CND meets and exceeds all laboratory quality standards. Dr. Feng is also a key contributor to CND’s research and development projects, continuous improvement initiatives, and future collaborations with the biopharma industry. An anatomic and clinical board-certified pathologist, she attended NYU School of Medicine and performed residency training at the University of Arizona. She has practiced pathology in both private and academic settings. Prior to starting at CND, she worked as a pathologist at Roche Tissue Diagnostics (formerly Ventana Medical Systems) for 17 years. Her accomplishments include developing a companion immune-oncology biomarker for hepatocellular carcinoma and developing biomarkers for HER2 in new tumor indications with high unmet medical needs such as biliary tract carcinomas, colorectal cancer, and NSCLC. For the past three years, she also served as the medical director for the CAP/CLIA Laboratory at Roche, overseeing more than 200 clinical trials sponsored by a variety of pharmaceutical companies. During her tenure as medical director, the laboratory maintained its accreditation by the College of American Pathologists and acquired accreditation by ISO 15189 and the New York State Department of Health.
Dr. Haydel joined CND Life Sciences in November 2021 as a Senior Pathologist in the company’s pathology services group. In her role with CND, Dr. Haydel performs histologic interpretation of bright field and fluorescent slides and images for patient diagnosis and categorization in support of the Syn-One Test™ and other cutaneous neurodiagnostic tools offered by CND. In addition, Dr. Haydel is a key contributor to CND’s pathology optimization efforts, ongoing scientific and innovation programs, and a range of research initiatives. She is a board-certified pathologist with both anatomic and clinical specialty training from UC Irvine and has dual subspecialty fellowship training in pediatric pathology from Children’s Hospital Los Angeles and in dermatopathology from UCLA. She has a special interest in genetics as it relates to inherited and epigenetic mechanisms of acquiring disease, including disease identification and pharmacologic intervention. She earned a Master’s of Science in Human Genetics from Tulane University and has worked in both academic and private practice settings.
Dee joined CND Life Sciences as an HR contractor in March of 2022 and came on permanently as Director of HR in June. She brings 15 years of experience across a variety of industries, with a focus on small- to medium-sized businesses. In her role at CND, Dee leads the HR department in all its functions, ranging from administrative responsibilities to strategic business partnerships with the organization’s senior leaders. Prior to joining CND, Dee worked as an HR professional at a start-up cloud-based accounting firm. Dee received her Master of Science in Management with a concentration in Leadership and Organizational Effectiveness from the University of South Florida and her BA in Communications from Jacksonville University.
Jade joined CND Life Sciences in November 2020 and brings a decade of experience in clinical research, predominantly in the neuroscience field. In her role, she oversees NIH-sponsored clinical studies by supporting the principal investigators, recruiting and enrolling subjects, and onboarding sites for participation. She is currently focusing on two NIH-SBIR-awarded grants, one of which is a validation study involving 500 subjects at 28 sites around the US. Prior to joining CND, Jade worked at Barrow Neurological Institute and Honor Health, with a focus on neurological research.
Dr. Enrique Carrazana has over 25 years of experience in drug development and the pharmaceutical industry. In addition to CND Life Sciences, Dr. Carrazana is on the board of directors of Hawaii Biotech and the American Society for Experimental Neurotherapeutics. He currently serves as the Chief Medical Officer for Neurelis, Inc., where he is responsible for the management of the drug development and safety programs. Previously, he was the Chief Medical Officer of Acorda Therapeutics. Dr. Carrazana also held various medical leadership roles at Novartis, where his last role was Vice President, Global Head Development Established Medicines Franchise, based in Basel, Switzerland. He was Director of the Epilepsy Center of Excellence at the Miami Veterans Administration Hospital and Associate Professor of Neurology at the University of Miami Miller School of Medicine. He has presented and published a wide range of research on various neurology topics. Dr. Carrazana received his medical degree from Harvard Medical School and completed his residency in neurology and fellowship in neurophysiology at the Harvard Longwood Neurology Program. He is a board-certified neurologist and Fellow of the American Epilepsy Society.
Peter has over 25 years of experience in the life sciences industry as an entrepreneur, business owner-operator, and investor. Prior to his involvement with CND Life Sciences, Peter was owner and CEO of B&V Testing, Inc., an industry-leading life sciences engineering services firm focused on contamination control technologies and serving the east coast’s premiere pharmaceutical, medical device, and biomedical research institutions. While at B&V, Peter pioneered the commercial application of hydrogen peroxide vapor technology for large-scale decontamination of cGMP pharmaceutical manufacturing facilities. A graduate of Duke University, Peter was a regular presenter at the annual biosafety conference of the American Biological Safety Association and the annual technical conference of the Controlled Environment Testing Association. His tenure at B&V culminated with a strategic sale to Stericycle, Inc. (NASDAQ: SRCL) in 2013. Since that time, he has been an active investor in mission-driven businesses. He lives in Brookline, MA with his wife and three children where he can be found coaching youth sports and serving as a volunteer mentor to aspiring business owners.
Dr. Levine is one of the three founders of CND Life Sciences and serves as its Chief Medical Officer, playing a key role in the delivery of diagnostic services and ongoing technology development. Dr. Levine also serves as the Medical Director of HonorHealth Neurology and has over 20 years of experience as a clinical neurologist with a sub-specialty in disorders of the peripheral nervous system. In 2010, he founded his first medical diagnostics company called Corinthian Reference Lab (CRL). CRL is based in Fort Worth, Texas and has processed over 50,000 skin biopsies, receiving specimens from over 4,000 different neurologists across the US and Canada. He received his medical degree from Duke University and did his residency and fellowship at Washington University in St Louis. He has served as the Chairman of the Neuromuscular Division of the American Academy of Neurology and is currently the Medical Director of Neurology for HonorHealth in Phoenix, AZ.
Andy is currently an active entrepreneur and Angel Investor with portfolio holdings in life sciences, software, e-learning, advanced manufacturing, AI, and real estate tech. He is currently an Entrepreneur-in-Residence at IESE Business School in Barcelona, where he mentors and advises a variety of entrepreneurs and start-ups. He is the founder of Component Sourcing International LLC (CSI), a Strategic Sourcing™ company that manufactures custom-engineered metal components in a variety of product categories. The company was acquired by a private equity firm in 2014.
Prior to founding CSI, Andy was a Partner in Osage Investments, a private equity firm based in Philadelphia, with funds dedicated to leveraged buyouts of middle-market manufacturers and early-stage venture investing. Andy held various board and management positions in Osage’s portfolio, and his venture investments include Inphonic (NASDAQ: INPC), Internet Capital Group (NASDAQ: ICGE), and GHR Systems (acquired by Metavante). He also served as CEO of Farmington Engineering, an Osage portfolio company later acquired by Swiss conglomerate KVT Group.
Andy holds a BS in Biology from Tufts University and an MBA in Finance and Entrepreneurial Management from the Wharton School, University of Pennsylvania. His current passion is social impact investing, and he just recently returned from two years in in Barcelona, Catalunya, Spain to reside in Connecticut with his family.
Rick joined CND Life Sciences as CEO in early 2020 and brings 25 years of experience with health and life sciences companies, serving in senior executive roles globally for medical device, digital health, and diagnostics firms. Prior to joining CND as CEO, Rick was the Global President of Life Sciences at Aptus Health, a former subsidiary of Merck, Inc. (acquired by WebMD) and CEO of Plasma Surgical, an innovative medical device company with technology used in open and laparoscopic procedures around the world. Rick began his career in strategy consulting, rising to Partner at Mercer Management Consulting where he helped build the Health & Life Sciences Practice and managed large biopharma and diagnostics clients. A Kellogg MBA and graduate of the University of Virginia, Rick also founded and helped grow three nonprofit organizations that have raised nearly $100 million in the last decade to fulfill health and social impact missions including Family Reach Foundation, which was included in the Obama White House’s Cancer Moonshot in 2016.
Dr. Gibbons, one of CND Life Sciences’ three founders and a senior scientific advisor, has played an integral role in translating key science in the field to help develop the company’s core diagnostic technology. Dr. Gibbons is a clinician-scientist involved in the investigation, evaluation, and treatment of patients with autonomic and peripheral nerve disorders. Dr. Gibbons’ clinical expertise extends to the investigation and treatment of autonomic and peripheral neuropathies. He has served as Chair of the Clinical Affairs Committee for the American Autonomic Society, and Chair of the Autonomic Section of the American Academy of Neurology, President of the American Autonomic Society and is currently Chair of the International Diabetes Neuropathy Consortium. Dr. Gibbons has established the neurocutaneous skin biopsy lab at Beth Israel Deaconess Medical Center (BIDMC), where he oversees all clinical testing. He has also received several grants to study cutaneous α-synuclein expression in nerves within the skin.
Dr. Gibbons attended Dartmouth College, completed his medical training at Albert Einstein College of Medicine and his residency in Neurology at Johns Hopkins Hospital. Dr. Gibbons also received a Master in Medical Science degree through a combined Harvard and MIT training program. Dr. Gibbons is an Associate Professor of Neurology at Harvard Medical School and on staff at BIDMC and Joslin Diabetes Center in Boston, Massachusetts.
Bailey joined CND Life Sciences in 2018 as one of the first full-time employees of the organization. In his current role as Manager, Research & Development, Bailey focuses on conducting laboratory process improvement, test optimization, exploratory research, and new product development. His team also supports the execution of Syn-One testing protocols as part of company- and grant-funded clinical studies and industry-sponsored trials involving drug candidates that target alpha-synuclein or related mechanisms of action. As a biomedical engineering graduate of the University of Arizona, Bailey brings foundational science and research capabilities to CND along with an understanding of pharmaceutical, organic chemistry, and personalized medicine disciplines.
Karina serves as CND Life Sciences’ Director of Billing Services and Operations, playing an integral role in establishing the company’s billing and reimbursement protocols, policies, and infrastructure in support of commercializing the Syn-One Test™. In addition to overseeing CND’s revenue cycle management processes, which include daily interactions with public and private payers, Karina conducts important prior-authorization and patient support services critical to offering the Syn-One Test as a new diagnostic tool in clinical practice. Karina joined CND Life Sciences in 2019 and helped implement the company’s laboratory infrastructure, quality standards, day-to-day processes, and CLIA certification. Prior to joining CND, Karina spent over a decade with other prominent laboratory companies, including Genzyme Genetics, LabCorp, and Agendia, where she successfully managed a large staff and assisted in laboratory set up, accreditation, and optimization. Karina received her bachelor’s degree in Public Health and Bio-Education from the University of California at Long Beach.
Jimmie joined CND Life Sciences in 2021 as the Laboratory Director, where he is responsible for managing, enhancing, and monitoring operational systems for the laboratory’s production, quality, staff development, and day-to-day specimen processing functions. In this important leadership role, Jimmie utilizes his training as a laboratory inspector to develop the Quality Assurance Plan for daily operations to ensure the highest quality test results. He has over 20 years of experience managing College of American Pathologist (CAP)-accredited laboratories and has worked for several large healthcare systems. Jimmie became a certified CAP inspector in 2017 and has conducted on-site laboratory inspections as a team member and as a team lead. Prior to joining CND, Jimmie spent decades working with prominent healthcare organizations including the American Red Cross, Sutter Health, Emory Healthcare, and United Blood Services. Jimmie attended the University of Arizona and received his Bachelor of Science degree in Clinical Laboratory Sciences from the University of Texas Health Science Center in San Antonio, Texas.
Dave joined CND Life Sciences as Vice President, Finance & Strategy in early 2022, and brings 15 years of healthcare, finance, and consulting experience. In his role at CND, Dave leads a range of finance and accounting activities, corporate development efforts, and strategic initiatives, including the evolution and management of the company’s Clinical Trials Services solutions for biopharma clients. Prior to joining CND, Dave worked on commercial assessments of neuroscience business development opportunities as well as various strategic initiatives at AbbVie. Dave also worked at J.P. Morgan in the Healthcare Investment Banking Group, where he provided financial and strategic advisory services for M&A and equity and debt transactions for pharmaceutical, biotechnology, healthcare services, and healthcare IT companies. Dave received his MBA from the Kellogg School of Management at Northwestern University and his BA from the University of Michigan. Dave and his wife like to sail, ski, and hike with their dog in their free time.
