C₂N Diagnostics is a molecular diagnostics and company aiming to transform the early diagnosis and early treatment of Alzheimer’s disease and related forms of neurodegeneration.
We were formed by scientific co-founders Drs. David Holtzman and Randall Bateman of Washington University School of Medicine in St. Louis, and LifeTech Research, a Maryland-based technology research and commercialization firm. Our CLIA certified clinical laboratory and research laboratory are based in St. Louis, MO.
Our core technology relies on state-of-the art mass spectrometry-based approaches to identify and quantify protein biomarkers that are important in the diagnosis, progression and treatment monitoring of human brain disorders.
We have developed a novel blood-based, in vitro diagnostic laboratory-developed test (LTD) for brain amyloid detection, a pathologic hallmark of Alzheimer’s disease. We offer the test under CLIA in most of the US and a CE Mark in the European Union. We are further developing and validating this test for FDA approval under FDA’s Breakthrough Devices Designation Program, with the goal of filling a major unmet medical need for a simple, widely accessible, and minimally invasive test to aid in Alzheimer’s diagnosis.
Our protein biomarkers are used in numerous collaborations throughout the world with leading academic investigators and also biopharmaceutical partners. Applications of our biomarkers include: accelerating the speed, lowering the cost, and improving the efficiency of enrolling individuals into clinical trials; informing researchers about the mechanism of action and biological activity of new treatments in clinical development; and following novel treatment responses.
Our Team
Joel B. Braunstein, MD, MBA
Co-Founder, President and CEO
Dr. Braunstein is Co-Founder and CEO of C₂N Diagnostics and has led the company's growth and commercial efforts since its inception. Dr. Braunstein has played a senior executive role in numerous emerging life sciences companies since 2004. He received his M.D. with Highest Distinction from Northwestern University Medical School in 1996. Subsequently, he trained in internal medicine at the Brigham and Women’s Hospital, Harvard Medical School, and was a Fellow in Cardiovascular Medicine and Robert Wood Johnson National Clinical Scholar at the Johns Hopkins Medical Institutions. Additionally, he completed an MBA with management and health policy focus and maintained an Assistant Professorship in Cardiology at Johns Hopkins University. In 2010, he was named a Distinguished Alumnus of Johns Hopkins University.
Micah Onixt, JD, MBA
Company Secretary
Mr. Onixt is currently General Counsel and a Managing Director of LTR. Through LTR, he brings to C₂N over 20 years of life sciences work experience. He was part of the team that helped to form C₂N and to transfer the SILK-related intellectual property out of WU. He also was a partner in the Chicago office of the law firm of DLA LLP US and a recipient of the “40 Illinois Attorneys Under 40 to Watch” award from the Law Bulletin Publishing Company. During his 12 year tenure at DLA Piper, his practice consisted of representing both institutional investment funds, and private and public life sciences companies in the areas of corporate securities, technology transfer (product licensing, M&A), and intellectual property management. He has negotiated many partnerships; and drafted and prosecuted patents, copyrights, and trade secrets within the biotechnology, pharmaceutical and medical device spaces. Mr. Onixt received his MBA from the Northwestern University Kellogg School of Management in 2007, JD from Loyola University in 1998, a MS in Biology from the Illinois Institute of Technology in 2017, and two bachelor’s degrees from the University of Michigan (English, ‘94) and University of Illinois at Chicago (Cellular Biology, ‘95).
Kevin Yarasheski, PhD
Senior Vice President
Dr. Yarasheski obtained the PhD in physiology from Kent State University and completed a three-year post-doctoral research fellowship in geriatrics, metabolism and endocrinology at Washington University School of Medicine. For 29+ years, Dr. Yarasheski remained in the Department of Internal Medicine at Washington University School of Medicine where he rose to the rank of tenured Full Professor, co-Directed the Biomedical Mass Spectrometry Research Facility, fully supported his independent mass spectrometry-based clinical research program, and collaborated with Drs. Bateman, West and Holtzman on their Alzheimer's disease projects that required mass spectrometry analysis. Dr. Yarasheski also conducted translational clinical research focused on using gas or liquid chromatography-mass spectrometry to detect, characterize and quantify biomolecules present in human biofluids and tissues, and that revealed underlying alterations in protein and amino acid metabolism that contributed to the pathogenesis of several conditions: unsuccessful aging, cachexia, malnutrition, and cardiometabolic complications. In 2016, Dr. Yarasheski joined C₂N Diagnostics as Senior Vice President where he directs and supervises laboratory personnel and mass spectrometry research, development and discovery efforts focused on biomarkers for neurodegeneration and AD pathology.
Tim West, PhD
VP, Research and Development
Dr. West obtained his PhD in molecular cell biology and neuroscience from Washington University. He conducted his graduate thesis research and post-doctoral training in the laboratory of Dr. David Holtzman, one of C₂N’s scientific founders. In those capacities, Dr. West led a group of scientists and technicians studying neonatal stroke and hypoxic-ischemic injury. During 2006 and 2007, he served as Staff Scientist and Assistant Director of Technology Development for the Hope Center for Neurological Disorders at the Washington University School of Medicine. Dr. West has extensive experience in database management and computer programming, and supports C₂N’s establishment of a software platform tracking work flow and inventories, stores data, and enhances quality control. Dr. West was a recipient of a Kauffman Fellowship for Bio-Entrepreneurship. He received his B.Sc. Honors in Molecular Biology at University College London and performed a laboratory internship at the Ludwig Institute for Cancer Research.
Ilana Fogelman, MD, MPH
VP, Regulatory and Clinical Affairs
Dr. Fogelman co-founded LTR with Dr. Braunstein in 2004 and through LTR was involved in the formation of C₂N Diagnostics. She specializes in corporate and product pipeline valuation, drug development, clinical trial design and analysis, and FDA regulations. Dr. Fogelman is an expert in regulatory strategies and risk, and interpreting FDA actions, decisions, and requirements. From 1999 to 2003, Dr. Fogelman worked as a biotechnology analyst for Merrill Lynch and Salomon Smith Barney, covering small- to mid-cap public companies. From 1993 to 1999, Dr. Fogelman worked as a medical reviewer for FDA's Center for Biologics Evaluation and Research, focusing on new products for infectious diseases, autoimmune and inflammatory disorders. In that position, she reviewed more than 80 INDs, 2 BLAs, and 2 BLA supplements for a variety of technologies, including monoclonal antibodies, cytokines, immunomodulators, cell and gene therapies, and vaccine therapies. While at the FDA, Dr. Fogelman was also the Principal Investigator of an HIV clinical trial, which she designed and implemented in collaboration with the NIH to evaluate the immunologic reconstitution of HIV-infected patients receiving highly active antiretroviral therapies. Dr. Fogelman obtained her M.D. from the University of São Paulo (Brazil) and a Master in Public Health from Harvard University. At Harvard, she also completed two postdoctoral research fellowships in HIV clinical trials and immunology.
Yan Helen Hu, Ph.D.
Director of Technologies and Business Development
Dr. Hu brings to C₂N unique expertise in bioanalytical technologies, biomarker and antibody therapeutics discovery and development. Dr. Hu obtained her PhD in Molecular Genetics from Washington University. Following graduation, she worked with Dr. David Holtzman, one of C₂N’s scientific founders, under the Ruth L. Kirschstein postdoctoral fellowship. In that position, she employed a comparative proteomics approach and discovered novel biomarkers for early stage Alzheimer’s Disease. Dr. Hu subsequently worked in the pre-clinical group at Genentech, Inc., where she successfully led the anti-interleukin 17 program from late stage research to preclinical development and played a key role in preparation of an IND filing. At C₂N, Dr. Hu has led the efforts in bioanalytical support of preclinical and early clinical development of ABBV-8E12 program. She currently leads the development of diagnostics for neurodegenerative diseases, focusing on building strategic partnerships and business relationships.
Philip Verghese, PhD
Director, Research, Development, and Operations
Dr. Verghese is a protein and lipid biochemist with extensive experience in acute and chronic neurodegenerative disease models. He conducted his post-doctoral training in the laboratory of Dr. David Holtzman, one of C₂N’s scientific founders, under the BrightFocus foundation postdoctoral research fellowship. His work on apolipoprotein E (apoE) (for Alzheimer’s disease) and nicotinamide mononucleotide adenylyltransferase 1 (NMNAT1) (for acute neurodegeneration in the developing brain) has been published in high impact journals and added new perspectives in the field of neurodegeneration. Dr. Verghese’s graduate work was focused on peripheral lipid metabolism. He also holds a Graduate Diploma in Business Studies from Dublin Business School, Dublin, Ireland.
Joni Henderson
Director, Marketing, Outreach and Strategic Growth
Ms. Henderson has a 25+ year career in partnership, business and program development with globally recognized organizations including: Global Alzheimer’s Platform Foundation, Discovery Communications, Smithsonian Institution, and National Board for Professional Teaching Standards. Ms. Henderson has created numerous national legacy initiatives in the healthcare and education sectors, including first-of-its-kind programs for transportation for clinical trial participants and a national Citizen Scientist Awards for clinical trial volunteers. In addition, she has created award-winning global K-12 educational initiatives with Fortune 500 companies on subjects such as STEM, online safety, health awareness, career development and literacy. Her work at the nation’s museum complex spanned fundraising and partnership development across all eighteen museums, six research centers and the National Zoo. Ms. Henderson earned her MS in non-profit administration from Drexel University and a BA in business administration from University of Redlands.
Matthew Meyer, PhD
Senior Proteomics Scientist
Dr. Meyer is a protein biochemist with broad expertise in the field of proteomics including mass spectrometry-based protein biomarker discovery, identification of post-translational modifications, and targeted, quantitative assay development. During his postdoctoral training from 2012-15 at Washington University in St. Louis, School of Medicine, Dr. Meyer focused on translational research establishing mass spectrometry workflows for quantitative, multiplexed assays as part of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC). While completing his time at Washington University, he successfully developed novel strategies for the enrichment and quantification of over 200 kinases in the human breast cancer kinome. His graduate thesis work included understanding the activation of protein receptor kinases via phosphorylation site mapping and biophysical characterization of kinase domain interfaces using hydrogen-deuterium exchange MS. He received his BS in Biochemistry from the University of Missouri-Columbia and his PhD in Biochemistry from Iowa State University.
Kristopher Kirmess, PhD
Senior Mass Spectrometry Scientist
Dr. Kirmess is an analytical chemist with a vast knowledge of chromatographic separations and mass spectrometry. Dr. Kirmess obtained his PhD in analytical chemistry from Southern Illinois University at Carbondale while investigating primary ion formation mechanisms within matrix assisted laser desorption/ionization. Dr. Kirmess conducted his post-doctoral training at Washington University School of Medicine in Dr. Kevin Yarasheski’s lab where he conducted assay development on liquid chromatography tandem mass spectrometry for comparative metabolomics. At C₂N Diagnostics, Dr. Kirmess applies state-of-the art mass spectrometry techniques to advance both basic and applied knowledge towards identifying, characterizing, and quantifying biomolecules that inform us about disease mechanisms, and can serve as diagnostic or theragnostic biomarkers.
Erin Smith, BS
Laboratory and Quality Assurance Manager
Ms. Smith’s role at C₂N includes supervision of the laboratory, shipping and quality assurance manager at C₂N. Her role includes supervision of the laboratory, shipping and receiving, creation and revision of standard operating procedures, quality auditing, and document control. Prior to joining C₂N, Ms. Smith spent over a decade co-managing a small animal imaging facility conducting collaborative research with investigators at Washington University School of Medicine.
Scott Harpstrite, MS
Laboratory and Quality Control Manager
Mr. Harpstrite is a laboratory manager with experience in biotech and academic research. He received an MS in chemistry from SIUE in 2002. In 14+ years at Washington University School of Medicine, he transitioned from chemical synthesis and characterization to in vitro and in vivo evaluation of preclinical agents, project leadership, and laboratory management. Mr. Harpstrite joined C₂N in 2015, his role includes quality control, oversight of safety and compliance, shipping and receiving, and development and implementation of SOPs.
Mary Holubasch, M.T., ASCP
Senior Clinical Lab Scientist
Mary came to C₂N in 2008 with over 15 years of experience in CLIA laboratories in both small esoteric hospital settings and high-throughput labs. She obtained her BS in Biology at SIUE and her American Society for Clinical Pathology (ASCP) board certification in laboratory science through the Mercy School of Medical Technology. She is proficient in all areas of laboratory operations from analysis with manual and automated techniques through documentation and reporting with adherence to CLIA standards.
Stephanie Knapik, BS
Research Associate
Stephanie joined C₂N in 2015 to assist with immunoassays supporting early clinical progress of the ABBV-8E12 program. Her role centers on facilitating the development efforts to translate novel biomarker assays into robust diagnostics. Prior to her work at C₂N, Stephanie obtained her BS in Biochemistry from the University of California, San Diego and then joined a biotechnology start-up that specialized in the discovery of therapeutic antibodies targeting bioactive lipids present in chronic inflammatory diseases. In addition to facilitating the production and selection of these monoclonal antibodies, her primary focus was the development of both in vitro and in vivo models to evaluate the efficacy of therapeutic candidates.
Board of Directors
David Holtzman, M.D.
Scientific Co-Founder
Dr. Holtzman is a Scientific Co-Founding Member of C₂N Diagnostics. Dr. Holtzman is an international authority in the field of Alzheimer’s Disease. He is the Andrew B. and Gretchen P. Jones Professor of Neurology and Developmental Biology at Washington University School of Medicine (WUSM). He is also head of WUSM’s Department of Neurology, the Associate Director of the institution’s Alzheimer's Disease Research Center, and Co-Director of the Hope Center for Protein Aggregation and Neurodegeneration. A major focus of Dr. Holtzman’s research is in understanding basic mechanisms underlying acute and chronic cell dysfunction in the CNS, particularly as these mechanisms may relate to Alzheimer’s disease and injury to the developing brain. Dr. Holtzman attended the Honors Program in Medical Education at Northwestern University receiving his B.S. (1983) and M.D. (1985). He completed his medical internship followed by Neurology residency at UCSF from 1985-1989. He then pursued post-doctoral research training in the lab of William C. Mobley, MD, PhD, at UCSF from 1989-1994. Also at UCSF, Dr. Holtzman established the Memory and Cognitive Disorders Clinic and was an Assistant Professor from 1991-1994. He moved to his own laboratory at WUSM in December of 1994. He was named as the Associate Professor of Neurology in 2001, Professor in November of 2002, and as the Andrew and Gretchen Jones Professor and Head of the Department of Neurology in October 2003. Dr. Holtzman is also involved in clinical and research activities at WUSM’s Alzheimer's Disease Research Center. Past honors include recipient of a Paul Beeson Physician Faculty Scholar Award in Aging Research, the 2003 Potamkin Prize from the American Academy of Neurology for research on Alzheimer's, election to the American Society for Clinical Investigation (2004), a MERIT award from the NIA (2004), and a 2006 recipient of the MetLife award on Alzheimer’s disease. In 2008, Dr. Holtzman was elected to the Institute of Medicine (IOM) of the National Academy of Sciences. He currently serves on the advisory council of the NINDS at the NIH.
Randall Bateman, M.D.
Scientific Co-Founder
Dr. Bateman is a Scientific Co-Founding Member of C₂N Diagnostics. He is the Charles F. and Joanne Knight Distinguished Professor of Neurology at Washington University School of Medicine (WUSM). Dr. Bateman attended Case Western Reserve University School of Medicine, earning a medical degree with special emphasis on the neurosciences. He completed a Neurology residency at WUSM and then completed post-doctoral research training with David Holtzman, M.D., and clinical research fellowship training with John C. Morris, M.D. Dr. Bateman’s laboratory investigates the causes, and future diagnosis and treatments of Alzheimer’s disease utilizing a wide variety of assays and techniques from basic applications, such as quantitative measurement of stable-isotope labeled peptides to clinical translational studies in diagnostic and therapeutic biomarkers of Alzheimer’s disease. Dr. Bateman led the development of the SILK technique, which made it possible to determine that clearance of Ab is impaired in patients with Alzheimer’s disease. Bateman and his colleagues are now studying whether alterations in Ab clearance levels can be used to predict AD years before symptoms become apparent. Dr. Bateman is Associate Director and Clinical Core Leader of the Dominantly Inherited Alzheimer’s Network (DIAN), an international collaboration of leading research centers dedicated to studying autosomal dominant AD (ADAD). He is the Director of the DIAN Therapeutic Trials Unit (TTU), which is leading efforts to launch clinical trials in ADAD aiming to prevent the onset of memory impairment and dementia. Dr. Bateman’s honors include the Scientific American 50 Award, recognizing the top 50 scientific achievements of 2006; the St. Louis Academy of Science Innovator of the Year Award; a 2011 Alzheimer’s Association Zenith Fellows Award; and the 2012 MetLife Promising Investigator Award. He serves as an editor and reviewer for many prominent scientific journals and is a sought-after lecturer nationally and internationally.
Michael Goldblatt, Ph.D., J.D.
Dr. Goldblatt is an active investor in technology startups and consultant to a variety of government agencies, national laboratories and corporations. He brings over 35 years of experience in the areas of biotechnology, product development, and regulatory affairs to C₂N. Michael was Chief Executive Officer of Functional Genetics, a biotechnology company focused on target discovery and antibody therapeutics, until 2013 when its assets were acquired by its collaboration partner Elanco. Michael joined Functional Genetics in 2003, after his appointment as Director of Defense Sciences at the Defense Advanced Research Projects Agency (DARPA), and before that Dr. Goldblatt was the Science and Technology Officer for the McDonald's Corporation with broad responsibilities, including nutrition, product development, food safety and corporate venture capital. Earlier, while at General Foods, he led research efforts in the use of nutrients for pharmaceutical effects and oversaw a variety of regulatory and legal issues. Michael holds dozens of active and pending US patents, and received his J.D. and Ph.D. from the University of California at Davis and a B.A. from Reed College.