Our Team

 

C₂N Diagnostics is a molecular diagnostics 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, CAP-accredited 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 (LDT) 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 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.


Ilana Fogelman, MD, MPH
Co-Founder and Senior Advisor for Medical Innovation

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.


Micah Onixt, JD, MBA
General Counsel, Privacy Officer and Corporate 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. Mr. Onixt serves as the Privacy Officer for C₂N and holds a Certified Information Privacy Professional (CIPP) certification. 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).

 

Philip Verghese, PhD
Senior Vice President, R&D and Laboratory Operations

Dr. Verghese serves as the Senior Vice President, R&D and Laboratory Operations at C₂N. In this role, he leads several facets of discovery stage portfolio, analytical and clinical validations, operations, and commercialization of C₂N products. Dr. Verghese is a protein and lipid biochemist with in-depth experience in basic and translational neurosciences of Alzheimer’s disease and related dementia. His work on crucial proteins associated in neurodegeneration, especially apolipoprotein E (ApoE) and ApoE receptors have been published in high impact journals and added new perspectives in the field of neurodegeneration. He has authored/co-authored approximately 30 peer reviewed scientific articles exploring basic and disease related mechanisms and biomarker and drug development. Prior to this position, Dr. Verghese was a Principal Scientist at C₂N, where he assumed key roles in preclinical and clinical activities, IND filings, creation of translational biomarker strategies and due diligence for licensing activities associated with therapeutic candidates in Alzheimer’s Disease and other neurodegenerative diseases. Prior to Joining C₂N, Dr. Verghese conducted his post-doctoral fellowship in the laboratory of Dr. David Holtzman, Washington University School of Medicine in Saint Louis, under the BrightFocus foundation postdoctoral research fellowship. He received his BSc in chemistry and MSc in Biochemistry from University of Pune, India. He obtained his PhD in Biochemistry from OSU, Stillwater and a Graduate Diploma in Business Studies from DBS, Dublin, Ireland.


Ozgur Sensoy
Senior Vice President of Commercial Operations

Mr. Sensoy’s extensive career has involved numerous market development, product launch, and commercialization efforts in multiple specialty disease states. Mr. Sensoy spent the last 11 years at Quest Diagnostics where he held multiple leadership positions, managed various mergers-and-acquisitions and integrations, and most recently served as Head of U.S. Specialty Genetics. Prior to Quest, he served in leadership positions at Sanofi and Bayer Pharmaceuticals. Mr. Sensoy earned his Master of Business Administration from Yale School of Management and Master of Science and Bachelor of Science Engineering degrees from Bogazici University in Turkey, his native country.


John Contois, PhD, DABCC, FAACC
Vice President, Laboratory Medicine

Dr. Contois received his PhD in nutritional sciences from the University of Connecticut where his doctoral research, in collaboration with the USDA Human Nutrition Research Center on Aging at Tufts University and the Framingham Heart Study, focused on the clinical utility of apolipoproteins as cardiovascular disease risk factors. Dr. Contois received his BS from the University of Massachusetts at Boston and MS from the University of Connecticut. He received postdoctoral training in Clinical Chemistry at Hartford Hospital and Epidemiology from the University of Texas M.D. Anderson Cancer Center. Dr. Contois received board certification in clinical chemistry (DABCC) and is a Fellow of the American Association of Clinical Chemistry (FAACC). He has served as Laboratory Director in both hospital and commercial laboratories, including Quest Diagnostics, the University of Massachusetts Medical Center, and LipoScience. Dr. Contois founded Sun Diagnostics as a “laboratory solutions provider” to provide products for labs and IVD manufacturers to simplify validation experiments and improve the quality of testing. He currently serves on the Editorial Boards of Clinica Chimica Acta, Practical Laboratory Medicine and the Journal of Clinical Lipidology. He has published more than 50 articles and book chapters

 

Tim West, PhD
Vice President, 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.


Sheena Aurora, MD
Vice President, Neurology

Dr. Aurora previously served as Vice President, Medical Affairs at Impel pharmaceuticals. Prior to her work at Impel pharmaceuticals she served as a Senior Medical Fellow, Global Launch Leader Pain at Eli Lilly. Before Eli Lilly she served as a Clinical Associate Professor, Neurology at Stanford University’s School of Medicine. Dr. Aurora trained as a resident in Neurology and fellow in Neurophysiology at Henry Ford Hospital. She is an avid clinical and epidemiology researcher with over 100 peer-reviewed publications ranging from Phase 1 to Phase 4 clinical trials, biomarkers, and neuroimaging. A national authority in migraine research and treatment, she was the lead investigator for the PREEMPT1 trial that led to the FDA approval of BOTOX® to treat chronic migraine. She continues to practice and mentor as an Adjunct Clinical Associate Professor of Neurology at Stanford University.


Patricia DeSimone, JD
Assistant General Counsel & Vice President of Human Resources

Ms. DeSimone has over 20 years of legal experience, working in law firms as well as serving as senior in-house counsel for publicly traded and private equity owned companies. Prior to attending law school, Ms. DeSimone worked in pharmaceutical sales for two multinational pharmaceutical companies. Ms. DeSimone received her BS in Biochemistry from Albright College, her MS in Biology from New York University Graduate School of Arts and Science and her JD from the University of Pennsylvania Law School.

 

Tim Reilly
Vice President of Finance

Mr. Reilly comes to C₂N with over 25 years of experience in financial and operational leadership roles across multiple industries. After several years in commercial banking, he held financial roles at Fortune 500 companies such as IBM and AT&T. He began working in the Life Sciences industry in 2010 when he ran global finance and operational teams supporting clinical trials for Covance Drug Development, which was later acquired by LabCorp. He subsequently worked for Private Equity backed services companies such as WCG Clinical and CellCarta, a lab based CRO. Mr. Reilly earned his BBA in Finance from the University of Notre Dame and his MBA from the University of North Carolina – Chapel Hill. Additionally, he completed the Senior Executive Program at Columbia Business School.


Joni Henderson
Senior Director, Corporate Communications

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.


Justine Coppinger, MS,CGC
Senior Director, Medical and Clincal Affairs

Ms. Coppinger has over 25 years of experience in molecular diagnostic laboratory testing and genetic counseling. She served the first decade of her career as a clinical genetic counselor in a variety of settings and specialties. In 2005, she joined Signature Genomic Laboratories as Senior Genetic Counselor with medical science liaison responsibilities and facilitated the integration of new genetic testing technologies into patient care. She has served as Manager of Scientific Affairs and Genetics Services at Asuragen, Inc., and Director of Clinical Affairs at Taueret Laboratories, and has expertise in laboratory test utilization management, bioinformatics pipelines and variant assessment, laboratory genetics services models, and collaborative research. She has authored or co-authored numerous papers examining the use of diagnostic testing technologies in patient cohorts and reporting new findings. She received her MS degree in Genetic Counseling from the University of South Carolina. She is Board-Certified by the American Board of Genetic Counseling, licensed in states of prior practice, and is a member of multiple professional societies.

 

Venky Venkatesh, PhD, PMP
Senior Director of Project Management

Dr. Venky Venkatesh, PhD, PMP, Senior Director of Project Management, is responsible for managing C₂N’s research studies portfolio including, academic and pharmaceutical collaborations. Dr. Venkatesh comes to C₂N with over 25 years of R&D expertise in the biotechnology industry including, biopharmaceutical project management. He has extensive experience in managing GLP/GCP/GMP Regulatory projects. Before joining C₂N, Venky worked at Eurofins and handled a variety of bioanalytical projects in support of clinical trials. Dr. Venkatesh has published more than 25 papers in peer-reviewed journals and is a co-inventor on seven issued patents. Before his career in the industry, Dr. Venkatesh held research positions at Yale University and the University of Michigan. He has a PhD in molecular biology from Jawaharlal Nehru University, New Delhi, India and a Project Management Professional (PMP) certification from the Project Management Institute.


Mark Monane
Senior Medical Advisor

Dr. Monane comes to C₂N with over 25 years in clinical care, outcomes research, equity analysis, and life sciences work. Previously, Dr. Monane served as Chief Medical Officer at CardioDx, a molecular diagnostics company. Prior to joining CardioDx, he served as managing director of biotechnology equity research for Needham & Company. Prior to Needham & Company, Dr. Monane served as Senior Director of Medical Policy and Practices at Merck-Medco, a pharmaceutical benefit manager. Dr. Monane holds an MD from New York University, an MS degree in health policy and management from Harvard University, and an MBA from Columbia University. He has completed fellowship training in geriatric medicine, clinical effectiveness, and geriatric clinical pharmacology.


Daniel Connell, MBA
Head of Strategic Alliances

Mr. Connell has devoted his career to solving real world healthcare challenges, bringing over 20 years of personalized healthcare and precision medicine experience to C₂N. He has extensive experience in sales, marketing, and strategy - both in the US and in global markets - having worked with leading industry players such as AstraZeneca, Biogen Novartis, Roche, and LabCorp. Prior to joining C₂N Daniel served in both Global Commercial Diagnostics and R&D Strategy roles with AstraZeneca. His experience in Alzheimer's disease includes helping to build diagnostic ecosystems in support of Aducanumab & Lecanemab launches in Biogen's Intercontinental Region. Mr. Connell received a BS in Biomedical Engineering from Washington University in St. Louis and an MBA from HEC Paris.

 

Kristopher Kirmess, PhD
Director of Clinical Chemistry and Commercial Assays

Dr. Kirmess is an analytical chemist with a vast knowledge of chromatographic separations and mass spectrometry. He obtained his PhD in analytical chemistry from Southern Illinois University at Carbondale while investigating primary ion formation mechanisms within matrix assisted laser desorption/ionization. He 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, he 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 theranostic biomarkers.


Matthew Meyer, PhD
Director of Research & Development

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 LC-MS assay development on multiple platforms.During his postdoctoral training at Washington University, 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 at Washington University, he successfully developed novel strategies for the enrichment and quantification of over 200 kinases in the human breast cancer kinome. He received his BS in Biochemistry from the University of Missouri-Columbia and his PhD in Biochemistry from Iowa State University. At C₂N Diagnostics he helped develop the components of the PrecivityADTM test and validated the test under CLIA standards. Dr. Meyer currently leads the R&D lab operations where they are focused on the development and automation of C₂N’s novel LC-MS based, biomarker assays.


Catherine Regni, PhD
Director of Quality Assurance

Dr. Regni obtained her PhD in Biochemistry with an emphasis in protein structural biology from the University of Missouri – Columbia and completed post-doctoral research at St. Jude Children’s Research Hospital in Memphis, TN, before transitioning to a career in the life science industry. For the past 15 years, she has worked in the reagent industry in various roles including product design and development, validation, quality assurance, and people leadership. Her areas of expertise include data integrity, where she has developed robust approaches to manage the data lifecycle in operational environments and audit readiness for in vitro diagnostics.

 

Chad Thieman
National Sales Director

Mr. Thieman came to C₂N with veritable success in complex sales solutions and change management within Fortune 200 organizations. With nearly three decades of experience in sales, leadership development and organizational strategy in the healthcare industry, he has been able to watch the healthcare environment evolve and build teams to successfully evolve with it. Prior to joining our team, Mr. Thieman instituted corporate-wide payer learning systems, built multiple national training curriculums, and started new Alzheimer’s and mental health divisions from ground zero. People development, capability development, and business development are his forte. Chad received his Bachelor of Science from Indiana State University and has multiple certifications in Training and Consulting.


Rachel Resnick
Controller

Ms. Resnick has been with C₂N Diagnostics, LLC for more than 15 years, and now serves as Controller. Bringing over 30 years of experience to the company, Ms. Resnick oversees the firm’s operational accounting, and leads the production of financial reports, maintains the accounting system, and cash flow. As part of the corporate management team, Rachel is responsible for developing the annual budget and prepares financial forecasts, ensuring the fiscal welfare of the company. Prior to joining C₂N, Ms. Resnick worked at a large law firm in Washington, DC as their in-house Tax Manager as well as a public accounting firm in Philadelphia PA. Ms. Resnick received her BS in Accounting from Drexel University.


Mary Holubasch, M.T., ASCP
Clinical Supervisor, Lead Technologist

Mary came to C₂N in 2008 with over 15 years of experience in several different CLIA laboratories, including esoteric hospital settings and a high-throughput lab environment at Quest Diagnostics. She obtained her BS in Biology at Southern Illinois University-Edwardsville 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 both CLIA and ISO 13485 standards. Her tenure at C₂N has been spent in both the research and assay development arena and clinical operations.

 

Scott Harpstrite , MS
Director, Laboratory Operations

Mr. Harpstrite received a MS in Chemistry from Southern Illinois University Edwardsville. He joined C₂N in 2015 after 15 years in academic research performing synthetic chemistry and laboratory management. His role at C₂N includes providing oversight to laboratory functions, quality control, and sample management.


Erin Smith
Senior Project Manager, Design and Development

Ms. Smith’s role at C₂N encompasses the general development and oversight of the Quality Assurance department. Additionally, she provides oversight on company compliance with College of American Pathologists and ISO 13485:2016 standards through an internal auditing program. Ms. Smith joined C₂N in 2014 after a robust career in academic research at a molecular imaging core facility.