Coagulation Sciences LLC is a development company specializing in the emerging field of Transfusion Management. The Company is privately funded.

Mission Statement: Coagulation Sciences LLC is dedicated to developing and marketing coagulation analyzers that will decrease blood transfusions, thereby improving patient safety and decreasing healthcare costs.

Sheldon Goldstein, M.D., Founder and CEO
Dr. Goldstein, Founder and CEO of Coagulation Sciences LLC, is a graduate of Hahnemann Medical School, Philadelphia, Pennsylvania. He is board certified in Internal Medicine and Anesthesiology, with subspecialty training in cardiothoracic anesthesia. He is an expert in the management of transfusion in the bleeding patient and has often been invited to speak on this subject. Dr. Goldstein founded Coagulation Sciences to commercialize the Multiple Coagulation Test System (MCTS) and the Platelet Response System (PRT), and has compiled advisory boards of highly experienced professionals to provide counsel for the company.

The Scientific Advisory Board is comprised of experts in hematology, blood banking, transfusion medicine and anesthesiology. Experts in finance, marketing and business development of medical technologies serve on the Business Advisory Board. Advisors’ work experience includes the American Red Cross, Baxter, DuPont, i-STAT, and these medical centers: Cleveland Clinic, Duke University, New York University, University of North Carolina, University of Miami, University of Rochester and Virginia Commonwealth University.

Scientific Advisory Board

Arthur Palfrey Bode, PhD: For over twenty years Dr. Bode served as scientific director of the clinical coagulation laboratory at East Carolina University (ECU) Health Systems in Greenville, NC. He is an active researcher in studies of platelet preservation for transfusion. He is co-founder of a start-up company now called Entegrion, Inc, based in Research Triangle Park, NC, which is licensed to commercialize freeze-dried platelets for acute arrest of hemorrhage utilizing stabilization technology he invented along with colleagues at The University of North Carolina at Chapel Hill. The company was founded as a start-up in May 2002 through joint efforts of ECU and UNC, and it has already conducted its pre-IND meetings with the US Food and Drug Administration in consideration of clinical testing of the freeze-dried platelets in cardiac surgery patients. Dr. Bode has published over fifty journal articles and book chapters and over seventy abstracts to (inter)national meetings, delivered over forty plenary talks or invited lectures on his research or clinical interests, and is co-inventor on five patents regarding preservation of platelets or red blood cells. The federal and corporate grant funding of his laboratory’s research has amounted so far to over $8 million, mostly from the US Office of Naval Research.

He obtained his PhD in Experimental Pathology at UNC-Chapel Hill in 1982, did a postdoctoral fellowship in blood banking at UNC, and is now retired as a tenured full professor in Pathology at ECU and director of the Platelet Research Laboratory in The Brody School of Medicine after 23 years of service. Presently he is working as scientific consultant for his startup company Entegrion. Dr. Bode is a regular reviewer of grants for the Canadian Blood Services, and of manuscripts for several journals including Transfusion, Blood, and The Journal of Laboratory and Clinical Medicine. He remains a member of the UNC Center in Thrombosis and Hemostasis and has continued interests in anticoagulation and platelet function in cardiac surgery.

Michael P. Eaton, M.D.:Dr. Eaton is Associate Professor and Vice Chair for Clinical Affairs, Dept. of Anesthesiology, at the University of Rochester Medical Center, where he assesses technology, focusing on hemostatic blood products. He is also Chief of the Division of Cardiac Anesthesiology at the University of Rochester Medical Center. He has performed research on pharmacologic therapy to decrease bleeding during cardiac surgery. He is a member of the American Heart Association’s Council on Cardiovascular Surgery and also Chairs the Society of Vascular Anesthesiologists Committee on Electronic Communications.

Maureane R. Hoffman, MD, PhD: Dr. Hoffman is tenured Professor of Pathology at Duke University, and Director of the Hematology, Transfusion Service and Clinical Chemistry Laboratories at the affiliated Durham VA Medical Center.

Dr. Hoffman’s research focuses on the role of cellular features in controlling hemostasis and thrombosis. Her collaboration with Dr. Mac Monroe and Dr. Harold Roberts has led to the development of an in vitro cell-based model that mimics many aspects of hemostasis in vivo. This work has produced an improved conceptual model of how the hemostatic process functions in vivo. Their work has clarified why the deficiency of Factor VIII or Factor IX in hemophilia leads to such a severe bleeding tendency, and how bypassing agents increase thrombin generation. They have also pioneered studies showing that impaired hemostasis leads to delayed wound healing.

Dr. Hoffman’s research is driven by her clinical role as Director of the Transfusion Service and Hematology/Coagulation Laboratories of the Durham VA Medical Center, an affiliate of Duke University. In this capacity she has strong interests and experience in component therapy for bleeding disorders, and mechanisms for monitoring anticoagulants and transfusion therapy. She has authored or co-authored over 115 journal articles and 15 book chapters, and has lectured extensively in the US and Europe on basic and clinical laboratory aspects of coagulation.

Dr. Hoffman obtained her MD and PhD (Pharmacology/Toxicology) degrees from the University of Iowa. She completed residency training in Anatomic and Clinical Pathology. She has been on the faculty of Duke University and the University of North Carolina.

Michael Kagan: Mr. Kagan has twenty-eight years of experience as an engineering and manufacturing executive, both developing and bringing products to market. Mr. Kagan has experience leading engineering and manufacturing initiatives, systems design and engineering, problem solving, establishment of regulatory design controls, lean manufacturing, budgeting and product cost analysis and reduction. At Immunicon Corporation he established design controls for FDA and ISO-13485:2003 compliance and worked with Johnson & Johnson as a partner in establishing world wide field service and support for Immunicon products.He served as Vice President of Manufacturing and Product Development at Molecular Biometrics, Inc where he was responsible for the development and commercialization of their Assisted Reproductive Technology platform. He currently serves on several advisory boards for in-vitro diagnostic companies.

Mark Lifshitz, M.D.: Dr. Lifshitz serves as Director of Clinical Laboratories at the New York University Medical Center. He is a leading expert on blood bank management and medical equipment, with four books and 14 book chapters published on these topics. His 80 published articles focus on medical equipment and devices, particularly blood analyzers..

Kandice Kottke-Marchant, M.D., Ph.D.: Dr. Kottke-Marchant is one of the world's leading experts in Hemostasis and Thrombosis. She is Chair, Pathology and Laboratory Medicine Institute, Chair and Section Head of Hemostasis and Thrombosis in the Clinical Pathology Department at Cleveland Clinic, in Cleveland, Ohio. She also is Chair, Department of Pathology at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University as well as Adjunct Professor, Dept. of Biomedical Engineering at Case Western Reserve University, Cleveland, Ohio. Her current research is on the functional and genomic associations with response to antiplatelet medications and development of tissue engineering approaches to biomimetic vascular graft implants. She is currently President of the International Society for Laboratory Hematology, a member of the Coagulation Resource Committee of the College of American Pathologists, and a member of the hematology testing committee of the American Board of Pathology. She is the author and co-author of over 250 articles, abstracts, and book chapters. She is the editor of a textbook: An Algorithmic Approach to Hemostasis Testing. Dr. Kottke-Marchant holds M.D. and Ph.D. degrees from Case Western Reserve University and a Bachelor's degree from Northwestern University.

Harold Ross Roberts, M.D.: Since 1986, Dr. Roberts has been the Sarah Graham Kenan Professor of Medicine and Pathology, University of North Carolina (UNC), School of Medicine. For 15 years he was chief of the Hematology Division of the UNC School of Medicine. He is a member of the editorial boards of Current Opinion in Hematology, Hematologic Pathology, and Bloodline Link. He has served, often as chairman, on a range of blue-ribbon committees and boards, both national and international, investigating new research and problems in coagulation. His is the author of over 270 articles and 170 abstracts on blood, coagulation, and related subjects.

Bruce Davis Spiess, M.D.: Dr. Spiess is Professor with Tenure, Department of Anesthesiology, Adjunct Professor, Emergency Medicine, and Director of the Virginia Commonwealth University Reanimation Engineering Shock Center (VCURES).

Dr Spiess speaks the world over as an authority on blood transfusion and has been keynote speaker for transfusion conferences in Australia, New Zealand, Denmark, Canada, Mexico, Chile, Great Britain and elsewhere. He has been a visiting professor on transfusion and also on the use of perfluorocarbon emulsions at Oxford University, Harvard, The Cleveland Clinic, Mayo Clinic as well as many other major academic institutions. He serves on the Joint Commission of Accreditation of Hospital Organizations (JCAHO) special task force on blood utilization. He reviews papers and sits on editorial boards for more than 15 academic journals, and sits on a blood transfusion study section of the National Institutes of Health. He has pioneered the efforts worldwide to reduce unnecessary transfusion and within Virginia Commonwealth University is Chair of the Hospital-wide Blood Utilization Committee as well as the Operating Rooms Laboratories/Satellite Blood Bank. Dr Spiess has created and drives the blood transfusion reduction program (PET Program- Practicing Excellence in Transfusion) at VCU, which has been instrumental in decreasing VCU’s demand for allogeneic blood. This single program has been copied by many in the nation, and is now the center of a statewide effort by the Virginia Cardiac Surgery Quality Initiative (VCSQI) to decrease transfusion for heart surgery in Virginia hospitals.

Dr Spiess is a recognized international leader in cardiac anesthesiology and has been on the Board of Director’s of the Society of Cardiovascular Anesthesiologists as well as past President of the American Association of Cardiac Anesthesiologists. For over 10 years he has been listed as one of the Best Doctors in America. Most recently, through the SCA he has conceived and driven the development of the Flawless Operative Cardiovascular Unified Systems (FOCUS) initiative. This is an on-going research and practice modification project to examine human error in cardiac operating rooms with a human factors engineering analysis approach. The project is now in its sixth year, and has garnered over 3 million dollars in philanthropic donations.

Dr. Spiess has authored or co-authored over 200 scientific research publications and served as Editor of Perioperative Transfusion Medicine, widely recognized as one of the most authoritative texts on blood usage in the perioperative period. He has garnered consistent (over 9 years of continuous support) funding by the Office of Naval Research for his work in decompression illness and air embolism treatment by perfluorocarbons.

Emeritus Member

Benjamin Lichtiger, M.D., Ph.D., MBA: Dr. Lichtiger is Professor and Chair of the Department of Laboratory Medicine and Chief of the Section of Transfusion Medicine at M. D. Anderson Cancer Center. He is board certified in both Anatomic and Clinical Pathology by the American Board of Pathology. As the Department Chair, Dr. Lichtiger interacts administratively and medically in the services provided by the Sections of Transfusion Medicine, HLA, Laboratory Hematology, Clinical Chemistry and Clinical Microbiology. His area of expertise is Transfusion Medicine. In this area he is involved daily in direct patient care and serves as a consultant in issues related to transfusion medicine, appropriate utilization of blood components, blood component support for bone marrow transplant and other patients with hematologic malignant diseases and support of peri-operative transfusion needs. He played a major role in the selection, and implementation of the Informatics System in the Blood Bank and also the Laboratory Informatics System for Laboratory Medicine. In addition, he played a pivotal role in the implementation and adoption of the Lean Manufacturing process for the Department of Laboratory Medicine.

Dr. Lichtiger oversees and participates in the department’s two fellowship programs, Transfusion Medicine and Chemical Pathology. He also trains professionals from foreign countries in the latest blood banking techniques and managing approaches in transfusion medicine.

Dr. Lichtiger is an active member on several institutional committees such as the Coordination of Care Subcommittee, Patient Safety Communication Task Force, Medical Practice Committee and serves as Vice-Chair of the Transfusion Committee. Dr. Lichtiger also actively participates in the following organizations’ activities: 1) Examiner, Malcolm Baldrige National Quality Award, appointed by the U. S. Department of Commerce, National Institute of Standards and Technology, 2) Member, Board of Directors San Jose Clinic, Houston, TX, 3) Chair, Standards Subcommittee for Evaluation of International Variances, American Association of Blood Banks (AABB), and the Standards Program Committee (AABB), 4) Member, AABB’s Bacterial Contamination Standard Task Force, 5) Treasurer and member, Executive Committee, American Society for Clinical Pathology, 6) Member, Professional and Technical Laboratory Advisory Committee, Joint Commission Accreditation of Hospitals 7) Member, Advisory Group on Blood Banking of the Pan American Health Organization, among others.

Business Advisory Board

Terry Fadem: Mr. Fadem is Managing Director, Corporate Alliances at the School of Medicine of The University of Pennsylvania, where he is also a member of the core team for the Mack Center for Managing Technological Innovation at the Wharton School. In addition, Mr. Fadem is the Director for the Commercialization and Entrepreneurship Core for the Institute for Translational Medicine and Therapeutics and serves on the Public Private Partnership Oversight Committee for the NIH Clinical Translational Science Award consortium of academic medical centers. He worked for the DuPont Company holding a number of business positions including Director, Corporate New Business Development. Mr. Fadem's experience includes work in the non-profit sector as the former Scientific Director for the National Committee for Clinical Laboratory Standards (NCCLS) and most recently with the Biomedical Research and Education Foundation (BREF) where he is President. He is a frequent lecturer on managing innovation, new business development and negotiation at the School of Medicine and at the Wharton School of Business where he was a Senior Fellow in the Mack Center.

Dennis Fallen, MBA: Mr. Fallen is currently Vice President and General Manager of Fisher BioServices a division of Thermo Fisher Scientific, Inc. Fisher BioServices is the worlds largest biorepository services company, handling and storing biological specimens, stem cells, and biologic pharmaceutical intermediates. Mr. Fallen is co-founder and President and CEO of Transfusion Management Services, Inc. (TxMS). TxMS provides management and outsourcing services to hospitals for the operation of their blood banks and transfusion services. Prior to founding TxMS, he was Vice President, Business Development at Baxter Healthcare’s Biotech Group. Prior to Baxter, he was Vice President of the Plasma Therapeutics division at the American Red Cross Biomedical Services. Mr. Fallen’s responsibilities have included management, business development, marketing, sales and advertising for national healthcare associations and private companies. As a founder and partner in a healthcare consulting firm, he developed strategic market plans and developed and implemented packaged clinical programs for hospitals throughout the U.S. Mr. Fallen is experienced in therapeutic product manufacturing and has managed contract manufacturing relationships and R&D programs in both the US and Europe. He has managed clinical trial programs and new product launches of plasma protein based therapeutics. He holds B.S. and MBA degrees from DePaul University.

Noah J. Kroloff: Mr. Kroloff is a Partner at NGN Capital, a healthcare venture capital firm with $430 million under management and offices in New York and Heidelberg.

Prior to joining NGN Capital, Mr. Kroloff, who has over 20 years experience in healthcare, served as an executive officer at i-STAT Corporation, a publicly-traded medical device company where he was Vice President for International Sales & Marketing and Corporate Development. He was actively involved in the sale of i-STAT to Abbott Laboratories for approximately $450 million. He also led the creation of a global alliance with Abbott, a $61 million alliance with Hewlett-Packard Medical Products Group and created i-STAT¹s international distribution network. Prior to i-STAT, Mr. Kroloff was an Engagement Manager at McKinsey & Co. where he advised leading pharmaceutical and diagnostic companies on R&D management, portfolio strategy, and alliance formation. Prior to his work in healthcare, he was a senior analyst at Fannie Mae. Mr. Kroloff received his BA in general science from Brandeis University and his MBA from the MIT Sloan School of Management, where he was a co-founder of and has served as a judge in the MIT $100K Entrepreneurship Competition. He is a member of the board of BeneChill and Coagulation Sciences, a board observer at Valtech Cardio and Cerapedics and is actively involved with OptiScan BioMedical and SpineView.

He was recently a member of McKinsey's alumni advisory council for 6 years.

David Lubarsky, MD, MBA: Since 2001, Dr. Lubarsky has served as the Emanuel M. Papper Professor and Chairman of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami Miller School of Medicine, running the largest anesthesia training program in the world at the country’s largest hospital. In 2006, he was additionally appointed as Senior Associate Dean for Safety, Quality and Risk Prevention and Assistant Vice President for Medical Administration for the University of Miami Health System. He is also a Professor in the Department of Management at the University of Miami School of Business, where he teaches about negotiations and incentive plans. Dr. Lubarsky has authored several books and over 100 peer-reviewed articles and book chapters. He is known for his contributions to the fields of healthcare economics, informatics, and systems/operating room management, and has won several awards and international renown for his research in these areas. He has had an active pharmaco-economics and medical marketing consulting practice, serving Abbott, Arkive, Aspect, Baxter, Docusys, Drager, Glaxo Smith Kline, Guilford, Hewlett-Packard, Infusion Dynamics, Organon, MGI, Pfizer, Picis, Roche and Somatogen among others.

Dr. Lubarsky served as tenured Professor and Vice Chair of Anesthesiology at Duke University Medical Center, where he led the division of general, vascular, and transplant anesthesia and critical care medicine before his departure at the end of 2001. While at Duke he worked closely with the office of technology transfer, and was active in developing business strategy of the Duke Healthcare system, and the physician group's new business development. He taught several full term courses at Duke's Fuqua School of Business and held an adjunct appointment at Fuqua from 2000 to 2002.

Dr. Lubarsky earned his MD at Washington University, St. Louis, in the highly regarded Scholars Program in Medicine. He completed his residency, and his fellowship in Cardiac Anesthesia and Clinical Research, in the Department of Anesthesiology at New York University Medical Center. He received his M.B.A. in 1999 from the Fuqua School of Business at Duke University and was honored as a Fuqua Scholar.

Bruce Taragin: Mr. Taragin has 17 years of experience as a venture capital investor, entrepreneur, technology investment banker and corporate attorney. Prior to joining Blumberg Capital in 1998, where he is a Managing Director, Bruce co-founded and held several senior management positions within technology companies including Charles River Computers. Bruce also structured and managed early-stage technology transactions at Hambrecht & Quist, Mayer Brown & Platt and Bankers Trust Company. Bruce serves as a member or observer on the Board of Directors of DoubleVerify, CaseStack, Insightix, LiteScape, Correlix, Nolio, Revionics and Sweepery. He also serves on the board and the investment monitoring committee of the Jewish Community Foundation of Northern California. Bruce earned his BA in Finance and Communications, cum laude, from Yeshiva University, and his MBA and JD from Fordham University.

Terry Williams: Mr. Williams is a business consultant with extensive expertise in
development, approval, and commercialization of medical devices. He is
Founder and CEO of a start-up medical device and software company that
successfully designed, manufactured and received FDA approval on 3 clinical
devices. His company also developed and received 5 US Patents with
successful acute care product offerings to Kinetic Concepts (KCI), General
Electric Medical Systems, Baxter Healthcare and Philips Medical Systems. He
currently directs a medical device company that distributes negative
pressure wound therapy devices and support surfaces for KCI.