The Industry’s Most Advanced Technology Delivered by the World’s Leading Experts in Cardiac Safety |
More than 100 years cumulative experience in advanced analytics, medical and scientific expertise |
iCardiac Technologies, Inc, provides drug development companies worldwide with a team of cardiac safety experts who collectively bring over 100 years of cardiology, electrophysiology, drug development, regulatory and academic experience. The iCardiac team has been a pioneer in the field of autonomic nervous system effects on the QT interval, which is estimated to produce false-positive results in conventional QT studies for as many as 25% of all molecules currently in clinical development. iCardiac team members are active contributors on several FDA working groups that are advancing the field of cardiac safety.
iCardiac’s core laboratory services include scientific consultation, protocol development, and end-to-end project and data management.
COMPAS: The Leading ICH E14 Compliant Solution to Reduce Cost and Eliminate False Positives/Negatives in Cardiac Safety Studies |
COMPAS was originally developed at the University of Rochester Heart Research Follow-Up Program, the international leader in the study of congenital Long QT Syndrome and electrophysiology research, and it has been used in clinical QT studies for more than a decade.
The COMPAS platform provides comprehensive analysis of cardiac repolarization signals and contains several advanced ECG signal processing tools. Thorough QT Plussm improves the precision of ECG extraction and QT measurements and helps reduce the sample size of a TQT study. QTbtbsm reduces the probability of false positive or negative results in QT studies by allowing for quantification of QT interval changes under varying conditions of heart rate and autonomic tone. Beyond QTsm provides a set of analytical services aimed at determining the relative risk of a HERG positive compound.
Our team of scientists and board-certified cardiologists boast expertise in world-wide multi-center, clinical research studies ranging from 100-3,500 subjects. The team’s experience represents all major therapeutic areas.
Executive Team
J. Mikael Totterman, Chief Executive Officer
Jean-Philippe Couderc, PhD, MBA, Chief Technology Officer
Wojciech Zareba, MD, PhD, Chief Medical Officer
Anthony A. Fossa, PhD, DABT, Vice President for
Cardiovascular Safety
Alex Zapesochny, President and Chief Operating Officer
Alexandra (Sasha) Latypova, Executive Vice President
Board of Directors
J. Mikael Totterman, Chief Executive Officer
Alex Zapesochny, President and Chief Operating Office
J. Montieth "Monty" Estes, Esq.
Brian S. Model (Board Advisor)
J. Mikael Totterman, Chairman and CEO |
Prior to iCardiac Technologies Mr. Totterman was the Chief Operating Officer of VirtualScopics Inc. (VSCP), a leading developer of image-based biomarkers for improving pharmaceutical development. During his tenure at VirtualScopics, he lead several of rounds of venture capital funding as well as striking strategic investment relationships with Pfizer, Inc. and GE Healthcare. Additionally, he was instrumental in developing VirtualScopics original business plan and overseeing the growth of the organization. Earlier in his career, Mr. Totterman also served as a principal at 3Com Ventures, a $250 million venture capital fund based in Santa Clara, CA as well as building 3Com’s Network of Global Strategic Alliances with companies including Philips, Siemens, AT&T and British Telecom. He has also held positions at Boston Consulting Group as well as Gemini Consulting. Mr. Totterman received his Bachelors Degree in Engineering from Stanford University where he was a David Starr Jordan Scholar and his Masters of Business Administration from the Amos Tuck School at Dartmouth College.
Jean-Philippe Couderc, PhD, MBA, Chief Technology Officer |
Dr. Couderc is an internally recognized authority in the development of computerized techniques for ECG signal evaluation in cardiac safety and Thorough QT (TQT studies). He is a founder and director of the Telemetric and Holter ECG Warehouse (THEW), a partnership between the Food and Drug Administration and the University of Rochester. The THEW serves as a platform for industry, academia and regulators to validate new methods for advancing the science and practice of conducting cardiac safety studies. Dr. Couderc has dedicated his career to quantitative electrocardiography focusing on the development and application of novel techniques for the analysis of ventricular repolarization from the surface ECG in human and in various animal models for clinical trials. Dr. Couderc is the author or co-author of numerous publications in computational science and engineering, numerical analysis, and computer science applied to electrophysiological signals. He is currently a member of the editorial boards of the Annals of Non-Invasive Electrocardiology and holds an SGE position at the Center for Drug Evaluation and Research for the US Food and Drug Administration. Dr. Couderc has participated in a wide range of clinical trials as well as being principal investigator and a co-investigator in several federally-funded research grants. He is a frequent lecturer at universities, laboratories, and industrial research centers in U.S and Europe involving industry and national agencies (NIH and EPA). Dr. Couderc obtained his PhD degree with highest honors from the French National Institute of Applied Sciences in Lyon, France. He was appointed Research Assistant Professor of Medicine in the Cardiology Department of Strong Memorial Hospital, University of Rochester Medical Center, NY and graduated as a Master of Business and Administration from the Simon School of Business of Rochester, NY. Additionally, he is the Assistant Director of the Heart Research Follow-up Program Laboratory, an international leader in the research of the long QT syndrome.
Wojciech Zareba, MD, PhD, Chief Medical Officer |
Dr. Zareba is an Associate Professor of Medicine (Cardiology) at the University of Rochester Medical Center Rochester, NY. Additionally, he is the Director of Clinical Research in the Medical Center’s Cardiology Unit, Director of the Heart Research Follow Up Program, and the Director of the ECG Core Lab for the Heart Research Follow Up Program. Dr. Zareba is Principal Investigator on several NIH and corporate grants focused on clinical usefulness and prognostic significance of ECG parameters and on risk stratification of cardiac death. He also serves as Principal Investigator of the ECG Core Labs for numerous studies including the International LQTS Registry, the North American ARVD Registry, MADIT II, and MADIT-CRT, large clinical trials testing clinical effectiveness and safety of implantable cardiac defibrillators and resynchronization devices. He participated in a number of corporate research projects focused on evaluating drug safety with companies including Hoffman LaRoche, Lorex, Pfizer, Warner-Lambert, Eli-Lilly, Genzyme, and Bristol Meyer Squib. He has also participated in a number of advisory councils on the topic of cardiac safety in drug trials including ISHNE Standards for Drug-Induced QT Prolongation Analysis and FDA Panel on Digital ECG Format for Drug Studies. Dr Zareba has contributed authored or co-authored more that 200 publications in cardiology research with many of them focused on QT prolongation and ECG related cardiac safety biomarkers. He has given over 300 abstract presentations and over 100 invited lectures during several national and international meetings. Dr. Zareba is the Editor in Chief of Cardiology Journal, Deputy Editor of Annals of Noninvasive Electrocardiology as well as a member of the editorial boards of a number of other leading cardiology-related publications including Journal of Cardiovascular Electrophysiology, Heart Rhythm Journal, Journal of Electrocardiology, and Journal of Arrhythmia. Dr. Zareba is President of the International Society for Holter and Noninvasive Electrocardiology. Dr. Zareba obtained his MD degree in Medicine as well as his Ph.D. degree in Cardiology from Medical University of Lodz, Poland.
Anthony A. Fossa, PhD, DABT, Vice President for Cardiovascular Safety |
Dr. Fossa is an international expert in both pre-clinical and clinical evaluation of cardiac drug safety, especially in compounds that may affect autonomic tone. His 25 years of research have focused on ensuring accurate characterization of drugs cardiac safety profiles using advanced continuous ECG based measurement techniques. Dr Fossa spent 25 years in the pharmaceutical industry, including 22 years at Pfizer. At Pfizer he held roles on numerous early Discovery/Development teams as a Research Fellow and helped to form the company’s General Pharmacology group in 1988. Dr. Fossa was responsible for conducting in vivo preclinical cardiovascular assessments on more than 150 clinical drug candidates and was a key contributor on 4 successful commercial products. He also was one of the original founding members of the General Pharmacology/Safety Pharmacology Steering committee, which today is known as the Safety Pharmacology Society. In that role, he served as chairman in 1996 and was responsible for organizing the annual scientific meetings from 1993 to 2000. As a leading scientist, he has authored a diverse range of publications related to cardiovascular assessment and is an inventor on numerous patents related to novel indications. Dr. Fossa’s research has focused on the use of beat-to-beat dynamics to assess arrhythmia liability related to human QT prolongation. His research has established in vivo models to differentiate pro-arrhythmic liability of drug candidates, with emphasis on the impact from changes in autonomic tone. Dr Fossa is an active contributor to regulatory efforts for improving the design and implementation of cardiac safety studies. Dr. Fossa received his Ph.D. and M.S. in Pharmacology and Toxicology from Purdue University.
Alex Zapesochny, Esq., President & COO, Board of Directors |
Mr. Zapesochny is an experienced technology executive and attorney. As General Counsel and Director of Business Development for Lenel Systems International, a developer and global supplier of high-end software, products and services for the security industry, Mr. Zapesochny was part of a small executive management team that guided the company to extraordinary growth. The company expanded to serving over 10,000 organizations throughout 75 countries, including security-conscious entities such as Microsoft, Cisco, all three New York City-area airports, the Department of Homeland Security and over sixty percent of all Fortune 100 companies. The company’s financial growth earned it 39th place on Inc. magazine’s ranking of the nation’s fastest-growing privately-held companies, and Lenel was acquired for $440 million by United Technologies Corporation (NYSE: UTX) in March 2005. Mr. Zapesochny remained with UTC after the acquisition and continued in his legal and business development roles within the Lenel Systems subsidiary. In private practice, Mr. Zapesochny has provided legal and business counsel to early-stage companies. Mr. Zapesochny’s other experience includes being a trial attorney during his tenure as a New York City prosecutor, a policy division staff member in the Washington headquarters of a presidential campaign, and Co-Founder and Executive Director of an award-winning non-profit that expands the national registry of potential bone marrow and blood stem cell donors. Mr. Zapesochny did his undergraduate work at Cornell University and his graduate work at American University and the University of Oxford.
Alexandra (Sasha) Latypova, Executive Vice President |
Prior to iCardiac Technologies, Ms. Latypova headed sales and business development at VirtualScopics, Inc. (VSCP) a leading developer of image-based biomarkers for improving pharmaceutical development. During her tenure at VirtualScopics, she expanded the client portfolio from one lead customer, Pfizer, to 6 of the top-10 pharmaceutical companies as well as multiple smaller pharmaceutical and medical device clients. In addition, she has been responsible for developing project management organization at VirtualScopics and hiring and training several project managers and business development associates. Prior to VirtualScopics, Ms. Latypova was a Manager in healthcare practice at Analysis Group, Inc., a Boston-based economics, financial and strategy consultancy, where she advised pharmaceutical clients on a wide range of issues concerning product and market development, as well as provided economic analyses and expertise in pharmaceutical litigation cases. Ms. Latypova holds Masters of Business Administration degree form the Amos Tuck School at Dartmouth College.
David E. Williams |
Mr. Williams is the co-founder of MedPharma Partners, a Boston-based health care strategy consulting firm, which serves clients in technology-enabled health care services, pharmaceuticals, biotech, medical devices, and medical software. Mr. Williams is an internationally recognized expert in the business of health care and is the author of the Health business blog. Before co-founding MedPharma Partners he worked for ten years in the health care practice of the Boston Consulting Group and as an independent consultant. He began his career at the LEK Partnership, where he was a strategy consultant and mergers and acquisitions advisor in a variety of industries. He holds a BA in Economics from Wesleyan University, where he was elected to Phi Beta Kappa, and an MBA from Harvard Business School, with First Year Honors. He has acted as an instructor in MIT’s graduate-level Dynamics of Biomedical Technologies course in the Biomedical Enterprise Program. Mr. Williams is Chairman of the Board of medical risk management company Advanced Practice Strategies and is a board member and head of the development committee of the Hearts and Noses Hospital Clown Troupe, which provides professionally trained volunteer clowns to children facing serious illnesses.
J. Montieth "Monty" Estes, Esq. |
Mr. Estes is Managing Partner of the Rochester office of Jaeckle Fleischmann & Mugel LLP and Administrator of the Firm's Intellectual Property practice group. He is also a partner in the Firm's Business, Corporate, Intellectual Property and Emerging Company practice groups where he concentrates his practice on advising emerging technology companies, including high tech start-ups, on legal and business issues, including how to develop and protect their intellectual property assets and how to secure stages of funding. Prior to joining Jaeckle Fleischmann, Mr. Estes served for four years as Counsel with Boylan, Brown, Code, Vigdor & Wilson. He started his legal career in 1969 with the law firm of Harris Beach as an associate and then a partner. From 1980 upon leaving Harris Beach, to 2000 when he joined Boylan Brown, he gained extensive experience as an executive and director of a number of public and private companies as well as financial service firms. He has served as Vice-President and General Counsel for Fourth Dimension Systems Corp., a Naples, Florida based ultrasound and electromagnetic wave technology supplier to the telecommunications and radar industries; Chairman and Chief Executive Officer of Optical Imaging Systems, Inc., a flat panel display manufacturer in Troy, Michigan; and Chief Operating Officer of Scientific Calculations, Inc., a CAD/CAM systems developer and vendor for electronic circuit and integrated circuit designers until the company was sold to Harris Corporation. He also worked in Florida for both Manning & Napier and Equitable prior to returning to Rochester in 2000. Mr. Estes is a member of the Upstate Alliance for Innovation, which is a consortium consisting of the University of Rochester, Rochester Institute of Technology, the University of Buffalo, the City of Rochester and the City of Buffalo. He is also a member of the Board of Directors of the High Tech Business Council, the Advisory Board of the Science and Technology Law Center of the Albany Law School, the Advisory Board of the Smart Start Venture Forum, the Board of Directors of the Upstate Venture Association of New York (UVANY), and the Advisory Board of Universities of Upstate New York Venture Forum (UNYTECH), which is a collaborative effort among leading research institutions in the Upstate New York.
Anik Bose |
Anik Bose is a seasoned executive with experience in both information technology and biotechnology businesses. He has headed the business development functions at communications technology companies such as 3Com as well as biotechnology focused companies such as Monsanto. In his business development roles he has managed a $250 million corporate venture fund, spearheaded dozens of venture capital investments and executed numerous spin out transactions as well as several large M&A transactions having over $1.4billion in value. For Monsanto, Mr. Bose developed and implemented global biotech growth strategies targeted towards achieving a significant return on Monsanto's $10 billion of acquisitions. On the communications technology side, Mr. Bose architected the launch of the fastest growing Asian networking company (H3C), which achieved annual revenues of over $700 million within 36 months of launch.
Mr. Bose is currently a partner at Benhamou Global Ventures. BGV is an early stage venture fund that assists entrepreneurs in building a new generation of high technology companies. Most recently he advised and led 3Com's $885 million acquisition of its joint venture in China with Huawei. Earlier in his career, Mr. Bose served as a Partner in the High Technology Practice of Deloitte Management Consulting in San Francisco.
Mr. Bose holds a MBA from Boston College and BA in Economics from the University of Delhi, India.
José J. Coronas |
Mr. Coronas is a General Partner in Trillium Group, a Rochester based private equity and venture capital firm. He also serves as Fund Manager of the University Technology Seed Fund. Mr. Coronas is an experienced executive with strong ties to the health industry. Prior to joining Trillium, he was president of Johnson and Johnson Clinical Diagnostics; vice president and general manager of Kodak's Clinical Diagnostics Division; and president and CEO of Genencor International, a Kodak bio-technology spinoff. He earned a B.S. from the University of Miami and an M.B.A. from the Simon School of Business, University of Rochester. Mr. Coronas is on the Board of Directors at CPAC, Inc; ESL Federal Credit Union; OyaGen, Inc; CL!X, Inc., Rocket Broadband Networks, Inc., New Scale Technologies, Inc., Thermal Gradient, Inc., ASTER Wireless, Inc., and Verant Identification Systems Inc.. He also serves as a trustee of Monroe Community College Foundation, Hillside Children's Foundation and Junior Achievement of Rochester. He is currently the Chairman of the Board of Trustees of St. John Fisher College.
Timothy G. Cockshutt |
Mr. Cockshutt is Managing Director of Advantage Capital Partners, which he joined in 1998. His responsibilities include assessing investment opportunities, evaluating and structuring transactions and managing existing portfolio relationships. Prior to joining Advantage Capital Partners, Mr. Cockshutt had 21 years of experience with institutional funds involved in venture capital, private equity, and microcap investing. Most recently, he was associated with Meridian Advisors, LTD, a private investment fund. Prior to that, he was with Ventex Management, a private equity firm that managed an SBIC, and Criterion Investments, a venture capital firm that managed three institutional partnerships. Before becoming involved with venture capital, Mr. Cockshutt was a mining exploration geologist for British Petroleum in Camden, South Carolina and a consulting geologist with Ernest K. Lehmann & Associates in Minneapolis, Minnesota. Mr. Cockshutt received a B.Sc. in Geology from Kings College, University of London and a B.A. in English and Philosophy from Amherst College. He also received an M.B.A. from Rice University, where he also served as an Adjunct Professor. Mr. Cockshutt sits on the boards of several Advantage Capital Partners portfolio companies.
Brian S. Model (Board Advisor) |
Mr. Model is Vice President at Stonehenge Capital Company and is responsible for the fund’s Early Stage and Start-Up investment activities in New York State. Stonehenge currently has 8 active Early Stage and Start-Up portfolio companies in New York. He has been with the firm since 2001. Mr. Model is currently a board member of Lumetrics and a board observer at PixFusion and Knovel. Prior to joining Stonehenge, Mr. Model spent 12 years in the retail industry as Founder of a men's sportswear e-tailer, Vice President and Merchandise Manager of an upscale multi-store apparel retailer in New Jersey and as a graduate of the Macy's Executive Training Program in San Francisco. Mr. Model received his undergraduate degree in Economics from Duke University. He has an MBA with Honors from Columbia Business School in Finance and Technology. Mr. Model is active in the regional venture investing community, speaking at events sponsored by UVANY (the Upstate Venture Association of New York), the Business Council of New York, Young StartUp Ventures, the Long Island Capital Alliance and Columbia Business School. Mr. Model has served as a judge for business plan competitions and venture financing events sponsored by the Empire State Venture Group, UNYTECH, SIIA (Software & Information Industry Association), NY Venture Summit, The Wharton School, and Columbia Business School. In addition, Mr. Model serves as a mentor for Columbia Business School's Lang Fund.
