Technology is only a piece of the clinical trials process. When you do business with iCardiac, you work with people.
Alex Zapesochny, President & CEO
An experienced technology entrepreneur and attorney, Alex co-founded iCardiac in 2006. Before that, he was general counsel and director of business development for Lenel Systems, a developer and global supplier of enterprise software, hardware and services for the electronic security industry. Alex was part of a small executive management team that guided that company to extraordinary growth. Lenel Systems expanded to serve over 10,000 organizations, including giants like Microsoft and Cisco, across 75 countries. In private practice, Alex has provided legal and business counsel to early-stage companies. He was 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 of an award-winning non-profit that expands the national registry of potential bone marrow and blood stem cell donors. Alex participates in numerous community activities, including as a member of the Entrepreneurship & Innovation Working Group of the Finger Lakes Regional Economic Development Council, as a trustee of the Center for Governmental Research and as a board member for two charter school organizations. Alex received his undergraduate degree from Cornell University and graduate degrees from American University and the University of Oxford.
Borje Darpo, MD, PhD, Chief Scientific Officer
Borje is board-certified in cardiology and internal medicine. In addition to his role at iCardiac, he is associate professor of cardiology at the Karolinska Institute in Sweden. Borje has more than 18 years of industry experience, including senior management positions at small, mid-size and large pharmaceutical firms and at a global contract research organization. He has led or has been responsible for projects in all phases of clinical development, including the filing and approval of a New Drug Application. Borje authored internal QT guidance documents for the design and conduct of clinical QT assessment, such as Thorough QT studies, for four sponsors, including Pharmacia and Pfizer. He has advised a large number of clinical trial sponsors on design, conduct, interpretation and regulatory communication on TQT studies for compounds within a wide range of therapeutic areas, including cardiovascular, anticoagulants, antiplatelets, metabolic, oncology, and neurology. When it comes to the cardiovascular safety assessment of drugs, Borje’s broad experience includes participation in the generation of existent regulatory guidance on QT assessment (CPMP and ICH E14). He was former co-chair of the International Life Sciences Institute/Health and Environmental Sciences Institute cardiovascular safety subcommittee and member and co-chair of the scientific oversight committee of the Cardiac Safety Research Consortium, generating internal company-specific guidance on cardiac safety assessment and numerous reviews of programs, both internally and as a consultant. Borje also served as the European Federation of Pharmaceutical Industries and Association deputy topic leader for the ICH E14 Implementation Working Group, which worked on regional implementation of this guidance and support to sponsors through a Q&A process, between 2001 and 2008. More recently, Borje, in collaboration with industry and the U.S. Food and Drug Administration, led the IQ-CSRC study, which validated the concept of applying exposure response analysis on data from early stage clinical trials to replace the TQT study. The results from this study paired with the experience from regulators led to the revision of the International Council on Harmonisation’s E14 guideline, which since December 2015, allows this approach to replace the TQT study.
Jean-Philippe Couderc, PhD, MBA, Chief Technology Officer
Jean-Philippe is an internationally recognized authority in the development of computerized techniques for ECG signal evaluation in cardiac safety and Thorough QT studies. He is a founder and director of the Telemetric and Holter ECG Warehouse, a partnership between the U.S. 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. Jean-Philippe 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. He is the author or co-author of numerous publications in computational science and engineering, numerical analysis, and computer science applied to electrophysiological signals. Jean-Philippe is currently a member of the editorial boards of the Annals of Non-Invasive Electrocardiology and holds a Special Government Employee position at the Center for Drug Evaluation and Research for the FDA. He 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. Jean-Philippe is a frequent lecturer at universities, laboratories, and industrial research centers in U.S and Europe involving industry and national agencies like the National Institutes of Health and the Environmental Protection Agency. He obtained his PhD degree with highest honors from the French National Institute of Applied Sciences in Lyon, France and was appointed Associate Professor of Medicine in the Cardiology Department of Strong Memorial Hospital at the University of Rochester Medical Center. Jean-Philippe also has an MBA from University of Rochester’s Simon Business School. He is 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
Wojciech has 35 years of expertise in cardiology research. In addition to his position at iCardiac, he is a professor of medicine at the University of Rochester Medical Center. Wojciech is the director of the Heart Research Follow-Up Program and is principal investigator on several corporate and National Institutes of Health grants focused on cardiac arrhythmias, heart failure, and novel pharmacological and device-based therapies. Over the years, Wojciech has been studying extensively clinical usefulness and prognostic significance of ECG parameters in risk stratification of sudden cardiac death. He also serves as principal investigator of the ECG Core Lab for numerous studies including the International LQTS Registry, the North American ARVD Registry, MADIT II, and MADIT-CRT, MADIT-RIT, RAID and other large clinical trials testing clinical effectiveness and safety of implantable cardiac defibrillators and resynchronization devices. Wojciech participated in a number of clinical research studies focused on evaluating drug safety with companies including Roche, Lorex, Pfizer, Warner-Lambert, Eli Lilly, Genzyme, and Bristol Meyers Squibb. He is an active participant in many advisory councils on the topic of cardiac safety in drug trials including ISHNE Standards for Drug-Induced QT Prolongation Analysis and the Cardiac Safety Research Consortium. Wojciech has contributed, authored or co-authored more than 550 publications in cardiology research, with many of them focused on QT prolongation and ECG-related cardiac safety biomarkers. He is the editor in chief of Annals of Noninvasive Electrocardiology, as well as a member of the editorial boards of a number of other leading cardiology-related publications. Wojciech is past president of the International Society for Holter and Noninvasive Electrocardiology and he currently serves as President of the International Society of Electrocardiology. He earned his MD and Ph.D. in cardiology from Medical University of Lodz, Poland.
Jay Baker, CPA, Chief Financial Officer
Jay oversees financial operations at iCardiac. An experienced startup technology executive and certified public accountant, he was controller for Lenel Systems International, a developer and global supplier of high-end software, products and services for the security industry. Jay arrived at Lenel when the company was in its infancy and was an integral part of a small executive management team that guided the company from a startup company to the dominant market leader in its industry. Lenel was acquired for $440 million by United Technologies Corporation in March 2005. Jay remained with UTC after the acquisition and assisted with the integration of the Lenel and UTC financial reporting systems. In April 2007, he joined iCardiac as its CFO. Jay and Alex co-founded an award-winning non-profit that expands the national registry of potential bone marrow and blood stem cell donors. He was selected from the Be the Match registry as a donor for a person in need of a transplant.
Tom Avery, Senior Vice President, Business Development
Tom joined iCardiac in December 2014. A graduate of the United States Air Force Academy and former USAF pilot, he has over 30 years of business and commercial development experience in the life sciences industry. Tom spent 18 years at the Diagnostics Division of Abbott Laboratories in various sales, training, and marketing positions, contributing to the launches of several key product lines, including the first blood test for HIV in 1985. Tom worked the next 12 years at ERT, rising from field sales to progressive management and marketing positions, where he built several segments of the global sales organization and ultimately was named chief commercial officer, responsible for all business development. During his tenure, the organization grew ten-fold in annual sales.
Jaimie Cole, Vice President, Technology
Jaimie leads the Global Technology Center at iCardiac, a team of talented and motivated technology professionals responsible for the COMPAS and eSP software platform, iClinica clinical trial management system, ePRO platform, and IT infrastructure. His direction and leadership has ushered in fresh methods for efficiently and effectively delivering validated software, systems, and technology for growth and scalability on the cutting edge of cardiac safety and spirometry technology. Prior to his work at iCardiac, Jaimie spent over 20 years in software development at Eastman Kodak, most notably on the Kodak Easyshare software team in Kodak’s Digital Camera division. His educational background in computer engineering from Rochester Institute of Technology and specialization in digital signal processing techniques have been key ingredients to the success of iCardiac’s validated software platforms. Jaimie is also an accomplished musician and entertainer, most notably as the former lead guitarist for Rochester’s own “Nik and the Nice Guys,” a well-known local musical group which has performed on TV and at major sporting events such as the Super Bowl.
Brian Smith, Vice President, Project Operations
Brian oversees Project Management, Project Support, Data Management, ECG Core Lab and Statistics departments at iCardiac. He ensures that iCardiac’s operations run smoothly and are in line with its overall business objectives. Under his leadership, the team has supported a range of domestic and international studies across therapeutic areas as well as stages covering from Phase I to Phase III studies including a large number of Thorough QT studies. Prior to his work at iCardiac, Brian worked as a senior project manager at ACM Global Central laboratories. At ACM he managed multiple domestic and international trials across a variety of different therapeutics areas for central laboratory testing in Phase I to Phase IV trials. Brian also worked at Wyeth as a research scientist and was involved in assay automation, coordination and testing of samples to determine efficacy in large vaccine trials. Brian has a B.S. in biotechnology from Rochester Institute of Technology. Outside work, Brian spends most his time with his wife and his two beautiful daughters.
John Sage, Senior Vice President, Respiratory and ePRO Services
John Sage joined iCardiac in July 2015 through the acquisition of nSpire Health’s clinical trials business. Prior to the acquisition, John was the leader of the clinical business of nSpire for 3 years. He has held senior leadership positions with Johns Manville, a Berkshire Hathaway Company, and General Electric. John has a B.Sc. in Chemical Engineering from The Ohio State University.
Thuan G Pham, Director, Software Development
Thuan leads the software development team at iCardiac, a group of highly skilled software developers and quality assurance members who develop and maintain our COMPAS software platform, iClinica clinical trial management system, and iCOMPAS software application, in addition to other application services. Thuan’s leadership has driven iCardiac’s software development processes to support our innovative application of new technologies in the cardiac safety and spirometry industries. He is responsible for building our offshore team by picking the best talent globally to join our U.S.-based team. Thuan spent over 7 years working as a software engineer and software architect for Citigroup and Fujifilm eSystems. He has a computer science degree from Rochester Institute of Technology.
Mark Ticktin, Director, Strategic Implementation
At iCardiac, Mark Ticktin has been responsible for the development and execution of processes that are critical to the core operational flow. Mark is responsible for the management of research and development projects, as well as technical and operational process improvement initiatives. He has experience in GxP regulations, including GLP, GMP, and GCP. Prior to iCardiac, Mark worked in Preclinical Development at Johnson & Johnson (JNJ) within the Genetic Toxicology group and in Product Development at Kensey Nash (KNSY). He received his Bachelor’s degree in Biomedical Engineering from Drexel University. While at Drexel, Mark concentrated in Biomedical Systems and Imaging, and completed a minor course of study in Electrical Engineering. Mark is a Philadelphia Phillies fan.
Kamlesh Naidu, Director, Data Management
At iCardiac, Kamlesh is responsible for the development and execution of data management processes that are critical to the core operational flow. He oversees the data management group at iCardiac and works primarily to support quality and on-time deliveries to clients. Kamlesh also is responsible for training and hiring in the data management group and overseeing the day-to-day activities. Previously, Kamlesh worked at Markin Tubing, LP where he helped in improving manufacturing and quality processes, reducing production errors, and closing out corrective and preventive actions. Kamlesh has an M.S. in industrial and systems engineering from the University of Florida and a B.E. in electronics & communications engineering from Nagpur University in India. Kamlesh is an avid NCAA basketball fan and his favorite team is the Florida Gators.
Charcy Schultz, Director, Quality & Regulatory
Charcy is responsible for the Quality Department at iCardiac. She ensures that iCardiac’s services and operations meet external and internal requirements, including all regulatory compliance standards and customer expectations. As part of overseeing the activities to meet these quality standards, she works closely with other leaders and staff throughout the organization to make sure the quality system is functioning properly. Charcy has over 10 years of experience in the conduct of clinical trials, including having served as a Project Manager at iCardiac. Prior to joining iCardiac, Charcy was at the University of Rochester Medical Center, where she held roles including Clinical Research Coordinator, Research Associate and Clinical Technologist. Charcy, who earned a bachelor’s degree in psychology from the State University of New York at Brockport, is an avid gardener and enjoys spending time with her husband and young daughter.