Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in 2003. Dr. Stepanians has more than 30 years of experience in drug development, with a specific focus on biostatistics and data management. In addition to overall responsibility for the company’s scientific and operational activities, Dr. Stepanians is a practicing biostatistician, directly involved in study design and analysis, strategic product development planning, and commercialization support. Dr. Stepanians has designed the analyses for the Integrated Summaries of Efficacy and Safety for more than 15 successful marketing applications (NDAs; MAAs) and has presented on behalf of sponsors in meetings with FDA. She has particular expertise in challenging study design and analysis problems, including adaptive design trials, and has participated as a voting or non-voting member of a number of Independent Data Monitoring Committees.
Prior to founding PROMETRIKA, Dr. Stepanians served as Director of Biostatistics and Data Management at Muro Pharmaceutical/Viatris, Inc., which she joined in 1993. In this capacity, Dr. Stepanians headed a department of 20 biostatisticians, programmers and data managers. As a member of several global project teams at Muro, Dr. Stepanians was a key contributor to the design of drug development programs and had primary oversight of statistical and data management activities. She had statistical oversight for the development and submission of three successful NDAs and interacted extensively with the FDA. Prior to joining Muro, Dr. Stepanians worked in the biostatistical arena for seven years, first at the New England Medical Center and then at Boston University’s Statistics and Consulting Unit, providing statistical services for a number of pharmaceutical companies in a wide range of indications. She has authored a number of journal articles.
Dr. Stepanians received her Doctor of Philosophy degree in Statistics from Boston University in 1994. She received her Master of Science degree in Mathematics (Statistics) from Massachusetts Institute of Technology in 1984 and her Bachelor of Science degree in Mathematics and Psychology from Boston University in 1982.
Ms. Heather Paden, Head of Clinical Operations, has more than 20 years of diverse experience in clinical research operations management, clinical science, trial management and monitoring, respiratory therapy, and education. She has published and presented her research on the effects of drug and exercise intervention in patients with COPD. Ms. Paden provides oversight of the Clinical Operations activities for each new project, with specific emphasis on translating business and client objectives into a working plan throughout the execution of studies. Ms. Paden has extensive experience in cross-disciplinary management of large and small trials, and has provided substantial contributions to the writing of protocols, clinical study reports, abstracts, and manuscripts. Her work has covered the therapeutic areas of oncology, cardiovascular disease, and respiratory disease.
Prior to joining PROMETRIKA, Ms. Paden was Head of Clinical Development Operations at ContrFect Corp. and a Senior Consultant at Halloran Consulting. Prior to these roles, Ms. Paden was Director of Clinical Development Medical Affairs at Boehringer Ingelheim Pharmaceuticals (BI). Her distinguished tenure at BI included planning, monitoring, and managing US and international studies. Early in her career, Ms. Paden practiced and taught in the field of respiratory therapy. She has authored several journal articles and has been recognized by BI with corporate research rewards for her work in cardiovascular health.
Ms. Paden received her Masters of Science from Northeastern University in 2012, and her Bachelor of Science (1996) and Bachelor of Arts (1994) degrees from the University of Kansas.
Ms. Cathy Hult has more than 20 years of experience in the biopharmaceutical industry. At PROMETRIKA, Ms. Hult leads an experienced group of clinical data managers in all facets of clinical trial data capture, review, and archiving. Calling on her broad experience, Ms. Hult collaborates with sponsors to translate their project objectives into feasible and efficient data management plans. She is also responsible for establishing and maintaining the data management systems and procedures that assure compliance with PROMETRIKA’s quality standards and cGCP. Ms. Hult’s extensive experience includes expert application of MedDRA and WHODRUG coding, contribution to protocol design, eCRF design, and data management leadership. Since 2013, she has managed studies using the Medidata Rave EDC platform.
Prior to joining PROMETRIKA in 2006, Ms. Hult held Senior Clinical Data Manager positions at Antigenics, Inc. and Wyeth Research. At PAREXEL International, Ms. Hult had roles as a Senior Clinical Data Manager and a Quality Assurance Auditor.
Ms. Hult earned her Bachelor of Arts in Political Science and her Bachelor of Science in Nursing from Salem State College in Salem, Massachusetts.
Dr. Nicole LaVallee, Director, Biostatistics, has more than 25 years of experience in the pharmaceutical industry. Dr. LaVallee manages a team of biostatisticians and SAS® programmers preparing analyses of phase 1 through 4 clinical studies and other analyses for regulatory submission or publication. Dr. LaVallee also contributes to the design of clinical development plans and the writing and review of study protocols, statistical analysis plans, and clinical study reports. She has been the lead statistician for the preparation of Integrated Summaries of Efficacy and Safety in support of several successful regulatory submissions and has served as a voting or non-voting member on several Independent Data Monitoring Committees.
Prior to joining PROMETRIKA, Dr. LaVallee was Senior Manager of Biostatistics at Muro Pharmaceutical/Viatris, Inc., which she joined in 1994. Prior to joining Muro, Dr. LaVallee worked as a biostatistician in clinical research for five years, first at the Hershey Pennsylvania Medical Center, and then at Parexel International. She has authored various journal articles in the areas of clinical trials and health services research.
Dr. LaVallee received her Doctor of Philosophy degree in Biostatistics from Boston University in 2001, her Master of Arts degree in Statistics from Pennsylvania State University in 1990, and her Bachelor of Science degree in Mathematics from the University of Massachusetts at Lowell in 1986.
Dr. Heidy Russell, Director, Biostatistics, has more than 20 years of experience in biostatistics. In addition to her responsibilities managing a team of biostatisticians and SAS® programmers, Dr. Russell provides scientific input and oversight to the statistical design of clinical trials, conduct of clinical trial analyses, and writing and review of statistical analysis plans, clinical study protocols and statistical sections of clinical study reports. She has been the lead statistician in many phase 1, phase 2 and phase 3 clinical trials and for the preparation of a number of Integrated Summaries of Efficacy and Safety in support of regulatory submissions. She has supported numerous statistical analyses for product commercialization and publications, and has served as a non-voting member on several Independent Data Monitoring Committees.
Prior to joining PROMETRIKA, Dr. Russell served as Principal Biostatistician at Muro Pharmaceutical/Viatris, Inc., which she joined in 1997. Prior to joining Muro, Dr. Russell worked as a statistician at Boston University’s Statistics and Consulting Unit providing statistical services to pharmaceutical sponsors and FDA. Dr. Russell has published in several scientific journals and was a co-author, in 1998, of 16 chapters in the Encyclopedia of Biostatistics (John Wiley & Sons, Ltd). She has also authored many abstracts and posters reporting the results of clinical trials.
Dr. Russell received her Doctor of Philosophy degree in Statistics from Boston University in 1997. She received her Master of Arts degree in Statistics from Boston University in 1992, and Bachelor of Arts degree in Mathematics in 1989 from Salem State College. She also holds a Bachelor of Science degree in Office Administration (1988) from Salem State College.
Susan Boquist, Associate Director, Statistical Programming, has more than 20 years of diverse experience in clinical database design and management, and statistical programming. She has shared her extensive knowledge of CDISC and SDTM at conferences and training programs in the US, Russia, Europe and Asia. Throughout her career, Susan has successfully led teams through change and rapid growth, with a focus on process improvement and training. Susan’s work in the biopharmaceutical and device sectors has covered the therapeutic areas of oncology, infectious disease, anesthesia, and allergy/immunology. She has been a team member on several successful FDA and PMDA new drug submissions.
Prior to joining PROMETRIKA, Susan enjoyed a distinguished 20 years of service at PAREXEL International Corp., with increasing managerial responsibilities in the areas of database design, programming, and implementation, and statistical programming, culminating in the position of Senior Manager, Statistical Programming. Earlier in her career, Susan participated as a research associate and data analyst in several projects sponsored by the US Military and NASA. She has authored several journal articles on nutrition in military field situations, and has presented her expertise on the implementation of CDISC at PharmaSUG and CDISC International Interchange conferences.
Susan received her Bachelor of Arts in Psychobiology (1986) from Mount Holyoke College.
Mr. James Gaiser, Associate Director, Statistical Programming, has over 30 years of experience in statistical programming and analysis in the biopharmaceutical industry. At PROMETRIKA, Mr. Gaiser manages the Statistical Programmers, which are responsible for all SAS® programming activities required for phase 1 through 4 clinical trials and regulatory submissions. He is an active member of the CDISC ADaM team and participates in PhUSE committees as time permits.
Prior to joining PROMETRIKA, Mr. Gaiser was Director of Statistical Programming at EMD Serono, where he led a global group of statistical programmers across multiple therapeutic areas. He planned and managed programming support for clinical trials, regulatory requests, communication and publication needs, and marketing objectives. Mr. Gaiser was a member of the internal teams that developed methods for converting studies to CDISC specifications. His responsibilities included setting up ADaM analysis dataset templates, review of study analysis datasets for CDISC compliance, and participating in SDTM creation.
Prior to EMD Serono, Mr. Gaiser held Principal Analyst and Manager positions at Bristol‑Myers Squibb. Within these positions, he was responsible for the successful implementation of all programming activities for numerous product reports and submissions. His work supported Independent Data Safety Monitoring Committees, Biologic Licensing Applications, Periodic Safety Update Reports, FDA Advisory Committee Briefing Documents, responses to FDA inquiries, and many international regulatory submissions.
Mr. Gaiser received his Bachelor of Science degree in Biomedical Computing from Rochester Institute of Technology in 1987.
Ms. Rohall, Senior Manager, Medical Writing, has more than 30 years of experience in clinical drug development, primarily in the preparation of regulatory submission documents and clinical trial reports. At PROMETRIKA, Ms. Rohall leads the medical writing group in the design of regulatory-compliant reports and summary documents. Her experience encompasses the planning and preparation of New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs).
Prior to joining PROMETRIKA, Ms. Rohall served as the Manager of Operations for North American Medical Writing Services at PAREXEL International. In that role, she managed the budgeting, resourcing, and planning of medical writing activities within the department. She was responsible for corporate proposal and contract development with regard to medical writing services.
Early in her career, Ms. Rohall was a clinical research associate with Ortho Pharmaceuticals (now Johnson & Johnson Pharmaceutical Research and Development) and began her writing activities with Besselaar (now Covance).
Ms. Rohall received her Bachelor of Arts degree in Biology from the University of Rochester (NY), and her certification in medical technology (MT ASCP) at St. Mary’s Hospital, Rochester, NY.
Ms. Harris, Head of Project Management, has more than 30 years of experience in drug development and clinical trial management. Ms. Harris manages a team of project managers who oversee multi-functional projects in conjunction with our sponsors. The project management team is responsible for making sure that projects are resourced and completed in time and within budget along with effective communication within the internal team and the sponsor. From 2004 until early 2017, Ms. Harris was also responsible for quality systems at PROMETRIKA.
Prior to joining PROMETRIKA, Ms. Harris served as a Program Manager at Muro Pharmaceutical/Viatris, Inc., which she joined in 1997, and worked as a pivotal member of the drug development team in the areas of clinical trials management, project management, and medical writing. Her responsibilities included establishing and coordinating multidisciplinary global project teams, ensuring adherence to timelines supporting dossier submissions, coordinating project budgets and tracking actual expenditures, writing study reports, INDs, NDAs, and Investigator Brochures, and preparing IND and NDA submissions.
Prior to joining Muro, Ms. Harris was employed at Biopure Corporation for 10 years, during which time she developed, trained and managed the in-house clinical research team, oversaw the clinical project management of a number of phase 1 and 2 clinical trials, and participated on the Clinical Development Board.
Ms. Harris received her Bachelor of Science (Hons.) degree in Biochemistry from the Polytechnic of Central London, UK.
Mr. Chris Gallant, Senior Manager, Client Relations, has served more than 15 years as PROMETRIKA’s primary liaison with sponsors. In this role, Mr. Gallant communicates with sponsors about their clinical research and support needs, develops budgets and proposals with input from PROMETRIKA’s project teams, and interacts with sponsors during the conduct of each project to provide support and facilitate communications. Mr. Gallant presents PROMETRIKA’s services to prospective clients and represents PROMETRIKA at industry conferences and trade shows.
Prior to joining PROMETRIKA, Mr. Gallant was a Data Manager at Muro Pharmaceutical/Viatris, Inc., which he joined in 1999. Mr. Gallant received his Bachelor of Science degree in Business Management from the University of Massachusetts at Lowell in 1996.
Mr. Barry Mirrer, Head of Quality Assurance, has more than 15 years of experience in the development and management of quality systems in the biopharmaceutical industry. At PROMETRIKA, Barry has overall responsibility for compliance and quality systems.
A quality, compliance, and software validation subject matter expert (SME), Barry has held the position of Director or Global Head of Quality Programs/Quality Management at Outcome Sciences, Quintiles and IQVIA, among others. With a background in computer science, Barry has successfully guided sponsors through the establishment of systems and practices that dramatically improved quality and training processes.
Barry holds a Bachelor’s degree in Computer Science and Engineering and a Master’s degree in Electrical Engineering and Computer Science, both from the Massachusetts Institute of Technology.
Mr. Rob A. Ferragamo, Head of Technology, is responsible for all business critical Technology including Infrastructure, General Business Systems and Validated Systems. With over 25 years of professional and operational expertise, Rob is committed to providing a robust and reliable technology strategy that encompasses scalable architecture, processes, practices, and standards supportive of PROMETRIKA's internal and external customers.
Prior to joining PROMETRIKA, Rob held the role of Global Information Technology Director at Data Intensity, LLC, a technology company providing enterprise solutions for application management and managed cloud services for Oracle environments. Rob also served as Senior Director, Information Technology at Courion Corporation, where he led global IT strategy that included expanding and merging enterprise technology solutions in the US and India offices during a time of rapid growth. Earlier in his career, Rob held other technical leadership positions with PROMETRIKA, LLC (Director, Information Technology and Infrastructure Services) and State Street Corporation (Vice President/Senior Network Analysis Manager).
Mr. Ferragamo holds many technical certifications and is a Certified Information Security Manager. He earned his Masters of Science in Information Assurance from Western Governor's University and his Bachelor of Science in Business Administration from Suffolk University.
Mr. Vahe Zeroonian is a founding member of PROMETRIKA and oversees all financial functions of the company. Mr. Zeroonian’s 30-year career in finance spans the private, government, and non-profit sectors.
Prior to joining PROMETRIKA, Mr. Zeroonian served as a Senior Fiscal Policy Analyst for the Commonwealth of Massachusetts. In this role, he advised the Governor’s Office on legislative budgets, bills, and programs, and prepared the Governor’s budget submissions. He subsequently held the role of Assistant Budget Manager for the Massachusetts Water Resources Authority.
With KPMG Peat Marwick Policy Economics Group, Mr. Zeroonian was assigned to Moscow in the role of Senior Consultant/Inter-governmental Finance Advisor to the Russian Republic’s Ministry of Finance, on the USAID Russia Fiscal Reform Project. His work on this project included policy recommendations for fiscal decentralization, design recommendations for a fiscal information and management system, and development of performance-based criteria for program evaluation and analysis.
In the non-profit sector, Mr. Zeroonian was the Executive Director of the international Armenian Relief Society of North America, Inc., and managed the organization’s budget and investments.
Mr. Zeroonian holds a Master of Public Policy (Public Finance and Economic Development) from the John F. Kennedy School of Government, Harvard University (1989), and Master (International Relations) and Bachelor of Arts degrees in Political Science from St. Louis University (1984).
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