Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in 2003. Dr. Stepanians has more than 25 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 10 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.
Rob A. Ferragamo returns to PROMETRIKA as our Head of Technology with responsibility for all business critical Technology including Infrastructure, General Business Systems and Validated Systems. With 25 years of professional 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. James Gaiser, Associate Director, Statistical Programming, has over 25 years of experience in statistical programming and analysis in the biopharmaceutical industry. At PROMETRIKA, Mr. Gaiser manages the Statistical Programming team, which is responsible for all SAS® programming activities required for phase 1 through 4 clinical trials and regulatory submissions.
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.
Mr. Chris Gallant, Senior Manager, Client Relations, has served more than 10 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.
Ms. Harris, Head of Project Management and Quality Systems, has more than 25 years of experience in clinical trials and the drug development arena. Ms. Harris has overall responsibility for compliance and quality systems at PROMETRIKA with oversight of the company’s computer systems validation, training program, sponsor audits, and internal and external audits. Ms. Harris also leads the project management effort at PROMETRIKA, ensuring efficient project team communications and adherence to project timelines and budgets.
Prior to joining PROMETRIKA, Ms. Harris served as 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 in 1983.
Dr. Nicole LaVallee, Director, Biostatistics, has more than 20 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 a number of Integrated Summaries of Efficacy and Safety in support of 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.
Ms. Rohall, Senior Manager, Medical Writing, has more than 25 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) in both the traditional and CTD formats.
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) in 1982, and her certification in medical technology (MT ASCP) at St. Mary’s Hospital, Rochester, NY, in 1983.
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 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.
Ms. Stacy Surensky has more than 20 years of experience in the biopharmaceutical industry. At PROMETRIKA, Ms. Surensky 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. Surensky 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. Surensky’s extensive experience includes SAS® programming, database development, and data management leadership. In addition to these skills, Ms. Surensky has led the strategic expansion of global data management teams and coached cross-functional teams in the successful completion of clinical studies and regulatory submissions.
Prior to joining PROMETRIKA, Ms. Surensky was Senior Director, Data Management at Vertex Pharmaceuticals, Inc., which she joined in 2003. Prior to joining Vertex, she held the positions of Associate Director, Statistical Programming at Averion, Inc., and Associate Director, Database Services at PAREXEL International Corp. In these roles, Ms. Surensky established electronic data capture (EDC) and storage installations and processes, developed standard SAS® macros and programs to improve quality, consistency, and timeliness of data deliverables, and formulated competency-based career ladders for data management professionals.
Ms. Surensky earned her Bachelor of Arts degree in Math Education from the Herzen State Pedagogical University in St. Petersburg, Russia and holds a High-performance Leadership Certificate from Cornell University, New York, NY. She has completed training and certificate programs in SAS® programming, EDC platforms, management, and leadership.
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