Session 6: Data Science Organizations and Career Development (Panel Discussion)

Join our panel of leading data science organizations as they share their experiences, insights, and best practices in building data-driven cultures and driving innovation within the pharmaceutical industry. Gain valuable knowledge on establishing data science teams, developing talent, and leveraging cutting-edge technologies to unlock the full potential of data in pharmaceutical research, development, and commercialization. Engage in thought-provoking discussions on the challenges and opportunities of integrating data science into the fabric of organizations.

Chair: Nareen Katta, AbbVie

Nareen Katta Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Nareen has over 20 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the advanced analytics strategy, that covers both Scientific and Business Operations, across Clinical Development Continuum, Geostrategy and Study start-up, Centralized and Risk Based Monitoring, Site Engagement, Business Performance, Precision Medicine, Patient Safety and R&D. In addition, Nareen is actively engaged in evaluating the opportunities created by the technology trends like big data, automation, machine learning and AI, digital health etc. and strategically instantiating them at AbbVie to drive organizational transformation. Nareen has an MBA from The University of Chicago Booth School of Business and a MS in Electrical Engineering from University of Texas at Arlington.

Greg Ball, ASAPprocess Consulting

Greg Ball Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. He co-led a company initiative at Merck between Clinical Safety and Safety Statistics to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). Greg co-leads, with Mary Nilsson and Scott Proestel, the PHUSE Safety Analytics working group; he established, with Bill Wang, the ASA Biopharm Safety Monitoring working group; and he pioneered, with Susan Duke, Mengchun Li, and Jim Buchanan, the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group – to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

Erik Pulkstenis, AbbVie

Erik Pulkstenis Erik Pulkstenis joined AbbVie in 2017 as the Vice President and Head of Data and Statistical Sciences in support of clinical development strategy, data science/analytics, statistical analysis and reporting, data operations, and digital science. The portfolio includes oncology, immunology, neuroscience, specialty, eyecare and aesthetics. Erik has more than 25 years of experience in drug and device development and clinical research. He has experienced success building, rehabilitating and leading biometrics departments including organizational design and operating model definition/implementation. He is also passionate about organizational leadership and culture. He has more than 30 peer-reviewed publications including one textbook and has directly supported 14 FDA approvals and multiple FDA advisory committee meetings.

Previously, Dr. Pulkstenis headed Clinical Biostatistics & Data Management at Medimmune, where he established the organizational infrastructure, underlying operating model and all associated processes in support of a diverse pipeline. Prior to that, Dr. Pulkstenis led the Biostatistics Department at Human Genome Sciences and served at C.L. McIntosh & Associates consulting with medical device manufacturers with respect to study design, regulatory strategy, and FDA Advisory Committee preparation.

Dr. Pulkstenis served from 2013-2019 on the American Statistical Association Biopharmaceutical Section Executive Committee. In addition, he currently serves on the ICH E20 Adaptive Design Expert Working Group (2017-current), CDISC Board of Directors (Chairperson 2023-2024), and the Biopharmaceutical Statistics Leaders Consortium (Chairperson 2023).

Dr. Pulkstenis received an M.S. and Ph.D. in statistics from the Pennsylvania State University.

Jingjing Ye, BeiGene

Dr. Jingjing Ye Dr. Jingjing Ye is an executive director and currently leads a global team, Data Science and Digital Innovations (DSDI), with Global Statistics and Data Sciences (GSDS) in BeiGene. She has over 17 years’ experience in pharmaceutical industry and US FDA, with focus in cancer drug discovery and development. Her statistical and regulatory experience expands full spectrum on patients’ treatment journey from diagnosis, treatment, to living with the condition. She is very active in statistical communities in US and between US and China DIA communities, including leading several cross-disciplinary and cross-company working groups. She received her PhD degree in statistics from University of California, Davis and BS in applied mathematics from Peking University.

Miganush Stepanians, PROMETRIKA

Dr. Miganush Stepanians 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 the pharmaceutical industry as well as academia. 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 20 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.

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.

Steve Wilson, FDA

Dr. Steve Wilson Dr. Wilson has worked as a mathematical statistician at FDA for 35 years. He is currently a Senior Staff Fellow with the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER). Steve received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984. His professional experience has also included positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank. His professional interests and activities are currently focused on issues related to ‘continuous improvement’ in clinical trials science and practice, data standards, and the review of drug and biological therapies.