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 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 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 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 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 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. 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.