Dr. Shuangge
Steven Ma is the President-Elect of the New England Statistical
Society (NESS). He received his Ph.D. degree in statistics at
the University of Wisconsin in 2004. Prior to arriving at Yale,
Dr. Ma was a Senior Fellow in Collaborative Health Studies
Coordinating Center (CHSCC) and Department of Biostatistics at
University of Washington. He has been involved in developing
novel statistical and bioinformatics methodologies for analysis
of cancer (NHL, breast cancer, melanoma, lung cancer), mental
disorders, and cardiovascular diseases. He has also been
involved in health economics research, with special interest in
health insurance in developing countries.
TBA
John Scott is Director
of the Division of Biostatistics in the FDA's Center for
Biologics Evaluation and Research, where he has also served as a
statistical reviewer for blood products and for cellular, tissue
and gene therapies. Prior to joining the FDA in 2008, he worked
in psychiatric clinical trials at the Western Psychiatric
Institute and Clinic of the University of Pittsburgh Medical
Center. He has authored or co-authored numerous articles in
areas including Bayesian and adaptive clinical trial design and
analysis, vaccine and drug safety, data and text mining, and
benefit-risk assessment. He is the CBER lead for 21st Century
Cures and PDUFA efforts in Complex and Innovative Trial Design
and has been heavily involved in a number of FDA's statistical
policy and outreach projects, including the 2019 Adaptive Design
Guidance for Drugs and Biologics, the 2020 Guidance on
Interacting with the FDA on Complex Innovative Trial Design, the
ICH E9(R1) expert working group on estimands and sensitivity
analyses, and the ICH E20 expert working group on adaptive
designs. Dr. Scott holds a Ph.D. in Biostatistics from the
University of Pittsburgh, an A.M. in Mathematics from Washington
University in St. Louis, and a B.A. in Liberal Arts from Sarah
Lawrence College. He is a Fellow of the American Statistical
Association and is a past Editor of the journal, Pharmaceutical
Statistics.
Kelley Kidwell,
Ph.D., is a Professor and Associate Chair of Academic Affairs of
Biostatistics at the University of Michigan School of Public
Health. She is an expert in large and small sample sequential,
multiple assignment, randomized trial (SMART) design and
analysis. She is the primary investigator of current FDA and
PCORI contracts, also had previous FDA and PCORI methods
contracts, all related to SMART design, and has been a
co-investigator on many NIH and industry funded, clinical trial
grants. Her current focus is on advancing small sample clinical
trial design and methods and incorporating patient treatment
preferences into clinical trials.
Doug is a neurologist
and neuroscientist with over 130 publications in medical
journals many of which involved stem cell transplantation for
preclinical models of neurologic disorders. He has led the
development of therapies for neurologic and rare genetic
diseases in the biotech industry and served on boards and
scientific advisory boards of various non-profits and companies.
Doug graduated from Princeton with a degree in molecular biology
and completed an MD/PhD at Jefferson Medical College. After a
neurology residency at Johns Hopkins, he served on its faculty
for 10 years, conducting research and clinical trials. Doug then
led neurodevelopmental and neurodegenerative disorder programs
at Biogen. Doug was the global lead for a series of programs in
Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS) and
Spinal Muscular Atrophy (SMA). Doug led the team that developed
the drug Spinraza™, now approved for SMA. After Biogen, Doug ran
the neurodevelopmental and neuroscience franchises at Shire. In
2017, Doug founded and joined Generation Bio-a biotech company
focused on non-viral gene therapy- as the head of R&D/CSO
and then the Chief Medical Officer. Currently, Doug is a Venture
Partner at Atlas Venture, creating new biotech startups.
Stephen Lake is the
Vice President of Quantitative Sciences at Alexion, the rare
disease unit of AstraZeneca. At Alexion, he leads the
biostatistics, statistical programming, epidemiology and real
world science, medical writing, and transparency and disclosure
functions. Prior to joining Alexion, he worked at Wave Life
Sciences and Clementia Pharmaceuticals and spent 15 years at
Genzyme and Sanofi. He holds a doctorate degree in Biostatistics
from the Harvard School of Public Health.