Gary Stevens, Ph.D.
President, DynaStat Consulting, Inc.
President, DynaStat Consulting, Inc.
Gary Stevens, Ph.D., President of DynaStat, Inc,. has 18 years of statistical experience in the
development of pharmaceutical products and medical devices.
He has experience in:
preclinical/nonclinical statistical research and analysis
formulation development and optimization, manufacturing, and statistical process control
clinical research and statistical design, analysis, and reporting in various therapeutic areas
data mining and meta analyses
integration of technologies into corporate work flow processes
The major areas of clinical involvement include imaging, oncology, CNS, cardiovascular, and
generics in all phases of development, including Phase IIIb, Phase IV and post marketing.
Dr. Stevens has been involved in numerous NDA submissions in these various therapeutic areas. He
has been involved in both regional and centralized submissions in Europe and NDA submissions to
the MHW in Japan. These experiences have allowed for interactions in face to face meetings with
the FDA, European and Japanese Regulatory Authorities. He has responded in writing to questions
from regulatory agencies in over 15 countries. This vast experience allows for a unique perspective
to product development and clinical trials.
Dr. Stevens has been involved in the clinical development, data analysis, and submissions of several
510k and PMA devices. DynaStat, Inc. is a founding partner of the Integrated Center for Device
Development.
development of pharmaceutical products and medical devices.
He has experience in:
preclinical/nonclinical statistical research and analysis
formulation development and optimization, manufacturing, and statistical process control
clinical research and statistical design, analysis, and reporting in various therapeutic areas
data mining and meta analyses
integration of technologies into corporate work flow processes
The major areas of clinical involvement include imaging, oncology, CNS, cardiovascular, and
generics in all phases of development, including Phase IIIb, Phase IV and post marketing.
Dr. Stevens has been involved in numerous NDA submissions in these various therapeutic areas. He
has been involved in both regional and centralized submissions in Europe and NDA submissions to
the MHW in Japan. These experiences have allowed for interactions in face to face meetings with
the FDA, European and Japanese Regulatory Authorities. He has responded in writing to questions
from regulatory agencies in over 15 countries. This vast experience allows for a unique perspective
to product development and clinical trials.
Dr. Stevens has been involved in the clinical development, data analysis, and submissions of several
510k and PMA devices. DynaStat, Inc. is a founding partner of the Integrated Center for Device
Development.
Biography
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DynaStat
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