Trk 15: Statistics [
clear filter]
10:45am EDT
#141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model
Chair
Project Leader in Applied Informatics and Architecture, Duke Translational Research Institute
Shelley Rusincovitch is a Project Leader in Applied Informatics & Architecture with the Duke Translational Research Institute (DTRI), with highly-technical experience in database programming, clinical trials, outcomes registries, and health system data warehousing. Her responsibilities...
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Speakers
Professor of Medicine; Director, Center for Pragmatic Health Systems Research, Duke Clinical Research Institute (DCRI)
A health services researcher by training, Dr. Curtis oversees a portfolio of projects that use observational data to address questions related to clinical and comparative effectiveness, pharmacoepidemiology, health care delivery, and epidemiological trends. Dr. Curtis has considerable...
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Senior Director, Worldwide Epidemiology, GlaxoSmithKline
Carol Koro currently works for GSK, focusing on metabolic and cardiovascular epidemiologic research. Dr. Koro has a PhD in Pharmaceutical Health Services Research from the University of Maryland and is a PA licensed pharmacist. She has done extensive research on the safety of diabetes...
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Director, Data Science Insights, Digital Science
Monday June 27, 2016 10:45am - 12:00pm EDT
201A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#273: Improving Adverse Drug Reaction Information in Product Labels
Chair
Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.
Speakers PR
Head, Epidemiology Analytics, Janssen Pharmaceuticals, Inc.
Patrick Ryan, PhD is Senior Director of Epidemiology and the Head of Epidemiology Analytics at Janssen Research and Development. He is currently a collaborator in Observational Health Data Sciences and Informatics (OHDSI, htttp://ohdsi.org). He served as a principal investigator of...
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Principal, Navitas Inc.
He has been a business consultant for more than 14 years. Since joining WCI, he has helped global pharmaceutical clients to optimize their processes in regards of content management, different compliance related issues, risk management and Pharmacovigilance.
Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
109AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 15: Statistics,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Labeling, Topics Related to Europe-EMEA
- Interest Area Clinical Safety & Pharmacovigilance, Regulatory Affairs
- format json
- Interest Area Clinical Safety & Pharmacovigilance,Regulatory Affairs
- Featured Topics Labeling,Topics Related to Europe/EMEA
- Credit Type ACPE, CME, IACET, RN
- Tags Session
4:00pm EDT
#274: Statistical Issues in the Evaluation of Biosimilars
Chair GL
Deputy Director, DBIII, OB, OTS, CDER, FDA
Greg Levin is a supervisory mathematical statistician at the Center for Drug Evaluation and Research within FDA. He joined FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped regulate products across a wide range of therapeutic...
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Speakers
Principal Biostatistician, PAREXEL International
Biostatistician with 25+ years of experience in clinical research. Currently (3 years) at PAREXEL (Principal Biostatistician) Previously (16 years) at Harvard Medical School (Assistant Professor) and at Duke University (post-doc fellow) and also a private consultant for industry...
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Senior Manager, Biostatistics, Amgen Inc.
Dr. Pan is a Biostatistics Senior Manager in Biosimilars Global Development at Amgen. As the global statistical lead, she provides strategic input to and is responsible for all statistical aspects of clinical development for multiple biosimilar products in oncology and inflammation...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
108B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#324: Implementing Adaptive Designs Involves Greater Teamwork
Chair
Independent Biostatistical Consultant, Self-Employed
Eva Miller is Senior Director, Biostatistics, at inVentiv Health. Eva works with sponsors to design and implement adaptive clinical trials in over 30 therapeutic areas.. Eva received her Ph.D. at the U of P and is a member of DIA, DIA Statistics SIAC, ASA, and Adaptive Designs Working...
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Speakers KL
Senior Principal Scientist, Merck & Co. Inc.
Kenneth Liu is a Senior Principal Scientist in the biostatistics department at Merck. Over his 15 years at Merck, he has designed, implemented, and published the results of adaptive trials in oncology and neuroscience. He graduated from the University of Pittsburgh’s Department...
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Head Randomization and Trial Supply Management, Janssen Pharmaceutical Companies of Johnson & Johnson
Micheline has 20 years’ experience developing and implementing Randomization & Trial Supply Management (RTSM) strategies. She is a proponent of the team approach with stakeholders from Clinical, Clinical Supplies, Regulatory, Quality and the Service Providers working together to...
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Statistical Fellow, Covance Inc.
Richard McNally is a Statistical Fellow at Covance, where he provides statistical consulting to clients on clinical study design, serves as the lead statistician on clinical studies, and is an independent statistician for Data Monitoring Committees. He has given presentations on adaptive...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
109AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies
Chair
Mathematical Statistician, Office of Equal Opportunity and Customer Outreach, National Institutes of Health (NIH)
Tammy Massie has worked as a mathematical statistician at various centers in the FDA for the past 13 years. In spring 2016, Tammy moved to NIH to perform statistical work on a variety of demographic subgroups within the Office of Equity, Diversity and Inclusion. Tammy recieved her...
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Speakers LK
Senior Statistical Science Director, AstraZeneca
Lisa Kammerman, PhD is a Senior Statistical Director in Oncology at AstraZeneca. She consults on PRO projects and regulatory submissions. She developed AZ's PRO guidance document and led AZ's missing data project. After 24 years of public service, she retired from the FDA, where she...
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Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past...
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Associate Therapeutic Strategy Director, Therapeutic Science and Strategy, Quintiles
I have 10 years of industry experience, starting as a clinical research coordinator and moving to site management and business development oversight for a large mutlispecialty research site in Raleigh, NC that focused on adult and pediatric phase Ib-IV clinical trials. For the past...
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Wednesday June 29, 2016 2:00pm - 3:00pm EDT
108B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 15: Statistics,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Pediatrics, Clinical Trial Designs
- Interest Area Statistics, Clinical Research
- format json
- Interest Area Statistics,Clinical Research
- Featured Topics Pediatrics,Clinical Trial Designs
- Credit Type ACPE, CME, IACET, RN
- Tags Session
10:45am EDT
#411: Nonclinical Statistics for Chemistry, Manufacturing, and Control: Case Studies and Regulatory Perspective
Chair
Consultant, Biostatistics and Statistical Programming, Savio Group Inc
Surya Chitra, PhD, MBA, is an experienced biostatistics and pharmacology professional currently working as a R&D consultant for pharmaceutical/ biotechnology companies with 25+ years experience in the industry. He has previously worked at Endo Pharmaceuticals, AstraZeneca and Merck...
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Speakers CD
Mathematical Statistician, Division of Biometrics VI, OTS, CDER, FDA
Cassie is a Statistics Reviewer in CMC Review Team at office of Biostatistics, FDA and holds a Masters in Chemistry and PhD in Statistics. She joined FDA in 2012. Her primary review work concentrates on the analytical similarity assessment and product quality control. She also has...
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Statistician, Teva Pharmaceuticals
Charles has been working as a statistician in Teva Phamaceuticals for 2 years. He is working primarily on non-clinical statistics projects. His job includes: (1) the analysis for immunogenicity assays, cut-point determination for the screening, confirmatory, neutralizing antibody...
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Statistician, GlaxoSmithKline
Shu Zhang is a non-clinical statistician in GlaxoSmithKline. She received a concurrent PhD degree in Biochemistry and MS degree in Statistics at Iowa State University and has 8 years of pharmaceutical industry experience in supporting non-clinical areas including CMC and discover...
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Thursday June 30, 2016 10:45am - 12:00pm EDT
108A
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA