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Trk 15: Statistics [clear filter]
Monday, June 27
 

10:45am

#141: Transforming Health Care Data for Clinical Research: Strategy and Experiences from the PCORnet Common Data Model
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will define the strategic importance of the PCORnet Common Data Model in the use of electronic health records(EHR) and health plan data for research, its key role in the ADAPTABLE pragmatic trial, and how these experiences are generalizable to other stakeholders.

Learning Objectives

Assess the opportunities and challenges of using electronic health data for clinical research, including data management processes, coordinating center practices, and data quality; Describe the strategic role and development of a common data model for a national distributed research network; Evaluate the application of a common data model in the design of a pragmatic clinical trial.

Chair

Shelley Rusincovitch

Speaker

Leveraging a Common Data Model for a Pragmatic Clinical Trial in a Distributed Research Network: The PCORnet ADAPTABLE Study
Lesley H. Curtis, PhD

A Common Data Model and Diversity of Stakeholder Beliefs: How Do You Know What You Actually Know, Collectively?
Aaron Sorensen, MA

Applying the PCORnet Common Data Model to the EHR Ancillary Study of the HARMONY Trial: Strategy and Design Considerations
Carol E Koro, PhD



Chair
avatar for Shelley Rusincovitch

Shelley Rusincovitch

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... Read More →

Speakers
avatar for Lesley Curtis

Lesley Curtis

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... Read More →
avatar for Carol Koro

Carol Koro

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... Read More →
avatar for Aaron Sorensen

Aaron Sorensen

Director, Data Science Insights, Digital Science


Monday June 27, 2016 10:45am - 12:00pm
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

4:00pm

#273: Improving Adverse Drug Reaction Information in Product Labels
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-587-L04-P; CME 1.25; IACET 1.25; RN 1.25

Adverse drug reactions (ADRs) are an important part of a product label. In this session, we will recommend ways to make ADR information in product labels more understandable and better reflective of the risk of a drug relative to a comparator. We will also discuss the importance of end-to-end labeling and tracking to ensure pharmacovigilance compliance.

Learning Objectives

Discuss how adverse drug reactions (ADRs) are presented in EU and US drug labels; Explain why the qualitative categories of ADR in an EU label and the pooling strategy to obtain ADR frequencies in a US label are inadequate; Describe improved approaches to summarize and present different types of adverse events; Describe key building blocks for a compliant end-to-end labeling system.

Chair

Brenda Crowe, PhD

Speaker

Rational Presentation of Adverse Reactions in Drug Labeling
Ellis Unger, MD

A New Paradigm in Patient Safety: The Importance of End-to-End Labeling and Tracking in Ensuring Pharmacovigilance Compliance
Oliver Steck, MBA

Augmenting Product Labels with Real-World Evidence: Lessons from OHDSI
Patrick Ryan



Chair
avatar for Brenda Crowe

Brenda Crowe

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

Patrick Ryan

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... Read More →
avatar for Oliver Steck

Oliver Steck

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.
avatar for Ellis Unger

Ellis Unger

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... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#274: Statistical Issues in the Evaluation of Biosimilars
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-588-L04-P; CME 1.25; IACET 1.25; RN 1.25

The 2010 Affordable Care Act amended the Public Health Service Act to create a new abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-licensed biological product. A biosimilar should be shown to be highly similar to and to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. In this session, we will discuss important regulatory and statistical issues in the evaluation of biosimilars. A regulatory perspective will be provided on key concepts, and and industry representatives will describe approaches to critical aspects of biosimilar development such as the evaluation of immunogenicity and inference based on the totality of the clinical evidence.

Learning Objectives

Discuss key regulatory and statistical issues in the development and evaluation of biosimilars; Describe approaches to critical aspects of biosimilar development.

Chair

Gregory Levin, PhD

Speaker

A Novel Statistical Model of the Relationship Between Exposure to a Biopharmaceutical and Immunogenic Reactions
Marek Ancukiewicz, PhD

Statistical Methodology to Assess Biosimilarity Based on Totality of the Evidence
Zhiying "Jean" Pan, PhD



Chair
GL

Gregory Levin

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... Read More →

Speakers
avatar for Marek Ancukiewicz

Marek Ancukiewicz

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... Read More →
ZQ

Zhiying "Jean" Pan

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... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#324: Implementing Adaptive Designs Involves Greater Teamwork
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-584-L05-P; CME 1.25; IACET 1.25; RN 1.25

Adaptive designs require more planning and teamwork than traditional clinical trials. In this session, the speakers will discuss their enhanced roles and those of the other team members.

Learning Objectives

Demonstrate how to lead and/or collaborate with all relevant parties on designing and executing adaptive clinical trials; Assess alternative adaptive trial designs for enhancing trial efficiency and patient safety; Describe how to design operational processes to minimize bias when unblinding data during interim analysis.

Chair

Eva R. Miller, PhD, MS

Speaker

The Biostatistician's Role in Adaptive Design Team: Power Calculations Using GSDesign
Kenneth Liu, PhD

The Drug Supplies Manager’s Role in Planning and Implementing Flexible Drug Supply Management in Adaptively Designed Trials
Micheline D Marshall, MBA

Pivotal Roles of the Statistician, Physician, and Project Manager in Simple and Complex Adaptive Trial Designs
Richard McNally



Chair
avatar for Eva Miller

Eva Miller

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... Read More →

Speakers
KL

Kenneth Liu

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... Read More →
avatar for Micheline Marshall

Micheline Marshall

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... Read More →
RM

Richard McNally

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... Read More →


Wednesday June 29, 2016 10:30am - 11:45am
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#351: Emergent Study Designs and Analysis Methods Addressing Issues Associated with Pediatric Clinical Studies
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-585-L01-P; CME 1.00; IACET 1.00; RN 1.00

Traditional clinical study designs and analysis methods may not be applicable to some pediatric studies due to unique issues with the pediatric population. This session presents emergent designs and methods appropriate to addressing these issues.

Learning Objectives

Recognize how clinical study design and statistical analysis methods can ease difficulties often found in pediatric clinical trials; Assess study designs and statistical methodology not typically used in standard clinical trials appropriate for pediatric clinical trials; Identify when and who to consult to improve the efficiency within a pediatric clinical trial.

Chair

Tammy J. Massie

Speaker

Enhancing Pediatric Clinical Trial Feasibility: Focus on the Use of Bayesian Statistics
Earl Seltzer, MBA

Panelist
Lisa A Kammerman, PhD, MS



Chair
avatar for Tammy Massie

Tammy Massie

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... Read More →

Speakers
LK

Lisa Kammerman

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... Read More →
avatar for Earl Seltzer

Earl Seltzer

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... Read More →
avatar for Earl Seltzer

Earl Seltzer

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... Read More →


Wednesday June 29, 2016 2:00pm - 3:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am

#411: Nonclinical Statistics for Chemistry, Manufacturing, and Control: Case Studies and Regulatory Perspective
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-586-L04-P; CME 1.25; IACET 1.25; RN 1.25

Due to recent regulatory issues in manufacturing, statistical tools are used increasingly to understand manufacturing data. This provides opportunities to improve the evaluation of safety, quality, and efficacy criteria specified by regulators.

Learning Objectives

Discuss lessons learned in the use of statistics in pharmaceutical manufacturing; Identify the challenges and opportunities with application of nonclinical statistics; Describe the regulatory developments in the CMC area and the opportunities for statistical applications.

Chair

Surya P. Chitra

Speaker

A Case Study of Statistical Analysis of Integration Site Assay in the Application of Gene Therapy
Shu Zhang, PhD

Overview of CMC Area Statistics
Cassie Dong, PhD

Quality by Design Case Studies for Biologics/Biosimilars
Charles Li, MS



Chair
avatar for Surya Chitra

Surya Chitra

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... Read More →

Speakers
CD

Cassie Dong

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... Read More →
CL

Charles Li

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... Read More →
avatar for Shu Zhang

Shu Zhang

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... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA