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Sunday, June 26
 

9:00am EDT

#40: Analysis of Safety Data from Clinical Trials
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-16-503-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.

Who should attend?

This tutorial is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.

Learning Objectives

• Discuss how to utilize guidelines and regulatory requirements for clinical trials;
• Describe ways to contribute to safety analysis plans;
• Discuss the statistical safety analysis process and pitfalls that could occur;
• Identify impact of benefit-risk assessment in safety data.


Speakers
avatar for Jürgen Kübler

Jürgen Kübler

Global Head, Quantitative Safety Sciences, CSL Behring GmbH
Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →
avatar for Jürgen Kübler

Jürgen Kübler

Global Head, Quantitative Safety Sciences, CSL Behring GmbH
Dr. Kübler has over 15 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →
avatar for Joachim Vollmar

Joachim Vollmar

Executive Consultant, International Clinical Development Consultants LLC (ICDC)
Mr. Vollmar has been an independent consultant since 2004 and founded International Clinical Development Consultants, LLC in 2005 and Preclinical Research and Scientific Consulting Services, LLC in 2008. From 1970-1992, he was with Boehringer Mannheim as a senior statistician in clinical... Read More →


Sunday June 26, 2016 9:00am - 5:00pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 15: Statistics, Tutorial

9:00am EDT

#42: Clinical Statistics for Nonstatisticians
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 6.50 Knowledge UAN: 0286-0000-16-504-L04-P; CME 6.50; IACET 6.50; RN 6.50

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

This tutorial will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the tutorial will be on the application of statistical concepts to clinical investigation.

Who should attend?

This tutorial is designed for professionals in the pharmaceutical industry involved in clinical research, medical affairs, medical writing, and other disciplines, who need to be familiar with statistical concepts.

Learning Objectives

• Discuss basic statistical concepts such as variability, confidence intervals, hypothesis testing, and p-values;
• Compare various study designs including techniques to avoid bias;
• Use statistical terminology with ease;
• Distinguish information needed for determining sample size.


Speakers
avatar for Michael Mosier

Michael Mosier

Director, Biostatistics, EMB Statistical Solutions, LLC
Michael Mosier, PhD is co-founder and Director of Biostatistics for EMB Statistical Solutions, a data management and statistical CRO. He has served on the editorial board of the Drug Information Journal and serves as instructor for the DIA Clinical Statistics for Nonstatisticians... Read More →


Sunday June 26, 2016 9:00am - 5:00pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 15: Statistics, Tutorial
 
Monday, June 27
 

8:30am EDT

#118: The Interpretation of PRO Scores and Responder Analyses in the Presence of Missing Data
Limited Capacity seats available

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

This forum will review best practices for quantifying a meaningful change in a patient-reported outcome (PRO) endpoint and establishing a responder definition in the presence of missing score data. Missing data strategies that do not assume absence of a PRO score means “non-responder.”

Learning Objectives

Recognize problems in responder analyses if subjects discontinue study treatment or withdraw from a trial; Compare approaches published by EMA, NAS, and in the ICH E9(R1): Addendum to Statistical Principles for Clinical Trials on Choosing Appropriate Estimands and Defining Sensitivity Analyses in Clinical Trials; Recognize how to combine multiple missing data approaches to tell the data story.

Chair

Scott Komo, DrPH

Speaker

Panelist
Yeh-Fong Chen, PhD

Panelist
Lisa A Kammerman, PhD, MS



Chair
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →

Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →
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 →


Monday June 27, 2016 8:30am - 9:45am EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum

10:45am EDT

#126: Hope Is Not a Strategy: Quantifying Knowledge for Better Decision Making in Clinical Development
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-596-L04-P; CME 1.25; IACET 1.25; RN 1.25

If studies have 90% power, why don’t 90% of studies have a successful outcome? This workshop will demonstrate how eliciting knowledge from experts and calculating the probability of success of a study or development program can leverage strategic decision-making.

**Due to workshop format, seating is limited and will be available on a first come, first served basis.

The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Explain the statistical concept of Assurance (a.k.a. Probability of Success or PoS) with respect to drug development strategy; Describe the benefits of quantifying current knowledge (prior elicitation) among product and disease experts; Quantify the probability of success of a future clinical trial by participating in a mock exercise to elicit a prior.

Chair

Colleen Russell, MS

Speaker

Facilitator
Sharon Cornell Murray, PhD

Facilitator
David A. Burt



Chair
avatar for Colleen Russell

Colleen Russell

Associate Director, Biostatistics, PAREXEL
Colleen is an experienced pharmaceutical R&D statistician who has oversight of drug development and execution, insuring that work processes and client expectations are satisfied. She is focused on applying published statistical methods for comparing like devices to understand the... Read More →

Speakers
DB

David Burt

Director, Biostatistics, Trevena Inc
David received his PhD in Statistics from Virginia Tech in 2000 and has since been working in the pharmaceutical industry for a number of different companies. Currently he is serving as the Director of Biostatistics at Trevena Inc a biotech company based out of King of Prussia, P... Read More →
avatar for Sharon Murray

Sharon Murray

Associate Director, Biostatistics, PAREXEL
Sharon Murray is Associate Director, Statistics at PAREXEL Ltd. She provides statistical support for the design, analysis and operational aspects of Oncology clinical trials as well as for drug development strategy. Sharon holds an MS and PhD in Biostatistics from the University of... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
102AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 02: Proj-Port Mgt-Strat Planning, Workshop

10:45am EDT

#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 EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

12:15pm EDT

#147: Interpreting Meaningful Change on PRO Instruments: Methods in Action
Limited Capacity seats available

Component Type: Workshop
Level: Intermediate

One aspect of patient-reported outcome (PRO) instrument development that continues to perplex the field is the interpretation of change scores. How much change must be observed on a PRO instrument to be able to say that a patient has experienced a treatment benefit? This session will provide a brief background on commonly-used and novel methods for assigning meaning to PRO score changes, and then attendees will participate in one of three activities where these methods are demonstrated. The goal of the methods demonstrated in each of these three activities is to identify a threshold at which changes on the PRO instrument are deemed meaningful. The first activity will be a mock exit interview where a participant is probed about their experience during a clinical trial and the meaning behind their observed PRO scores. The second activity will be a mock bookmarking exercise where a participant rates hypothetical vignettes as better, worse, or the same as their own condition using items from a PRO instrument. The third activity will be a group exercise on synthesizing results from multiple methods into one responder definition (i.e., the triangulation process). The session attendees will reconvene at the end of these exercises to discuss the value and challenges of each method.

**Due to session format, seating will be limited to 50 participants and available on a first come, first served basis. Once all seats are occupied, DIA will be required to close the session, and no more participants will be admitted. Interested attendees are encouraged to arrive early in order to ensure seating.

Learning Objectives

Recognize the value of and challenges with different methods for informing the interpretation of change on PRO instruments by engaging in mock exercises demonstrating these methods in practice.

Chair

Cheryl D. Coon, PhD

Speaker

Facilitator
Scott Komo, DrPH



Chair
avatar for Cheryl Coon

Cheryl Coon

Principal, Outcometrix
Cheryl D. Coon, PhD is a psychometrician with over a decade of experience in the pharmaceutical field. She applies qualitative and quantitative methods to the development and evaluation of PRO instruments. During her years in the field, she has been involved in all stages of instrument... Read More →

Speakers
SK

Scott Komo

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining... Read More →


Monday June 27, 2016 12:15pm - 1:15pm EDT
Exhibit Hall A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 22: Engage and Exchange, Workshop
 
Tuesday, June 28
 

10:30am EDT

#212: Special Populations in Clinical Pharmacology Studies
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-524-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium examines the complex challenges encountered in special population study design. Appropriate management of specialty populations with comorbidities on multiple medications creates challenges in protocol design and enrollment to ensure patient safety and accurate and quality data.

Learning Objectives

Discuss strategies to adapt to industry trends and changing demands of special population studies; Identify options in protocol design and the process for screening patients with comorbidities and concomitant medications; Evaluate the impact of subject population on subject safety data and on assessment of drug safety.

Chair

William B Smith

Speaker

Special Populations in Clinical Pharmacology Studies: Evolving Challenges
William B Smith

Investigational Product and Drug-Drug Interactions in Specialty Populations with Comorbidities: Options in Addressing Safety, Data, Timelines, and Costs
Harry W Alcorn, JR, PharmD

Fast to Patient: Shifting from Healthy Volunteer to Patient Population
Richard Scheyer, MD

QTcF in Special Populations
Robert Kleiman



Chair
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

Speakers
avatar for Harry Alcorn

Harry Alcorn

Chief Scientific Officer, DaVita Clinical Research
Chief Scientific Officer for DaVita Clinical Research a CRO, located in Minneapolis Minnesota and Lakewood Colorado. He has served as PI on over 150 protocols and Sub Investigator on over 300 protocols which have included Renal (Full and Adaptive), Hepatic and Pulmonary, along with... Read More →
RK

Robert Kleiman

Chief Medical Officer and Vice President, Global Cardiology, ERT
Dr. Kleiman is a cardiac electrophysiologist who has performed research in both basic and clinical electrophysiology and practiced clinical electrophysiology for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer, and works with pharmaceutical... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium

10:30am EDT

#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
Limited Capacity seats available

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

During this session, the value of metadata repositories will be discussed, and the audience will be provided with real-world practical experience regarding the traps to avoid, and the process to follow, to enable a successful metadata repository implementation.

Learning Objectives

Describe the complexities associated with defining metadata repository requirements; Discuss how to develop a methodology for implementing a successful metadata repository.

Chair

David Handelsman

Speaker

Semantic Metadata Repository at the Core of E2E eClinical Solutions
Isabelle M de Zegher

Implementing a Metadata Repository Based on Value and Not Technology
David Handelsman

Metadata Repositories: From the Outside In
Wayne R. Kubick, MBA



Chair
avatar for David Handelsman

David Handelsman

Senior Director, Industry Strategy, d-Wise
Dave Handelsman is a life sciences expert with 25 years of industry, software and management experience. As Senior Director of Strategy and Product Development at d-Wise, Dave is responsible for d-Wise’s growth and evolution, and for further establishing d-Wise as the go-to partner... Read More →

Speakers
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

2:00pm EDT

#250: Open-Label, Long-Term Extension Studies: Study Designs and Ethics
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-583-L04-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, we will discuss open-label, delayed-start studies and open-label extension studies that are conducted to evaluate safety and efficacy. A statistician will describe delayed-start study designs and an epidemiologist will discuss when such studies are needed, and the interpretation of study findings. An ethicist will identify the ethical aspects of these study designs and their conduct.

Learning Objectives

Explain the objectives of open-label, long-term extension studies; Describe the role and design of delayed-start studies and single-arm extension studies in the evaluation of efficacy and safety; Discuss ethical considerations when designing and conducting open-label, long-term extension studies.

Chair

Lisa A Kammerman, PhD, MS

Speaker

Delayed-Start Study Design and Analyses for Demonstrating Disease Modification
Scott Andersen, MS

Bioethics of Open-Label Extension Studies
Robert M Nelson

When, if Ever, Open-Label Extension Studies Are Needed and Appropriate (and What Are the Alternatives)?
Jesse Aaron Berlin, DrSc



Chair
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 →

Speakers
SA

Scott Andersen

Principal Research Scientist, Eli Lilly and Company
Scott has been a statistician designing and analyzing neuroscience clinical trials for nearly 20 years. While most of his research has focused on depression and schizophrenia disease states, Scott has spent the last five years working on Alzheimer's Disease. In 2015, Scott co-authored... Read More →
avatar for Jesse Berlin

Jesse Berlin

Vice President and Global Head of Epidemiology, Johnson & Johnson
Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored... Read More →
avatar for Robert Nelson

Robert Nelson

Deputy Director & Senior Pediatric Ethicist, Ofc of Pediatric Therapeutics, OC, FDA
Robert “Skip” Nelson, M.D., M.Div., Ph.D. is currently the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and Drug Administration. Prior to joining FDA full-time in 2009, he was Professor of Anesthesiology... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum

4:00pm EDT

#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 EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session
 
Wednesday, June 29
 

10:30am EDT

#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 EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session

2:00pm EDT

#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 EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session

2:00pm EDT

#338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-525-L01-P; CME 1.25; IACET 1.25; RN 1.25

Analgesics are useful drugs but have limitations of effectiveness, safety, and tolerability in some patients. In this symposium, we will discuss why evaluating abuse deterrent opioids, drug interactions and targeting specific pain phenotypes are critical areas of analgesic research.

Learning Objectives

Discuss the benchtop/clinical evaluations required to assess abuse deterrent opioid formulations; Explain the challenges in evaluating drug-drug interactions between pain medications or withdrawal maintenance drugs and other drugs; Describe European Medicine Agency views on how particular biomarker methods can be used in the stratification of patient populations in neuropathic pain trials.

Chair

Beatrice Setnik, PhD

Speaker

Abuse Deterrent Opioids: Benchtop and Clinical Approaches to Testing Real World Drug Abuse
Beatrice Setnik, PhD

A Quantitative Approach to Understanding the Dynamic Interplay Between Pain and Concomitant Medications, and Genetics
Galina Bernstein, PhD

Proposal for the Use of Biomarker Methods to Enable Stratification of Patient Populations in Clinical Trials for Neuropathic Pain
Andrew Whiles, LLM, MBA



Chair
avatar for Beatrice Setnik

Beatrice Setnik

Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →

Speakers
avatar for Galina Bernstein

Galina Bernstein

Director of Pharmacometrics, Early Phase, INC Research
Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, small... Read More →
AW

Andrew Whiles

Director, Regulatory Affairs, Pfizer Ltd
Andrew Whiles has 29 years’ regulatory experience in researching , registering and maintaining pharmaceuticals and devices on the market. Over the last four years he has focused on early development regulatory strategies from Phase 1 through to Proof of concept studies within the... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium

2:00pm EDT

#342: Big Data in Health Care and Life Sciences
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-542-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research and include recent developments and novel techniques applied to big data integration and analysis that have the potential to improve the quality and costs associated with both early stage discovery and clinical development from conduct to completion of clinical trials.

Learning Objectives

Discuss how big data and new technology can be used to enhance patient experience, manage outcomes, and enhance research; Identify how to use big data analytics to develop new insights from patient data long before previously possible.

Chair

John Piccone

Speaker

IBM Watson Health: Creative Innovation of Health Care and Life Sciences
John Piccone

Exploiting Big Data in Precision Medicine
Amrita Basu, PhD

The Big Data Gap: Harnessing Big Data to Accelerate Clinical Development
James Streeter



Chair
avatar for John Piccone

John Piccone

Lead Partner Life Sciences Strategy and Analytics, IBM Watson Health
John Piccone currently leads the Watson Health offerings for life sciences at IBM. In this role, he defines the analytics and cognitive solutions that Watson Health is offering to it’s pharmaceutical, biopharma, medical device and biotech clients. The current focus of his work is... Read More →

Speakers
AB

Amrita Basu

Genomics and Computational Biology Lead, Health and Life Sciences, Lockheed Martin Information Systems & Global Solutions
Amrita Basu is the Genomics and Computational Biology Lead at Lockheed Martin. Previously, she worked at the Broad Institute of Harvard and MIT on predictive modeling approaches for cancer drug discovery. Amrita holds a Bachelors degree in Electrical Engineering from Cornell University... Read More →
avatar for James Streeter

James Streeter

Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences, United States
As the global head of life sciences product strategy for Oracle, Jim collaborates closely with Oracle customers, regulatory agencies, analysts, and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#374: Design and Execution of Futility Analysis Using Real-World Case Studies: Key Considerations
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Futility analysis is increasingly used in clinical studies. The implementation of futility rules present some special considerations in study design and conduct, and this forum will focus on some of these critical aspects. Through the use of case studies, we will review a futility analysis based on preliminary questionnaire data where interim and final results were discordant and a phase 3 adaptive study design that includes futility analysis methods. Further discussions and considerations include the pros and cons of the futility analysis, clinical considerations, recruitment rate, and impact on the clinical program.

Learning Objectives

Describe the limitations and risks of futility analysis; Explain the role of data management in futility analysis; Discuss the risks associated with interpretation of results from dirty data.

Chair

Brenda Crowe, PhD

Speaker

The Futility of Futility Analysis
Imogene McCanless Dunn

Design of Futility Analysis in a Phase 3 Clinical Trial
Feng Liu, MSc



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
avatar for Imogene Dunn

Imogene Dunn

Senior Vice President, Biometrics and Regulatory Affairs, vTv Therapeutics
Imogene McCanless Dunn, Ph.D., has more than 25 years experience in data sciences (data management, biostatistics, and informatics, and regulatory affairs). A key focus of career has been regulatory data sciences, leveraging progressive regulatory methodologies and strategies while... Read More →
avatar for Feng Liu

Feng Liu

Manager, Statistics, RD Projects Clinical Platforms and Sciences, GlaxoSmithKline
Mr. Feng Liu is Manager, in Clinical Statistics Department at GSK. He has more than fifteen years of experience in non-clinical and phase I-III pharmaceutical development. He advocates the application of efficient designs to improve productivity and reduce the failure rate in the... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Forum
 
Thursday, June 30
 

10:45am EDT

#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 EDT
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 15: Statistics, Session