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DIA/FDA Statistics Forum 2014

Apr 7 2014 8:30AM - Apr 9 2014 4:30PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

Tutorials: April 6, 2014



Now in its eighth year, the DIA/FDA Statistic Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. This unique workshop continues the dialogue on issues including FDA guidance development and regulatory science initiatives.

You will have the opportunity to focus on statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the pre- and post-market settings.

WHAT YOU WILL LEARN:

  • Key topics relevant to the evaluation of therapeutic products
  • Input from key thought leaders from regulatory agencies, industry, and academia
  • Regulatory and statistical solutions associated with innovative approaches to the design and analysis of clinical trials data

Examine your role in these changes and improvements to help develop appropriate, scientific/regulatory consensus.


 



This program is cosponsored with FDA and developed in collaboration with the DIA Statistics Community

Featured Topics 

  • Late-breaking Guidances
  • Subgroup Analyses
  • Risk-benefit Assessment
  • Meta-analysis
  • Much More

Who Should Attend 

  • Statisticians
  • Clinicians
  • Epidemiologists
  • Pharmacometricians
  • Drug Safety Professionals
  • Regulatory and Medical Communication Scientists

Learning Objectives 

At the conclusion of this meeting, participants should be able to:

  • Recognize innovative statistical solutions to issues associated with the evidence and regulatory review of medical products
  • Describe the application of statistical methodologies and thinking to the development of new medical products
  • Assess the impact of regulations and guidance on statistical practice
  • Discuss ideas for improving the communication between industry statisticians and reviewers

Hotel & Travel 

Bethesda North Marriott Hotel and Conference Center
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until April 3, 2014, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link or call +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #14008.

Standard Room Rate $209

Hotel Address: 5701 Marinelli Road North Bethesda, MD 20852

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Washington Dulles International Airport or Ronald Reagan Washington National Airport and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details and Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Continuing Education 

 Drug Information Association has been accredited as an Authorized Provider by the International Association  for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102;  +1.703.506.3275.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer up to 2.4 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 12 Elective Units
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
For more information go to www.diahome.org/certificateprograms

To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE

Name Credit Type Max Credits CEU
Workshop: Dropouts from Randomized Trials in the R IACET 3.00 0.300
Tutorial #2: Bayesian Methods for Drug Safety IACET 3.00 0.300
Tutorial #1: Subgroup Analysis in Clinical Trials: IACET 3.00 0.300
DIA/FDA Statistics Forum 2014 IACET 17.75 1.800

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the program, sign in at the DIA registration desk each day of the program, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, April 23, 2014.

Program Committee 

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Agenda  

Tutorials Sunday, April 06, 2014

  • 9:00AM - 12:00PM

    Tutorial #1: Subgroup Analysis in Clinical Trials: Statistical Considerations for Interpretation of Study Findings and Design Issues

    Clinical trials enroll subjects expected to benefit from the treatment under investigation, although the magnitude of their benefits, when it exits, may vary by their background characteristics. For a completed trial that demonstrates treatment efficacy in the overall population, subgroup analysis are usually carried out for checking consistency of treatment effect across subgroups for proper interpretation of study findings and for providing guidance on treatment use. However, observed heterogeneity in treatment effect across subgroups can be, partly at least, due to chance factors; furthermore, true heterogeneity, when present, may not be detected by statistical tests due to their low power. This tutorial considers these issues related to subgroup analyses for a completed trial and investigates whether subgroup findings can be supportive for those of the overall population. In addition, it discusses statistical considerations for the design and analysis of a confirmatory clinical trial with the objective of establishing efficacy claims in a targeted subgroup and the overall population.


    At the conclusion of this tutorial, participants should be able to:

    • Identify the impact of chance findings on the interpretation of subgroup analysis findings
    • Describe how to critically assess findings of testing for treatment-by-subgroup interaction and their utility in determining the treatments use
    • Discuss how to handle statistical considerations, including study power and multiplicity issues, for the design and analysis of a clinical trial with claim for a targeted subgroup
  • 9:00AM - 12:00PM

    Tutorial #2: Bayesian Methods for Drug Safety Evaluation and Signal Detection

    As the era of "big data" arrives in full force for health care and pharmaceutical development, researchers in these areas must turn to increasingly sophisticated statistical tools for their proper analysis. Bayesian statistical methods, while dating in principle to the publication of Bayes' Rule in 1763, have only recently begun to see widespread practical application due to advances in computation and software. This tutorial, sponsored by the DIA Bayesian Scientific Working Group, will provide an overview of Bayesian statistical methods and computation, and then explore their use in meta-analysis and hierarchical modeling especially with regard to drug safety. We will demonstrate methods via case examples and discuss the impact of utilizing these approaches throughout pharmaceutical development.


    At the conclusion of this tutorial, participants should be able to:

    • Describe the key concepts of Bayesian statistical methods, hierarchical modeling, computation, and software.
    • Provide a review of meta-analysis and Bayesian meta-analysis
    • Discuss how these methods may be used in conjunction with adaptive clinical trial designs that continuously monitor an adverse event of interest.
    • Explain how the basic ideas of Bayesian meta-analysis can be extended to network meta-analysis and provide an example in the context of safety.
    • Examine techniques for safety signal detection in clinical trial AE data that utilize Bayesian hierarchical modeling
    • Discuss Bayesian hierarchical modeling of lab measurements as a possible technique that can be used to incorporate historical control information for early signal detection.
  • 1:30PM - 4:30PM

    Workshop: Dropouts from Randomized Trials in the Regulatory Environment

    The NRC report on missing data was highly critical of past practices in drug trials and recommended changes in design and conduct, sophisticated methods of analysis, and careful attention to the definition of causal estimands. In protocols and discussions with sponsors since the report appeared, we have seen relatively minor changes in design and conduct, somewhat simplified versions of the sophisticated methods of analysis, and indications of some confusion about what was meant by causal estimands.

    We will explain what we think causal estimands are and what estimands may be appropriate for regulatory trials. Some estimands indeed require a substantial change in design and conduct, namely the continuing collection of primary outcome data on most subjects notwithstanding discontinuation of treatment, and we will discuss methods for achieving this continuing collection. Other estimands consider the discontinuation itself to be the outcome and therefore do not require further information on subjects after discontinuation. Still other estimands depend only on data before discontinuation; these estimands may have some usefulness in certain settings, but they cannot be assumed to be sufficient in all cases.

    We will talk about the general classes of methods that may be used for testing and estimation of various estimands, but we will not broadly recommend particular methods. Our message (and NRC’s, we think) is that there is no general solution for all missing data problems. Rather, methods need to be chosen in light of careful thinking about what the specific problem is.


    At the conclusion of this tutorial, participants should be able to:

    • Discuss the Office of Biostatistic’s current thinking on handling  dropouts from clinical trials
    • Identify general classes of methods used in testing and estimation of various estimands

Day 1 Monday, April 07, 2014

  • 8:45AM - 9:00AM

    Welcome and Opening Remarks

    Speaker(s):

    • Joan Buenconsejo, PhD,MPH
      Statistics Team Lead, Division of Biometrics II, OB, OTS, CDER
      FDA, United States
    • Walter Offen, PhD
      Global Head of Statistical Innovation & Data and Statistical Sciences
      Abbvie, United States
  • 9:00AM - 10:00AM

    Keynote Address: Future of Clinical Trials (Innovation)

    Speaker(s):

    • The Right Treatment for the Right Patient (at the Right Time)
      Marie Davidian, PhD
      William Neal Reynolds Professor, Statistics
      North Carolina State University, United States
    • Efforts to Engage Patients in Clinical Trials
      Thomas A. Krohn, MBA,RPh
      Advisor, Clinical Open Innovation
      Eli Lilly and Company, United States
  • 11:00AM - 12:30PM

    Session 1- Biomarkers and Surrogate Endpoints


    Session Chair(s):

    • Greg Levin
      Staff Fellow, CDER
      FDA, United States
    • Keaven Anderson, PhD
      Executive Director,Statistics: Late Stage Development
      Merck Research Laboratories, United States

    At the request of the FDA, the Institute of Medicine published a report on the evaluation of biomarkers and surrogate endpoints. In this session, we will review the principle recommendations of the report, provide a regulatory perspective, and discuss the ongoing I-SPY2 study. This study recently generated a Phase III candidate drug using a design that includes one biomarker as an endpoint and several others for subgroup identification. A discussant from the FDA will provide perspective for the session.

    Speaker(s):

    • Issues in Qualifying Biomarkers As Surrogate Endpoints
      Victor DeGruttola
      Henry Pickering Walcott Prof of Biostatistics & Chair, Dept of Biostatistics
      Harvard School of Public Health, United States
    • Choosing Outcomes in Clinical Research: Biomarkers and Other Indirect Outcome Measures
      John H. Powers, MD,FACP
      Associate Clinical Professor of Medicine
      George Washington University School of Medicine, United States
    • Biomarkers and Longitudinal Modeling in I-SPY 2 and I-SPY 3
      Donald A Berry, FACP
      Professor, Department of Biostatistics
      The University of Texas, United States
    • Discussant
      Sue-Jane Wang, PhD,MA,MS
      Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER
      FDA, United States
  • 1:30PM - 3:00PM

    Session 2 - Meta-analysis for Safety Assessment


    Session Chair(s):

    • Brenda Crowe, PhD
      Senior Research Advisor, Global Statistical Sciences
      Eli Lilly and Company, United States
    • Aloka Chakravarty, PhD
      Director, Division of Biometrics VII, OTS, CDER
      FDA, United States

    This session will have a particular focus on "network meta-analysis" for assessment of product safety. Standard meta-analysis, whether of continuous or discrete outcomes, has focused exclusively on comparing two treatments or classes of treatments. Recently, methods have been developed to integrate comparisons of multiple treatments into coherent models that allow simultaneous comparison of all treatments. Applications of these methods are beginning to become popular in the clinical literature. Called variously network meta-analysis, multiple treatments meta-analysis and mixed treatment comparisons, the basic idea is that the direct evidence from head-to-head trials may be combined with the indirect evidence from trials that involve common comparators. For instance, trials of A vs. B and A vs. C give indirect information about the comparison of B vs. C under the assumption of consistency that the direct and indirect comparisons estimate the same quantity. Our speaker will discuss basic principles of networks and their analysis including the assumptions of consistency and treatment of heterogeneity and will discuss the validity of these assumptions in the context of safety studies relative to efficacy studies. Some important features of safety data to be discussed include length of follow-up, rare events, varying patient populations, differing exposures, variation in medical practice, age of treatments, trial sponsor. Extensions to multiple outcomes and longitudinal designs with incomplete data will also be discussed. A panel will discuss questions related to meta-analysis, network meta-analysis and the FDA Public Meeting on meta-analysis held November 2013.

    Speaker(s):

    • Network Meta-Analysis for Safety Assessment
      Christopher H. Schmid, PhD
      Professor of Biostatistics, Center for Evidence Based Medicine
      Brown University School of Public Health, United States
    • Panelists
      Mark S. Levenson, PhD
      Deputy Director, Division of Biometrics VI, Office of Biostatistics, CDER
      FDA, United States
    • Jesse A. Berlin, DrSc
      Vice President, Epidemiology
      Johnson & Johnson, United States
    • Hong Amy Xia, PhD
      Executive Director, Biostatistics
      Amgen, Inc., United States
  • 3:30PM - 5:00PM

    Session 3 - Benefit-Risk Assessment: Foundations and Emerging Frontiers


    Session Chair(s):

    • John Scott, PhD
      Deputy Director, Division of Biostatistics, OBE, CBER
      FDA, United States

    Drug development and regulatory decision-making have long been guided by informal weighing of the benefits and risks of medical treatments. Due in part to new regulatory initiatives, formal benefit-risk assessments are increasingly important to industry and regulatory stakeholders. Statisticians play a key role in benefit-risk assessment, helping to develop and implement explicitly quantitative benefit-risk methodologies, as well as providing input to more qualitative approaches. In this session, we will hear from three benefit-risk experts: an FDA representative, who will provide an overview of the current regulatory environment for benefit-risk assessment and ongoing initiatives; a member of the QSPI Benefit-Risk Working Group, who will discuss existing methodologies for benefit-risk assessment; and a representative from industry, who will present a case study applying a benefit-risk assessment in a regulatory filing.

    Speaker(s):

    • Qi Jiang, PhD
      Executive Director, Global Biostatistical Science
      Amgen Inc., United States
    • Benefit-risk Assessment Across the Lifecycle of Products: Methods and Challenges
      Chunlei Ke, PhD
      Amgen Inc., United States
    • Evaluation of Benefit and Risk
      Ellis Unger, MD
      Director, Office of Drug Evaluation I, OND, CDER
      FDA, United States
    • Carmen R. Bozic, MD
      Senior Vice President, Clinical and Safety Sciences
      Biogen Idec, United States
    • Panelist
      Thomas J. Permutt, PhD
      Director, Division of Biometrics II, OB, OTS, CDER
      FDA, United States

Day 2 Tuesday, April 08, 2014

  • 8:30AM - 10:00AM

    Session 4 - Clinical Trials Data: Using Standards and Establishing Transparency


    Session Chair(s):

    • Ivan S. F. Chan, PhD
      Executive Director, Biostatistics, Late Development Statistics
      Merck Research Laboratories, United States
    • No-image Stephen E. Wilson, DrPH
      Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
      FDA, United States

    Statisticians and clinicians who develop and review medical products depend heavily on high quality clinical trials data to provide evidence for approval and labeling claims. This is a “Data Session” – designed to bring us all up-to-date on the progress of two important initiatives associated with these clinical trials data. 1) PDUFA V Goals point towards the development of CDISC data standards for the submission of these data to FDA/CDER. This session will provide an FDA review perspective on the progress made with the development and application of these standards for data collection, data management, statistical programming, analysis, reporting and review (from protocol to decision). 2) It has also become very apparent that there is growing interest in making these clinical trials data more available to the public, more “transparent.” The European Medicines Agency has announced that it will proactively publish clinical-trial data and enable access to full data sets by interested parties.” Companies are thinking hard and dedicating staff to figure out what this will look like. What are the concerns, complexities and processes? Data privacy and “stewardship” are two major issues. In this session we will learn more about what companies are thinking and doing to assure the secure access and the privacy of “shared” clinical trials data – to become responsible “stewards” for the secondary use of these important/expensive/valuable data.

    Speaker(s):

    • Data Transparency: Protecting the Patient and the Sponsor
      Jonathan S. Hartzel, PhD
      Biometrician
      Merck and Co., United States
    • FDASIA/PDUFA V, Data Standards and Statistical Review: An Update
      Benjamin Peter Vali, MS
      Biostatistical Reviewer, Division of Biometrics III, OTS, OB, CDER
      FDA, United States
    • Increased Clinical Data Transparency: Building Trust and Advancing Public Health
      Jesse A. Berlin, DrSc
      Vice President, Epidemiology
      Johnson & Johnson, United States
  • 10:30AM - 12:00PM

    Session 5 – Innovative Trial Design


    Session Chair(s):

    • Dean Follmann, PhD
      Assistant Director for Biostatistics; NIAID Chief Biostatistics Research Branch
      National Institute of Allergy and Infectious Diseases, United States
    • Estelle Russek-Cohen, PhD
      Division Director, Division of Biostatistics, OBE, CBER
      FDA, United States

    Session 5 – Innovative Trial Design

    Speaker(s):

    • Introduction to the Design and Analysis of SMARTs
      Michael R Kosorok
      W. R. Kenan, Jr. Distinguished Professor and Chair, Department of Biostatistics
      University of North Carolina at Chapel Hill, United States
    • A Modest Proposal
      Michael A. Proschan
      Biostatistics Research
      National Institute of Allergy & Infectious Disease, United States
    • Optimal Tests of Treatment E ects for the Overall Population and Two Subpopulations in Randomized Trials, using Sparse Linear Programming
      Michael Rosenblum, PhD
      Assistant Professor
      Johns Hopkins University, United States
    • Panelists
      Qi Jiang, PhD
      Executive Director, Global Biostatistical Science
      Amgen Inc., United States
    • Robert J. Temple, MD
      Deputy Center Director for Clinical Science, CDER
      FDA, United States
  • 12:00PM - 1:30PM

    Luncheon and Roundtable Discussions


    Session Chair(s):

    • Brenda Crowe, PhD
      Senior Research Advisor, Global Statistical Sciences
      Eli Lilly and Company, United States
    • Eugenio Andraca-Carrera, PhD
      Mathematical Statistician
      FDA, United States
    • Carmen Mak, PhD
      Independent Statistical Consultant, United States
    • Bo Yang
      China
  • 1:30PM - 3:00PM

    Session 6 – Subgroup Analyses


    Session Chair(s):

    • Mark Rothmann, PhD
      Team Leader, Division of Biometrics II, Office of Biostatistics, OTS, CDER
      FDA, United States
    • Joachim Vollmar, MSc
      Executive Consultant
      International Clinical Development Consultants LLC, United States

    Subgroup analyses are commonly conducted in completed confirmatory clinical trials with the objective of learning about differential treatment effects across subgroups. This is import for a comprehensive assessment of trials in marketing authorization applications, however, clinical trials are seldom properly planned for establishing an efficacy or safety claim for a subgroup in case the trial fails to establish the same claim for the total population. EMA (CHMP) has drafted a guideline on this topic. Presentations in this session will focus on methodological issues related to interpretation of subgroup findings from completed clinical trials and designing clinical trials with the objective of establishing efficacy/safety claims for the total population or a targeted subgroup and will be followed by a panel discussion with additional experts.

    Speaker(s):

    • Assessment of subgroups in significant and non-significant clinical trials
      Armin Koch, DrSc
      Head, Institute of Biometry
      Hannover Medical School, Germany
    • Subgroup Analysis Issues in FDA-Reviewed Clinical Trials
      Kathleen S. Fritsch, PhD
      Mathematical Statistician, OTS, CDER
      FDA, United States
    • Case Studies of Confirmatory Subgroup Analyses
      Frank Bretz, PhD
      Global Head of Statistical Methodology
      Novartis Pharma AG, Switzerland
    • Panelists
      Mohamed A. Alosh, PhD
      Team Leader, Office of Biostatistics, OTS, CDER
      FDA, United States
    • Mohammad Huque, PhD
      Office of Biostatistics, OTS, CDER, FDA
      FDA, United States
    • Ralph B. D'Agostino, PhD,MA
      Chair, Mathematics and Statistics Department
      Boston University, United States
  • 3:30PM - 5:00PM

    Session 7 – Leadership in a Collaborative Environment


    Session Chair(s):

    • Joan Buenconsejo, PhD,MPH
      Statistics Team Lead, Division of Biometrics II, OB, OTS, CDER
      FDA, United States
    • Christy Chuang-Stein, PhD,MA,MS
      Vice President, Statistics
      Pfizer Inc, United States

    With the support of professional organizations like the Drug Information Association, the American Statistical Association and the Society for Clinical Trials, statisticians involved in the development and regulation of new medical products now have many more opportunities for open scientific collaboration. To be productive and to make real progress, these collaborative efforts require high levels of volunteer effort and energy, and they must be directed and supported by effective leaders. This session will highlight the goals and accomplishments of some of these efforts, providing Forum participants an opportunity to learn from these leaders on how these groups achieved their objectives. Leaders will describe successful strategies used to manage challenges, to oversee multiple workstreams, how to seize opportunities and most importantly, how to influence without authority.

    Speaker(s):

    • Jerald S. Schindler, DrPH
      Vice President, Biostatistics and Research Decision Sciences
      Merck Research Laboratories, United States
    • Leadership in a Collaborative “RegSci” Environment: Elements & Challenges
      Stephen E. Wilson, DrPH
      Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
      FDA, United States
    • DIA Bayesian Scientific Working Group
      Karen Lynn Price, PhD,MA
      Research Advisor
      Eli Lilly and Company, United States
    • Brenda Crowe, PhD
      Senior Research Advisor, Global Statistical Sciences
      Eli Lilly and Company, United States
    • The MRCT Experience
      Bruce Binkowitz, PhD,MSc
      Senior Director, Clinical Biostatistics
      Merck Research Laboratories, United States
    • Leadership in a Regulatory Environment
      Estelle Russek-Cohen, PhD
      Division Director, Division of Biostatistics, OBE, CBER
      FDA, United States
  • 5:00PM - 7:00PM

    Networking Reception and Poster Session


    Session Chair(s):

    • Barry H. Schwab, PhD
      Vice President, Clinical Biostatistics
      Janssen Research & Development, LLC, United States
    • Cristiana Mayer, PhD
      Scientific Director, Statistical Modeling, Model-Based Drug Development
      Janssen R&D, Johnson & Johnson, United States
    • Judy Li, PhD
      Mathematical Statistician, Division of Biostatistics, OBE, CBER
      FDA, United States
    • David S. Keller
      Pfizer, United States

Day 3 Wednesday, April 09, 2014

  • 8:30AM - 10:00AM

    Session 8 – Phase 2 Dose-Finding Studies, Part I


    Session Chair(s):

    • Jose C. Pinheiro, PhD
      Senior Director, Quantitative Decision Strategies
      Janssen Research & Development, LLC, United States
    • H. M. James Hung, PhD
      Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
      FDA, United States

    This is an intertwined pair of sessions focused on statistical and modeling methods for dose finding studies. Dose selection remains one of the most challenging steps in clinical drug development, being directly associated with the success, or failure, of confirmatory studies and regulatory submissions. A common approach drug development has been to consider a dose finding study (also referred to as Phase 2B trial) as having the potential to be a pivotal study in the program. As a result, emphasis has been placed on multiple comparisons between active doses and control with strong control of Type I error, making studies that should, in principle, be exploratory in nature, look more like mini-Phase 3 studies. Poor dose selection has often been observed in such cases, eventually leading to costly failures in confirmatory programs or regulatory submissions. In the first session, three expert speakers (from regulatory agencies and industry) will review some of the critical issues related to dose finding studies and will present alternative, potentially more efficient dose selection approaches, including model-based methods.

    Speaker(s):

    • MCP-Mod: A Statistical Approach to Design and Analyze Phase II Dose Finding Studies
      Frank Bretz, PhD
      Global Head of Statistical Methodology
      Novartis Pharma AG, Switzerland
    • Dose Response and Dose Finding
      H. M. James Hung, PhD
      Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
      FDA, United States
    • Dose Finding Dose - Exposure Response Characterisation
      Efthymios Manolis, PharmD,MSc
      EMA, United Kingdom
  • 10:30AM - 12:00PM

    Session 9 – Phase 2 Dose-Finding Studies, Part II


    Session Chair(s):

    • Jose C. Pinheiro, PhD
      Senior Director, Quantitative Decision Strategies
      Janssen Research & Development, LLC, United States
    • H. M. James Hung, PhD
      Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
      FDA, United States

    The second session will feature the presentation of a case study of a real dose finding trial, followed by an expert panel, which will include the three speakers from the first session plus two additional discussants. The discussion will include the topics and methods presented in the first session and the case study, but will also cover future directions and trends in dose finding studies.

    Speaker(s):

    • Characterizing Dose-Response in the development of Novel Treatments for Multiple Sclerosis
      David Ohlssen, PhD
      Senior Expert Methodologist
      Novartis Pharmaceuticals Corporation, United States
    • Discussants
      Neal Thomas, PhD
      Pfizer Inc., United States
    • Sue-Jane Wang, PhD,MA,MS
      Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER
      FDA, United States
    • Frank Bretz, PhD
      Global Head of Statistical Methodology
      Novartis Pharma AG, Switzerland
    • H. M. James Hung, PhD
      Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
      FDA, United States
  • 1:00PM - 2:30PM

    Session 10 – Adaptive Design: New FDA Experiences


    Session Chair(s):

    • Jerald S. Schindler, DrPH
      Vice President, Biostatistics and Research Decision Sciences
      Merck Research Laboratories, United States
    • Rajeshwari Sridhara, PhD
      Director, Division of Biometric V, Office of Biostatistics, OTS, CDER
      FDA, United States

    This session will explore the recent successful uses of Adaptive Design during the drug development process. We will also explore the recent trend towards the increased use of adaptive designs in late development as well as expanded use of Bayesian methods. These discussions will include strategies for successful adaptive design planning with appropriate early simulations to define the operating characteristics. We will also discuss the requirement to ensure that any late stage adaptive designs allow sufficient flexibility and also are rigorous enough to be considered “adequate and well controlled.”

    Speaker(s):

    • FDA Oncology Experience in Innovative Adaptive Trial Designs
      Rajeshwari Sridhara, PhD
      Director, Division of Biometric V, Office of Biostatistics, OTS, CDER
      FDA, United States
    • Adaptive Population Enrichment for Oncology Trials
      Cyrus R. Mehta, PhD
      Founder and President
      Cytel Inc., United States
    • Panelist
      Lisa M. LaVange, PhD
      Director, Office of Biostatistics, Office of Translational Science, CDER
      FDA, United States
  • 3:00PM - 4:30PM

    Session 11 – Statistics Town Hall


    Session Chair(s):

    • Lisa M. LaVange, PhD
      Director, Office of Biostatistics, Office of Translational Science, CDER
      FDA, United States
    • Walter Offen, PhD
      Global Head of Statistical Innovation & Data and Statistical Sciences
      Abbvie, United States

    This session will be an open-microphone and broad Q&A session. Panelists will address questions posed by attendees in one of several manners: Via e-mail before or during the meeting, writing questions on 3x5 cards available at the registration desk, or by asking them live at the session. Topics may focus on the sessions held at this meeting, but can also branch out into other areas of regulatory statistics.

    Speaker(s):

    • Moderator
      Walter Offen, PhD
      Global Head of Statistical Innovation & Data and Statistical Sciences
      Abbvie, United States
    • Panelists
      Lisa M. LaVange, PhD
      Director, Office of Biostatistics, Office of Translational Science, CDER
      FDA, United States
    • Gregory Campbell, PhD
      Director, Division of Biostatistics, CDRH
      FDA, United States
    • Estelle Russek-Cohen, PhD
      Division Director, Division of Biostatistics, OBE, CBER
      FDA, United States
    • Frank Bretz, PhD
      Global Head of Statistical Methodology
      Novartis Pharma AG, Switzerland

Registration Fees 

Other Fees

Charitable Nonprofit/Academia
$720.00
Government (Full Time)
$430.00
Industry
$1440.00
Registration Fees for Additional Offerings
Tutorial #1: Subgroup Analysis in Clinical Trials: - Tutorial Rate
$405.00
Tutorial #2: Bayesian Methods for Drug Safety - Tutorial Rate
$405.00
Workshop: Dropouts from Randomized Trials in the Regulatory Environment - Tutorial Rate
$295.00
Registration Information

Although registration for this event is always available, on-line registration closes at midnight on April 3, 2014. Individuals wishing to register after this time are encouraged to complete a registration form and fax it to 215-442-6199 or register on-site.

Register Online

CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. Administrative fee that will be withheld from refund amount:

  • Member or Nonmember = $200
  • Government or Academia or Nonprofit (Member or Nonmember) = $100
  • Tutorial (if applicable) = $50

Cancellations must be in writing and be received two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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