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Joint Adaptive Design and Bayesian Statistics Conference: Drivers of Efficiency in Modern Medical Product Development

Feb 11 2015 8:00AM - Feb 12 2015 4:30PM | DoubleTree by Hilton Washington DC - Crystal City 300 Army Navy Drive Arlington, VA 22202

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Overview 

SAVE THE DATE
February 10, 2015 | 1:30 - 5:00 PM
Concurrent Tutorials
Tutorial 1: Baysian Dose Response Modeling
Tutorial 2: Bayesian Safety


As the complexity of pharmaceutical development escalates, researchers must leverage increasingly sophisticated statistical tools for design and analysis, including broader use of Bayesian methods and adaptive designs. There has been an upturn in interest and application of adaptive design and Bayesian statistics, in part due to their inclusion within the FDA's Critical Path Opportunities List.

While these methods have already contributed in many ways to reductions in risk, time, and cost of medical product development, and to overall improvements in decision making; for many drug developers, device, and diagnostic manufactures adaptive design and Bayesian statistics are still buzz-words.  Per a recent survey conducted by DIA’s Bayesian Scientific Working Group, education continues to be a significant gap in a broader appropriate uptake of Bayesian methods, including their use in adaptive designs.  In order to improve the implementation of adaptive design and Bayesian statistics, we must demystify the practice and application of these proven methodologies.

February 2015 marks the 5th anniversary of the publication of the FDA’s draft guidance on adaptive clinical trials and the final guidance of the use of Bayesian statistics in medical device clinical trials. Join us to celebrate these important milestones for clinical trials as well as to engage FDA representatives in discussions regarding the progress of both adaptive design and Bayesian statistics and to speculate the future for this science.

This conference will present the latest advancements in the application of adaptive design and Bayesian statistics to include critical aspects such as a better understanding of methodologies, identifying opportunities for when to apply them, analysis, and improved decision making. Presentations will be given from statistical, clinical, and regulatory viewpoints to provide a more complete picture of appropriate adaptive design and Bayesian statistics implementation.

Sessions will consist of joint and independent adaptive design and Bayesian statistic plenaries as well as concurrent breakout sessions for each class of methods.   Case studies will be presented throughout the conference to encourage discussions and debates regarding the use of Bayesian and adaptive design methods within modern medical product development from presenters across industry, regulatory, and academia.

This program has been developed in collaboration with the DIA Adaptive Design Scientific Working Group and the Bayesian Statistics Scientific Working Group.

Featured Topics 

  • 5th anniversary of FDA’s final guidance of the use of Bayesian statistics
  • 5th anniversary of FDA’s draft guidance on adaptive clinical trials in medical device clinical trials

Who Should Attend 

Professionals from industry, academia, and government involved in medical product development from learning to confirmatory phases or in new drug/device application review:

  • Clinician
  • Pharmacologists
  • R&D Design-makers
  • Comparative Effectiveness
  • Evidence Based Medicine
  • Statisticians
  • Regulatory Scientists
  • Safety and Pharmacovigilance
  • Epidemiologists
  • Post Marketing

Learning Objectives 

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

  • Apply concepts related to adaptive design and Bayesian methods
  • Identify opportunities for improving pharmaceutical, device, and diagnostic product development by application of adaptive design and/or Bayesian statistics
  • Assess whether the application of adaptive design and/or Bayesian methods would improve metrics such as cost, time of development, and probability of success, compared to the application of more traditional method

Special Offers 

EARLY BIRD RATE!
DIA Industry Members who register by
January 22, 2015, save $150!


Group Discounts Available!
Register 3 and Get the 4th FREE!

Hotel & Travel 

Double Tree by Hilton Washington DC - Crystal City  A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until January 19, 2015, 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 to make reservations online, or call toll free in the US 1.855.355.0302 or +1.212.532.1660. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #15009.

Standard Room Rate: $172
Hotel Address: 300 Army Navy Drive, Arlington, VA 22202

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Ronald Reagan Washington National Airport or Washington Dulles International Airport - 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
Meredith Kaganovskiy, Content Lead
Phone +1.215.442.6117
Fax +1.215.442.6199
Meredith.Kaganovskiy@diahome.org

Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Tabletop Exhibit Information
Jeff Korn, Exhibits Manager
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@diahome.org

Program Committee 

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Agenda  

Day 1 Wednesday, Feb 11, 2015

  • 7:00AM - 8:00AM

    Continental Breakfast
  • 7:00AM - 6:00PM

    Registration Day 1
  • 8:00AM - 8:30AM

    Welcome Remarks and Overview of the 1st Joint Adaptive Design and Bayesian Statistics Conference

    Speaker(s):

    • Zoran Antonijevic, MSc
      Senior Director
      Cytel Consulting, United States
    • Karen Lynn Price, PhD, MA
      Research Advisor
      Eli Lilly and Company, United States
  • 8:30AM - 9:30AM

    Keynote Address

    Speaker(s):

    • Speaker Invited
      United States
  • 9:30AM - 10:00AM

    Refreshment Break
  • 10:00AM - 11:30AM

    Session 1: 5th Anniversary of the Draft Guidance for Adaptive Design


    Session Chair(s):

    • No-image Zoran Antonijevic, MSc
      Senior Director
      Cytel Consulting, United States

    Speaker(s):

    • FDA’s Perspective
      FDA Speaker Invited
      United States
    • Industry’s Perspective of the Progress Made Implementing Adaptive Trials and the Potential for the Future
      Jerald S. Schindler, DrPH
      Vice President, Biostatistics and Research Decision Sciences
      Merck Research Laboratories, United States
    • Q&A Panel Discussion
      Joining the Speakers:
      Christy Chuang-Stein, PhD
      Vice President, Head of Statistical Research and Consulting Center
      Pfizer Inc., United States
    • FDA Speaker Invited
      United States
  • 11:30AM - 1:00PM

    Lunch
  • 1:00PM - 2:30PM

    Session 2: 5th Anniversary of the Guidance for Bayesian Statistics


    Session Chair(s):

    • FDA Session Chair Invited
      United States

    Speaker(s):

    • FDA’s Perspective
      FDA Speaker Invited
      United States
    • Industry’s Perspective
      Roger J. Lewis, MD, PhD
      Professor of Medicine, Department of Emergency Medicine
      Harbor UCLA Medical Center, United States
    • Q&A Panel Discussion - Joining the speakers:
      Karen Lynn Price, PhD, MA
      Research Advisor
      Eli Lilly and Company, United States
    • Donald A Berry, PhD, FACP
      Professor, Department of Biostatistics
      The University of Texas, United States
    • Estelle Russek-Cohen, PhD
      Director, Division of Biostatistics, OBE, CBER
      FDA, United States
  • 2:30PM - 3:00PM

    Refreshment Break
  • 3:00PM - 4:30PM

    Session 3: Bayesian and Adaptive Design Approaches in Special Populations


    Session Chair(s):

    • No-image Karen Lynn Price, PhD, MA
      Research Advisor
      Eli Lilly and Company, United States

    Speaker(s):

    • Bayesian Methods in Pediatric Development
      FDA Speaker Invited
      United States
    • Case Study: Use of Bayesian Statistics and Adaptive Design in Rare Diseases
      Melanie Quintana, PhD
      Statistical Scientist
      Berry Consultants, LLC, United States
    • Bayesian Methods in Rare Diseases
      Speaker Invited
      United States
    • Q&A Panel Discussion
      FDA Speaker Invited
      United States
  • 4:30PM - 5:30PM

    Reception

Day 2 Thursday, Feb 12, 2015

  • 7:00AM - 8:00AM

    Continental Breakfast
  • 7:00AM - 5:00PM

    Registration Day 2
  • 8:00AM - 8:10AM

    Welcome to Day 2

    Speaker(s):

    • Zoran Antonijevic, MSc
      Senior Director
      Cytel Consulting, United States
    • Karen Lynn Price, PhD, MA
      Research Advisor
      Eli Lilly and Company, United States
  • 8:10AM - 9:40AM

    Session 4: Master Protocol


    Session Chair(s):

    • FDA Session Chair Invited
      United States

    Speaker(s):

    • Platform Trials with Bayesian Adaptive Design
      Donald A Berry, PhD, FACP
      Professor, Department of Biostatistics
      The University of Texas, United States
    • Regulatory Perspectives on Platform Trials: Lung Map Master Protocol
      FDA Speaker Invited
      United States
    • Operational Aspects of Platform Trials
      Speaker Invited
      United States
    • Q&A Panel Discussion
      Joining the speakers:
      FDA Speaker Invited
      United States
  • 9:40AM - 10:00AM

    Refreshment Break
  • 10:00AM - 11:30AM

    Concurrent Breakout Session 1A: Adaptive Design Case Studies


    Session Chair(s):

    • Yili Pritchett, PhD
      Senior Director, Global Development
      Astellas Pharma Inc., United States

    Speaker(s):

    • Adaptive Sequential Stage Design in the Gazyva Registration Trial
      FDA Speaker Invited
      United States
    • 2-Stage Design in the Crofelemer Pivotal Program
      M. Scott Harris
      Principal
      Avaxia Biologics, United States
    • Moving Drugs from Phase 2 into Phase 3
      Brenda L. Gaydos, PhD
      Research Fellow, Advance Analytics; Head of Clinical Trial Optimization
      Eli Lilly and Company, United States
    • Q&A Panel Discussion
      FDA Speaker Invited
      United States
  • 10:00AM - 11:30AM

    Concurrent Breakout Session 1B: Bayesian Methods for a Better Decision Making Process


    Session Chair(s):

    • FDA Session Chair Invited
      United States

    Speaker(s):

    • CDRH’s Perspective: Bayesian Quantiative benefit/risk
      FDA Speaker Invited
      United States
    • Bayesian Decision Making in Oncology Studies
      Speaker Invited
      United States
    • Bayesian Decision Making: Industry‘s Perspective
      David Ohlssen, PhD
      Senior Expert Methodologist
      Novartis Pharmaceuticals Corporation, United States
    • Q&A Panel Discussion
      FDA Speaker Invited
      United States
  • 11:30AM - 1:00PM

    Lunch
  • 1:00PM - 2:30PM

    Concurrent Breakout Session 2A: Optimization of R&D Programs and Portfolios


    Session Chair(s):

    • No-image Zoran Antonijevic, MSc
      Senior Director
      Cytel Consulting, United States

    Speaker(s):

    • Simulating the Whole Development Program to Help Optimize the Design of a Phase 2 Trial in Oncology
      Tom Parke
      Consultant
      Tessella, United Kingdom
    • Drug Development Program Optimization Case Study in Neuropathic Pain
      James Bolognese
      Senior Director of Clinical Trial Services
      Cytel Inc., United States
    • Maximizing Return on Investment in Designing Clinical Trials
      Cong Chen, PhD
      Director
      Merck & Co., Inc., United States
    • Q&A Panel Discussion
      Panel Discussion
      All Session Speakers, United States
  • 1:00PM - 2:30PM

    Concurrent Breakout Session 2B: Bayesian Evidence Synthesis


    Session Chair(s):

    • John W. Seaman, PhD
      Professor of Statistics
      Baylor University, United States

    Speaker(s):

    • Meta-analysis in Safety Data
      FDA Speaker Invited
      United States
    • Bayesian Network Meta-analysis
      Bradley P. Carlin, PhD, MS
      Professor and Head of Biostatistics
      University of Minnesota, United States
    • Bayesian Methods for CV Outcomes Studies
      Amy Xia, PhD
      Executive Director, Biostatistics
      Amgen, Inc., United States
    • Q&A Panel Discussion
      Panel Discussion
      All Session Speakers, United States
  • 2:30PM - 3:00PM

    Refreshment Break
  • 3:00PM - 4:30PM

    Session 7: Closing Session – Moving Forward: Adaptive Design and Bayesian Statistics Drivers of Efficiency in Modern Medical Product Development


    Session Chair(s):

    • No-image Zoran Antonijevic, MSc
      Senior Director
      Cytel Consulting, United States
    • No-image Karen Lynn Price, PhD, MA
      Research Advisor
      Eli Lilly and Company, United States

    Speaker(s):

    • Panelists
      M. Scott Harris
      Principal
      Avaxia Biologics, United States
    • Donald A Berry, PhD, FACP
      Professor, Department of Biostatistics
      The University of Texas, United States
    • Robert Metcalf, PhD
      Vice President, Global Regulatory Affairs - US
      Eli Lilly and Company, United States
    • Panelist Invited
      FDA, United States

Exhibits  

The Joint Adaptive Design and Bayesian Statistics Conference offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates
February 11-12, 2015

Useful Links

Registration Fees 

Member

Member Government
$630.00
Member Academia
$785.00
Member Standard
$1420.00
Member Standard (As of 01/23/2015)
$1570.00

Non-Member

NonMember Government
$855.00
NonMember Academia
$1010.00
NonMember Standard
$1795.00
Group Discounts

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

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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