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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 5:00PM | Double Tree by Hilton Washington DC - Crystal City 300 Army Navy Drive Arlington, VA 22202

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Overview 

Tutorials:  February 10, 2015
Main Meeting:  February 11-12, 2015

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February 2015 marks the 5th anniversary of the publication of the FDA’s draft guidance on adaptive clinical trials and the final guidance of the use of Bayesian statistics in medical device clinical trials.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

Program Committee 

Previous Next

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
  • 8:30AM - 9:30AM

    Keynote Address
  • 9:30AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Session 1: 5th Anniversary of the Draft Guidance for Adaptive Design
  • 12:00PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 2: 5th Anniversary of the Guidance for Bayesian Statistics
  • 3:00PM - 3:30PM

    Refreshment Break
  • 3:30PM - 5:00PM

    Session 3: Bayesian and Adaptive Design Approaches in Special Populations
  • 5:00PM - 6:00PM

    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
  • 8:10AM - 9:40AM

    Session 4: Master Protocol
  • 9:40AM - 10:00AM

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

    Concurrent Breakout Session 1A: Adaptive Design Case Studies
  • 10:00AM - 11:30AM

    Concurrent Breakout Session 1B: Bayesian Methods for a Better Decision Making Process
  • 11:30AM - 1:00PM

    Lunch
  • 1:00PM - 2:30PM

    Concurrent Breakout Session 2A: Optimization of R&D Programs and Portfolios
  • 1:00PM - 2:30PM

    Concurrent Breakout Session 2B: Bayesian Evidence Synthesis
  • 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

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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