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DIA Meeting on Companion Diagnostics

Oct 30 2014 7:00AM - Oct 30 2014 5:00PM | Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA

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Overview 

Travel Once, Learn Twice and Save!
Save when you register for both the DIA Meeting on Companion Diagnostics
and the DIA Meeting on Combination Products
*You must register for both events at the same time.


Advances in scientific knowledge and technology are driving growth and innovation for companion diagnostics, thereby enabling personalized therapies that:

  • target those patients most likely to benefit from treatment;
  • exclude those patients most likely to suffer harm; and
  • can be monitored during treatment for clinically significant changes.

Drug and device pairings allow treatment decisions to be tailored for each patient. However, development of companion diagnostics and targeted drug therapy still face challenges in clinical development as regulatory policy tries to keep up with and accommodate this growing field. One of the primary goals of the FDA Safety and Innovation Act (FDASIA) involves the advancement and modernization of regulatory science. Such enhancements have had direct impact on both biopharmaceutical and in vitro diagnostic manufacturers.

This conference will provide a practical approach to the development processes and regulations in this evolving landscape. The day will focus on:

  • Innovative Clinical Trial Designs
  • Multimarker Diagnostics and Next Generation Sequencing 
  • New Developments from FDA


*ADDITIONAL SESSION JUST ADDED!

This evening session is included in the Combination Products and Companion Diagnostics program registrations. For additional information see Tutorial Agenda below.

October 29, 2014
5:30 to 7:00 PM
Washington Marriott Wardman Park

If you can’t attend the Combination Products or Companion Diagnostics meetings but want to hear the LDT discussion, register for this evening session for just $99! Register now!


DIA is hosting a related one-day meeting on Combination Products, October 29.

Who Should Attend 

Pharmaceutical, academic and government senior-level professionals and decision-makers involved in:

  • Drug Development and R&D
  • Pharmaceutical and Medical Device and Diagnostics Professionals
  • Regulatory, Clinical and Other Professionals Responsible for Developing Drug/Device Combinations and Companion Diagnostics
  • Regulatory Affairs Professionals

Learning Objectives 

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

  • Discuss the US regulatory framework for drug/diagnostic development and registration
  • Identify key challenges facing companion diagnostic manufacturers as well as potential  options to address these challenges
  • Discuss the current status and emerging issues in the EU

Special Offers 

Additional Session Added*

This evening session is included in the Combination Products and Companion Diagnostics program registrations. See below for more information!


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

Hotel & Travel 

Washington Marriott Wardman Park Hotel
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 13, 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 to make their hotel reservations, or by calling  +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 #14024.

Standard Room Rate $239 (single or double occupancy)
$259 (triple occupancy)
$279 (quad occupancy)

Hotel Address: 2660 Woodly Road NW, Washington D.C., 20008 

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Washington Dulles International Airport – IAD or Ronald Reagan Washington National Airport - DCA 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
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

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).

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 .7 CEUs for the 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: 4 Elective Units
• Regulatory Affairs Certificate Program: 4 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
DIA Meeting on Companion Diagnostics IACET 7.00 0.700

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, 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 Thursday, November 13, 2014.

Program Committee 

Previous Next

Agenda  

Tutorials Wednesday, Oct 29, 2014

  • 5:30PM - 7:00PM

    Competing Regulatory Oversight of Investigational Tests, including LDTs, for Co-Development Programs

    The recent FDA draft guidance, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), proposes a risk-based framework for FDA regulatory oversight of a subset of in vitro diagnostics (IVDs) referred to as laboratory-developed tests (LDTs).  FDA’s pre- and post-market requirements for IVDs would apply under certain circumstances to LDTs developed in laboratories, which are also regulated under the Clinical Laboratory Improvement Amendments (CLIA). 

    The importance of investigational tests, including LDTs, to diagnosis and treatment decisions is increasing, especially with the advancement of personalized medicine and companion diagnostics.  Stakeholders agree that the tests, regardless of their source, must be analytically and clinically valid as well safe for patients. 

    What impact will the FDA oversight have, and where are the overlaps and potential conflicts with CLIA regulation?  What is the most effective means of assuring clinical validity of LDTs?  Will approvals under the proposed framework be able to keep pace with technology based advances in testing?  How can patient safety be best balanced with innovation? 

    These and other questions will be discussed in depth from the perspectives of regulators, diagnostics developers, laboratories, and pharma sponsors.

    This evening session is included in the Combination Product and Companion Diagnostics program registrations.

    If you are not registered for the Combination Products and/or Companion Diagnostics programs, Register Now!

    If you can’t attend these two meetings but want to hear the LDT discussion, register for the evening session for just $99! Register now!

Day 1 Thursday, Oct 30, 2014

  • 7:30AM - 8:00AM

    Registration & Continental Breakfast
  • 8:00AM - 8:10AM

    Welcome and Opening Remarks
  • 8:10AM - 8:30AM

    Keynote Address

    Speaker(s):

    • Elizabeth A. Mansfield, PhD
      Director, Personalized Medicine Staff, CDRH
      FDA, United States
  • 8:30AM - 10:00AM

    Session 1: FDA Update


    Session Chair(s):

    • Jennifer Shen, PhD, RAC
      Scientific Reviewer, Office of In Vitro Diagnostics & Radiological Health, CDRH
      FDA, United States

    Speaker(s):

    • OIR Developments
      Eunice Lee, PhD
      Division of Molecular Genetics and Pathology, CDRH
      FDA, United States
    • Case Study
      Judith Finlayson, PhD
      Senior Manager, Regulatory Affairs
      Qiagen, United States
    • Jonathan Perkins, PhD
      Manager, Personalized Healthcare
      Qiagen, United States
    • Andreas Koehler, PhD
      Head, Pharmacogenomics
      Boehringer Ingelheim Pharma GmbH & Co. KG, United States
    • Panel Discussion: Joining Session Speakers
      Reena Philip, PhD
      Division Director, Division of Molecular Genetics and Pathology, CDRH
      FDA, United States
    • Gideon Blumenthal, MD
      Lead Medical Officer
      CDER/FDA, United States
  • 10:00AM - 10:30AM

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

    Session 2: Multimarker Diagnostics and Next-Generation Sequencing


    Session Chair(s):

    • Jennifer Dudinak, PharmD
      Vice President, Regulatory Affairs, Oncology
      Glaxosmithkline, United States

    Multiple marker diagnostics (multiplex) or next-generation sequencing (NGS) platforms offer the ability to test for a wide array of biomarkers and mutations at once. These platforms can be instrumental in fostering efficient healthcare utilization, maximizing sampling for tissue/specimen/biopsy and advancing innovations in molecularly-targeted therapeutic development and registration across a variety of therapy areas. There are several regulatory and development strategic considerations when employing a multiple marker diagnostic approach in a therapeutic development program. This session will explore challenges and opportunities of utilizing a multiple marker approach including test, bridging, analytical validation and labeling.

    Speaker(s):

    • FDA Update
      Jennifer Dickey, PhD
      Regulatory Reviewer, Office of In Vitro Diagnostics and Radiological Health
      CDRH, DFA, United States
    • NCI Match
      Gregory F. Heath, PhD
      Senior Vice President, IVD Development
      Illumina, Inc., United States
    • Presentation Title TBA
      William J. Pignato, MS
      Former Global Head of Regulatory Affairs, Companion Diagnostic - Novartis
      W.J. Pignato & Associates, LLC, United States
  • 12:00PM - 1:00PM

    Luncheon
  • 1:00PM - 3:00PM

    Session 3: Leveraging Advanced Companion Diagnostics in Innovative Clinical Trial Designs: New Frontiers and Lessons Learned


    Session Chair(s):

    • Eric Slosberg, PhD
      Senior Director, Translational Medicine US Clinical Development & Medical Affair
      Novartis Oncology, United States

    Over the last decade, there has been rapid expansion in the knowledge of molecular mechanisms that drive disease and the associated diagnostics and therapies that detect and target these disease drivers. Increasingly, diseases are being recognized as more heterogeneous entities, potentially dividing patients into ever-smaller subsets for individualized therapy. As our knowledge of disease mechanisms continues to evolve, personalized medicine will likely become even more complex, straining the traditional drug-diagnostic development paradigm associated with large, single-sponsor clinical studies. This session reflects on recent efforts to reshape clinical trials for precision therapies and their companion diagnostics, and envisions future activities that may propel the advancement of innovative breakthrough therapies to biomarker-defined patients with high unmet medical need.

    Speaker(s):

    • Clinical
      Patricia LoRusso, DO
      Associate Center Director - Innovative Medicine
      Smilow Cancer Center, Yale University, United States
    • Roman Yelensky, PhD
      Senior Director, Biomarker and Companion Diagnostic Development
      Foundation Medicine, Inc., United States
    • Stats
      Meijuan Li
      Lead Mathematical Statistican
      CDRH/FDA, United States
    • FDA CDER
      Christopher Leptak, MD, PhD
      OND Biomarker and Companion Diagnostic Lead, CDER
      FDA, United States
    • Europe
      Marisa Papaluca-Amati, MD
      Head of Scientific Support Office, Specialised Scientific Disciplines Department
      European Medicines Agency, European Union, United Kingdom
  • 3:00PM - 3:30PM

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

    Session 4: Global Perspective: EU, Consultant, Japan, RoW


    Session Chair(s):

    • Miu Chau, PhD
      Regulatory Program Director
      Genentech, A Member of the Roche Group, United States

    Currently companion diagnostics do not require pre-marker authorization by a regulatory authority in the EU. The manufacturers only need to perform conformity assessment on the in vitro diagnostics (IVDs), i.e., self-certification, for CE marking. In other countries, such as China and Japan, companion diagnostics registrations are independent of drug approval. However, with the increasing number of drugs requiring companion diagnostics to identify patients for treatment the global regulatory framework is gradually changing to keep up with the innovations. For example, the European Commission put forward a proposal for a regulation on in vitro diagnostic medical devices in 2012. This session will explore the potential impact of the changing global regulatory framework on different aspects of companion diagnostic development, e.g., analytical and clinical performance requirements, risk-based classification, regulatory approval/certification process, etc.
    • How the CPDx will be reviewed
    • Revised IVD directive
    • Chinese perspective

    Speaker(s):

    • Julie S. Engel, PhD, RAC
      Director, Companion Diagnostics Regulatory Affairs
      Ventana Medical Systems, United States
    • Rosanne Welcher, PhD, MBA, RAC
      Senior Director, Quality Assurance, Regulatory and Clinical Affairs
      Dako North America, an Agilent Technologies Company, United States

Registration Fees 

Member

Member Government
$435.00
Member Academia
$580.00
Member Standard
$965.00

Non-Member

NonMember Government
$660.00
NonMember Academia
$805.00
NonMember Standard
$1190.00
Registration Fees for Additional Offerings
Laboratory-developed Tests (LDTs) - Complimentary with Meeting Registration Rate
$0.00
Laboratory-developed Tests (LDTs) - Purchase without Meeting Registration Rate
$99.00
Registration Information

Travel Once, Learn Twice Discount Information

Pricing for both the DIA Meeting on Combination Products and the DIA Meeting on Companion Diagnostics:
Early Bird Industry Member: $1136
Industry Member: $1256
Industry Non-Member: $1436

Non Profit/Academic Member: $785
Non Profit Academic Non-Member: $1010

Government Member: $630
Government Non-Member: $855

See how that compares to purchasing both meetings separately:
Industry Member: $1930
Industry Non-Member: $2380

Non Profit/Academic Member: $1160
Non Profit Academic Non-Member: $1610

Government Member: $870
Government Non-Member: $1320

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.

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.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.

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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