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DIA Meeting on Personalized Medicines and Companion Diagnostics

Nov 6 2013 7:30AM - Nov 6 2013 5:30PM | Embassy Suites Old Town Alexandria 1900 Diagonal Road, Alexandria, VA 22314 USA

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Travel Once, Learn Twice and Save up to 35%
Register for both the DIA Meeting on Personalized Medicines and Companion Diagnostics and the  DIA Meeting on Combination Products – and Save up to 35%*
*You must register for both events at the same time. 
Price savings varies by registration fees

Advances in scientific knowledge and technology are driving growth and innovation for combination products and 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.

This conference will provide a practical approach to development processes and regulations in these evolving landscapes. This one-day meeting will focus on personalized medicines and their companion diagnostics. DIA is hosting a related one-day meeting on combination products, November 5: DIA Meeting on Combination Products

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 day will focus on:

  • Innovative Clinical Trial Designs for Drug-Diagnostic Co-registration
  • Multimarker Diagnostics and Development Complexities
  • New Developments in CDER/CDRH Working Framework 
  • Emerging Guidances for Companion Diagnostics and Co-development

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 

Travel Once, Learn Twice and Save up to 35%

Hotel & Travel 

The meeting will be held at the Embassy Suites Alexandria Old Town.
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 15, 2013, or until room block is filled).  Please note: In order to receive the reduce 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 #13025.

Standard Room Rate $189
Rate includeds the following for all rooms booked using link or phone number noted above:

  • Complimentary meeting room wireless
  • Complimentary sleeping room wireless
  • Complimentary full hot breakfast
  • Complimentary evening reception

Hotel Address: 1900 Diagonal Road Alexandria, VA 22314

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 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET

Agenda Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199

Event Logistics
Benjamin Zaitz, Event Planner
Phone +
Fax +1.215.442.6199

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; (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 .7 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: 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 Personalized Medicines and Companio 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:

All participants must sign-in to record attendance at the program to receive a statement of credit. If attendance is not recorded, a participant will not be eligible to receive credit. No partial credit will be awarded. To request credit, complete the on-line credit request process through My Transcript at www.diahome.org. 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, November 20, 2013.

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

Program Committee 

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Day 1 Wednesday, November 06, 2013

  • 7:30AM - 8:30AM

    Registration and Continental Breakfast
  • 8:30AM - 8:40AM

    Welcome and Opening Remarks


    • Jennifer Paine, MS,RAC
      Worldwide Vice President of Quality, Regulatory and Compliance
      Ortho Clinical Diagnostic - Part of the Johnson & Johnson Family of Companies, United States
  • 8:40AM - 9:00AM

    Keynote Address


    • Keynote Address
      Reena Philip, PhD
      Deputy Division Director, DIHD/OIR/CDRH
      FDA, United States
  • 9:00AM - 11:00AM

    Innovative Clinical Trial Designs for Diagnostic Co-registration

    Session Chair(s):

    • Jeffrey N. Stuart, PhD,RAC
      Director, Regulatory Affairs
      Novartis Pharmaceuticals Corporation, United States

    The registration study for a personalized biopharmaceutical therapy also serves as the registration study for the accompanying companion diagnostic, and it is often conducted in a small, molecularly-defined rare disease population. The frequent lack of available alternative treatment options in rare diseases makes it important for industry and FDA to reach a mutual understanding on the standards and evidentiary expectations needed for co-registration of novel personalized therapies in the rare disease setting with their companion diagnostics, so that safe and effective treatment options can be made available to patients as quickly as possible. In this session, a panel of experts from industry and government will discuss the latest innovations in registration study design for biomarker-defined rare diseases.


    • Speakers
      Anne R. Pariser, MD
      Associate Director for Rare Diseases, CDER
      FDA, United States
    • Speakers
      Michael Pacanowski, PharmD,MPH
      Assoc. Dir. for Genomics & Target Therapy, Office of Clinical Pharmacology, CDER
      FDA, United States
    • Speakers
      Axel Hoos, MD,PhD
      Vice President, Oncology R&D
      GlaxoSmithKline, United States
    • Speakers
      Boris Freidlin, PhD
      Mathematical Statistician, Biometric Research Branch, DCTD
      National Cancer Institute (NCI), United States
    • Speakers
      Sue-Jane Wang, PhD,MA,MS
      Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER
      FDA, United States
  • 11:00AM - 11:30AM

    Refreshment Break
  • 11:30AM - 1:30PM

    Multimarker Diagnostics and Development Complexities

    Session Chair(s):

    • Jennifer Dudinak
      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.


    • Speakers
      Anne-Marie Martin
      Head, Precision Medicine & Diagnostics; Head, Molecular Medicine, Oncology R&D
      GlaxoSmithKline, United States
    • Speakers
      William Pignato, MS
      Global Head of Regulatory Affairs, Companion Diagnostics
      Novartis, United States
    • Speakers
      Eunice Lee, PhD
      Division of Immunology & Hematology Devices, CDHR
      FDA, United States
    • Panel Discussion - Additional Speaker
      Reena Philip, PhD
      Deputy Division Director, DIHD/OIR/CDRH
      FDA, United States
  • 1:30PM - 2:30PM

  • 2:30PM - 4:00PM

    New Developments in CDER/CDRH Working Framework

    Session Chair(s):

    • Azin Shahzamani
      Senior Director, Regulatory Affairs
      Genentech, A Member of the Roche Group, United States

    Over the last year, with the introduction of the breakthrough development path, the need for coordinated administrative processes and management commitment for development of co-diagnostics at FDA and in industry has been highlighted. In this session the panelists will provide their perspectives and experiences on CDER/CDRH working framework.


    • Speakers
      Jeff Allen, PhD
      Executive Director
      Friends of Cancer Research, United States
    • Speakers
      Pamela Bradley
      Staff Fellow, Office of In Vitro Diagnostics & Radiological Health, CDRH
      FDA, United States
    • Speakers
      Christopher Leptak
      Medical Officer, Office of New Drugs, CDER
      FDA, United States
    • Speakers
      Mya Thomae, RAC
      Founder and Chief Executive Officer
      Myraqa, United States
  • 4:00PM - 4:30PM

    Refreshment Break
  • 4:30PM - 5:30PM

    Emerging Guidances for Companion Diagnostics and Co-development

    Session Chair(s):

    • Jeffrey N. Stuart, PhD,RAC
      Director, Regulatory Affairs
      Novartis Pharmaceuticals Corporation, United States

    Technologies supporting breakthrough therapies and their companion diagnostics are rapidly evolving, and global regulation is attempting to keep pace with fast-moving innovation in this field. This session will forecast how emerging global health authority regulations and guidance may evolve and what companies should be considering to prepare.


    • Speakers
      Mya Thomae, RAC
      Founder and Chief Executive Officer
      Myraqa, United States
    • Speakers
      Erik Vollebregt, LLM
      AXON Lawyers, Netherlands
  • 5:30PM - 5:30PM

    Closing Remarks

Registration Fees 


Member Government
Member Academia
Member Standard


NonMember Government
NonMember Academia
NonMember Standard
Group Discounts

Printable Registration Form

Group Discount

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.

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. 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.

Register Online

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.

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