Current Region: North America
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Nov 6 2013 7:30AM - Nov 6 2013 5:30PM | Embassy Suites Old Town Alexandria
1900 Diagonal Road,
Alexandria, VA 22314
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:
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:
Pharmaceutical, academic and government senior-level professionals and decision-makers involved in:
At the conclusion of this meeting, participants should be able to:
Travel Once, Learn Twice and Save up to 35%
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 $189Rate includeds the following for all rooms booked using link or phone number noted above:
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.
Registration QuestionsToll Free 1.888.257.6457Phone +1.215.6100Fax +1.215.442.6199Monday-Friday 8:30AM - 8:00PM ETCustomerService@diahome.org
Agenda DetailsMelissa Buchanan, Content LeadPhone +1.215.442.6158Fax +1.215.442.6199Melissa.Buchanan@diahome.org
Event LogisticsBenjamin Zaitz, Event PlannerPhone +1.215.293.5803Fax +1.215.442.6199Benjamin.Zaitz@diahome.org
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
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.
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
Worldwide Vice President of Quality, Regulatory and ComplianceOrtho Clinical Diagnostic - Part of the Johnson & Johnson Family of Companies, United States
Director/Corporate Regulatory/Women's Health and CancerBecton Dickinson, United States
Vice President, Regulatory Affairs, OncologyGlaxosmithkline, United States
Senior Director, Regulatory AffairsGenentech, A Member of the Roche Group, United States
Director, Regulatory AffairsNovartis Pharmaceuticals Corporation, United States
PartnerEpstein, Becker and Green P.C., United States
Associate Director for Policy and Product Classification Officer, OCPFDA, 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.
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.
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.
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.
Printable Registration Form
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.
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:
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.