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DIA Meeting on Combination Products

Oct 29 2014 8:00AM - Oct 29 2014 7:00PM | Washington Marriott Wardman Park 2660 Woodley Road, NW, Washington, DC 20008 USA

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Overview 

Tutorial:  October 28th - Combination Products: A Comprehensive Overview of Premarket Opportunities and Postmarket Challenges!
Meeting:  October 29th


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


Advances in scientific knowledge and technology are driving growth and innovation for combination products. Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

Because combination products involve components that would normally be regulated under different types of regulatory pathways, and frequently by different FDA Centers, they may raise challenging policy, regulatory, and review management issues. Differences in pathways ordinarily associated with each component can raise questions for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.

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

  • Innovations
  • Classification and Development Challenges
  • Pre- and Postmarket Issues
  • Regulatory Developments   


*LATE BREAKING SESSION JUST ADDED!

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

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!


LATE BREAKING SESSION: The recent FDA draft guidance, Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), proposes a risk-based framework for FDA regulatory oversight of a subset of in vitro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.


DIA is hosting a related one-day meeting on Companion Diagnostics on October 30th.

Who Should Attend 

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

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

Learning Objectives 

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

  • Discuss the US regulatory framework for drug/device combination products
  • Identify key challenges facing combination product developers as well as potential  options to address these challenges
  • Discuss the current status and emerging issues in the EU

Special Offers 

Late Breaking 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 #14016.

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 

DIA has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer 1.4 CEUs for the program (.7 CEUs for the tutorial, if applicable and .7 CEUs for the meeting). 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 Combination Products IACET 7.00 0.700
Combination Products: A Comprehensive Overview 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 Wednesday, November 12, 2014.

To view DIA’s grievance policy, please visit the CE page on the DIA website at www.DIAHome.org/CE

Program Committee 

Previous Next

Agenda  

Tutorials Tuesday, Oct 28, 2014

  • 8:30AM - 4:30PM

    Combination Products: A Comprehensive Overview of Premarket Opportunities and Postmarket Challenges!

    An estimated 30% of all new health care products under development today are combination products and the global drug-device combination products market is expected to grow to $115B by 2019. In order to tackle the clinical problems of the future, combination products will be used to treat a wide range of diseases from heart attack and stroke to Alzheimer’s, cancer, diabetes and beyond! In fact, every area of medicine will benefit because we can potentially erase the damage of disease or injury, not just stop it.

    This tutorial will highlight the regulatory strategies needed to get products to market.  This tutorial will also look at change management concerns including design changes, documentation and reporting. A case study of a fictitious product will also be utilized for practical application of all these elements.

Day 1 Wednesday, Oct 29, 2014

  • 7:30AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 8:15AM

    Welcome and Opening Remarks
  • 8:15AM - 9:00AM

    Combination Products State of the Union

    Speaker(s):

    • Trends and New Developments
      Thinh X. Nguyen
      Director, Office of Combination Products
      FDA, United States
    • Combination Products Regulation in Brief and its Theory
      John (Barr) Weiner, JD
      Associate Director for Policy and Product Classification Officer, OCP
      FDA, United States
  • 9:00AM - 10:30AM

    Session 1: Premarket Considerations


    Session Chair(s):

    • Valerie Fenster
      Senior Manager, Human Factors Engineering, Device Technologies
      Amgen Inc., United States

    Speaker(s):

    • Human Factors: A Case Study Driven Discussion of What Human Factors Studies Are, When They Are Needed, and How to Conduct Them Successfully for Combination Products
      Kathleen E. O'Sullivan, MS, RAC
      Associate Director, Regulatory Affairs
      BD Medical - Pharmaceutical Systems, United States
    • Raza Ahmed, MD
      Worldwide Director, Medical Affairs, Self Administration Injection Systems
      BD Medical- Pharmaceutical Systems, United States
    • Redefining Focus: Lessons Learned in Transitioning from a Biologics to a Combination Products Company
      Dave Anderson
      Associate Director Quality for Combination Products
      AstraZeneca Biologics (MedImmune), United States
    • Lessons Learned: Tips for Sponsors to Navigate the Premarket Authorization for Combination Products
      Patricia Y. Love, MD, MBA
      Deputy Director, Office of Combination Products, OC
      FDA, United States
  • 10:30AM - 11:00AM

    Refreshment Break
  • 11:00AM - 12:30PM

    Session 2: Postmarket Considerations


    Session Chair(s):

    • Steven B. Binion, PhD, MBA
      Director, Corporate Regulatory
      Becton Dickinson, United States

    The intent of FDA’s Final rule on Current Good Manufacturing Practices (CGMP) requirements for combination products was to help ensure that CGMP requirements that apply to single-entity and co-packaged combination products are clear and consistent, regardless of which Agency component has lead jurisdiction for the combination product, or which type of application is submitted for marketing authorization. The final rule also provides an approach that combination product manufacturers can take to streamline demonstrating compliance with CGMP requirements for these types of combination products. In this session, FDA representatives from OCP, CDER, CBER, CDRH, and ORA will share an update based on their experiences in working with combination product manufacturers on CGMP issues and answer questions from the audience in an interactive panel format.

    Speaker(s):

    • Current Good Manufacturing Practices for Combination Products: Final Rule in Brief
      John (Barr) Weiner, JD
      Associate Director for Policy and Product Classification Officer, OCP
      FDA, United States
    • Steven Hertz, MBA, MS
      Consumer Safety Officer, OMPQ, OC, CDER
      FDA, United States
    • Melissa Torres
      Acting Deputy Director, Division of Cardiovascular Devices, ODE, CDRH
      FDA, United States
    • Melissa B. Burns
      Senior Program Manager, ODE, CDRH
      FDA, United States
    • M. Isabel Tejero del Rio, MD, PhD
      Quality Systems Working Group Lead, DMQ, OC, CDRH
      FDA, United States
    • Additional FDA Speakers Invited
      United States
  • 12:30PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Session 3: Collaboration in the Industry


    Session Chair(s):

    • James A. Boiani, JD, MS
      Senior Counsel
      Epstein Becker Green, United States

    Speaker(s):

    • Development Plans: Who does What
      Kirsten H. Paulson, MS, RAC
      Senior Director, Global CMC-Medical Devices
      Pfizer Inc, United States
    • Important Considerations in Partnering
      David E. Paul, JD
      Principal Consultant - Regulatory, US Regulatory Policy & Strategy
      Eli Lilly and Company, United States
    • Panel Discussion: Joining the Session Speakers
      Aaron Kemp
      Senior R&D Manager
      BD Medical, Pharmaceutical Systems, United States
  • 3:00PM - 3:30PM

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

    Session 4: Developing Products for Global Distribution


    Session Chair(s):

    • Dave Anderson
      Associate Director Quality for Combination Products
      AstraZeneca Biologics (MedImmune), United States

    In this session, speakers will delve into topics that detail how to develop products for global distribution, including:
    • European regulation of combination products: the regulatory approach, updates, and challenges
    • Preparing for a multi-jurisdictional launch: Getting to market around the world, an industry perspective
    • Panel discussion on priorities, challenges and goals from a regulatory and industry perspective

    Speaker(s):

    • Europe: Drug-Device Combinations Device components of medicines
      Elizabeth Baker
      Group Manager Licensing Division
      Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    • Challenges of Global Combination Product Registrations
      Mayank Choudhary
      Senior Regulatory Affairs Specialist, Regulatory Affairs
      BD Medical - Pharmaceutical Systems, United States
    • Device/Drug Combination Products
      Paul C Brooks
      Senior Vice President
      Healthcare Solutions, United States
  • 5:00PM - 5:30PM

    Light Reception
  • 5:30PM - 7:00PM

    Complimentary Tutorial Panel Discussion: FDA and CMS Oversight of Companion Diagnostic LDTs

    Speaker(s):

    • Moderator
      James A. Boiani, JD, MS
      Senior Counsel
      Epstein Becker Green, United States
    • Panelists
      Andrew Fish, JD
      Executive Director
      AdvamedDX, United States
    • Christine Gathers, MS, RAC
      Senior Director, Global Regulatory Affairs, Diagnostics
      Eli Lilly and Company, United States
    • Elizabeth A. Mansfield, PhD
      Director, Personalized Medicine Staff, CDRH
      FDA, United States
    • Gary Paul
      Director Quality Assurance
      Covance Central Laboratory Services, Inc., 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
Combination Products: A Comprehensive Overview - Standard Rate
$755.00
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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