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DIA Biosimilars 2014

Sep 18 2014 7:00AM - Sep 19 2014 5:00PM | Washington Marriott Metro Center 775 12th Street, NW, Washington, DC 20005 USA

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Overview 

With the expiration of numerous patents for originator biologicals and the development of follow-on products, the market for biosimilars is growing at a rapid pace. These biosimilars and follow-on biologics have garnered great interest for their cost-effective benefits in patient care as well as development opportunities for sponsors who see a new revenue stream.

As biosimilars become more available to patients, there are important factors for patients and health care providers that must be addressed. This meeting will focus on the innovations, technologies, and regulatory information surrounding biosimilars.

This two-day interactive meeting will include topics on:

  • US Regulatory Developments
  • Scientific Advances: The Concept of Biosimilarity
  • Global Regulatory Landscape
  • Interchangeability
  • Labeling
  • Naming 
  • Extrapolation
  • Life-cycle Management
  • US State Laws on Biosimilar Substitution
  • And More

Who Should Attend 

  • Pharmaceutical Executives
  • Biomedical Product Developers
  • Regulatory Affairs Professionals
  • Clinical and Nonclinical Researchers
  • Biostatisticians and Data Managers

Learning Objectives 

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

  • Identify the unique challenges and complexities associated with demonstrating biosimilarity to a reference product
  • Examine the implications for patients and healthcare professionals as biosimilars and (potentially) interchangeable biologics are introduced into the market

Special Offers 

EARLY BIRD RATE!
DIA Industry Members who register by
August 28, 2014, save $150!


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

Hotel & Travel 

Washington Marriott at Metro Center
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until August 26, 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 #14012.

Standard Room Rate: $259 for single or double occupancy room

Hotel Address: 775 12th St NW, Washington, DC 20005

 

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
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
Fax: +1.215.442.6199
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
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Tabletop Exhibit Information
Jeff Korn, Exhibits Associate
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@diahome.org

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program and applicable tutorial are designated for up to 6.5 contact hours or .65 continuing education units (CEU’s).

Type of Activity: Knowledge

ACPE Credit Request Update
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

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 1.3 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: 8 Elective Units
• Regulatory Affairs Certificate Program: 8 Elective Units

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

Name Credit Type Max Credits CEU
DIA Biosimilars 2014 ACPE 6.50 0.650
DIA Biosimilars 2014 IACET 13.25 1.300

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 each day of the program, and complete the on-line credit request process through My Transcript. 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 Friday, October 3, 2014.

CONTINUING EDUCATION CREDIT ALLOCATION

Meeting:
IACET: 1.3 CEUs
Pharmacy:
• Session 1 - Scientific Advances: The Concept of Biosimilarity: 1.5 contact hours or .15 CEUs, 0286-0000-14-078-L04-P
• Session 2 - Policy Considerations: 2 contact hours or .2 CEUs, 0286-0000-14-079-L04-P
• Session 3 - Naming, Labeling and Postmarketing Activities: 2 contact hours or .2 CEUs, 0286-0000-14-080-L04-P
• Session 7 - Regulatory Update: 1 contact hour or .1 CEU, 0286-0000-14-081-L04-P

Program Committee 

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Agenda  

Day 1 Thursday, Sep 18, 2014

  • 7:45AM - 8:45AM

    Registration and Continental Breakfast
  • 8:45AM - 9:00AM

    Welcome & Opening Remarks

    Speaker(s):

    • Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom
    • Joerg Windisch, PhD
      Chief Science Officer
      Sandoz Biopharmaceuticals, Austria
  • 9:00AM - 10:00AM

    Keynote Session

    Speaker(s):

    • Keynote Speaker Invited
      United States
  • 10:00AM - 10:30AM

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

    Session 1 - Scientific Advances: The Concept of Biosimilarity


    Session Chair(s):

    • Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom

    Speaker(s):

    • Value of Physiochemical and Biological Data in Demonstrating Biosimilarity
      Speaker Invited
      United States
    • Quantitative Approach to Quality and Biological Data
      Speaker Invited
      United States
    • Value of Nonclinical and Clinical Data in Supporting Biosimilarity & Extrapolation
      Joerg Windisch, PhD
      Chief Science Officer
      Sandoz Biopharmaceuticals, Austria
    • Panel Discussion
      All Session Speakers, United States
  • 12:00PM - 1:00PM

    Luncheon
  • 1:00PM - 3:00PM

    Session 2 - Policy Considerations


    Session Chair(s):

    • David Gaugh, RPh
      Senior Vice President for Sciences and Regulatory Affairs
      Generic Pharmaceutical Association (GPhA), United States

    Speaker(s):

    • FDA Perspective
      FDA Speaker Invited
      United States
    • Will State Law Substitution Statues and Unique Naming Restrict Biologic Innovation?
      Bruce Leicher, JD
      Momenta Pharmaceuticals, Inc., United States
    • Ed Clere
      Representative, Indiana House Republicans
      State of Indiana House of Representatives, United States
    • Pharmocovigilance
      Thomas Felix, MD
      Director, Research and Development Policy
      Amgen Inc., United States
    • Panel Discussion: Joining the Session Speakers
      Gerald McEvoy, PharmD
      Assistant Vice President of Drug Information
      American Society of Health-System Pharmacists, United States
  • 3:00PM - 3:30PM

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

    Session 3 - Naming, Labeling and Postmarketing Activities


    Session Chair(s):

    • Sundar Ramanan, PhD
      Director, Global Biosimilars R&D Policy
      Amgen Inc., United States

    Speaker(s):

    • Naming: A Global Perspective
      Juergen Schmider
      VP Global Pharmacovigilance and Product Safety
      Hospira Inc., United States
    • Naming: A Global Perspective
      Geoff Eich
      Executive Director, Regulatory Affairs - R&D Policy
      Amgen, United States
    • Labeling Product Information
      Erika F. Lietzan, JD, MA
      Associate Professor of Law
      University of Missouri, United States
    • Pharmacy Practice
      Gerald McEvoy, PharmD
      Assistant Vice President of Drug Information
      American Society of Health-System Pharmacists, United States
    • Pharmacovigilance and Risk Management
      John D Ayres, JD, MD
      Senior Director, Product Safety Assessments, Global Patient Safety
      Eli Lilly & Company Ltd., United States
    • Panel Discussion
      All Session Speakers, United States
  • 5:30PM - 6:30PM

    Networking Reception

Day 2 Friday, Sep 19, 2014

  • 7:30AM - 8:30AM

    Registration and Continental Breakfast
  • 8:30AM - 10:00AM

    Session 4 - Global Regulatory Landscape


    Session Chair(s):

    • Jian Wang, MD, PhD
      Chief, Clinical Evaluation Division - Haematology/Oncology
      Health Canada, Canada

    Speaker(s):

    • Europe
      Speaker Invited
      United States
    • Canada
      Cathy A. Parker
      Senior Executive Director, Biologics & Genetic Therapies Directorate HPFB
      Health Canada, Canada
    • Korea (Virtual Presentation)
      Jeewon Joung, PhD
      Deputy Director
      Korean Ministry of Food and Drug Safety (MFDS) , Korea, Republic of
    • Panel Discussion: Joining the Session Speakers
      Leah Christl, PhD
      Associate Director for Therapeutic Biologics, OMBT, OND, CDER
      FDA, United States
  • 10:00AM - 10:30AM

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

    Session 5 - Clinical Perspectives


    Session Chair(s):

    • Stan Bukofzer
      Corporate Vice President and Chief Medical Officer
      Hospira, Inc., United States

    Speaker(s):

    • Constructs of Biosimilar Approval
      Rachel Sherman, MD, MPH
      Greenleaf Health, United States
    • FDA Draft Guidance Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
      Darrell Abernethy, MD, PhD
      Associate Director for Drug Safety Office of Clinical Pharmacology
      FDA, United States
    • Interchangeability
      Mark McCamish, MD, PhD
      Head of Global Development
      Sandoz Biopharmaceuticals, a Novartis Company, Germany
    • Extrapolation
      Sumant Ramachandra, MD, PhD
      Sr Vice President, R&D and Medical Affairs, Chief Scientific Officer
      Hospira, Inc., United States
    • Panel Discussion
      All Session Speakers, United States
  • 12:30PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Session 6 - Commercialization


    Session Chair(s):

    • Steve Miller, MD
      Senior Vice President & Chief Medical Officer
      Express Scripts, United States

    Speaker(s):

    • Cost of Investing in Biosimilar Development
      Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom
    • Sustainability Studies
      Steve Miller, MD
      Senior Vice President & Chief Medical Officer
      Express Scripts, United States
    • The Role of Biosimilars in Patient Care: The Medicare and Medicaid Perspective
      Speaker Invited
      United States
    • Panel Discussion
      All Session Speakers, United States
  • 3:00PM - 3:30PM

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

    Session 7 - Regulatory Update


    Session Chair(s):

    • Joerg Windisch, PhD
      Chief Science Officer
      Sandoz Biopharmaceuticals, Austria

    Session 7 - Regulatory Update

    Speaker(s):

    • Panel Discussion
      Leah Christl, PhD
      Associate Director for Therapeutic Biologics, OMBT, OND, CDER
      FDA, United States
    • Darrell Abernethy, MD, PhD
      Associate Director for Drug Safety Office of Clinical Pharmacology
      FDA, United States
    • Cathy A. Parker
      Senior Executive Director, Biologics & Genetic Therapies Directorate HPFB
      Health Canada, Canada
    • Jian Wang, MD, PhD
      Chief, Clinical Evaluation Division - Haematology/Oncology
      Health Canada, Canada

Exhibits  

The Biosimilars meeting offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates: September 18-19, 2014

Useful Links:

Registration Fees 

Member

Member Government
$630.00
Member Academia
$785.00
Member Standard
$1420.00
Member Standard (As of 08/29/2014)
$1570.00

Non-Member

NonMember Government
$855.00
NonMember Academia
$1010.00
NonMember Standard
$1795.00
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

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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