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DIA Biosimilars 2013

Nov 13 2013 7:15AM - Nov 14 2013 4:30PM | Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Avenue Bethesda, MD 20814-5326

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Overview 

With the expiration of numerous patents for originator biologicals over the next decade, the market for biosimilars continues to grow with rapid force. In fact, the global biosimilars market is expected to double by 2017. To help support this growing sector, this meeting will focus on the challenges, innovations and technologies surrounding biosimilars.

This two-day meeting will provide an interactive format to discuss biosimilarity. Day one will focus on the US & EU Regulatory Landscape. Topics will include:

  • Harmonization
  • EU guidance on monoclonal antibodies
  • Bridging
  • Immunogenicity
  • Interchangeability
  • Endpoints
  • Extrapolation
  • Quality & Nonclinical
  • Models for Demonstrating Therapeutic Equivalence
  • Level of Physical, Chemical and Biological Similarity

Day two will focus on the Rest of the World, Commercialization and Emerging Markets:

  • Commercialization, Naming, Labeling
  • Interchangeability

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:

  • Discuss the importance of a regulatory pathway for biosimilars that is distinct from the traditional generic approach
  • Identify the unique challenges and complexities associated with demonstrating biosimilarity to a reference product
  • Examine the implications for patients and doctors as biosimilars and (potentially) interchangeable biologics are introduced into the market

Special Offers 

GROUP DISCOUNT AVAILABLE!
BUY 3 AND GET 1 FREE!

Hotel & Travel 

Hyatt Regency, Bethesda, MD
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until October 22, 2013, or until room block is filled). Please Note: In order to receive the reduced room rate, hotel reservations must be made as noted above and not directly with the hotel.  Attendees can follow this link to make their hotel reservations, or by calling +1.212.532.1660 or in the USA at 1.800.221.3531 for reservations. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event# 13012.

Standard Room Rate $209

Hotel Address: One Bethesda Metro Center,  Bethesda, MD 20814

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
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda and Event Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1 215.442.6199
Melissa.Buchanan@diahome.org

Event Logistics
JoAnn Boileau, Event Planner
Phone +1.215.442.6175
Fax +1.215.442.6199
JoAnn.Boileau@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 is designated for up to 13.75 contact hours or 1.375 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 http://www.nabp.net/.

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 1.4 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

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

Name Credit Type Max Credits CEU
DIA Biosimilars 2013 ACPE 13.75 1.375
DIA Biosimilars 2013 IACET 13.75 1.400

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 Wednesday, November 27, 2013.

PHARMACY CREDIT ALLOCATION
• Day 1: Welcome, Keynote, Sessions 1, 2 & 3, Part I: 4.75 contact hours or .475 CEUs; 0286-0000-13-081-L04-P
• Day 1: Sessions 3, Part II & 4: 3 contact hours or .3 CEUs; 0286-0000-13-082-L04-P
• Day 2: Sessions 5 & 6: 3 contact hours or .3 CEUs; 0286-0000-13-083-L04-P
• Day 2: Sessions 7, 8 & Closing Remarks: 3 contact hours or .3 CEUs; 0286-0000-13-084-L04-P

Program Committee 

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Agenda  

Day 1 Wednesday, November 13, 2013

  • 7:15AM - 7:55AM

    Registration and Continental Breakfast
  • 7:55AM - 8:00AM

    Welcome and Opening Remarks

    Speaker(s):

    • Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom
  • 8:00AM - 8:45AM

    Keynote Session

    Speaker(s):

    • Key Challenges Companies are Facing in the Development of Biosimilars
      Leah Christl, PhD
      Associate Director for Therapeutic Biologics, OMBT, OND, CDER
      FDA, United States
  • 8:45AM - 10:45AM

    Quality Considerations for Biosimilarity


    Session Chair(s):

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

    Quality (chemistry, manufacturing and controls) plays a larger role in biosimilar development than traditional biologic medicine development. The challenges as well as opportunities are many. This session will cover diverse topics including analytical (physiochemical and functional) considerations, drug product development utilizing QbD and post-approval considerations. In addition, keeping with long-standing successful DIA tradition of bringing diverse perspectives these topics will be presented by various biosimilar developers. Attendees will be able to gain insights into various biosimilar development strategies, interact with peers from regulatory agencies and industry in sessions enabling cross-functional discussions.

    Speaker(s):

    • Post Approval Regulatory Considerations for Biosimilars
      Gustavo Grampp
      Amgen Inc., United States
    • Level of Physicochemical and Biological Similarity
      Emily Shacter
      Independent Consultant
      ThinkFDA, LLC, United States
    • Role of Functional Assays in the Assessment of Similarity
      Cornelius Fritsch, PhD
      Fellow, External Bioassay Support
      Novartis Pharma AG, Switzerland
    • Drug Product Development of Biosimilars: Quality by Design Considerations and Strategies
      Krishnan Sampath, PhD
      Associate Director, Formulation and DP Process Development, Global Biologics R&D
      Hospira Inc., United States
    • Practical Considerations for Biosimilarity Development
      Jim Anderson, PhD
      Vice President, Analytical Development
      Momenta Pharmaceuticals, United States
    • Panel Discussion
      All Session Speakers, United States
  • 10:45AM - 11:15AM

    Demonstration of Biosimilarity: Nonclinical Considerations and Challenges


    Session Chair(s):

    • Mary Ellen Cosenza, PhD,MS,RAC
      Executive Director, US Regulatory Affairs
      Amgen Inc., United States

    The nonclinical studies consist of pharmacology, pharmacokinetics and/or toxicology studies, and while the nonclinical studies are an important component of the biosimilarity exercise, the regulatory authorities generally recommend an abbreviated approach (vs. the traditional nonclinical package) be applied in demonstrating a proposed biosimilar is similar to the reference product. Certain challenges must be addressed when conducting comparative nonclinical studies, including selection of relevant in vitro and/or in vivo models and the development of the analytical assays. This presentation will review the various points that should be considered in designing a nonclinical package as part of the biosimilarity exercise, as well as provide an overview of the challenges that often arise when performing these nonclinical studies.

    Speaker(s):

    • Speaker
      Barbara Mounho-Zamora, PhD
      Biopharmaceuticals/Pharmaceuticals Practice Leader
      ToxStrategies, United States
  • 11:15AM - 11:30AM

    Refreshment Break
  • 11:30AM - 1:00PM

    Clinical - Part I


    Session Chair(s):

    • Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom
    • Jian Wang, MD
      Chief, Pre-market Clinical Evaluation Division - Haematology/Oncology
      Health Canada, Canada

    This session will cover the challenging clinical safety, efficacy and practice issues faced by manufacturers, regulators and healthcare professionals in developing, authorizing and prescribing biosimilars.

    Speaker(s):

    • PKPD
      Klaus Francke, MD,PhD
      Medical Affairs Consultant
      PAREXEL International, Germany
    • Demonstrating Equivalent Efficacy
      Kerry B Barker, PhD
      Senior Director Leadership, Bio-Therapeutics Research
      Pfizer Inc, United States
    • Clinical Data Extrapolation
      Carlos Sattler, MD
      VP, US Clinical Development and Medical Affairs
      Sandoz Inc. (a Novartis Company), United States
  • 1:00PM - 2:00PM

    Luncheon
  • 2:00PM - 3:30PM

    Clinical - Part II


    Session Chair(s):

    • Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom
    • Jian Wang, MD
      Chief, Pre-market Clinical Evaluation Division - Haematology/Oncology
      Health Canada, Canada

    Clinical - Part II

    Speaker(s):

    • Immunogenicity
      Meena Subramanyam
      Vice President, Development Translational Medicine
      Biogen Idec Inc., United States
    • Interchangeability
      Jaap Venema, PhD,PMP
      Therapeutic Area Lead Biotherapeutics, Global Medical Affairs
      Abbvie, United States
    • Interchangeability
      James M Roach, MD,FACP
      SVP Development, CMO
      Momenta Pharmaceuticals, Inc., United States
    • Panel Discussion
      All Session Speakers, United States
  • 3:30PM - 4:00PM

    Refreshment Break
  • 4:00PM - 5:30PM

    Lessons from the EU


    Session Chair(s):

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

    The European Union (EU) was the first jurisdiction to introduce legislation for biosimilars in 2004, followed by the issuance of guidelines by EMA. Today, the EU has multiple biosimilars on the market, some of which go back more than seven years. Also, the EU has developed a detailed framework of guidelines for biosimilars, many of which are currently being revised based on the experience gained. This session will review the evolution of the regulations for biosimilars in the EU and take a look into the future of these regulations. One of the key challenges going forward will be the harmonization of regulations in the US and the EU, so programs do not have to be duplicated. Regulators will share on the progress in the FDA-EMA cluster on biosimilars they have set up. Also, a report on a study conducted by the European Commission (EC) on the biosimilars markets in the various EU countries will be shared. This study analyzed which barriers need to be removed and which incentives need to be put in place to create a fair marketplace for biologics.

    Speaker(s):

    • Regulatory Evolution in EU
      Martina Weise, MD
      Head, Unit on Diabetes/Cardiology, German CHMP Alernate
      Bfarm, Germany
    • Market Experience in EU
      Steffen Thirstrup, MD,PhD
      Medical Advisor & Advisory Board Member
      NDA Group, Denmark
    • Global Development: FDA-EMA Biosimilars Cluster
      Leah Christl, PhD
      Associate Director for Therapeutic Biologics, OMBT, OND, CDER
      FDA, United States
    • Panel Discussion
      All Session Speakers, United States
  • 5:30PM - 6:30PM

    Networking Reception

Day 2 Thursday, November 14, 2013

  • 7:30AM - 8:30AM

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

    Commercialization


    Session Chair(s):

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

    During this session, government and industry experts, from a broad range of backgrounds and experiences, will provide in-depth overviews on substitution and interchangeability and on naming and labeling as they relate to the biosimilar market. Experiences from the European biosimilar market as well as other non-US regulated markets will be incorporated to provide overviews.

    Speaker(s):

    • Interchangeability & Substitution
      Gillian Woollett, PhD
      Vice President
      Avalere, United States
    • Interchangeability & Substitution
      Steve Miller, MD
      Senior Vice President & Chief Medical Officer
      Express Scripts, United States
    • Interchangeability & Substitution
      Thomas Felix, MD
      Director, Research and Development Policy
      Amgen Inc., United States
    • Naming & Labeling
      Erika F. Lietzan, JD,MA
      Partner
      Covington & Burling LLP, United States
    • Naming & Labeling
      Joerg Windisch, PhD
      Chief Science Officer
      Sandoz Biopharmaceuticals, Austria
    • Panel Discussion
      All Session Speakers, United States
  • 10:00AM - 10:30AM

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

    Postmarketing and Risk Management


    Session Chair(s):

    • Sumant Ramachandra, MD,PhD
      Sr Vice President, R&D and Medical Affairs, Chief Scientific Officer
      Hospira, Inc., United States

    In this session, industry experts in pharmacovigilance will provide perspectives on post-approval safety evaluations and risk management plans/REMS for biologics and biosimilars. Using case studies, global experience with such programs will be reviewed with a focus to understanding challenges and opportunities.

    Speaker(s):

    • Post-marketing Requirements and Pharmacovigilance
      Freddy J Faccin
      Assoc. Medical Director, Lat. America Biotherapeutics, Immunology Medical Affair
      AbbVie, Puerto Rico
    • Trending, Signal Detection and Risk
      Juergen Schmider
      VP Global Pharmacovigilance and Product Safety
      Hospira Inc., United States
    • Panel Discussion - Additional Speaker
      Martina Weise, MD
      Head, Unit on Diabetes/Cardiology, German CHMP Alernate
      Bfarm, Germany
  • 12:00PM - 1:00PM

    Luncheon
  • 1:00PM - 2:30PM

    Global Considerations


    Session Chair(s):

    • Mary Ellen Cosenza, PhD,MS,RAC
      Executive Director, US Regulatory Affairs
      Amgen Inc., United States
    • Jian Wang, MD
      Chief, Pre-market Clinical Evaluation Division - Haematology/Oncology
      Health Canada, Canada

    This session will provide high-level reviews on the regulatory framework developed for biosimilars in Canada and in key Latin America and Asia Pacific markets, identifying similarities and differences in the regulatory requirements in these markets.

    Speaker(s):

    • Canadian Perspective
      Anthony Ridgway, PhD
      Senior Regulatory Scientist, Office of the Director
      Health Canada, Canada
    • Mexican Perspective
      Christian Alejandro Lopez-Silva
      Partner
      Baker & McKenzie S.C., Mexico
    • Asian Perspective
      Hee Kyung Kim, MBA,RPh
      Vice President, Regulatory Affairs
      Samsung Bioepis Co., Ltd., Korea, Republic of
    • Panel Discussion
      All Session Speakers, United States
  • 2:30PM - 3:00PM

    Refreshment Break
  • 3:00PM - 4:00PM

    Monoclonal Antibodies


    Session Chair(s):

    • Richard M Lewis, PhD
      CEO
      Access BIO, United States

    Monoclonal antibodies will be an important target for the development of biosimilar therapeutic products. This session will offer an example of the development of a monoclonal for the European market and some insights into the structure function relationship of monoclonal antibodies with respect to their evaluation of biosimilarity. The session will include a panel discussion of these issues and include the presenters and FDA.

    Speaker(s):

    • Case Study
      Stanley Hong
      President of Research & Development
      Celltrion, Inc., Korea, Republic of
    • Technical Importance of Understanding Structural Activity Relationship
      Cecil J. Nick, MS
      FTOPRA, Vice President (Technical)
      PAREXEL Consulting, United Kingdom
    • Panel Discussion - Additional Speaker
      Leah Christl, PhD
      Associate Director for Therapeutic Biologics, OMBT, OND, CDER
      FDA, United States
  • 4:00PM - 4:30PM

    Closing Remarks

    Speaker(s):

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

Registration Fees 

Member

Member Government
$595.00
Member Academia
$745.00
Member Individual
$1490.00

Non-Member

NonMember Government
$770.00
NonMember Academia
$920.00
NonMember Individual
$1665.00
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

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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