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2018 PDA Biosimilars Workshop

Sep 26 - Sep 27, 2018
Washington, DC

Getting it Right the First Time for Biosimilar Marketing Applications

  • Workshop
  • Western Hemisphere Events

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Program Highlights

Over two days, noted industry experts and speakers from the U.S. FDA, EMA, Health Canada, and the Medicines Evaluation Board (MEB) in The Netherlands will share the most common challenges they've identified in biosimilar applications, both in established requirements and in more progressive areas, such as statistical tools. Gain practical approaches to tackle technical obstacles and avoid the pitfalls frequently encountered during biosimilar candidate development!

Overview

The 2018 PDA Biosimilars Workshop will bring together industry experts and regulators to discuss and highlight the strategies required to successfully bring biosimilars to market. The Program Planning Committee, which includes members from industry and the U.S. FDA, has developed the Workshop agenda with a specific focus on the remaining challenges for the development and marketing approval for biosimilars. 

Multiple speakers from various health authorities will provide their experience and views on key aspects for a biosimilar development program, setting the framework for what should be included in a marketing application. Other Workshop sessions will address important topics, such as:

  • Analytical similarity testing - statistics and methodology
  • Compliance standards for analytical similarity data
  • Expectations for manufacturing
  • The role of devices and container closure systems
  • Suitable reference standard lifecycle program
  • Method validation strategies
  • Globalization of biosimilars programs, complexity of supply chains

Throughout this Workshop, successful case studies and practical examples will be used to illustrate how analytical similarity can be demonstrated and practical control strategies can be developed. Current updates from the regulatory agencies will be presented, and CMC reviewer perspectives will elucidate CMC issues that have been most challenging for review of 351(k) BLA applications. Attendees will have the opportunity to raise questions and concerns during the conference.

Learning Objectives

Participants will gain knowledge from industry and regulatory experts and be able to:

  • Discuss the latest advancements and strategies required to successfully bring biosimilars to market
  • Identify successful development strategies for biosimilars
  • Illustrate how analytical similarity can be demonstrated and practical control strategies be developed

Who Should Attend

VPs | Directors | Heads | Managers | Senior Scientists

Professionals with intermediate to advanced knowledge and experience in the following: Biotechnology | Bioanalytics | Biomanufacturing | Biopharmaceuticals | Bioprocessing | Biosimilars | Biotherapeutics | Cell Line | Clinical Immunology | Development | Commercial Biologics | Drug Safety & Risk Management | Expression Systems | Immunogenicity Testing | Market Entry | Partnering and Licensing | Patient Safety | Product Development | Protein Characterization | Scale-up Processes | Quality Assurance | Regulatory Affairs | Regulatory CMC

Contact

Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111
Email: schneider@pda.org

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: hall@pda.org

Agenda

  • Wednesday, September 26

    11:30 a.m. – 6:15 p.m.
    Registration Open

    1:45 p.m. – 2:00 p.m.
    Welcome and Opening Remarks from Workshop Co-Chair
    Stephan O. Krause, PhD,
    Director, QA Technology, AstraZeneca Biologics

    2:00 p.m. – 3:15 p.m.
    P1: Regulatory Perspective on Biosimilar Marketing Applications
    Moderator: Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics

    This session will explore the challenges encountered with submission of biosimilar marketing applications from the regulatory agencies’ perspectives. The presentations will provide an overview of these challenges, with a focus on manufacturing development, commercial production, and control strategy. Expectations for a successful submission of the CMC information will also be described.

    2:00 p.m. – 2:20 p.m.
    Regulatory Perspective on Biosimilar Marketing Applications
    Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA 

    2:20 p.m. – 2:40 p.m.
    Evolving EU Views on Analytical Similarity
    R. Martijn van der Plas, PhD, Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands

    2:40 p.m. – 3:00 p.m.
    A Reviewer’s Perspective of Biosimilar Submissions
    Chantal Depatie, PhD, Senior Biologist Evaluator, Health Canada

    3:00 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:00 p.m. – 7:30 p.m.
    Exhibit Area Open

    3:15 p.m. – 3:45 p.m.
    Refreshment Break in Exhibit Area

    3:45 p.m. – 5:15 p.m.
    P1: Concurrent Breakout Sessions

    These breakout sessions will offer a deep dive into regulatory authorities' expectations and common issues observed to date in review of biosimilar dossiers by agencies in different regions. The objective is to highlight specific gaps and shortfalls using fictional case studies and to obtain a mutual understanding of both the authorities' expectations and the limitations and challenges industry is facing in biosimilar development to meet these expectations. Participants will have an interactive discussion to collectively dissect the problems and brainstorm solutions.

    Breakout 1
    Moderator: Marjorie A. Shapiro, PhD, Supervisory Biologist, Chief, Laboratory of Molecular and Developmental Immunology, CDER, FDA
    Record Keeper: Alla Polozova, PhD, Scientific Director, Amgen Inc.

    Breakout 2
    Moderator: Chantal Depatie, PhD, Biologist Evaluator, Health Canada
    Record Keeper: Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc.

    5:15 p.m. – 6:15 p.m.
    P1: Panel Discussion
    Moderator: Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics

    Chantal Depatie, PhD, Biologist Evaluator, Health Canada
    Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA
    R. Martijn van der Plas, PhD, Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands
    Marjorie A. Shapiro, PhDSupervisory Biologist, Chief, Laboratory of Molecular and Developmental Immunology, CDER, FDA

    6:15 p.m. – 7:30 p.m.
    Networking Reception in Exhibit Area

    Thursday, September 27

    7:30 a.m. – 6:15 p.m.
    Registration Open

    7:30 a.m. – 8:30 a.m.
    Continental Breakfast

    8:30 a.m. – 9:45 a.m.
    P2: The Trapeze and the Trap Door: Navigating High-Level Technical Challenges in Biosimilar Development
    Moderator: Joel T. Welch, PhD, Review Chief, CDER, FDA

    This session will describe approaches to addressing high-level technical challenges and avoiding pitfalls frequently encountered during biosimilar candidate development, including data quality expectations, the creation of the final control strategy, and strategic choices necessary for candidate selection and development. Both a regulatory perspective and industry experiences will be shared. Presentations will provide practical perspective on developing “fit for purpose” analytical methods, inspectional expectations, the intersection of the analytical similarity assessment with the proposal of a final control strategy, and critical strategic decisions necessary in a biosimilar development program.

    8:30 a.m. – 8:50 a.m.
    Data Quality Considerations for Biosimilar Development
    Jee Chung, PhD, Biologist, CDER, FDA

    8:50 a.m. – 9:10 a.m.
    Key Lessons Learned from Navigating the Challenges Associated with Biosimilar Product Development
    Catherine A. Srebalus Barnes, PhD, Senior Director, Biosimilars Analytical R&D, Pfizer Inc.

    9:10 a.m. – 9:30 a.m.
    A Systematic Approach to Establish a Manufacturing Control Strategy in Biosimilar Development: A Regulatory Perspective 
    Daeseok Choi, PhD, Regulatory Affairs, CELLTRION, Inc.

    9:30 a.m. – 9:45 a.m.
    Questions and Answers/Discussion

    9:30 a.m. – 4:00 p.m.
    Exhibit Area Open

    9:45 a.m. – 10:15 a.m.
    Refreshment Break in Exhibit Area

    10:15 a.m. – 11:30 a.m.
    P2: Concurrent Breakout Sessions

    These breakout sessions will offer a chance at an interactive discussion of the key messages and issues described in the session presentations. Meeting attendees will have the opportunity to vote on which two session topics they would like to focus on the breakouts. Case studies and examples will be provided to facilitate breakout discussions. Themes, concerns, critical questions, and gaps will be identified and summarized for follow up in the session’s panel discussion.

    Breakout 1
    Moderator: Barbara Rellahan, PhD, Director, Product Quality, Amgen Inc.
    Record Keeper: Nozomi Sakakibara, Scientist/Product Quality Reviewer, CDER, FDA

    Breakout 2
    Moderator: Catherine A. Srebalus Barnes, PhD, Senior Director, Biosimilars Analytical R&D, Pfizer Inc.
    Record Keeper: Shadia Zaman, Product Quality Reviewer, CDER, FDA

    11:30 a.m. – 12:30 p.m.
    P2: Panel Discussion
    Moderator: Joel T. Welch, PhD, Review Chief, CDER, FDA

    Cathy Srebalus Barnes, Senior Director, Biosimilars Analytical R&D, Pfizer Inc.
    Daeseok Choi, PhD, 
    Regulatory Affairs, CELLTRION, Inc.
    Jee Chung, PhD, Biologist, CDER, FDA
    U.S. Regulatory Representative Invited

    12:30 p.m. – 2:00 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk.

    2:00 p.m. – 3:15 p.m.
    P3: Demonstrating Analytical Similarity: The Role of Statistical Tools
    Moderator: Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc.

    This session will explore the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity. The presentations will highlight common issues and practical challenges that arise during the application of statistical tools. Solutions and options that could be used to address the known challenges will be discussed, including practical alternative solutions to current approaches. Experiences and opinions from regulatory agencies outside the U.S. will be shared to complement the details presented in the U.S. FDA draft guideline (statistical approaches to evaluate analytical similarity).

    2:00 p.m. – 2:20 p.m.
    Reflections on Comparability (Similarity) and Methodology
    R. Martijn van der Plas, PhD, 
    Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands

    2:20 p.m. – 2:40 p.m.
    Statistical Tools for Demonstrating Analytical Similarity: Range Tests, Equivalence Test of Means, and Distribution Comparisons 
    Richard K. Burdick, PhDChief Statistician, Elion Labs, a division of KBI Biopharma, Inc.

    2:40 p.m. – 3:00 p.m.
    Performance Characteristics of Commonly Used Statistical Approaches in the Evaluation of Analytical Similarity
    Thomas Stangler, Regulatory CMC Team Leader, Novartis

    3:00 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:15 p.m. – 3:45 p.m.
    Refreshment Break in Exhibit Area

    3:45 p.m. – 5:00 p.m.
    P3: Concurrent Breakout Sessions

    This breakout session is intended to foster discussion on the practical challenges of applying statistical tools to support the demonstration of similarity: the nature of the data generation during biosimilar product development; the practical challenges experienced when statistical tools are applied and the approaches to the similarity study design; the potential strategies that can be considered; and alternative solutions and options to address the known issues. Participants will be invited to propose solutions that can be applied to common challenges and consider how statistical outputs can be complemented by other data supporting the biosimilar application, including control strategy and process knowledge.

    Breakout 1
    Moderator: Emily Shacter, PhD, Independent Consultant, ThinkFDA, LLC
    Record Keeper: Alla Polozova, PhD, Scientific Director, Amgen Inc.

    Breakout 2
    Moderator: Stephan O. Krause, PhD, Director, QA Technology, AstraZeneca Biologics
    Record Keeper: Thomas Stangler, Regulatory CMC Team Leader, Novartis

    5:00 p.m. – 6:00 p.m.
    P3: Panel Discussion
    Moderator: Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc.

    Richard K. Burdick, PhD, Chief Statistician, Elion Labs, a division of KBI Biopharma, Inc.
    Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA
    R. Martijn van der Plas, PhD,
    Senior Assessor Biologicals, Medicines Evaluation Board (MEB) The Netherlands
    Alla Polozova, PhD, Scientific Director, Amgen Inc.
    Emily Shacter, PhD, Independent Consultant, ThinkFDA, LLC
    Thomas Stangler, Regulatory CMC Team Leader, Novartis

    6:00 p.m.
    Closing Remarks from Workshop Co-Chair
    Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA










Highlighted Speakers

Bev Ingram
Bev Ingram
Pfizer Inc.
Alla Polozova
Alla Polozova
Amgen Inc.
Barbara Rellahan
Barbara Rellahan
Amgen Inc.
Joel T. Welch
Joel T. Welch
FDA

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC

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Registration Fees

Regular Price

Workshop Registration | September 26-27

Member

By July 30, 2018
$1,495

After July 30, 2018
$1,695

Non-member

By July 30, 2018
$1,695

After July 30, 2018
$1,895


Young Professional Member †

Member

By July 30, 2018
$748

After July 30, 2018
$848

† You must be a member to take advantage of this rate.


Government/Health Authority

Member*

By July 30, 2018
$700

After July 30, 2018
$700

Non-member*

By July 30, 2018
$800

After July 30, 2018
$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Academic

Member

By July 30, 2018
$700

After July 30, 2018
$700

Non-member*

By July 30, 2018
$800

After July 30, 2018
$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Student

Member

By July 30, 2018
$280

After July 30, 2018
$280

Non-member*

By July 30, 2018
$310

After July 30, 2018
$310

*For this member type or discounted rate, online registration is not available and must be faxed in.

All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by July 26, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before July 26, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING: Tape recordings are prohibited at all PDA events.

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
  • Jason E. Brown
    Assistant Director, Programs
    Tel: +1 (301) 656-5900 ext. 131
    brown@pda.org

Exhibition Inquiries
  • David Hall
    Vice President
    Tel: +1 (301) 656-5900 ext. 160
    hall@pda.org

Training Course Inquiries
  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
    ko@pda.org

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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