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2018 PDA Biosimilars Workshop

Getting it Right the First Time for Biosimilar Marketing Applications
Sep 26 - Sep 27, 2018 |
Sep 27, 2018 |
Renaissance Washington, DC Downtown Hotel | Washington, DC
  • Workshop
  • Western Hemisphere Events
Exhibition: September 26-27
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Speaker Biographies

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

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










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.

Renaissance Washington, DC Downtown Hotel
999 9th Street NW
Washington, DC 20001
Phone: +1 (202) 898-9000

Rate: Single: $317.00, plus applicable taxes.

Cut Off Date: Friday, August 10 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.

Hotel Accommodations

To make reservations at the Renaissance Washington, DC Downtown Hotel, please call the Hotel at +1 (202) 898-9000 and reference the 2018 PDA Workshop to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. All cancellations must be received by 11:59 p.m., 3 days before arrival to avoid a penalty of one night's room and tax.

Amenities

The Renaissance Washington, DC Hotel is located in Penn Quarter; in the heart of downtown Washington DC. Local attractions include the National Portrait Gallery, Smithsonian Institute and Air Space Museum, Washington Monument, Capitol Hill, and many more. All 794 guest rooms and suites provide high-speed Internet, upgraded Luxurious bedding, coffee makers, hair dryers, iron, and an ironing board.

Travel

Area Airports
Ronald Reagan Washington National (DCA) is approximately 5 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 32 miles away.

Ground Transportation
Taxi fares from Reagan National are approximately $20 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is approximately $75 and from BWI is about $75.

Metro
Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.

Train
Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit www.amtrak.com.

Driving
Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking
$35 / Daily Self-Parking
$45 / Daily Valet Parking

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Biosimilars Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility and help you connect with industry leaders. This Conference will bring together VPs, directors, department heads, managers and senior scientists from biopharmaceuticals, bioprocessing, clinical immunology, product development, scale-up, quality assurance and regulatory.

Good foot traffic is one thing; good leads are another. At this Workshop, you will have access to attendees from a variety of manufacturing companies – making this a must-attend meeting. In addition, high-profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and the Networking Reception. We’ll create a customized sponsorship package to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3905

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