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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA/FDA Biosimilars Conference

Jun 26 - Jun 27, 2017 |
Jun 27, 2017 |
Hyatt Regency Bethesda | Bethesda, MD
  • Conference
  • Western Hemisphere Events
Exhibition: June 26-27
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The 2017 PDA/FDA Biosimilars Conference will bring together industry experts and regulators to discuss the latest advancements and strategies required to successfully bring biosimilars to market. In response to the industry’s need for current and reliable information on this rapidly growing area of pharmaceutical manufacturing, the Program Planning Committee has developed an agenda that brings together industry experts and regulators to review successful development strategies 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 conference sessions will address Demonstration of Analytical Similarity, Post-Marketing Change Management, Control Strategy for Biosimilars, Product Specifications for Biosimilars and “Data Quality” Expectations for Biosimilars.

Throughout the Conference, successful case studies and practical examples will be used to illustrate how analytical similarity can be demonstrated and practical control strategies be developed. Current updates from the regulatory agencies, including the U.S. FDA, the Finnish Medicines Agenda and the Federal Institute for Drugs and Medical Devices (BfArM), will be presented, and CMC reviewer perspectives will elucidate those CMC issues that have been most challenging to approve. Attendees will have the opportunity to raise questions and concerns during the conference.


Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405

Monday, June 26, 2017

7:45 a.m. – 5:30 p.m.
Registration Open

7:45 a.m. – 8:45 a.m.
Continental Breakfast

8:45 a.m. – 9:00 a.m.
Welcome and Opening Remarks
Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca, and Co-Chair, 2017 PDA/FDA Biosimilars Conference Program Planning Committee

9:00 a.m.-10:30 a.m.
P1: Opening Plenary: Current Agency Expectations for Approval of Biosimilars
Moderator: Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca

Session Description: This session will review recent regulatory experiences and expectations for Biosimilars development. In particular, differences in various regional perspectives will be explored, as well as current efforts for harmonization.

9:00 a.m. – 9:30 a.m.
Biosimilars in the United States: Regulatory Update
Steven Kozlowski, MD, Supervisory Medical Officer, CDER, FDA 

9:30 a.m. – 10:00 a.m.
Biosimilars in the European Union: Regulatory Update
Niklas Ekman, PhD, Senior Researcher, Finnish Medicines Agency

10:00 a.m. – 10:30 a.m.
Panel Discussion
Niklas Ekman, PhD, 
Senior Researcher, Finnish Medicines Agency
Sarah B. Kennett, PhD,
Review Chief, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, FDA
Steven Kozlowski, MD, 
Supervisory Medical Officer, CDER, FDA 
Birgit Schmauser, PhD,
Quality Assessor, Pharmaceutical Biotechnology, Inspections Quality, Federal Institute for Drugs and Medical Devices

10:15 a.m. – 6:30 p.m. 
Exhibit Area Open

10:30 a.m. – 11:15 a.m.
Refreshment Break
Thank you to our exhibitor, Cardinal Health Regulatory Sciences

11:15 a.m. – 12:45 p.m.
P2: Strategies for Reverse Engineering
Moderator: Michael VanDerWerf, 
Senior Director, Regulatory Affairs CMC, Halozyme Therapeutics, Inc.

Session Description: The first step in biosimilar development is to adequately define and understand the reference biological product; this requires thorough analytical characterization and a strategy for producing the molecule to have similar structural and functional attributes as the originator’s product. This session will explore the “reverse engineering” approaches developers take including patent and literature searches, characterization of the innovator molecule and the planning that goes into cell line development and clone selection for producing a biosimilar.

11:15 a.m. – 11:45 a.m.
Analytical Implications of Reverse Engineering for Biosimilar Development
Laurent Chevalet, PhD, Director, Head of Analytical & Pharmaceutical Development, Merck Biosimilars

11:45 a.m. – 12:15 p.m.
Quality Target Product Profile as a Tool for Reverse-Engineering of Biosimilars
Alla Polozova, PhD,
Principal Scientist, Amgen, Inc.

12:15 p.m. – 12:45 p.m.
Questions and Answers/Discussion

12:45 p.m. –2:00 p.m.
Networking Luncheon

2:00 p.m. – 3:20 p.m.
P3: Expectations and Practical Considerations for Analytical Similarity: Industry Case Studies
Barbara Rellahan, Director, Product Quality, Amgen, Inc.

Session Description: A demonstration that a proposed biosimilar product is highly similar to its reference product is the foundation of a biosimilar development program. This session will provide regulatory and industry perspective on the expectations, approaches (including lessons learned), and challenges for development/approval of a biosimilar.

2:00 p.m. – 2:20 p.m.
Lessons Learned from an Etanercept Biosimilar Development/Approval Process
Jens Schletter, PhD, Head Regulatory CMC Group, Sandoz Biopharmaceuticals

2:20 p.m. – 2:40 p.m.
Best Practices and Lessons Learned for Demonstrating Analytical Similarity
Emily Shacter, PhD, Independent Consultant, ThinkFDA, LLC  

2:40 p.m. – 3:00 p.m.
Biosimilar Development Case Studies 
Jeff Yant, PhD, Biosimilars Operations Director, Amgen, Inc.

3:00 p.m. – 3:20 p.m.
A Regulatory Perspective on Analytical Similarity Studies for Development of Biosimilar Products
Patrick J. Lynch, PhD, Biologist, CDER, FDA

3:20 p.m. – 4:00 p.m.
Refreshment Break
Thank you to our exhibitor, Cardinal Health Regulatory Sciences

4:00 p.m. – 5:30 p.m.
P4: Expectations and Practical Considerations for Analytical Similarity: Panel Discussion
Marjorie A. Shapiro, PhD, Chief, Laboratory of Molecular and Developmental Immunology, CDER, FDA

Session Description: This session is a panel discussion with both the presenters from P3 and some additional panelists.

4:00 p.m. – 5:30 p.m.
Panel Discussion
Patrick J. Lynch, PhD, Biologist, CDER, FDA
Jens Schletter, PhD,
Head Regulatory CMC Group, Sandoz Biopharmaceuticals
Birgit Schmauser, PhD, Quality Assessor, Pharmaceutical Biotechnology, Inspections Quality, Federal Institute for Drugs and Medical Devices
Emily Shacter, PhD,
Independent Consultant, ThinkFDA, LLC
Jeff Yant, PhD, Biosimilars Operations Director, Amgen

5:30 p.m. - 6:30 p.m.
Networking Reception

Tuesday, June 27, 2017

7:30 a.m. – 4:00 p.m.
Registration Open

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

8:30 a.m. – 10:00 a.m.
P5: Post-Marketing Change Management
Moderator: Jens Schletter, PhD, Head Regulatory CMC Group, Sandoz Biopharmaceuticals

Session Description: This session will examine current thinking from industry and regulators on requirements for post approval changes to Biosimilar products. In particular, instances where comparability is adequate or where additional similarity studies may be needed will be discussed.

8:30 a.m. – 9:00 a.m.
Experiences from 10 Years of Global Post-Marketing Experience of a Biosimilar
Monika Lang-Salchner, PhD, Head Regulatory CMC Oncology Products, Sandoz Biopharmaceuticals

9:00 a.m. – 9:30 a.m.
10 Years of Evaluation of Biosimilars Marketing Authorization Applications: Along a Winding Road
Birgit Schmauser, PhD, Quality Assessor, Pharmaceutical Biotechnology, Inspections Quality, Federal Institute for Drugs and Medical Devices (BfArM)

9:30 a.m. – 10:00 a.m.
Questions and Answers/Discussion

9:45 a.m. – 4:00 p.m.
Exhibit Area Open

10:00 a.m. – 10:45 a.m.
Refreshment Break
Thank you to our exhibitor, Cardinal Health Regulatory Sciences

10:45 a.m. – 12:15 p.m.
P6: Control Strategy for Biosimilars
Moderator: Laurie J. Graham, Acting Director, Division of Internal Policies and Programs, CDER, FDA

Session Description: The development of an appropriate control strategy ensures that critical quality attributes are within the appropriate range, limit, or distribution to assure quality. This session will focus on the lifecycle development of control strategies for biosimilar products, which will include consideration for the unique features of biosimilar product control strategies, such as the relationship, throughout development, between the control strategy and analytical similarity.

10:45 a.m. – 11:15 a.m.
Control Strategy for Biosimilar Products: A Regulatory Perspective
Maria-Teresa Gutierrez Lugo, PhD, Chemist, CDER, FDA

11:15 a.m. – 11:45 a.m.
Specifications for Biosimilars
Deborah Baly, PhD, Vice President, Quality Control, Coherus

11:45 a.m. – 12:15 p.m.
Questions and Answers/Discussion

12:15 p.m. – 1:30 p.m.
Networking Luncheon

1:30 p.m. – 3:00 p.m.
P7: Product Specifications for Biosimilars
Moderator: Stephan O. Krause, PhD, Director of QA Technical Support, AstraZeneca

Session Description: This session focuses on the determination of which Tier 1-3 (critical) quality attributes should become product release/stability specifications. Industry and agency perspectives will be provided and discussed. Questions such as whether specifications can be justified based on a combination of reference product and biosimilar manufacturing capability and product stability will be answered.

1:30 p.m. – 2:00 p.m.
Setting Product Specifications: An Agency Perspective
Leslie Rivera Rosado, PhD, Director Regulatory Review Officer, CDER, FDA

2:00 p.m. – 2:30 p.m.
Setting Specifications of Biosimilars: An Industry Perspective
Helmut Lerch, PhD, Head Compliance Development Biopharma, Sandoz Biopharmaceuticals

2:30 p.m. – 3:00 p.m.
Questions and Answers/Discussion

3:00 p.m. – 3:45 p.m.
Refreshment Break
Thank you to our exhibitor, Cardinal Health Regulatory Sciences

3:45 p.m. – 5:15 p.m.
P8: Closing Plenary: Data Quality Expectations in Biosimilar Development
Moderator: Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA

Session Description: This session will explore additional consideration for biosimilars development, discussing the type of data needed to support a biosimilars program.

3:45 p.m. – 4:10 p.m.
Points for Consideration in Analytical Similarity Assessment
Katariina (Kate) Hutterer, PhD, Senior Scientist, Amgen, Inc.

4:10 p.m. – 4:35 p.m.
The Devil is in the Data: Expectations for "Data Quality" and "Quality Data" in Biosimilar Development
Joel T. Welch, PhD, Acting Review Chief, CDER, FDA

4:35 p.m. – 5:00 p.m.
Quality-Focused Biosimilar Development Strategy
Kyung-Ah Kim, PhD, Vice President, Head of Bioanalysis, Samsung Bioepis

5:00 p.m. – 5:30 p.m.
Questions and Answers/Discussion

5:30 p.m.
Closing Remarks
Emanuela Lacana, PhD, Associate Director for Biosimilars and Biologics Policy, CDER, FDA, and Co-Chair, 2017 PDA/FDA Biosimilars Conference Program Planning Committee

Conference Registration | June 26-27, 2017


Before April 14, 2017

April 14, 2017 – May 12, 2017

After May 12, 2017


Before April 14, 2017

April 14, 2017 – May 12, 2017

After May 12, 2017

Government/Health Authority/Academic


Before April 14, 2017

April 14, 2017 – May 12, 2017

After May 12, 2017


Before April 14, 2017

April 14, 2017 – May 12, 2017

After May 12, 2017



Before April 14, 2017

April 14, 2017 – May 12, 2017

After May 12, 2017


Before April 14, 2017

April 14, 2017 – May 12, 2017

After May 12, 2017

All prices in US dollars.

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

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 Conference.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the Conference and receive the 5th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may accommodate. Please contact us at 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 April 27, 2017 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including on site at the prevailing rate. 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). If your written request in received on or before April 27, 2017, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. On-site 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 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 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/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy or violation of copyright ownership. Recordings are prohibited at all PDA Conferences.

Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814
Phone: +1 (301) 657-1234
Rate: Single: $219.00, plus applicable state and local taxes.

Hotel Accommodations

The PDA reservation weblink is now closed. At this point it will be on a case-by-case basis if the hotel can honor the group rate. To make reservations at the Hyatt Regency Bethesda Hotel, please call the central hotel reservation line at +1 800-233-1234 and reference the Hyatt Regency Bethesda and the 2017 PDA/FDA Biosimilars Workshop. Check in time is 4:00 p.m., and check out time is 12:00 noon.

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. The cancellation policy is cancel 24 hours prior to the date of arrival by 3 p.m. to avoid cancellation charges.


Just one mile from the MD/DC line, Hyatt Regency Bethesda is perfectly-positioned to allow you to take advantage of all Washington, DC has to offer. Located directly above the Bethesda Metro station (Red Line), you’re walking distance to numerous area businesses and minutes from Maryland’s best shopping, dining and cultural attractions.  Take advantage of the hotel’s Smart Phone Check-in and the 24 hour StayFit™ fitness center during your stay. The Hyatt Regency offers complimentary Wi-Fi in all guestrooms and public areas.


Area Airports
Reagan National Airport (DCA) is approximately 12.7 miles from the hotel and all major carriers service this airport. Other area airports that also service all major carriers are Dulles International Airport (IAD), 25 miles away and Baltimore Washington International (BWI), 35.2 miles away.

Ground Transportation
Taxi fares from Reagan National (DCA) are approximately $45-55.00 one way, not including tip, and will take about 30 minutes.  One way taxi fares from Dulles (IAD) is approximately $75 and from Baltimore/Washington (BWI) is about $95.

Hyatt Regency Bethesda hotel is located on One Bethesda Metro Center.

Hotel Parking
$22.50 / Daily Self-Parking
$28.00 / Daily Valet Parking

*Extensive garage improvements are now underway. Please expect dust, changes in traffic patterns and potential delays when using the garage located directly under the hotel. In an effort to keep our guests well-informed as you travel, please let us know if there is any assistance you need while with us. We highly encourage valet parking to avoid any challenges on arrival.

The 2017 PDA/FDA Biosimilars Conference 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 Conference, 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: