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2019 Biopharmaceuticals Week

2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges

May 09 - May 10, 2019
Long Beach, CA

End-to-End Product Development – Manufacturing, Supply, and Quality

  • Conference
  • Western Hemisphere Events

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Program Highlights

Get the latest on registration, speakers, session details, exhibitor information, courses, and more by signing up to receive updates on the 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges as part of the 2019 PDA Biopharmaceuticals Week.

Important Dates: Register by March 22 and save up to $600!


As part of its inaugural 2019 PDA Biopharmaceuticals Week, PDA will host the 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges, May 9-10. This Conference will close out the week with two full days of sessions divided into tracks, covering both biosimilars and vaccines. The Program Planning Committee is developing a comprehensive agenda focusing on topics such as continuous manufacturing, lifecycle management, product comparability and similarity, and much more.

Don’t miss the mix of plenary sessions, focused tracks, and exciting question and answer sessions with the foremost industry experts in the worlds of biosimilars and vaccines.


  • Day 1
  • Day 2
  • Thursday, May 9

    7:00 a.m. – 6:30 p.m.
    Registration Open

    7:00 a.m. – 8:15 a.m.
    Continental Breakfast

    8:15 a.m. – 8:30 a.m.
    Welcome and Opening Remarks from Conference Co-Chair
    Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing

    8:30 a.m. – 10:00 a.m.
    P1: Evaluating Comparability and Demonstrating Similarity
    Moderator: Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing

    Throughout a products lifecycle, various changes will take place that could potentially impact product quality attributes and therefore the product safety and efficacy. Demonstrating product similarity with robust techniques is crucial to ensuring patient safety. This session will discuss best practices in biosimilars and vaccines, so attendees can not only hear about the latest trends in their field but also how this is viewed through a slightly different lens by the other modality.

    9:45 a.m. – 6:30 p.m.
    Exhibit Area Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    10:45 a.m. – 12:15 p.m.
    Concurrent Sessions 


    A1: Management of Lifecycle Similarities in Biosimilars
    Moderator: Jennifer L. Liu, Director of Process Development, Bipsimilars, Amgen Inc.

    Lifecycle management is a systematic approach to managing the product evolution from initial design and development through approval, to commercialization. Biosimilar products must demonstrate similarity at approval but become stand-alone products after approval. Hence the opportunity arises to introduce changes, even innovations outside the comparison to the reference product. This session will explore the development approaches that can be employed and consider the role regulators play in increasing confidence in biosimilars by establishing regulatory oversight throughout their lifecycle, from development to post-licensing.


    B1: Current Topics in Vaccine Modernization: Comparability Strategies and Other Approaches
    Moderator: Jane Halpern, PhD, Independent Consultant

    This session will cover the challenges and strategies used to manage consistency as changes are introduced into a vaccine product.  Both during development and post approval, manufacturing and testing procedures can be modified in response to improved technologies, supplier-driven changes and evolving regulatory requirements.  Many vaccines are marketed for a number of years and manufacturers must develop strategies to ensure that modifications do not affect the purity, safety or potency of a vaccine.  The diverse nature of vaccines and complexity of vaccines leads to unique challenges when developing strategies to modernize older products and develop comparability programs.

    12:15 p.m. – 1:45 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk.

    1:45 p.m. – 3:15 p.m.
    Concurrent Sessions


    A2: Comparability and Similarity in Biosimilars
    Moderator: Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, FDA

    The demonstration of analytical similarity between biosimilar and reference product is based on the well-established scientific principle of comparability. Since the term comparability first appeared describing head-to-head product comparisons in the FDA 1996 guidance, the concept has been extensively used to support an array of changes, during all stages of product lifecycle. Both comparability and similarity are data-driven, with the burden placed with the developer to generate appropriate data to satisfy the expectations of Regulators. This session will discuss practical challenges and resulting strategies for the evaluating analytical comparability and similarity.


    B2: Vaccines Lifecycle Management in the 21st Century
    Moderator: Sabrina Restrepo, PhD, Director, Sterile & Validation CoE, Merck & Co., Inc.

    This session will provide perspective around the challenge’s vaccines face from a lifecycle management perspective. Although ICH Q12 is seeking to address some of challenges, the question is still there for legacy vaccines and the increased complexity of a more diverse regulatory environment worldwide. A case study will be presented seeking to illustrate the challenges this complexity brings in terms of supply and potential enablers to allow vaccines reach patients worldwide.

    3:15 p.m. – 4:00 p.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    4:00 p.m. – 5:30 p.m.
    P2: Biosimilars and Vaccines Lifecycle Management in the Digital Era
    Moderator: Sabrina Restrepo, PhD, Director, Sterile & Validation CoE, Merck & Co., Inc.

    More biosimilars and vaccines are becoming available to people in conjunction with an increased demand for existing and new products which is driving more complexity around product lifecycle management. We are in the digital era and in several instances, we manufacture products developed prior to many of today’s technologies being available to process developers. Also, new products are in development which are seeking to bring innovation. There is a possibility to bring elements of the digital era into lifecycle management that could enable a leaner approach in the near future. This session will create a forum to discuss challenges and opportunities for lifecycle management and the evolution needed to align with the demands of the current public health landscape.

    5:30 p.m. – 6:30 p.m.
    Networking Reception in Exhibit Area

  • Friday, May 10

    7:00 a.m. – 5:30 p.m.
    Registration Open
    7:00 a.m. – 8:45 a.m.;
    Continental Breakfast

    7:30 a.m. – 8:30 a.m.
    Concurrent Breakfast Sessions


    Biosimilars Interest Group Breakfast Session
    Moderator: Stephan O. Krause, PhD,Head of Product Quality Group,AstraZeneca Biologics

    This session will review and discuss the highlights from the recent PDA Biosimilars Workshop, co-chaired by Emanuela Lacana, PhD, CDER,FDA. The workshop was set up to capture lessons learned and well-working practices. The Workshop covered expectations for data quality, the creation of a final control strategy, and practical alternative solutions to current statistical approaches. Experiences from regulatory agencies outside the U.S. were discussed with the intent to consider complementing some of the content in the U.S. FDA Draft Guidance. Attendees will have the opportunity to ask questions and/or provide their experience.


    Vaccines Interest Group Breakfast Session
    Moderator: Jane Halpern, PhD,Independent Consultant and Sabrina Restrepo, PhD, Director, Sterile & Validation CoE, Merck & Co., Inc.

    The session will present to the participants the status of the ongoing activities within the Vaccines Interest Group which are mainly focused around the development of technical report(s) or key deliverables regarding vaccines lifecycle management, vaccines specifications and new technologies.

    Participants will have the opportunity to listen case study or studies that frame the relevance of these topics and share their perspective as well.

    8:45 a.m. – 10:15 a.m.
    P3: Lessons Learned: Applying QbD Principles to Vaccines and Biosimilars
    Moderator: Jane Halpern, PhD, Independent Consultant

    The development of new biologic products, their launch, and ensuring their supply, present multiple challenges across technical, regulatory, and market concerns. Setting a successful strategy and leveraging previous experiences are essential for this process.  Quality by design is a systematic approach to development and manufacturing that emphasizes product understanding and process control and can minimize the impact of challenges that arise during product development and commercial manufacturing.  The presentations in this session will address how quality by design principles are being used to address challenges in both vaccine and biosimilar development and/or manufacturing and how they are addressed.

    10:15 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations

    10:45 a.m. – 12:15 p.m.
    Concurrent Sessions


    A3: Challenges in Biosimilars
    Moderator: Stephan O. Krause, PhD,Head of Product Quality Group,AstraZeneca Biologics

    This session will address technical challenges with the intent to avoid pitfalls often encountered during biosimilar candidate development. Continued from the Breakfast Interest Group session, the following topics will be covered: Data quality expectations, “fit for purpose” analytical methods, inspectional expectations, the intersection of the analytical similarity assessment with the final control strategy, and critical strategic decisions necessary in a biosimilar development program.


    B3: New Technologies, New Platforms
    Moderator: Jody A. Gould, PhD,Senior Director, Head, Regulatory Policy & Intelligence,GSK Vaccines

    Advances in technology have resulted in a wide array of new platforms and new adjuvants that potentially can improve the clinical performance of existing vaccines and lead to efficacious vaccines for diseases for which no vaccine is currently available. This session will include talks on new technologies that are being use for investigational vaccines and how unique regulatory, manufacturing, and quality concerns could be addressed.

    12:15 p.m. – 1:45 p.m. 
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA Registration Desk.

    1:45 p.m. – 3:15 p.m. 
    Concurrent Sessions


    A4: Maximizing Global Development
    Moderator: Bev Ingram, PhD,Senior Director, Portfolio Lead Biosimilars Regulatory Affairs,Pfizer Inc.

    The regulatory science for biosimilars is well established, however expectations globally does differ. For example, most regulators require a biosimilar to be similar to their source originator product. As a result, creating a global biosimilar product requires conducting multiple 3-way studies (a source-licensed product, a non-source licensed product, and biosimilar). Such requirements create an increased complexity during development, additional testing burdens, and delay the registration of biosimilar products globally. This session will explore global development approaches and innovations that can help reduce the burden of additional studies and address delays in the global registration of biosimilar products.


    B4: Challenges in Vaccines
    Moderator: Christopher M. Bussineau, PhD, Senior Consultant, Biologics Consulting Group, Inc

    With so many medical needs where vaccines are an option, innovation and reliable supply are becoming more relevant. Innovative approaches are important for addressing existing regulatory requirements and for introducing new technologies into manufacturing processes. This session will share some of the experiences and opportunities vaccine developers and manufacturers have faced and are seeking to pursue to overcome these challenges.

    3:15 p.m. – 3:45 p.m.
    Refreshment Break and Poster Presentations

    3:45 p.m. – 5:15 p.m.
    P4: Continuous Manufacturing and its Future in Biosimilars and Vaccines
    Moderator: Peter Makowenskyj,Director of Sales Engineering,G-CON Manufacturing

    Continuous Manufacturing is at the cusp of being a viable platform for large molecule therapies. Continuous manufacturing has been demonstrated to show many benefits, primary among them the ability to drive down costs and decrease time to market. We will look at the efforts taking place in the field of biosimilars and vaccines as it relates to continuous manufacturing and how this manufacturing concept is shaping our industries future.

    5:15 p.m. 
    Closing Remarks from Conference Co-Chair
    Peter Makowenskyj, Director of Sales Engineering, G-CON Manufacturing

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this event, attendees will be able to:

    • Understand the challenges faced in lifecycle management of legacy products especially in relation to change management to incorporate current technologies
    • Develop proper techniques to demonstrate product similarity
    • Establish improved and more robust strategies during product development or manufacturing that will translate into more robust process and product consistency
    • Evaluate how continuous manufacturing is shaping process development and impacting COGS
    • Recognize the latest innovative and new technologies being utilized for both modalities
    • Assess how current guidance’s are shaping regulatory framework
  • Who Should Attend

    Who Should Attend

    Job Functions
    Biologist | Engineer | Manager | Technician | Scientist | Site Head

    Biochemistry | Biology | Executive Management | Manufacturing | Regulatory Affairs | Technical Operations | Validation

  • 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:

    Type of Activity: Knowledge

    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.

Got a Question? We have answers

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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.

Hilton Long Beach

701 West Ocean Boulevard
Long Beach, CA
Phone: +1 (562)-753-2107

Make a Reservation
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Hilton Long Beach. The rate is $199 for single (king bed) or double (two queen beds) room. Guestroom rates are subject to State and Local taxes which are currently 15.40% per room night. Reservations must be secured by Monday, April 8, 2019. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Hilton Long Beach at +1 (562)-753-2107. Please make sure to mention the group code PD2 in reference to the PDA group block.

    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 72 hours prior to check-in to avoid cancellation fees.

  • Amenities

    Whether conducting business, keeping up with a fitness routine or looking to spend quality time with your family, our Long Beach, California hotel is here to help you make the most of your stay by offering the services you need, the amenities you expect, and the extras you deserve.

    Read more about the amenities offered at the Hilton Long Beach.

How to Get Here

By Air

The Hilton Long Beach is located less than an hour from three airports:

Long Beach Airport(LGB) is located 7 miles (about a 15 minute drive time) northeast of the Hilton Long Beach, an estimated $25 taxi ride.

Los Angeles International (LAX) is located 21 miles (about a 30 minute drive time) northwest of the Hilton Long Beach, an estimated $50 taxi ride.

John Wayne/Orange County Airport (SNA) is located 20 miles (about a 40 minute drive time) southeast of the Hilton Long Beach, an estimated $50 taxi ride.

By Car

Hilton Long Beach is located at 701 West Ocean Boulevard, Long Beach, CA 90831.

Take the 405 Freeway to the 710 Freeway South, the Long Beach Freeway. Once on the 710 South, exit Downtown/Broadway/Pine Avenue (exit is on the left side of the freeway). Make the next right on Magnolia and the next right on Ocean Blvd. Hilton is down two lights on the right hand side (the corner of Ocean and Golden Avenues).

PDA attendees will receive a discounted $15/day self-parking rate (garage and surface). Valet parking is also available at $28/day.

Other Options

More information coming soon.


Registration Fees

Early Registration
Registration Type Price by March 22
Member $1,995
Non-member $2,274
Young Professional Member $998
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member* $800
Academic Member $700
Academic Non-member* $800
Student Member $280
Student Non-member* $310

Regular Registration
Registration Type Price after March 22
Member $2,595
Non-member $2,874
Young Professional Member $1,298
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member* $800
Academic Member $700
Academic Non-member* $800
Student Member $280
Student Non-member* $310

* 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 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 Phone messages are not accepted.


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Program Inquiries
  • Brooke Schneider, CMP
    Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111

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

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  • Stephanie Ko
    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151

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


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