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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
  • The Americas
Program Highlights

The 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges is right around the corner! Stay tuned to this page for any updates as we get closer to the event. For questions, please feel free to contact us at your convenience.

Overview

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.

Agenda

  • 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.

    8:30 a.m. – 9:15 a.m.
    Evaluating Comparability and Demonstrating Similarity of Vaccines and Biosimilars
    Hillel P. Cohen, PhD, Executive Director, Sandoz, Inc.

    9:15 a.m. – 10:00 a.m.
    Questions and Answers/Discussion with Additional Panelists
    Anissa M. Cheung, MSc,
    Senior Regulatory Coordinator, CBER, FDA
    Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, FDA
    Patrick J. Lynch, PhD, Lead Biologist, CDER, FDA

    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

    Poster Presentations

    The following posters will be presented during refreshment breaks on Thursday and Friday
    1. Cleaning Cycle Development for Parts Washer
      Richard Chai, Technical Service Manager, STERIS Corporation
    2. Evaluation of a Semi-Automated Endotoxin Testing Workflow Using a Recombinant Factor C (rFC) Assay and an Automated Pipetting Robot
      Gregory Devulder, PhD, Endotoxin Program Director, bioMerieux
    3. The Emerging Immune Context in Microbiological Control as Developed by FDA Researchers
      Kevin L. Williams, Senior Scientist R&D, BioMerieux
    4. Case Study on the Use of an Online Water Bioburden Analyzer to Support a Reduction in Traditional Grab Samples
      Allison A. Scott, PhD, Senior Principal Scientist, Azbil North America Research and Development - BioVigilant
    5. Enabling the Development of Oxygen Sensitive Products: A Case Study of Process Development, Key Learnings, and Conclusions
      Margaret B. Musser, PhD, Senior Scientist, Process Development, Abbvie
    6. A New Approach for Biosimilarity Assessments: Case Study
      Jose C. Menezes, PhD, CEO, 4Tune Engineering
    7. Analytical Similarity Assessment of a Candidate Biosimilar to Eculizumab
      Katariina M. Hutterer, PhD, Senior Scientist, Amgen Inc.
    8. Factors that Impact Process Efficiency and Product Quality of Lyophilized Biologicals
      Charu Srinivasan, PhD, Scientist, CDER, FDA

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

    TRACK: BIOSIMILARS

    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.

    10:45 a.m. – 11:15 a.m.
    Regulatory Perspective on the Management of Lifecycle Similarities in Biosimilars
    Maria T. Gutierrez Lugo, Supervisory Chemist, CDER, FDA

    11:15 a.m. – 11:45 a.m.
    Monitoring Post-Approval Process Changes of Biosimilars
    Hillel P. Cohen, PhD, Executive Director, Sandoz, Inc.

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

    TRACK: VACCINES

    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.

    10:45 a.m. – 11:15 a.m.
    3Rs in Quality Control of Human Vaccines: Opportunities and Challenges
    Sue C. Nelson, PhD, Global Analytical Expert, 3Rs and Immunology, Sanofi Pasteur

    11:15 a.m. – 11:45 a.m.
    The Use of Comparability Protocols to Manage Post-Approval Changes in Biologics
    Anissa M. Cheung, MSc, Senior Regulatory Coordinator, CBER, FDA

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

    12:15 p.m. – 1:45 p.m.
    Networking Lunch

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

    TRACK: BIOSIMILARS

    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.

    1:45 p.m. – 2:05 p.m.
    A Streamlined Bioanalytical Approach to Select a Compatible Primary Container System for Biosimilars Early in the Drug Development Program
    Ranjana Singh, PhD, Senior Scientist, West Pharmaceuticals, Inc.

    2:05 p.m. – 2:25 p.m.
    Regulatory Perspective on the Comparability and Similarity in Biosimilars
    Klara C. Tiitso, MSc, Scientific Administrator, European Medicines Agency

    2:25 p.m. – 2:45 p.m.
    The Biosimilar Comparability Journey 
    Maria Fernanda R S Thees, Manager of the Office of Biological Products, Agência Nacional de Vigilância Sanitária - ANVISA  

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    TRACK: VACCINES

    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.

    1:45 p.m. – 2:15 p.m.
    Case Study: Complexity of Vaccine Lifecycle Management, Associated Supply Challenges, and Potential Enablers
    Kimberly Duffy, Executive Director, Global Regulatory Affairs Vaccines CMC, Merck & Co., Inc.

    2:15 p.m. – 2:45 p.m.
    Optimizing Critical Reagent Manufacture for Consistency: Understanding the Impact of Production Parameters and Bioassay Performance
    Jodi A. Pegg, Principal Scientist, Pfizer Biotherapeutics Pharmaceutical Analytical Research and Development

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    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.

    4:00p.m. – 5:30 p.m.
    Panel Discussion
    Kimberly Duffy,
    Executive Director, Global Regulatory Affairs Vaccines CMC, Merck & Co., Inc.
    Maria Fernanda R S Thees,
    Manager of the Office of Biological Products, Agência Nacional de Vigilância Sanitária - ANVISA
    Klara C. Tiitso, MSc, Scientific Administrator, European Medicines Agency

    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

    TRACK: BIOSIMILARS

    Biosimilars Interest Group Breakfast Session
    Moderator: Stephan O. Krause, PhD,Head of Product Quality Group,AstraZeneca Biologics and Bev Ingram, PhD, Senior Director, Portfolio Lead Biosimilars Regulatory Affairs, Pfizer Inc.

    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.

    7:30 a.m. – 8:00 a.m.
    Challenges for Demonstrating Analytical Similarity and Data Quality for Sponsors of Biosimilars for the U.S. Market
    Stephan O. Krause, PhD, Head of Product Quality Group, AstraZeneca Biologics

    8:00 a.m. – 8:30 a.m.
    Questions and Answers/Discussion

    TRACK: VACCINES

    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) that will address vaccine-specific issues related to the topics of lifecycle management, specifications, and manufacturing considerations.

    Participants will have the opportunity to provide input to the technical report(s) proposal, become part of the task force and learn from your colleagues in the vaccines field.

    7:30 a.m. – 8:30 a.m.
    Open Discussion

    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.

    8:45 a.m. – 9:15 a.m.
    Statistical Approaches and Considerations for QbD in Bioassay Development
    Ryan T.  Yamagata, MS, US Function Head, CMC Statistical Sciences, GSK Vaccines

    9:15 a.m. – 9:45 a.m.
    QbD Considerations for Biosimilar Drug Development
    Stanley M. Speaker, MS, Co-Development Team Leader, Pfizer Inc.

    9:45 a.m. – 10:15 a.m.
    Questions and Answers/Discussion

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

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

    TRACK: BIOSIMILARS

    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.

    10:45 a.m. – 11:15 a.m.
    Expectations and Approaches for Development of Biosimilar Products: A Regulatory Perspective
    Patrick J. Lynch, PhD, Lead Biologist, CDER, FDA

    11:15 a.m. – 11:45 a.m.
    Challenges in Biosimilars Development with Evolving Reference Product PQ Attribute Ranges
    Suresh Vunnum, PhD, Director, Global Operations & Biosimilars PD, Amgen Inc.

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

    TRACK: VACCINES

    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.

    10:45 a.m. – 11:15 a.m.
    Novel Self-Amplifying mRNA (SAM) Technology
    Kunal Aggarwal, PhD, Director, Head of Technical R&D Programs, US R&D Center, GSK Vaccines

    11:15 a.m. – 11:45 a.m.
    Adjuvant Formulations: Manufacturing and Control
    Erik Laursen, Director, GMP Operations, Infectious Disease Research Institute

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

    12:15 p.m. – 1:45 p.m. 
    Networking Lunch

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

    TRACK: BIOSIMILARS

    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.

    1:45 p.m. – 2:15 p.m.
    Biosimilar Global Submissions: Challenges and Opportunities
    Janett E. Mugaburu-Richards, MS, Global Regulatory Strategist, Pfizer Inc.

    2:15 p.m. – 2:45 p.m.
    Global CMC Requirements for Biosimilars
    Sian E. Estdale, MSc, PhD, Head of Science and Innovation, Chemistry Solutions, Covance 

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion with Additional Panelist
    Maria Fernanda R S Thees,
    Manager of the Office of Biological Products, Agência Nacional de Vigilância Sanitária - ANVISA

    TRACK: VACCINES

    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.

    1:45 p.m. – 2:15 p.m.
    Novel Low-Cost, High Intensity Viral Vaccine Manufacturing Platform
    Alfred Luitjens, Global Technical Director, Batavia Biosciences

    2:15 p.m. – 2:45 p.m.
    Challenges in Novel Therapeutic Vaccines: New Generation Biologics
    Indu Conley, Department Manager, DPS

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

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

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

    We are constantly challenged to develop new and innovative ways to develop drugs. Various modes, such as continuous manufacturing, has 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 advanced manufacturing platforms and how these concepts can shape our industries future.

    3:45 p.m. – 4:15 p.m.
    End-to-End Modular Manufacturing for Distributed Production of Biopharmaceuticals
    Chris Love, PhD, Professor, Massachusetts Institute of Technology

    4:15 p.m. – 4:45 p.m.
    cGMP Plasmid Vaccines: Breakthroughs in Electroporation, Manufacturing and Quality Control
    EJ Brandreth, III, MBA, Senior, Vice President, Quality, Inovio Pharmaceuticals

    4:45 p.m. – 5:15 p.m.
    Questions and Answers/Discussion

    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:

    • Identify 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 guidances are shaping regulatory framework
  • Who Should Attend

    Who Should Attend

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

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

  • 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:

    ACPE # 0116-0000-19-022-L04-P | 1.2 CEUs
    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.

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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.

Hilton Long Beach

701 West Ocean Boulevard
Long Beach, CA
Phone: +1 (562)-983-3400

  • Accommodations

    The cut off date has now past, however reservations can still be made on a space-and rate-available basis only. To make a reservation, please contact the Hilton Long Beach directly at +1 (562)-983-3400. Check-in time is 3:00 p.m.; 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. 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.

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More information coming soon.

Directions

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Registration Type Early/Regular Registration Prices
Conference
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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

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