Day 1
20 June 2019
  • 0700 - 1800
    Registration Open
  • 1300 - 1400
    Opening Plenary Session - Setting the stage: Key Regulatory Aspects of Successful Bio Process Validation
    This session will include opening remarks from ISPE President and CEO, John Bournas. That will be followed by a keynote presentation on Regulatory insights and trends on key aspects of successful bio process validation.
    Session Leaders
    Senior Director, TL Validation
    Pfizer Inc.
    Session Description
    [Regulatory Trends Related to Bio Product Validation]
    Speaker: Keith Webber
    Since the regulation establishment of the FDA’s Good Manufacturing Practices regulations in 1978, there have been continual efforts to keep their implementation current with technological advancements in the pharmaceutical and medical fields. Recent technological advancements include new manufacturing methods (e.g., single-use bioreactors), new products (e.g., cell and gene therapies), new analytical test methods, and increased use of computer control systems. This presentation will focus on the impact of these changes on validation requirements and what the future may hold.
    || [Welcome and Opening Remarks ]
    Speaker: John Bournas
    Speakers
    Placeholder Person Graphic
    VP, Biotechnology
    Lachman Consultant Services
    CEO and President
    ISPE
  • 1400 - 1530
    Process Development and Design for Process Validation Success
    This session includes several presentations related to Stage 1 of process validation: process development and design. These presentations include one by GSK on leveraging clinical manufacturing experience to develop a process control strategy, one by Roche-Genentech on accelerated development for a breakthrough therapy product, and a blood product case study which leveraged Stage 1 information.
    Session Leaders
    Senior Director, TL Validation
    Pfizer Inc.
    Session Description
    [Case Study: Stage 1 Process Validation Approaches for an Accelerated Biologic]
    Speaker: Thanmaya Peram
    Accelerated CMC development is the “new normal”, with a focus on getting transformative therapies to patients faster. This presentation explores process validation approaches that could potentially enable a faster path to submission, and still meet Health Authority expectations. In this case study, prior knowledge and manufacturing experience was used extensively in risk assessments to eliminate stage 1 process validation studies, identify critical process parameters, and establish acceptable ranges for manufacturing. This case study demonstrates that this lean approach can be used to deliver a validated process and complete data package in the initial marketing application for an accelerated biologic. || [Leveraging a Robust PV Stage 1 to Ensure Successful PV – A Blood Products Case Study ]
    Speakers: Louis Traglia & Diana McCray
    The focus of this topic is a case study in preparing a Blood Plasma purification facility for Process Validation runs, with the realized goal of having process performance at or better than the established transferring facility.
    Many organizations proceed into process validation runs with high levels of trepidation and concerns over the risk of failures. Each failure in the form of deviations of course raises the risk of overall process failure, resulting in run failures, extra runs, and in the worst cases failure to obtain regulatory release. However, the presenters contend, that a well planned and executed engineering run program, which is used to groom all aspects of the process, can dramatically lower the chance of failure, and give management confidence to move forward.
    Comprehensive engineering runs should be used to not only test, but to refine the entire manufacturing process. Our proposed presentation will discuss a successful effort and the comprehensive program that was developed. This presentation is a case study of a greenfield blood plasma purification facility. Ms. McCray, who was the PV lead, will focus her comments on issues around testing and improving the process during the engineering runs. Intermixed with this, Mr. Traglia, who was the overall plant lead for the project will focus his comments on all the other aspects that needed to be groomed in order to ensure that the facility was fully ready for PV runs, and the metrics used to demonstrate readiness. This will include development of the Electronic Batch system, Training and other aspects of the program.
    || [Leveraging Clinical Manufacturing Experience in Development of the Commercial Process Control Strategy]
    Speaker: Phil Smith
    For accelerated clinical programs such as those with FDA Breakthrough Therapy designation, product-specific experience in the commercial manufacturing facility may be limited or simply not available when the initial version of the PCS is being developed. This presentation will outline an approach to PCS development for accelerated Biopharmaceutical programs that leverages clinical manufacturing experience in direct support of Process Qualification in the commercial facility.
    Attendees will build their understanding of control strategy development, clinical manufacturing, and Process Validation.
    Speakers
    Placeholder Person Graphic
    Senior Engineer & Group Leader
    Genentech
    Placeholder Person Graphic
    Principal Consultant
    Commissioning Agents, Inc.
    Director, Process Technology
    GlaxoSmithKline
  • 1530 - 1600
    Networking Break
  • 1600 - 1800
    Next Generation Challenges in Process Validation
    The approach to process validation (PV) has become an area of rapid evolution starting with the publication of the numerous regulatory guides (FDA, EU Annex 15, etc.) which drove industry implementation of a lifecycle approach with on-going process knowledge and optimization. This session will provide case studies and discussion on how the next frontier of Bioprocessing PV challenges are being addressed which include:
    - PV of continuous biomanufacturing, which potentially offers process efficiencies but, only with technical experience and sufficient data to model product quality's dependence on raw materials as well as process parameters and the various permutations within,
    - Questions raised and pragmatic solutions identified for the validation of unique cell/gene therapies such as CAR-T with patient specific batches.
    Session Leaders
    Vice President of Quality & Manufacturing Sciences
    Maia Pharmaceuticals
    Session Description
    [Process Validation for Continuous Manufacturing ]
    Speaker: Jie Chen
    Speakers
    Placeholder Person Graphic
    VP, CMC Management
    Wuxi Apptec
    Placeholder Person Graphic
    Director, Manufacturing Science & Technology
    Xellia Pharmaceuticals
  • 1800 - 1930
    Welcome Reception
Day 2
21 June 2019
  • 0700 - 1600
    Registration Open
  • 0800 - 0900
    Regulatory Insights on Bio Process Validation
    The lifecycle approach to process validation places additional challenges on how companies demonstrate that drug substances and products are ready for commercialization and these challenges are most marked in the area of biological and emerging products where submissions need to clearly demonstrate that manufacturing processes are robust in situations where often sample sizes are small and understanding of the impact of variation from some sources may still be developing at scale.

    Regulatory submissions for bio products utilizing life-cycle approaches have become more common-place. In this session, we will hear one regulator's view of the challenges they see specific to process validation for these products and concerns they have through their lens - primarily from the perspective of what is presented for review or during site inspections. Following this we will hear from an industry consultant specializing in planning for and remediating problematic submissions and/or products on their perspectives and trends they have observed in this area. We will follow these presentations with a panel discussion on the points made with the opportunity for delegates to present questions or their own observations specific to these issues.


    Session Leaders
    Partner
    SynoloStats LLC
    Principal/Director
    New Wayz Consulting Ltd
    Session Description
    [One Reviewer’s Perspective on the Challenges of Process Validation]
    Speaker: Alexey Khrenov
    Process validation is defined as the collection and evaluation of study results to establish scientific evidence that a manufacturing process can consistently deliver quality product. For biological products, an adequate validation of the manufacturing processes of the drug substance and drug product is required prior to the submission of the Biologics License Application. Review of information related to process validation is central to both the BLA review and pre-license facility inspection. Deficient process validation frequently results in failures in product manufacture, and license application. In this presentation, I will discuss and illustrate with case studies the common challenges to validation of the manufacturing process for biological products.
    Speakers
    Senior Staff Fellow
    USFDA/ CBER/OTAT/DPPT/HB
  • 0900 - 0930
    Networking Break
  • 0930 - 1100
    Process Performance Qualification: PV Stage 2 & 3
    This session is focused on emerging challenges and solutions for biologics in Stage 2 of the lifecycle, Process Performance Qualification.
    Session Leaders
    Partner
    SynoloStats LLC
    Principal/Director
    New Wayz Consulting Ltd
    Session Description
    [Beyond Core ProcessesEnhancing and Expanding APC and CPV Application]
    Speaker: Jaden Taylor
    Speakers
    Partner
    SynoloStats LLC
    Manufacturing Scientist II
    Biogen
  • 1100 - 1200
    Workshop Part 1 - Emerging Process Validation Challenges - Collaborative Problem-Solving
    This event is called "a workshop" for good reason. This is the sixth iteration of the ISPE PV Conference, and much of the work ISPE has completed in the area of PV has come from industry discussing and sharing their concerns and experiences around challenges we face in application of lifecycle approaches to validation. We intend to continue this successful formula to understanding best practice and improving outcomes for our companies and patients during this event.

    Prior to this workshop we have identified some of the key and/or emerging concerns and challenges of implementation of lifecycle approaches for Bio Process validation. Prior to the start of this session, we will present delegates with a selection of these "hot topics" and provide an opportunity to add to the list. We will then encourage attendees to select a small number of these topics and break out into facilitated groups to formulate problem statements, discuss these issues and share experiences regarding them in an effort to develop further understanding of potential solutions or to break down these issues further. The discussion will then continue in Workshop Part 2.
    Session Leaders
    Partner
    SynoloStats LLC
    Principal/Director
    New Wayz Consulting Ltd
  • 1200 - 1300
    Networking Lunch
  • 1300 - 1400
    Workshop Part 2 - Emerging Process Validation Challenges - Collaborative Problem-Solving
    Following the breakout discussions in Workshop Part 1, we will reconvene for readouts and a panel discussion. Facilitators from the breakout sessions will share a summary of discussions and conclusions, and serve as panelists for the continuing discussion of key areas of interest identified in the session. This work will be used to inform ISPE's PV team on new projects to consider or areas where existing work could/should be revisited. We will also provide delegates with the opportunity to continue their involvement with areas of ongoing interest arising out of these discussions.
    Session Leaders
    Partner
    SynoloStats LLC
    Principal/Director
    New Wayz Consulting Ltd
  • 1415 - 1515
    Ongoing Process Verification
    Continued Process Verification / Ongoing Process Verification programs are essential to maintaining a validated state and can be especailly challenging for Bio Product processes. This session will explore appropriate use of statistics and other data evaluation methods for bioproduct processes including real examples. Additionally, a case study of garnering support for and effective implementation of a corporate wide initiative to assure appropriate manufacturing process monitoring and visibility to management will be shared.
    Session Leaders
    Director of Commissioning, Qualification, and Validation
    DPS
    Advisor, Global Validation
    Eli Lilly and Company
    Session Description
    [Solving Common Data Challenges for Process Validation of Biopharmaceutical Products]
    Speaker: Tara Scherder
    Validation of biopharmaceutical processes is often complicated by data challenges less prevalent in other product platforms. For instance, a lack of data needed to easily develop process understanding or establish acceptance criteria is a common challenge during Process Design and Process Performance Qualification stages for cell/gene therapy products, and particularly any product having breakthrough therapy status. On the other hand, the dilemma for Continued Process Verification may be the efficient evaluation of an overabundance of data from both the upstream and downstream unit operations. Addressing these challenges requires balancing patient risk (including any risk from delay of delivery to market) and resources. In this talk, several statistical and data management approaches that are particularly effective for balancing these often competing needs and successfully implementing the lifecycle approach for biopharmaceutical processes will be presented. || [Driving Continuous Improvement with Product Robustness Framework and CPV]
    Speaker: Maneesha Altekar
    Continued Process Verification (CPV) has now been a regulatory expectation for several years. This presentation will share how AstraZeneca is using this process to proactively identify opportunities for improvement to continue to meet supply chain requirements and ensure successful changes.
    Speakers
    Placeholder Person Graphic
    Partner
    SynoloStats, LLC
    Sr. Technical Manager, Product Robustness CoE
    AstraZeneca
  • 1515 - 1645
    Next Generation Validation Challenges: FDA Presentation and Regulatory & Industry Panel Discussion
    The FDA will explain biosimilar PV related concerns resulting from recent FDA experience with PV information included in biosimilar submissions and discovered in pre-approval site visits. The session will conclude will a panel discussion including FDA and industry experts answering bio product PV questions submitted by the participants.
    Session Leaders
    Advisor, Global Validation
    Eli Lilly and Company
    Session Description
    [Closing Remarks ]
    Speaker: Gretchen Allison
    || [Manufacturing and Process Validation Challenges and Expectations Associated with Biosimilar Applications]
    Speaker: Jeffrey Baker, PhD
    The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in March 2010 and created an abbreviated pathway for regulatory approval of biologic medicinal products that are highly similar with no clinically relevant differences to an FDA approved biologic product. In addition to providing additional options for the sourcing of medicines, the biosimilars program in the United States has provided an opportunity to employ new analytics and manufacturing control schemes to established biomolecules and has renewed discussions about concepts associated with clinical relevance, statistical analysis of product and processing, and employment of a Totality of the Evidence approach to regulatory oversight, developments which have proven relevant to the entire biologics portfolio. This talk will discuss lessons learned about bioprocess validation and the assurance of reproducible bioprocessing from the review of biosimilar applications and relevance to our understanding process validation for biopharmaceuticals in general.
    Speakers
    Placeholder Person Graphic
    VP, Biotechnology
    Lachman Consultant Services
    Senior Staff Fellow
    USFDA/ CBER/OTAT/DPPT/HB
    Manufacturing Scientist II
    Biogen
    Senior Director, TL Validation
    Pfizer Inc.
    Deputy Director, Office of Biotechnology Products
    FDA/CDER/OPQ/OBP
    Placeholder Person Graphic
    Partner
    SynoloStats, LLC
    Sr. Technical Manager, Product Robustness CoE
    AstraZeneca