Agenda

Virtual session times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.


 

Day 1 - Day 3
15 March - 17 March 2021
Day 1
Monday, 15 March 2021
  • 0830 - 1000
    Opening Plenary Session
    In this opening session, representatives from FDA and from industry will give their high-level perspective on where the Pharmaceutical Industry is heading. The COVID-19 crisis saw drastic changes in the way of working, but also tremendous efforts from the pharmaceutical industry to develop therapies and vaccines for SARS-Cov2 infections. Rapid development, commercial upscaling and distribution are needed to deliver to the patients. Ways of working need to be rethought, procedures developed and implemented at high speed.
    Session Leaders

    Joerg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers

    Joydeep Ganguly

    Senior Vice President, Corporate Operations
    Gilead Sciences Inc

    Joerg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Presentation Information
    [Public-Private Partnership for Pandemic Preparedness and Response]
    Speaker: Jean Hu-Primmer
    The world has come together during these unprecedented times to respond to the COVID-19 pandemic. Health authorities and regulatory agencies are working closer than ever with industry in an effort to expedite and make available COVID-19 medical countermeasures globally. Public-private partnership demonstrates that the steadiness and resolve of the public sector coupled with the innovation and agility of the private sector can move mountains to save lives.
    || [ISPE Foundation Update]
    Speaker: Tony Moreira
    Co-Speaker: Joydeep Ganguly
  • 1015 - 1115
    Intersection of ATMPs and New Technologies
    Advanced Therapy Medicinal Products (ATMPs), are medicines for human use that are based on genes, tissues, or cells. ATMPs offer novel ways to treat a variety of diseases, and in some instances can be curative. As ATMPs move out of the clinic and become commercialized, manufacturers face traditional challenges of scale-up, transfer and the application of new technologies. This session will explore this intersection. You will hear from experts in the field who will provide valuable technical insight and case studies to the participants.
    Session Leaders
    Speakers

    Melanie Bull

    Director, Oxbox & Fill Finish Operations
    Oxford Biomedica

    Rob Roman

    Head of Quality Systems & Compliance
    Roche / Genentech
    Presentation Information
    [Tech Transfer of ATMP Applications from Cleanroom to Isolator]
    Speaker: Marco Fadda
    The use of Isolators technology in the production of ATMPs has been recently developed. For this reason, we need to set transfer of protocols initially developed for grade B. Habits need to change and procedures carefully tuned to avoid bottlenecks and to ensure smooth running. Introduction of raw and starting materials needs a careful evaluation. Containers study and procedures for cleaning and disinfection must be defined and validated. Evaluate the need of an initial package of consumables when starting a batch and what can be introduced using the pass box. Limit the materials introduced in one shot. Special attention deserve waste disposal, cells cultivation and finished product; Different solutions can be applied, like canisters, continuous tubes, dedicated waste containers. All the points above call for detailed procedural approach, good workbench organisation and optimised space management. Space is limited and every item should be considered and studied in details. Despite this great and careful work, it is worthwhile to do, so given the advantages offered by isolators. SSCB Swiss Stem Cells Biotech, a year ago undertook the tech transfer of the Adipose-derived SVF (Stromal Vascular Fraction) production from clean room to isolators. We now produce ATMPs only using isolator technology.
    || [Combined Formulation-Fill-Finish of ATMPs: Lentiviral Vector – Oxbox Case Study Revisited – One Year Out]
    Speaker: James Drinkwater,
    Co-Speaker: Melanie Bull
    This presentation is part 2 of the Oxford biomedica Oxbox project case study presenting a combined Formulation-Fill-Finish platform for ATMPs including a lentiviral vector for CarT Cell therapy. The presentation covers an inventive approach to remote-virtual FAT through the Covid 19 crisis, the development of a Contamination Control Strategy (CCS) for Annex 1 compliance that also covers an Aseptic-Containment strategy to manage cross contamination control. The processing platform combines manual and highly automated processes for vial filling with consideration to IV Bag filling. Processing is fundamentally applied with use of pre-sterilized containers and single use systems with aseptic processing applied with limited glove interventions into the barrier to a minimize risks yet provide flexibility for processing different ATMPs. The Oxbox project also follows Scale out rather than Scale up principles with modular yet flexible cleanrooms and barrier technology.
  • 1015 - 1115
    Contamination and Cross Contamination Control for Bio Safety
    The ISPE Student Chapter (SC) Munich is currently working on an industry project named "Biosafety Project" together with all other ISPE D/A/CH Student Chapters. The aim is to develop a guideline on how to define organizational and technical measures for keeping the operator and environment safe when manufacturing cell and gene therapies (CGT) - whilst fulfilling GMP requirements at the same time. In the first presentation the current work of the team regarding Biosafety requirements and implementation is presented, current obstacles are discussed, and future steps are shown.

    Operator Safety was one of the major goals to combine the flexibility to handle liquid and lyo products with fully isolated equipment, to guarantee the highest degree for a BSL 2 Viral Vaccine Fill and Finish Facility. The major hurdles from a project execution perspective will be presented from Bavarian Nordic/ CDMO.
    Session Leaders

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Speakers

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Presentation Information
    [BioSafety and Requirements for GMP and Occupational Safety during Manufacturing]
    Speaker: Christoph Bierer
    Co-Speaker: Florian Burkart
    The ISPE Student Chapter (SC) Munich is currently working in an industry project named "Biosafety Project" together with all other ISPE D/A/CH SC's. The aim is to develop a guideline on how to define organisational and technical measures for keeping the operator and environment safe when manufacturing cell and gene therapies (CGT) - whilst fulfilling GMP requirements at the same time. In this presentation the current work of the team regarding Biosafety requirements and implementation is presented, current obstacles are discussed and future steps are shown.
    || [Vaccines for the World - Insights into Design and Execution of a BSL2 Fill-Finish Facility ]
    Speaker: Rutger Vandiest
    Co-Speaker: Matthias Angelmaier
    Co-Speaker: Mark Miller
    The design and implementation of a state-of-the art fill finish facility for viral vaccines faces numerous challenges. Besides the right facility design with focus on BSL2 aspects, this project had the challenge of a very short timeline (fast-track project) combined with facility space limitations. One major goal was to combine the flexibility to handle liquid and lyo products with fully-isolated equipment, to guarantee the highest degree of operator safety . Besides that, the presentation covers also insights into the background for handling of viral vaccines as well as the major hurdles from a project execution perspective.
  • 1115 - 1215
    EXHIBIT SHOWCASE / POSTER PRESENTATIONS / LIVE DEMOS
    Visit the Partner Showcase to get the latest information on new technologies, and services.  Check out the product demos and Professional Posters as well. Open 24 hours for your convenience!
  • 1115 - 1215
    BRING YOUR OWN LUNCH Networking Opportunity
    Join us in the Networking Lounge to reconnect with colleagues. Make a plan to meet there and share a virtual lunch!
  • 1215 - 1315
    Facility Considerations for Next-Generation Manufacturing
    Facility Considerations for Next-Generation Sterile Product Manufacturing | The rise of advanced therapy medicinal products has taken the industry by storm over the past few years. This session will look at the engineering challenges that these products present to facility designers and operators. Flexibility is a key with the reduced batch size associated with these products. This session will address how this needed flexibility can be designed into ATMP manufacturing facilities.
    Session Leaders
    Speakers
    Presentation Information
    [Challenges Associated with Gene/Cell Therapy Facilities]
    Speaker: Tyler Kaleta
    Gene/Cell Therapy is a rapidly emerging novel therapeutic technology in the biotech industry. Applications for these therapies are wide-ranging from cellular immunotherapies to cancer vaccines, and new facilities are being designed and built quickly to support the production of these new drugs. Manufacturing facilities that are designed to handle cell/gene therapy unique challenges compared to traditional bulk biologics and mAB facilities as their processes/products are still in development and are subject to change. Many gene/cell therapy facilities will utilize live virus during production which poses additional design/operational considerations to ensure aseptic product handling throughout the manufacturing process. This panel discussion aims to bring together knowledgeable people that have worked through the design and startup of gene/cell therapy facilities from organizations that are leading the charge for this novel technology. Conversation around major challenges/considerations in design, startup and operation of these facilities will be the focal point of this discussion.
    || [ATMP Facilities: Multimodal Manufacturing for a Magic Bullet]
    Speaker: Peter Walters
    Co-Speaker: Matthew Hewitt
    CMOs need the flexibility to respond to ever-evolving client needs. Likewise, manufacturers who are bringing their ATMP production activities in-house have complex product pipelines and need the flexibility to develop different modalities in parallel, unsure of which will ultimately go to market. Both are united by the same challenge: they need a facility that can accommodate a pipeline of four or five product types, each requiring a highly sensitive process. But designing a bespoke production suite unique to each modality would lead to astronomical costs and a sprawling, inefficient facility. This presentation will illustrate how multimodal suites allow ATMP manufacturers to campaign between modality-specific process platforms, which raises the value of each square foot inside a facility. This level of flexibility, once considered outside the realm of possibility for such highly customized and novel processes, is now emerging as an essential feature of an efficient ATMP facility design. Each attendee will learn how to: - Protect investments with a facility built for change - Get up and running with industry-leading rapid deployment -Easily scale a facility as pipeline evolves - Understand costs and schedule Fight cancer with an mAb product. Fight a pandemic with a vaccine platform. Do it all in the same manufacturing suite, weeks apart.
  • 1215 - 1315
    Containment - Understanding Why, When, and What Regulatory Agencies Expect
    For10 years - the Risk Based Manufacture of Pharmaceutical Products has defined expectations for cross contamination control to protect patients. Understand what cross contamination control: why it is needed, when it is needed, how to determine the extent of what is needed, and what the regulatory environment is regarding cross contamination control to protect patients. This protection translates into requirements to also protect operators.
    Session Leaders
    Speakers

    Tom Evans

    Director; Environmental Health and Safety
    Abzena
    Presentation Information
    [Are You Protecting Your Employees During HPAPI Manufacturing?]
    Speaker: Tom Evans
    This presentation will discuss the planning, resources, and capabilities necessary to effectively produce a client’s highly potent active pharmaceutical ingredient (HPAPI) therapeutic, while effectively controlling the risk of exposure to operating personnel. Controlling exposure is a critical factor in successfully bringing many of today’s novel highly-potent drugs to the clinic and eventually to the commercial market. Successful manufacture of HPAPIs includes containment design and installation considerations, Best Industrial Hygiene Practices vs. Good Manufacturing Practices, and the process of characterizing, challenging, and verifying isolator performance..
    || [ Aseptic Meets High-Potent – Next Level ADC Processing]
    Speaker: Christoph, PhD Knoop
    Co-Speaker: Matthias Angelmaier
    The processing of HPAPI's, especially ADC's faces multiple challenges in terms of equipment design ,execution as well as handling/operation. This presentation covers besides an introduction into ADC's, a realized customer project to identity the major challenges in terms of aseptic high-potent fill-finish equipment. Besides having the right Isolator and filter systems design, the focus needs to be on the filling equipment and the right cleaning and wash-in-place procedures to secure both the product as well as the operators.
  • 1315 - 1400
    ASK THE EXPERTS Networking Opportunity
    Join us in the Networking Lounge to engage with the speakers about their topics. Ask questions, share your experiences, make new connections!
Day 2
Tuesday, 16 March 2021
  • 0800 - 0900
    EXHIBIT SHOWCASE / POSTER PRESENTATIONS / LIVE DEMOS
    Visit the Partner Showcase to get the latest information on new technologies, and services.  Check out the product demos and Professional Posters as well. Open 24 hours for your convenience!
  • 0900 - 1000
    Plenary Session
    2020 saw the commenting of the draft Annex 1, which included many changes to the 2017 version. In this session, we will cover the commenting process both from the ISPE and the PHSS perspective. Selected topics will be discussed in detail. Based on the outcome of the session with regulators from the 2020 ISPE Annual Meeting, we will give an outlook on the implementation of the final guidance issued by EMA.
    Session Leaders

    Joerg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Speakers

    Joerg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.
    Presentation Information
    [ISPE Annex 1 Comments – Part 1]
    Speaker: Jean Francois Duliere
    || [Annex 1 Barrier Technologies, Classification-Qualification (PHSS)]
    Speaker: James Drinkwater
    Annex 1 is highly important to all involved in sterile medicinal and Advance Therapeutic medicinal products manufacturing as such clarity of requirements is essential. The targeted consultation of Annex 1 version 12 received many comments on the concern in the lack of clarity in sections for Barrier technologies and Cleanroom and clean air devices classification and qualification. The PHSS prepared alternative test to address the industry concerns and submitted to the EC in the formal targeted consultation process. The main concerns with the barrier technology section in version 12 of Annex 1 was the lack of differentiation between RABS and Isolators. The concerns with Classification and Qualification related to interpreting the generic classification requirements from ISO 14644 and application in a Pharmaceutical setting particularly handing at rest and in operation classification. This presentation considers the key points to understand clarity of regulatory expectations, how barrier technologies have developed to meet CGMP requirements and how Classification-Qualification should be applied as a phased process through Classification, environmental qualification and APS qualification into routine production process monitoring.
  • 1015 - 1115
    H2O2: Not the Same Old Topic
    H2O2 decontamination has evolved over the years. As aseptic processing has progressed within isolators and within operating rooms, H2O2 has evolved to be used not only as equipment decontamination but also as room decontamination. As ATMP processing has progressed in the past few years, H2O2 has taken on new importance. How should you use H2O2 and what do you need to understand? This panel knows.
    Session Leaders
    Speakers

    Markus Lesch, PhD

    Head of Microbiological Validation
    Vetter Pharma-Fertigung GmbH & Co KG
    Presentation Information
    [How can hydrogen peroxide affect your aseptic process?]
    Speaker: Andreas Schachtschneider
    In aseptic production using barrier systems, a variety of differing materials like packaging materials or consumables are present. Nowadays, further new technologies emerge for application of hydrogen peroxide for biodecontamination. However, hydrogen peroxide can interact with materials. This can have significant critical impact on the aseptic process or product. Especially biopharmaceuticals (as most vaccines) are highly prone towards oxidation. In this presentation a basic introduction to the interaction processes between hydrogen peroxide and materials is given, explaining the resulting possible impacts on products or processes. Approaches for practical investigation are discussed and evaluated by means of experimental data of real-life examples from pharmaceutical production. It can be concluded that careful evaluation of interactions between hydrogen peroxide and materials is inevitable when performing process risk analysis and will provide additional safety for the respective aseptic processes. As a result, the conference participant will learn which interactions may occur, how they can have impact on process or product and how to investigate this. Therefore, he will become aware of the necessity of a comprehensive assessment on interactions of hydrogen peroxide and materials.
    || [Cycle development & validation of automated AHP decontamination processes for cleanrooms.]
    Speaker: Markus Lesch, PhD.
    Decontamination of cleanrooms as opposed to Isolators present unique challenges. The volume of the room and the geometric limitations needs to be taken into account. This presentation will describe the development and qualification of a system that was developed to decontaminate RABS cleanrooms using aerosolized hydrogen peroxide. This is specifically useful for flexible cleanrooms with frequent product changeover.
    The details include: Design of decontamination system & cleanroom, optimization of the aerosolized amount of H2O2 selection of positions to be challenged with indicators, optimization of relative humidity, optimization of the decontamination time value of chemical indicators for validation of bio-decontamination processes..
  • 1015 - 1115
    Modular Robotic Fill/Finish Lines
    The use of robotics is a hot topic in pharma, particularly in the area of fill/finish. While robots are able to accomplish numerous tasks, in aseptic processing, their use is primarily for container handling or replacing a classical transport system. They provide very smooth individual transport and, from a line perspective, a completely modular approach. More and more experts are claiming this is not enough. Robotics can and should do more like settle plate handling, trouble shooting, gloveless operation, quick change over, easy efficient cleaning/washing, increased product and operator safety to name some of the possibilities. The need for expanding the use of robotics into a variety of functions was a key topic of discussion during last year’s Aseptic Conference. This year’s session has been designed to continue that conversation and learn from industry experts who are moving forward with implementation.
    Session Leaders
    Speakers

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG

    Thomas Thurn

    Director Drug Product Clinical Supply Chain
    Janssen Pharmaceuticals
    Presentation Information
    [Project Concept & Decision of a Flexible Fully Automated Pilot Plant]
    Speaker: George Frinke
    || [EM for Fully Automated Aseptic Operations]
    Speaker: Thomas Thurn
    Co-Speaker: Richard Denk
    In the new draft Annex 1 the use of automated processes and Rapid Micro Method technologies are mentioned. How can be current technologies for EM monitoring replaced through new innovative technologies.
  • 1115 - 1215
    EXHIBIT SHOWCASE / POSTER PRESENTATIONS / LIVE DEMOS
    Visit the Partner Showcase to get the latest information on new technologies, and services.  Check out the product demos and Professional Posters as well. Open 24 hours for your convenience!
  • 1115 - 1215
    BRING YOUR OWN LUNCH Networking Opportunity
    Join us in the Networking Lounge to reconnect with colleagues. Make a plan to meet there and share a virtual lunch!
  • 1215 - 1315
    Single Use Technologies - Are they sustainable?
    Over more than two decades, the pharmaceutical industry has increasingly adopted single-use technologies primarily to simplify manufacturing and seemingly to reduce cost; however, the need to reduce environmental burden has a huge impact on these facilities. This session will focus on single-use technologies for gene and cell therapy facilities, while considering the impact on sustainability.

    Our first presenter will investigate the impact of single-use with respect to proper cleaning, disposal, and handling, and how it relates to vaccine production including Industry 4.0 and implementation of the 6R's.

    Our second presenter will discuss the unique nature of Advanced Therapy Facilities including the advantages and disadvantages of single-use and modular clean room technology as well as flexible manufacturing for gene and cell therapies.
    Session Leaders
    Speakers
    Presentation Information
    [Utilizing Modular Clean Rooms and Single-Use Technologies ]
    Speaker: Joe Neroni
    Presenters will discuss the unique nature of advanced therapy facilities with a focus on the advantages of using modular cleanrooms and single use technologies in cell and gene therapy. Primary topics include discussion of the following: Modular cleanrooms, Single-use technologies, Advantages of each, Advantages of flexible manufacturing in advanced therapies and Any shortcomings of these technologies.
    || [Cell-based Vaccine Production: Improving the Environmental Footprint]
    Spreaker: William Whitofrd
    Recent national initiatives and international organizational goals speak to the need to address sustainable vaccine manufacturing. Single-Use (SU) based manufacturing technology provides unique health and safety benefits, while contributing a very small fraction of total plastic waste. Nevertheless, materials suppliers, engineers, architects and vaccine manufacturers desire to reduce SU environmental burdens. They report that such powerful initiatives as Industry 4.0, process intensifications and LCA are contributing to the 6 Rs approach to greener use of SU materials: rethink, reduce, reengineer, reuse, recycle and recover energy.
  • 1215 - 1315
    Process Safety
    Robust and safe processes are the foundation of pharmaceutical manufacturing. Changes to processes are inevitable, but often result in increased risks. New processes such as those associated with changes in raw materials or transfer of production to other sites have to be managed properly. In this session, two different examples will demonstrate which methods and structured approaches can be used to effectively maintain process safety, even when they involve major changes.
    Session Leaders
    Speakers
    Presentation Information
    [QRM-Based C&Q for an Animal Health Biopharmaceutical Facility]
    Speaker: Stephen Jackowell
    Co-Speaker:William (Chip) Bennett
    Elanco Animal Health recently completed a facility expansion at its Fort Dodge, IA, site to accommodate the technical transfer of 70 additional products to the facility. This topic will discuss how Elanco incorporated QRM principles into its approach to commissioning and qualification of the facility expansion, following ASTM E2500 and fully compliant with the revised ISPE Baseline Guide Volume 5, which was published while the project was ongoing. Elanco Animal Health in Fort Dodge is a biopharmaceutical facility that produces injectable vaccines for agricultural and domestic animals. The facility is USDA-regulated and must maintain GMPs and aseptic manufacturing conditions to deliver product quality analogous to FDA-regulated facilities for human patients. The nature of patients may differ, but the principles of delivering product quality and patient safety do not. As such, QRM principles can be applied equally to the approach to facility C&Q. This topic will discuss how QRM principles were applied to actual project deliverables throughout the C&Q process, the challenges encountered – and overcome – in applying a QRM-based approach to C&Q, the project outcome, regulatory receptiveness to the approach, and lessons learned.
    || [Replacing Silicone Oil Emulsion in Parenteral Filling]
    Speaker: Stefan Schreyer
    Siliconization of glass containers is a central process in the preparation for filling of parenterals. A change in the main component, namely the silicone oil emulsion, therefore represents a sensitive intervention in the aseptic process. Especially when more than 40 products are affected, careful planning and implementation of such a change is essential. Together with studies in the laboratory, stability studies and the application for further use of this central component, a complex project is created, which is to be presented here. The details will include: The participants will get insights into: Design of the lab study, design of the stability study, insights into ECHA application.
    || [] >
  • 1315 - 1400
    ASK THE EXPERTS Networking Opportunity
    Join us in the Networking Lounge to engage with the speakers about their topics. Ask questions, share your experiences, make new connections!
Day 3
Wednesday, 17 March 2021
  • 0800 - 0900
    EXHIBIT SHOWCASE / POSTER PRESENTATIONS / LIVE DEMOS
    Visit the Partner Showcase to get the latest information on new technologies, and services.  Check out the product demos and Professional Posters as well. Open 24 hours for your convenience!
  • 0900 - 1000
    Devices and Decontamination—Overcoming Challenges
    Aseptic products are oftentimes a component part of a Combination Product. These aseptically filled present technical challenges that will be addressed in this session. Additionally, manufacturers are often tasked with utilizing legacy equipment. This session will also present a unique isolator decontamination approach.
    Session Leaders
    Speakers
    Presentation Information
    [Innovative Decontamination for ATMPs and Aging Isolator]
    Speaker: Ken Nagai
    Robust decontamination for ATMPs, especially for material transfer, has been challenging due to reagent penetration, time inefficiency, temperature increase and so on. This presentation introduces an innovative decontamination method called UltraDecon that can be applied to cell transfer. UltraDecon uses hydrogen peroxide with special ultrasonic for decontamination. This can reduce 6-log decontamination time to as fast as 5 minutes. Of course, this technology is applicable to pharmaceutical sterile manufacturing. Aging isolator can be upgraded with this new decontamination technology. Participants will learn a new decontamination method, which makes new concept of sterile manufacturing possible.
    || [Combination Products Aseptically Filled - Challenges ]
    Speaker: Massimiliano Cesarini
    The presentation will showcase one project to introduce technology advancements in aseptic processing. It relates to a new device to be launched in the market (https://vimeo.com/258993081) which is composed of a freeze dried vial and an aseptically filled bag. The coupling of this two which will constitute the ready-to-mix device needs to take place in an aseptic environment. Due to this some new technology in the aseptic processing within isolator technology have needed to get implemented such as the VHP continous tunnel to have the freeze dried vials entering the Grade A environmnet and IV Bags decontamination. In particular being the first time of implementation of the VHP tunnel technology, performance verification methods as well as regulatory aspects had to be assessed during the project development.
  • 0900 - 1000
    Regulatory View on ATMPs and Make Vs. Buy
    Make vs. Buy in Gene and Cell Therapy and the update on PIC/S Annex 2A Revision for ATMPs will be the topics during this ATMP Session.  Which considerations should be used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third-party manufacturers or use a hybrid approach? This presentation from Project Pharma explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing.  Francesco Cicirello’s update on PIC/S Annex 2A Revision for ATMPs will provide a view of his former position as Senior Subject Matter Expert and GMP Inspector at the TGA in Australia and Chair of the PIC/S Annex 2 working Group about the challenges providing a Guideline for ATMPs. The Interview with Francesco will cover most ask questions related to the PIC/S Annex 2A. A must to attend for all working with ATMPs.
    Session Leaders

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Speakers

    Richard Denk

    Senior Consultant Aseptic Processing & Containment
    SKAN AG
    Presentation Information
    [Make vs. Buy in the Gene and Cell Therapy Space]
    Speaker: Parla Hoelter,
    Co-Speaker: Daniel Foody
    Project Farma details the considerations used in determining whether an advanced therapy company should manufacture therapies internally, utilize external third party manufacturers or use a hybrid approach. This discussion explores the rationale of cell and gene therapy companies using an external CMO or relying on internal manufacturing. With insight from an advanced therapy company that utilizes internal and external manufacturing, Project Farma provides the considerations for both cases. || [Update PIC/S Annex 2A Draft for ATMPs Revision. Interview about the most ask questions on ATMPs ]
    Speaker: Francesco Cicirello
  • 1015 - 1200
    Regulatory and Industry Panel
    The Regulatory and Industry Panel is one of the highlights of this conference. This session features questions and answers of the most daunting regulatory issues facing regulators and industry at this time. You will learn the most current perspectives of thought leaders regarding your most pressing challenges. The session is completely interactive, providing for a very rich experience. You will not want to miss this session.
    Session Leaders

    David Doleski

    Compliance Head for Biologics Quality Operations
    Sanofi
    Speakers

    David Doleski

    Compliance Head for Biologics Quality Operations
    Sanofi

    Brooke Higgins

    Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
    FDA/CDER/OC/OMQ

    Joerg Zimmermann

    Vice President, Vetter Development Service, External Affairs
    Vetter Pharma-Fertigung GmbH & Co.