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Monday
12:30pm - 01:45pm Eastern - October 31, 2022

With the free ISPE mobile app, you can chat with exhibitors, attendees and speakers.


Monday

Biologics Facilities: From now and into the future
Carl J. Carlson,
SME - Biopharma Process, Exyte

A Journey to Digitalization: Autolus Therapeutics

Steve Chapman, Partner, Barry-Wehmiller Design Group

Strategies in Updating an Aging Pilot Plant Facility

Jennifer Jacob, Director, MERCK; Shane Helm, Mechanical Design Engineer, Precis Engineering, Inc.; Raymond Ducoat, Director, Process Operations, Merck & Co Inc

New Blender, Old Facility: A Case Study

Lonna Gordon, Senior Process Design Engineer, PM Group

Innovative Modular Facility Design

Peter Hanson, SME, Process Architecture, Exyte

Optimising Commercial Scale Autologous Cell Therapy Facility Design using Discrete Event Simulation

Philip Lyman, Director of Process Simulation, DPS

Plug & Produce: A case study of MODULAR PRODUCTION thanks to MTP (Module Type Package)

Giuseppe Menin, Industry Manager Pharmaceutical, Ing. Punzenberger COPA DATA GmbH

Is high voltage leak detection ready for Annex I and USP?

Andrea Sardella, PhD, Pharma Inspection Product Development, Stevanato Group S.P.A.

Modeling Defects during Tableting: Formation of Bubbles Resulting from Entrapped Air

Joseph Wright, Research Fellow/PhD Candidate, Drexel University


01:45pm - 03:15pm Eastern - October 31, 2022
Heather Watson, Session Leader, Company Director and Consultant, TenTenTen Consulting Limited; Sion Wyn, Director, Conformity Ltd.; Dr. Arthur D. Perez, PhD, Retired Director Information Governance and Management, Novartis Pharmaceuticals; Dr. Guy Wingate, PhD, Independent Consultant, Glaxosmithkline PLC (Retired)

Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, expanded use of software tools and automation, and modern approaches to managing infrastructure.

The session highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.

Presentations delivered in this session will provide a foundation for the "**New GAMP 5** 2nd Edition roundtable" session which follows on after this session and will allow for a deeper dive into the detail of the Second Edition.


Monday
01:45pm - 03:15pm Eastern - October 31, 2022
Sion Wyn, Director, Conformity Ltd.

An Overview of GAMP 5 Second Edition including drivers and objectives, new topics, and updated materials.


Monday
01:45pm - 03:15pm Eastern - October 31, 2022
Dr. Arthur D. Perez, PhD, Retired Director Information Governance and Management, Novartis Pharmaceuticals

Modern tools for developing and managing computer systems are becoming ubiquitous, and in some cases making traditional "compliance" documents redundant. Learn how GAMP 5 2nd edition leverages this in order to maximize efficiency and maintain patient safety, product quality, and data integrity.


Monday
01:45pm - 03:15pm Eastern - October 31, 2022
Dr. Guy Wingate, PhD, Independent Consultant, Glaxosmithkline PLC (Retired)

The new second edition of GAMP5 provides more than just an update on good practice and facilitating innovative new technologies. It also promotes critical thinking to make validation practices ever more cost effective and efficient. In this presentation learn about the importance of context (seeing the role of the computer system within the broader business process being supported), making better use of supplier activities to reduce duplicated validation effort, and leveraging automated tools alongside the application of science-based risk management.


01:45pm - 03:15pm Eastern - October 31, 2022
Charlotte Enghave Fruergaard, PhD, Session Leader, CEO & Co-founder, PRO Devices A/S; Mr. Steven Hertz, MBA, PE, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER/FDA; Ms. Susan W. Neadle, FAAO, FBCLA, President, Combination Products Consulting Services LLC; Andrei Yosef, PhD, General Manager, Pharmaceutical Solutions, Eitan Medical

Growing expectations for state-of-the-art innovation in the combination product space continue to evolve around the world. Shifts in regulatory frameworks, guidance, control strategies and technical product solutions are making substantive impacts on the delivery of new medicinal therapies. Yet, efforts to drive convergence are in their infancy. 

This session will discuss a range of key shifts in the expectations, practices and state-of-the-art technology solutions, including the QSR Amendment proposed rule, the Genus v. FDA court decision, Essential Performance Requirements, Combination Products Human Factors and Risk Management, EU MDR, and Harmonization Efforts underway. 

Case studies will be presented, reflecting the impacts of these evolving expectations on combination products.


Monday
01:45pm - 03:15pm Eastern - October 31, 2022
Boaz Eitan, PhD, Founder, Chairman and CTO, Eitan Medical; Andrei Yosef, PhD, General Manager, Pharmaceutical Solutions, Eitan Medical

Combination products are an attractive solution for many patients. Such solutions offer both ease of use in treatment administration and also enable the shift of care administration to the home environment. The available device solutions, however, are few, and include simple mechanical autoinjectors or more complex on-body wearable drug delivery devices. The decision regarding which device to utilize is mainly driven by the volume to be injected, or the drug type. Biological drugs, for instance, are composed of large and sensitive molecules, requiring more sophisticated drug delivery solutions.

While good for patients, combination devices are only chosen for specific clinical situations. This is due to the complexity of these products for all stake holders. This complexity stems from the barriers between patient needs, regulatory approval, human factors expert recommendations, drug and device company’s needs, and the current knowledge available to all.

This presentation will bring to the table the possible technologies and concepts that helps reduce the barriers, time and cost in reaching the market.


Monday
01:45pm - 03:15pm Eastern - October 31, 2022
Mr. Steven Hertz, MBA, PE, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER/FDA

Many mission-critical therapeutic solutions may be found in combination products. In this presentation the Agency will provide information to assist industry in its development, application submission, and CGMP compliance of these products. 

Highlights of the recent and evolving regulatory environment that have implications for innovative therapeutic solutions, include: 

  • The Genus Court Decision
  • The QSR Amendment Proposed Rule 
  • FDA Remote Regulatory Assessments (RRA) and how combination products have been impacted 
  • De Novo and other recent submission approvals Combination product manufacturing case studies will also be presented, reflecting the impacts of evolving expectations.

Monday
01:45pm - 03:15pm Eastern - October 31, 2022
Ms. Susan W. Neadle, FAAO, FBCLA, President, Combination Products Consulting Services LLC

As the prevalence of combined-use products continues to grow, the regulatory landscape in this space is increasingly complex. There are, however, common issues and considerations to be addressed across jurisdictions, including systems’ risk-based approaches to development and lifecycle management, ensuring safe and efficacious combined-use of constituent parts, robust collaboration and coordination with suppliers, and sustained market supply for the intended indications. Classification and regulatory constructs for combined-use medical products across jurisdictions are neither stable nor consistent globally. As technology continues to rapidly evolve, harmonization opportunities are evident. Industry needs to exercise caution and be aware of what regulations apply to such combined-use products across jurisdictions.

This presentation will:

  • Review the dynamic global combination product regulatory landscape.
  • Review harmonization efforts underway, including:
    • ASTM International Combination Product Working Group and Standards
    • FDA Proposed rule on 21 CFR 820 harmonization with ISO 13485:2016
    • WHO
    • ISO 14971:2019 and AAMI TIR 105:2020
    • ISPE Module 2 risk-based QoS Harmonization effort

Monday
03:15pm - 03:30pm Eastern - October 31, 2022

03:30pm - 05:00pm Eastern - October 31, 2022
Chris Schwartz, Session Leader, Senior Consultant, L.E.K. Consulting; Christa B. Myers, Aseptic and Sterile Products Market Director, CRB; Mr. Jason S. Collins, AIA, Director of Process Architecture, IPS-Integrated Project Services, LLC

There are countless aging pharma manufacturing facilities around the world that continue to operate on the edge of regulatory failure. They continue limping along for years, squeezing through audits based on extensive data reviews and the application of increased procedural controls. While the need to upgrade, or replace these facilities may be clear to those that operate them every day, teams often find it difficult to receive the significant capital approval to bring the facility up to today’s regulatory standards. If you are responsible for, or work in such a facility, and are looking for some tools and guidance to make facility or equipment improvements, this session is for you.

This session is the next installation of the “Is Your Facility on Borrowed Time” series brought to you by the ISPE Sterile Products Processing Community of Practice. In this interactive session, you will learn how to assess different options for upgrading a legacy sterile manufacturing facility (e.g., transfer to alternative asset, retrofit in place, build adjacent, build greenfield), and determine how to get the most “Bang for your buck” given fixed capital allocation. 

The presentation will discuss decision points and implications of each option, and will include an evaluation of the options against a business case framework to make a robust recommendation to leadership.


Monday
03:30pm - 05:00pm Eastern - October 31, 2022
Chris Schwartz, Senior Consultant, L.E.K. Consulting; Mr. Jason S. Collins, AIA, Director of Process Architecture, IPS-Integrated Project Services, LLC; Christa B. Myers, Aseptic and Sterile Products Market Director, CRB

This presentation will be interactive, engaging the audience to participate by posing questions and asking for their experiences and examples. We start by introducing “the why,” followed with an outline of the regulatory drivers for upgrading a legacy facility, associated consequences, and so forth. 

Following the introduction, we then introduce the business case framework.

  • Problem statement: Regulatory issues and their associated consequences are described in detail.
  • Scope: Alignment on current portfolio and future capabilities.
  • Financials: Robust project financials, especially COGS analysis.
  • Socialization: Key stakeholders are included in the development of the story and leveraged when seeking leadership approval.

The session will then apply this framework to a case study.

  • Introduce a hypothetical case study (e.g., conventional/legacy filling line).
  • Summarize regulatory challenges (problem statement).
  • Summarize scope options for upgrading (e.g., upgrade in place, build adjacent, brownfield, do nothing).
  • Run the financials for each option.
  • Deep dive into the pros / cons / decision points for each option.
  • Develop a recommendation.
  • Summarize potential socialization plan

03:30pm - 05:00pm Eastern - October 31, 2022
Chelsea Coffey, Session Leader, Clinical Drug Supply Change Control, Biogen; Christian Lavarreda, Global Product Manager, Syntegon Technology; Alan Kelly, Vice President, Head of Alofisel Manufacturing and Supply, Takeda Pharmaceuticals Inc.; James Shovlin, Director Project Management - Engineering & Property Services, J&J; Hans Weverling, Project Director Strategic Projects, Janssen Biologics BV (The Neterlands)

Innovation in challenging times has reshaped the global pharmaceutical manufacturing supply infrastructure. The speed and scale of investment into pharmaceutical industry manufacturing capacity brings novel advances to new modalities and digital solutions and with those innovations come challenges with implications for manufacturers worldwide. An integrated and collaborative project execution approach involving various internal and external stakeholders is required to overcome these implications.

This Session will recognize ISPE FOYA 2022 Award Winners in the Pharma 4.0, Supply Chain, Social Impact and Project Execution categories. Takeda’s TaSiVa project exemplifies how the application of innovation in advanced digital technologies leads to improved outcomes in terms of safety, product quality, and productivity in a pharmaceutical manufacturing facility. Takeda has demonstrated the industry’s ability to use IoT solutions to bring manufacturing rights to the patient to overcome shelf-life challenges which may be presented with new and novel products in the coming years.

Janssen is a J&J biopharmaceutical production and laboratory testing facility who utilized its existing vaccine launch facility (VLF) for an opportunity to enable large-scale COVID-19 vaccine drug substance manufacturing by building a new, 25,000 square-foot sterile manufacturing facility adjacent to the existing VLF. This presentation will describe the current manufacturing capacity environment, explain the new modalities and the processes involved in their production, their supply to patients, and provide a perspective on how the industry can most effectively reallocate capacity and future-proof facilities. This was critical to resolving an unmet medical need during the COVID-19 pandemic by providing the world with a single shot COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. An integrated and collaborative project execution approach involving various internal and external stakeholders was required to meet these challenging deadlines.

Syntegon presents a case study that expresses how the number, speed, and scale of manufacturing investments in these COVID-19 vaccines reflect both the proven potential of ATMP modalities as well as the vast implications for bio-manufacturers as they seek to simultaneously meet current demand and future-proof their manufacturing infrastructure. Syntegon discusses the new modalities, describes the specific processes involved in their production, and provides a perspective on the challenges involved in, and solutions needed for, successfully adapting today’s manufacturing infrastructure.


Monday
03:30pm - 05:00pm Eastern - October 31, 2022
Christian Lavarreda, Global Product Manager, Syntegon Technology

The preeminence of mRNA and viral vector-based vaccines in the COVID-19 pandemic response has reshaped the global pharmaceutical manufacturing infrastructure. The speed and scale of investment into manufacturing capacity for these life-saving COVID-19 vaccines has brought these new modalities to commercial maturity in heroic fashion; but in so doing, has also created a massive supply glut with vast implications for manufacturers across the globe. As they seek to simultaneously satisfy current contracts and reposition their production capacity towards products with longer-term demand, manufacturers now face a huge challenge in how best to adapt. 

This presentation will describe the current manufacturing capacity environment, explain the new modalities and the processes involved in their production, and provide a perspective on how the industry can most effectively reallocate capacity and future-proof facilities.


Monday
03:30pm - 05:00pm Eastern - October 31, 2022
Alan Kelly, Vice President, Head of Alofisel Manufacturing and Supply, Takeda Pharmaceuticals Inc.

Takeda was the recipient of 2 FOYA awards this year for pharma 4.0 and Supply Chain. In this session, we’ll learn how Takeda approaches and drives innovation during capital project execution. During the execution of both projects, the project teams were presented with a set of unique challenges and needed to consider novel and innovative solutions to deliver on the objectives of both projects. Learn how Takeda overcame these challenges across using novel automation and digital solutions.

We’ll deep dive into some examples from both projects while also covering the cultural considerations which are critical to driving the digital transformation in our industry today.


Monday
03:30pm - 05:00pm Eastern - October 31, 2022
Hans Weverling, Project Director Strategic Projects, Janssen Biologics BV (The Neterlands); James Shovlin, Director Project Management - Engineering & Property Services, J&J

As COVID-19 started to spread across the world, Johnson & Johnson (J&J) initiated global efforts to develop a potential vaccine against the coronavirus. Soon, successful vaccine candidates were developed. To provide the world with COVID-19 vaccines, J&J needed to increase production capacity. Janssen Biologics, a production facility of biotherapeutics and vaccines in Leiden and part of J&J, was identified to potentially have this capacity. To become one of the main suppliers of J&J’s COVID-19 vaccine, the Vaccines Facility (VF) needed to be expanded at a fast pace.

A project team was installed to build a new, 25,000-square-foot sterile manufacturing facility adjacent to the existing VF. The plans available at the time aimed to expand the facility in five to seven years. However, the current health crisis drove Janssen to develop an enhanced, fast track project plan. The plan aimed for building a brand-new facility and getting it fully operational in twelve months.

These timelines were challenging. But the team did it all within 1 year and 1 day. Hans Weverling, program lead, and James Shovlin, responsible for engineering readiness, will share their key learnings. These learnings include the importance of internal expertise of a dedicated team and an agile mindset, in combination with good collaboration with trusted external partners to bring the best solutions, and efficient cooperation with (local) authorities to pursue all regulatory steps in record time.


Monday
05:00pm - 07:00pm Eastern - October 31, 2022

Tuesday
07:30am - 08:30am Eastern - November 1, 2022

With the free ISPE mobile app, you can chat with exhibitors, attendees and speakers.


Tuesday
10:00am - 10:30am Eastern - November 1, 2022

With the free ISPE mobile app, you can chat with exhibitors, attendees and speakers.