As we enter a transitional period within the pandemic, some uncertainties remain. The need to continually improve supply chain resiliency remains certain, as demonstrated by the challenges with Single Use Systems. Health Authorities (HA) globally demonstrate continued interest in adopting measures targeted towards drug shortage prevention activities, particularly in regard to risk assessment and business continuity planning. In parallel over this past year, the ISPE Drug Shortages Initiative has modernized the drug shortages prevention plan and prepared an example of how to apply risk management concepts to drug availability. Experts from the front line will present experiences.

As a result of this session participants will gain:

• Experience and learnings from the COVID 19 pandemic supply chain pressures particularly as applicable to Single Use Systems (SUS).
• Learnings relevant to Single Use Systems shortages and strains in the supply chain during and after the COVID 19 pandemic.
• An overview of initiatives which aim to achieve further transparency across the supply chain.
• Example approach of Quality Risk Management to address Product Availability Risks, as discussed in the draft ICH Q9(R1).
• An understanding of HA perspectives (e.g., FDA, ANVISA, ANSM, etc.)
  
  Opportunities to interact with FDA and industry in a Q&A session and informally at the conference.

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.

In this session, the panelists will provide brief presentations on key topic areas of the GAMP 5 revision, including Critical Thinking; Applicability of iterative and incremental software development methods; IT infrastructure; Blockchain; Artificial intelligence and machine learning; and Computer Software Assurance. In addition, attendees will have the opportunity to engage in direct discussion with the primary authors of the material covering these topics.

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.

ISPE is aligned with FDA’s vision of the value of QMM and initiated the ISPE Advancing Pharmaceutical Quality (APQ) program in 2018 as an industry-led approach to advance pharmaceutical quality. The basic framework of the program is to “assess, aspire, act and advance” quality maturity based upon international ICH Q10 standards.

The APQ program, which is scheduled to be completed in 2022, provides a framework for assessing and enhancing the effectiveness of the Pharmaceutical Quality System (PQS). The program consists of five Good Practice Guides, one for each of the four elements of an ICH Q10 Pharmaceutical Quality System, a foundational Cultural Excellence Guide, and bookended by an optional benchmarking tool developed by University of St. Gallen. Three guides have been published and are available to use: Corrective Action and Preventive Action, Change Management System, and Management Responsibilities and Management Review. The fourth guide, Process Performance and Product Quality Monitoring System, is scheduled to be published in 2022. The 2017 ISPE Cultural Excellence Report will be converted into a fifth APQ Guide with enhanced features and case studies and also is scheduled to be published in 2022. In this interactive session, ISPE APQ team will deep-dive into the final two guides: Cultural Excellence and Process Performance & Product Quality Monitoring System.

ISPE supports a voluntary, industry led program for QMM whereby industry can assess, aspire, act, and advance their level of quality management maturity and share it independently with their patients, consumers, customers, and health authorities globally, based upon international ICH Q10 standards. A robust QMM program should entail assessment, measures, improvement tools for advancement, and case studies for application.

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.

With the advancement and continuous emerging technologies, a lot of biopharmaceutical industries have started incorporating them to optimize equipment maintenance, meet sustainability goals, and reduce project delivery times. 

In this session, we will have speakers from leading companies share their lessons learned, tips, insights, and technologies used to solve difficult problems and meet their goals.

In the first quarter of 2022 drafts of ICH Q2(R2) and Q14 were released for public comment. This is the first time there have been significant changes to the guidance for analytical methods since the release of Q2 in the 1990's. Stop and think for a moment how much change there has been in the past several decades. The speed of development has increased, the diversity of therapeutic products has changed, and the technology employed (including use of multivariate methods) to test these materials has continued to evolve. 

This session will bring together the opinions of thought leaders in this area (EWG industry, EWG regulatory, and the practitioner) to share their perspectives and lead a discussion on the new operating system that is possible given the new draft ICH guidelines. 

Presentations will be followed by a roundtable/panel discussion to address questions and obtain feedback on the guidance documents (including implementation and case studies) and/or solicit input on any available feedback from the EWG.

Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information to enable (automated) decision-making. The fundamentals of the digitalization process lies in in the structure underneath the data being created, used, reported, stored, and destroyed. 

Currently, in the Pharma 3.0 environment the approach for automation is in a process-centric environment. However, moving to Pharma 4.0™, a different approach in which the data life cycle is centralized, will lead to a data-centric approach. Each data life cycle needs to be completed and aligned to be considered a data set. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data or duplicate data. Moving to Pharma 4.0™, each data set will need to be assessable at any time in any business layer. 

Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical transformational methodologies to a digitalized Pharma 4.0™ Operating Model-based organization.