The pharmaceutical industry is very highly regulated because it deals with products that are essential to human health. The Holistic Pharma 4.0 Digital Maturity assessment is a key step for pharma companies seeking to implement digital transformation initiatives in the context of Industry 4.0 or Pharma 4.0. The goal of this Workshop is for the audience learn to evaluate the organization's readiness for digital transformation and identify opportunities for improvement and to apply and conduct the Holistic Pharma 4.0 digital maturity assessment. After conducting the Holistic Pharma 4.0 Maturity Assessment a heatmap will show the strong and weak structural areas of an organization and to get recommendations in which areas it will help to apply a digital transformational process and to which maturity level.

The Holistic Pharma 4.0 Digital Maturity assessment is a key step for pharma companies seeking to implement digital transformation initiatives in the context of Industry 4.0 or Pharma 4.0.

Key Steps to follow:

1. Conduct the Pharma 4.0 MAturity Assessment: Collect data on your organization's digital capabilities, processes, and infrastructure according to the Holistic Pharma 4.0 Maturity Model, and benchmark them against the chosen framework. You can use surveys, interviews, and site visits to gather information.
2. Analyze the results: Once you have gathered the data, analyze it to identify gaps and opportunities for improvement. Look for areas where the organization can leverage digital technologies to enhance efficiency, reduce costs, and improve customer experience.
3. Develop a roadmap: Based on the results of the assessment, develop a roadmap that outlines the steps needed to improve the organization's digital capabilities. The roadmap should be aligned with the organization's strategic objectives and should prioritize initiatives that deliver the greatest value.
4. Implement and monitor progress: Implement the roadmap and monitor progress to ensure that the organization is achieving its digital transformation goals.

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According to Annex 1, CCS is referred to as a family of documents that unite, evaluate, and record the adequacy of tools used to assure the purity and quality of drug products. The heightened focus on the CCS is centered around not only physical mechanisms to control contamination but now also emphasizes how the mechanisms work together and how they are managed as a group. This workshop will engage attendees in the development of a CCS using a case study and supporting documentation from an existing cGMP facility. Attendees will be exposed to a methodology to develop a CCS that was performed for the actual facility that is used for the case study. Attendees will interact with different procedures and design documents and see how the documents support each other and work together to ensure that the facility operates in a way to prevent contamination of drug products. Attendees will be exposed to the use of Layers of Protection Analysis (LOPA) for the CCS. Lastly, attendees will experience realistic challenges during the creation of the CCS and gain valuable lessons learned from the actual team that executed the same CCS methodology.

In this session you will hear about how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA) including how organizations are adapting to a CSA environment, the significant areas of progress and, conversely the remaining challenges and understanding how a Maturity model approach may provide a framework to enable innovation and plan future progress.

Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software" on 13th September 2022, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11.  The session will focus on the implications and opportunities of CSA draft guidance and GAMP 5 Second Edition on 21 CFR Part 11 through presentations delivered by members of the GAMP Global Steering Committee and a panel discussion, including leading industry experts along with representatives from the FDA.

Please join us for what should be a very engaging and informative session.

• 10:00 – 10:15: GAMP 5 Second Edition – A Year On by Heather Watson
• 10:15 – 10:40: GAMP 5 Second Edition - Maximizing Value by Sion Wyn
• 10:40 – 11:00: GAMP 5 Second Edition and Future Guidance by Chris Clark
• 11:00 – 11:30: Implications and Opportunities of CSA on GAMP 5 Second Edition and 21 CFR Part 11 by Francisco Vicenty, Daniel Walter, Ken Shitamoto, Jason Spiegler, Sion Wyn, Chris Clark and Heather Watson, moderated by Khaled Moussally

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The first part of the Process Analytical Technology session discusses best practices in the design, implementation, and operation of PAT for actual GMP operations. The design and implementation drive the digital transformation. This includes the IT infrasructure requirements to facilitate the data management under GMP standards, the application of 'classical' PAT based on spectroscopic equipment through to soft sensors i.e., data-driven analytics, and process insights revealed by PAT back to the control strategy as a holistic instrument.

The second part of the session is a case study from Takeda's Neuchatel site, tying the strategic vision of digitalization in manufacturing to the real-time benefits of PAT. The Digital Twin Model allows monitoring, investigation and prediction of critical quality attributes (outputs) by varying the process parameters (inputs). Predictive modeling is a key attribute to ensure operational excellence and a robust manufacturing process. This promises to be a great session showing how far PAT techniques and technologies have moved pharmaceutical manufacturing from feedback, reactive approaches to predictive modelling for maximum efficiency and yield.

• 1530 – 1600: Digital Evolution Strategies in MSAT by Veronika Nindl
• 1600 – 1700: Application of PAT for Real-World GMP Operations by Dr. Hubertus Rehbaum, Line Lundsberg-Nielsen and Andrew Palm

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This session will be focused on different types of facility designs and installed critical systems that support/enable manufacturing excellence and stability.

In the first talk, attendees will learn about Restricted Access Barrier Systems (RABS) that are regularly utilized in sterile manufacturing clean rooms.  Each facility typically has its own needs and requirements, and requires careful evaluation before new RABS systems are installed on-site.  A case study will demonstrate how analysis of the facility and the manufacturing process before RABS installation is a critical first step to ensure sterility assurance.

Next, attendees will learn about time-to-market deployment of a new manufacturing facility through use of a hybrid modular delivery method.  The case study discussion surrounding the hybrid modular (“box-in-box”) project will demonstrate time savings, execution efficiency and reduction of site congestion at the site as well as how the design and manufacturing processes impact the environmental impact of the facility as it is built and will be operated.

Third, there will be two FOYA Introductions of winners announced during the ISPE Europe Annual Conference. Each presentation will conclude with a brief Q&A and discussion where everybody is encouraged to ask questions and discuss with the speakers.

• 13:45 – 14:15: RABS Retrofit - Solutions for Compliance and Performance by Brian K. Smith & Leslie M. Edwards
• 14:15 – 14:45: Hybrid Modular (Box-in-Box) Sterile Facility Case Study by Pär Almhem, Bob A. Brady, and Richard Sanderson
• 14:45 – 15:00: FOYA Winner 1 - FJ2 Breaking new ground - beyond the “Wall of 0.05µg/m3”: Containment Facility Construction Concept and Verification by Daisuke Hirasawa
• 15:00 – 15:15: FOYA Winner 2 by TBC

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This session will highlight the importance of commissioning and qualification throughout the biopharmaceutical facility with a focus on manufacturing operations.

First, the audience will learn about the importance of harmonized decision-making framework and risk-based evaluation of the need for manufacturing a pre-PV (process validation) demonstration batch.  Included are decision flow chart, previously manufactured batch assessment tools and case study application examples. Next, the speakers will provide an overview on of the current state of the industry in regard to adoption rate of Quality Risk Management (QRM) Based Integrated C&Q, C&Q best practices, benchmarking and key performance indicators.

To conclude this session, the last presentation of the session will discuss relevant topics necessary to develop a comprehensive assessment to characterize cleaning program practices, typical observations from assessments, and sustainability opportunities identified in reduced water usage, optimized chemistries, cleaning cycle duration reduction, potential energy reductions, and developmental studies to support identified solutions. Each presentation will conclude with a brief Q&A and discussion where everybody is encouraged to ask questions and discuss with the speakers.

• 15:30 –16:05: Risk Based Decision Process for Pre-PV Demo Batch by Joanne R. Barrick
• 16:05 – 16:30: Adoption of Integrated C&Q – Benchmarking & Survey Results by Nathan W. Temple
• 16:30 – 17:00: Sustainability Through Cleaning Program Standardization by Keith Bader and Andy Brewer

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As the world attempts to emerge from the pandemic and return to activity reminiscent of pre-pandemic times, there are still uncertainties remaining related to supply chain stability.  Many valuable lessons can be learned from the pandemic and applied to planning for the possibility of another pandemic, or even a tripledemic. Some global Health Authorities have been active in developing guidance and recommendations to mitigate disruption in the supply chain and secure patient access to critical medicines based on these recent learnings in an effort to improve planning and preventative measures.  Additionally, some governments have imposed legislative measures to encouraging onshoring as a protective measure to insulate domestic supply chains from disruption.  In parallel, to appreciate and align with regulatory efforts to address shortages and supply chain instability, the ISPE Drug Shortages Initiative team has developed expanded guidance on the quality, technical, and regulatory aspects of drug shortage prevention.  Regulators and experts will present experiences related to securing supply chain, mitigating drug shortages, and efforts to proactively be prepared for the possibility of a future pandemic. As a result of this session participants will gain:

• Insights from experiences endured during the SARS-CoV-2 pandemic and potentially longer-lasting impacts on the global supply chain, from both regulatory and industry perspectives.
• Overviews of regulatory and industry initiatives which aim to achieve further transparency across the supply chain.
• An understanding of HA perspectives related to regulatory expectations to mitigate drug shortages and supply chain strain (e.g., FDA, EU)
• Opportunities to interact with global regulators (including FDA and European Commission) and industry in a Q&A session and informally at the conference.

10:00 – 10:25: Updates on Drug Shortages and Supply Chain Challenge by Emily Thakur
10:25 – 10:40: The ISPE Drug Shortages Prevention Model (ISPE DSPM) – Guidance for Drug Shortage Prevention Excellence by Diane Hustead
10:40 – 10:55: Updates Regarding European Commission Drug Shortage Prevention and Mitigation by Wolfgang Philipp
10:55 – 11:10: Title Pending by Speaker invited
11:10 – 11:30: Question and Answer/Panel Discussion

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This session will focus on the integration of sustainable development practices in different aspects of business operations. The first segment will explore the importance of having a comprehensive sustainability strategy and governance structure in place.

Attendees will learn about best practices for setting sustainability goals, measuring progress, and integrating sustainability into the company's overall business strategy. The second segment will showcase the role of technology in driving sustainable development. Attendees will gain insights into the latest trends and innovations in sustainable technology, including renewable energy, green buildings, and sustainable transportation. The presentation will also examine the challenges and opportunities of adopting sustainable technology in business operations. In the third segment, attendees will learn about the importance of product traceability in achieving accurate carbon accounting. The presentation will explore the tools and technologies available for tracking the carbon footprint of products throughout the supply chain. Attendees will gain insights into the benefits of trusted carbon accounting, including improved sustainability reporting and increased stakeholder trust.

Over the three presentations, attendees will gain a comprehensive understanding of the critical role of sustainability in modern business operations. They will learn how to integrate sustainable development practices into their business strategy, leverage technology to drive sustainability, and use product traceability to achieve accurate carbon accounting. The session will equip attendees with practical insights and tools to drive sustainable growth and create value for all stakeholders.

• 1530 – 1600: Sustainability Strategy & Governance: Integrated Change by Patricia (Trish) Melton, Guy Wingate and Ylva Ek
• 1600 – 1630: Enabling Technologies in Sustainable Development by Jie Chen
• 1630 – 1700: Project Nishwas: Providing a Breath of Relief for Lives during the Covid 19 Pandemic by Parag Deshmukh

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The journey of introducing a new therapy to the market involves more than just its development. Join our upcoming session to explore the critical role of facility design and construction in the success of a therapy. Our esteemed speakers will share their experiences through compelling case studies, providing invaluable insights into the entire process, from the initial stages of therapy development to the later phases of facility design and construction. Don't miss this opportunity to gain a comprehensive understanding of how to navigate the path to market for a successful therapy.

• 1000 – 1030: FOYA Operations: Resilient Project Execution, Design-Assist Model Success by Gene Russell and Brendan McGrath
• 1030 – 1100: Scaling New Heights by Emily Heffernan, Laura Berberian, and Mario Miele
• 1100 – 1130: Building cGMP Facilities in Challenging Times by Laura Whelan, Sal Ceja, Nima Payan, and Nino Adamo

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We are living in a time where both industries and regulatory bodies are actively advocating for the integration of advanced technologies more than ever before. Join us in this session as we showcase various examples of these technologies that are readily available to help you reduce costs, improve efficiency, and enhance overall quality. Don't miss out on this opportunity to discover cutting-edge solutions that can take your business to the next level.

• 1350 – 1415: An Innovative Approach for a Faster Small Batch Release by Dominic Baca and Giacomo Girotto
• 1415 – 1440: Development of an Aseptic Filling Platform Technology by Austin Lock
• 1440 – 1505: Recent Advances in Membrane based WFI Generation by Nissan Cohen, Joseph Manfredi and Anders Widov
• 1505 – 1515: Question and Answer/Panel Discussion moderated by Pierre Winnepenninckx

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The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry expert representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself to provide a range of sustainable and practical quality management improvement strategies.

This ISPE Advancing Pharmaceutical Quality Program is a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness. It has been developed to support organizations to Assess, Aspire, Act and Advance the maturity and effectiveness of their quality management. It provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System.

Further, FDA will share learnings from FDA QMM Pilot studies and risk management model studies in partnership with St. Gallen University.
ISPE enables industry to proactively demonstrate the value of quality management maturity which benefits regulators, industry, and patients. The ISPE APQ program is 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. The APQ QMM program entails quality system assessment, performance measures, improvement tools for advancement, and case studies for robust application.

Training for the ISPE APQ program will begin in 2023 where our expert team will share practical examples and case studies of the five guides in action.

• 1015 – 1040: FDA Quality Management Maturity Program Learnings by Marcus Yambot
• 1040 – 1055: Robust Advancing Pharmaceutical Quality Program- QMM through Assess, Aspire, Act, Advance by Tami Frederick
• 1055 – 1145: ISPE Advancing Pharmaceutical Quality Program (QMM) Sets Up Your Organization for Success! by Maria Amaya, Michael Grischeau, Andrew Denny,

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The session will discuss the current challenges of static and unstructured PDF-based CMC regulatory submissions for drug applications and the modernization efforts of utilizing structured data for regulatory CMC submissions. The session will address actionable steps companies can take to enable digital transformation to streamline and improve the current process of preparing regulatory CMC submissions. Specifically, the session will provide insights on how industry can incorporate advanced technologies to prepare for emerging global regulatory requirements that will change the CMC regulatory submission and review paradigm. Ultimately, companies will need to modify their internal processes to ensure compliance with new regulatory requirements, but there is less clarity across industry on the roadmap for implementation and how to best navigate a stepwise approach towards modernization. The session will also include a Regulator’s perspective to the challenges of PDF-based submissions and the need of digitization, digitalization and automation to readily capture information and effectively utilize modern knowledge management tools. Recently, FDA’s Office of Digital Transformation (ODT) has rolled out a series of action plans for technology and data modernization. The session will give an overview of FDA’s digital transformation history including some CMC-specific initiatives such as the Knowledge-Aided Assessment and Structured Application (KASA) and Pharmaceutical Quality/Chemistry, Manufacturing, and Controls (PQ/CMC) initiatives to modernize the CMC submission and review process. Together, industry and regulators can leverage technology to collaboratively build towards a future vision of enhanced efficiency, reduced filing timelines, and improved speed  to market for critical therapeutics.

• 13:45 – 14:10: Unleashing the Power of Data Standardization for Optimized CMC Regulatory Information Management and Submissions by Marquerita Algorri and Sheetal Gaiki
• 14:10 – 14:25: Balancing Data and Narrative with the Use of the Overall Control Strategy by Ciby Abraham, Ph.D.
• 14:25 – 14:40: Regulatory Consideration on Digital Transformation of the CMC Submission and Review Process by Maotang Zhou, Ph.D.
• 14:40 – 15:15: Question and Answer/Panel Discussion moderated by Nina Cauchon

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