Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Digital Transformation
Mon, 14 Oct
Tue, 15 Oct
1000 – 1030
Digital Transformation
Brandi Stockton, The Triality Group, LLC
Eric Staib, Syneos
Integration of AI brings inherent challenges that must be understood for effective digital innovation. The inherent challenges range from availability and governance of data to the need for agile development processes and organizational change management. In response to such challenges, identification of strategies and best practices is essential and should include such things as data governance frameworks, promoting diversity in both training data and development teams, adopting flexible methodologies to accommodate the iterative nature of AI. Learning to effectively implement AI involves not only technical expertise but also an organizational culture that supports experimentation and continuous improvement. This includes a cross-disciplinary approach leveraging insights from data scientists, IT, business stakeholders, and the quality organization to ensure the AI enabled technologies are aligned with objectives of the business, are ethically and responsibly integrated into operations.
1030 – 1100
Digital Transformation
Nikolai Makaranka, Bristol Myers Squibb
There is a lot of buzz surrounding AI and its potential to revolutionize various industries, including pharma. However, despite the hype, the adoption of AI often lags, and its actual implementations remain limited to proof-of-concepts. This presentation will bridge this gap by showcasing an in-house-built AI solution that leverages the latest advancements in NLP for deviations analysis.The presentation will walk the audience through practical aspects of building and scaling an AI solution, focusing on key points such as preparing data and training a model. It will delve into the business impact of the solution and, whenever possible, demonstrate examples where the solution adds value. Specifically, it will demo search capabilities, similarity or recurrence analysis, and automated trending. Furthermore, the presentation will address a crucial aspect of building an AI solution -- assessing solution's performance. It will discuss what a validation protocol might look like for AI solutions to ensuring their reliability and effectiveness.Lastly, the audience will be guided through steps to kickstart the adoption of AI for Quality within their organizations. By the end of the presentation, attendees will have a clear understanding of how to leverage AI to reengineer and enhance quality processes.
1100 – 1130
Process validation encompasses a lifecycle approach of three stages, from Process Design or Development, (Stage 1) through a Continued/On-going Process Verification (CPV), (Stage 3). Since Stage 3 is typically a long manufacturing phase, extensive data is accumulated, trended, and analysed there. While established conditions (EC), critical quality attributes (CQA), and critical process parameters (CPP) offer a good foundation in this work- they alone fail to provide a comprehensive depiction of the entire process including its extensive historical context. Therefore, to accomplish effective CPV implementation, it is highly recommended to incorporate process automation, Process Analytical Technologies (PAT), and a profound understanding of both the manufacturing process and drug product. To enrich data evaluation in Stage 3, statistical methodologies and multivariable analysis are now complemented with the integration of artificial intelligence (AI). AI-empowered CPV not only facilitates real-time release (RTR) and the adoption of continuous manufacturing, but also heightens the power of such concepts as the Golden Batch. Leveraging AI here expands the predictive, classifying, recognizing, and recommendation capabilities essential for continual improvement of the process, ultimately contributing to elevated product quality.
1300 – 1330
Digital Transformation
James Weidner, Amgen
Yvonne Duckworth, CRB
Amgen Ohio’s new state-of-the-art packaging facility achieved dramatic operational efficiencies in capacity, productivity, and environmental sustainability. But how did they get there? This presentation delves into the foresight, planning and collaboration that was necessary to achieve a truly automated and integrated next-generation facility, including the development of a Pharma 4.0™ digital roadmap and site-specific digital tool deployment whitepaper. This connected facility harnesses smart communication between packaging equipment like automated storage and retrieval systems (ASRS), automated guided vehicles (AGV), manufacturing execution systems (MES), and laboratory information management system (LIMS) with integration across mechanical systems for operationally efficient automation. From design to development, greater efficiencies were continuously sought out. Leveraging the latest project execution technologies, like advanced material movement modeling, led to reorienting equipment, conveyers, ASRS and AGV routes to optimize facility design and material flows.A key factor of this digitally enabled facility is the impact on the workforce, which provided opportunities for new roles, as well as up-skilling or re-skilling employees. Through practical insights and lessons learned, attendees will gain invaluable perspectives on optimizing the integration of new technologies to drive operational excellence.
1330 – 1400
Digital Transformation
Steven Chan, Gilead Sciences Inc
Sarah Hinchin, Gilead Sciences
Jennifer Hedborn, Gilead Sciences
Our presentation will showcase a real-life example of how Gilead’s Research and Engineering teams work together to bring Innovation and Pharma 4.0 into the lab. Our proposed session will build on the 2023 Vegas ISPE keynote fireside chat between Gilead’s Head of Research, Flavius Martin, and our SVP of Corporate Operations, Joydeep Ganguly. In the keynote last year, they discussed the role engineering plays as a catalyst to Gilead’s science. As we are the ‘boots on the ground’ execution team, we would like to circle back to this keynote and share some returns realized in how we’ve collectively built both an innovation framework, and to showcase a brand-new Pharma 4.0 lab that was built as a direct result. Our presentation would include Strategizing Bringing Pharma 4.0 to Life in the Lab, Engineering and Constructing the Pharma 4.0 Lab, and Maintaining and Systematizing our Successes. We would like to finish our session by sharing our new co-designed Research Robotics lab.
1400 – 1430
Digital Transformation
Peterjohn Millan, Spark Therapeutics, Inc.
Michelle Vuolo, Tulip Interfaces
Now that the Pharma 4.0 Baseline guide is published, this presentation will show how to execute a Validation 4.0 approach. We will start with showing how to apply things we should already be doing, like risk management and then will dive into a real and practical example on how effective risk management can unlock Validation 4.0. This approach is expected to enable a scalable and therefore sustainable approach to achieve validation in today’s rapidly changing environment.We will have an interactive discussion on how a cutting-edge approach to validation can dramatically reduce the time and cost of maintaining compliance but also focus on decreasing risk and ultimately increasing quality. By combining technology, structured risk assessment, and mature process controls, attendees will learn how to position their validation approach to speed the deployment of enterprise systems, new products, and even AI. We will dive into a case study to exemplify this approach and the benefits gained.
1530 – 1600
Digital Transformation
Ken Shitamoto, Gilead Sciences
Jeff Gensler, Kindeva Drug Delivery
Pierre Winnepenninckx, No Deviation Pte Ltd
Join us for an insightful session where three industry leaders will introduce us to the world of digital tools in pharmaceuticals. Explore the deployment of digital validation tools, automated testing and monitoring tools, and innovative VR training tools shaping the future of the industry.
1600 – 1630
Digital Transformation
Ken Shitamoto, Gilead Sciences
Patrick Mullin, Sanofi
Jeff Gensler, Kindeva Drug Delivery
Pierre Winnepenninckx, No Deviation Pte Ltd
Engage in a dynamic panel discussion moderated by industry experts as we delve into the wider applications of digital tools in pharmaceuticals. Explore the challenges, regulatory requirements, and industry perspectives surrounding digital validation tools, automated testing and monitoring tools, and innovative VR training tools. Gain valuable insights from established leaders in the field during this interactive session.
1630 – 1700
Digital Transformation
Ken Shitamoto, Gilead Sciences
Patrick Mullin, Sanofi
Miguelina Matthews, PhD, Sanofi Aventis
Jeff Gensler, Kindeva Drug Delivery
Pierre Winnepenninckx, No Deviation Pte Ltd
This session will spotlight data analytics and other quality tools. Join our esteemed panelists as they delve into making informed GxP decisions based on insights gleaned from existing digital tools. Don't miss this opportunity to gain valuable knowledge and insights from industry leaders.
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences
Gilead Sciences
Patrick Mullin
Commissioning & Qualification Lead, Specialty Care GBU
Sanofi
Sanofi
Miguelina Matthews, PhD
Head External Liaison, Global Quality
Sanofi Aventis
Sanofi Aventis
Jeff Gensler
Kindeva Drug Delivery
Pierre Winnepenninckx
CEO
No Deviation Pte Ltd
No Deviation Pte Ltd
1015 – 1045
Digital Transformation
Frank Henrichmann, Q-FINITY Quality Management
Due to the increasing digitalization of the industry, we are highly dependent on IT systems and data. Cybersecurity attacks have been on the rise for many years, with ransomware and phishing being the biggest threats to our industry. Unfortunately, people tend to assume that disasters "only happen to other people" and therefore do not pay enough attention to disaster recovery and business continuity planning. When a ransomware attack hits an organization, the value of pre-planning and preparation becomes clear and allows for efficient recovery. The presentation examines a hypothetical case of a successful ransomware attack and outlines the recovery activities required and the issues that arise from inadequate disaster recovery planning. It also examines the potential challenges for the quality organization, such as root cause analysis and documentation of recovery activities, risk management and assessment of data integrity during recovery activities or the evaluation of short-term workarounds.
1045 – 1115
Digital Transformation
Abhishek Bachchan, Gilead Sciences
I intend to introduce an ongoing initiative at my workplace that focuses on enhancing efficiency and resilience in the Periodic System Monitoring Process for GxP Systems. This initiative involves automating the data gathering from various sources, and assessments associated with Infrastructure System Periodic Assessments using Microsoft SCORCH (System Center - Orchestrator) and PowerAutomate. The anticipated outcome is a reduction of over 2500 documents generated annually, resulting in significant time savings amounting to thousands of man-hours.By automating the data collection, we aim to facilitate trending analysis and hopefully predictive modeling. This approach not only minimizes human errors but also enhances the timeliness of monitoring and alerts. Overall, these improvements are expected to make the process more robust, efficient, reliable, and easily scalable.
1115 – 1145
Digital Transformation
The recently published EMA guideline on computerised systems and electronic data in clinical trials defines a detailed perspective of regulatory requirements and expectations for the clinical area. As regulated companies define their own quality management system to meet CSV and Di requirements, the current guideline could lead to a direction that reduces the possibility of interpretation and flexibility.Another indicator of the current thinking of the EU regulators could be the concept paper for the update of the EU GMP Annex 11, which implies a significant change.This presentation will provide an overview of current GCP expectations and how to address the upcoming challenges in digital transformation of clinical processes and compare these requirements with current GxPs. Finally, the presentation will provide an outlook on what the future may hold for the regulation of computerized systems and data integrity.
1530 – 1700
Digital Transformation
Michael Schmeiszer, Sanofi
Brandi Stockton, The Triality Group, LLC
Nader Shafiei, Sanofi-Aventis
1530-1600: Responsible Use of AI in a Regulated Environment by Michael Schmeiszer and Nade Shafiei
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
The rapid evolution of Artificial Intelligence (AI) brings immense opportunity to the pharmaceutical and biotech industries to boost drug discovery, accelerate development, and increase efficiency in manufacturing. At the same time the regulatory environment is still very much in flux and robust regulatory guidance does not yet exist.The combination of rapid innovation and uncertain regulatory context creates a high-risk environment for companies that want to adopt AI at scale across the value chain.We will discuss a framework to assess AI-related risks and implement appropriate controls in a pragmatic way, leveraging existing system life-cycle processes, to enable both innovative and responsible use of AI in a regulated environment.
1600-1700: AI Discussion Panel - Reflections on Past Missed Opportunities (QbD, PAT) and How to Navigate AI for Success
The rapid evolution of Artificial Intelligence (AI) brings immense opportunity to the pharmaceutical and biotech industries to boost drug discovery, accelerate development, and increase efficiency in manufacturing. At the same time the regulatory environment is still very much in flux and robust regulatory guidance does not yet exist.The combination of rapid innovation and uncertain regulatory context creates a high-risk environment for companies that want to adopt AI at scale across the value chain.We will discuss a framework to assess AI-related risks and implement appropriate controls in a pragmatic way, leveraging existing system life-cycle processes, to enable both innovative and responsible use of AI in a regulated environment.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.