Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Manufacturing - Quality Control - Operational Excellence
Mon, 14 Oct
Tue, 15 Oct
1000 – 1030
Manufacturing - Quality Control - Operational Excellence
Kent Abrahamson, AbbVie
Alan Stevens, AbbVie
This presentation is meant to provide an outline of reliability considerations for the development of combination products that can be tailored for the specific application. A core principle of developing a reliable product is that reliability engineering needs to occur at a system level. Every decision, from which technologies are used, to the number of parts, to testing strategies, needs to incorporate reliability engineers into the decision-making process. Reliability starts with the user needs, gets translated into product requirements, gets incorporated into risk management, is a critical component of design development activities, a cornerstone of testing, influences manufacturing processes, directs on-market activities, and is critical for patient benefit. Reliability engagement at combination products begins at the product design and development through the commercialization of product lunch and its continuous improvement of patients’ feedback and field observations. Reliability is more than testing or a demonstration, but rather, it is an application of scientific principles to a set of decisions that impacts patients, product performance, and business success.
1030 – 1100
Manufacturing - Quality Control - Operational Excellence
Wifred Mascarenhas, Eli Lilly
In today's pharmaceutical manufacturing landscape, the effective management of alarms is paramount for ensuring operational efficiency, product quality, and regulatory compliance. Eli Lilly, a global leader in pharmaceuticals, has embarked on a journey to enhance its alarm management practices using innovative technologies. Leveraging an advanced analytics platform, Eli Lilly has initiated a transformative initiative aimed at consolidating alarms and optimizing their management workflows. By implementing a centralized approach, Eli Lilly aims to achieve consistency in alarm handling, improve response times, and reduce the potential for alarm fatigue among operators. Furthermore, this initiative serves as a catalyst for global collaboration by facilitating data and knowledge sharing between sites. Through the standardization of workflows and the establishment of a centralized repository for alarm data, Eli Lilly is fostering a culture of continuous improvement and harmonization across its manufacturing network.
1100 – 1130
Manufacturing - Quality Control - Operational Excellence
Miguelina Matthews, PhD, Sanofi Aventis
As part of the company transformation, Sanofi has embraced digitization tools to complement and improve quality decisions. During this presentation, we will describe one to two use-cases/tolls recently deployed. Both tools use elements of Artificial intelligence for collecting and analyzing data.One tool is a mobile and web app that delivers real-time, reactive data dashboards, giving a 360° view across our activities. The tool brings data from across Manufacturing & Supply, Supply Chain, QA, Regulatory, Clinical Operations, R&D into one, accessible place. And, through the power of AI, the tool uses this data to deliver actionable insights to help make informed decisions. For the presentation, we would focus on how the tool is used or Complaints. The second tool, for monitoring of deviations, uses machine and language learning. The tool has eliminated the need for manual and time-consuming searches, and it allows to identify deviation recurrence across multiple sites. The multifunctional tool is based on a search engine, a deviation cluster browser, a root cause analysis assistant, and performance dashboards., allowing manufacturing and quality to readily identify trends and prioritize specific topics, accelerating problem solving for Manufacturing & Quality personnel.
1300 – 1330
Manufacturing - Quality Control - Operational Excellence
Vishnampet Venkatraman, Datamura Solutions, LLC
An organization’s culture is the critical factor for success in changing environments and globalization. Cultural dynamics are the most challenging elements to manage, yet they yield the most return on investment. Implementing strategies for growth and value creation are insufficient without a cultural transformation strategy. We will outline principles and strategies to identify the benefits of a cultural transformation journey. If conceptualized, designed, and implemented correctly these benefits will vastly outweigh the investment. We will demonstrate the value creation through growth opportunities, loyalty, innovation, and the overall happiness index. We will focus on the challenges, opportunities, and untapped value that an organization can derive from initiating and designing a well-integrated approach. We will demonstrate how AstraZeneca is propelling cultural changes systematically by creating a futuristic vision and redefining their priorities. We expand on the tried-and-true tactics of breaking down silos and leveraging information technology, and introducing new concepts to aid in cultural transformation. Unlocking lateral thinking, coordinated activities, and the humanization of leaders and peers, all accelerate innovation and develop a future proof team poised to meet the company's sustainability vision and strategic goals. We will demonstrate a progressive approach to creating a holistic roadmap to drive cultural change.
1330 – 1400
Manufacturing - Quality Control - Operational Excellence
Cole Brunson, Flad Architects
Cyril Buckley, Takeda Pharmaceuticals Inc.
Elizabeth Strutz, Flad Architects
With the ultimate goal of delivering therapeutic treatments to patients at the lowest possible cost, manufacturing facility planning efforts understandably focus on efficient flows, optimal adjacencies, and streamlined infrastructure, while also considering options for future expansion, but what about the people actually performing the work? Too often, human-centric concerns are overshadowed by the need for process improvements and operational efficiencies.With an ever-increasing competitive landscape, attracting and retaining skilled staff has become a critical challenge.Our research has uncovered key criteria that shape pharmaceutical facility architecture, establishing crucial characteristics that ensure the well-being and overall health of the people tasked with delivering these lifesaving therapies, while enhancing an organization’s ability to attract and retain the best talent.This presentation will demonstrate how an integrated design and planning approach, coupled with the clear vision and mission of an organization, can create efficient and sustainable manufacturing environments, while also supporting the effectiveness, health, and well-being of the staff working within them.This presentation will also address technologies and innovative processes that enable organizations to measure the efficacy of these design strategies.A 3rd speaker has been confirmed for this session: Elizabeth Strutz, Associate AIA, MSIE, PMP, Director of Process Innovation, Flad Architects
1400 – 1430
Manufacturing - Quality Control - Operational Excellence
Jennifer Kilroy, Sequoia Biotech Consulting
Andrea Liess Karlsson, Boehringer Ingelheim
Leaders across pharma and biotechnology are facing unprecedented changes driven by technology innovation, post-pandemic workforce dynamics expectations, as well as an evolving compliance landscape. They are also challenged with high utilization from multi-product facilities requiring minimized downtime and quick turnaround. Transforming the way to work where agility, smart risk-taking and collaboration is key to business success. Our presentation will share a case-study of how one technical leader (Head of Engineering, Facilities & EHS) at Boehringer-Ingelheim developed a strategy, operating mechanisms and culture that is able to leverage that pace of change to fuel innovation, partnerships, and results. We will share the presenting challenges, the methodology employed, and the results experienced.
1530 – 1600
Manufacturing - Quality Control - Operational Excellence
Erich Bozenhardt, United Therapeutics
Charles Heffernan, PM Group
Selecting a Cell Therapy Manufacturing Approach: A comparative cost analysis of leading technology platforms.In the rapidly evolving field of cell therapy manufacturing, companies are grappling with significant cost pressures as they strive to bring groundbreaking therapies to market. A critical factor influencing these costs is the selection of manufacturing technologies, which directly impacts facility design requirements, including the size and specification of cleanroom environments. Our presentation delves into the financial implications of technology choices on the construction and operational expenses of manufacturing facilities. We offer a comprehensive comparative cost analysis of various cell therapy manufacturing platforms, including:- Manual operations in Biological Safety Cabinets (BSCs)- Closed operations in automated processing equipment, such as the Miltenyi Prodigy- Isolator lines- Automated isolated processing units This analysis spans both capital expenditures (CAPEX) and operating expenses (OPEX), evaluated against facility area and production throughput. Furthermore, we explore innovative facility organization strategies that promise to mitigate costs.
1600 – 1630
Manufacturing - Quality Control - Operational Excellence
Jim Love, CRB
Francis Ring, Ionis Pharmaceuticals
Paul Richards, Biogen Inc.
The oligonucleotide modality has seen a significant uptick in commercial approvals in the last five to seven years. As commercial capacity has come online and future capacity is being planned to support anticipated indications that will plausibly include larger production capabilities, the broader industry is examining best practices for facility design. Paul, Francis and Jim are part of the group that has come together to author a new baseline guide for industry for oligonucleotide facilities. We will present the approach taken, including scope boundaries with other emerging therapeutic modalities, timeline for the guide to be published, and sample content section previews.
1630 – 1700
Manufacturing - Quality Control - Operational Excellence
Yuk Chun Chiu, Wheeler Bio
Steven Attig, CRB
Industry trade groups have been discussing the merits of ballrooms and connectivity for some time. But many biopharmaceutical companies are quite conservative and assume there is too much regulatory risk in designing a facility as an open ballroom with closed processing as the foundation, especially when executing multiple product manufacturing simultaneously within the same space.This presentation will follow a case study on Wheeler Bio. A company that is challenging industry norms by embracing a novel facility design, merging a single fully open ballroom concept with process closure, backed by comprehensive risk assessments and data.The presenters will highlight how they integrated the risk analysis outcomes into commissioning, qualification strategies, standard procedures, and batch records. We will discuss the Process Closure Analysis (PCA) and its role in identifying and mitigating contamination and mix-up risks during simultaneous product runs and how various process risk assessments (pFMEAs) scrutinized and mitigated operational risks. By balancing risk with right-sized processes, Wheeler Bio’s new hyper-flexible GMP manufacturing facility accelerates the development of new therapies for patients while lowering costs to clients.
1015 – 1045
Manufacturing - Quality Control - Operational Excellence
Yiming Peng, Genentech Inc
In recent years, AI/ML has sparked growing interest in pharmaceutical science and manufacturing. In this talk, we will share an overview of our journey integrating digital transformation, advanced data analytics, and operational excellence, focusing on AI/ML which we strategically pioneered and delivered significant business values in Pharma Technical Operations. We will dive into a few AI/ML use cases, including predictive & adaptive manufacturing process controls, scheduling optimization, GenAI and more. We will share the lessons learned, discuss the challenges and opportunities of applying AI/ML in the evolving yet regulated Pharma industry, and continue scaling AI/ML to enable more efficient and reliable manufacturing and supply of our critical medicines for the patients.
1045 – 1115
Manufacturing - Quality Control - Operational Excellence
Karin Benoit, Eli Lilly And Company
The implementation model for Eli Lilly and Company’s policy mandating automated data capture for all GMP output data involves assignment of a data integrity (DI) classification to control strategy data, alignment of instruments generating that data to the DI classification, assessment of the instrument to the requirements (stratified by DI classification) for automated data capture (based on mitigation of specific vulnerabilities like falsification and pre-testing) and remediation of identified gaps.Our team encountered and devised strategies to combat numerous challenges to implementation. Lack of DI classification for supporting systems, like sterilization and calibration standards, led to speculation and scope creep. The scenario-based vulnerabilities were difficult to grasp. Moreover, the individual instrument assessments to the vulnerabilities are resource-intensive, often requiring a time-consuming, detailed review from a cross-functional team of subject matter experts. Finally, the burden of change could be very high for existing installations with less computerized infrastructure.This model was most successful in helping new processes/installations design data integrity controls into their systems. In addition, subject matter experts who participated in the assessments became skilled at identifying potential DI vulnerabilities and creating logic and design solutions to mitigate them, thus transferring the improvements to the next project.
1115 – 1145
Manufacturing - Quality Control - Operational Excellence
Antonello Finucci, Exyte Central Europe GmbH
This presentation aims to showcase the cutting-edge concepts of Federated Digital Twins and Artificial Intelligence. Federated Digital Twins are a network of digital twins that share data, insights, and learning. These advanced frameworks and AI are essential for harnessing the full spectrum of benefits in the biopharmaceutical manufacturing.The presentation will explore how the interconnection of multiple digital twins, can create a comprehensive and holistic virtual representation of biopharma operations and their Critical Business Parameters. This Digital Twins ecosystem allows for more nuanced insights and a deeper understanding of complex systems, enhancing predictive analytics and operational efficiency across multiple facilities and processes.This approach enables unprecedented scalability and agility in decision-making, optimizing the entire lifecycle of biopharma manufacturing from design to decommissioning.Incorporating AI, the presentation will highlight its indispensable role in supporting advanced analytics and streamlining the creation and operation of digital twins. AI agents are pivotal in simplifying complex processes, automating data analysis, and facilitating the rapid realization of digital twins.This comprehensive presentation offers a forward-looking perspective on the synergistic integration of digital twins and AI in biopharma manufacturing, showcasing how these technologies can be leveraged to drive innovation, efficiency, and excellence in the industry.
1530 – 1700
Manufacturing - Quality Control - Operational Excellence
Kristopher Le, Amicus GMP Consultants
Rebecca Welton, Lachman Consultant Services, Inc.
Ian Deveau, FDA
Anil Mathai, STAQ Pharma Inc
Join us for an engaging discussion into the critical facets of 503B compounding at this year's ISPE Annual Conference through a panel comprised of industry experts. This session begins with a comprehensive overview of the ISPE Guide related to 503B compounding, setting the stage with foundational knowledge and industry standards. The following presentation will address the practical aspects of implementing a deviation and investigation program, providing attendees with actionable insights on managing compliance effectively. Concluding the panel, we will hear from industry experts on the regulatory perspectives that shape 503B compounding practices. This series is essential for professionals involved in all levels of pharmaceutical compounding, regulatory compliance, and quality assurance, offering a platform for in-depth discussion and expert guidance. Engage with our speakers in a dynamic Q&A session to further enhance your understanding and application of these crucial topics.
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.