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Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
*Restrictions apply. Offer applies to In-Person All Access Pass and In-Person Essential Pass member/non-member Industry rates only. Offer ends at 2359 EDT on Friday, 20 September 2024
Featured Sessions
Lifecycle Management Considerations for C&G Therapy
Oct 14, 2024 | 1015 - 1045
Presenter: FDA
This session will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.
Global AI Healthcare Regulations: Trends and Future
Oct 14, 2024 | 1300 - 1330
Presenter: Attrayee Chakraborty, Northeastern University
Artificial intelligence (AI) is rapidly transforming the healthcare sector. With over 520 AI medical algorithms cleared by the FDA and a growing number of AI-enabled devices, staying ahead of regulatory trends is crucial. This session will provide in-depth insights into the regulatory landscape for AI in the medical device industry worldwide.
Regulatory Considerations on Complex APIs' Sameness
Oct 15, 2024 | 1015 - 1045
Presenter: Maotang Zhou, FDA
Navigating the regulatory landscape for complex Active Pharmaceutical Ingredients (APIs) is a significant challenge. Complex APIs, often composed of multiple components with varying molecular weights, cannot be characterized using traditional analytical techniques. The FDA recommends a comprehensive “totality-of-the-evidence” approach to assess API sameness in generic drug products.
Filters
Sat, 12 Oct
Sun, 13 Oct
Mon, 14 Oct
Tue, 15 Oct
Wed, 16 Oct
Thu, 17 Oct
Fri, 18 Oct
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0800 – 1700
Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present to a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Tuesday afternoon.
1300 – 1800
0700 – 1800
0800 – 1300
On Sunday, each hackathon team will present to the panel of Hackathon judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best-proposed solution. The winning team will be announced during the ISPE Membership Meeting & Awards Lunch on Tuesday afternoon.
1300 – 1600
Workshops
Guido Kremer-van Der Kamp, Merck Chemicals GmbH
Jill Hammond, FDA
Yolanda McLean, Alnylam Pharmaceuticals
CDR June Page, FDA
Tonya Wilbon, FDA
Vivien Santillan, Novatek International
Women in Pharma Proudly Presents the Adaptable Leadership Workshop
Join us for a transformative three-hour workshop dedicated to leadership development, team building, and personal growth, with a special focus on enhancing the audit and compliance experience, as led by Guido Kremer-van der Kamp and Yolanda McClean.
Ideal for professionals in leadership roles, compliance officers, and those seeking to enhance their influence within a team, this workshop will delve into essential areas such as trust-building, emotional intelligence, and fostering team confidence. The session will feature engaging icebreaker activities and will culminate in an insightful panel discussion with FDA representatives and other compliance experts.
Workshop Agenda:
Adaptable Leadership
Explore strategies for developing leadership skills that can flexibly adapt to changing environments and challenges.
We are all Humans – Regulatory Interaction
Gain insights into effective audit practices, focusing on behaviors that foster cooperation and ensure compliance.
Team Building and Emotional Intelligence
Engage in activities designed to enhance trust, communication, and emotional intelligence within your team.
Fostering Team Confidence
Learn techniques to inspire and build confidence among your team members, empowering them to excel in their roles.
Panel Discussion with the FDA and Other Compliance Professionals
Participate in an interactive discussion with leading experts, including representatives from the FDA, on best practices and emerging trends in compliance, moderated by Yolanda McLean.
Join us for a transformative three-hour workshop dedicated to leadership development, team building, and personal growth, with a special focus on enhancing the audit and compliance experience, as led by Guido Kremer-van der Kamp and Yolanda McClean.
Ideal for professionals in leadership roles, compliance officers, and those seeking to enhance their influence within a team, this workshop will delve into essential areas such as trust-building, emotional intelligence, and fostering team confidence. The session will feature engaging icebreaker activities and will culminate in an insightful panel discussion with FDA representatives and other compliance experts.
Workshop Agenda:
Adaptable Leadership
Explore strategies for developing leadership skills that can flexibly adapt to changing environments and challenges.
We are all Humans – Regulatory Interaction
Gain insights into effective audit practices, focusing on behaviors that foster cooperation and ensure compliance.
Team Building and Emotional Intelligence
Engage in activities designed to enhance trust, communication, and emotional intelligence within your team.
Fostering Team Confidence
Learn techniques to inspire and build confidence among your team members, empowering them to excel in their roles.
Panel Discussion with the FDA and Other Compliance Professionals
Participate in an interactive discussion with leading experts, including representatives from the FDA, on best practices and emerging trends in compliance, moderated by Yolanda McLean.
Guido Kremer-van Der Kamp
Senior Consultant, Global BioPharm Center of Excellence
Merck Chemicals GmbH
Merck Chemicals GmbH
Jill Hammond
Director of Training and Regulatory Science
FDA
FDA
Yolanda McLean
Senior Director, Quality Control
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals
CDR June Page
Senior Regulatory Officer
FDA
FDA
Tonya Wilbon
Assistant Director for DICE and Branch Chief for CDRH
FDA
FDA
Vivien Santillan
Regional Director, Asia
Novatek International
Novatek International
1300 – 1600
Workshops
Ken Rando, COMECER
David Raab, Genesis AEC
Evan Lamb, SKAN US, Inc
Erich Bozenhardt, United Therapeutics
Jeffery Odum, Genesis AEC
Optimizing Cost of Goods for Cell Therapy Production--Current and Future Tools for Consideration This session will present two case study vignettes where companies used the Baseline Guide concepts to form the basis of design for a new manufacturing asset. The case studies focus on key Guide principles that identify the synergies between process closure, operation efficiency, contamination risk mitigation, and facility optimization. Specific references to the Guide will be provided as part of the interaction with the Audience.
Ken Rando
Head of Business Development for North America
COMECER
COMECER
David Raab
Senior Process Engineer
Genesis AEC
Genesis AEC
Evan Lamb
Product Specialist
SKAN US, Inc
SKAN US, Inc
Erich Bozenhardt
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
United Therapeutics
Jeffery Odum
Practice Leader: ATMPs & Biologics
Genesis AEC
Genesis AEC
1300 – 1600
Workshops
Thomas Friedli, University of St.Gallen
Tami Frederick, Perrigo
Nuala Calnan, Biopharm Excel Ltd
The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry 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 and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies.This ISPE Advancing Pharmaceutical Quality Program is intended to provide 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 within an organization. The Advancing Pharmaceutical Quality (APQ) Program provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System using the new APQ Assess, Aspire, Act & Advance Framework. APQ includes practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can be evaluated and then improved upon.
1300 – 1600
Workshops
Geetanjali Abbi, Alkermes
Lorrie Vuolo-Schuessler, Retired
Brandi Stockton, The Triality Group, LLC
Petch Ashida Druar, Syneos Health
In light of the requirements discussed within the EU Guideline on computerised systems and electronic data in clinical trials and the information provided within the new GAMP Good eClinical Practice guide the workshop will explore challenges with implementing new technologies used in support of clinical trials, e.g.
1. Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence. OUTLINE
13:00 – 13:10 Welcome, Announcements, Introductions
13:10 – 13:30 Introduction to the eClinical Guide 2nd Edition and the EMA Guideline on Computerized Systems used in Clinical Trials
13:30 – 14:00 Decentralized Clinical Trials (DCT)
14:00– 14:30 Good Clinical Laboratory Practice
14:30-15:00 - Break
15:00– 15:30 Data Science and AI-Enabled Systems
15:30– 16:00 Real World Data / Real World Evidence
1. Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence. OUTLINE
13:00 – 13:10 Welcome, Announcements, Introductions
13:10 – 13:30 Introduction to the eClinical Guide 2nd Edition and the EMA Guideline on Computerized Systems used in Clinical Trials
13:30 – 14:00 Decentralized Clinical Trials (DCT)
14:00– 14:30 Good Clinical Laboratory Practice
14:30-15:00 - Break
15:00– 15:30 Data Science and AI-Enabled Systems
15:30– 16:00 Real World Data / Real World Evidence
1300 – 1600
Workshops
Hubertus Rehbaum, PhD, Dr. Rehbaum Technology Consulting GmbH
Mark O'Connor, AstraZeneca
Andrew Palm, Pfizer
Paige Kane, MSD
Organizations seeking to keep up with the digital transformation are investing in new technologies with an end-to-end (E2E) focus on their products and processes, aiming to improve operational excellence, worker experience, product quality and delivery timelines. Adoption of these new technologies requires a systematic, structural, and holistic transformation of individuals and the organization. Smart organizations of today and the future need to effectively capture, maintain and share their data, information and knowledge - including their people’s implicit and tacit knowledge - to maintain a competitive advantage and meet these high demands. This workshop is a continuation of the European Annual Meeting Workshop and will include learnings and output from attendees. As well, comparisons from US and European attendees’ experiences will be made to benefit future ISPE content.
1500 – 1600
An orientation for ISPE Foundation Professional Development Grant recipients to gain insight on how to maximize their conference experience.
1600 – 1800
Networking
Check-in, un-wind and enjoy yourself at the ISPE Sunday Social! Conveniently located on-property, come join us for beverages, hors d'oeuvres, giveaways* and a chance to meet with your peers. Whether you attend the Sunday workshops or are arriving after a long day of travel, be sure to start the 2024 ISPE Annual Meeting & Expo off right!
*Attendees of the Sunday Social (up to 100) will receive an exclusive giveaway bag of ISPE items when visiting the Membership table during the event. These free giveaway bags are available on a first-come, first-serve basis and are limited to 100.
*Attendees of the Sunday Social (up to 100) will receive an exclusive giveaway bag of ISPE items when visiting the Membership table during the event. These free giveaway bags are available on a first-come, first-serve basis and are limited to 100.
1900 – 2230
Networking
Join ISPE to celebrate the 2024 FOYA Banquet and Awards Celebration where we will formally recognize and celebrate the 2024 Category winners' achievements at ISPE’s premier award presentation ceremony and dinner. Please note, the In-Person All Access Pass includes the FOYA Reception and Banquet. All other registration types, MUST register separately and pay.
0600 – 0730
Networking
Join us for ISPE 15th Annual ISPE 5K Run/Walk held during the ISPE Annual Meeting & Expo. Your participation in this year’s 5K event will again support ISPE Foundation’s mission fueling global health equity by fostering access to knowledge and nurturing diverse talent. Additional registration and a donation fee of $50 is required to participate. Registrants must collect their bibs and t-shirts at the Information Desk onsite..
0700 – 1800
0700 – 0800
Networking
0800 – 0810
General Session
Michael Rutherford, Rutherford Consulting, LLC
0810 – 0815
0815 – 0840
Ensuring the Availability of Medicines for Patients Recent advances in biomedical science, technology, and treatment modalities offer the promise of delivering safe and effective treatments for patients. A patient-centered approach to product quality also means seeing beyond product manufacturing, to the patient who needs the product, addressing quality through innovations to develop new medicines and the ensuring availability of already-approved medicines addressing vital needs. This requires effective pharmaceutical quality management, updating and innovating throughout the life cycle and applying knowledge gained during commercial operations to continually improve process and product. Regulators are working to better enable industry quality management, through coordinated efforts in ICMRA, ICH, PIC/S and IPRP, to build a global regulatory reliance capability. The resulting capability is expected to enable more agile quality management, improve operational resilience for both regulators and industry, and increase reliability in the supply of needed medicines for patients.
0840 – 0900
Emma Black’s inspiring journey living with a rare neurological condition called Rett Syndrome. Mrs. Jill Black, Emma’s mother, will share six-year-old Emma’s story including the diagnosis, her day-to-day life, therapies and treatments, and what brings her hope for Emma's future. Individuals with Rett syndrome may not lead a “typical” life, but they can lead an incredible one
0900 – 0910
Renetta Mosley, Acadia
Magnolia’s Guide to Adventuring is a documentary video series created by AJ and Jenny Tesler and supported by Acadia Pharmaceuticals Inc. The series is inspired by their 13-year-old daughter Magnolia ("Maggie") who is living with Rett syndrome. Individuals with Rett syndrome may not lead a "typical" life, but they can lead an incredible one. Follow Maggie and her family as they head out on adventures across the United States with others living with Rett syndrome.
www.rettrevealed.com/adventuring-with-magnolia/
www.rettrevealed.com/adventuring-with-magnolia/
0910 – 0915
0915 – 1900
0915 – 1900
Join us at the ISPE Career Center & Headshot Booth in the Expo Hall. The ISPE Career Center & Headshot Booth is a one-stop shop, available to all attendees, for professional development and personal branding resources. Whether you are seeking new employment, looking to advance your career, or simply want to update your headshot, we have something for you
0915 – 1015
Networking
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Welcome Reception by the CaSA Chapter at Booth #813
FOYA Booth #1117
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Welcome Reception by the CaSA Chapter at Booth #813
FOYA Booth #1117
1015 – 1045
Digital Transformation
Brandi Stockton, The Triality Group, LLC
Eric. Staib, Syneos Health
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.
1015 – 1045
Regulatory - Compliance - Quality
Christopher Potter
The presentation describes the objectives of the ISPE initiative, Enabling Pharmaceutical Innovation: Delivering for Patients which was initiated ib 2023. A first activity of the initiative was to conduct a 3-part survey of ISPE members to understand the circumstances and confirm sources that create barriers to innovation. A full report of the survey was published in April 2024 on the ISPE web site (https://ispe.org/initiatives/regulatory/enabling-global-pharmaceutical-innovation-delivering-patients). A summary of the findings from the survey, which had 391 respondents will be presented as well as respondent’s suggestions for reducing regulatory challenges and next steps for the initiative team.
1015 – 1045
Advanced Therapy Medicinal Products
Ingrid Markovic, Genentech Inc
Regulatory Representative (Invited)
Lifecycle Management Considerations for Cell And Gene Therapy Products to Expand Access And Drive Affordability
Join us as we delve into the realm of lifecycle management considerations for cell and gene therapy products. In this enlightening presentation, the audience will learn more about regulatory strategies aimed at broadening patient access while fostering affordability in the realm of transformative medical innovations. The presentation will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.
Join us as we delve into the realm of lifecycle management considerations for cell and gene therapy products. In this enlightening presentation, the audience will learn more about regulatory strategies aimed at broadening patient access while fostering affordability in the realm of transformative medical innovations. The presentation will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.
1015 – 1045
Sustainability - Supply Chain Resiliency
John Magner, Johnson & Johnson
Supporting J&J's vision for a sustainable future is their commitment to sustainable facilities. Recognizing the importance of what we build and how we build, we started a challenging initiative last year, focusing on embodied carbon emissions for our capital construction projects. While operational carbon emissions have received significant attention, embodied carbon remains relatively unknown in the construction sector and within our Project Delivery teams (PD). Our mission was clear: to bring clarity and quantification to the concept of embodied carbon in our construction projects and look for opportunities to reduce our footprint. We asked an external consultant to provide us this quantification based on 3 pilot projects. This mission gave us interesting insights into our carbon footprint, providing us with key takeaways to integrate into our future projects. Furthermore, we worked towards generic guidelines on how to implement embodied carbon reduction strategies into our future construction projects. Our next steps involve disseminating these insights to our global Project Delivery and Engineering team, ensuring this knowledge becomes embedded in our organization. Additionally, we aim to establish a benchmark to implement sustainable practices across our entire (future) building portfolio.This way we put our corporate’s sustainability ambitions to practice in our facilities.
1015 – 1045
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.
1045 – 1115
Sustainability - Supply Chain Resiliency
Gary Dugdale, AstraZeneca
Michael Keohane, PM Group
Buildings account for almost 40% of global greenhouse gas (GHG) emissions. This relates to emissions arising from materials of construction and operational emissions such as energy. The global transition to Net-zero will require decarbonization changes across all elements of society, including the way we design our buildings and manufacture products. Decarbonization strategies for manufacturing facilities, both existing and new build, are essential.To achieve Net-zero Buildings, the embodied carbon emissions associated with building construction must be understood and reduced. Reducing operational emissions alone will not achieve Net-zero. Regulatory authorities globally are now recognizing this and introducing legislation for the reporting of whole life carbon emissions associated with building construction.This presentation will provide an insight into the source of carbon in pharmaceutical buildings with case study findings on whole life carbon assessment of pharma manufacturing facilities. An overview of life cycle assessment (LCA) for carbon emissions will be provided including the challenges & design strategy opportunities for the construction of industrial buildings.
1045 – 1115
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.
1045 – 1115
Manufacturing - Quality Control - Operational Excellence
Mathew Kishe, Eli Lilly
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.
1045 – 1115
Regulatory - Compliance - Quality
Gregory Rullo, AstraZeneca
Modeling plays a critical role in drug manufacturing by providing a systematic and data-driven approach to optimize and streamline various production of pharmaceuticals. Physiological models are used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological and pharmaceutical data to simulate and predict drug behavior in vivo. Recently significant progress has been made to advance Health Authority acceptance of Physiological Based Biopharmaceutical Models, PBBMs. Using PBBMs, researchers can simulate the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug under different scenarios, including different formulations, dosing regimens, and patient populations. By leveraging PBBMs, scientists can potentially predict how changes in formulation or other factors may affect drug exposure and therapeutic outcomes. In some cases, regulatory agencies may accept well-validated PBBMs as a substitute for certain types of BA studies. The presentation will provide an overview of the application of Physiological Based Biopharmaceutical Models including in drug development, set specifications and managing post approval change. Additionally, a summary of the significant progress in the regulatory landscape and acceptance of PBBMs.
1045 – 1115
Advanced Therapy Medicinal Products
Stephanie Martin, Adaptimmune
Establishing a Particle Control Lifecycle: Regulatory and Quality Perspectives
Particle control in cellular ATMPs (Advanced Therapy Medicinal Products) presents a unique challenge to the industry. This presentation will cover a lifecycle approach to understanding and controlling the presence of particles in your product, integrating both regulatory requirements and quality considerations to ensure compliance and product quality
Particle control in cellular ATMPs (Advanced Therapy Medicinal Products) presents a unique challenge to the industry. This presentation will cover a lifecycle approach to understanding and controlling the presence of particles in your product, integrating both regulatory requirements and quality considerations to ensure compliance and product quality
1115 – 1145
Sustainability - Supply Chain Resiliency
Kevin Conkright, AstraZeneca
Allen Koester, PCI (A Salas O'Brien Company)
Sustainability is a focus area in the pharmaceutical industry. The pharmaceutical industry is a customer focused industry that puts its patients first. A sustainable process is healthy for our environment. A healthy environment supports a healthy patient. AstraZeneca has a bold sustainability ambition which includes being carbon neutral by 2025. Our presentation will display the journey of the Mt. Vernon AstraZeneca Supply Site to becoming a sustainable manufacturing facility achieving carbon neutrality by 2025. This journey highlights a true corporate commitment, the role of technical partnerships, the importance of engaging your team across all levels, and of capitalizing on both big and small opportunities.
1115 – 1145
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.
1115 – 1145
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.
1115 – 1145
Regulatory - Compliance - Quality
James Wabby, AbbVie, Inc.
Combination products are emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative, or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality, and performance of combination products. Taken together, the fast development of combination products with great potential in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.
1115 – 1145
Advanced Therapy Medicinal Products
Jon Halling, Catapult Cell and Gene Therapy
Alfred Penfold, PM Group
Over the last decade, Cell & Gene Therapy Catapult in the UK has worked with industry in the development, production and adoption of ATMPs. CGT Catapult is an independent innovation and technology organization committed to the advancement of cell and gene therapies, with a vision for a thriving industry delivering life-changing advanced therapies to the world. The collaboration with regulators, a total of 15 agency visits / inspections to date, has been a key contributing factor to the success of the Cell & Gene Therapy Facility. Learn how multiple ATMP modalities have been successfully accommodated in the same facility and the steps taken to remain fully compliant.
1145 – 1300
Networking
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Meet the ISPE Staff at Booth #813
FOYA Booth #1117
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Meet the ISPE Staff at Booth #813
FOYA Booth #1117
1300 – 1330
Sustainability - Supply Chain Resiliency
Thomas Roades, Duke-Margolis Institute for Health Policy
Supply chain reliability is top of mind in the U.S. and globally. Supply chain breakdowns from manufacturing quality issues and other disruptive events are too frequently causing drug shortages with devastating impacts on patient care.Recently launched in 2023, the Duke-Margolis Institute's ReVAMP Drug Supply Chain Consortium is driving robust discussion on drug supply chain improvement opportunities for the US market. The Consortium’s mission is to generate effective policy solutions that promote a reliable drug supply chain with advanced manufacturing capabilities and, ultimately, to improve patient outcomes by reducing the frequency and severity of drug shortages. Based on input from a wide range of experts involved in manufacturing, distributing, purchasing, prescribing, and regulating prescription drugs, the Consortium puts forward written policy recommendations and other work products to advance these aims. The Consortium aims to build a drug supply chain that ensures patients access to safe and effective drugs, in adequate quantities, when they’re needed.
1300 – 1430
Francesco Intoccia, CSL Behring
Parag Sane, Amgen Inc.
Christina Stern, Takeda Austria GmbH
Patrick Poisson, United Therapeutics Corporation
Vishal Shah, Cadila Healthcare Ltd
Dave DiProspero, CRB
2024 Facility of the Year (FOYA) Category Winners Showcase: Exploring Excellence in Facility Projects
Join us for an engaging and interactive session led by Dave DiProspero, featuring esteemed FOYA judges and category winners as they delve into the intricacies of their 2024 FOYA award-winning facility projects. Through a dynamic roundtable type panel discussion, we'll uncover the motivations behind FOYA submissions, dissecting the challenges faced and the innovative award winning solutions devised. From forging strong partnerships to embracing patient-centric design, each various aspects of project development and execution will be explored. This interactive session isn't just about celebrating achievements—it's about sharing insights and lessons learned to inspire future excellence in facility projects. Don't miss this opportunity to interact and gain firsthand knowledge from industry leaders and key players, shaping the future of pharmaceutical facility design, construction and operations.
Join us for an engaging and interactive session led by Dave DiProspero, featuring esteemed FOYA judges and category winners as they delve into the intricacies of their 2024 FOYA award-winning facility projects. Through a dynamic roundtable type panel discussion, we'll uncover the motivations behind FOYA submissions, dissecting the challenges faced and the innovative award winning solutions devised. From forging strong partnerships to embracing patient-centric design, each various aspects of project development and execution will be explored. This interactive session isn't just about celebrating achievements—it's about sharing insights and lessons learned to inspire future excellence in facility projects. Don't miss this opportunity to interact and gain firsthand knowledge from industry leaders and key players, shaping the future of pharmaceutical facility design, construction and operations.
Francesco Intoccia
Senior Vice President Global Engineering Innovation
CSL Behring
CSL Behring
Parag Sane
Executive Director Engineering Projects
Amgen Inc.
Amgen Inc.
Christina Stern
Sterile Production, Production Lead Syringe
Takeda Austria GmbH
Takeda Austria GmbH
Patrick Poisson
Executive Vice President, Technical Operations
United Therapeutics Corporation
United Therapeutics Corporation
Vishal Shah
Manager - Production
Cadila Healthcare Ltd
Cadila Healthcare Ltd
Dave DiProspero
Senior Fellow | Director of Pharmaceutical Process Technology
CRB
CRB
1300 – 1330
Advanced Therapy Medicinal Products
Ian Moy, Catalent Pharma Solutions
Komal Hatti, IPS
This discussion is adapted from the 2024 ISPE Allogeneic Cell Therapy Guide, which focuses on manufacturing facility development and design for allogeneic cell therapies. The development, regulatory path, facility design, qualification, and manufacture of ATMPs present significant challenges to manufacturers, engineers, and suppliers. The GMP regulations are evolving as novel processes are presented and manufacturing paradigms are being tested. This discussion addresses facility engineering issues that are most applicable in facility design today, as allogeneic cell therapy manufacturing processes – and ATMPs in general – continue to rapidly evolve.The first section will discuss contamination control strategies and multi-product processing.The second section will discuss the allogeneic cell therapy manufacturing process.The third section will discuss allogeneic cell therapy facilities, key design elements, and common challenges.
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.
1300 – 1330
Regulatory - Compliance - Quality
Attrayee Chakraborty, Northeastern University
Artificial intelligence (AI) has disrupted almost every sector, including that of healthcare. As of December 2023, the FDA has cleared more than 520 artificial intelligence (AI) medical algorithms since 1995, with 171 AI-enabled medical devices added to the list in 2023. However, international harmonization on AI is far from achievable currently.
I will delve into the regulatory landscape surrounding the utilization of AI in the medical device industry across the globe, offering insights into the diverse philosophies shaping such regulations. The primary emphasis is on examining international initiatives, notably the WHO's comprehensive principles governing ethical AI and its regulatory frameworks and also conduct an in-depth exploration of country-specific regulations, spotlighting the regulatory approaches of the EU, UK, China, India and Saudi Arabia while also providing an overview of emerging regulations in Japan and Italy. I will also focus on how to validate and build reliance on AI systems used internally within companies through risk-based methodologies to effectively use AI solutions in the workplace.
I will delve into the regulatory landscape surrounding the utilization of AI in the medical device industry across the globe, offering insights into the diverse philosophies shaping such regulations. The primary emphasis is on examining international initiatives, notably the WHO's comprehensive principles governing ethical AI and its regulatory frameworks and also conduct an in-depth exploration of country-specific regulations, spotlighting the regulatory approaches of the EU, UK, China, India and Saudi Arabia while also providing an overview of emerging regulations in Japan and Italy. I will also focus on how to validate and build reliance on AI systems used internally within companies through risk-based methodologies to effectively use AI solutions in the workplace.
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 organizations are 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
Regulatory - Compliance - Quality
Kabir Ahluwalia, Amgen
In response to the need for faster regulatory timelines and growing patient demand, this session proposes a technological shift in CMC submissions through structured content and generative AI (GenAI). We aim to transition from manual, siloed processes to a seamless, technology-driven approach, enhancing efficiency and data integration. The presentation will: 1) Demonstrate the synergy between structured content and GenAI throughout the authoring process; 2) Highlight the advantages of a structured, standardized, interoperable ecosystem, addressing adoption barriers; and 3) Provide real-world examples showing the impact of this integration on regulatory submissions.By embracing technological advancement, the biopharmaceutical industry can achieve significant strides in reducing submission timelines and accelerating the delivery of therapeutics. We aim to provide a comprehensive overview that not only showcases the potential of AI and structured content in regulatory affairs but also inspires a shift towards more dynamic and technology-driven processes by providing real-world examples that can be implemented today. However, it is essential to bring industry and regulators together to collaboratively build towards a future vision. As such, this proposal would benefit from additional speakers building similar authoring technologies, and more so, from regulators who can speak to considerations and expectations from the health authority perspective.
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.
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
1330 – 1400
Sustainability - Supply Chain Resiliency
Jessica Hale, Merck & Co Inc
The regulatory landscape related to drug shortage prevention has changed over the last several years due to large-scale, highly visible events (e.g., COVID-19 pandemic, geopolitical issues, hurricanes, etc.). Rapidly evolving drug shortage requirements followed and has generated nuanced differences across multiple markets in definitions/ approaches, reporting expectations, and risk management planning. As a result, ISPE formed a Global Convergence Opportunities team with its Drug Shortages Initiative to assess trends in drug shortage-related requirements and identify opportunities to harmonize definitions and approaches across markets. This presentation will discuss the findings and correlating recommendations being made in the interest of bolstering supply chain resiliency.
1330 – 1400
Advanced Therapy Medicinal Products
Andrew Applebury, Fujifilm Diosynth Biotechnologies
George Todorov, IPS
With the number of cell and ex-vivo gene therapy products entering the clinic growing exponentially, we must, as an industry, look ahead and plan accordingly so that we can deliver these revolutionary medicines to large patient populations safely and efficiently. Regardless of the specific modality – and the autologous or allogeneic format – cell therapy processes are not standardized and present significant challenges to facility designs intended to support transitions towards process closure and scale-up, multiple products and/or multiple clients. This presentation will share lessons learned from recent flexible cell therapy facility design projects that enable organizations to meet the needs of evolving cell and ex-vivo gene therapy manufacturing processes.
1400 – 1430
Sustainability - Supply Chain Resiliency
Chris Musteikis, Gsk
How do differences in global requirements and filing timelines lead to drug shortages?
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.
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.
1400 – 1430
Advanced Therapy Medicinal Products
Omar Melendez, AstraZeneca
Maya DeHart, Clark, Richardson, Biskup
AstraZeneca is redefining industry norms and setting a benchmark for sustainable practices on a global scale. A holistic look at AstraZeneca’s global sustainability policy and approach that integrates environmental responsibility, patient-centricity, and operational excellence in cell therapy manufacturing. In this presentation, we will highlight a case study – AstraZeneca’s new cell therapy manufacturing facility in Maryland, which serves as a prime example of the company's sustainability efforts in action. The facility design incorporates an array of features into the design, including 100% electrification, designed for LEED Platinum certification, water reclaim, waste handling, and innovative energy-efficient technologies. The presenters will demonstrate site-specific examples on how to minimize environmental impact while maximizing operational efficiency in cell therapy manufacturing. Lastly, the presentation will explore how sustainability initiatives connect to the resiliency and continuity of supply chain. The discussion will encompass various aspects, including facility design choices, operational readiness, and the company's overarching commitment to patient care. The presenters will elaborate on the strategies implemented for this project, emphasizing this facility’s role in maintaining cell therapy supply chain integrity.
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.
1400 – 1430
Regulatory - Compliance - Quality
Loganathan Kumarasamy, Zifo Technologies
As a service industry head, I have the opportunity to work with various different companies and large pharmaceuticals on their digital transformation programs. We are noticing a very high trend of AI/ML implementation on R&D as well as in Manufacturing arena. The regulations does not clear explain the needs to remain compliance when implementing ML models in GMP but various companies and quality assurance departments approaches based on their understanding. This proposal will combine the best of best practices implemented at various companies and examines the regulatory considerations when implementing AI/ML in Good Manufacturing Practices (GMP) arena. The session will also cover certain use cases implemented in the industry.
1430 – 1530
Networking
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
FOYA Booth #1117
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
FOYA Booth #1117
1530 – 1600
The pharmaceutical and biopharmaceutical industries have struggled to implement effective quality risk management (QRM) programs and risk assessment strategies since the inception of ICH Q9 in 2009. In ICH Q9’s infancy, industry began performing risk assessments, lots of risk assessments without a holistic strategy or thought to an organization’s overarching risk assessment portfolio. A historic lack of emphasis on QRM planning is a plausible reason why the industry has struggled with the administration of the QRM program and the creation of myriad risk assessments with no holistic vision. The lack of strategic planning could also contribute to a siloed approach to QRM application and risk assessment performance. By outlining overarching objectives for the QRM program, the use of a Quality Risk Management Master Plan can enable the pharmaceutical and biopharmaceutical industries to spend less time “doing QRM” and more time managing risk to the patient. This plan would be a living document over time to demonstrate the current state of the program, as well as updating the future of QRM implementation.
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.
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.
1530 – 1600
Advanced Therapy Medicinal Products
Biana Torres, Encoded Therapeutics
Ryan Murray, Valsource Inc
Per Alliance for Regenerative Medicine, there are almost 2000 ongoing clinical trials with an ATMP therapeutic focus as of Q4 2023. The industry often speaks about using risk based approaches to ensure that ATMP products are produced ensuring patient safety, product quality while enabling speed to market. There is a lack of guidance for the framework of risk-based validation in autologous and allogeneic ATMPs. This lack of guidance is leading to a slowdown in clinical trial approaches and commercialization of these novel therapies. This presentation will cover the phase appropriate and risk based approaches specific to process, analytical, cleaning, and supply chain validation strategies that are unique to ATMPs. This presentation will give a preview and provide some examples from an ISPE ATMP Guide covering this topic.
1530 – 1600
Sustainability - Supply Chain Resiliency
Sarah Mandlebaum, Takeda
Nikki Imbergamo, Takeda Pharmaceuticals Inc.
We aim to delve into the critical connection between high-level sustainability goals, such as Net-Zero Climate, and the necessity for data transparency in product manufacturing. By examining the role of data transparency within the supply chain (scope 3) and the manufacturing facility (scope 1 and 2), this presentation will shed light on how data can drive sustainable practices through informed decision-making, process optimization, collaboration with suppliers, and resource usage optimization. The presentation will discuss how product design influences site operations and energy/waste reduction. Additionally, it will explore how sites utilizing renewable energy and innovative manufacturing equipment and techniques can further minimize product footprints. The shift towards data-driven product-level emission calculations for Scope 3 reporting will be examined, along with how manufacturing sites can provide this data using Bill of Materials (BOMs), metering, and allocation. A case study will be presented to showcase these concepts in action, providing practical examples of how data transparency drives sustainable practices and contributes to the achievement of high-level sustainability goals.
1600 – 1630
Regulatory - Compliance - Quality
George Kwiecinski, The Cooper Union for the Advancement of Science and Art
This presentation will offer a novel perspective on interpreting compliance data by charting significant trends in legal citations within the public domain. We will dissect how these patterns can influence corporate compliance strategies and operational frameworks. By integrating data analytics with legal insights, the session aims to provide attendees with actionable knowledge to navigate the complex regulatory environment effectively. Emphasis will be on practical applications, enhancing attendees’ ability to forecast regulatory shifts and implement preemptive compliance measures. This forward-thinking approach is essential for professionals aiming to maintain robust regulatory adherence amidst an evolving legal landscape. Overall, an open forum and additional facets can be added to the presentation to best add substance beyond pure data analysis.
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.
1600 – 1630
Digital Transformation
Ken Shitamoto, Gilead Sciences
Patrick Mullin, Sanofi
Philip Jarvis, Veqtor
Miguelina Matthews, PhD, Sanofi Aventis
Jeff Gensler, Kindeva Drug Delivery
Stephen Ferrell, Strike Graph
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.
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences
Gilead Sciences
Patrick Mullin
Commissioning & Qualification Lead, Specialty Care GBU
Sanofi
Sanofi
Philip Jarvis
Director, Integrated C&Q and Paperless Strategy
Veqtor
Veqtor
Miguelina Matthews, PhD
Head External Liaison, Global Quality
Sanofi Aventis
Sanofi Aventis
Jeff Gensler
Vice President of Quality
Kindeva Drug Delivery
Kindeva Drug Delivery
Stephen Ferrell
Chief Strategy Officer
Strike Graph
Strike Graph
Pierre Winnepenninckx
CEO
No Deviation Pte Ltd
No Deviation Pte Ltd
1600 – 1630
Advanced Therapy Medicinal Products
Robin Newman, Core Services Group
Gretchen Smith, Advanced Medicine Partners
CDMOs have taken over the pharmaceutical field especially when it comes to development of novel therapies such as cell therapies, gene therapies, and RNA products which are critical to the patient population facing rare diseases. Advanced Medicine Partners has shifted the paradigm that CDMOs should work independently from clients and has taken the approach to partner with clients in various phases of development, including providing an extended workbench as a novel offering. ATMPs can leverage AMP’s wide range of analytical, process optimization and development, and GMP manufacturing capabilities to accelerate successful drug candidates getting to patients.This presentation proposes to delve into the relationship of client-partnerships, CQV deliverables, and project management tools that impact the flexibility and speed of a CDMO. Implementation of efficient site procedures with project controls over CQV deliverables can facilitate seamless tech transfers. The presentation will go over how to build a robust CQV plan, which plays an important role in the life cycle as it demonstrates product integrity and regulatory compliance. The presentation will demonstrate how using proper CQV & project management tools to manage resources, timelines, and deliverables helps not only to deliver quality products faster-to-market but can help control costs and optimize spending.
Gretchen Smith is a highly accomplished manufacturing executive with an impressive track record spanning over 25 years in the pharmaceutical industry. Currently serving as the Senior Vice President of Manufacturing and Site Head at Advanced Medicine Partners, she plays a pivotal role in leading the establishment of a cutting-edge Contract Development and Manufacturing Organization (CDMO) facility. This state-of-the-art facility is dedicated to providing unparalleled chemistry, manufacturing, and controls (CMC) capabilities for advanced medicines, including gene and cell therapies. Gretchen's expertise allows her to address the critical challenges of product quality and scalability that are often encountered in the development and production of highly technical medicines.
Gretchen Smith is a highly accomplished manufacturing executive with an impressive track record spanning over 25 years in the pharmaceutical industry. Currently serving as the Senior Vice President of Manufacturing and Site Head at Advanced Medicine Partners, she plays a pivotal role in leading the establishment of a cutting-edge Contract Development and Manufacturing Organization (CDMO) facility. This state-of-the-art facility is dedicated to providing unparalleled chemistry, manufacturing, and controls (CMC) capabilities for advanced medicines, including gene and cell therapies. Gretchen's expertise allows her to address the critical challenges of product quality and scalability that are often encountered in the development and production of highly technical medicines.
1600 – 1630
Sustainability - Supply Chain Resiliency
Ryan Waldhart, Grand River Aseptic Mfg Inc
Christopher Schwartz, L.E.K. Consulting
Given the lag time between an investment decision and having a sterile injectable facility ready to produce commercial product, having a robust manufacturing and supply chain strategy is critical to the success of sterile injectable manufacturers. In recent years, there have been many direct and indirect shocks to sterile injectable supply chains including COVID disruptions, the rise and fall of COVID vaccine demand, the explosion of GLP-1's, the signing of the Inflation Reduction Act, and a spike in interest rates. These events and trends have required sterile injectable manufacturers and CDMOs to reevaluate their manufacturing investment and supply chain strategies to efficiently allocate capital while building resiliency. This presentation is intended deep dive into the impact of these recent trends and hypothesize the future of sterile injectable manufacturing investment and supply chain strategies.
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.
1630 – 1700
Digital Transformation
Ken Shitamoto, Gilead Sciences
Patrick Mullin, Sanofi
Philip Jarvis, Veqtor
Miguelina Matthews, PhD, Sanofi Aventis
Jeff Gensler, Kindeva Drug Delivery
Stephen Ferrell, Strike Graph
Pierre Winnepenninckx, No Deviation Pte Ltd
Hear how a leading healthcare company has leveraged a global tool to gain quality insights around deviations and complaints. Join our esteemed panelists as they delve into making informed 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
Philip Jarvis
Director, Integrated C&Q and Paperless Strategy
Veqtor
Veqtor
Miguelina Matthews, PhD
Head External Liaison, Global Quality
Sanofi Aventis
Sanofi Aventis
Jeff Gensler
Vice President of Quality
Kindeva Drug Delivery
Kindeva Drug Delivery
Stephen Ferrell
Chief Strategy Officer
Strike Graph
Strike Graph
Pierre Winnepenninckx
CEO
No Deviation Pte Ltd
No Deviation Pte Ltd
1630 – 1700
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
In 2024, two major reorganizations occurred in FDA that significantly changed where and how drug quality oversight is conducted. First, the quality assessment offices (formerly ONDP, OLDP, OBP) and research office were reconfigured, with the intent to create a more streamlined, agile and flexible organization and to reinforce the connections between assessment, inspection, surveillance, research and policy operations. Second, the Office of Regulatory Affairs is being reorganized into the Office of Inspectional and Investigations, with the intent to reduce duplication and streamline actions, hopefully leading to more clarity and promptness in enforcement actions for regulated industry.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality assessment initiatives include Knowledge-Aided Assessment & Structured Application (KASA), Emerging Technology Program (ETP), and the ICMRA pilots for international joint assessment and inspection.
These changes, in conjunction with ongoing initiatives to streamline and modernize FDA's internal review process, should make FDA more adaptable to public health emergencies, new pharmaceutical technologies, and market dynamic for pharmaceutical quality. Ongoing quality assessment initiatives include Knowledge-Aided Assessment & Structured Application (KASA), Emerging Technology Program (ETP), and the ICMRA pilots for international joint assessment and inspection.
1630 – 1700
Sustainability - Supply Chain Resiliency
Jochen Schlag, Belimed Life Science
Sustainability is a term that is currently in the spotlight almost everywhere in the world. Thereby sustainability does not have to mean doing without but should be seen from the perspective of saving. Because if resources can be saved, money can also be saved. As a rule: It doesn't have to be expensive technologies such as nuclear fusion research or battery storage. There are also much simpler ways. The pharmaceutical world in particular requires a lot of energy and resources. Reducing these is not rocket science if you follow a few basic rules and focus on the right type of energy. Where is the most energy needed? What is the best technology for heating a medium? Can energy be recovered? A great deal can be achieved with a simple approach. What do you think takes more energy: Heating 1 gallon of water by 50°F or the same amount of stainless steel by the same temperature?
1630 – 1700
Advanced Therapy Medicinal Products
Apurv Puri, Pharmatech Associates
The gene therapy industry has witnessed comparability issues manifest throughout the clinical trial phases. While these issues were not attributed to process changes per se, they highlight the lack of thorough process understanding and process robustness when manufacturing novel products. AAV vectors are not considered “well characterized” products. This creates a challenging landscape for demonstrating comparability - and with rapidly evolving technology and manufacturing platforms, there is a need to drive systematic approaches to equipment selection and evaluation. The ISPE ATMP CoP has recently published a guide on rAAV Comparability to bridge this gap. This session will present a case study on demonstrating rAAV product comparability when changing the production bioreactor configuration and scaling up.
1700 – 1900
Networking
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Emerging Leader Social at Booth #105 (Students & Recent Graduates are also welcome)
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
FOYA Booth #1117
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Emerging Leader Social at Booth #105 (Students & Recent Graduates are also welcome)
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
FOYA Booth #1117
1930 – 2130
Sponsored by AstraZeneca
Join us for an evening of art, history, and culture as Women in Pharma® gathers once again in celebration of accelerated equality and inclusivity within our industry. Throughout the two-hour event, you’ll immerse yourself in the ambiance of Italian culture, enjoying cocktails, Italian cuisine, conversations, and appreciating the rich history and cultural significance of the masquerade tradition dating back to the 15th century Venice. Veiled behind your mask, relish the freedom of anonymity, fostering uninhibited exchanges and forging genuine connections. As the night unfolds, masks will be shed, unveiling identities, paving the way for the exchange of business cards, and the cultivation of professional ties, fortified by the shared bond of ISPE’s Women in Pharma. Please note: All attendees must wear a Venetian-style mask throughout the duration of the event. We highly encourage masks to be elaborate and decorative, covering the eyes and nose area, but should not obstruct vision or impede conversation.
Join us for an evening of art, history, and culture as Women in Pharma® gathers once again in celebration of accelerated equality and inclusivity within our industry. Throughout the two-hour event, you’ll immerse yourself in the ambiance of Italian culture, enjoying cocktails, Italian cuisine, conversations, and appreciating the rich history and cultural significance of the masquerade tradition dating back to the 15th century Venice. Veiled behind your mask, relish the freedom of anonymity, fostering uninhibited exchanges and forging genuine connections. As the night unfolds, masks will be shed, unveiling identities, paving the way for the exchange of business cards, and the cultivation of professional ties, fortified by the shared bond of ISPE’s Women in Pharma. Please note: All attendees must wear a Venetian-style mask throughout the duration of the event. We highly encourage masks to be elaborate and decorative, covering the eyes and nose area, but should not obstruct vision or impede conversation.
0700 – 1800
0700 – 0800
Networking
0800 – 0810
General Session
0810 – 0815
0815 – 0840
General Session
Syed Abbas Yar-Khan, Eli Lilly and Company
In a world where millions of patients await, Lilly stands at the forefront of a transformative era. With a dynamic strategy, Lilly's commitment to innovation in pipeline, workforce, technology, safety, and quality is unwavering.
Discover the art of navigating these tides with Abbas Yar-Khan, Lilly's Group Vice President of Global Parenteral Products and Devices. Dive into an inspiring session where agility meets urgency and learn how Lilly's accelerated efforts are shaping a healthier future for patients across the globe.
Discover the art of navigating these tides with Abbas Yar-Khan, Lilly's Group Vice President of Global Parenteral Products and Devices. Dive into an inspiring session where agility meets urgency and learn how Lilly's accelerated efforts are shaping a healthier future for patients across the globe.
0840 – 0905
General Session
Chris Stevens, Spark Therapeutics, Inc.
Gene therapy offers tremendous potential and is continually evolving. Today the industry is tackling incurable diseases, providing durable cures and modifying diseases for relatively small patient populations. In the not-too-distant future gene therapy will provide permanent cures for much larger patient populations, enhancing existing treatments with precision medicine and preventing disease altogether. Almost by definition, the evolving nature of gene therapy drives the need for continual changes in technology, talent, platforms and development – all with the requirement for inherent flexibility.
Spark Therapeutics developed and launched the very first gene therapy for a genetic disease approved in both the US and EU. As a leader and driving force in gene therapy, Spark is continually evolving ahead of the industry and working to achieve its vision of a world where no life is limited by disease. Join Chris Stevens, Spark’s Chief Patient Supply Officer, for an in-depth conversation on how Spark is:
- Developing emerging technology and platforms with inherent adaptability; - Building capability and the talent Spark needs for today and tomorrow; - Investing and innovating in Philadelphia; and - Bringing their new Gene Therapy Innovation Center to life in West Philadelphia in the heart of University City.
Spark is on a mission to unlock the power of gene therapy to accelerate healthcare transformation. Chris will share how he and Spark’s Patient Supply Organization are making that mission a reality via (e)merging tech and talent, innovation and investment in the city of Philadelphia.
Spark Therapeutics developed and launched the very first gene therapy for a genetic disease approved in both the US and EU. As a leader and driving force in gene therapy, Spark is continually evolving ahead of the industry and working to achieve its vision of a world where no life is limited by disease. Join Chris Stevens, Spark’s Chief Patient Supply Officer, for an in-depth conversation on how Spark is:
- Developing emerging technology and platforms with inherent adaptability; - Building capability and the talent Spark needs for today and tomorrow; - Investing and innovating in Philadelphia; and - Bringing their new Gene Therapy Innovation Center to life in West Philadelphia in the heart of University City.
Spark is on a mission to unlock the power of gene therapy to accelerate healthcare transformation. Chris will share how he and Spark’s Patient Supply Organization are making that mission a reality via (e)merging tech and talent, innovation and investment in the city of Philadelphia.
0910 – 0915
0915 – 1015
Networking
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Grant Recipient and Board Member Meet & Greet at Booth #813
FOYA Booth #1117
ISPE Mobile App Giveaway Game. Details are located in the ISPE Mobile App.
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
ISPE PUBlications Lounge
Grant Recipient and Board Member Meet & Greet at Booth #813
FOYA Booth #1117
0915 – 1530
Join us at the ISPE Career Center & Headshot Booth in the EXPO Hall. The ISPE Career Center & Headshot Booth is a one-stop shop, available to all attendees, for professional development and personal branding resources. Whether you are seeking new employment, looking to advance your career, or simply want to update your headshot, we have something for you
0915 – 1530
1015 – 1045
Manufacturing - Quality Control - Operational Excellence
Yiming Peng, Genentech Inc
Margaux Penwarden
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.
1015 – 1045
Sustainability - Supply Chain Resiliency
Arlene Joyner, HHS/ASPR/IBMSC
The global COVID-19 pandemic exposed weaknesses in a supply chain that relies heavily on just-in-time manufacturing for personal protective equipment (PPE), medical equipment, and pharmaceuticals. Critical components involved in every step of development and distribution of medical countermeasures (MCMs), from raw materials to intermediate steps to tools that facilitate product delivery, experienced bottle necks during the pandemic. The world competed for the same supplies to meet the demands brought on by surging cases and exposed major vulnerabilities to foreign sourced products. This was keenly felt with critical medicines required to treat the most vulnerable patients. This dependency on foreign suppliers and developers resulted in high drug prices and, in many cases, shortages. This discussion will offer lessons learned from the pandemic, the current state of the domestic medical supply chain and measures IBMSC is taking to ensure our medical supply chain is robust and prepared to tackle any future medical domestic supply chain events with full confidence. This session will examine the USG posture pre- and during the COVID-19 pandemic, explore the lessons learned from the pandemic, the technological advances that have been made since the start of the pandemic, and examine the future of the medical supply chain.
1015 – 1045
Sponsored Sessions
Small but mighty: how digital technology can support small-batch manufacturing of mRNA therapeutics
Manufacturing of mRNA offers great benefits. The therapeutics produced can be treatments for infectious diseases or used for personalized medicine due to their flexibility, cost, and speed of development. But there are still challenges to overcome to fully realize their potential especially when it comes to small-batch manufacturing. Considering manufacturability and scale-up from the beginning of development will help deliver process efficiency and scalability along the spectrum of mRNA products. In this presentation, we’ll discuss small batch manufacturing solutions and how digital technology can help accelerate therapeutic development. We’ll also describe strategies to adopt a paper-free approach at all stages of development. Key points: Small and flexible manufacturing allows optimized solutions for personalized therapeutics and small-batch manufacturing. Digital technology can support mRNA therapeutics by helping to accelerate batch release and improve compliance. Using paper during development can carry hidden costs.
Manufacturing of mRNA offers great benefits. The therapeutics produced can be treatments for infectious diseases or used for personalized medicine due to their flexibility, cost, and speed of development. But there are still challenges to overcome to fully realize their potential especially when it comes to small-batch manufacturing. Considering manufacturability and scale-up from the beginning of development will help deliver process efficiency and scalability along the spectrum of mRNA products. In this presentation, we’ll discuss small batch manufacturing solutions and how digital technology can help accelerate therapeutic development. We’ll also describe strategies to adopt a paper-free approach at all stages of development. Key points: Small and flexible manufacturing allows optimized solutions for personalized therapeutics and small-batch manufacturing. Digital technology can support mRNA therapeutics by helping to accelerate batch release and improve compliance. Using paper during development can carry hidden costs.
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.
1015 – 1045
Regulatory - Compliance - Quality
Maotang Zhou, FDA
As part of the abbreviated new drug application (ANDA) evaluation, FDA recommends applicants fully understand the potential for changes in or to the active ingredient during the manufacturing process. Complex APIs are often mixtures of different components and can contain a distribution of molecular weight. Due to their complexity in both composition and structure, complex APIs cannot be characterized by typical analytical techniques. To demonstrate the sameness of a complex API in a generic drug product, a “totality-of-the-evidence” approach is generally employed during regulatory assessment. This approach includes three key components: manufacturing process understanding, orthogonal characterization, and comparative biological activity analysis, if necessary. Unlike well-defined small molecule APIs, manufacturing processes are especially critical in ensuring the consistency of composition and properties for complex APIs. This presentation will provide an overview of key regulatory considerations on demonstrating complex API sameness. Additionally, we will present regulatory resources that are available to facilitate the development of complex generic drug products containing complex APIs.
1015 – 1045
Advanced Therapy Medicinal Products
Senthil Ramaswamy, PhD, Lonza
The breadth of Senthil's perspective in the Cell and Gene Therapy space encompasses early research laboratories purchasing Lonza's media, tool & technologies as well as large biotechs and big pharma, outsourcing commercial manufacturing to Lonza. During this address, Senthil will reflect on where the field stands and on the sequence of development and CMC innovations necessary for cell and gene therapies to become truly mainstream and adopted as the standard of care for a wide range of indications and large patient populations. Further to this, Senthil will reflect on the potential futures of cell and gene therapies, depending on a range of potential scenarios.
1045 – 1115
Sustainability - Supply Chain Resiliency
Nissan Cohen, PhD, Biopharmaceutical Water Doc
There is a new European directive EUR-Lex - 32022L2464 - EN - EUR-Lex (europa.eu). In 2025, large companies will have to report, in a more stringent way than 2023, on their data and actions of 2024 for sustainability. In 2026, all European companies with more than 250 employees will have to report on the data and actions of sustainability from the operations during 2025. This is a more stringent and more complex reporting, than any previous year. According to the directive, reporting will have to be approved by external statutory auditors, as per financial reports and report all actions for sustainability.
1045 – 1115
Decentralized Pharma: Pioneering Patient-Centric Manufacturing
Background: Germfree, an innovator in biosafety and containment technologies, has been at the forefront of deploying more than 100 mobile cleanrooms in seven years. Challenge: Healthcare faces ongoing challenges in patient access, drug shortages, manufacturing inefficiencies, and the need for rapid response to patient needs. Traditional centralized manufacturing models often struggle to adapt quickly to these demands, creating a pressing need for innovative solutions.Solution: Germfree responded to this challenge by developing and deploying advanced mobile cleanroom technologies. These units are designed to be flexible, scalable, and capable of meeting the stringent requirements for aseptic processing and manufacturing of cell and gene therapies, as well as other pharmaceutical products.Implementation: The case study will detail the deployment process of these mobile cleanrooms, including site selection, logistics, setup, and integration into existing healthcare and pharmaceutical frameworks. Lessons Learned:Future Outlook: Looking ahead, Germfree's work signals a shift in pharmaceutical manufacturing, highlighting the potential for decentralized models to make healthcare more accessible, efficient, and patient-centered. The case study will conclude with predictions for the industry and the role of mobile cleanroom technology in shaping the future of pharmaceuticals.
Background: Germfree, an innovator in biosafety and containment technologies, has been at the forefront of deploying more than 100 mobile cleanrooms in seven years. Challenge: Healthcare faces ongoing challenges in patient access, drug shortages, manufacturing inefficiencies, and the need for rapid response to patient needs. Traditional centralized manufacturing models often struggle to adapt quickly to these demands, creating a pressing need for innovative solutions.Solution: Germfree responded to this challenge by developing and deploying advanced mobile cleanroom technologies. These units are designed to be flexible, scalable, and capable of meeting the stringent requirements for aseptic processing and manufacturing of cell and gene therapies, as well as other pharmaceutical products.Implementation: The case study will detail the deployment process of these mobile cleanrooms, including site selection, logistics, setup, and integration into existing healthcare and pharmaceutical frameworks. Lessons Learned:Future Outlook: Looking ahead, Germfree's work signals a shift in pharmaceutical manufacturing, highlighting the potential for decentralized models to make healthcare more accessible, efficient, and patient-centered. The case study will conclude with predictions for the industry and the role of mobile cleanroom technology in shaping the future of pharmaceuticals.
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.
1045 – 1115
In a concerted effort to collect data, industry experts have put together a study that presents and analyses changes in global in-country testing (i.e., registration and import testing) requirements of the recent years. In addition, the implications of in-country testing and the industry position are presented.The review identified about 40 changes in testing requirements in more than 25 countries across the globe. The predominant trend derived from the analysis is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system. A second trend is the replacement of routine in-country testing by post-marketing surveillance testing.The results show that countries increasingly acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Furthermore it shows, that more countries extend the unilateral reliance approach to testing to further reduce duplications and associated delays in patient access to medicines.Testing waivers can help to make progress in two important concerns: substandard and falsified products as well as supply interruptions. Patients around the world would benefit from accelerated access to safe products manufactured in facilities inspected for GMP/GDP compliance by mature NRAs, which is a clearly demonstrated benefit of reliance, including for testing.
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
Advanced Therapy Medicinal Products
Holger Kranenburg, KyooBe Tech GmbH
Patrick Wieland, Bausch+Ströbel SE + Co. KG
In this presentation we explore a visionary approach to aseptic fill and finish processes. With operational flexibility based on technical solutions, we provide an answer to challenges deriving from diversified product portfolios and changing pipelines. The approach is applying highly standardized robotic isolator cells addressing the growing demands for highest quality as well as contamination and cross contamination control. In the matrix framework all modules are combined into a versatile functional unit to deliver efficiency, flexibility and reliability at a new level.The concept is applied as a suggested production layout that will highlight the matrix approach benefits in comparison to a conventional layout. This layout is designed to efficiently handle diverse requirements, from fill and finish of very small batch applications like personalized ATMPs to mid-scale production of conventional biologics (e.g. 25.000 units/batch).
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.
1115 – 1145
Regulatory - Compliance - Quality
Jennifer Maguire, CDER/FDA
This presentation will focus on transformative initiatives within Office of Quality Surveillance (OQS) in FDA's Center for Drug Evaluation and Research (CDER) aimed at enhancing and modernizing the agency's approach to drug quality oversight. OQS plays a pivotal role in safeguarding dug quality by leveraging various data sources and analytical methods to monitor, assess, and report on the state of drug product quality and manufacturing facilities. The OQS speaker will discuss key advancements and implementation of innovative programs that enhance FDA’s oversight of drug quality. These programs include the New Inspection Protocol Project which streamlines inspection processes; the Drug Quality Sampling and Testing Program which ensures that the drugs sold in the US meet rigorous standards; and the Quality Management Maturity Program aimed at elevating industry quality oversight. Attendees will gain insights on how these programs enhance FDA’s quality oversight and encourage continual improvement from manufacturers.
1115 – 1145
Sponsored Sessions
Matt Humphreys, Deloitte
Ravi Yalamanchili, Merck
Transforming Deviation Management Leveraging AI and GenAI
In the world of biopharma manufacturing, effective Deviation Management is the cornerstone of quality and efficiency. Traditional manual methods are not only labor-intensive but also susceptible to errors, leading to recurring quality issues.
Join us as we explore:
1.Quality Processes and Systems: Dive into the intricacies of quality management, uncovering the challenges posed by manual deviation handling such as subjectivity, repeat deviations, and inconsistent root cause analysis. Learn how to overcome these hurdles and streamline your processes for better outcomes.
2.AI Strategy and Execution: Discover the cutting-edge innovations in AI and GenAI and see how integrating these advanced technologies with your existing quality systems can transform your operations. Witness firsthand how AI could minimize repeat deviations, enhance productivity, compliance, and most importantly, work diligently towards patient safety.
Join us as we explore how AI can enhance your deviation management practices and elevate your biopharma manufacturing to new levels of excellence.
In the world of biopharma manufacturing, effective Deviation Management is the cornerstone of quality and efficiency. Traditional manual methods are not only labor-intensive but also susceptible to errors, leading to recurring quality issues.
Join us as we explore:
1.Quality Processes and Systems: Dive into the intricacies of quality management, uncovering the challenges posed by manual deviation handling such as subjectivity, repeat deviations, and inconsistent root cause analysis. Learn how to overcome these hurdles and streamline your processes for better outcomes.
2.AI Strategy and Execution: Discover the cutting-edge innovations in AI and GenAI and see how integrating these advanced technologies with your existing quality systems can transform your operations. Witness firsthand how AI could minimize repeat deviations, enhance productivity, compliance, and most importantly, work diligently towards patient safety.
Join us as we explore how AI can enhance your deviation management practices and elevate your biopharma manufacturing to new levels of excellence.
1115 – 1145
Digital Transformation
Oliver Herrmann, Q-FINITY Quality Management
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.
1115 – 1145
Sustainability - Supply Chain Resiliency
Bill Celenza, Burns & McDonnell
Afolabi George, AbbVie
Pharmaceutical manufacturing employs a variety of production processes that generate off-gas containing potentially odorous molecules. Controlling these compounds is crucial for protecting a community from unpleasant odors and health risks, and pharmaceutical makers employ a variety of technologies to treat such potential odor sources. As pharmaceutical production facilities seek to establish more rigorous standards for emission control, optimal control systems must mitigate odors in even the most challenging conditions, remain resilient to potential failure modes, and align with each facility’s budget and operational constraints. Comprehensive modeling and system design processes are critical to thoroughly consider when implementing or upgrading off-gas control systems at pharmaceutical production plants. The ideal mix of emission control technologies is a balancing act of cost and capabilities that must be carefully aligned to the unique requirements of each manufacturing facility.
1145 – 1400
The ISPE Membership Meeting and Awards Lunch is open to all In-Person All Access and Essentials Pass Attendees. Meet and hear from the ISPE leadership and colleagues while learning about significant achievements made by the industry in the past year. Celebrate with your peers as the ISPE International Honor Awards are presented and learn about the 2024 Facility of the Year Awards (FOYA) Category Winners & Overall Winner.
1400 – 1530
Networking
Indulge Your Senses at the Sweetest Soiree of the Year!
Join us on Tuesday, October 15th, immediately following the Membership Meeting and Awards Luncheon, for a decadent Dessert Reception in the Expo Hall. Satisfy your sweet tooth and mingle with industry peers at our delightful Dessert Reception, all served in the vibrant ambiance of the Expo Hall. This event is your chance to unwind, connect, and enjoy the final moments of this year's Annual Meeting & Expo.
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game Winner Announcements
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
FOYA Booth Meet & Greet at Booth #1117
ISPE PUBlications Lounge
Meet the ISPE Staff at Booth #813
FOYA Booth #1117
Join us on Tuesday, October 15th, immediately following the Membership Meeting and Awards Luncheon, for a decadent Dessert Reception in the Expo Hall. Satisfy your sweet tooth and mingle with industry peers at our delightful Dessert Reception, all served in the vibrant ambiance of the Expo Hall. This event is your chance to unwind, connect, and enjoy the final moments of this year's Annual Meeting & Expo.
Available activities to participate in while exploring the Expo Hall:
ISPE Mobile App Giveaway Game Winner Announcements
ISPE Career Center & Headshot Booth #105
Free Custom ISPE T-shirt Booth
FOYA Booth Meet & Greet at Booth #1117
ISPE PUBlications Lounge
Meet the ISPE Staff at Booth #813
FOYA Booth #1117
1530 – 1700
Manufacturing - Quality Control - Operational Excellence
Kristopher Le, PhD, Amicus GMP Consultants
Rebecca Welton, Lachman Consultant Services, Inc.
Ivan Martinez, PhD., Leiters Health
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.
Kristopher Le, PhD
Principal
Amicus GMP Consultants
Amicus GMP Consultants
Rebecca Welton
Senior Consultant, Regulatory Affairs
Lachman Consultant Services, Inc.
Lachman Consultant Services, Inc.
Ivan Martinez, PhD.
Senior Vice President of Quality and Research & Development
Leiters Health
Leiters Health
Ian Deveau
Compliance Officer
FDA
FDA
Anil Mathai
Vice President - Quality & Regulatory Compliance
STAQ Pharma Inc
STAQ Pharma Inc
1530 – 1700
Digital Transformation
Michael Schmeiszer, Sanofi
Nikolai Makaranka, Bristol Myers Squibb
Seneca Toms, U.S. Food and Drug Administration (FDA)
Michael Crowthers, Deloitte & Touche LLP
Nick Armstrong, CAI
Brandi Stockton, The Triality Group, LLC
Nader Shafiei, Sanofi
1530-1600: Responsible Use of AI in a Regulated Environment by Michael Schmeiszer and Nade Shafiei
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
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
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
Join our expert panel as we reflect on missed opportunities in QbD and PAT, exploring how the biopharmaceutical industry can learn from past experiences to successfully navigate AI implementation. While AI holds immense potential to revolutionize the industry, adoption has been uneven. We'll delve into the challenges faced, including data quality, regulatory hurdles, talent shortages, and ethical considerations, discussing how to overcome these obstacles and leverage AI's transformative power in a rapidly changing technological landscape.
Michael Schmeiszer
Head, Digital Risk & Compliance, Strategy & Governance
Sanofi
Sanofi
Nikolai Makaranka
Director, Manufacturing Analytics
Bristol Myers Squibb
Bristol Myers Squibb
Seneca Toms
National Expert, Drugs
U.S. Food and Drug Administration (FDA)
U.S. Food and Drug Administration (FDA)
Michael Crowthers
Managing Director
Deloitte & Touche LLP
Deloitte & Touche LLP
Nick Armstrong
Sr Director, Digital Enablement
CAI
CAI
Brandi Stockton
Founder | Managing Partner
The Triality Group, LLC
The Triality Group, LLC
Nader Shafiei
Head, Digital Risk & Compliance – Data and SaMD
Sanofi
Sanofi
1530 – 1700
Sustainability - Supply Chain Resiliency
Erik Anderson, Novavax
Jason Collins, IPS-Integrated Project Services, LLC
James Fisher, Amgen Inc
Christa Myers, CRB
There is growing importance of flexibility and sustainability in the pharmaceutical manufacturing industry. This session will discuss the challenges and solutions for supporting a highly flexible supply chain in a varying drug product environment, explore the boundaries of flexible facility design, highlight the key principles for agile/flexible facilities, showcase the successful integration of environmental sustainability into capital project delivery process, and recognize the results of being green from the start. These topics demonstrate the importance of planning, innovation, and adaptability in achieving sustainability and flexibility in the pharmaceutical industry.
1530 – 1700
Advanced Therapy Medicinal Products
James Wabby, AbbVie, Inc.
Senthil Ramaswamy, PhD, Lonza
Nicole Verdun, FDA
Robert Dream, HDR COMPANY LLC
Erich Bozenhardt, United Therapeutics
Peter Millili, Johnson & Johnson
In the rapidly evolving field of cell and gene 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. Automation is recognized as a tool to enable a combination of scalability, reduced manufacturing costs and increased quality. This panel aims to discuss the technical, quality, and regulatory considerations associated with expanding access of these therapies.
James Wabby
Global Head, Regulatory Affairs
AbbVie, Inc.
AbbVie, Inc.
Senthil Ramaswamy, PhD
Vice-President of R&D, Cell & Gene Division
Lonza
Lonza
Nicole Verdun
CBER Super Office Director, Office of Therapeutic Products (OTP)
FDA
FDA
Robert Dream
Managing Director
HDR COMPANY LLC
HDR COMPANY LLC
Erich Bozenhardt
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
United Therapeutics
Peter Millili
Senior Director, Manufacturing Science and Technology
Johnson & Johnson
Johnson & Johnson
1530 – 1700
Regulatory - Compliance - Quality
Regulatory Representative (Invited)
Eli Zavialov, GlaxoSmithKline
Stuart Finnie, PhD, Gilead Sciences Inc.
Qinggang Wang, PhD, Bristol-Myers Squibb
Jayda Siggers, Health Canada
Joel Welch, FDA
Global Adoption Status and Implementation Strategies for Q2(R2)/Q14and Q12
The guidelines ICH Q12 (2019) and ICH Q2(R2)/Q14 (2023) embody a science- and risk-based approach to lifecycle management to ensure the continued quality of the quality of drug substances and drug products. ICH Q12 describes the tools that can be utilized for effective post approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focus on development, validation, and lifecycle of analytical procedures; and covers concepts such as the Analytical Target Profile (ATP) and the applicability of enhanced knowledge to manage Q12 concepts such as Established Conditions. There are many expected benefits which include harmonizing scientific approaches and terminology, enabling effective knowledge and risk management to facilitate continual improvement, and improving communication between health authorities and industry. This session will talk about real-life examples from industry and the challenges encountered when implementing these guidelines both from the sponsor and regulator perspectives. Topics presented from industry (the ISPE PQLI ICH Q2(R2)/Q14 and Q12 teams) will include platform analytical procedures, enhanced approaches to development practices, change management utilizing the principles of ICH Q12 and Q2(R2)/Q14 and how ECs can work, and the status of guideline adoption across various companies and health authorities. These presentations from four major companies will be followed by an extended panel discussion including regulators to provide a format for a candid exchange of experiences and ideas to address the perceived challenges.
Regulatory Representative (Invited)
Eli Zavialov
Senior Director
GlaxoSmithKline
GlaxoSmithKline
Stuart Finnie, PhD
Senior Director, Regulatory Affairs CMC
Gilead Sciences Inc.
Gilead Sciences Inc.
Qinggang Wang, PhD
Director of Chemical Process Development
Bristol-Myers Squibb
Bristol-Myers Squibb
Jayda Siggers
Senior Scientific Evaluator
Health Canada
Health Canada
Joel Welch
Associate Director for Science& Biosimilar Strategy
FDA
FDA
1600 – 1630
A Digital Shift in Pharma: Enhancing Production Quality & Efficiency
The digitization of the pharmaceutical industry’s manufacturing process is a critical step towards enhancing quality and productivity. This transformation allows for better knowledge management, accelerated innovation, and improved data security, while reducing time to market. Digitalization can be accelerated with AI to enable full integration of supply chains and improve operational processes, making them more adaptive and responsive. In terms of quality improvement, digitization and automation have resulted in a more than 65% reduction in overall deviations and over 90% faster closure times. Moreover, it has led to a 30 to 50% reduction in deviations, a 25 to 40% increase in plant capacity, a 15 to 20% reduction in lead times, and a 30 to 50% increase in direct and indirect plant operation productivity.
As a result, digitization is not only improving the quality of pharmaceutical manufacturing but also driving significant operational enhancements. It is imperative for the pharmaceutical industry to continue this digital transformation in manufacturing to match the pace of their R&D efforts.
The digitization of the pharmaceutical industry’s manufacturing process is a critical step towards enhancing quality and productivity. This transformation allows for better knowledge management, accelerated innovation, and improved data security, while reducing time to market. Digitalization can be accelerated with AI to enable full integration of supply chains and improve operational processes, making them more adaptive and responsive. In terms of quality improvement, digitization and automation have resulted in a more than 65% reduction in overall deviations and over 90% faster closure times. Moreover, it has led to a 30 to 50% reduction in deviations, a 25 to 40% increase in plant capacity, a 15 to 20% reduction in lead times, and a 30 to 50% increase in direct and indirect plant operation productivity.
As a result, digitization is not only improving the quality of pharmaceutical manufacturing but also driving significant operational enhancements. It is imperative for the pharmaceutical industry to continue this digital transformation in manufacturing to match the pace of their R&D efforts.
1630 – 1700
From Chaos to Control: Streamlining Calibration and Maintenance for Global Operations
Inefficiencies stemming from fragmented systems, inconsistent processes, and labor-intensive manual tasks in calibration and maintenance are prevalent challenges in regulated industries. These issues can result in significant operational costs, compliance risks, and productivity losses.
This session will explore how Siemens Healthcare addressed these challenges by implementing best practices for the management of calibration and preventive maintenance across multiple global sites. Learn how the organization improved process standardization, enhanced operational efficiency, and realized over $3 million in annual cost savings while strengthening compliance and audit performance.
This session will provide valuable insights for organizations seeking to enhance operational efficiency, reduce costs, and ensure regulatory compliance across their maintenance and calibration activities.
1900 – 2200
Networking
Included with the In-Person All Access Pass, the add-on fee for the Tuesday Night Celebration is $225. Immerse yourself in an evening of unparalleled networking, delicious food, refreshing drinks, and engaging activities at The House of Blues, where the essence of classic Florida comes alive. Whether you're reconnecting with old friends or forging new professional relationships, this celebration is the perfect opportunity to mingle with industry leaders and colleagues. We've taken care of transportation logistics with round-trip buses provided, ensuring you can focus on enjoying every moment of this vibrant event. Prepare to experience the best of what the pharmaceutical industry has to offer – this is an evening you won't want to miss!
0800 – 1300
0800 – 0900
Networking
0900 – 0910
General Session
0910 – 0920
General Session
Sarah Pope Miksinski, Gilead Sciences, Inc.
ISPE Regulatory Groups: Driving Harmonization and Quality to Benefit Patients
Join us as the ISPE Regulatory Steering Committee (RSC) provides an update on ISPE’s current regulatory activities and initiatives. Gain valuable insights into the groups that are bringing visibility and solutions to challenges faced by the industry with regard to regulatory/quality aspects and facilitating the flow of information between ISPE members and global Health Authorities. Don't miss this opportunity to stay informed and engaged in the latest developments within ISPE's regulatory landscape.
Join us as the ISPE Regulatory Steering Committee (RSC) provides an update on ISPE’s current regulatory activities and initiatives. Gain valuable insights into the groups that are bringing visibility and solutions to challenges faced by the industry with regard to regulatory/quality aspects and facilitating the flow of information between ISPE members and global Health Authorities. Don't miss this opportunity to stay informed and engaged in the latest developments within ISPE's regulatory landscape.
0920 – 0950
In this engaging session, Ms. Cooke will share insights and perspectives on crucial topics shaping the pharmaceutical industry, including EU regulatory initiatives, ICMRA collaborations, and outcomes from the EU-US MRA.
Explore the integration of innovation into pharma operations, updates on Pharma Legislation for 2025, and the transformative potential of AI/ML in Pharma Operations. Gain valuable insights into the EU harmonized approach to Drug shortages, including outcomes from HERA and related activities from EMA, as well as international collaboration efforts between EMA/FDA and EMA/Industry.
Explore the integration of innovation into pharma operations, updates on Pharma Legislation for 2025, and the transformative potential of AI/ML in Pharma Operations. Gain valuable insights into the EU harmonized approach to Drug shortages, including outcomes from HERA and related activities from EMA, as well as international collaboration efforts between EMA/FDA and EMA/Industry.
0950 – 1120
General Session
Peter Marks, CBER/FDA
Megan Zoschg Canniere, Spark Therapeutics, Inc.
Anabela Marcal, EMA
Anabela Marcal, EMA
Roger Nosal, NGT Biopharma
Timothy Watson, Gilead Sciences
Hugo Hamel, Health Canada
Andrew McKillop, Pfizer, Inc
Yasuhiro Kishioka, PhD, PMDA
Chris Stevens, Spark Therapeutics, Inc.
A Regulatory Town Hall Meeting focused on the challenges and opportunities to expand innovation, improve product quality assurance and patient access to medicines relies on global regulatory harmonization and collaborative approaches in establishing effective policies. This paradigm shift is predicated on transformation that only a future-looking workforce can deliver.
The pharmaceutical industry is advancing through an unprecedented innovative transformation, driven by the development of new product modalities, the emergence of innovative technologies, the evolution of alternative and adaptive regulatory frameworks, and the expeditious approaches introduced and leveraged in response to the COVID-19 pandemic experience.
The Regulatory Town Hall will cultivate a compelling discussion among several panelists on the merits, opportunities and challenges associated with the introduction of innovative technologies, the use of modelling, artificial intelligence, and digital platforms that are shaping the future of pharmaceutical development and commercialization. The key messages from this event will provide a template for the attributes and qualities necessary to enlist and engage a skilled and competent workforce capable of adapting to the fluid demands and expectations of patients and health care providers globally.
The panel will include six representatives from industry and regulatory authorities who will address the following evolving topics:
1. Mutual reliance: How can the industry and regulators leverage the existing frameworks and initiatives, such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the Mutual Recognition Agreement (MRA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to enhance the mutual recognition and reliance of inspections, assessments, and standards across different jurisdictions?
2. Information sharing: How can the industry and regulators enhance the information sharing and communication between and among themselves, as well as with other stakeholders, such as patients, health care professionals, and the public, using the available and emerging digital platforms and tools?
3. Modelling: How can the industry and regulators increase the global acceptability and use of modelling and simulation techniques, such as mechanistic models, physiologically based pharmacokinetic (PBPK) models to support the design, development, and evaluation of medicines and vaccines?
4. AI algorithms: How can the industry and regulators ensure the quality, reliability, and validity of the artificial intelligence (AI) algorithms and systems that are increasingly used in the pharmaceutical sector, such as for drug discovery, clinical trials, pharmacovigilance, and manufacturing?
5. Inspection harmonization: How can the industry and regulators harmonize the implementation and interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (GMP), especially the Annex 1 on the manufacture of sterile medicinal products?
6. Supply chain management: How can the industry and regulators improve the resilience, transparency, and security of the global pharmaceutical supply chain, especially in the post-pandemic context, where the demand and supply of medicines and vaccines are subject to unprecedented fluctuations and disruptions?
7. Structuring the data: How to address the terminology when submitting data to different regulatory agencies? How to harmonize the data? What kind of standard should be used?
We invite all the participants to share their questions on these topics and engage in a constructive and productive dialogue on charting the direction for innovation in the industry to embrace the future that is now!
Peter Marks
Director, Center for Biologics Evaluation and Research
CBER/FDA
CBER/FDA
Megan Zoschg Canniere
Head of Regulatory Affairs & Patient Safety
Spark Therapeutics, Inc.
Spark Therapeutics, Inc.
Anabela Marcal
EMA Liaison Official To FDA
EMA
EMA
Anabela Marcal
EMA Liaison Official To FDA
EMA
EMA
Roger Nosal
Head of Global Regulatory Strategy and Submissions
NGT Biopharma
NGT Biopharma
Timothy Watson
Vice President – Head of CMC Regulatory Affairs
Gilead Sciences
Gilead Sciences
Hugo Hamel
Manager, Biotherapeutic Quality Division
Health Canada
Health Canada
Andrew McKillop
VP, PSSM
Pfizer, Inc
Pfizer, Inc
Yasuhiro Kishioka, PhD
Principal Reviewer
PMDA
PMDA
Chris Stevens
Chief Patient Supply Officer
Spark Therapeutics, Inc.
Spark Therapeutics, Inc.
1120 – 1150
Unlocking the Future of Pharma 4.0 and a Global Digital Transformation Era The pharmaceutical industry is facing a multitude of external challenges, including cost pressures from healthcare systems, such as the Inflation Reduction Act (IRA), patent cliffs, and changes in the global political landscape, exemplified by the BioSecure Act. Amidst these challenges, Pharma 4.0 is emerging has one of the path to sustainably bring innovation to patients. The ISPE's frameworks have supported and encouraged steps towards digitalization and outlined benefits and use case. However, the pharma industry has been slow to change compared to other sectors. Already in 2021, the FDA was stating that "some industries are now well into Industry 3.0, but in many ways the pharmaceutical industry is still very much transitioning into it." With two-thirds of drug shortages historically still attributed to quality-related issues, the opportunities to continue the digitalization journey are plentiful. Exploring the root causes, many companies are lost on the journey, either organizationally or technologically, with some unsure of where to start, others pursuing multiple pilot projects, and some finding that the technology journey is just the beginning of the transformation journey. Additionally, the industry faces a tension between decentralized, democratic, and duplicative organizing principles versus centralized, cumbersome kingdoms. Takeda has been on this journey for many years and taken the challenges head on. From the Facility of the Year (FOYA) awards for Singen and Linz awards in 2022 and 2024 to public commitments to sustainability Pharma 4.0, Takeda's approach has enabled the implementation of numerous technologies and new ways of working. As the industry faces an increasingly diverse portfolio and an ever-complex manufacturing landscape, Pharma 4.0 will be a key driver of growth to meet patients’ demand. We would like to explore some of the good practices we learnt on our digital transformation journey.
1150 – 1200
1200 – 1800
Networking
Join us at the Annual ISPE Foundation Golf Tournament for a day of friendly competition, casual networking, and giving back! The tournament will take place at 12:00pm on 16 October at Celebration Golf Club. Proceeds from the event directly benefit the ISPE Foundation whose mission is “fueling global health equity by fostering access to knowledge and nurturing diverse talent.” Prior to the shotgun start, lunch will be provided and an awards ceremony filled with exciting giveaways will conclude the day. A wide range of exciting sponsorship levels are available to meet your organization's unique preferences and objectives. To learn more about sponsorship opportunities please contact Dave Dunham (ddunham@ispe.org).
0830 – 1630
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
0830 – 1630
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
0830 – 1630
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. This classroom course has been updated to include the new revised GAMP® 5 Second Edition.
0830 – 1630
In this training, you will be led through the APQ guide series for Quality Management Maturity including how to leverage structured tools using a tested industry best-practice approach to coordinating, conducting, presenting, and reporting out on assessment outcomes. You will learn how the APQ methodology is used to improve the current state of quality and how it can benefit your organization through the Assess, Aspire, Act, Advance Framework.
0830 – 1630
0830 – 1630
0830 – 1630
0830 – 1630
Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry
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.