Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
Featured Events & Activities
All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.
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Mon, 2 Jun
Tue, 3 Jun
Wed, 4 Jun
0730 – 0830
Networking
0730 – 1800
Registration open: Monday, 2 June 0730-1900 ET.
Registration will also be open on Sunday, 1 June from 1300-1700 ET.
Registration will also be open on Sunday, 1 June from 1300-1700 ET.
0830 – 0850
0850 – 0920
General Session
Magaly Aham, Takeda - Boston
Global Quality Takeda is reimagining our quality commitments across the value chain. By harnessing data, digital, and emerging technologies like AI, we aim to accelerate product delivery, foster a culture of learning and innovation, and ensure environmental sustainability. We are simplifying, standardizing, and digitalizing quality processes with increased automation and AI, demonstrated through case studies such as one-day batch release, investigation reports, and APQRs. These examples highlight how AI can enable sustainable quality transformation.
0920 – 0950
General Session
Ronald Bauer, PhD, Austrian Agency for Health and Food Safety (AGES)
This presentation will highlight the requirements for data management in the light of sterile manufacturing. The inspector will share experiences with the implementation of Annex 1 in reference to Chapter 4 and Annex 11 based on new developments in the field. They will highlight expectations on successful contamination control strategy implementation and on data driven manufacturing processes and quality oversight.
0950 – 1020
General Session
Eamonn Warren, Eli Lilly and Company
This keynote will explore the strategic journey of a leading medicine company’s manufacturing expansion, highlighting data-driven decisions that have led to industry leadership. The presentation will share key innovations such as the integration of digital technologies, robotics, and advanced process technologies. It will emphasize the importance of site culture and staffing philosophy. Additionally, the session will underscore the value of partnerships with external manufacturersand collaborations with academic and industry institutions. The presentation will also cover the evolution of the company's compliance culture, sharing strategic steps taken to strengthen compliance and regulatory alignment, and discussing initiatives to foster a proactive compliance culture. The conclusion will reflect on current achievements and future goals, encouraging the audience to embrace continuous improvement and collaboration within their own organizations.
1020 – 1030
General Session
Michelangelo Canzoneri, Merck KGaA Darmstadt, Germany
1030 – 1115
Networking
1030 – 1900
Networking
1115 – 1145
Process Intensification Continuous Manuf. and Sustainability
Paolo Leani, MD, Stilmas
The biopharmaceutical industry has been witnessing an essential transition towards sustainability and digitalization. In particular, clean utilities are one of the focus areas experiencing the most significant discussion as they are one of the largest energy and water consumers. New technologies and process solutions go hand in hand with improving existing systems with the common goal of using energy and water more efficiently, as water is a resource that has become very rare in many areas of the world. This presentation aims to show an overview of sustainability in clean utilities for the Facility of the Future-As a supplier of clean utilities systems, we will address end user needs in term of more sustainable technologies and process solutions. A consolidated method called Sustainability Assessment will be described, which aims to analyze new or existing clean utility systems and identify solutions to improve sustainability cost-effectively, all contextualized to site and geographical area conditions through a holistic view of the system. In addition to presenting the main steps of the assessment, a real case study will be shown for the implementation of advanced technology in critical utilities.
1115 – 1145
Accelerating Biopharma with AI & ML
Srividya Narayanan, Northeastern University
This cutting-edge presentation explores the transformative integration of AI and ML technologies across the biopharma landscape, offering a comprehensive analysis of current innovations and future possibilities. Through real-world case studies and data-driven insights, I'll examine how intelligent automation is revolutionizing every stage of the pharmaceutical value chain, from drug discovery to market delivery. I'll delve into how AI is reducing compound screening time and improving hit prediction rates through advanced algorithms, explore ML-powered clinical trial optimization including patient matching and predictive modeling, and showcase smart manufacturing systems. The presentation will also highlight AI-driven supply chain enhancements with reduction in operational costs. Combining theoretical frameworks with practical implementation strategies, I'll address critical challenges including data quality, regulatory compliance, and integration with legacy systems.
1145 – 1215
Accelerating Biopharma with AI & ML
Matthias Kress, BioGrasp GmbH
James Sunna, Theos-CES GmbH
In this presentation, we demonstrate how data-centric architectures in manufacturing can enhance process development. An integrated data foundation connecting lab, office, and shop floor offers significant advantages, especially when implementing a Quality by Design approach. Combining this foundation with artificial intelligence further improves efficiency and effectiveness. These architectures provide a robust platform for AI and machine learning applications, enabling real-time process control during operations, not just post-process analysis. We will showcase a proof-of-concept environment to illustrate these benefits.Following the demonstration, we will discuss the necessary steps for industry stakeholders and suppliers to implement such architectures in real-world settings. We will highlight our contributions within the ISPE Pharma 4.0™ Plug and Produce Architecture workstream, which aims to closely follow developments in this field and help conceptualize data-centric solutions.
1145 – 1215
Process Intensification Continuous Manuf. and Sustainability
Neil Gamble, PE, Arcadis
How much plastic waste is generated in a single-use (SU) monoclonal antibody (mAb) train? How much water is consumed in a stainless steel (SS) mAb train? Decision makers know these are important considerations for master planning, but rarely have quantitative benchmarks. Even when design teams arrive at mass totals, there is not a simple conversion ratio SU waste to SS water – the conversation ends at operational cost (OPEX). This presentation carries the conversation beyond OPEX and into sustainability. Process Mass Intensity (PMI) is a ratio of the total mass of consumable input materials to the mass of commercial product. In biotechnology, PMI should be used to measure the total kilograms of bags, tubes, resins, filters, packaging, water, and raw materials that are consumed to produce a single kilogram of drug substance. Through four hypothetical facilities, this presentation demonstrates how decision makers in new biotechnology facilities can evaluate their planned systems’ PMI and convert the mass consumed into two common languages: equivalent carbon dioxide (eCO2) and OPEX. The facilities evaluated will be a 15kL SS mAb train and a 2kL SU mAb train (with the same titer) each placed in two geographic locations with dissimilar EPA eGRID subregions.
1215 – 1245
Accelerating Biopharma with AI & ML
Michael De La Torre, Redica Systems
Redica Systems, a leader in leveraging AI/ML to augment Quality and Regulatory decision making, will share the latest concepts and capabilities for AI/ML applied to Pharma 4.0. Redica is helping firms augment and automate decisions that impact the company's reputation with regulators, providing relevant and engaging examples from real world data. In addition, the presentation will include an ML-powered analysis of trends of how Annex 1 concepts (QRM and CCS) are actually being cited and enforced by regulators. Including analysis of trends of new and emerging topics from regulators.
1215 – 1245
Process Intensification Continuous Manuf. and Sustainability
Riju Saini, CRB
Keisuke Shibuya, PhD, Hitachi, Ltd.
Current bioreactor design strategies are generally geared toward cell densities of 1 million to 5 million cells/mL. Improvements in cell growth intensification have led to bioreactor cell densities reaching levels exceeding 200 million cells/mL. Applying traditional bioreactor design strategies to intensified cell culture may lead to non-optimal operating conditions, impacting quality and productivity. In this presentation, we outline a bioreactor design strategy specifically geared toward high cell densities leveraging Computational Fluid Dynamics (CFD) to rapidly evaluate multiple critical process parameters simultaneously to define an optimized operating condition or “design space.” This technique can be used to design the “perfect” bioreactor, to retrofit an existing bioreactor, or simply to understand the limitations of an existing system.
1245 – 1400
Networking
1400 – 1430
Accelerating Biopharma with AI & ML
Christian Gay, Aizon
Continued Process Verification (CPV) is vital for maintaining product quality throughout long-term manufacturing. Traditionally, CPV relies on established conditions (EC), critical quality attributes (CQA), and critical process parameters (CPP). However, these metrics alone don’t capture the full process context. This presentation explores how Artificial Intelligence (AI), combined with Process Automation and Process Analytical Technologies (PAT), transforms CPV by enabling real-time release (RTR) and continuous manufacturing. Through a real-world case study of AI-driven fermentation management, we’ll demonstrate how AI enhances batch performance, predicts deviations, and supports Golden Batch concepts. Attendees will gain practical insights on integrating AI into CPV for predictive control, process optimization, and continual improvement—ensuring elevated product quality and compliance with GMP standards.
1430 – 1500
Process Intensification Continuous Manuf. and Sustainability
John Rubero, CRB
The biomanufacturing landscape is rapidly evolving, with process intensification emerging as a key trend over the past decade. This presentation explores continuous chromatography applications and how this manufacturing philosophy empowers manufacturers. It highlights findings from a recent white paper comparing a conventional commercial-scale batch manufacturing process with a future design that incorporates continuous perfusion cell culture integrated with Multi-Column Capture Chromatography (MCC). This presentation will detail how an intensified process impacts equipment size and scale, raw material consumption, and overall productivity. Continuous liquid chromatography methods, such as MCC, reduce resin and buffer consumption by approximately 30% while optimizing resin utilization through feed breakthrough and recovery steps. Technologies like MCC demonstrate improved resin contact efficiency, enabling smaller column footprints and offering compatibility with advanced process analytical technologies (PAT). This shift toward intensified processes enhances productivity, cost efficiency, and sustainability in large-scale commercial operations. Learn how this growing trend not only improves operational efficiency but also supports more sustainable and flexible biomanufacturing practices.
1500 – 1530
Accelerating Biopharma with AI & ML
Chris Conry, RoviSys
In Manufacturing, the "Silver Tsunami" has many companies facing the departure of decades of experience due to retirement. RoviSys is countering this trend by employing Reinforcement Learning to retain these skills and offer automation and guidance to less experienced operators. Chris Conry will demonstrate RoviSys' process of designing and constructing process simulations for using Reinforcement Learning to train agents. These simulations range from fully Data Driven from process historians to physical and mechanical (first principle) simulation. Resulting agents are then taught to emulate operators, enabling them to perform complex tasks ranging from scheduling entire plant operations to managing individual units.
1500 – 1530
Process Intensification Continuous Manuf. and Sustainability
Stephen Judd, CEng, MICHemE, FIEI, Arcadis
Sustainability and decarbonization are now executive priorities for organizations and sit at the forefront of everything we do. This applies equally to optimization of existing facilities as it does to new facilities. Use of advanced digital platforms can facilitate site optimization strategies with respect to meeting a sites sustainability goals. System integrated real-time data analytics combined with engineering expertise can help to identify opportunities on complex manufacturing sites to reduce carbon emissions, optimize energy use, and align operational actions with strategic goals. One focus area for such activities being the life blood of biopharmaceutical facilities, WFI.Water for Injection (WFI) is a critical material for biopharmaceutical manufacturing facilities. Generation of WFI can take several forms as can the methodology for sanitisation of the Storage and Distribution (S&D) systems. The traditional approach being generation of WFI via distillation and maintaining hot S&D systems for the purpose of sanitization which results in high energy consumption leading to significant input to a sites operational carbon emissions. There is however a whole lot more to decarbonization of your WFI systems than swapping out your old distillation system for a membrane generation system or exchanging heat sanitization of your S&D systems for ozone.
1530 – 1615
Networking
1615 – 1625
General Session
1615 – 1730
General Session
Dorrian Fragola, C&W Services
Caren Jenkins, Shawmut
Join Women in Pharma leaders in an engaging session where you will not only have the opportunity to network with colleagues in small groups but also to share your personal and professional experiences to help others grow. Come to the session ready to fill in the blank “Never Have I Ever….” and walk away with new knowledge and an expanded network!
1730 – 1900
Networking
0730 – 0830
Networking
0730 – 1700
0830 – 0900
Implementing Digital Initiatives in the Biopharma Industry
Dhanuka Wasalathanthri, PhD, Bristol Myers Squibb
Biopharmaceutical landscape is getting increasing complex with a broad spectrum of modalities to meet unmet medical needs, while external geo-political, regulatory, generic competition and sustainability challenges demand acceleration of drug development pipelines. Despite significant advancements in the development and manufacturing workflows for faster and more efficient processes such as intensified and continuous operations, in-process analytical testing is still mainly centric around manual testing. Harnessing the power of automation enables fit-for-purpose and plug-and-play modular units with end-to-end parallel testing of multiple analytical assays with significant improvement in speed and productivity. The concept of robotic process automation (RPA) tools resembles as “Digital Workers” to automatically process, analyze and transcribe analytical results in real time which greatly improves the rapid availability of data to the stakeholders. Complex modalities in the pipeline often require non-platform analytical methods, unique approaches, and upfront investment on method development. Such efforts can be greatly simplified using data interrogation techniques such as Machine Learning and Deep Learning approaches. Herein a vision, roadmap and case studies of automation and digital transformation efforts measured against main KPI’s such as speed and productivity for in-process analytics for biologics are presented.
0830 – 0900
Biomanufacturing Facility Lifecycle
Minhazuddin Mohammed, Takeda
Our site is a multi-product biologics manufacturing facility with shared equipment, utilities, and resources across multiple suites and common areas. The variability and constraints in resource use across products result in a complex, interdependent operational network. This complexity makes optimizing production schedules, managing resource efficiency, and planning for future demands or new product introductions challenging. Historically, as new products were introduced, resource utilization and steady-state operations were not fully optimized. While capacity models are traditionally used for plant design or facility upgrades, we aim to use our model as a continuous tool. This approach allows us to maintain an optimized state and strategically prepare for growth and diversification. This work aims to analyze bottlenecks and efficiency—spanning equipment, utilities, materials, and labor—in our operations. We identified facility, equipment, and operational improvements necessary to achieve an optimized steady state. Building on this, we identified operational adjustments and capital investments necessary to support plant growth in alignment with our long-range plan, while minimizing impacts on efficiency and throughput. We evaluated efficiency margins through scenario analyses, including equipment failures, process variability, supply chain disruptions, and shutdown strategies. These insights will inform actionable strategies for scaling production and ensuring readiness for unforeseen challenges.
0900 – 0930
Implementing Digital Initiatives in the Biopharma Industry
Soumyopriyo Saha, TCG Digital Solutions LLC
Biopharmaceutical manufacturing operates in a complex landscape of stringent regulations, legacy systems, and fragmented data. As the industry evolves, how can organizations harness AI to drive efficiency, enhance decision-making, and future-proof operations?
This session explores how a leading plasma-derived product manufacturer successfully integrated AI-driven solutions to optimize inventory, improve real-time visibility, and enhance production planning—leading to over $1M in cost savings annually and a transformational increase in valuation from $800M to $4.3B in a year. We will discuss key challenges, lessons learned, and the road ahead.
0900 – 0930
Biomanufacturing Facility Lifecycle
Jacob Greenwood, Project Farma
Sue Marrichi, Ultragenyx Pharmaceutical Inc
Expert panelists will discuss the unique nature of current manufacturing practices and the impact of emerging technologies to maximize efficiency in facility development. Primary topics will include the following: Innovations in facility design, construction, and digital integration to enhance efficiency Sustainability, flexible manufacturing, and global collaboration shaping facility requirements Overcoming regulatory complexity, cost pressures and workforce shortages Strategies for planning, scaling and adapting facilities to meet diverse product needs Impact of emerging technologies Project Farma is looking to host a panel of industry experts to discuss this topic.
0930 – 1000
Biomanufacturing Facility Lifecycle
Angelo Bernardis, MD, Wood Plc
Barbara Bagatta, Wood
Sustainability and energy efficiency are, more than ever, a must for the biopharma industry. The ISO 14644/16 standard gives guidance and recommendation for optimizing energy usage and maintaining energy efficiency in cleanrooms environment; it not only provides concepts but also actual recommendations for a wise design of energy usage, eg. use of CFD in the design, adaptive control to modulate the airflow rate, etc. The presentation will be focused on key aspects derived from the ISO 14644/16 standard for the design of an HVAC system of biopharma manufacturing plants, addressing the challenge of combining the production requirements with the goal of maximizing sustainability, in particular minimizing energy demand and plant carbon footprint. The presentation will also demonstrate how the close collaboration among the different Parties involved in the design (eg. the different Owner representative, the design Firm, the Vendors/Contractors, but also the approval Authorities) is instrumental for the success of the design process and key to achieve optimal results.
1000 – 1345
Networking
1000 – 1045
Networking
1045 – 1115
Implementing Digital Initiatives in the Biopharma Industry
Jennifer Tonning, Takeda
Sarbajita Ray, Takeda
This presentation will focus on the approach taken at Takeda to implement a robust lifecycle management strategy from building a team, identifying and prioritizing the pain points across the organization, to selecting a digital solution. The presentation will also cover the following: identifying a sponsor and business process owner, building a charter, building a team for each stage/phase of the process and ensuring the key stakeholders are included to represent their functions, performing cross functional Voice of Customers (VOC) across the organization to identify pain points, a review of the process mapping of the current state and design sprints for the “to-be” process design, individual workstreams focused to achieve final results, digital tool evaluation and selection. Solutions identified by the team will be discussed as well as the process of industry benchmarking to ensure the lifecycle management process is sustainable. This multi-year project will be implemented in phases and each phase with the outputs such as document revisions and playbooks digital tools will be discussed.
1045 – 1145
Biomanufacturing Facility Lifecycle
Daryl Kern, PM Group
Grace Linton, CRB
Nevine Williams, IPS
Felix Diaz, RA, NCARB, Barry-Wehmiller Design Group
Geoffrey Middleton, CGMA, Incorporated
Daryl Kern
Director of Architecture / Process Architect SME
PM Group
PM Group
Grace Linton
Director, Process Architecture
CRB
CRB
Nevine Williams
Director, Process Architect
IPS
IPS
Felix Diaz, RA, NCARB
Process Architecture
Barry-Wehmiller Design Group
Barry-Wehmiller Design Group
Geoffrey Middleton
Architect & Independent Consultant
CGMA, Incorporated
CGMA, Incorporated
1115 – 1145
Implementing Digital Initiatives in the Biopharma Industry
Clarence Friedman, Waters Corporation
The pharmaceutical industry is undergoing a transformative shift fueled by automation, connectivity, and data analytics. The talk, "Digital Transformation in QC Labs: Progress and Possibilities," will examine how these advancements are redefining drug quality control (QC) processes.
Part 1: Tackling Heterogeneous Molecules The growing complexity of biopharmaceuticals demands QC labs integrate diverse instruments like chromatography systems, mass spectrometers, and multi-angle light scattering detectors. AI and machine learning synthesize data from these sources, enabling real-time decision-making, regulatory compliance, and addressing analytical challenges.
Part 2: Leveraging Cloud for Compliance and Efficiency Cloud-based solutions revolutionize QC by providing scalable storage, automating routine analyses, and facilitating collaboration with external partners. This reduces scientists' cognitive load, enhances data security, and improves operational efficiency.
Part 3: Advancing Toward Lights-Out Labs The future lies in fully automated “lights-out” labs where manual intervention is minimal. By integrating advanced technologies and workflows, these labs offer unparalleled precision, adaptability, and efficiency, ensuring QC processes meet the evolving needs of the pharmaceutical industry. This presentation highlights how digital transformation is reshaping QC labs, paving the way for a smarter, faster, and more compliant future.
Part 1: Tackling Heterogeneous Molecules The growing complexity of biopharmaceuticals demands QC labs integrate diverse instruments like chromatography systems, mass spectrometers, and multi-angle light scattering detectors. AI and machine learning synthesize data from these sources, enabling real-time decision-making, regulatory compliance, and addressing analytical challenges.
Part 2: Leveraging Cloud for Compliance and Efficiency Cloud-based solutions revolutionize QC by providing scalable storage, automating routine analyses, and facilitating collaboration with external partners. This reduces scientists' cognitive load, enhances data security, and improves operational efficiency.
Part 3: Advancing Toward Lights-Out Labs The future lies in fully automated “lights-out” labs where manual intervention is minimal. By integrating advanced technologies and workflows, these labs offer unparalleled precision, adaptability, and efficiency, ensuring QC processes meet the evolving needs of the pharmaceutical industry. This presentation highlights how digital transformation is reshaping QC labs, paving the way for a smarter, faster, and more compliant future.
1145 – 1215
Implementing Digital Initiatives in the Biopharma Industry
Mike LeBlanc, Trinity Life Sciences – Aztec Consulting
Jim Elliott, Trinity Life Sciences - ADVENT Engineering
Traditional methods of capturing and utilizing data from benchtop manufacturing systems involve paper strip printouts, manual data entry, manual/physical data storage, and uncontrolled spreadsheets, leading to potential errors, inconsistencies, and difficulties in data retrieval and analysis. This presentation explores how leveraging a site PI Historian can significantly improve data integrity and enable enhanced data analytics for manufacturing operations. By integrating benchtop systems with a PI Historian, real-time and historical batch data can be automatically collected, stored, and accessed in a secure and auditable manner. This eliminates paper printouts, manual data entry, reduces the risk of human error, and ensures data accuracy, traceability, and compliance.
The presentation will discuss:
• Enhance Data Integrity: Eliminate manual data entry, ensure data accuracy and traceability, and meet regulatory requirements for data integrity.
• Improve Data Quality: Collect high-quality data without data loss and ensure data consistency across different batches, operations, and systems.
• Increase Data Visibility and Enable Advanced Analytics: Utilize historical data for trend analysis, root cause analysis, alarm analysis, process optimization, and predictive maintenance.
• Increase Efficiency: Streamline data management processes, reduce manual effort, and improve overall operational efficiency.
The presentation will discuss:
• Enhance Data Integrity: Eliminate manual data entry, ensure data accuracy and traceability, and meet regulatory requirements for data integrity.
• Improve Data Quality: Collect high-quality data without data loss and ensure data consistency across different batches, operations, and systems.
• Increase Data Visibility and Enable Advanced Analytics: Utilize historical data for trend analysis, root cause analysis, alarm analysis, process optimization, and predictive maintenance.
• Increase Efficiency: Streamline data management processes, reduce manual effort, and improve overall operational efficiency.
1145 – 1215
Biomanufacturing Facility Lifecycle
Christian Lavarreda, Syntegon
Integral to time to market in the biopharmaceutical industry, the need for enhanced functionality and compliance in biomanufacturing operations continues to grow rapidly. Biopharma companies are under intense pressure to bring progressively sophisticated production capacity online in ever-shorter timelines. This presentation will delve into the role that modular hardware and automation design frameworks are increasingly playing in helping meet this need, in particular by enabling the implementation of digitalization and sophisticated control strategies. The outperformance of modular facilities will only increase as they embrace digitalization and are able to adopt highly disruptive (i.e. productive) AI & ML technologies. As we venture into the future of pharmaceutical production, this presentation addresses the accelerating modularity trend and the implications for industry.
1215 – 1345
Networking
1345 – 1415
Operational Readiness and Cultural Excellence
Varun Choudhary, Moderna
As the Global Operations Readiness Manager at Moderna, I lead efforts to ensure readiness for pivotal commercial and global PPQ milestones. This role encompasses strategic alignment across programs to meet regulatory timelines, operational objectives, and commercial priorities. By building a cohesive global readiness framework, we can elevate our program management and operational execution to deliver excellence in PPQ processes.Objectives:Global Readiness Framework: Establish a scalable, standardized approach to support program readiness for PPQ across multiple markets and regulatory landscapes. Program Integration and Alignment: Enhance synchronization of program activities, bridging the gap between operational, regulatory, and commercial teams. Excellence in Execution: Foster a high-performing culture that drives operational agility and proactive risk management.
1345 – 1415
Analytical Enhanced Quality
Brian Bosso, STERIS
John Schallom, Steris
Routine cleaning validation programs rely heavily on quality control labs to analyze samples and report results in minimal time, leading to resource constraints and delayed product or equipment release. Biopharmaceutical manufacturing cleaning validation programs utilize specialized assays, instruments and reagents to demonstrate the presence, degradation or activity of residual product on cleaned equipment. A lean analytical panel at each stage of the cleaning validation lifecycle can build upon previous stages, minimizing risk of surface contamination and optimizing lab resources. Continuous, in-line monitoring, such as conductivity, TOC and UV, in addition to a robust visual inspection program, shift the testing from the lab but some technologies can be prone to false positives. Other spectroscopy methods such as FTIR, RAMAN, and fluorescence can be used to assist in residue identification and development of preventive maintenance procedures. These techniques require a balance of quality and compliance with manufacturing throughput. The strategy is supported through carefully planned studies that enhance the understanding of the manufacturing, cleaning and analytical process. This presentation will include applied laboratory models as well as case studies to better understand and incorporate a lean analytical panel and spectroscopic analytical methods to your cleaning validation program.
1415 – 1445
Operational Readiness and Cultural Excellence
Justin Cook, Sequence Inc
Jared Auclair, PhD, Northeastern University
Adam Sokolnicki, Millipore Sigma
In an era of rapid technological advancement and evolving regulatory landscapes, operational readiness is more than just having the right systems in place—it requires a strong culture that fosters innovation, adaptability, and continuous learning. How are leading organizations in the biotechnology industry cultivating environments that empower their teams to embrace change, drive innovation, and sustain long-term success?
This dynamic panel will bring together senior leaders from key sectors—biotechnology operating companies, engineering service providers, contract manufacturers, and university pilot facilities—to engage in a candid discussion about cultural excellence as a foundation for operational readiness. Panelists will share insights on:
- Building a high-performance culture that encourages innovation and agility in an evolving industry.
- Overcoming resistance to change by fostering a mindset of adaptability and continuous learning.
- Developing workforce capabilities to keep pace with cutting-edge technologies and new operational models.
- Bridging the gap between technical excellence and cultural transformation to drive long-term success.
Join us for an engaging conversation with industry experts who are shaping the future of biotechnology operations by prioritizing people, culture, and innovation.
This dynamic panel will bring together senior leaders from key sectors—biotechnology operating companies, engineering service providers, contract manufacturers, and university pilot facilities—to engage in a candid discussion about cultural excellence as a foundation for operational readiness. Panelists will share insights on:
- Building a high-performance culture that encourages innovation and agility in an evolving industry.
- Overcoming resistance to change by fostering a mindset of adaptability and continuous learning.
- Developing workforce capabilities to keep pace with cutting-edge technologies and new operational models.
- Bridging the gap between technical excellence and cultural transformation to drive long-term success.
Join us for an engaging conversation with industry experts who are shaping the future of biotechnology operations by prioritizing people, culture, and innovation.
1445 – 1515
Analytical Enhanced Quality
Warren Roche, PhD, Sanofi
Predicting Stability of Biologics and Vaccines applying Advanced Kinetic Modeling: The stability of biologics and vaccines is of great interest industries and government institutions. It is defined by the rate of change over time of a critical quality attribute (CQA) under specific conditions. We used Arrhenius-based equations (namely Advanced Kinetic Modeling) to fit the stability data obtained under recommended storage (2-8°C) and accelerated (+25°C, +37°C, 40°C) conditions by computed kinetic parameters, and finally, to predict valuable the long term stability of vaccines and adjuvants. Ensuring ‘Good Modeling Practices’ the modeling approach combines advanced kinetic and statistical analysis to describe degradation rates of products as function of time and temperatures. Various cases illustrated the ability of this method to accurately predict shelf life of products, anticipate product degradation during temperature excursions (cold chain breaks), rank formulations, compare batches and monitoring real-time shelf-life of products.
1445 – 1515
Agile and Lean Technology Transfer to Take on the Next Pandemic!Recent infectious disease outbreaks such as the 2020-23 covid-19 pandemic and 2022-23 RSV epidemic have demonstrated how critical it is for the pharmaceutical industry to be ready to rapidly respond to these types of public health emergencies. An agile and lean approach to technology transfer is essential for the successful scale-up and launch of biopharmaceutical drug products under such highly pressurized and accelerated circumstances. The presentation will describe a strategic and nimble technology transfer methodology utilized during the COVID-19 and RSV crises, to enable the timely production of the urgently needed immunizations. Real-world examples are used to showcase how this agile and lean inspired approach can streamline the technology transfer process without compromising on product quality or introducing additional risk. Strategies for navigating the challenges posed by regulatory constraints will be discussed and attendees will learn best practices for ensuring operational readiness and maintaining flexibility across processes. This presentation will highlight the importance of developing a more robust and nimble technology transfer execution plan in readiness for the next national health crisis. Are you ready for it?
1515 – 1530
1530 – 1540
1540 – 1610
General Session
Oliver Thiel, Amgen
The biopharmaceutical sector is currently producing vast amounts of data, a trend set to amplify with new tech like smart sensors, PAT, and process automation. This presentation will highlight the significance of a holistic digital strategy, incorporating AI, machine learning, predictive modeling, and data visualization, to spearhead the evolution of biomanufacturing. Emphasizing enhanced efficiency and innovation, this strategy will enable the efficient manufacture of complex biologic molecules with reliability of supply, agility, and differentiation. By leveraging these advanced technologies, biomanufacturing can achieve high throughput, ensuring metric tons of life-saving medicines to patients in need around the globe.
1610 – 1700
Description coming soon
1700 – 1710
0900 – 1300
Facility Tour
Participants will view a brief presentation on ElevateBio and then tour the BaseCamp Waltham facility with members of the leadership team. Refreshments and Q&A to follow.
ElevateBio is a technology-driven company powering the creation of life-transforming genetic medicines, combining manufacturing capabilities and R&D technologies, to accelerate the discovery and development of advanced therapeutics.
BaseCamp® is ElevateBio’s genetic medicine current Good Manufacturing Practice (cGMP) manufacturing and process development business enabling biopharmaceutical partners with end-to-end capabilities. ElevateBio’s 140,000 sq. ft. flagship BaseCamp facility in Waltham, Massachusetts provides the tools, expertise, and resources necessary to bring these advanced therapies from concept to commercialization. The facility features Grade B and C BSL2 cleanrooms, three viral vector suits for lentiviral, AAV, and mRNA production, and six dedicated cell therapy suites. Through BaseCamp, ElevateBio supports a growing number of partners across a wide breadth of modalities, including lentiviral gene therapies, AAV gene therapies, TCR-T and CAR-T cell therapies, engineered B cells, mRNA vaccines, and more.
Transportation and Lunch are provided! To reserve your spot, be sure to add this to your registration for $75. Attendance is limited to 50.
Important Notice: No videos or photos allowed.
ElevateBio is a technology-driven company powering the creation of life-transforming genetic medicines, combining manufacturing capabilities and R&D technologies, to accelerate the discovery and development of advanced therapeutics.
BaseCamp® is ElevateBio’s genetic medicine current Good Manufacturing Practice (cGMP) manufacturing and process development business enabling biopharmaceutical partners with end-to-end capabilities. ElevateBio’s 140,000 sq. ft. flagship BaseCamp facility in Waltham, Massachusetts provides the tools, expertise, and resources necessary to bring these advanced therapies from concept to commercialization. The facility features Grade B and C BSL2 cleanrooms, three viral vector suits for lentiviral, AAV, and mRNA production, and six dedicated cell therapy suites. Through BaseCamp, ElevateBio supports a growing number of partners across a wide breadth of modalities, including lentiviral gene therapies, AAV gene therapies, TCR-T and CAR-T cell therapies, engineered B cells, mRNA vaccines, and more.
Transportation and Lunch are provided! To reserve your spot, be sure to add this to your registration for $75. Attendance is limited to 50.
Important Notice: No videos or photos allowed.
0900 – 1300
Facility Tour
Welcome to the Lexington site of Takeda's Massachusetts Biologics Operations. Our mission here is to deliver innovative medicines that provide life-changing treatments for our patients. We focus on achieving commercial supply excellence and pioneering new therapies through innovation, people, and performance. The Lexington site supports approximately $846 million in revenue through the production of drug substances such as Replagal, VPRIV, and Takhzyro, which serve patients with various rare and genetic disorders.
Manufacturing Capabilities:
- Multiproduct Biologics: We specialize in both clinical and commercial drug substance (DS) manufacturing.
- Quality Control (QC) Testing: Ensuring the highest standards of product consistency, quality, and purity.
- Cell Bank Manufacturing and Testing: We manage the production and testing of cell banks, crucial for biologics manufacturing.
- Cell Therapy Manufacturing: The site is equipped to support innovative cell therapy manufacturing processes.
Transportation and lunch are provided! To reserve your spot, be sure to add this to your registration for $75. Attendance is limited to 21.
Important Notice: The tour guidelines for attendees include the following.
- Cameras are not permitted.
- Attendees will be required to sign a non-disclosure agreement.
- A minimum dress code requirement of at least short-sleeve shirts, long pants, socks, and closed-toe shoes. No tank tops, sleeveless shirts, shorts, or high heel or open-toe shoes are allowed in the facility. For a window tour in 400SW, all visitors will proceed through a locker room into a pre-gowning area, where they will be required to wear safety glasses and shoe covers. For tours through the classified areas of 300SW and 400SW additional gowning is required (hairnets, gloves, jumpsuits, and shoe covers). Visitors will have the opportunity to leave their suit coats in a secure area prior to the start of the tour.
- Hand sanitization is required.
- All dangling/ visible jewelry and make-up shall be removed; wedding rings/ bands and medical ID bracelets are allowed. Watches must be removed.
- All consumables are prohibited in the facility; this includes food, drinks, gum, cigarettes, medication, throat/cough lozenges, lip balm, etc.
- Visitors shall not have a medical condition that could compromise the product/process (i.e. contagious illness or open lesions).
- Once gowned and in the process area, cell phones, and other electronic devices that visitors may wear into the facility, cannot be accessed; cell phones may be accessed if placed in provided plastic bags.
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.