PDA Week 2026

Registration Now Open for PDA Members!

The Premier Annual Homecoming Event for the Global Pharma Community

22 - 27 Mar 2026
Denver, CO

Educational Sessions | Tours and Activities | Workshops | Training Courses
Networking Opportunities | Exhibit Hall | Interest Group Meetings
Industry and Honor Awards | Roundtables

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Join the PDA Global Pharmaceutical Student (GPS) Experience to grow your professional network, strengthen your resume, and gain real-world insight into careers in pharmaceutical science and regulation. Student volunteers receive complimentary registration and access to exclusive student program activities. The PDA Week 2026 opportunity is limited to 24 student volunteers!

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Agenda

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Sun 22 Mar Mon 23 Mar Tue 24 Mar Wed 25 Mar Thu 26 Mar
Sunday, 22 March

MDT Daylight Time (UTC -6:00)

  • PDA Chapter Council Meeting (Invite Only)

  • PDA Advisory Board and Chapter Council Joint Luncheon (Invite Only)

  • PDA Technical Advisory Board (AB) Meetings (Invite Only)

  • Presenter Ready Room Open

  • Registration Open

  • PDA Industry and Honor Awards Ceremony (Ticket Required – Cocktail Attire)

    Join us as we open PDA Week with an elegant evening dedicated to celebrating those shaping the future of pharmaceutical and biopharmaceutical science. The PDA Industry and Honor Awards shine a spotlight on members and companies whose leadership, innovation, and volunteer contributions have made a lasting impact on both the industry and the Association.

    Established in 1958, these prestigious awards represent one of PDA’s most enduring traditions, one that feels especially meaningful as PDA celebrates 80 years in the United States and 20 years since expanding into Europe, marking our strong and growing global presence!

    Each year, we honor extraordinary individuals and teams whose work strengthens our global community and moves the field forward. This annual celebration, hosted at PDA Week, sets the tone for an immersive week filled with cutting-edge education, visionary plenaries, hands-on training, workshops, exhibitions, and countless opportunities to make meaningful connections. It’s a night of recognition, inspiration, and community you won’t want to miss!

    Cocktail Attire – tailored suits, cocktail dresses, or polished evening separates. Guests are encouraged to incorporate a splash of PDA blue (e.g., a tie, scarf, accessory, or pop of color) in honor of this milestone year celebrating 80 years in the U.S. and 20 years in Europe!
Monday, 23 March

MDT Daylight Time (UTC -6:00)

  • Registration Open

  • Roundtable 1: From Constraint to Catalyst: Turning Regulatory Challenges into Drivers of Aseptic Innovation (Ticket Required)

    Innovation in aseptic processing is accelerating, fueled by advanced technologies, automation, and shifting patient needs. However, regulatory uncertainty and a culture of risk aversion continue to challenge progress. This roundtable will explore how the industry can balance the drive for innovation with the need for compliance and control.

    Bringing together stakeholders from the industry (e.g., health authorities, pharmaceutical manufacturers, and OEMs), the session will foster a collaborative dialogue on evolving regulatory frameworks, overcoming internal resistance to change, and cultivating a mindset that embraces calculated risk and continuous improvement. Through case studies and expert insights, participants will identify actionable strategies—from agile development models to proactive regulatory engagement—that enable innovation without compromising product safety.

    Attendees will leave with a clearer understanding of how to navigate regulatory and organizational hurdles, and with practical approaches to unlock the full potential of aseptic innovation. This discussion is highly relevant to industry leaders seeking to shape a future where innovation and assurance work hand in hand to drive meaningful progress.

  • Roundtable 2: AI Implementation in Biopharma: A Hands-On Roundtable on People-Centric Training and Knowledge Parallelization (Ticket Required)

    The biomanufacturing industry is asking: How do we integrate Gen AI without sacrificing human expertise? Join us for an interactive discussion on the Human-AI Training Parallelization system, a novel approach developed to empower people and processes in Life Sciences. We’ll start with an overview of where our industry is with AI use, and how AI implementation is going, and its biggest opportunity: People.

    Then we’ll explore two methods: Human-AI Training Parallelization: Learning (HATPL), which uses Digitally Interactive SOPs (DISOPs) to create competency-focused training and robust assessments, and Project-Based Human-AI Training Parallelization (PBHATP), which integrates AI Assistant development to capture tribal knowledge and boost project efficiency.

    Bring your device! We'll dedicate a portion of the session to using Gen AI tools to simulate the method’s utility, fostering peer-to-peer problem-solving on key issues like knowledge transfer and continuous improvement. Let’s discuss the future of AI implementation in your organization and how to make it a people-centric process.

    Key Discussion Points:
    • Workforce Pulse: Current challenges in biomanufacturing training and knowledge retention.
    • Live Demo: Interactive use of Gen AI tools to mirror our approach.
    • Strategy Exchange: Best practices for integrating AI to enhance, not replace, human expertise.

  • Roundtable 3: The Future is Here: Is Your Quality Organization Ready? (Ticket Required)

    AI, Digitalization, new modalities, and other advances in manufacturing technologies are all speeding towards us at a breakneck pace transforming the way we have made medicines in the past and challenging the traditional approaches to quality systems. A prepared and enabled Quality workforce is key to achieving a proactive, responsive and sustainable quality system able to provide the guard rails for change implementation without compromising innovation; and to ensure patient safety while not creating a bottleneck.

    This roundtable will explore through scenario discussion and shared learning what approaches are working in Quality organizations today that can spark innovation in your own teams.

    Discussion topics may include:
    • Embracing health authority transparency
    • Quality system integration
    • Improving signal detection
    • Enhanced change assessment
    • Upskilling workforce capabilities
    • Streamlined decision making
    • Predictive modeling

    Don't miss this opportunity to future proof your teams.

  • Student and Early Career Professional Skill-Building Studio: Communicating and Networking with Confidence (Ticket Required)

    Ready to elevate your communication and networking skills? This interactive session is designed for students, early career professionals, and anyone looking to approach professional conversations with more clarity and confidence. Guided by industry experts, you’ll explore practical strategies to strengthen your communication style and build connections that last beyond PDA Week.

    During the session, you will:
    • Learn simple frameworks for introducing yourself and keeping conversations going
    • Practice asking thoughtful questions that support more meaningful interactions
    • Explore approaches for maintaining new relationships
    • Gain practical tips for using LinkedIn in a purposeful, professional way

    The session concludes with a short networking warm-up to help you enter the Rapid Connect Speed Networking event with greater comfort and confidence.

  • Mini-Workshop 1: Generative AI for Pharmaceutical Quality: Literacy, Oversight, and Implementation Pathways (Ticket Required)

    Generative AI technologies—such as Large Language Models (LLMs) and Large Reasoning Models (LRMs)—are quickly making their way into pharmaceutical quality and regulatory operations. Their successful adoption requires shared literacy, clear expectations, and strong compliance foundations.

    This mini-workshop will establish a common vocabulary for AI so QA, regulatory, IT, and leadership teams can communicate effectively. It will then explore the evolving regulatory landscape, including expectations from FDA, EMA, MHRA, and the EU Commission, with discussion of validation, audit readiness, traceability, human-in-the-loop oversight, and context-of-use classification.

    Participants will examine key architecture considerations—such as model design, memory behavior, inference endpoints, and prompt controls—and how these choices directly influence compliance and operational performance. The session will also outline practical deployment strategies, from piloting and scaling to measuring ROI while maintaining GxP requirements.

    This mini-workshop will equip attendees with the clarity, tools, and real-world insights needed to confidently evaluate and implement generative AI within regulated pharmaceutical environments.

  • Presenter Ready Room Open

  • PDA Rapid Connect Speed Networking

    Join PDA for a fast-paced, high-energy networking session! This dynamic event features a series of quick, 4-minute conversations designed to help you rapidly expand your network, spark fresh connections, and meet peers across the industry.

    Bring your elevator pitch, business cards, LinkedIn QR codes, and magnetizing energy! Everyone is welcome.

  • P1: Leading Through Transformation: Building Smarter, Human-Centered Organizations

    The world of work has changed. Organizations and leaders are grappling with unprecedented change, driven by disruptive technology, demographics, customer expectations, new ways of working and new ways of leading. Such disruption offers a great opportunity for organizations to innovate through cultures of growth.

    Based on extensive research and experience from the former Director of the NASA Academy and Chief Knowledge Officer, who led the development and team support for NASA Science and Engineering projects, The Smart Mission: NASA’s Lessons for Managing Knowledge, People, and Projects provides a framework for navigating the future of work. The Smart Mission is centered on the human element, connection, and expertise for successful teaming. While there is a tendency to prioritize process and technology, success is dependent on human collaboration and exchange.

    Drawing on examples, stories, and case studies from NASA and other organizations, Dr. Hoffman will explore the six factors—learning, knowledge, teaming, global collaboration, culture, and story—that promote a smart mission. You will walk away with a practical framework for team success—one that applies whether you’re leading a global pharmaceutical organization, managing a manufacturing site, or driving operational excellence within a technical team.

  • Exhibit Hall Open

  • Grand Opening Lunch in the Exhibit Hall

  • Poster Presentations in the Exhibit Hall

  • Solution Partner Tours

    Aurora Exhibit Halls 2-3

    PDA is excited to offer its first-ever guided Solution Partner Tours, designed to help attendees efficiently explore the equipment, technologies, and services most relevant to their work. Led by subject matter experts, these small-group tours will spotlight key exhibitors on the show floor, making it easier to discover the right partners, solutions, and innovations to support your projects, teams, and organizational goals.

  • Lightning Talks

    PDA's Lightning Presentations will use the Pecha Kucha presentation method, which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. Each presentation will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total talk time of 6 minutes and 40 seconds.

    • Freeze with Care: Navigating the Complexities of Lyophilizing Antibody Drug Conjugates

      Lyophilization of antibody-drug conjugates (ADCs) presents unique technical and safety challenges due to their combination of large-molecule instability and highly potent small-molecule payloads with low occupational exposure limits (OELs). Designing and operating lyophilizers for ADCs requires balancing product quality, regulatory expectations, and operator safety while minimizing contamination risks. This presentation will explore key design and operational considerations for lyophilizing hazardous materials, with a focus on containment and integration strategies. Topics include clean-in-place (CIP) systems for freeze dryers, best practices for safe HEPA filter changeout, and approaches to managing system residue. We will also examine methods for integrating upstream unit operations with lyophilizers under isolator protection to maintain both sterility assurance and operator safety. Drawing from project experience, practical case examples will highlight common pitfalls and lessons learned in facility and equipment design. Attendees will gain actionable insights into engineering and operational strategies that mitigate risk, enhance containment, and ensure product and operator protection.

    • Integrating and Formalizing Generative AI in Laboratory Workflows

      When should I use generative AI tools and workflows for laboratory functions? Join me on the journey as we explore how to verify which generative AI tools are appropriate to use in your workflow, the formalization and validation of generative AI workflow processes, and the development of generative AI tools for privacy and efficacy. Our presentation will focus on the necessity of a Human-in-the-Loop model essential for providing expert interpretation of complex data and acting as the final arbiter, and the required validation framework to assess model accuracy, reliability, and robustness against adversarial data. A key priority will be addressing privacy and data governance concerns in AI implementation and consulting usecases. We will be going through a development and validation framework for how and when to develop AI workflows, using what off-the-shelf and specially developed tools, and how to maintain complete human-backed controllability throughout the process development and in the workflow that is designed. We’ll share practical use cases and tools we’ve developed in areas like gel electrophoresis analysis, scientific paper dissection, and graph-based resource-augmented (RAG) generation and search in the life sciences.

    • Unlocking Access: A Low‑Cost, Low‑Waste Alternative to Auto‑Injectors for Reliable Emergency and Routine Medication Delivery

      Global medication logistics struggle to deliver timely, usable doses at the last mile. Vials and ampoules demand training and time. Auto‑injectors offer simplicity, yet their high unit costs, bulky formats, and environmental burden constrain access, adoption, and sustainability. This lightning talk presents our research and development on a new delivery approach that preserves the ease‑of‑use and reliability of auto‑injectors while dramatically lowering cost and material footprint. We will share human‑factors findings from simulated emergency use, bench data on dosing accuracy and reliability, packaging and cold‑chain compatibility, and preliminary cost and lifecycle assessments versus vials, ampoules, and commercial auto‑injectors. We will also outline pathways for vaccine and emergency medication deployment in low‑resource, high‑throughput, and disaster settings. Attendees will leave with a concise framework for evaluating delivery modalities across usability, cost‑to‑serve, and environmental impact, plus a set of actionable design criteria to improve access without compromising safety or quality. Our goal is straightforward: make the simplest option the most affordable and the most sustainable.

    • Q&A

  • A1: Building a Culture of Compliance

    This session will challenge attendees to think beyond traditional knowledge-transfer methods and auditing approaches. It will explore innovative, human-centered solutions for transferring knowledge more effectively and efficiently, as well as flexible, risk-based audit models aligned with evolving regulatory expectations. Attendees will gain insights into modern auditor training and the design of audit tools that support a more adaptive, future-ready quality system.

    • Strengthening GMP Audit Readiness for Emerging Technologies: Oversight, Regulation, and Enforcement Trends

      AstraZeneca’s global audit program integrates proactive regulatory intelligence, enforcement trend monitoring, and pipeline and technology oversight to sustain GMP auditor competency. This presentation aligns with PDA Week tracks in aseptic processing and ATMP commercialization, detailing how we operationalize continuous learning across modalities central to PDA’s audience—Cell Therapy/ATMPs (manufacturing technologies, aseptic considerations, chain-of-identity/integrity), oligonucleotides (critical quality attributes, impurity control), Software as a Medical Device (validation, cybersecurity), and the use and qualification of AI (data integrity, model lifecycle controls) to ensure patient safety and our license to operate. We will outline our risk-based model for translating evolving expectations (EU Annexes 1, 11, 22; PIC/S; FDA inspection themes) into targeted training, practical tools, and ongoing competency uplift. Examples include modular curricula tailored to modality and lifecycle stage, auditor training materials, and refreshers driven by real inspection findings. The session is intended to spark discussion on pragmatic approaches to upskilling auditors for advanced therapies and digital technologies, share lessons learned across regions and products, and highlight partnerships between the audit function, internal and external Quality, QPs, and product teams to ensure audits remain technically rigorous and aligned with evolving regulatory expectations.

    • Bridging the Gap: Human Centered Strategies for Successful Knowledge Transfer

      In today’s globalized industry, the critical importance of knowledge continuity is often overshadowed by a narrow focus on documentation. Yet, organizations repeatedly discover that process documents are not adequate for transferring true operational knowledge, a gap that becomes particularly painful during technical transfer. This presentation explores practical approaches to bridge this gap. By distinguishing between documentation and true knowledge transfer, we highlight why traditional methods fall short and how human-centered strategies can ensure a successful technical transfer. Drawing from the experience of a small company executing successful global technical transfer during the COVID-19 pandemic, we present the challenges faced, innovative solutions taken to transfer knowledge across borders, and lessons learned. Case studies reveal how informal knowledge channels and intentional learning enable effective process transfer. These findings underscore the need for companies to move beyond document focused approaches and develop people driven knowledge transfer strategies.

    • Q&A

  • B1: Digital Twins and AI: Transforming Bioprocessing Through Secure, Compliant, and Scalable Digital Innovation

    This session will explore how digital twins are transforming pharmaceutical manufacturing by enabling secure, compliant, and data-driven operations. This session will highlight ALCOA+–aligned continuous process verification, cybersecurity safeguards, and regulatory expectations for AI-enabled digital twins in bioprocessing. Real-world examples will showcase practical system architectures, predictive control strategies, and verification approaches that accelerate batch release, reduce experimentation, and strengthen product quality—offering a clear path toward proactive digital quality systems.

    • Digital Twin-Driven Continuous Process Verification: Securing Data Integrity and Compliance

      Digital Twin–Driven Continuous Process Verification (CPV) leverages virtual replicas of pharmaceutical manufacturing processes to enable real-time monitoring, control, and optimisation of critical quality attributes. By integrating ALCOA+–compliant data capture and audit trails within these digital models, organisations can ensure the accuracy, integrity, and traceability of production data throughout the product lifecycle. Advanced cybersecurity frameworks safeguard the twin ecosystem—protecting against unauthorised access, data breaches, and ransomware threats—while supporting FDA 21 CFR Part 11 and ICH Q13 regulatory requirements. This presentation will outline the technological architecture of digital twins in GMP environments, demonstrate how CPV accelerates batch release and inspection readiness, and provide a practical roadmap for implementing a secure, compliant digital twin infrastructure that transforms traditional quality systems into proactive, data-driven operations.

    • BioScAI: Advancing Digital Twins with Embedded AI for Fast and Effective Bioprocess Scale-Up

      The BioScAI project builds on the successful CPV of the Future initiative, which proved the feasibility of AI-enabled continued process verification (CPV) at the 5-liter bioreactor scale. Supported by PDA’s Regulatory and Quality Advisory Board (RAQAB), BioScAI takes the next step by embedding artificial intelligence within digital twins to accelerate and strengthen biopharmaceutical scale-up. The project aims to demonstrate how AI-driven digital twins can deliver more efficient, data-driven, and reliable approaches to process development. BioScAI focuses on fed-batch fermentations of Pichia pastoris, using industrial enzyme production as a model application. The experimental program will include 20 large-scale fermentations conducted in multiple cycles. Real-time data streams, capturing critical process parameters and sensor outputs, will feed into digital twins enhanced by AI-based multivariate control. These predictive and adaptive capabilities are expected to reduce the number of experiments required, shorten timelines, and improve robustness in managing complex bioprocess environments. The project’s outcomes will provide both scientific and regulatory insights into the integration of AI in digital twins. By progressing from small-scale proof-of-concept to larger-scale demonstrations, BioScAI addresses an urgent industry challenge: enabling faster, cost-effective, and regulatory-compliant scale-up while safeguarding product quality and aligning with GxP principles.

    • Q&A

  • IG1: Filtration

  • Mini-Workshop 2: Systems and Safety Engineering Approach for Safe, Effective, and Reliable Drug–Device Combination Products (Ticket Required)

    This mini-workshop will offer a practical, integrated roadmap for developing safe, effective, and reliable drug–device combination products. Participants will explore core development challenges, essential design principles, and the role of systems engineering in managing lifecycle complexity.

    Building on this foundation, the session will introduce a structured approach to modeling safety and effectiveness, highlight key safety engineering tools, and outline assurance milestones that help teams anticipate risks, strengthen controls, and meet regulatory expectations.

    Real-world case studies will demonstrate these concepts in action—from leveraging existing platforms to designing interoperable systems and evaluating disruptive, next-generation technologies.

  • A2: Driving Change Across Boundaries

    Success in biopharma innovation depends as much on culture and collaboration as it does on process. This session will showcase real-world examples of organizations that advanced global tech transfers through cultural intelligence and regulatory agility, and strengthened laboratory operations by aligning people, quality, and infrastructure. Together, these stories offer a practical roadmap for translating vision into execution and delivering lasting impact across teams and functions.

    • So Your Lab Needs an Upgrade? Here’s How It’s Done

      This presentation will discuss the hurdles that forward-thinking scientists and employees face when challenging existing infrastructure for change. Listeners will learn how to change hearts and minds to make lasting change within their organizations that can make a real difference. • Step 1 / Case Study: Assess the baseline. I’ll share how I observed company culture to target key decision-makers and objectors to change. I’ll share how I used intel that I gathered to develop a change plan for implementing a process upgrade within laboratory testing. The change facilitated a higher level of compliance and improved the working day of laboratory scientists. • Step 2 / Case Study: How to Hire and Develop Key Talent. Making change is about building the right team. I’ll share a personal example about how I changed the recruiting and development processes of staff to build a key team for business success that is now relied on every day as world experts in their craft. • Step 3 / Case Study: Make best friends with Quality Assurance. I’ll share an example of how making friends with QA and honestly taking stock of a quality problem in the lab led to a necessary facilities upgrade.

    • Global Tech Transfer in a Fragmented World

      This presentation explores a case study in global tech transfer of a COVID-19 vaccine drug substance, executed across multiple external manufacturing sites in the US, Europe, and Asia. Over five years, Novavax Inc. navigated supply chain complexities, varying regulatory expectations, and diverse cultural norms to launch compliant, scalable production under pandemic urgency. Key themes include best practices for concurrent transfer of biologics across geographies with varying expectations, harmonizing technical standards, and building resilient external manufacturing networks. The talk will highlight strategies for regulatory alignment, agile execution, and knowledge management across multi-site launches. The presentation will also cover how insights from an unexpected source (the book "The Culture Map" by Erin Meyer) became a cornerstone in tech transfer team selection and how cultural intelligence enhanced collaboration and communication across global teams, contributing to successful outcomes.

    • Q&A

  • B2: Radiopharmaceuticals: A Rapidly Expanding Modality with High Potential

    The current wave of targeted radiotherapies and next-generation imaging agents represent a shift in nuclear medicine with high potential. New isotopes, precision targeting ligands, and new manufacturing approaches have accelerated interest, placing radiopharmaceuticals alongside other “new modalities” like cell and gene therapy, ADCs, and mRNA. This session will explore the progression of nuclear medicine and its future, highlighting evolving regulatory expectations and unique manufacturing and supply challenges.

    • The Progression of Nuclear Medicine

      Radiopharmaceuticals show great promise as advanced cancer therapies, with targeted delivery of radioisotopes for the efficient destruction of cancer cells, using specially engineered ligands. The choice of ligand and type of radioisotope, the severe health risks to operators posed by working with radioactive materials, and the use of a material whose potency is continuously reducing from the moment of production bring unique challenges in manufacturing and facility design. Through these challenges, quality and patient safety need to remain paramount with aseptic production techniques in accordance with Eudralex/ PICS Annex 1 needing to be maintained. The choice of ligand dictates the efficiency of the targeting mechanism with antibodies and synthetic peptides both being potential options. The type of radiation emitted by the radioisotope affects both the potential efficacy of the therapy and the containment measures required for its production, current trends moving towards the more dangerous alpha particle emitting isotopes. The containment systems, the manufacturing areas and HVAC systems all need to be appropriately designed to ensure that the operators and the environment are protected. All this while considering the logistical challenges which are not dissimilar to the “vein to vein” time associated with autologous cell therapy.

    • Shaping the Future of Radiopharma Manufacturing

      Radiopharmaceutical manufacturing is defined by short product lifespans, stringent safety requirements, and the need for speed without compromising quality. This presentation will explore recent advancements in hot cell and filling technology that are shaping the future of the field, improving efficiency, reliability, and operator safety. We will examine the unique aspects of facility and equipment design required for integrating filling isolators in radiopharma manufacturing. Special attention will be given to how these systems are engineered to maintain compliance while supporting seamless, sterile operations in an environment where every minute matters. Finally, the session will address the accelerated QA/QC processes that are critical to the just-in-time manufacturing model of radiopharmaceuticals. Strategies for streamlining quality oversight without sacrificing rigor will be discussed, with an emphasis on balancing regulatory expectations and operational demands. By connecting advancements in technology, facility design, and quality systems, this talk will provide a comprehensive view of how the radiopharmaceutical industry is meeting its unique manufacturing challenges.

    • Q&A

  • IG2: Packaging Science

  • The Welcome Reception – Flannel Fest!

    Mountain View Pavilion

    Kick off PDA Week 2026 in true Colorado style at Monday’s Welcome Reception! Throw on your preferred plaid and step into a mountain-inspired evening filled with glowing lanterns, campfire vibes, and that crisp alpine air the Rocky Mountains do best. Dig into hearty chili, cornbread, and gooey s’mores as evergreens and starry skies set the scene. Toast to 80 years of PDA in the U.S. and 20 years since our expansion into Europe with local craft beer and whiskey while live music keeps the mood lively. It’s the perfect chance to settle in, mingle, and start the week wrapped in comfort and camaraderie, all fueled by flannel-fest fun!
Tuesday, 24 March

MDT Daylight Time (UTC -6:00)

  • Continental Breakfast

  • Registration Open

  • Presenter Ready Room Open

  • A3: Elevating Quality System Performance Through AI Integration

    This session will explore how responsibly deployed AI can strengthen pharmaceutical quality systems by improving investigations and reducing human error. Presenters will showcase an AI Assistant that streamlines investigations while enhancing compliance and driving efficient continual improvement, alongside an AI-driven behavioral nudging platform that boosts human reliability in challenging workplace environments. Together, these case studies demonstrate how AI and behavioral science can elevate quality performance across diverse manufacturing environments.

    • A Case Study on AI Implementation in Quality Management

      The integration of AI in quality management is a pivotal component of Takeda’s holistic digital transformation strategy aimed at enhancing business processes. This presentation will focus on the AI Investigation Digital Assistant (AIDA), designed to improve the management of deviations, lab investigations, and complaints within the framework of responsible AI practices. AIDA leverages advanced machine learning algorithms to streamline data analysis, identify patterns, and flag potential quality issues, leading to better, faster, and more efficient investigations. We will present case studies that illustrate AIDA’s effectiveness in real-world applications, showcasing its role in enhancing compliance, reducing risks, and driving continuous improvement. By enabling more robust investigations with less time and effort, AIDA produces outputs that are easier for reviewers to understand. Emphasizing our commitment to responsible AI, we will discuss the governance and ethical considerations integral to the AI implementation process, underscoring how AI can be responsibly harnessed to enhance quality systems, ultimately supporting Takeda’s mission to deliver safe and effective products.

    • AI and Behavioural Compliance: Reduction of Human Error Using AI, Behavioural Sciences, Persuasive Technology, Nudge and Large Group Gamification

      Human error is a critical challenge in pharmaceutical manufacturing accounting for about 40% of reported deviations globally. In the period between 2022 and 2024, 70% FDA warning letters to Indian facilities cite human error or data integrity lapses. While SOPs, internal audits, checklists, training and retraining address the cognitive side of errors, aspects of behaviour, workforce dynamics and cultural factors, along with high turnover, inexperienced operators, and hierarchical workplace norms reduce adherence to SOPs. Also, fatigue, multitasking, and routine bias increase susceptibility to mistakes. Fear of blame and low engagement with quality culture further discourage proactive error reporting, making traditional compliance systems insufficient to prevent deviations. SEEK is an AI platform based on principles of behavioural science, persuasive technology, nudge and critical mass effect to reduce error, improve compliance and increase human reliability. This presentation evaluates the impact of SEEK, i.e. behavioural nudging with AI for a quality team of a Pharma Manufacturing firm resulting in a sustainable 45% reduction of errors and deviations over a 9-month period. This presentation also demonstrates how AI and behavioural sciences can enhance human reliability and improve overall quality especially in emerging markets with high employee turnover, resource constraints, generic training and fragmented processes.

    • Q&A

  • B3: Innovative Contamination Control: Far-UVC Technology and Risk-Based Approaches

    Advanced contamination control requires both innovative technology and strategic risk management. This session will explore two complementary approaches transforming pharmaceutical contamination control. Discover how Far-UVC technology is enabling continuous, human-safe cleanroom decontamination that addresses persistent personnel-related contamination and how Takeda implemented risk-based Contamination Control Strategies to eliminate recurring bioprocess contamination. Attendees will gain actionable insights for integrating advanced technology and strategic frameworks to enhance product quality, operational consistency, and patient safety.

    • Continuous Cleanroom Decontamination: Implementation of Far-UVC

      Human activity remains a significant challenge in maintaining the cleanliness and integrity of cleanroom environments. Despite the use of specialized cleanroom suits, rigorous time-consuming protocols, multiple operator training procedures and air filtration systems, the generation of contamination from human-related factors is a persistent concern. Scientific studies have unveiled the potential of shorter UV-C wavelengths, residing within the "Far-UVC" range, spanning at 200–230 nm. These studies have shown that these wavelengths are unable to penetrate the outer layer of mammalian skin or the ocular surface and have less material degradation. Among these, light at 222 nm, generated by excimer lamps based on krypton-chloride, presents a groundbreaking advantage: UV light at 222 nm is highly effective for inactivation of microorganisms, while being safe for human beings. This opens a new potential usages for Far-UVC, achieving continuous decontamination of classified areas such as cleanrooms or hospital areas. The talk will focus on presenting Far-UVC from a scientific point of view, different practices, implementations, and case-studies in pharmaceutical facilities to become the leading facilities of the future and mitigate contamination risks – at all times.

    • Global Implementation of Risk-Based Contamination Control Strategies to Prevent Bioprocess Contamination

      Contamination Control Strategies (CCS) are increasingly recognized as critical to ensuring product quality and patient safety across pharmaceutical manufacturing. This presentation explores the global implementation of a risk-based CCS framework, aligned with regulatory expectations such as EU Annex 1, and its practical application in a high-impact case study at a drug substance manufacturing facility. The case study highlights recurring contamination events in perfusion-based bioprocessing, which, despite multiple initiatives, persisted until a holistic CCS was deployed, integrating Quality Risk Management (QRM), targeted corrective actions, and cross-functional engagement. The CCS framework enabled identification of modality-specific risks, mapping of control elements, and prioritization of mitigation strategies. Target effectiveness will be significant reduction in contamination events and improved operational consistency. This session will provide attendees with actionable insights into CCS development, implementation, and lifecycle management, emphasizing the importance of proactive contamination prevention and continuous improvement.

    • Q&A

  • IG3: Visual Inspection of Parenterals

  • A4: Turning Signals into Strategy

    Data integration and advanced analytics are reshaping how pharmaceutical organizations anticipate and manage risk. This session will explore innovative applications of predictive modeling that connect insights across the value chain—from early detection of supplier reliability issues to proactive quality interventions in manufacturing. Presenters will share real-world case studies demonstrating how unified data foundations, AI-driven signal interpretation, and causal machine learning are advancing a more intelligent and resilient quality ecosystem.

    • From Fragmented Data to Predictive Quality: Integrating Internal and External Signals to Predict Supply Chain Risk

      Pharmaceutical manufacturers face persistent challenges in ensuring supply chain reliability due to fragmented, siloed data and limited visibility across internal and external risk signals. Traditional supplier quality management has relied heavily on retrospective, manual reviews, often missing early warning signs of disruptions. This presentation will share a case study unifying and analyzing diverse internal (audits, deviations, complaints, change controls, manufacturing deliveries) and external (regulatory inspections, enforcement actions, recalls, ESG, financial data) data streams and the development of predictive hazard models. By linking these sources into a common data foundation, we enable continuous risk monitoring, benchmarking of key suppliers, and proactive quality interventions. Key elements include: • Building robust data pipelines and entity resolution to connect disparate systems and documents into unified supplier profiles. • Moving beyond subjective “traffic light” dashboards toward quantitative, traceable heatmaps of supplier risk. • Applying AI-based enrichment to extract root causes, classify events, and surface leading indicators of emerging risk. • Case examples where integrated data identified declining health authority scores and recurring audit findings in advance of a supply chain disruption.

    • From Data to Decisions: Enhancing Yield and Quality in Pharmaceutical Manufacturing with Advanced Analytics

      The Advanced Data Analytics Pharma Technology (ADAPT) program at Roche leverages data science to optimize pharmaceutical manufacturing processes, leading to improved yield and quality. This presentation highlights a use case within ADAPT where predictive models support manufacturing specialists in proactively mitigating out-of-specification risks during commercial drug manufacturing. The models were developed with features extracted and engineered from early-phase production culture. This approach enables daily risk predictions using relevant data accumulated up to that point, giving process experts timely insights for evidence-based interventions. From a data science perspective, several techniques that enhance predictive performance will be discussed, including upsampling and weighted bootstrapping to address data imbalance, as well as model robustness evaluation and uncertainty quantification. Together, these elements strengthen the reliability and interpretability of the predictions, allowing process experts to make more confident decisions and implement effective risk mitigation strategies. To provide learnings for future production, we also explored state-of-the-art causal machine learning techniques to estimate the effect of the implemented treatment on process parameters. This work enabled a deeper understanding of how this specific intervention impacted yield and product quality, offering valuable evidence to guide future process decisions.

    • Q&A

  • B4: Next-Generation Aseptic Operations: Traceability, Gloveless Filling, and Real-Time Monitoring

    Aseptic processing is undergoing rapid transformation as manufacturers adopt digital tools that enhance quality, reliability, and throughput. This session will highlight two technologies reshaping modern fill/finish operations: RFID-enabled unit-level traceability for improved visual inspection efficiency and mix-up prevention, and gloveless isolator systems equipped with real-time biofluorescent particle monitoring. Presenters will share practical implementation insights, validation strategies, and measurable performance gains that help organizations meet rising regulatory expectations while accelerating production.

    • RFID-Based Unit Level Traceability: A Case Study for Visual Inspection

      Optimizing process efficiency while meeting increasingly stringent regulatory requirements presents a critical challenge. This study demonstrates a novel approach to expanding fill/finish capacity and enhancing quality assurance through unit-level traceability systems. Individual unit tracking is enabled by embedding RFID tags within rigid needle shields of prefilled syringes. This technological advancement serves multiple functions: it provides technical safeguards against batch mix-ups, enhances production efficiency through precise batch segregation during quality incidents, enables automated reconciliation across production stages, and streamlines manual visual inspection and related operator qualification by reducing or eliminating labour intensive tasks. We present a comprehensive analysis of unit-level traceability implementation in parenteral product fill/finish operations within GMP environments, addressing both technological benefits and implementation challenges. Our case study on visual inspection processes provides quantitative data comparing conventional methods with RFID-enabled systems, demonstrating measurable improvements in processing time, quality assurance metrics, and operator qualification procedures.

    • Future Forward: Implementing and Validating Gloveless Isolators with Real-Time Biofluorescent Particle Counting

      Join us to hear how one company implemented, qualified, and validated a closed, gloveless SA25 aseptic filling workcell – using a rigorous, standardized approach to earn GMP certification in just 18 months. Explore the advantages of real-time monitoring using biofluorescent particle counters (BFPC). And discover how to use BFPC for Grade A monitoring, from setting baselines to handling interference and getting ready for inspections. This approach cuts down extra validation work for end users. Leave with practical tips for using gloveless isolators and BFPC to boost aseptic monitoring, stay compliant, and speed up your path to market.

    • Q&A

  • IG4: Early Career Professionals

  • P2: Every Body Counts: Innovation That Reaches Everyone

    Join Dr. Amy Beckley, founder and CEO of Proov, as she shares her journey from a basement startup to earning FDA clearance for a first-of-its-kind, crowdsourced at-home hormone test. Motivated by her own experiences and a mission to ensure women’s health is rigorously studied, Dr. Beckley will illustrate how patient-centered innovation, scientific rigor, and persistence can advance research in areas historically underrepresented in medical science. Her story will demonstrate the transformative impact of focusing on women’s health and empowering patients with actionable insights.

  • Exhibit Hall Open

  • Networking Lunch in the Exhibit Hall

  • Poster Showcase in the Exhibit Hall

  • A5: Practical Applications of AI in the Modern Pharmaceutical Workplace

    Not sure how to bring AI into your workplace? This session will provide practical, real-world approaches for integrating AI safely and effectively. Attendees will learn first-hand through a simulated GenAI demonstration showing how AI can enhance peer learning and workforce training. The session will also share insights from cross-site assessments of 25 products, illustrating how standardized metrics and shared vocabulary help organizations prioritize investments and measure the success of their AI initiatives.

    • Human-AI Training Parallelization: AI Implementation in Biopharma Success Requires a People-Centric Approach to Training and AI Literacy

      The biomanufacturing industry is facing a critical challenge: successfully integrating Generative AI (Gen AI) without sacrificing the proven expertise of its workforce. This presentation reintroduces the Human-AI Training Parallelization (HATP) system, a novel, people-centric framework designed to both augment human capability and resolve systemic knowledge retention issues across Life Sciences. We detail two complementary methodologies. Human-AI Training Parallelization (HATP): Learning employs Digitally Interactive Standard Operating Procedures (DISOPs) and robust assessments to ensure personnel develop critical competency by learning to evaluate and direct AI output, not just accept it. The second, Project-Based HATP integrates AI Assistant development (such as a Custom GPT or Gemini Gem) directly into the project lifecycle. As teams execute projects, this parallel process systematically captures and digitizes tribal knowledge and tacit expertise, transforming it into a dynamic, verifiable "North Star" of institutional memory. The session will include a live (simulated) demonstration of a Gen AI tool to mirror the system’s utility for peer-to-peer problem-solving. HATP offers a clear strategy for continuous improvement and knowledge transfer, positioning AI as an indispensable partner for enhancing, not replacing, the biopharma workforce. This is the future of AI implementation, a strategy focused on human empowerment.

    • Are We There Yet? A Digital Maturity Model for Enabling Process Monitoring and AI in Biologics Manufacturing

      Digital transformation promises to revolutionize biopharmaceutical manufacturing, yet most organizations leverage only a small fraction of their process data. Paradoxically, the challenges of data utilization are increasing with globalization and digitization, driven by conflicting stakeholder priorities, evolving technologies, and complex business constraints. This presentation introduces a practical maturity model specifically designed for assessing bioprocess monitoring and data analytics readiness in biologics manufacturing. The framework employs a balanced scorecard approach that evaluates both "what" data is available (quality attributes, yields, batch data, continuous sensor data, genealogy, and calculated features) and "how" effectively it is delivered (freshness, speed, accessibility, authenticity, scalability, and structure). Drawing on real-world assessments of 25 products across multiple manufacturing sites, the presentation reveals that while organizations excel at collecting critical quality and yield data, significant gaps exist in making this data accessible for improvement initiatives. The model provides an objective scoring methodology that enables organizations to benchmark their current state, identify specific improvement opportunities, and track progress over time. By establishing common metrics and vocabulary, companies can prioritize investments and measure the effectiveness of their digital transformation initiatives.

    • Q&A

  • B5: Device Integrity and Therapeutic Safety: Advances in Testing Strategies

    From next-generation autoinjector technologies to cutting-edge cell and gene therapies, this session will bring together two rapidly advancing areas with a shared goal: uncompromising drug quality and patient safety. This session will highlight a new container closure integrity (CCI) method for precise leak detection in prefilled syringes and share science-based strategies for managing cell and gene therapy (CGT) manufacturing that ensure safety, regulatory confidence, and reliability for life-saving therapies.

    • Innovative Design and Testing Strategy for an Autoinjector to Precisely Determine Leaks in the Pre-Filled Syringe

      Autoinjectors are widely used drug delivery devices designed to ensure convenient and reliable self-administration of injectable medications. However, accurately measuring Container Closure Integrity (CCI) on the prefilled syringe (PFS) inside a fully assembled autoinjector presents significant challenges. Fundamentally, the convoluted design of autoinjectors restricts access to the PFS and limits the use of established vacuum-based CCI testing. Such methods rely on stabilisation of the syringe plunger as vacuum effects alter its position. Hence, testing is commonly conducted on isolated PFS only which require autoinjector disassembly. Disruptive dismantling methods in combination with autoinjector design constraints pose significant risk to the sterility of the PFS. To overcome these challenges, we propose a novel testing strategy that evaluates the autoinjector in a partially disassembled state: The distal drive package is removed from the finally assembled autoinjector and solely the PFS-containing section is tested for CCI using deep vacuum (LFC). This approach minimizes the risk on PFS sterility as the partial disassembly does not involve PFS removal and splits the autoinjector at an inherent separation point. The gained access allows the syringe plunger to be precisely positioned and held in place using a floating pin concept. This method ensures reliable detection of smallest leaks.

    • Cell and Gene Therapies: Navigating Extractable and Leachable Testing Challenges for Life-Saving Treatments

      In the rapidly advancing field of Cell & Gene Therapy (C>) manufacturing, the use of single-use processing components is integral for efficiency and flexibility. C>s represent critical breakthroughs in medicine, offering hope to patients for previously incurable diseases. These therapies pose unique extractable and leachable (E&L) testing challenges due to their reliance on single-use systems, cryopreservation storage conditions, limited batch volume and the use of dimethyl sulfoxide (DMSO) in cryopreservation media. A case study will be presented on overcoming complexities with performing E&L for ex-vivo applications, while highlighting necessary modifications to traditional E&L approaches. Key strategies include scientifically justified cryogenic storage simulations and the use of DMSO-containing extraction solutions. Additionally, the case study dives into the detection and identification of per- and polyfluoroalkyl substances (PFAS) from fluoropolymer components used in C> manufacturing. By adopting a simulation approach, appropriate analytical methodology and safety concern thresholds for single-dose therapeutics, the program achieved successful regulatory acceptance. Together, these scientifically justified approaches demonstrate how innovative E&L testing strategies can ensure patient safety, accelerate regulatory approval, and establish a forward-looking E&L strategy for the broader C> industry.

    • Q&A

  • IG5: Drug Compounding

  • IG6: Microbiology/Environmental Monitoring and Quality Risk Management

  • Mini-Workshop 3: Hands-On Workshop: Data Governance (Ticket Required)

    This mini-workshop will guide participants in developing practical data governance (DG) programs that deliver quality data aligned with business and compliance needs. The workshop will introduce core DG principles and show how they are emerging in regulatory frameworks such as the draft EU GMP Chapter 4 and ICH E6 (R3). Participants will explore how DG connects quality risk management, knowledge management, and data management, linking data integrity (ALCOA) and data quality to applied quality intelligence for sustainable compliance and stronger decision-making. Through interactive group work and role-play scenarios, attendees will design and test DG strategy elements using real-world use cases.

    Each participant will receive a practical handout to support launching or strengthening DG programs within their organization.

  • A6: Accelerating Combination Product Development Through Platform Design and Lifecycle Excellence

    This session will explore strategic approaches to improving speed, consistency, and long-term reliability in combination product development. It will highlight a master-platform architecture that harmonizes QbD, design controls, and risk management to reduce rework and accelerate development across product families. The session will also examine how early lifecycle integration can minimize future remediation, strengthen supply continuity, and create more efficient, patient-focused pathways from early-phase design to commercial launch.

    • Master-Platform for Drug-Device Combination Products: Maximizing Reuse and Minimizing Rework with Regulatory Rigor

      Drug-device combination products involve multiple development paradigms and engineering disciplines such as QbD, design controls, risk management, and regulatory strategy. Although much work across a combination product portfolio can be leveraged or reused, many organizations develop in silos, resulting in duplicated work, inconsistencies, and barriers to reuse. This presentation proposes a master-platform architecture that harmonizes QbD, design controls, risk management, safety assurance, and regulatory submission within a model-based digital ecosystem. The unified structure supports scalable reuse across product families while preserving regulatory rigor and traceability. We will walk through a real-world example of how to build a master platform for the development and lifecycle management of multiple drug delivery variants. We will showcase the associated benefits: reductions in duplicated design and test effort, more efficient change control propagation across variants, and shorter regulatory review cycles. Attendees will depart with a practical blueprint and key considerations for building master platforms in drug-device combination product development—enabling greater reuse, consistency, and regulatory confidence.

    • Designing for the Future: Embedding Lifecycle Thinking in Early-Phase Development

      In early-phase development, speed to clinic often drives decision-making, but operational realities in commercial supply reveal the long shadow of these Phase I/II choices. Early development design (e.g., platform adoption, raw material selection, analytical strategy, process control design) becomes the foundation for commercial lifecycle management. Decisions made without lifecycle awareness can lock organizations into rigid processes, create costly comparability exercises, or drive late-stage remediation that delays supply or requires post-approval changes. This presentation explores how to embed lifecycle thinking from the start, showing how forward-looking design enables flexibility for scale-up, regulatory alignment, and global market expansion. Real-world case studies will illustrate how early choices (e.g., insufficient analytics, materials that trigger supply risks, control strategies that limit process evolution) lead to post-approval changes, manufacturing complexities, and expensive remediation, while examples of forward-looking development will demonstrate how embedding lifecycle thinking reduces transfer risk, simplifies global operations, and positions organizations for efficient long-term supply, enabling efficient tech transfers and a more cost-effective path for commercialization. Attendees will leave with practical strategies to balance clinical urgency to be first-in-human with efficient development to be fit-for-future for operational sustainability, ensuring early-phase choices accelerate rather than constrain future success of these early phase programs.

    • Q&A

  • B6: Breaking Boundaries: Rethinking Pyrogen Testing and Sterilization Risk in the Age of Innovation

    This session will challenge outdated assumptions in pharmaceutical safety—from the industry’s traditional focus on endotoxins to the often-overlooked influence of sterilization methods on cell culture viability. Attendees will discover how the Monocyte Activation Test (MAT) will provide a broader, AI-ready approach to pyrogen detection, and will explore emerging data comparing gamma and X-ray irradiation in CHO cell growth risk assessments. Two studies, one goal: enabling smarter, safer, and future-proofed pharmaceutical practices.

    • Out of the Endotoxin Box: Addressing Pyrogen Diversity Challenges Using the MAT

      The extensive characterization of pattern recognition receptors and their ligands known as pathogen-associated molecular patterns (PAMPs) and damage-associated molecular patterns (DAMPs) have not significantly changed practices in pharmaceutical microbiology. The use of autoclaves and other sterilization methods assumes that only live microbes pose a threat to therapeutic products. Further, the popularity of endotoxin detection using horseshoe crab blood cell lysates also assumes that all endotoxins or lipopolysaccharides are pyrogenic, and conversely suggests that endotoxins alone can cause fever, sepsis, multiple organ failure or death. In this presentation, we will contrast the compendial methods based on bacterial endotoxin tests and the monocyte activation test (MAT). We will introduce new concepts and algorithms that illuminate the superiority of the MAT over current testing methods, and its advantages in providing a comprehensive view of parenteral drugs’ and implants’ safety status to inform business decisions. We will show that the MAT is the ultimate tool for toxicological studies in this new era of artificial intelligence (AI)-assisted drug discovery and development, regulatory shifts, and the quest for alternatives to animal use in testing.

    • Comparative Study of Gamma and X-Ray Irradiation on CHO Cell Culture Growth: Risk Analysis and Performance Evaluation

      This study, conducted by Sartorius and AstraZeneca, investigates the effects of gamma versus X-ray irradiation on sterile filter and bag assemblies in contact with Chinese Hamster Ovary (CHO) cell culture media. The research aims to evaluate the indirect impact of these sterilization technologies on cell growth when media is exposed to the single use assemblies, considering worst-case scenarios and risk assessments. The study assesses the equivalency of gamma and X-ray irradiation in maintaining cell growth and viability, as a part of a comprehensive risk analysis to ensure the safety and effectiveness of sterilization processes in line with the BioPhorum risk evaluation guidance (1,2,3). Sterilization of filter assemblies was performed using Gamma and X-ray irradiation at comparable doses, followed by extraction of materials using cell culture media at varying surface-area-to-volume (S/V) ratios, simulating worst-case scenarios with a tenfold safety margin. CHO DG44 cells were inoculated in media extracts and cultivated over six days, with cell numbers analyzed to evaluate the impact of irradiation methods on cell growth. 1- Guidance for risk evaluation of X-ray irradiation of single-use systems - BioPhorum 2- Confirming the equivalency of gamma and x-ray irradiation - BioPhorum 3- X-ray sterilization for single use systems - BioPhorum

    • Q&A

  • IG7: Annex 1 Implementation

  • PDA Journal of Pharmaceutical Science and Technology—The Members' Journal

    In this session, the authors who won the ‘paper of the year award for 2026’ will be invited to present their study along with brief but interesting presentations by other authors who have made consistent contributions to the Journal. The participants will have a chance to meet with the editors of the journal and ask questions and make suggestions. All current and potentially interested authors and reviewers are especially invited to attend.

  • Happy Hour in the Exhibit Hall

  • Optional Activity: PDA Battle of the Bags Cornhole Tournament (Ticket Required)

    Join us for a lively evening of friendly competition, great food, and plenty of fun at the PDA Battle of the Bags Cornhole Tournament!

    Players
    Player tickets give you full access to the action—step onto the court, compete in quick-paced matches, and enjoy a friendly, high-energy atmosphere.

    Players will be paired into teams onsite, no partner or prior experience needed. With multiple courts running at once and an easy-to-follow format, the tournament moves fast and keeps the excitement high. Between matches you can grab dinner and cheer on fellow players as they compete for trophies and bragging rights.

    Come play, eat, and connect in a relaxed, spirited setting. Player spots are limited, secure your place early!

    Spectators
    Want in on the fun without joining the tournament? Grab a Spectator Ticket and enjoy the full social experience at the PDA Battle of the Bags Cornhole Tournament! Settle into the cheering section, enjoy dinner, and watch as teams face off in quick, high-energy matchups for trophies and bragging rights.

    It’s the perfect way to relax, socialize, and take in the excitement of the tournament – no gameplay required. Come cheer, eat, and connect in a laid-back, high-spirit atmosphere!

  • Optional Activity: Gentle Evening Slow-Flow Yoga (Ticket Required)

    Unwind after a busy day at PDA Week with a slow, calming evening yoga session designed to help you reset and relax. This gentle class blends a slow-flow sequence, long holds, and restorative postures—perfect for settling both mind and body before turning in for the night. All levels are welcome, and no prior yoga experience is needed. Wear comfortable clothing you can move in, just show up and enjoy; mats will be provided, and post-session tea will be available. Join us for a peaceful evening reset.
Wednesday, 25 March

MDT Daylight Time (UTC -6:00)

  • Registration Open

  • Presenter Ready Room Open

  • Continental Breakfast in the Exhibit Hall

  • Posters and Pastries in the Exhibit Hall

  • Exhibit Hall Open

  • A7: Advancing AI-Driven Autonomy Across GxP Operations

    This session will explore the emerging future of autonomous cell and gene therapy manufacturing and the utilization of AI in GxP decision making. Presenters will examine the potential benefits and challenges of enabling “dark” manufacturing facilities and outline how using a standardized risk-based model to define and implement a fit-for-purpose, compliant AI framework that supports activities within a GxP-regulated environments.

    • Dark Facilities: Is Autonomous Manufacturing the Future?

      As anyone working in cell and gene therapy knows, manufacturing is hard. It’s complicated, expensive, and not always predictable, especially when you're dealing with live cells, small batch sizes, and a workforce that has to be highly trained and constantly vigilant. But what if we could take people out of the cleanroom altogether? This session looks at the idea of “dark” or fully autonomous CGT facilities, not as science fiction, but as a possible future we’re slowly building toward. We’ll talk about what this could look like: robots handling materials, AI running in-line adjustments, and facilities that don’t need to be designed around human movement or HVAC load for people in gowns. We’ll also get real about the challenges. Automation in pharma is not plug-and-play. There are hurdles around validation, integration, and convincing regulators you’ve got eyes on a process no one’s physically watching. But there are examples from other industries and early efforts in pharma that show us where we might be headed. This won’t be a “perfect solution” talk. It’s more about: What parts can we start doing now? Where does it make sense? And how do we design facilities today that won’t hold us back tomorrow?

    • Assessing the Risk of AI in the GxP Environment

      Despite its transformative potential, Artificial Intelligence (A.I.) presents unique challenges in the GxP-regulated environment. A.I. systems are typically opaque, lacking traceability between their inputs and outputs. When granted autonomy to do so, some A.I. systems can modify themselves during use. And although they simulate reasoning at a remarkably high level, A.I. systems are prone to occasional, profound lapses. To understand the risk that these and other aspects of A.I. may pose within the GxP-regulated environment requires systematic assessment of both the A.I. tool in question and its intended context of use. In this session, we present a framework for assessing the risk of using A.I. to support GxP activities and decisions. Following a brief overview of relevant regulatory guidance, we describe a two-component risk model that is 1) aligned with current guidance, 2) informed by A.I.-specific hazards, and 3) suitable for use in assessment at varying levels of formality. We examine the risk-reducing effects of having a “human in the loop” and identify important limitations and contingencies. Finally, we remark on some of the challenges inherent in this type of risk assessment and offer recommendations for practical application.

    • Q&A

  • B7: Smart Systems, Smarter Solutions: Reinventing Drug Manufacturing and Delivery

    From digital twins to collapsible syringes, this session will explore how innovation will reshape drug product manufacturing and delivery. Attendees will learn how virtual modeling will transform fill-finish operations with predictive insights, and how a redesigned prefilled syringe will cut costs, reduce waste, and expand access to care. Two bold ideas, one shared vision: making pharma more agile, equitable, and sustainable.

    • The Future of Fill-Finish: Implementing Digital Twin Technology for Drug Product Manufacturing

      As pharmaceutical manufacturers are looking to navigate and excel in Pharma 4.0, a key aspect of the digitization breakthrough is the exploration of digital twin technology. A digital twin is a dynamic, predictive virtual model that synthesizes real-time data, physical operations, and virtual environments in an exact digital replica of a machine, system, or complete manufacturing operation. With the rise of this advanced technology, a host of opportunities and questions now face drug product manufacturers. The innovative integration of the physical, digital, and data spaces offered by digital twin provides exciting possibilities for the production of liquid pharmaceuticals at every stage of drug development through to commercial manufacturing. This presentation will provide an overview of the evolution of digital manufacturing solutions and Pharma 4.0, a primer on digital twin technology, and what the industry can anticipate going into the future. Teaching highlights include: • Definitions and principles of digital twin technology • Three real-world use cases of digital twin for fill-finish • An exploration of potential applications and benefits for drug product manufacturing, including time to market, process formulation, quality control, risk assessment, and predictive analytics

    • Redesigning Pre-Filled Syringes: A Way to Increase Equitable Access, Decrease Costs, and Reduce Environmental Impact

      We will showcase our research, development, and engineering work to create a compact prefilled syringe that addresses overlooked and complex medical logistics and healthcare challenges. Our work seeks to expand equitable access to high-quality healthcare, save costs, improve the well-being of communities in rural and low-resource settings, all while reducing environmental impacts of key medical procedures. The concept we will present and show physical prototypes of is for a compact and resource-saving pre-filled syringe for use across the healthcare industry. Though pre-filled syringes provide many benefits - including safety, precision, speed, and convenience - switching away from vials and empty syringes to pre-filled syringes has led to fewer syringes fitting on pallets than before. This is because pre-filled syringes come with their plungers almost fully extended. This wastes significant space during sterilization, shipping, storage, and distribution. We are developing a collapsible syringe with a 40% smaller packaging footprint relative to traditional pre-filled syringes. The compact syringe concept in question aims to save costs throughout the supply chain, reduce environmental impact, and bring the safety and quality benefits of pre-filled syringes to more patients around the world, especially those living and working in rural, low-resource, and/or disaster settings.

    • Q&A

  • IG8: Process Validation

  • Mini-Training Course 2: Applied GMP Behaviors: Cleaning Conduct and Gowning (Ticket Required)

    This mini-training course is designed to equip personnel with the knowledge and practical skills required to maintain contamination control in pharmaceutical cleanrooms. It will cover the principles of Good Manufacturing Practice (GMP), proper gowning techniques, and cleanroom behavior essential for ensuring product integrity and patient safety. Attendees will get to apply knowledge with a hands-on experience with gowning supplies.

  • A8: Optimizing Product Safety Through AI and Digitalization

    Digital transformation and the use of AI will be central to this session’s focus on contamination control and cleaning validation. Attendees will learn how AI can be integrated into daily sterility assurance and environmental monitoring programs to predict potential contamination events before they occur, and how cleaning validation processes will be digitalized to fully support Pharma 4.0

    • Digital Transformation in Cleaning Validation Use Cases: Key Benefits and Lessons Learned

      An effective cleaning validation program is essential for regulatory compliance and efficient manufacturing. Over the years, it has been a challenge to develop and maintain a cleaning validation program that meets all regulatory expectations and supports manufacturing needs. A robust program includes strategies for cleaning process development, product bracketing, grouping of product contact equipment, training of operators, analytical methods, and analytical sampling as well as acceptance criteria and limit setting for cleaning validation. Many cleaning validation activities are still performed manually using non-validated spread sheets. However, over the past 5 years we have seen more companies digitalizing their cleaning validation. This presentation will demonstrate how to identify the worst-case product and calculate maximum Surface Acceptance Limits (SAL) for cleaning validation in a multipurpose facility using a digital tool. This session shows the preparation and the implementation phases required to digitalize a paper-based cleaning validation program and outlines a representative timeline of such a project. The aim of the digital transformation in cleaning is often also to get critical cleaning process data digitalized to support a shift to Pharma 4.0. This aspect will also be discussed using an additional case study.

    • Detection Disrupted: AI and the New Era of Predictive Contamination Control

      Contamination control traditionally relies on lagging indicators to demonstrate if a system is in control, waiting for microbial growth, QC results, or deviation trends to reveal potential risks. This approach fosters a non-value-added reactive environment where more time and effort are spent fixing past problems than preventing future issues. Artificial intelligence (AI) offers a disruptive alternative by being able to predict contamination events, transforming environmental monitoring and sterility assurance and allowing a company to be more proactive. This session will provide a high-level practical roadmap for how pharmaceutical manufacturers can integrate AI into their daily sterility assurance and contamination control operations. Attendees will learn into how predictive AI can strengthen sterility assurance, reduce or prevent contamination events, and support compliance, with the goal of demonstrating how manufacturers can start now to make the shift from detection to prediction and introduce a new era of contamination control.

    • Q&A

  • B8: Smart Supply Chains: Predictive Insights and Digital Defense for Product Integrity

    From transport validation to counterfeit prevention, innovation is reshaping how the industry protects medicines and patients. This session will bring together experts pioneering the use of predictive modeling, simulation, and digital authentication tools to build smarter, more resilient supply chains and prevent counterfeiting. Learn how data-driven decision-making and cross-sector collaboration are accelerating regulatory readiness, reducing risk, and ensuring patient trust in every shipment and every dose.

    • Revolutionizing Product Protection: Digital Collaboration to Combat Counterfeit Medicines

      Counterfeit medicines continue to pose a global threat to patient safety, eroding trust in healthcare systems and undermining pharmaceutical integrity. In response, Takeda’s Global Product Protection (GPP) team has pioneered a multi-year strategy that leverages digital technologies and cross-sector collaboration to transform the landscape of product protection. This presentation will explore how digital authentication tools—such as blockchain-enabled traceability, eFingerprint packaging, and smartphone-verifiable digital signatures—are being deployed to detect and prevent falsified medicines across global supply chains. Through strategic partnerships with law enforcement, regulatory bodies, and technology innovators, Takeda has operationalized a risk-based framework that integrates predictive analytics, forensic field testing, and internet monitoring to proactively identify threats. The session will highlight case studies demonstrating how collaborative intelligence and digital packaging innovations have disrupted counterfeit networks and safeguarded patients in high-risk regions. As the pharmaceutical industry enters a new era of digital transformation, this presentation will offer actionable insights into how companies can build resilient, tech-enabled defenses against illicit trade. Attendees will gain a deeper understanding of how collaboration and innovation are reshaping product protection—and why these efforts are essential to preserving patient trust and global health.

    • PDA Survey 2025: Transportation Validation Benchmarking Review and Analysis

      The survey provided an evaluation of transportation through simulated environments versus real-world qualification of temperature-controlled shipping systems. The goal to assess the use of simulated data as a reliable source for regulatory submissions as opposed to conducting real-world studies, which require time and resources that can often delay approvals. Ultimately, those delays can prevent patients from receiving critical medicines in a timely manner. In addition, through the results of this survey, the industry aims to identify opportunities for improving supply-chain efficiency through the use of predictive models. With the increasing use of digitization and artificial intelligence across multiple industries, more consideration should be given to the use of predictive models. The significant number of industry respondents highlights a clear need for the consideration of simulated transport data in regulatory submissions and the desire for uniformly drafted future guidance on transportation-qualification practices.

    • Q&A

  • IG9: Quality Risk Management and Sterile Processing/Parenteral Drug Manufacturing

  • Networking Lunch and Passport Drawing in the Exhibit Hall

  • Poster Awards in the Exhibit Hall

  • Innovation Session 1

  • Innovation Session 2

  • Innovation Session 3

  • P3: Decision-Making Under Uncertainty

  • Optional Wednesday Evening Activity

Thursday, 26 March

MDT Daylight Time (UTC -6:00)

  • Registration Open

  • Aseptic Processing Essentials Workshop (PDA 374) (Separate Registration Required)

    This essentials workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. It will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

    Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.

    Essentials Workshop Information and Registration

  • Contamination Control Strategy Essentials Workshop (PDA 293) (Separate Registration Required)

    A comprehensive contamination control strategy (CCS) transcends a mere compliance document. A CCS embodies a suite of contamination control principals integral to a company’s all-encompassing approach to managing, mitigating, and assessing contamination risks. The efficacy of each CCS component is closely tied to the collective performance, with the overall success of the CCS hinging on the cooperation of its parts to minimize contamination threats in each process. A well-implemented CCS serves as a conduit for knowledge sharing and continuous improvement.

    This essentials workshop will dive into the practical application of CCS development, moving beyond theory to develop the essential skills for creating a comprehensive CCS. These strategies encompass every facet of production, from facility layout and utilities to environmental management, validation, monitoring, quality systems, personnel, and operational processes.

    Participants will receive a complimentary copy of the PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing (TR 90), a valuable resource for essentials workshop preparation. This interactive essentials workshop is your gateway to understanding CCS and its implementation in your manufacturing settings — a hands-on guide to formulating and executing an effective CCS.

    Essentials Workshop Information and Registration

Program Planning Committee

The Team Behind the Event's Agenda

  • Virginia Boldt

    Fusion Pharmaceuticals

    Supply Chain Planner

    Read Bio

  • Yeissa M. Chabrier-Rosello, PhD

    U.S. FDA

    Senior Pharmaceutical Quality Assessor, OPQ, CDER

    Read Bio

  • Michelle Dennis

    MilliporeSigma

    QC Microbiology Application Specialist, North Carolina

    Read Bio

  • Rozhin Derakhshandeh

    Merck & Co., Inc.

    Senior Scientist in Drug/Device Combination Products

    Read Bio

  • Christopher Lewis

    Umoja Biopharma

    Head of Quality

  • Ryan Murray, MS

    ValSource, Inc.

    Senior Consultant

    Read Bio

  • Divyang Patel

    AtkinsRéalis

    Senior Consultant & Project Manager

    Read Bio

  • Julian Petersen

    groninger & co gmbh

    Head of Business Development Pharma

    Read Bio

  • Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Distinguished Fellow

    Read Bio

  • Sebastian B. Teitz, PhD

    Novo Nordisk

    Senior Development Scientist

    Read Bio

  • Robin Usselman

    PBL (Performing Beyond Limits)

    Senior Business Development Manager, USA & Canada

    Read Bio

  • Rebecca C. Walden, MSc

    Irish Blood Transfusion Service

    Senior Quality Systems Specialist

    Read Bio

Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Gaylord Rockies

6700 N Gaylord Rockies Boulevard
Denver, CO 80019 USA
Reservation Instructions

The Gaylord Rockies is the official headquarter hotel for PDA Week 2026! Located just minutes from the Denver International Airport at the edge of the Front Range, the Gaylord Rockies offers an alpine escape with stunning mountain views.

Make a Reservation Online

Should you need to cancel your reservation, the deposit will be refunded if notice is received at least five (5) working days prior to arrival, and a cancellation number is obtained.

How to Get Here
By Air The Gaylord Rockies is accessible from the Denver International Airport (DEN - approx. 7 miles/11 km).
By Car On-site hourly and overnight parking is available at the Gaylord Rockies.

Registration

Pricing Options

Members-Only Savings Are Live!

PDA Members enjoy exclusive PDA Week 2026 discounts through Sunday, 07 December. Renew or join today and make the most of this limited-time offer.

Join or Renew Today

Member Appreciation Week

Register by 07 December 2025

Member Price

$1,875

GovernmentMember Only

$750

Health AuthorityMember Only

$750

Early Career ProfessionalMember Only

$1,125

StudentMember Only

$375

AcademicMember Only

$1,125

Non-Member

N/A

Early Registration

Register by 19 February 2026

Member Price

$2,000

GovernmentMember Only

$800

Health AuthorityMember Only

$800

Early Career ProfessionalMember Only

$1,200

StudentMember Only

$400

AcademicMember Only

$1,200

Non-Member

$2,500

Standard Registration

Register after 19 February 2026

Member Price

$2,500

GovernmentMember Only

$1,000

Health AuthorityMember Only

$1,000

Early Career ProfessionalMember Only

$1,500

StudentMember Only

$500

AcademicMember Only

$1,500

Non-Member

$3,125

See Qualifying Criteria for Member Types.

GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Presenters

PDA events bring together top-notch industry experts, innovators, and practitioners who are shaping the future of pharmaceutical science and manufacturing. Our presenters are selected for their experience, insight, and commitment to elevating the global community through knowledge sharing.

Presenting at this event?

Access important instructions, templates, deadlines, and tools in our Presenter Resources section to ensure a smooth and successful experience.

Presenter Resources

  • Tommy Adler

    Takeda

    Presenter
  • Sam Albeke

    Sam Albeke

    Element Materials Technology

    Chromatography Manager

    Presenter
    Read Bio
  • Thomas Altmann

    Thomas Altmann

    Ecolab

    Principal Global Technical Consultant

    Presenter
    Read Bio
  • Jordi Amagat Molas, PhD

    Jordi Amagat Molas, PhD

    UV Medico

    Segment Project Manager, Life Science and Pharma

    Presenter
    Read Bio
  • Arie Anahory, MS

    Arie Anahory, MS

    Regulatory Compliance Associates Inc.

    Global Head of Operations

    Interest Group Leader
    Read Bio
  • Denyse Baker, PE, RAC

    Denyse Baker, PE, RAC

    Eli Lilly and Company

    Associate Vice President, External Engagement and Advocacy/Global Quality Compliance

    Discussion Leader
    Read Bio
  • Peter Baker, MS

    Peter Baker, MS

    Live Oak Quality Assurance LLC

    President

    Presenter
    Read Bio
  • Adithya Balasubramanian, MS

    Adithya Balasubramanian, MS

    ten23 health

    Senior Director

    Presenter
    Read Bio
  • Marcia C. Baroni, MBA

    Marcia C. Baroni, MBA

    Emergent BioSolutions

    VP Quality, Enterprise GxP Compliance & Systems

    Interest Group Leader
    Read Bio

  • Jack Bauers

    CRB

    Market Lead, Nuclear Medicine

    Presenter
    Read Bio
  • Amy Beckley, PhD, MBA

    Amy Beckley, PhD, MBA

    Proov

    Owner & CEO

    Presenter
    Read Bio
  • Antonio Burazer

    Antonio Burazer

    Takeda

    Global Head Visual Inspection & Particle LCM

    Interest Group Leader
    Read Bio
  • Hilary Chan, MS

    Hilary Chan, MS

    Takeda

    Global Sterility Assurance and Microbiology Lead

    Presenter
    Read Bio
  • Brian Chviruk

    Brian Chviruk

    Takeda

    Quality Systems Innovation Lead

    Presenter
    Read Bio
  • Richard Denk

    Richard Denk

    SKAN AG

    Senior Consultant Aseptic Processing

    Discussion Leader
    Read Bio
  • Rozhin Derakhshandeh

    Rozhin Derakhshandeh

    Merck & Co., Inc.

    Senior Scientist in Drug/Device Combination Products

    Committee Member
    Discussion Leader
    Moderator
    Read Bio
  • Ranran Dong, PhD

    Ranran Dong, PhD

    Genentech, Inc.

    Principal Data Scientist

    Presenter
    Read Bio
  • Samuel Dorey, PhD

    Samuel Dorey, PhD

    Sartorius Stedim FMT

    Principal Scientist Materials & Irradiation

    Presenter
    Read Bio
  • Robert Dream

    Robert Dream

    HDR Company

    Managing Director

    Interest Group Leader
    Read Bio
  • Mauro Giusti, MSc

    Mauro Giusti, MSc

    Eli Lilly and Company

    Executive Director, TSMS Technical Capabilities Training

    Interest Group Leader
    Read Bio
  • Gabriele Gori

    Gabriele Gori

    Consultant

    Senior Quality Advisor

    Interest Group Leader
    Read Bio
  • Shanker Gupta, PhD

    Shanker Gupta, PhD

    PDA Journal of Pharmaceutical Science and Technology

    Editor-In-Chief

    Presenter
    Read Bio
  • Robert Halvorsen, MIIPS

    Robert Halvorsen, MIIPS

    Pacto Medical

    Chief Technology Officer

    Presenter
    Read Bio
  • Edward J Hoffman, PhD

    Edward J Hoffman, PhD

    Knowledge Strategies

    CEO

    Presenter
    Read Bio
  • Joseph A. Horvath, PhD

    Joseph A. Horvath, PhD

    Takeda

    Head, Quality Risk Management

    Presenter
    Read Bio
  • Kurt Jaecques, MA

    Kurt Jaecques, MA

    GSK

    Global Quality Technical Senior Lead

    Interest Group Leader
    Read Bio
  • David J. Jaenisch

    David J. Jaenisch

    PICLLC

    Director of Technology

    Discussion Leader
    Presenter
    Read Bio
  • Richard Jaenisch, MPH

    Richard Jaenisch, MPH

    Open Biopharma Research and Training Institute

    Senior Director of Education, Outreach and Digital Experience

    Discussion Leader
    Presenter
    Read Bio

  • Renee Jesser, MS

    Novavax

    Lead Bioprocess Engineer

    Presenter
    Read Bio
  • Stephen Judd, CEng, FIChemE FIEI

    Stephen Judd, CEng, FIChemE FIEI

    Arcadis

    European Director of Process Technology

    Presenter
    Read Bio
  • Matthias Kahl

    Matthias Kahl

    WILCO AG

    Head of R&D and Lab Services

    Presenter
    Read Bio

  • Scott Kammer

    Takeda

    Head, Global Product Protection

    Presenter
    Read Bio
  • Faryal Khan

    Faryal Khan

    CRB

    Lead Process Engineer

    Presenter
    Read Bio
  • Ana Kuschel, PhD

    Ana Kuschel, PhD

    West Pharmaceutical Services

    Principal Scientific Affairs

    Interest Group Leader
    Read Bio
  • Stephen E. Langille, PhD

    Stephen E. Langille, PhD

    ValSource, Inc.

    Senior Microbiology Consultant

    Interest Group Leader
    Read Bio
  • Sarah Lanning, PE

    Sarah Lanning, PE

    CRB

    Process Engineer

    Presenter
    Read Bio
  • Brent N. Lieffers

    Brent N. Lieffers

    Cytiva

    Senior Director, Innovation Advocacy

    Presenter
    Read Bio
  • Toni Manzano, PhD

    Toni Manzano, PhD

    Aizon

    CSO and Compliance Officer

    Presenter
    Read Bio
  • Djikolngar Maouyo, PhD

    Djikolngar Maouyo, PhD

    PyroDex LLC

    Founder, Managing Director and President

    Presenter
    Read Bio
  • Amanda McFarland, MS

    Amanda McFarland, MS

    ValSource, Inc.

    Senior Consultant

    Interest Group Leader
    Read Bio
  • Jahanvi Miller, MBA

    Jahanvi Miller, MBA

    Baxter

    Head of Global Quality External Affairs

    Presenter
    Read Bio
  • Renee T. Morley, MBA

    Renee T. Morley, MBA

    Contec Inc.

    Senior Technical Services Specialist

    Discussion Leader
    Interest Group Leader
    Read Bio
  • Srividya Narayanan, MDS MSc

    Srividya Narayanan, MDS MSc

    Northeastern University

    Graduate Student

    Presenter
    Read Bio
  • Priya Nataraj

    Priya Nataraj

    Novavax

    MS&T Associate Director

    Presenter
    Read Bio
  • Malav Parikh, ME

    Malav Parikh, ME

    Takeda

    Director, Quality Risk Management, Global Quality Compliance and Systems

    Co-Chair
    Interest Group Leader
    Moderator
    Read Bio
  • Tony A. Perry

    Tony A. Perry

    SCHOTT Pharma

    Regional Director of Quality

    Interest Group Leader
    Read Bio
  • Julian Petersen

    Julian Petersen

    groninger & co gmbh

    Head of Business Development Pharma

    Committee Member
    Discussion Leader
    Interest Group Leader
    Moderator
    Read Bio
  • William Peterson

    William Peterson

    Merck & Co., Inc.

    Director, Global QA

    Interest Group Leader
    Read Bio
  • Jack Prior, ScD

    Jack Prior, ScD

    Sanofi

    Head, MSAT Process Monitoring & Data Science/AI Strategy

    Presenter
    Read Bio
  • Deepa Rachel, MBA

    Deepa Rachel, MBA

    Eidolon Learning Pvt Ltd

    Founder

    Presenter
    Read Bio
  • Stacey Ramsey, MSc

    Stacey Ramsey, MSc

    Charles River Labs

    Senior Manager - Microbial Applications Lab

    Presenter
    Read Bio
  • Josh Russell

    Josh Russell

    AST

    Vice President of Technical Sales

    Presenter
    Read Bio
  • Alison Sathe

    Alison Sathe

    Redica Systems

    Senior Vice President of Data Strategy & Analytics

    Presenter
    Read Bio
  • David Short

    David Short

    QuVa Pharma

    Chief Quality Officer

    Interest Group Leader
    Read Bio
  • Kim Sobien, MBA

    Kim Sobien, MBA

    ValSource, Inc.

    Senior Microbiology Consultant

    Interest Group Leader
    Presenter
    Read Bio
  • Ian Speers, MPH, CPH, MedLog

    Ian Speers, MPH, CPH, MedLog

    Pacto Medical

    CEO and Co-Founder

    Presenter
    Read Bio
  • Tita Tavares

    Tita Tavares

    PDA

    Head of Strategic Marketing and Communication

    Discussion Leader
    Read Bio
  • Brian Trdina, MS

    Brian Trdina, MS

    AstraZeneca

    GQA Director of Emerging Technology

    Presenter
    Read Bio
  • Katherine Windham

    Katherine Windham

    Novavax Inc.

    Director, External Manufacturing Operations

    Presenter
    Read Bio
  • Fubin Wu, MS

    Fubin Wu, MS

    GessNet

    Co-founder and President

    Presenter
    Read Bio

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

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Become a Sponsor

Elevate your brand and maximize your exposure by becoming a sponsor at the PDA Week 2026! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

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Become an Exhibitor

Boost your brand and visibility by becoming an exhibitor at the PDA Week 2026! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

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Contact

Program Inquiries
Tel: +1 (301) 656-5900
Exhibition/Sponsorship Inquiries
David Hall
Tel: +1 (240) 688-4405
Training Course Inquiries
Tel: +1 (301) 656-5900
Registration Customer Care
Tel: +1 (301) 656-5900