From Breakthrough to Bedside: Turning Scientific Innovation into Therapies Patients Can Access
Innovative medicines are advancing across a broad range of therapeutic modalities, from small molecules and biologics to next-generation therapies such as ATMPs, ADCs, radiopharmaceuticals, and mRNA-based products. Yet scientific breakthroughs alone are not enough. Transformative therapies only fulfill their promise when they can be manufactured reliably, scaled efficiently, navigated through regulatory pathways, and ultimately delivered to the patients who need them.
This challenge sits at the heart of the From Breakthrough to Bedside track at the 2026 ISPE Annual Meeting & Expo, taking place 18-21 October 2026 in Washington, D.C., USA. The track brings together leaders from industry, regulatory agencies, engineering firms, and technology innovators to explore how organizations can bridge the gap between scientific discovery and commercial reality.
Through real-world case studies and practical lessons learned, attendees will gain insight into the technologies, manufacturing strategies, quality systems, facility designs, and regulatory approaches that are shaping the future of pharmaceutical development and delivery.
Designing Innovation for Manufacturability
One of the defining themes of this track is the need to consider manufacturability from the earliest stages of development. As therapies become increasingly complex, successful commercialization depends on integrating regulatory, quality, and manufacturing considerations long before market approval.
A compelling example comes from the session “Early Regulatory Alignment to Implement NGS at GMP Scale,” presented by experts from Astellas. Next-generation sequencing (NGS) is rapidly becoming a preferred method for viral detection in cell, gene, and biologic therapies due to its ability to identify both known and novel adventitious agents. However, introducing innovative technologies into GMP environments requires thoughtful engagement with regulators.
This session highlights how early collaboration with global health authorities can accelerate adoption of new analytical methods while establishing confidence in validation, control strategies, and intended use. As the industry seeks faster and more reliable ways to enable advanced therapies, proactive regulatory alignment is becoming a key enabler of innovation rather than a downstream hurdle.
Similarly, the presentation on “Risk Based Control Strategies to Enable Lifecycle Agility” demonstrates how organizations are moving toward more patient-centric specifications and analytical control strategies. By leveraging scientific understanding, clinical relevance, and development knowledge, manufacturers can create more flexible quality systems while maintaining robust product assurance and enabling more efficient post-approval changes.
Reimagining Quality and Regulatory Operations for Advanced Therapies
Advanced therapies are challenging traditional pharmaceutical operating models. Many ATMPs require highly individualized manufacturing processes and operate within shorter timelines, creating greater variability and operational complexity than conventional products.
The session “Fit-for-Purpose Quality Assurance and Regulatory Affairs for ATMPs” addresses these realities directly. Attendees will explore common bottlenecks that can slow development and commercialization, including quality control turnaround times, batch review processes, deviation management, and governance structures.
The discussion focuses on practical approaches such as risk-based decision-making, rapid testing methodologies, electronic batch records, and review-by-exception practices. These strategies are increasingly important as organizations seek to support growing ATMP pipelines while maintaining compliance and accelerating patient access.
The track further explores the role of automation in advanced therapy manufacturing through “Automated ATMP Manufacturing, Consistency and Quality.” Automation and robotics are transforming ATMP production by reducing operator-dependent variability, improving repeatability, and strengthening process control. As advanced therapies move toward broader clinical and commercial adoption, scalable and inspection-ready manufacturing models will become increasingly critical to meeting patient needs.
Building Facilities for the Therapies of Tomorrow
Scientific innovation often requires entirely new approaches to facility design and infrastructure.
The theme of future readiness continues in “Flexibility: Planning for Future Growth in Manufacturing.” Promega, alongside design and engineering partners, will share how intentional planning enabled long-term expansion while minimizing disruption to active operations. Topics include designing for future automation, accommodating evolving manufacturing needs, and balancing flexibility with financial considerations.
These sessions underscore an important industry reality: facilities must be designed not only for current products but also for future technologies, process evolution, and capacity growth. Building adaptability into facilities from the beginning can reduce future costs, improve operational agility, and support long-term commercial success.
Scaling Novel Therapies from Lab to Commercial Reality
A defining challenge in moving therapies from breakthrough to bedside is scaling innovative products to meet patient demand while maintaining quality, regulatory compliance, and supply continuity.
The session “Growing mAb Capacity in an Operating Commercial Facility” illustrates this challenge through the expansion of manufacturing capacity for the first US Department of Agriculture-approved monoclonal antibody treatment for canine parvovirus. The case study demonstrates how engineering, manufacturing, and quality teams worked together to increase production capacity while maintaining supply continuity, regulatory compliance, and inspection readiness.
Likewise, “Scaling PRINT® for High Dose Treprostinil Delivery” showcases the commercialization journey of Liquidia’s particle-engineering platform. What began as a novel research technology evolved into a commercially validated manufacturing platform supporting the US Food and Drug Administration-approved product YUTREPIA®. The presentation offers a rare look at the technical, operational, and regulatory milestones required to transform an innovative technology into a market-ready therapy.
Together, these examples reflect a broader reality across the industry. Scientific innovation must be accompanied by scalable manufacturing strategies, effective technology transfer, and operational excellence to achieve meaningful patient impact.
Strengthening Analytical and Manufacturing Foundations
Bringing innovative medicines to market also depends on robust analytical methods, laboratory infrastructure, and quality systems. Several sessions address these critical functions.
“Analytical Method Transfer for Biologics per USP <1224>” provides practical guidance for ensuring analytical procedures perform consistently across global laboratory networks. Using a risk-based framework aligned with regulatory expectations, attendees will learn strategies to maintain data integrity and product quality throughout the biologics lifecycle.
Meanwhile, “Process Modeling for Analytical Lab Sizing” highlights how dynamic simulation tools can improve facility planning and laboratory design. By linking process sampling strategies with laboratory capacity requirements, organizations can identify constraints early and make more informed investment decisions.
Additional insights come from presentations exploring cleaning validation challenges associated with antibody-drug conjugates and the application of advanced kinetic modeling to stability assessment. These sessions demonstrate how science-based decision-making can reduce risk, accelerate development timelines, and improve operational efficiency across the product lifecycle.
Navigating Emerging Modalities and Complex Supply Chains
The increasing diversity of therapeutic modalities is creating new challenges across manufacturing, logistics, and facility operations.
Radiopharmaceuticals, for example, present unique complexities due to short isotope half-lives, specialized handling requirements, and highly time-sensitive supply chains. In a session about radiopharmaceutical design considerations, experts from Arcadis and Exubrion Therapeutics examine how these factors influence facility design, operational risk management, and commercialization strategies.
The track also explores how organizations can address supply chain resilience while supporting emerging therapeutic platforms. Whether developing products for human or veterinary applications, companies must increasingly design systems that can accommodate evolving technologies, varying regulatory expectations, and growing market demand.
By examining real-world examples across modalities, attendees will gain valuable insight into how organizations are successfully navigating these challenges while maintaining quality, compliance, and operational efficiency.
Accelerating Patient Access Through Collaboration
A consistent message throughout the From Breakthrough to Bedside track is that successful commercialization depends on collaboration. Bringing innovative therapies to patients requires alignment among scientists, engineers, quality professionals, regulatory specialists, technology providers, and manufacturing teams.
The sessions within this track showcase how organizations are breaking down traditional silos to create integrated approaches that support faster development, greater scalability, improved quality, and enhanced patient access. Whether addressing automation in ATMP manufacturing, data-driven laboratory design, regulatory implementation of novel analytical technologies, facility strategies for emerging modalities, or innovative approaches to quality and control strategies, the focus remains the same: ensuring groundbreaking science can become accessible medicine.
As therapeutic innovation continues to expand across increasingly complex modalities, the ability to translate discovery into manufacturable, scalable, and globally available treatments will remain one of the industry's most important capabilities. The organizations that successfully connect scientific innovation with operational execution will be best positioned to deliver the next generation of life-changing therapies to patients around the world.
