Agenda March 18, 2027: Main Conference Day Two - PT (Pacific Time, GMT-08:00)
A major opportunity to reduce CLD timelines lies in reducing manual effort and improving screening efficiency. This session will examine high-throughput clone screening, automation, data-rich selection workflows, and the use of smarter decision frameworks to reduce experimental burden. It also creates a natural home for practical digital and AI-enabled CLD workflows.
As portfolios shift toward more complex molecules, companies are rethinking how far CLD standardization can stretch. This panel will explore where platform approaches still create major speed advantages, where they begin to fail, and how teams decide when to customize.
This session will focus on intensified seed trains, hybrid formats, high-density cell culture, and the consequences intensification creates for control, monitoring, harvest, and downstream fit. Talks should emphasize what is truly working now.
End-to-end continuous case studies remain limited and that simply linking batch steps is not always true next-generation downstream. This session will move beyond aspiration and examine where connected or semi-continuous DSP has created value and where redesign is still needed.
This panel will focus candidly on the areas where downstream still lacks the breakthrough technologies the industry wants, especially around harvest, membrane performance, high-throughput DSP, and high-concentration handling.
Fragmented knowledge flow slows everything down. This session will focus on how organizations structure data, documentation, templates, governance, and cross-functional visibility so that prior work becomes reusable and CMC execution becomes faster and less fragile.
This panel will examine when outsourcing genuinely saves time, when it creates hidden coordination burdens, and how sponsor oversight models need to evolve — including how onshoring pressure and shifting manufacturing footprints (in reaction to evolving trade policy and data/technology security requirements) are changing where companies choose to place development and manufacturing work.
There is growing interest in mRNA, plasmids, oligonucleotides, circular RNA, and LNP-enabled therapies when framed as real manufacturing and CMC topics. This session will cover production, purification, characterization, and end-to-end manufacturing opportunities for nucleic-acid-based products.
For advanced therapies, especially patient-specific products, process success extends far beyond the unit operation. This panel will frame supply chain through the lens of data, visibility, chain of identity, chain of custody, and end-to-end operational readiness.
CLD performance increasingly depends on how organizations balance scientific depth, speed, platform leverage, and cross-functional alignment. This session will focus on team design, investment choices, and workflow structures that help CLD organizations accelerate without compromising quality or manufacturability. It is designed to attract directors and heads of development.
One of the clearest ways to reduce development timelines is to reduce the experimental burden required to reach confident process decisions. This session will focus on high-throughput upstream platforms, automation, smarter experimental design, and the use of prior knowledge to shorten development cycles while preserving process understanding.
Speed comes from smarter early DSP decisions, not just faster lab work. This session will focus on phase-appropriate purification strategy, process fit for later stages, and how teams can move rapidly without creating expensive redesigns or comparability pain later.
Late-stage and commercial pain often originates much earlier in development than companies admit. This session will focus on launch supply, shelf life, specification strategy, process robustness, site fit, and profitability while programs are still evolving.
Cost of goods and commercial viability are critical for cell therapy and gene therapy success. This session will address whether current manufacturing models can support scalable, profitable products and which manufacturing changes matter most.
As development timelines compress, cell line development teams are being asked to make earlier decisions with greater downstream consequences. This session will focus on clone selection, stability assessment, developability screening, and early product-quality evaluation to reduce risk before molecules move deeper into process development. Talks will show how earlier insight can prevent late-stage rework and manufacturability issues.
Senior leaders are increasingly asking not only how to move faster, but how to do so with fewer manual steps and less scientist touch time. This session will focus on organizational and technology strategies for reducing effort while increasing output and confidence in upstream development.
There is a technology gap in high-throughput downstream processing compared with upstream tools. This session will focus on where DSP automation is still lagging, what capabilities are most needed, and how better automation could reduce development burden and improve process decision-making.
Comparability and validation have been identified as major rate-limiting steps that often receive too little practical conference attention. This session will focus on how comparability strategy changes by phase, when process changes are worth the burden they create, and how validation and qualification decisions affect flexibility later — including how evolving ICH Q2(R2)/Q14 guidance on analytical procedures and model-based stability is changing what's possible, and what biosimilar programs can teach originator programs about built-in comparability flexibility.
This session will focus on the strategic choices organizations must make to scale advanced modalities more effectively, including platform maturity, manufacturing fit, raw materials strategy, process standardization, and value chain design. It should be practical and business-aware.
As pipelines become more complex, leaders need to determine how CLD organizations should evolve to support speed, manufacturability, and long-term competitiveness. This session will connect molecule trends with organizational and technology investment decisions.
This session will focus on how upstream organizations need to evolve in team design, capabilities, investments, and cross-functional integration to support faster development and stronger manufacturing performance. It will connect process science to long-term organizational strategy.
This session will connect the technical content of the track to longer-horizon portfolio and capability decisions. As pipelines diversify, leaders need to decide how much to standardize, where to specialize, and which DSP capabilities and technologies to invest in next.
This session will move from individual bottlenecks to organizational design. Acceleration is an operating model problem as much as a technical one, and this session will examine governance, cross-functional accountability, staged investment, and decision rights across CMC, regulatory, and manufacturing organizations.
This session will shift the conversation from individual process problems to portfolio-level decisions. The advanced modality landscape is evolving quickly, but investment appetite has become more selective, making manufacturability, economics, and regulatory path central to decision-making.