In-Person Breakout Discussions

Engage in in-depth discussions with industry experts and your peers about the progress, trends and challenges you face in your research! Interactive discussion groups play an integral role in networking with potential collaborators, provide an opportunity to share examples from your work, and be part of a group problem-solving endeavor.

These will take place IN-PERSON ONLY. Please check back for more!

Tuesday, August 19th: 10:45 – 11:30 AM

TABLE: AI-Empowering PAT and Continued Process Verification
Moderator: William Whitford, Founder, Oamaru BioSystems

What new analytics and monitoring tools are most increasing the amount of valuable process data?
What AI/ML-empowered tools are being employed to improve bioprocess development and control?
How is AI/ML involved in the third stage of process validation: continued process verification (CPV)?
What are the unique aspects of applying GAMP 5 to AI-empowered PAT tools in a GxP environment?

TABLE: Under What Situations Is Continuous Biomanufacturing Justified?

Moderator: Alois Jungbauer, PhD, Professor & Head, Biotechnology, Institute of Bioprocess Science and Engineering, BOKU University

Decision criteria business case: market size and dose of the product
Distributed versus centralized manufacturing
Stability of product and manufacturing complexity

TABLE: Translating Machine Learning into Predictive Tools for High-Concentration Antibody Viscosity: Opportunities and Bottlenecks
Moderator: Pin-Kuang Lai, PhD, Assistant Professor, Chemical Engineering and Materials Science, Stevens Institute of Technology

Data bottlenecks and model generalizability
Hybrid models: merging structure-based simulations with ML
Collaboration between formulation scientists and data scientists
Validation strategies and industrial deployment

TABLE: Commercializing Gene Therapies: Where Do We Go from Here?
Moderator: Francesca Vitelli, PhD, Former, VP, Cell Therapy & AAV Process Dev, Intellia Therapeutics Inc

Evaluate whether current gene therapy trial designs are optimized to demonstrate durable clinical benefit and value to payers.
Identify manufacturing challenges—including cost, scale, and consistency—that are slowing commercial success.
Explore gene therapy business models that begin with the end in mind: reimbursement, access, and lifetime value.
Unpack investor perceptions of gene therapy risk and how strategic clarity can reshape confidence and capital flow.

TABLE: Protecting Patient and Donor Data Privacy in the Age of Comprehensive Data Sets and AI
Moderator: Kat Kozyrytska, Founder, Cell Therapy Manufacturability Program

Define benefits of integrative analysis of healthcare, digital health, and CMC data (improving efficacy through precision medicine, decreasing healthcare costs through companion diagnostics etc)
Outline risks to patients and donors (data reidentification, comprehensive LLMs, sales to 3rd parties etc)
Define stakeholder set (patient/donor advocacy organizations, pharma/biotech etc)
Discuss requirements for ethical LLMs/Agentic AI (confidentiality, accountability, integrity, compliance, competence etc)

TABLE: Downstream Process Development of RNA and Oligonucleotides
Moderator: Ratnesh Joshi, Associate Director, Downstream Process Development, Editas Medicine

Examine the evolving purification challenges for RNA and oligonucleotide therapeutics, including impurity profiles and product heterogeneity
Compare platform strategies versus molecule-specific solutions in downstream development.
Highlight key technologies—such as chromatography, TFF, and enzymatic treatments—advancing purification efficiency and scalability
Explore regulatory expectations and process validation considerations for RNA and oligo manufacturing

TABLE: Stability Predictive Modeling and Quality by Design (QbD) in Drug Development
Moderator: Jiewei Wu, PhD, Principal Scientist, Formulation Development, Regeneron Pharmaceuticals

Enhancing protein production processes and manufacture through stability modeling and quality by design (QbD): recent advancements in stability modeling and quality by design have significantly improved protein production processes. These developments encompass a range of techniques including predictive stability modeling, Quality by Design (QbD), and pertinent analytical testing, and regulatory guidance and expectations.

Explore the practical opportunities and challenges of applying predictive modeling based on the Arrhenius equation, utilizing short-term data for long-term stability prediction. Share insights on the application of stability predictive models at different clinical phases and their role in accelerating drug product development.
Discuss the recent revisions to the ICH Q1E/Q5C guidelines that encompass the alternative modeling tools for shelf-life determination and discuss their impact on stability assessments.
Identify and explore the challenges associated with implementing predictive modeling in drug development, with a particular focus on phase-appropriate application criteria and regulatory acceptance.
Discuss the application of QbD approaches in formulation, analytical and process development, with a focus on practical challenges and solutions.
Identify and discuss the challenges faced in applying QbD in drug product development and manufacturing, including integration with existing processes and regulatory compliance.

TABLE: Challenges and Recent Advancements in Formulation Development for Biologics
Moderator: Kruti Soni, PhD, Scientist, Technical Development, Biogen

High and low concentration formulation development – how to cover the clinical dose range?
In-use stability – temperature and hold time expectations
Forced degradation study design
Device selection – interplay between formulation and device functionality, especially for viscous products

Data bottlenecks and model generalizability
Hybrid models: merging structure-based simulations with ML
Collaboration between formulation scientists and data scientists
Validation strategies and industrial deployment

Thursday, August 21st: 9:30 – 10:30 AM

TABLE: Using Modeling to Improve Process Optimization/Understanding, CQAs and Technology Transfer for Upstream Bioprocessing
Moderator: Chadakarn Sirasitthichoke, PhD, Process Engineer, MS&T Process Analytics and Engineering, Bristol Myers Squibb Co.

TABLE: Media and Feed Strategy Optimization
Moderator: Jianfa Ou, PhD, Principal Scientist, Evonik Corporation
The design of cell culture media and feeding strategies continues to evolve as the industry advances toward more intensified and robust bioprocesses. The growing demand to produce complex molecules and novel modalities introduces additional layers of complexity. This roundtable discussion provides a platform to openly share challenges related to media formulation and feeding strategies, as well as successful optimization approaches. It also serves as a forum for brainstorming innovative ideas and compiling a wish list for future technological or material advancements.

TABLE: Beyond Chromatography: Exploring Metal-Induced Aggregation for Efficient Protein Purification
Moderator: Khai Wooi Jason Lee, PhD, Senior Lecturer, School of Biosciences, Taylors University

Rethinking purification: How metal-induced aggregation simplifies protein recovery by reducing reliance on chromatography.
Efficiency vs purity: Comparing aggregation-based methods with traditional techniques like IMAC. Where does it excel, and what are the trade-offs?
Scalability & industrial applications: Can this approach be adapted for large-scale bioprocessing and high-yield protein recovery?
Future perspectives: What advancements are needed to make metal-induced aggregation a mainstream purification strategy?

TABLE: Navigating the Digital Future
Moderator: Kristina Lopez, Senior Director, Analytical Operations, BioTherapeutics Development & Supply, Johnson and Johnson Innovative Medicine
Navigating the digital future in bioprocessing involves integrating advanced analytics, automation, and AI to optimize production, enhance quality control, and accelerate decision-making. As digital tools become central to biomanufacturing, companies must adapt by upskilling their workforce and modernizing infrastructure to remain competitive and compliant.

TABLE: Addressing Workforce Gaps: Cross-Sector Collaboration, Targeted Training Programs, and Global Talent Mobility
Moderator: Jason Beckwith, PhD, Professor, School of Business, University of Dundee

Cross-Sector Collaboration: Foster partnerships between academia, industry, and government to align skills development with bioprocessing needs.
Targeted Training Programs: Develop specialized education and upskilling initiatives to equip workers with the latest digital and AI-driven biomanufacturing skills.
Global Talent Mobility: Streamline policies and initiatives to attract and retain skilled professionals worldwide, ensuring a diverse and adaptable workforce.

TABLE: Evaluating Potency for Multispecific Molecules
Moderator: Theresa O'Brien, Scientist, Sanofi

What methods does industry use in general to evaluate the multispecific molecule?
Is efficiency for release testing a consideration?
Regulatory feedback on strategy employed to evaluate potency of multispecifics; dual binding approach for bispecifics feedback discussions
Regulatory expectations around cell-based vs binding potency: Has any company managed to replace the cell-based w/binding for novel modalities?

TABLE: QC of ADCs in Discovery: First Batch to First Dose
Moderator: John "Jack" Kellie, PhD, Group Director, Integrated Bioanalysis, AstraZeneca

What testing of ADC reference materials helps ensure meaningful outcomes from early in-life studies?
Role of serum stability for ADCs
1st dosed-study: In-life stability, in-life PK, or both?
Thresholds and characterizations of free payload in early discovery ADC reference material

TABLE: Best Practices in Viral Vector Scale-up and Working with CDMOs
Moderator: Nesredin A. Mussa, PhD, President, Dynamica Biologics

Outline critical factors in scaling viral vector production for clinical and commercial applications.
Share strategies for building strong, efficient partnerships with CDMOs to support development goals.
Address common challenges in tech transfer and approaches to streamline the scale-up process.
Highlight emerging technologies and process innovations driving improvements in yield and robustness

TABLE: In Vivo CAR T: The Next Frontier for Cell and Gene Therapies?
Moderator: Francesca Vitelli, PhD, Former, VP, Cell Therapy & AAV Process Dev, Intellia Therapeutics Inc

Examine the limitations of ex vivo CAR T manufacturing and why in vivo approaches are gaining traction.
Explore current delivery platforms—from viral vectors to lipid nanoparticles—enabling in vivo CAR T cell generation.
Address CMC considerations unique to in vivo CAR T, including vector characterization, dosing precision, and release testing.
Discuss the regulatory, safety, and scalability challenges that must be overcome to bring in vivo CAR T therapies to patients.

TABLE: Commercializing Cell Therapies
Moderator: Bharathi Vellalore, PhD, Senior Manager, Drug Product Development and Delivery, Johnson and Johnson Innovative Medicine

Explore the late-stage drug product development challenges unique to cell therapies, from harvest through infusion
Discuss strategies for effective technology transfer across multiple manufacturing sites
Address key considerations in scaling up and standardizing processes to meet commercial demands
Examine the integration of supply chain planning with clinical and commercial production goals