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.

Tuesday, August 11th | 5:40 – 6:30 pm

Cell Line Development & Engineering

TABLE 1: AI in Cell Line Development - Enhancing Expression and Manufacturability of CHO Cells
Moderator: Susan Sharfstein, PhD, Professor of Nanoscale Science and Engineering, University at Albany
Location: Contemporary

  • Predictive clone selection and productivity modeling
  • AI-guided genetic engineering of CHO cells
  • Linking cell line genotype to manufacturability
  • Building robust training data: integrating CLD, bioprocess and developability data

Formulation Stability & Delivery

TABLE 2: Emerging Drug Delivery Technologies and Devices, including Patient-Centric and 3D-Printed Systems
Kruti Soni, PhD, Senior Scientist, Biologics Drug Product Development, Biogen
Location: Ensemble E

  • Convergence of high-concentration biologics and device innovation
  • Patient-centric delivery paradigms beyond self-injection
  • 3D printing and additive manufacturing for personalized drug delivery
  • Smart and adaptive drug delivery systems
  • Translation to clinic: challenges due to system complexity at both technical and regulatory level

Intensified & Continuous Bioprocessing

TABLE 3: End-to-End Continuous Bioprocess and Integrated Facility Design
Moderator: William Whitford, Founder, Oamaru BioSystems
Location: Ensemble F

  • Fully continuous bioprocessing: current perspectives on end-to-end continuous as a goal for bioprocessing operations
  • Facility design philosophy: suite optimization for continuous operation versus modular, flexible architectures enabling alterable or hybrid deployments
  • Holistic process/facility co-design: integration of continuous unit operations with new manufacturing modalities, facility infrastructures, and emerging equipment control platforms 
  • Adoption challenges: technical, organizational, and regulatory barriers to continuous manufacturing and recent advanced modeling, control, and automations
TABLE 4: Fed-batch vs Perfusion Systems in Upstream Processing
Moderator: Jin Guo, Principal Scientist, Gilead Sciences Inc.
Location: Ensemble F
  • When is perfusion worth the pain? Which non-negotiable breakpoints force the move from fed-batch to N-1 perfusion, production perfusion, or true continuous manufacturing—and where should teams stop?
  • Platform or exception? Is perfusion a disciplined strategy—or a rescue tool for problematic molecules?
  • GMP reality check: which failures only show up at scale, and what did readiness—not science—break first?
  • Real value or complexity shift? Does perfusion truly buy speed and COGs, or just move risk elsewhere?

Analytical Intelligence

TABLE 5: Designing Protein Therapeutics with Developability in Mind: Bridging Early Molecular Insights to CMC Outcomes
Moderator: Krishna D. Bharadwaj Anapindi, PhD, Senior Scientist, Biology, Gilead Sciences Inc.
Location: Ensemble G

  • Incorporating developability considerations early in discovery, including identifying risks related to aggregation, hydrophobicity, viscosity, stability, and expression before nomination
  • Navigating trade-offs between functional performance and molecular robustness, particularly in advanced formats such as bispecific antibodies and antibody drug conjugates (ADCs)
  • Leveraging predictive and high-throughput approaches, including computational tools and machine learning, alongside biophysical screening to inform candidate selection
  • Linking early-stage molecular assessment with downstream manufacturing considerations, including implications for purification, formulation, and scalability
  • Establishing practical, stage-appropriate criteria for progressing candidates that balance efficacy, safety, and developability

Oligonucleotide and Peptide CMC and Manufacturing

Table 6: CMC Strategies for Oligonucleotide and Conjugated Therapies
Moderator: Robert Dream, PhD, Managing Director, HDR Co. LLC
Location: Modern

  • Discuss the unique CMC challenges associated with oligonucleotide therapeutics and emerging conjugated modalities, including antibody oligonucleotide conjugates
  • Explore critical considerations for synthesis, conjugation, purification, and analytical characterization
  • Highlight strategies to control product quality, impurity profiles, potency, stability, and batch consistency
  • Examine how evolving regulatory expectations are shaping CMC development for increasingly complex oligonucleotide-based therapies