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 20: 10:45 – 11:30 AM

INTENSIFIED & CONTINUOUS PROCESSING

BREAKOUT DISCUSSION: What Are the Remaining Technical Barriers Limiting the Widespread Adoption of More Sustainable Manufacturing?
Moderator: Philip Probert, PhD, Technology Lead, CPI, United Kingdom

  • Despite interest and demonstration of intensified and continuous platforms for biologics manufacturing, uptake remains low. 
  • What are the perceived risks in moving away from conventional batch-based processing for new products?
  • Will there ever be a sufficiently strong driver for moving approved drugs to more sustainable manufacturing approaches?
  • What further advice could regulators give to guide process developers and manufacturers to de-risk more complex production approaches?
  • Are we confident that product quality is sufficiently maintained in more complex production processes, and do we have right methods to show this?

BREAKOUT DISCUSSION: Process Intensification Strategies: What To Do When and Where in Your Product Lifecycle
Moderator: Stefan R. Schmidt, PhD, MBA, CEO, evitria AG

  • Early development: Increase speed and reduce material consumption
  • Late stage development: Maximize robustness
  • Commercial: Adapt to facility and reduce COGS

GENE THERAPY CMC AND ANALYTICS

BREAKOUT DISCUSSION: Formulation Strategies for Gene Therapies
Moderator: Kruti Soni, PhD, Scientist, Technical Development, Biogen

  • Formulation
  • Stability for Gene Therapies
  • Forced Degradation
  • Device Selection​

CELL THERAPY CMC AND ANALYTICS

BREAKOUT DISCUSSION: Potency Assays for Cell and Gene Therapies
Moderator: Diana Colleluori, PhD, MBA, Senior CMC Consultant, CMC Analytical, Biologics Consulting Group

  • ​Regulatory Expectations and Updates
  • Assay Development Across Product Lifecycle  
  • Standardization and Validation
  • Common Challenges

BREAKOUT DISCUSSION: Developing Successful Cell Therapies
Moderator: Scott R. Burger, Principal, Advanced Cell & Gene Therapy LLC

  • ​Latest FDA Guidance
  • Translating Science into Products
  • Target Product Profiles
  • Maintaining Quality Across Lifecycle

Accelerating Analytical Development

BREAKOUT DISCUSSION: Digitizing Historical Bioprocess Data: Challenges and Solutions
Moderator: Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, Biologics Consulting Group, Inc.

  • What methods are people using to convert written/non-electronic historical data into electronic data or formats that can be easily searched via electronic means?
  • What controls are in place to assure data integrity in the conversion of historical data to electronic formats
  • What is the scope of data transformation? Early development through commercial, or just PPQ and beyond, or??? Release and stability data only or in-process data?
  • Are you handling non-GMP data that is reported in filings in the same manner that you are handling GMP release/stability data?
  • What is the biggest hurdle to assimilating historical data?

BREAKOUT DISCUSSION: Turn Workflow Challenges into Data Science Projects
Moderator: Varsha Daswani, PhD, PMP, Senior Director, Data Strategy, Lumilytics

  • How would you summarize your workflow?
  • What are the major bottlenecks?
  • How could automation, data science, or AI eliminate these bottlenecks?
  • How to turn these ideas into a data science project

THURSDAY AUGUST 22: 9:30 – 10:30 AM

DIGITAL TRANSFORMATION & AI IN BIOPROCESS

BREAKOUT DISCUSSION: Post Model Establishment: Meaningfully Implementing Models in Process Development
Moderator: Terrence Dobrowsky, PhD, Head, Gene Therapy Drug Substance, Biogen

BREAKOUT DISCUSSION: Digital Bioprocessing and Industry 4.0: How Far along Are We?
Moderator: Mark Duerkop, CEO, Novasign GmbH
This interactive roundtable discussion will cover the following topics:

  • Critical evaluation of the current industrial evolution?
  • AI vs. mechanistic modeling: what to choose?
  • Workflow vs. data: where to invest?
  • Outlook—how AI will change the way of bioprocessing in the future?

BREAKOUT DISCUSSION: In-house vs Off-the-Shelf Solutions for a Digital R&D Ecosystem
Moderator: Victor Sanchez Tarre, PhD, Dir Data Science, Mfg Science & Technology, MeiraGTX

  • Factors to be considered when deciding on building an in-house software solution vs. off-the-shelf offerings
  • Tools to build a successful digital ecosystem—from specific code packages to ELN and data exploration platforms of choice
  • Infrastructure supporting the functions from Data Engineering like data capture, data storage, and ETL pipelines; to Data Science like model versioning, data exploration, and advanced analytics
  • Challenges—assay nomenclature harmonization, standardization of data capture and data processing workflows, and strategies to routinely generate FAIR data

 

ADVANCES IN PURIFICATION & RECOVERY

BREAKOUT DISCUSSION: Challenges and Opportunities in Membrane-Based Separations in Bioprocessing
Moderator: Jian Ren, PhD, Principal Scientist, AbbVie

  • ​​Membrane-based separation techniques are essential in bioprocessing to enable clarification, virus filtration, UFDF, and sterile filtration etc.
  • There is strong demand for high performance membrane-based separations for high cell density culture, high throughput viral filtration, and high concentration formulations
  • Opportunities also arise in using membrane-based techniques for novel modes of separation, such as membrane chromatography

BREAKOUT DISCUSSION: Alternative Approaches to Protein Affinity Chromatography
Moderator: Jean-Francois P. Hamel, PhD, Lecturer, Chemical Engineering, Massachusetts Institute of Technology

 

CELL THERAPY MANUFACTURING

BREAKOUT DISCUSSION: Process Development for TILs
Moderator: Kathryn L Aron, PhD, Director, Process Development, Obsidian Therapeutics, Inc.

  • Optimization of TIL Isolation and Expansion Techniques
  • Manufacturing for Commercial Use
  • Improving TIL Efficacy through Genetic Engineering​

BREAKOUT DISCUSSION: Promises and Challenges of Bioprocessing for PSC-Derived NK Cell Therapies
Moderator: Allen Qiang Feng, PhD, Founder and CSO, HebeCell Corp.

  • Advancements in PSC Differentiation Protocols 
  • Overcoming Scale-Up Challenges
  • Regulatory and Safety Considerations​

 

NEXT GENERATION ANALYTICAL METHODS

BREAKOUT DISCUSSION: Advancing Multi-Specific Molecules: Innovations and Challenges in Analytical Characterization
Moderator: Hirsh Nanda, PhD, Director, Analytical Sciences, Janssen

  • Discuss the various platforms used in designing multi-specific proteins
  • Identify common challenges faced in the engineering and development of these molecules
  • Current analytical methods 
  • Emerging technologies 
  • Stage-appropriate methods