Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated. For virtual attendees, the format will be in an online networking platform. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing.
TUESDAY, AUGUST 17 | 4:45 - 5:45 PM EDT
DISCUSSION TOPIC: Impact of Omics, Bioinformatics and Emerging Technologies on CHO Cell Line Stability and Development
Derrick C. Scott, PhD, Associate Professor, Bioinformatics and Executive Director, DSU Molecular Diagnostics Laboratory, Delaware State University
DISCUSSION TOPIC: Novel Approaches in Continuous Biologics Processing
Ehsan Mahdinia, PhD, Assistant Professor, Stack Family Center for Biopharmaceutical Education & Training, Albany College of Pharmacy & Health Sciences
DISCUSSION TOPIC: Advances in Process Analytical Technology (PAT) for Therapeutic Protein and Cell/Gene Therapy Development and Manufacturing
Danny K. Chou, PharmD, PhD, President, Biopharmaceutical Characterization and Formulation Development, Compassion BioSolution, LLC
- What is the role of PAT in the biopharmaceutical industry? How does this role differ between protein pharmaceutical development/manufacturing and Advanced Medicinal Products like gene therapy and cell therapy?
- What are some of the critical quality attributes that can be monitored by real-time methods and what the key gaps that remain unfulfilled?
- What can we do to make PAT more efficient and easy to implement in the real world?
DISCUSSION TOPIC: Gene Therapy Analytics
Victor Chen, Principal Scientist, Regenxbio
- Common challenges in gene therapy technical development
- Analytical strategies
- Emerging technologies
DISCUSSION TOPIC: Future of Vaccine Development and Manufacturing
George Robertson, PhD, CSO, Cambra Consulting, Inc.
- Supplying vaccines in a pandemic
- Emerging trends in vaccine development
- Manufacturing networks, collaborating across industry
DISCUSSION TOPIC: Selection of Analytical Methods for Host Cell Proteins
Hui Xiao, Senior Staff Scientist, Regeneron Pharmaceuticals, Inc.
- Since so many different methods for analyzing HCP have been developed, what is best/preferred method? And what is the coverage and sensitivity of each different HCP analysis method?
- Is it necessary to develop a universal targeted method to quantitate all problematic HCPs?
- What would be the strategy for absolute quantitation of HCP? How should we quantitate the low abundance ones with biological activity?
- Is it necessary to monitor individual HCPs for all in-process samples? If so, can the clearance map guide the purification process?
- Is it necessary to include a reference standard to control method repeatability? If so, what would be the criteria for choosing a reference standard?
THURSDAY, AUGUST 19 | 10:30 - 11:30 AM EDT
(11:00 - 11:45 AM EDT) DISCUSSION TOPIC: Pushing the Envelope in Bioprocess Development – From Disposables, Continuous Manufacturing to Bioprocessing-in-a-Container
David W. Wood, PhD, Professor, Chemical & Biomolecular Engineering, The Ohio State University
- What cutting edge technologies are likely to change the industry in the next 10 years?
- What sorts of big ideas have been enabled by these new technologies, beyond the obvious applications?
- What problems are likely to remain, which will require additional disruptive innovations to solve?
- How can a company balance vision with risk when making bold steps ahead?
DISCUSSION TOPIC: Future Challenges in Gene Therapy Manufacturing
Meisam Bakhshayeshi, PhD, Director, Process Development, Tessera Therapeutics
- Current challenges in gene therapy development
- Increasing yields
- Platform development
- Future developments, new modalities
DISCUSSION TOPIC: Staging for Commercialization – Navigating the Transition from Development
Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair & Global Head, Cell Therapy, HemaCare Corp.
- Manufacturing trends and commercial considerations
- CMC challenges
- Emerging cell types
DISCUSSION TOPIC: Impurities in Biologics
Sunny Zhou, PhD, Professor, Chemistry & Chemical Biology, Northeastern University
- What are the emerging issues and problems in your area?
- What specific individual HCPs have gained a deeper understanding of in the past years?
- What specific individual HCPs are still lacking in understanding but should be prioritized?
- What are the new features for new modalities such as gene therapy?
DISCUSSION TOPIC: Analytical Strategies to Support Advancement of New Technologies
Elena A. Smith, PhD, Deputy Director Quality Analytical Expert, Quality, Sanofi Pasteur
- Consideration during life cycle management of analytical methods
- New analytical methods vs established traditional methods
- Alternative methods and alternative reference material
Additional Interactive Discussions to be Announced