Sunday
2:00 pm - 9:00 pm
Arrival and Check-in
6:00 pm - 7:00 pm
Dinner
7:30 pm - 7:40 pm
Introductory Comments by GRC Site Staff / Welcome from the GRC Chair
7:40 pm - 9:30 pm
Keynote Session: The Future of Vaccines and Biotherapeutics Development
7:40 pm - 8:20 pm
"The Development of Novel Therapeutic Modalities: What’s Novel in Development"
8:20 pm - 8:35 pm
Discussion
8:35 pm - 9:15 pm
"mRNA-Based Vaccine Development"
9:15 pm - 9:30 pm
Discussion
Monday
7:30 am - 8:30 am
Breakfast
8:30 am - 9:00 am
Group Photo
9:00 am - 12:30 pm
Therapeutic Engineering and Optimization
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
"Predicting Antibody Developability"
9:25 am - 9:35 am
Discussion
9:35 am - 9:55 am
"Using Antibody Structure and Machine Learning to Improve Biotherapeutics"
9:55 am - 10:05 am
Discussion
10:05 am - 10:40 am
Coffee Break
10:40 am - 11:00 am
"Predicting Antibody Developability Profiles Through Early Stage Discovery Screening: Experimental Assessment, Correlations, and Computational Predictions"
11:00 am - 11:10 am
Discussion
11:10 am - 11:30 am
"Antibody and Enzyme Transport Vehicles: Engineering Macromolecule Delivery Across the Blood-Brain Barrier"
11:30 am - 11:40 am
Discussion
11:40 am - 12:00 pm
"Why Not Develop Personalized Vaccines for the Next Pandemic? Yes, We Can."
12:00 pm - 12:10 pm
Discussion
12:10 pm - 12:30 pm
General Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
AI and Big Data in Development and Manufacturing
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
"Combining AI & High Throughput Digital Microscopy to Analyze and Monitor Biologics"
7:55 pm - 8:05 pm
Discussion
8:05 pm - 8:25 pm
"AI-Enabled Insights in Biopharmaceutical Process Development"
8:25 pm - 8:35 pm
Discussion
8:35 pm - 8:55 pm
"Hybrid Machine Learning and Genome-Scale Mechanistic Models for Studying Mammalian Bioprocesses"
8:55 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
"Big Data for Protein Engineering"
9:20 pm - 9:30 pm
Discussion
Tuesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Cell Culture and Expression
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
"Automation and Digital Tools for Cell Line and Bioprocess Development"
9:25 am - 9:35 am
Discussion
9:35 am - 9:55 am
"The Power of Targeted Integration"
9:55 am - 10:05 am
Discussion
10:05 am - 10:35 am
Coffee Break
10:35 am - 10:55 am
"Expression Platform Development"
10:55 am - 11:05 am
Discussion
11:05 am - 11:25 am
"More is Not Always Better – Regulating Recombinant Gene Expression for Biotherapeutic Protein Production"
11:25 am - 11:30 am
Discussion
11:30 am - 11:50 am
"exoVACCTM : An Exosome-Based Vaccine Platform Targeting Infectious Disease and Cancer"
11:50 am - 12:00 pm
Discussion
12:00 pm - 12:20 pm
"The Power of ‘And’…Engineering Next-Generation Hosts for Biologics"
12:20 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Properties of Biologics Impacting Safety and Efficacy
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
"Therapeutic Insulin: Safety and Efficacy Considerations"
7:55 pm - 8:05 pm
Discussion
8:05 pm - 8:25 pm
"Rapid Response Development of Pre-Fusion Stabilized Viral Subunit Vaccines with the Molecular Clamp Platform"
8:25 pm - 8:35 pm
Discussion
8:35 pm - 8:55 pm
"Immunogenicity Risk Assessments and Bioanalytical Considerations for Novel Biologics"
8:55 pm - 9:05 pm
Discussion
9:05 pm - 9:25 pm
"Counting Molecules, Dodging Blood Cells: Continuous, Real-Time Measurements of Therapeutics and Biomarkers Directly in the Living Body"
9:25 pm - 9:30 pm
Discussion
Wednesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Early-Career Investigator Presentations
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:20 am
"Computational Guided Antigen Designs to Create Immune Response for Highly Conserved Epitopes Within the Spike Protein"
9:20 am - 9:30 am
Discussion
9:30 am - 9:45 am
"Rapid Development of a SARS-CoV-2 Antibody Cocktail Therapeutic During a Global Pandemic"
9:45 am - 9:55 am
Discussion
9:55 am - 10:10 am
"Application of High-Pressure and Sub-Zero Temperature to Gain Insights into Unfolding and Aggregation for MAbs and Their Fragments"
10:10 am - 10:20 am
Discussion
10:20 am - 10:50 am
Coffee Break
10:50 am - 11:05 am
"Screening Colloidal Protein Interactions in Crowding-Induced Phase Separation"
11:05 am - 11:15 am
Discussion
11:15 am - 11:30 am
"Lyophilized Filovirus Glycoprotein Vaccines: Peroxides in a Vaccine Formulation with Polysorbate 80-Containing Adjuvant Lower Neutralizing Antibody Titers in both Mice and Non-Human Primates"
11:30 am - 11:40 am
Discussion
11:40 am - 11:55 am
"Antibodies Generated Against an Aß-Derived Oligomer: Efforts Toward a Novel Alzheimer's Disease Immunotherapy"
11:55 am - 12:05 pm
Discussion
12:05 pm - 12:20 pm
"Nanoparticle Vaccine Protects Against A. baumannii Sepsis and Pneumonia"
12:20 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:00 pm - 7:30 pm
Business Meeting
Nominations for the Next Vice Chair; Fill in Conference Evaluation Forms; Discuss Future Site and Scheduling Preferences; Election of the Next Vice Chair
7:30 pm - 9:30 pm
7:30 pm - 7:50 pm
"Aqueous Two-Phase Systems: A Disruptive Approach to Downstream Processing of Biologicals"
7:50 pm - 8:00 pm
Discussion
8:00 pm - 8:20 pm
"Sterile Filtration of Live Attenuated Virus and Lipid Nanoparticle Vaccine"
8:20 pm - 8:30 pm
Discussion
8:30 pm - 8:50 pm
"Leveraging mRNA Platform Technologies to Enable Pandemic Supply of COVID-19 Vx"
8:50 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
"A Shared Vision and Collaboration to Transform Biopharmaceutical Manufacturing: The First Steps"
9:20 pm - 9:30 pm
Discussion
Thursday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Formulation, Drug Product and Delivery
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
"NMR Approaches for Objective, Automated HOS Assessment of Formulated mAbs and Beyond"
9:25 am - 9:35 am
Discussion
9:35 am - 9:55 am
"Development of a Lentivirus DP for In Vivo Delivery"
9:55 am - 10:05 am
Discussion
10:05 am - 10:35 am
Coffee Break
10:35 am - 10:55 am
"Nanoformulations for Immuno-Chemotherapy of Cancer"
10:55 am - 11:00 am
Discussion
11:00 am - 11:20 am
"Challenges of Using Closed System Transfer Devices (CSTDs) with Biological Products"
11:20 am - 11:30 am
Discussion
11:30 am - 11:50 am
"Challenges and Opportunities in Development of IV to Sub-Q Conversion of Biotherapeutics"
11:50 am - 12:00 pm
Discussion
12:00 pm - 12:20 pm
"Can We Stabilize Monoclonal Antibodies Against Aggregation?"
12:20 pm - 12:30 pm
Discussion
12:30 pm - 1:30 pm
Lunch
1:30 pm - 4:00 pm
Free Time
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Novel Therapeutic Modalities
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
"Engineering RNA and Viruses for Gene Therapy"
7:55 pm - 8:05 pm
Discussion
8:05 pm - 8:25 pm
"Engineering Human Pluripotent Stem Cells to Produce Immune Cells with Improved Anti-Tumor Activity"
8:25 pm - 8:35 pm
Discussion
8:35 pm - 8:55 pm
"Intersection of Vector Design and Adverse Immune Responses: Humanizing rAAV Products"
8:55 pm - 9:05 pm
Discussion
9:05 pm - 9:25 pm
"Advanced Cell Imaging Reveals Dynamics and Heterogeneity of Viral Vector Therapeutic Function"
9:25 pm - 9:30 pm
Discussion
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure