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
Discussion Leaders: Peter Tessier (University of Michigan, United States) and Jessica Molek (GlaxoSmithKline, United States)
7:40 pm - 8:20 pm
Alison Moore (Allogene Therapeutics, United States)
"The Development of Novel Therapeutic Modalities: What’s Novel in Development"
8:20 pm - 8:35 pm
Discussion
8:35 pm - 9:15 pm
Satish Singh (Moderna, United States)
"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
Discussion Leaders: Gunasekaran Kannan (Nutcracker Therapeutics, United States) and Veysel Kayser (University of Sydney, Australia)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
Emily Makowski (University of Michigan, United States)
"Predicting Antibody Developability"
9:25 am - 9:35 am
Discussion
9:35 am - 9:55 am
Charlotte Deane (University of Oxford, United Kingdom)
"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
Laurence Fayadat- Dilman (Merck & Co., United States)
"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
Robert Thorne (Denali Therapeutics / University of Minnesota, United States)
"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
Anne De Groot (EpiVax, Inc., United States)
"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
3:00 pm - 4:00 pm
The GRC Power Hour™
The GRC Power Hour™ is designed to address challenges women face in science and issues of diversity and inclusion. The program supports the professional growth of all members of our communities by providing an open forum for discussion and mentoring.
Organizers: Jessica Molek (GlaxoSmithKline, United States) and Eva Chi (University of New Mexico, United States)
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
Discussion Leaders: Theodore Randolph (University of Colorado Boulder, United States) and Cenk Undey (AMGEN INC., United States)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
Christopher Calderon (Ursa Analytics, United States)
"Combining AI & High Throughput Digital Microscopy to Analyze and Monitor Biologics"
7:55 pm - 8:05 pm
Discussion
8:05 pm - 8:25 pm
Elif Bayrak (Amgen, United States)
"AI-Enabled Insights in Biopharmaceutical Process Development"
8:25 pm - 8:35 pm
Discussion
8:35 pm - 8:55 pm
Nathan Lewis (University of California, San Diego, United States)
"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
Peter Tessier (University of Michigan, United States)
"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
Discussion Leaders: Christina Alves (Biogen, United States) and Trent Munro (University of Queensland, Australia)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
Jennitte Stevens (Amgen, United States)
"Automation and Digital Tools for Cell Line and Bioprocess Development"
9:25 am - 9:35 am
Discussion
9:35 am - 9:55 am
Gavin Barnard (Genentech, United States)
"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
Brian Mickus (Gilead Sciences, Inc., United States)
"Expression Platform Development"
10:55 am - 11:05 am
Discussion
11:05 am - 11:25 am
Jie Zhu (Astrazeneca, United States)
"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
Scott Estes (Codiak Bio, United States)
"exoVACCTM : An Exosome-Based Vaccine Platform Targeting Infectious Disease and Cancer"
11:50 am - 12:00 pm
Discussion
12:00 pm - 12:20 pm
Christopher Love (Koch Institute at MIT, United States)
"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
Discussion Leaders: Tim Menzen (Coriolis Pharma, Germany) and William Weiss IV (Eli Lilly and Company, United States)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
Chad Paavola (Eli Lilly and Company, United States)
"Therapeutic Insulin: Safety and Efficacy Considerations"
7:55 pm - 8:05 pm
Discussion
8:05 pm - 8:25 pm
Keith Chappell (The University of Queensland, Australia)
"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
Vibha Jawa (Bristol Myers Squibb, United States)
"Immunogenicity Risk Assessments and Bioanalytical Considerations for Novel Biologics"
8:55 pm - 9:05 pm
Discussion
9:05 pm - 9:25 pm
Kevin Plaxco (University of California, Santa Barbara, United States)
"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
Discussion Leaders: Maria Monica Castellanos (GlaxoSmithKline, United States) and John Schardt (University of Michigan, United States)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:20 am
Aravinda Munasinghe (Harvard University, United States)
"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
Jennifer Nguyen (Regeneron Pharmaceuticals, United States)
"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
Jordan Berger (University of Delaware, United States)
"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
Erica Graff (Pennsylvania State University, United States)
"Screening Colloidal Protein Interactions in Crowding-Induced Phase Separation"
11:05 am - 11:15 am
Discussion
11:15 am - 11:30 am
Kendall Preston (University of Colorado Boulder, United States)
"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
Chelsea Marie Parrocha (University of California, Irvine, United States)
"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
Elisabet Bjanes (University of California San Diego, United States)
"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
Downstream Purification
Discussion Leaders: Mark Brower (Merck & Co., United States) and Todd Przybycien (Rensselaer Polytechnic Institute, United States)
7:30 pm - 7:50 pm
Raquel Aires-Barros (Instituto Superior Técnico, Portugal)
"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
Andrew Zydney (Penn State University, United States)
"Sterile Filtration of Live Attenuated Virus and Lipid Nanoparticle Vaccine"
8:20 pm - 8:30 pm
Discussion
8:30 pm - 8:50 pm
Rodney Combs (Pfizer, United States)
"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
John Erickson (NIIMBL, United States)
"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
Discussion Leader: Ping-Yang Yeh (AltruBio Taiwan, Inc., Taiwan)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
John Marino (National Institute of Standards and Technology, United States)
"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
Bruce Kerwin (Umoja Biopharma, United States)
"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
Alexander Kabanov (University of North Carolina at Chapel Hill, United States)
"Nanoformulations for Immuno-Chemotherapy of Cancer"
10:55 am - 11:00 am
Discussion
11:00 am - 11:20 am
Twinkle Christian (Amgen, United States)
"Challenges of Using Closed System Transfer Devices (CSTDs) with Biological Products"
11:20 am - 11:30 am
Discussion
11:30 am - 11:50 am
Sekhar Kanapuram (Jazz Pharmaceuticals Inc, United States)
"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
Veysel Kayser (University of Sydney, Australia)
"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
Discussion Leader: Ran Zhang (Landmark Bio, United States)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
Aravind Asokan (Duke University School of Medicine, United States)
"Engineering RNA and Viruses for Gene Therapy"
7:55 pm - 8:05 pm
Discussion
8:05 pm - 8:25 pm
Dan Kaufman (University of California, San Diego, United States)
"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
J Fraser Wright (Stanford University, United States)
"Intersection of Vector Design and Adverse Immune Responses: Humanizing rAAV Products"
8:55 pm - 9:05 pm
Discussion
9:05 pm - 9:25 pm
Edward Kwee (National Institute of Standards and Technology, United States)
"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