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, USA) and Jessica Molek (GlaxoSmithKline, USA)
7:40 pm - 8:20 pm
Alison Moore (Allogene Therapeutics, USA)
"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, USA)
"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, USA) and Veysel Kayser (University of Sydney, Australia)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:25 am
Amanda Rohrbach (Just Evotec Biologics, USA)
"AI Enabled Strategies for Rapid Pandemic Response"
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., USA)
"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, USA)
"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., USA)
"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, USA) and Eva Chi (University of New Mexico, USA)
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, USA) and Cenk Undey (AMGEN INC., USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
Christopher Calderon (Ursa Analytics, USA)
"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, USA)
"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, USA)
"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
Late-Breaking Topic
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, USA) 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, USA)
"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, USA)
"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., USA)
"Expression Platform Development"
10:55 am - 11:05 am
Discussion
11:05 am - 11:25 am
Jie Zhu (Astrazeneca, USA)
"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, USA)
"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, USA)
"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, USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
Chad Paavola (Eli Lilly and Company, USA)
"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, USA)
"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, USA)
"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, USA) and John Schardt (University of Michigan, USA)
9:00 am - 9:05 am
Introduction by Discussion Leader
9:05 am - 9:20 am
Short Talk Selected from Poster Abstracts
9:20 am - 9:30 am
Discussion
9:30 am - 9:45 am
Short Talk Selected from Poster Abstracts
9:45 am - 9:55 am
Discussion
9:55 am - 10:10 am
Short Talk Selected from Poster Abstracts
10:10 am - 10:20 am
Discussion
10:20 am - 10:50 am
Coffee Break
10:50 am - 11:05 am
Short Talk Selected from Poster Abstracts
11:05 am - 11:15 am
Discussion
11:15 am - 11:30 am
Short Talk Selected from Poster Abstracts
11:30 am - 11:40 am
Discussion
11:40 am - 11:55 am
Short Talk Selected from Poster Abstracts
11:55 am - 12:05 pm
Discussion
12:05 pm - 12:20 pm
Short Talk Selected from Poster Abstracts
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., USA) and Todd Przybycien (Rensselaer Polytechnic Institute, USA)
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, USA)
"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, USA)
"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, USA)
"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, USA)
"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, USA)
"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, USA)
"Nanoformulations for Immuno-Chemotherapy of Cancer"
10:55 am - 11:00 am
Discussion
11:00 am - 11:20 am
Twinkle Christian (Amgen, USA)
"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, USA)
"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
Late-Breaking Topic
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, USA)
7:30 pm - 7:35 pm
Introduction by Discussion Leader
7:35 pm - 7:55 pm
Aravind Asokan (Duke University School of Medicine, USA)
"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, USA)
"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, USA)
"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, USA)
"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