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 Staff / Welcome and Introduction from the Chairs
7:40 pm - 9:30 pm
Keynote Session: The Future of Biotherapeutics and Vaccines Development
Discussion Leaders: Linda Narhi (Consultant, Biophia Consulting Group, United States) and Michael Tarlov (National Inst of Standards & Technology, United States)
7:40 pm - 7:45 pm
Introduction by Discussion Leader
7:45 pm - 8:10 pm
Drew Weissman (university of pennsylvania, United States)
"Nucleoside Modified mRNA-LNP Therapeutics"
8:10 pm - 8:20 pm
Discussion
8:20 pm - 8:45 pm
Ann Lee (Prime Medicine, United States)
"Building Modular Manufacturing Technology Platforms to Rapidly Translate Prime Editing into Genomic Medicines"
8:45 pm - 8:55 pm
Discussion
8:55 pm - 9:20 pm
Peter Marks (US Food and Drug Administration, United States)
"Regulatory Tools Facilitating the Development of Rare Disease Gene Therapy"
9:20 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: Marissa Mock (Amgen, United States) and Jennifer Maynard (University of Texas at Austin, United States)
9:00 am - 9:20 am
George Georgiou (University of Texas, Austin, United States)
"Biochemical and Biophysical Properties of Circulating Human Antibodies Elicited by Infection or Vaccination"
9:20 am - 9:30 am
Discussion
9:30 am - 9:50 am
Suzanne Edavettal (Amgen, United States)
"New Technologies Fuel the Next Wave of Innovation in Therapeutic Protein Engineering"
9:50 am - 10:00 am
Discussion
10:00 am - 10:20 am
Jamie Spangler (Johns Hopkins University, United States)
"Redirecting the Specificity of Tripartite Motif Containing-21 Scaffolds for Targeted Protein Degradation"
10:20 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:20 am
Sarel Fleishman (Weizmann Institute of Science, Israel)
"One-Shot Optimization of Therapeutic Antibodies, Enzymes, and Vaccines by Computational Design"
11:20 am - 11:30 am
Discussion
11:30 am - 11:50 am
Qing Chai (Lilly, United States)
"Accelerating Antibody Discovery and Engineering Through Integrated Computational Approaches"
11:50 am - 12:00 pm
Discussion
12:00 pm - 12:20 pm
Possu Huang (Stanford University, United States)
"A Novel Platform for Multimodal Antigen-focused Targeting of MHC"
12:20 pm - 12:30 pm
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 diversity and inclusion in the scientific workplace by providing a safe environment for informal and meaningful conversations amongst colleagues of all career stages. The program supports the professional growth of all members of our communities, including ethnicity, race and/or gender identity by providing an open forum for discussion and mentoring.
Organizer: Jennitte Stevens (Amgen, United States)
4:00 pm - 6:00 pm
Poster Session
6:00 pm - 7:00 pm
Dinner
7:30 pm - 9:30 pm
Cell Culture and Expression
Discussion Leaders: Anne Robinson (Carnegie Mellon University, United States) and Scott Estes (Asimov, United States)
7:30 pm - 7:50 pm
Brian Kelley (Vir Biotechnology, United States)
"A History of mAb Process Development & Manufacturing: The Past and Future in Four Chapters"
7:50 pm - 8:00 pm
Discussion
8:00 pm - 8:20 pm
Natalia Gomez (Amgen, United States)
"Innovation to Advance a Multi-Modality Portfolio: Transition from a 20+ Year Legacy System to an Optimized End-to-End CHO Expression Platform"
8:20 pm - 8:30 pm
Discussion
8:30 pm - 8:50 pm
Michael Betenbaugh (Johns Hopkins University, United States)
"Addressing Engineering Research Challenges in Cell Culture"
8:50 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
Paula Alves (iBET and NOVA Univ Lisbon, Portugal)
"Process Development and Manufacturing Strategies for Stem Cell Derived Products and Therapies."
9:20 pm - 9:30 pm
Discussion
Tuesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Artificial Intelligence and Machine Learning in Development and Manufacturing
Discussion Leaders: Charlotte Deane (University of Oxford, United Kingdom) and Camille Bilodeau (University of Virginia, United States)
9:00 am - 9:20 am
Jeffrey Gray (Johns Hopkins University, United States)
"Deep Learning Approaches for Antibody Engineering"
9:20 am - 9:30 am
Discussion
9:30 am - 9:50 am
Peyton Greenside (BigHat Biosciences, United States)
"Designing Therapeutic Antibodies with Synthetic Biology and Machine Learning"
9:50 am - 10:00 am
Discussion
10:00 am - 10:20 am
Yanay Ofran (Biolojic Design, Israel)
"Turning Human Antibodies into Programmable Switches Using Machine Learning"
10:20 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:20 am
Myra Coufal (Amgen, United States)
"The Bumpy Road to Implementation: Why There Isn’t More AI in Manufacturing, and How to Reroute the Course"
11:20 am - 11:30 am
Discussion
11:30 am - 11:50 am
Richard Braatz (Massachusetts Institute of Technology, United States)
"AI and Machine Learning in Biotherapeutics Process Development"
11:50 am - 12:00 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
Downstream Operations: Purification and Conjugation
Discussion Leaders: Andrew Zydney (Penn State University, United States) and Stephanie Parker (Alexion Pharamceuticals, United States)
7:30 pm - 7:50 pm
Joanna Pezzini (PAK BioSolutions, Inc., United States)
"Real-Time Adaptive Control for Continuous Purification Processes"
7:50 pm - 8:00 pm
Discussion
8:00 pm - 8:20 pm
Juergen Hubbuch (Karlsruhe Institute of Technology, Germany)
"Downstream Processing: Past, Present and Future Challenges"
8:20 pm - 8:30 pm
Discussion
8:30 pm - 8:50 pm
Stefano Menegatti (NC State University, United States)
"Transforming the Toolbox of Unit Operations and Process Designs for the Purification of Gene and Cell Therapies"
8:50 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
Hanne Bak (Regeneron, United States)
"Where is my Platform? Speed to Clinic with Non-Platform Proteins"
9:20 pm - 9:30 pm
Discussion
Wednesday
7:30 am - 8:30 am
Breakfast
9:00 am - 12:30 pm
Formulation, Drug Product and Delivery
Discussion Leaders: Christian Schoneich (University of Kansas, United States) and Ankit Patel (Denali Therapeutics, United States)
9:00 am - 9:20 am
Bob Kelley (Genentech, Inc., United States)
"Formulation Design for Long-Acting Delivery of Biotherapeutics"
9:20 am - 9:30 am
Discussion
9:30 am - 9:50 am
Lotte Bjerre Knudsen (Novo Nordisk, Denmark)
"The Story of Long-acting GLP-1s in Diabetes, Obesity, Cardiovascular Disease, and Fatty-acid Acylation as a Platform Technology"
9:50 am - 10:00 am
Discussion
10:00 am - 10:20 am
Mihalis Kariolis (Denali Therapeutics, United States)
"Engineering Brain Delivery of Biotherapeutics"
10:20 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:20 am
Mark Brader (Moderna Inc., United States)
"Stabilizing mRNA-LNP as a Non-Covalent Ensemble"
11:20 am - 11:30 am
Discussion
11:30 am - 11:50 am
Olivia Merkel (Ludwig Maximilian University of Munich, Germany)
"Shaping the Future of Inhalable RNA Nanoformulations"
11:50 am - 12:00 pm
Discussion
12:00 pm - 12:20 pm
Omar Khan (Azane Therapeutics, Inc. / University of Toronto, Canada)
"Potent RNA Delivery with Ionizable Lipids: Ultimate Control Through Heteroatomic Tuning"
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
Therapeutic Product Characterization: Analytical, Biophysical, Immunogenicity, Pharmacokinetics and Structure-Function
Discussion Leaders: Krishna Mallela (University of Colorado Anschutz Medical Campus, United States) and Marisa Joubert (Amgen, United States)
7:30 pm - 7:50 pm
Jamie Moore (Gilead, United States)
"Characterization to Support Life-Cycle Management"
7:50 pm - 8:00 pm
Discussion
8:00 pm - 8:20 pm
Theodore Randolph (University of Colorado Boulder, United States)
"Atomic Layer Deposition Techniques to Control Stability and Release of Vaccines"
8:20 pm - 8:30 pm
Discussion
8:30 pm - 8:50 pm
Sathy Balu-iyer (SUNYUniversity at Buffalo, United States)
"Factors Influencing Immunogenicity of Biologics"
8:50 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
Karoline Bechtold-Peters (Novartis Pharma AG, Switzerland)
"Highly Concentrated Formulations of Biologics for the Subcutaneous Space: Tolerability, Immunogenicity, and Pharmacokinetics"
9:20 pm - 9:30 pm
Discussion
Thursday
7:30 am - 8:30 am
Breakfast
8:30 am - 9:00 am
Business Meeting
Nominations for the Next Vice Chair(s); Complete the GRC Evaluation Forms; Discuss Future Dates and Venue; Election of the Next Vice Chair(s)
9:00 am - 12:30 pm
Novel Therapeutic Modalities: mRNA, Synthetic Nucleic Acids and Antibody-Drug Conjugates
Discussion Leader: Mohamed ElSayed, Ph.D. (RVAC Medicines, Inc., United States)
9:00 am - 9:20 am
Frank Bennett (Ionis Pharmaceuticals, United States)
"Antisense Therapies for Neurological Diseases"
9:20 am - 9:30 am
Discussion
9:30 am - 9:50 am
Anastasia Khvorova (University of Massachusetts Medical School, United States)
"Chemical Engineering of Therapeutic RNAs"
9:50 am - 10:00 am
Discussion
10:00 am - 10:20 am
Robert Mabry (Orna Therapeutics, United States)
"Surmounting Therapeutic Modality Limitations with oRNA LNP Technology"
10:20 am - 10:30 am
Discussion
10:30 am - 11:00 am
Coffee Break
11:00 am - 11:20 am
Vinod Balachandran (Memorial Sloan Kettering Cancer Center, United States)
"Pancreatic Cancer – Exceptional Survivors to RNA Vaccines"
11:20 am - 11:30 am
Discussion
11:30 am - 11:50 am
Puja Sapra (AstraZeneca, United States)
"The Renaissance of Antibody-Drug Conjugates in Oncology"
11:50 am - 12:00 pm
Discussion
12:00 pm - 12:20 pm
Joseph Balthasar (University at Buffalo, United States)
"Pharmacokinetic Strategies to Increase the Safety and Efficacy of Anti-Cancer ADC Therapy"
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: Gene and Cell Therapy
Discussion Leader: Irina Balyasnikova (Northwestern University, United States)
7:30 pm - 7:50 pm
David Schaffer (University of California, Berkeley, United States)
"Directed Evolution of Novel AAV Vectors for Clinical Gene Therapy"
7:50 pm - 8:00 pm
Discussion
8:00 pm - 8:20 pm
Todd Carter (Voyager Therapeutics, United States)
"Novel Cross-Species BBB-Penetrant Capsids for the Treatment of CNS Disorders"
8:20 pm - 8:30 pm
Discussion
8:30 pm - 8:50 pm
Christine Brown (City of Hope, United States)
"Clinical Evaluation of CAR T Cells in Glioblastoma: Understanding Response Versus Resistance"
8:50 pm - 9:00 pm
Discussion
9:00 pm - 9:20 pm
Catherine Bollard (Children's National and The George Washington University, United States)
"Cell Therapies for Blood Cancers: Beyond Traditional CAR-T"
9:20 pm - 9:30 pm
Discussion
Friday
7:30 am - 8:30 am
Breakfast
9:00 am
Departure