Pre-Conference Day (May 11)
Pre-Conference Day (May 11)
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Streams
7:30am - 8:30am60 mins
Registration
8:30am - 9:00am30 mins
Breakfast Spotlight Presentations 1
Purification of TIDES Molecules with Reverse Phase and Anion Exchange Chromatography
- Hadi Fares, PhD - Senior Scientist, DuPont Water Solutions
8:30am - 9:00am30 mins
Breakfast Spotlight Presentations 2
Bio-Works Spotlight Presentation
8:30am - 9:00am30 mins
Breakfast Spotlight Presentations 3
Analytical Strategies for Quantifying Lipid-Conjugated Oligo, GalNAc-Conjugated siRNA, and Antisense Oligonucleotide Therapeutics via Solid Phase Extraction Coupled with LC-MS
- Roxana Eggleston-Rangel - Advanced Workflows Applications Manager, Phenomenex
9:00am - 10:20am80 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
9:00am - 9:10am10 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Workshop Leaders’ Welcome and Opening Remarks
9:00am - 9:05am5 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Workshop Leaders’ Welcome and Opening Remarks
9:00am - 9:10am10 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
Workshop Leader’s Welcome and Opening Remarks
9:05am - 9:45am40 mins
Workshop AM3: Introduction to Genome Editing and Delivery
The History and Evolution of Genome Editing
9:10am - 9:45am35 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Evolution of Oligonucleotide Therapeutics: Impact on Manufacturing and CMC Strategy
9:10am - 9:45am35 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
Introduction to Fast Tracking to First in Humans and CMC Requirements and Considerations
9:45am - 10:20am35 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Oligonucleotide Solution API: Navigating the Regulatory Landscape
9:45am - 10:30am45 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Genome Editing Modalities and Their Applications
9:45am - 10:30am45 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
ADME of Peptides to Support First in Human Studies
10:20am - 10:50am30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Networking Refreshment Break
10:20am - 10:50am30 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Networking Refreshment Break
10:30am - 11:00am30 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Networking Refreshment Break
10:30am - 11:00am30 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
Networking Refreshment Break
10:50am - 12:30pm100 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
10:50am - 11:25am35 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
The Impact of Manufacturing Innovation on Clinical Development: Manufacturing Controls and Regulatory Strategy
11:00am - 11:45am45 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Optimizing Ex Vivo and In Vivo Applications
11:00am - 11:45am45 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
Toxicity and Safety Pharmacology Studies to Support First in Human Studies
11:25am - 12:00pm35 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Establishing an RNAi Production Strategy for Large Indications
11:45am - 12:30pm45 mins
Workshop AM3: Introduction to Genome Editing and Delivery
The Current Status Genome Editing Applications in the Clinic
11:45am - 12:30pm45 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
The Importance of CMC and Safety Studies in the Design and Execution of First in Human Studies
12:00pm - 12:30pm30 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Panel Discussion with Workshop Speakers
12:30pm - 12:45pm15 mins
Close of Workshops and Transition to Luncheon Spotlight Presentation Rooms
1:15pm - 1:30pm15 mins
Short Networking Break
1:30pm - 1:35pm5 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Workshop Leader’s Welcome and Opening Remarks
1:30pm - 2:30pm60 mins
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
1:30pm - 1:35pm5 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
Workshop Leaders' Welcome and Opening Remarks
1:30pm - 1:35pm5 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Workshop Leader’s Welcome and Opening Remarks
1:35pm - 2:05pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Foundation Models: A New Hope for Emergent Drug Discovery Intelligence
1:35pm - 2:15pm40 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
Structure, Detection, Formation, and Potential for Purging of Impurities in ASO and siRNA Oligonucleotides
1:35pm - 2:10pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Breaking with Traditions: Supporting Next Generation Peptide and Oligonucleotide Drugs with Intensified Processes
2:05pm - 2:35pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Eschewing Trial-and-error in Favor of Engineering Oligonucleotides: Purpose-built Data and Modern AI/ML Can Accurately Predict Oligonucleotide Pharmacology
2:10pm - 2:45pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Continuous Manufacturing of Tirzepatide Using Online UHPLC-Based PAT: An Enabling Technology for Commercialization of a Synthetic Peptide
2:15pm - 3:00pm45 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
Elucidating guide RNA Purity and Impurities through NGS and LC-MS(/MS) Technologies
2:30pm - 3:00pm30 mins
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
Networking Refreshment Break
2:35pm - 3:05pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Modeling Nucleic Acids at Creyon Bio
2:45pm - 3:20pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Process Intensification in Large Scale Peptide Manufacturing
3:00pm - 4:30pm90 mins
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
3:00pm - 3:30pm30 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
Networking Refreshment Break
3:05pm - 3:30pm25 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Networking Refreshment Break
3:20pm - 3:50pm30 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Networking Refreshment Break
3:30pm - 4:00pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Machine Learning Designs New GCGR/GLP- 1R Dual Agonists with Enhanced Biological Potency
3:30pm - 4:15pm45 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
LC and MS Strategies for Streamlined Digested Oligo Mapping of RNA Based Therapeutics and Vaccines
3:50pm - 4:25pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Evolve Flow Chemistry into Liquid Phase Peptide Synthesis Technology
4:00pm - 4:30pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Peptide Hit Discovery and Optimization Using Machine Learning and Small Peptide Arrays
4:15pm - 5:00pm45 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
Validation and Use of Platform Methods for Oligonucleotide Therapeutics
4:25pm - 5:00pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Continuous Peptide Synthesis via Flow Mechanochemistry
4:30pm - 5:00pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Exploring Chemical Giga Spaces for New Drug Candidates with Complex Target Profiles
5:00pm - 5:05pm5 mins
Close of Workshops
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。