プレ会議（5月19日）
7:30am - 8:30am60 mins
Registration
8:30am - 9:00am30 mins
Breakfast Spotlight Presentations 1
CMC Best Practices and Lessons Learned in Manufacturing from Sequence to IND for a Gene Editing Program
- Melanie Cerullo - Cheif Quality and Regulatory Officer, ReciBioPharm
8:30am - 9:00am30 mins
Breakfast Spotlight Presentations 2
Purification of Oligonucleotides Using Reverse Phase and Anion Exchange Resins
- Hadi Fares, PhD - Senior Scientist, DuPont Water Solutions
8:30am - 9:00am30 mins
Breakfast Spotlight Presentations 3
Wave Your Way to Success: Unboxing Long RNA Synthesis Aiming for Scale-up
- Gregory Farlow - Senior Oligonucleotide Product Sales Specialist, Cytiva
9:00am - 12:30pm210 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
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
- G. Susan Srivatsa, PhD - President, ElixinPharma
- Fran Wincott, PhD - President, Wincott & Associates, LLC
9:00am - 9:05am5 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Workshop Leaders’ Welcome and Opening Remarks
- Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
- John Zuris, PhD - Director of Delivery and Editing Technologies, Editas Medicine
9:00am - 9:10am10 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
Workshop Leader’s Welcome and Opening Remarks
- Dave Garman, PhD - VP of Translation and Development, ProteinQure
9:05am - 9:45am40 mins
Workshop AM3: Introduction to Genome Editing and Delivery
The History and Evolution of Genome Editing
- John Zuris, PhD - Director of Delivery and Editing Technologies, Editas Medicine
9:10am - 9:40am30 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
- James Powell - SVP, Manufacturing, Dicerna Pharmaceuticals
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
- Dave Garman, PhD - VP of Translation and Development, ProteinQure
9:40am - 10:10am30 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Oligonucleotide Solution API: Navigating the Regulatory Landscape
- Chris Chorley - Associate Director, Regulatory Affairs CMC, Biogen
9:45am - 10:30am45 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Genome Editing Modalities and Their Applications
- John Zuris, PhD - Director of Delivery and Editing Technologies, Editas Medicine
9:45am - 10:30am45 mins
Workshop AM4: Translational Strategies to Accelerate Peptides to the Clinic
ADME of Peptides to Support First in Human Studies
- Jennifer Martin - Senior Advisor, ADME, Eli Lilly and Company
10:10am - 10:40am30 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
- Martin Johnson, PhD - Vice President, Engineering, Eli Lilly
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
10:40am - 11:10am30 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Networking Refreshment Break
11:00am - 11:45am45 mins
Workshop AM3: Introduction to Genome Editing and Delivery
Optimizing Ex Vivo and In Vivo Applications
- Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
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
- Peter Korytko, Ph.D. - President, Preclinical GPS
11:10am - 11:40am30 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
Establishing an RNAi Production Strategy for Large Indications
- Kurt Vagle - Senior Director - Chemical Development RNAi CMC, Novo Nordisk
11:40am - 12:10pm30 mins
Workshop AM2: Novel Paradigms for the Manufacture of Synthetic Oligonucleotides, Regulatory Strategies and Controls
A Ligation Platform Approach to Enzymatic Oligonucleotide Assembly
- Doug Fuerst - Executive Director, GSK
11:45am - 12:30pm45 mins
Workshop AM3: Introduction to Genome Editing and Delivery
The Current Status Genome Editing Applications in the Clinic
- Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
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
- Bruce Morimoto, PhD - Drug Development Advisor, Alto Neuroscience
12:10pm - 12:30pm20 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
12:45pm - 1:15pm30 mins
Spotlight Presentation Luncheon 1
Feasibility of GAP-PS Technology for GLP-1 Peptide Synthesis
- Cole Seifert, PhD - Research & Technology Specialist, Croda Inc.
12:45pm - 1:15pm30 mins
Spotlight Presentation Luncheon 2
Available for Sponsorship. Contact Jennifer.Wickett@informa.com for details.
12:45pm - 1:15pm30 mins
Spotlight Presentation Luncheon 3
An Enhanced Processing Approach for TFF
- Martin Leuthold, PhD - Head of PD Filtration and Chromatography Consumables, Sartorius
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
- Swagatam Mukhopadhyay, PhD - Co-founder & Chief Scientific Officer, Creyon Bio
1:30pm - 5:00pm210 mins
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
1:30pm - 1:35pm5 mins
Workshop PM3: Next-Gen Quality Control: Advancements in Oligonucleotide Analysis and Testing
Workshop Leaders' Welcome and Opening Remarks
- Jan Nickolaus, PhD - Head of Quality Control, BioSpring GmbH
- Claus Rentel, PhD - Vice President, Analytical Development/QC, Ionis Pharmaceuticals, Inc.
1:30pm - 1:35pm5 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Workshop Leader’s Welcome and Opening Remarks
- Marc Jacob, PhD - Head of Strategic Development, Chromatography Products, YMC America
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
- Brendan Frey, PhD - Founder and Chief Innovation Officer, Deep Genomics
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
- Brandon Bock - Associate Director, Analytical Development/QC, Ionis Pharmaceuticals
1:35pm - 2:10pm35 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
- Stephen Groskreutz, PhD - Senior Director of Analytical Development in Bioproduct Research and Development, Eli Lilly and Company
2:05pm - 2:35pm30 mins
Workshop PM1: Leveraging Artificial Intelligence (AI) & Machine Learning (ML) in Drug Design and Development
Advancements in DNA-to-RNA Modeling and Implications for Oligo Design
- Kalin Vetsigian, PhD - Senior Director, AI & Machine Learning, GSK
2:10pm - 2:45pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Process Intensification in Large Scale Peptide Manufacturing
- Olivier Ludemann-Hombourger, PhD - Director, Global Innovation and Technology, PolyPeptide Group
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
- Jan Nickolaus, PhD - Head of Quality Control, BioSpring GmbH
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
- David Pekker, PhD - Senior Director, Theory, Creyon Bio
2:45pm - 3:20pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Breaking with Traditions: Supporting Next Generation Peptide and Oligonucleotide Drugs with Intensified Processes
- Ralf Eisenhuth, PhD - Principal Scientist, Bachem AG
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
- Anna Puszkarska, PhD - Machine Learning Lead, Sanofi
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
- Martin Gilar, PhD - Research Fellow, Waters Corporation
3:50pm - 4:25pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Evolve Flow Chemistry into Liquid Phase Peptide Synthesis Technology
- Eric Fang, PhD - General Manager and Site Head, Snapdragon Chemistry, a Cambrex Company
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
- Ewa Lis, PhD - Founder and CEO, Koliber Biosciences
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
- Jonathan Chan - Assistant Director, Analytical Development/Quality Control, Ionis Pharmaceuticals
4:25pm - 5:00pm35 mins
Workshop PM4: Sustainable Manufacturing: Continuous Processing and Green Chemistry
Continuous Peptide Synthesis via Flow Mechanochemistry
- Frederic Lamaty, Ph.D. - Director of Research, Head of Green Chemistry Team, University of Montpellier
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
- Ruben Abagyan, PhD - Professor, University of California, San Diego
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。