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 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 - 9:05am5 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Workshop Leaders' Welcome and Opening Remarks
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
9:00am - 9:10am10 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Workshop Leaders’ Welcome and Opening Remarks
- Fran Wincott, PhD - President, Wincott & Associates, LLC
- G. Susan Srivatsa, PhD - President, ElixinPharma
9:00am - 9:10am10 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Workshop Leaders’ Welcome and Opening Remarks
- Firoz Antia, PhD - Vice President, Oligonucleotide & Small Molecule CMC, Denali Therapeutics
- Yogesh Sanghvi, PhD - President, Rasayan Inc.
9:00am - 9:10am10 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Workshop Leader’s Welcome and Opening Remarks
- Fernando Albericio, Ph.D - Research Professor, University of Kwazulu-Natal
9:05am - 9:30am25 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Introduction to Therapeutic Oligonucleotides As a New Drug Class
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
9:10am - 9:40am30 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Overview of Novel Synthetic Paradigms: Opportunities and Challenges
- Joshua Brooks, PhD - Director, Process Sciences, Alnylam Pharmaceuticals
9:10am - 9:40am30 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Design Considerations for Antibody-Oligonucleotide Conjugates: Focusing on Protein Engineering, Bioconjugation Chemistry, and Conjugation Site Selection
- Padma Akkapeddi, PhD - Senior Scientist, Discovery Sciences, Denali Therapeutics
9:10am - 9:40am30 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Breaking the Solid-Phase Mold: Liquid-Phase Peptide Synthesis is Changing the Game
- Beatriz De La Torre, Ph.D. - Research Professor, Laboratory of Medicine and Med, University Of KwaZulu-Natal
9:30am - 10:00am30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Therapeutic Oligonucleotide Design
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
9:40am - 10:10am30 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Liquid Phase Oligonucleotide Synthesis
- Piers Gaffney, Ph.D. - Engineering Chemist, Imperial College London
9:40am - 10:10am30 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Nucleic Acid Conjugates: Remote Control, Targeting, and Entirely New Functions
- Michael Booth - Associate Professor of Chemical Biology and Organic Chemistry, University College London
9:40am - 10:10am30 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Late Breaking Presentation
10:00am - 10:30am30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Preclinical Considerations
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
10:10am - 10:40am30 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Development of Enzymatic Strategies for Oligonucleotide Manufacturing
- Jill Caswell, PhD - Biology Team Leader, Almac Sciences
10:10am - 10:40am30 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Chemistry at the Interface of Nucleic Acid (Bio)conjugation
- Derek O'Flaherty, Ph.D - Assistant Professor, University of Guelph
10:10am - 10:40am30 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Late Breaking Presentation
10:30am - 11:00am30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Networking Refreshment Break
10:40am - 11:10am30 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Networking Refreshment Break
10:40am - 11:10am30 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Networking Refreshment Break
10:40am - 11:10am30 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Networking Refreshment Break
11:00am - 11:30am30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Formulation Design
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
11:10am - 11:40am30 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Late Breaking Presentation
11:10am - 11:40am30 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Modification of Oligonucleotides at Phosphorus
- Kurt Vesterager Gothelf, Ph.D. - Professor, Department of Chemistry and iNANO, Aarhus University
11:10am - 11:40am30 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Late Breaking Presentation
11:30am - 12:00pm30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Clinical Considerations
- Sonja Merkas, PhD - Founder, Creator and Doer, Livinovea
11:40am - 12:10pm30 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Regulatory Strategy for Chemoenzymatic siRNA Manufacturing Process
- Yansheng Wu - Vice President, Global Head of CMC & Regulatory, Hongene Biotech Corporation, USA
11:40am - 12:10pm30 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Late Breaking Presentation
11:40am - 12:10pm30 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Late Breaking Presentation
12:00pm - 12:30pm30 mins
Workshop AM1: Introduction to Therapeutic Oligonucleotides - Design, Function and Delivery
Oligonucleotide Manufacture and Control
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
12:10pm - 12:30pm20 mins
Workshop AM2: Implementation of Novel Paradigms for the Manufacture of Synthetic Oligonucleotides
Panel Discussion with Workshop Speakers
12:10pm - 12:30pm20 mins
Workshop AM3: Chemistries Enabling Oligonucleotide Conjugates
Panel Discussion with Workshop Speakers
12:10pm - 12:30pm20 mins
Workshop AM4: The Next Wave of Innovation in Peptide Manufacturing Technologies
Panel Discussion with Workshop Speakers
- Fernando Albericio, Ph.D - Research Professor, University of Kwazulu-Natal
- Matteo Villain, PhD - Vice President of Peptide and Oligonucleotide, Veranova
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 - 1:40pm10 mins
Workshop PM1: CMC and Nonclinical Strategies for an Oligonucleotide Phase 1 IND
Workshop Leader’s Welcome and Opening Remarks
- Kathryn Ackley, PhD - CMC Consultant Specializing in Oligonucleotides, Independent Consultant
1:30pm - 3:00pm90 mins
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
Workshop Leader's Welcome and Opening Remarks
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
1:30pm - 1:35pm5 mins
Workshop PM3: In Vivo Genome Editing: Targeted Delivery & Large Gene Knock-ins
Workshop Leaders' Welcome and Opening Remarks
- John Zuris, PhD - Principal, John Zuris Consulting LLC
- Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
1:30pm - 1:35pm5 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Workshop Leader’s Welcome and Opening Remarks
- Matteo Villain, PhD - Vice President of Peptide and Oligonucleotide, Veranova
1:35pm - 2:15pm40 mins
Workshop PM3: In Vivo Genome Editing: Targeted Delivery & Large Gene Knock-ins
Targeted Delivery: Basic Designs and Places to Go
- Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
1:35pm - 2:10pm35 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Lyophilization Potential to Impact Delivery of Peptides
- Walter Pebley - Chief Science Officer, OFD Life Sciences
1:40pm - 2:25pm45 mins
Workshop PM1: CMC and Nonclinical Strategies for an Oligonucleotide Phase 1 IND
Nonclinical Aspects of an IND
- Peter Korytko, Ph.D. - President, Preclinical GPS
2:10pm - 2:45pm35 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Spray Drying Theory and How It Can Be Used for Spraying Peptides
- David Vodak, PhD - Chief Scientific Officer, Bend Bioscience
2:15pm - 3:00pm45 mins
Workshop PM3: In Vivo Genome Editing: Targeted Delivery & Large Gene Knock-ins
Targeted Delivery for In Vivo CAR-T: Current State and Recent Progress
- John Zuris, PhD - Principal, John Zuris Consulting LLC
2:25pm - 3:00pm35 mins
Workshop PM1: CMC and Nonclinical Strategies for an Oligonucleotide Phase 1 IND
Manufacturing Aspects of an IND
- Pablo Lores Lareo, PhD - CMC Director, Sylentis
2:45pm - 3:20pm35 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Process Approach in Electrostatic Drying of Peptides
- Katherine Buzecky - Director of Scientific Services, Fluid Air
3:00pm - 3:30pm30 mins
Workshop PM1: CMC and Nonclinical Strategies for an Oligonucleotide Phase 1 IND
Networking Refreshment Break
3:00pm - 3:30pm30 mins
Workshop PM2: Introduction to Analytical Control Strategies for Therapeutic Oligonucleotides
Networking Refreshment Break
3:00pm - 3:30pm30 mins
Workshop PM3: In Vivo Genome Editing: Targeted Delivery & Large Gene Knock-ins
Networking Refreshment Break
3:20pm - 3:50pm30 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Networking Refreshment Break
3:30pm - 4:15pm45 mins
Workshop PM1: CMC and Nonclinical Strategies for an Oligonucleotide Phase 1 IND
Quality and Regulatory Aspects of an IND
- Judy Carmody, Ph.D. - Founder and Principal Consultant, Carmody Quality Solutions, LLC
3:30pm - 5:00pm90 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
3:30pm - 4:15pm45 mins
Workshop PM3: In Vivo Genome Editing: Targeted Delivery & Large Gene Knock-ins
Large Knock-ins (Exons and Whole Genes): Current State and Recent Progress
- Steven Wolk, PhD - President, Siniwali Biotechnology Solutions
3:50pm - 4:25pm35 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Development and Use of Spray Drying for Peptides
- Emily Guinn, PhD - Senior Engineering Advisory, Eli Lilly and Company
4:15pm - 5:00pm45 mins
Workshop PM1: CMC and Nonclinical Strategies for an Oligonucleotide Phase 1 IND
Panel Discussion and Ask the Consultants
- Kathryn Ackley, PhD - CMC Consultant Specializing in Oligonucleotides, Independent Consultant
- Peter Korytko, Ph.D. - President, Preclinical GPS
- Pablo Lores Lareo, PhD - CMC Director, Sylentis
- Judy Carmody, Ph.D. - Founder and Principal Consultant, Carmody Quality Solutions, LLC
4:15pm - 5:00pm45 mins
Workshop PM3: In Vivo Genome Editing: Targeted Delivery & Large Gene Knock-ins
Targeted Delivery & Large Gene Knock-ins in the Therapeutic Space: Acquisitions, Patents, and Trials
- John Zuris, PhD - Principal, John Zuris Consulting LLC
4:25pm - 5:00pm35 mins
Workshop PM4: Optimizing the Final Isolation Step of Peptide API
Solid Form Strategies for Screening, Crystallization and Purification of Peptides: Vancomycin, a Case Study
- Craig Grant - Vice President and General Manager Cambridge, Veranova
5:00pm - 5:05pm5 mins
Close of Workshops
* 活动内容有可能不事先告知作更动及调整。