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Pre-Conference Workshops
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Pre-Conference Workshops
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7:00am - 8:00am60 mins
Workshop Registration
8:00am - 8:20am20 mins
Workshop #1: The State of the Art in mRNA Delivery
Workshop Moderator’s Opening Remarks
- Örn Almarsson, PhD - Head of Formulations, Moderna Therapeutics
8:00am - 8:15am15 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
Workshop Moderator’s Opening Remarks
- Bruce Morimoto, PhD - Vice President, Drug Development Operations, Alkahest
8:00am - 8:15am15 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Workshop Moderator’s Opening Remarks
- Trishul Shah, MS - Director Business Development, PolyPeptide Group
8:00am - 8:20am20 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Workshop Co-Moderators’ Opening Remarks
- G. Susan Srivatsa, PhD - President, ElixinPharma
- Fran Wincott, PhD - President, Wincott & Associates, LLC
8:15am - 9:00am45 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
Analytical Methods, Pre-formulation, and Formulation for Early Phase Development
- Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts
8:15am - 9:00am45 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Solid-Phase Peptide Synthesis: Being Greener, Being Better
- Fernando Albericio, PhD - Department of Organic Chemistry, University of Barcelona
8:20am - 8:50am30 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Points to Consider with US and EU Expedited Regulatory Pathways
- Paul Manley - President and Principal Consultant, Orvieto Consulting
8:20am - 8:55am35 mins
Workshop #1: The State of the Art in mRNA Delivery
LUNAR®: Enabling mRNA Therapeutics and Vaccines
- Pad Chivukula, Ph.D. - Chief Scientific Officer and COO, Arcturus Therapeutics
8:50am - 9:20am30 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
From Target to Patient; Options for Oligonucleotides as Personalized Medicines
- Chantal Reed, PhD - Vice President, Brain Hz Consulting, Inc.
8:55am - 9:30am35 mins
Workshop #1: The State of the Art in mRNA Delivery
Safe Delivery of Nucleic Acid Cargoes Using Anionic Carriers
- Steffen Panzner - CEO, Lipocalyx GmbH
9:00am - 9:45am45 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Evolved Enzymes for Commercial Chemical Synthesis Pathways
- Christina Boville, PhD - Resnick Prize Postdoctoral Scholar at Caltech, Founder & CSO, Aralez Bio
9:00am - 9:45am45 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
IND-enabling, Nonclinical Safety Studies for Peptides: Pharmacokinetics, Bioanalysis and Toxicology
- Bruce Morimoto, PhD - Vice President, Drug Development Operations, Alkahest
9:20am - 9:50am30 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Use of Prior Knowledge to Establish Enhanced Flexible Platform-based Control Strategies
- Zhijie Sui, PhD - Senior Scientist, Biogen
9:30am - 10:00am30 mins
Workshop #1: The State of the Art in mRNA Delivery
Networking Refreshment Break
9:45am - 10:15am30 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Networking Refreshment Break
9:45am - 10:15am30 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
Networking Refreshment Break
9:50am - 10:20am30 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Networking Refreshment Break
10:00am - 10:35am35 mins
Workshop #1: The State of the Art in mRNA Delivery
Advancing the Delivery of LNP-encapsulated mRNA Therapeutics
- Frank DeRosa, PhD - SVP, Research and Process Development, Translate Bio
10:15am - 11:00am45 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
Peptide CMC Approaches for a Fast and Successful IND Filing
- Mimoun Ayoub, PhD - Director and Head of North American and Emerging Markets, CordenPharma International
10:15am - 11:00am45 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Convergent Peptide Synthesis in Flow: Preferred Regulatory Strategies for Commercial Peptide Manufacture
- Michael Kopach, Ph.D. - Senior Research Advisor, Eli Lilly and Company
10:20am - 10:50am30 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Process Validation Approaches for Accelerated Programs
- Lisa DeCardenas - Regulatory Program Manager, Genentech
10:35am - 11:10am35 mins
Workshop #1: The State of the Art in mRNA Delivery
Design Aspects of Lipid Nanoparticles for mRNA Delivery
- James Heyes, PhD - SVP Technology Development, Genevant Sciences
10:50am - 11:20am30 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Supporting Accelerated Development - Stability Approaches
- Eric McKinney - Director, Stability and Specifications, Alnylam Pharmaceuticals
11:00am - 11:45am45 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Perspectives on Green Chemistry
- Jon Holbech Rasmussen, Ph.D. - Director Global Development, PolyPeptide Group
11:00am - 11:45am45 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
Regulatory Perspectives on Peptide Drug Development
- Mark Longer, Ph.D. - Vice President, Regulatory Affairs and Quality, Arena Pharmaceuticals
11:10am - 11:45am35 mins
Workshop #1: The State of the Art in mRNA Delivery
Delivering mRNA Products from Discovery through Development - Opportunities and Challenges
- Hari Pujar, PhD - Head, Technical Development, Moderna Therapeutics
11:20am - 12:00pm40 mins
Workshop #2: Oligonucleotide Drug Development at Warp Speed: Managing CMC Operations to Support Accelerated Clinical Development
Panel Discussion with Workshop Speakers
11:45am - 12:00pm15 mins
Workshop #3: Potential Green Chemistry Solutions for Peptide Manufacturing
Concluding Remarks and Discussion
11:45am - 12:00pm15 mins
Workshop #1: The State of the Art in mRNA Delivery
Concluding Remarks and Discussion
11:45am - 12:00pm15 mins
Workshop #4: Accelerating Peptides to IND: Moving to the Clinic, CMC and Beyond
Concluding Remarks and Discussion
12:00pm - 1:00pm60 mins
Spotlight Presentations 1
spotlight luncheon
12:00pm - 1:00pm60 mins
Spotlight Presentations 2
Spotlight Luncheons
12:00pm - 1:00pm60 mins
Spotlight Presentations 4
Spotlight Luncheons
1:00pm - 1:15pm15 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Workshop Moderator’s Opening Remarks
- Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts
1:00pm - 1:15pm15 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Workshop Moderator's Welcome and Opening Remarks
- Klaus Charisse, PhD - Director, Analytical R&D, Alnylam Pharmaceuticals
1:00pm - 1:15pm15 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
Workshop Moderator’s Opening Remarks
- Gary Musso, PhD - President, Musso and Associates LLC
1:00pm - 1:15pm15 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Workshop Moderator’s Opening Remarks
- Jennifer Lockridge, PhD - Senior Vice President, Program Development, Dicerna Pharmaceuticals, Inc.
1:15pm - 2:00pm45 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
Locking the Process- Is It Moving Earlier in Development?
- Gary Musso, PhD - President, Musso and Associates LLC
1:15pm - 1:45pm30 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Characterization Methods for Physical Properties of Lipid Nano Particles (LNPs)
- Matthias Kretschmer, PhD - Senior Director Analytical Sciences, Alnylam Pharmaceuticals
1:15pm - 2:00pm45 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Regulatory Perspectives and Points to Consider in Making Successful Oligonucleotide IND/CTA Submissions
- Paul Manley - President and Principal Consultant, Orvieto Consulting
1:15pm - 1:45pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Introduction to Peptide Aggregation, Gelation, and Injection Site Precipitation, and the Consequences
- Christopher Rhodes, PhD - President and CEO, Drug Delivery Experts
1:45pm - 2:15pm30 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Analytical and Bioanalytical Characterization of Antisense Oligonucleotides
- Hans Gaus, Ph.D. - Director of Structural Biology, Ionis Pharmaceuticals, Inc.
1:45pm - 2:15pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Non-aqueous Approaches to Peptide Aggregation
- Steven Prestrelski, Ph.D., MBA - Chief Scientific Officer, Xeris Pharmaceuticals, Inc.
2:00pm - 2:30pm30 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
European Regulatory Update on CMC Requirements for Synthetic Peptides
- René Thürmer, PhD - Deputy Head, Unit Pharmaceutical Biotechnology, BfArM Federal Institute for Drugs and Medical Devices
2:00pm - 2:45pm45 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
CMC Perspectives on Oligonucleotides
- Doug Brooks, PhD - Consultant, Matapalo Pharma Consulting Services
2:15pm - 2:45pm30 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Bioanalytical strategies for the development of stereo pure oligonucleotide therapeutics
- Pallavi Lonkar, PhD - Principal Scientist, WAVE Life Sciences
2:15pm - 2:45pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
In Vitro and in Vivo Models for Injection Site Precipitation and Formulation Solutions
- Laxma Reddy, PhD - Fellow, Formulation and Product Development, Drug Delivery Eexperts
2:30pm - 3:00pm30 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
Networking Refreshment Break
2:45pm - 3:15pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Networking Refreshment Break
2:45pm - 3:15pm30 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Networking Refreshment Break
2:45pm - 3:15pm30 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Networking Refreshment Break
3:00pm - 3:45pm45 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
Of Peptides and PANDAS: Innovative Preclinical Assessment Tools for Safety and Efficacy of Protein and Peptide Therapeutics
- Annie De Groot, MD - Founder, CEO and CSO, EpiVax, Inc.
3:15pm - 3:45pm30 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Analytical Approaches for Determination of Therapeutic Oligonucleotides from Biological Samples
- Ingo Roehl, PhD - Director, Analytical Chemistry, LGC Axolabs
3:15pm - 3:45pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Charge Variant Analysis of Therapeutic Peptides
- Anuja Rane, PhD - Associate Scientist, Teva Pharmaceuticals
3:15pm - 4:00pm45 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Getting Your ASO in Top Shape for IND/IMPD Submission: How to Successfully and Efficiently Identify A Solid Development Candidate
- Sebastien Burel, PhD - Executive Director, Nonclinical Development, Ionis Pharmaceuticals
3:45pm - 4:30pm45 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
Quantification of Impurities in Synthetic Peptides Using Proteolytic Sample Preparation and RP Chromatography
- Michael Berger - Director, Quality Control, Bachem AG
3:45pm - 4:15pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Shining Light on Therapeutic Peptide Aggregation Kinetics in the Presence of Excipients
- Katelyn Smith, PhD - Sr. Scientist, Merck & Co., Inc.
3:45pm - 4:15pm30 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
mRNA Analytics
- Julie Powers, Ph.D. - Associate Director, Production, TriLink BioTechnologies
4:00pm - 4:45pm45 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Case Study: DCR-PHXC, An siRNA Therapeutic Being Developed for the Treatment of Primary Hyperoxaluria
- Jeffrey Foy, PhD - Senior Director, Toxicology, Dicerna Pharmaceuticals
4:15pm - 5:00pm45 mins
Workshop #8: Analytical and Bioanalytical Strategies and Techniques for the Discovery and Development of Oligonucleotide Therapeutics
Panel Discussion with Workshop Speakers
4:15pm - 4:45pm30 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Precious Peptides: Phase-appropriate Aggregation Risk Assessment Across Pharmaceutical Development
- Suzanne D'Addio, PhD - Associate Principal Scientist, Merck & Co., Inc
4:30pm - 5:00pm30 mins
Workshop #7: Evolving Regulatory CMC Requirements for Peptides
Genotoxicity Assessment of Impurities in Peptide/Protein-containing Biotherapeutics
- Zhanna Sobol, PhD - Genetic Toxicology Head, Pfizer, Inc.
4:45pm - 5:00pm15 mins
Workshop #5: Peptide Aggregation – Challenges, Effects, and Solutions
Concluding Remarks and Discussion
4:45pm - 5:00pm15 mins
Workshop #6: The Path to A Successful Oligonucleotide IND/IMPD Submission: Regulatory, Nonclinical and CMC Perspectives
Concluding Remarks and Discussion
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