Pre-Conference Workshops
Pre-Conference Workshops are offered as part of the "All Access Conference & Workshop Pass" and will take place in-person on Monday, September 20, 2021 at the BCEC in Boston, MA.
MORNING WORKSHOPS:
Workshop #1: Path to a Successful IND/IMPD for Oligonucleotide Therapeutics
Jennifer Lockridge, Ph.D., Senior Vice President, Program Development, Dicerna Pharmaceuticals, Inc.
G. Susan Srivatsa, Ph.D. , President, ElixinPharma
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Workshop #2: Best Practices in Peptide Drug Development: Avoiding Pitfalls and Roadblocks through the Product Lifecycle
Workshop Leaders:
- Gary F. Musso, Ph.D., President, Musso and Associates LLC
- Bruce Morimoto, Ph.D., Vice President, Cerecin
Best Practices for Nonclinical Peptide Development: Bioanalysis, Pharmacokinetics, and Toxicity
Bruce Morimoto, Ph.D., Vice President, Cerecin
Formulation Development
Christopher Rhodes, Ph.D., President and CEO, Drug Delivery Experts
CMC Regulatory Strategies for Peptides
Gary F. Musso, Ph.D., President, Musso and Associates LLC
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Workshop #3: To be announced
AFTERNOON WORKSHOPS:
Workshop #4: Strategies and Alternative Technologies for the Manufacturing Process of Therapeutic Oligonucleotides
Workshop Leaders:
- Marc J. Jacob, Ph.D., Director of Business Development, Analytical Services, Ampac Analytical Laboratories Services
- Marc Lemaitre, Ph.D., Consultant, ML Consult
Practical Applications of P-V Methodology Towards the Synthesis of Stereo-pure Oligonucleotides
Ravi Natarajan, Ph.D., President, Socrates Biosciences
The Use of Boronic Acid for the Chromatography of Oligonucleotides
Christopher Gabriel, Ph.D., Senior Scientist, Process Organic Chemistry, Ionis Pharmaceuticals, Inc.
Purification of Synthetic Oligonucleotides: A CMO Perspective
Ralf Eisenhuth, Ph.D., Scientific Expert API Production, Bachem AG
P(III) vs. P(V): A P(V) Reagent for Thiophosphoramidate Linkages and Application to An Asymmetric Synthesis of a Cyclic Dinucleotide STING Agonist
Michael Schmidt, Scientist, Bristol-Myers Squibb
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Workshop #5: FDA Draft Guidance on ANDA Filings for Peptides
Workshop Leader:
- Trishul Shah, Director, Business Development, North America, PolyPeptide Laboratories
Methods for Assessing the Immunogenicity of Peptide Drugs and Their Impurities
Annie De Groot, M.D., Professor (Research) and Annie De Groot, M.D., Professor (Research) and Director, Institute for Immunology and Informatics, University of Rhode Island and Founder, CEO and CSO, EpiVax, Inc., USA
Considerations in Submitting Abbreviated New Drug Application of Generic Peptide Drug Products
Deyi Zhang, Ph.D., Senior Chemist, Office of Research and Standards, Office of Generic Drugs, CDER, US FDA
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Workshop #6: To be announced
Keynote Sessions
These keynote sessions will be offered as part of all TIDES USA conference passes. They will take place in-person on September 21 at the live event, and will be available on-demand for all digital attendees from September 28-30, 2021. More keynote speakers/sessions will be added.
My Long Road from the 2’-5’ Oligos to the mRNA Vaccine
Katalin Karikó, Ph.D., Senior Vice President RNA Protein Replacement Therapy, BioNTech RNA Pharmaceuticals GmbH, Germany
RNAi Therapeutics: Past, Present, and (Mostly) Future
John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals
Antisense Oligonucleotides for the Treatment of Neurological Diseases
Holly Kordasiewicz, Ph.D., Vice President Neurology Research, Ionis Pharmaceuticals
Approved Commercial Peptide Vyleesi and A Family of Melanocortin Peptides in Late Stage Development
Carl Spana, CEO, Palatin Technologies
Discovery and Development of Rusfertide (PTG-300) Being Developed for Treatment of PV
David Liu, Ph.D. Chief Scientific Officer, Head of Discovery & Pre-Clinical Development, Protagonist Therapeutics
Main Conference Sessions
These sessions will be offered as part of all TIDES USA conference passes. They will take place in-person during the September 21-23 live event, and will be available on-demand for all digital attendees from September 28-30, 2021. More sessions will be added.
TRACK: Oligonucleotide Discovery, Preclinical and Clinical
Oligonucleotide Discovery Program Update
Tasuku Kitada, Ph.D., President and Head of R&D, Strand Therapeutics
Investigations into Disruptive Delivery Approaches for LNA ASOs - Evaluation of Bovine Milk Derived Extracellular Vesicles as Oral DDS
Michael Keller, Ph.D., Senior Principal Scientist, pCMC Drug Delivery and Preformulation Sciences, Roche pRED, Switzerland
DCR-AUD program
Bob D. Brown, Ph.D., Chief Scientific Officer and Senior Vice President, Research, Dicerna Pharmaceuticals
Identification and Optimization of a Minor Allele-specific siRNA to Prevent PNPLA3 I148M-driven Nonalcoholic Fatty Liver Disease
Justin Murray, Ph.D., Senior Principal Scientist, Selection & Modality Engineering, Amgen
CNS Oligonucleotides
Moderator: Yogesh Sanghvi, Ph.D., President, Rasayan, Inc.
Treating Repeat Expansion Disorders by Stopping Somatic Expansion
Brian Bettencourt, Ph.D., SVP Research, Triplet Therapeutics
Nucleic Acid Chemical Modifications
Moderator: Punit P. Seth, Ph.D., Vice President, Medicinal Chemistry, Ionis Pharmaceuticals
Old Dogs and New Puppies of Chemical Modifications for RNA Therapeutics
Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals
Chemical Modification of Guide RNA to Improve the CRISPR- Cas9 Activity for Genome Editing
Rubina Parmar, Ph.D., Senior Director, Chemistry and Delivery Sciences, Intellia Therapeutics
Oligonucleotide Backbone Engineering for Enhancing Metabolic Stability, Potency, and Selectivity of siRNAs
Ken Yamada, Ph.D., Assistant Professor, University of Massachusetts Medical School
Exploring New Oligonucleotide Backbone Chemistries and Their Deployment to Improve the Properties of Stereopure Oligonucleotides
Chandra Vargeese, Ph.D., SVP, Head of Drug Discovery, WAVE Life Sciences
Redefining the Chemical Space for Antisense Therapeutics
Punit P. Seth, Ph.D., Vice President, Medicinal Chemistry, Ionis Pharmaceuticals
Sequence-specific Recognition of Double-stranded RNA by Cationic Nucleobase and Backbone-modified Peptide Nucleic Acids
Eriks Rozners, Ph.D., Professor and Chair of Chemistry Department, Binghamton University
Emerging Oligonucleotide Drug Discovery
Moderator: Troels Koch, Ph.D., Industry Expert
Targeting ANGPTL4 in the Liver with ASO – A Novel Treatment for Cardiometabolic Disease
Stefan Nilsson, Ph.D., CEO, Lipigon Pharmaceuticals AB, Sweden
U1 Adaptors Bioconjugates for Targeted Gene Silencing in Extrahepatic Tissues
P. Peter Ghoroghchian, M.D., Ph.D., President and CEO, Silagene, Inc.
A Novel, RNA-based Anti-viral Approach to Limit BK Virus Propagation in Immunocompromised Patients
Eric van der Veer, Ph.D., Chief Scientific Officer, Hybridize Therapeutics, The Netherlands
Platform Optimization to Enable Therapeutic Development of ADAR-mediated RNA editing
Stuart Milstein, Ph.D., VP Platform Biology, Korro Bio
Targeted Delivery of Therapeutic Oligonucleotides
Moderator: Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Discovery, Alnylam Pharmaceuticals
Improved Delivery of RNA Therapeutics in the Eye, Muscle, and Beyond Using Fatty-Acid Conjugation
Charles R. Allerson, Ph.D., Vice President of Chemistry & Drug Development, DTx Pharma
Targeted Delivery of Base Editors to Hepatocytes in vivo
Kallanthottathil Rajeev, Ph.D., Vice President, CMC, Verve Therapeutics
Delivery of RNA Therapeutics: The Great Endosomal Escape!
Steven Dowdy, Ph.D., Professor, Cellular and Molecular Medicine, UCSD School of Medicine
Antibody Oligonucleotide Conjugates: Taking Receptor-Mediated Uptake One Step Further
Arthur Levin, Ph.D., Chief Scientific Officer, Avidity Biosciences
Muscle Targeted Delivery of Therapeutic Oligonucleotides with the FORCE™ Platform
Oxana Beskrovnaya, Ph.D., Senior Vice President, Head of Research, Dyne Therapeutics
Targeted Delivery of Therapeutics
Karyn O'Neil, Ph.D., Co-founder and CSO, Aro Biotherapeuitics
Targeted Delivery of ASO Therapeutics
Punit P. Seth, Ph.D., Vice President, Medicinal Chemistry, Ionis Pharmaceuticals
Development of An antimiR-based Therapy to Treat Myotonic Dystrophy Disease
Beatriz Llamusí Troísi, Arthex Biotech
TRACK: Oligonucleotide Chemistry, Manufacturing and Controls
Improved Oxidizer Formulations for the Synthesis of PO/PS Mixed Backbone Oligonucleotides
Andrew Rodriguez, Ph.D., Associate Director, Process Chemistry, Ionis Pharmaceuticals
Analytics of Oligonucleotides
Moderator: Claus Rentel, Ph.D., Executive Director, Analytical Development/QC, Ionis Pharmaceuticals
Automated Online UPLC and Data Processing for Oligonucleotide Synthesis and Purification Monitoring
Andrew Argo, Scientist I, Quality Control Analytical Technology-Advanced Process Control, Biogen
Analytical Method Development of Complementary Related Organic Impurity Methods for Oligonucleotides
Chris Gripton, Ph.D., Investigator, Drug Substance and Product Analysis UK, CMC Analytical, GSK Medicines Research Centre, United Kingdom
Manufacturing and Analytical Challenges of Oligonucleotide Lipid Delivery Systems and Their Translation to the Clinic
Angela Wagner, Associate Principal Scientist, Sterile & Specialty, Merck
Developing Methods to Control Critical Impurities in Phosphoramidites
Dennis Rhodes, Assistant Director, Analytical Development and QC, Ionis Pharmaceuticals
Identification and Quantitation of Thermal Degradation Products of Antisense oligonucleotides (ASOs) Enables Understanding of Degradation Mechanism
Rasika Phansalkar, Ph.D., Scientist I, Technical Development, Biogen
Sustainable Manufacturing of Oligonucleotides
Moderator: Firoz D. Antia, Ph.D., Director, Antisense Oligonucleotide Process Development and Manufacturing, Biogen
Sustainability Challenges and Opportunities in Oligonucleotide Manufacturing
Ben Andrews, Ph.D., Investigator, Chemical Development, GlaxoSmithKline, United Kingdom
Oligonucleotide Starting Materials – Drivers (or Disasters) for Sustainability
Louis Diorazio, Ph.D., Principal Scientist, Chemical Development, AstraZeneca, United Kingdom
Development of a Scalable Synthesis Process for Oligonucleotides
Xianglin Shi, Ph.D., Head of Oligonucleotide Chemical Process Development, Biogen
Issues to Resolve for Very Large-Scale Oligonucleotide Manufacturing
Anthony Scozzari, Vice President, Development Chemistry & Manufacturing, Ionis Pharmaceuticals
TRACK: Peptide Discovery, Preclinical and Clinical
Solid-Phase Peptide Synthesis Using a Four-Dimensional Protecting Group Scheme
Fernando Albericio, Ph.D., Research Professor, School of Chemistry, University of Kwazulu-Natal, South Africaram
Discovery and Optimization of Long-acting, Unimolecular Peptide Triple Agonists of the GLP-1, GIP, and Glucagon Receptors
Patrick J. Knerr, Ph.D., Research Scientist II – Chemistry, Novo Nordisk Research Center Indianapolis
Journey Beyond the Margin: Development of Imaging System to Assist Tumor Resections
Jorge Ferrer, Ph.D., SVP of Clinical Research and Strategy, Lumicell
Peptide Clinical Candidates for Rare Diseases
Moderator: Jesper Lau, Ph.D., Vice President, Chemical Biology, Novo Nordisk A/S, Denmark
Oral Delivery of PTH 1-34 in the Treatment of Hypoparathyroidism and Osteoporosis
Phillip Schwartz, Ph.D., President of R&D and EVP, Entera Bio Ltd., Israel
Targeted Radioligand Therapies, Diagnostic Imaging and Peptide Receptor Radionuclide Therapy
Moderator: Jesse Z. Dong, Ph.D., Vice President, Peptide Chemistry, BioNTech, USA
Tumor-targeted Radionuclides Using De Novo Macrocyclic Peptide-mimetics
Deborah Charych, Ph.D., Chief Technology Officer and Co-founder, RayzeBio, Inc.
Peptides Radiopharmaceuticals
Joe McCann, CEO, Point Biopharmaceuticals
Targeted Alpha Therapeutics to Improve the Safety of Radiopharmaceuticals
John Rhoden, Ph.D., Director, Preclinical Development, Fusion Pharmaceuticals
30 Years of Peptide Nucleic Acids and On the Road to Precision Antisense Antibiotics Against Multidrug Resistant Bacteria
Peter E. Nielsen, Ph.D., Professor, Center for Peptide-Based Antibiotics, University of Copenhagen, Denmark
Latest Advances in PNA Research
Dietrich Stephan, CEO, Neubase Therapeutics
TRACK: Peptide Chemistry, Manufacturing and Controls
Refractive Index: The Ultimate Tool for Real-Time Monitoring of Solid-Phase Peptide Synthesis. Greening the Process
Beatriz de la Torre, Ph.D., Research Professor, Laboratory of Medicine and Medical Sciences, University of KwaZulu-Natal
Peptides for COVID-19 Therapy
Moderator: Trishul Shah, Director, Business Development, North America, PolyPeptide Laboratories
Case Study of Rapid Acceleration of Manufacturing for a COVID Vaccine
Tim Culbreth, Site Director, Polypeptide
Peptide Treatment for COVID-19 Symptoms
Jonathan Javitt, CEO, NeuroRx
TRACK: mRNA Therapeutics/Vaccines & Genome Editing
mRNA Therapeutics, Vaccines and Applications
Moderator: Nicole Roth, Ph.D., Senior Scientist, CureVac AG, Germany
A Novel Vaccine Approach Using Messenger RNA‐Lipid Nanoparticles: Preclinical and Clinical Perspective
Ying Tam, Ph.D., Chief Scientific Officer, Acuitas Therapeutics, Inc.
Subcutaneous Administration of mRNA
Nigel Davies, Scientist, AstraZeneca
Development of Broadly Protective Influenza Vaccines Using Nucleoside-modified mRNA
Norbert Pardi, Ph.D., Research Assistant Professor of Medicine, University of Pennsylvania
Genome Editing Advances to the Clinic
Moderators: Cecilia Fernández, Ph.D., Cecilia Fernández, Strategy and Operations, 5AM Ventures and
Rubina Parmar, Ph.D., Director, Chemistry, Intellia Therapeutics
Clinical Progress in Genome Editing
Laura Sepp-Lorenzino, Ph.D., Chief Scientific Officer, Intellia Therapeutics
Analytical Characterization of Guide RNAs and Ribonucleoproteins for CRISPR Applications
Steven Wolk, Ph.D., Senior Director of Analytical Chemistry, Editas Medicine
In vivo CRISPR Base Editing of PCSK9 Durably Lowers Cholesterol in Primates
Andrew Bellinger, M.D., Ph.D., CSO, Verve Therapeutics
Non-Viral Delivery Platform Work with Preclinical Data
Delai Chen, Ph.D., Associate Director Nanoparticle Formulation, Beam Therapeutics