Pre-Conference Workshops
Workshops take place on September 20 and consist of (2) half-day workshop options.
Choose between 2 morning sessions and 2 afternoon sessions.
Morning Workshop: Path to a Successful IND/IMPD for Oligonucleotide Therapeutics
Workshop Leaders:
- Jennifer Lockridge, Ph.D., Senior Vice President, Program Development, Dicerna Pharmaceuticals, Inc.
- G. Susan Srivatsa, Ph.D. , President, ElixinPharma
Topics Covered:
- Regulatory expectations: Pharm/Tox and CMC
- Content of the Nonclinical and CMC Sections of an IND/IMPD dossier
- Considerations for design of GLP toxicology studies
- ADME characterization
- Drug Substance manufacturing, quality control and stability
- Drug Product manufacturing, quality control and stability
Morning 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
Topics Covered:
- Best Practices for Nonclinical Peptide Development: Bioanalysis, Pharmacokinetics, and Toxicity
- Peptide Formulation: Initial Clinical Development, Final Dosage Forms and Life Cycle Management
- Best Practices for CMC Regulatory Strategy for Peptides
- Quality Strategies for Peptide Development
Afternoon Workshop 1: 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
Topics Covered:
- P(III) vs. P(V): A General P(V) Reagent Platform for Phosphorous Linkages and Application to An Asymmetric Synthesis of a Cyclic Dinucleotide STING Agonist and Antisense Oligonucleotides
- Practical Applications of P-V Methodology Towards the Synthesis of Stereo-pure Oligonucleotides
- Boronic Acid-Assisted Purification of GalNAc-Conjugated ASO’s
- Purification of Synthetic Oligonucleotides: A CMO Perspective
Afternoon Workshop 2: FDA Guidance on ANDA Submission for Peptides
Workshop Leader:
- Trishul Shah, Director, Business Development, North America, PolyPeptide Laboratories
Topics Covered:
- The PANDA Approach to Immunogenicity Assessment for New Drugs and Generic ANDAs
- Considerations in Submitting Abbreviated New Drug Application of
Generic Peptide Drug Products
Workshop Speakers
Below are all the speakers participating in the Pre-Conference Workshop Day