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Delivered as Hybrid Event from September 20-30, 2021
Live In-Person Experience Delivered September 20-23Boston Convention and Exhibition Center

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