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

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

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

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