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Optional Pre-Conference Workshops

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Optional Pre-Conference Workshops

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Morning Half-Day Workshops
08:00 - 08:1515 mins
Workshop 1: Managing CMC Activities to Accelerate Oligonucleotide Development and Manufacturing
Workshop Moderator’s Opening Remarks
  • Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany
08:00 - 08:1515 mins
Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
Workshop Moderator’s Opening Remarks
  • Vivian Lindo - Associate Director, Analytical Sciences, AstraZeneca
08:15 - 09:1560 mins
Workshop 1: Managing CMC Activities to Accelerate Oligonucleotide Development and Manufacturing
Technologies and CMC Challenges in the Manufacturing of Oligonucleotides
  • Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany
08:15 - 08:5035 mins
Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
Probing Protein Higher Order Structure with Mass Spectrometry
  • Vivian Lindo - Associate Director, Analytical Sciences, AstraZeneca
08:50 - 09:2535 mins
Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
Development and Validation of a Peptide Bioassay
  • Michael Postlethwaithe, Ph.D - Business Development Manager, Bachem AG
09:15 - 10:0045 mins
Workshop 1: Managing CMC Activities to Accelerate Oligonucleotide Development and Manufacturing
CMC and Regulatory Experiences through Development of the Oligonucleotide Cobitolimod
  • Christine Dieterich Johansson, Ph.D. - Senior Project Manager CMC and Pre-clinical, InDex Pharmaceuticals
09:25 - 10:0035 mins
Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
Understanding the 3-D structures of a Peptide to Determine the Control Strategy for Biological Activity
  • Mark Drew - Business Programme Lead, AstraZeneca
10:00 - 10:3030 mins
Networking Refreshment Break
    10:30 - 11:1545 mins
    Workshop 1: Managing CMC Activities to Accelerate Oligonucleotide Development and Manufacturing
    Accelerating Early Phase Development of Oligonucleotides
    • Kris Ruanjaikaen, Ph.D. - Senior Engineer, ASO Process Development and Manufacturing, Biogen
    10:30 - 11:0535 mins
    Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
    Peptide Oligomers – Friends or Enemies?
    • Lise Giehm, Ph.D - Principal Scientist, Zealand Pharma A/S
    11:05 - 11:4035 mins
    Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
    Automated Approaches to Peptide Preformulation and Biophysics
    • Jesper Søndergaard Marino, Ph.D. - Principal Scientist, Biophysics and Injectable Formulation 1, Novo Nordisk A/S
    11:15 - 12:0045 mins
    Workshop 1: Managing CMC Activities to Accelerate Oligonucleotide Development and Manufacturing
    Panel Discussion with Workshop Speakers
      11:40 - 12:0020 mins
      Workshop 2: Analytical Strategies and Technologies for Peptide Therapeutics
      Concluding Remarks and Discussion
        12:00 - 12:055 mins
        Close of Workshops
          Afternoon Half-Day Workshops
          13:00 - 13:1515 mins
          Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
          Workshop Moderator’s Opening Remarks
          • Stefan Vonhoff - Vice President CMC, NOXXON Pharma AG
          13:00 - 13:1515 mins
          Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
          Workshop Moderator’s Opening Remarks
          • Mimoun Ayoub, PhD - Director and Head of North American and Emerging Markets, CordenPharma International
          13:15 - 13:4530 mins
          Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
          Optimization of Novel Polymeric Delivery Vehicles by Chemical Evolution
          • Ernst Wagner, Ph.D. - Professor and Chair, Pharmaceutical Biotechnology,, Ludwig Maximilans University
          13:15 - 13:5540 mins
          Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
          Stage Appropriate CMC Overview and Requirements for a Robust Dossier
          • Mimoun Ayoub, PhD - Director and Head of North American and Emerging Markets, CordenPharma International
          13:45 - 14:1530 mins
          Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
          Investigations into Disruptive Delivery Approaches for LNA Antisense Oligonucleotides (ASO LNA)
          • Michael Keller, Ph.D. - Senior Principal Scientist, pRED, pCMC, Roche
          13:55 - 14:3540 mins
          Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
          CMC Technical and Regulatory Strategies for Development of Peptides and Oligonucleotides
          • Gary Musso, PhD - President, Musso and Associates LLC
          14:15 - 14:4530 mins
          Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
          Oligonucleotide Drug Product (Development) for (Ultra) Orphan Ophthalmic Diseases
          • Vera Brinks - Director, Pharmaceutics, ProQR Therapeutics
          14:35 - 15:1035 mins
          Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
          Networking Refreshment Break
            14:45 - 15:1530 mins
            Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
            Networking Refreshment Break
              15:10 - 15:5040 mins
              Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
              Scale-up Peptide Manufacturing Case Study: Transition from Solid-phase to Liquid Phase Synthesis
              • Bruce Morimoto, PhD - Vice President, Drug Development, Cerecin
              15:15 - 15:4530 mins
              Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
              Drug Product Strategies for Peptides
              • Dhananjay Jere, PhD - Senior Principal Scientist - Principal Group Leader, Drug Product Services, Lonza AG
              15:45 - 16:1530 mins
              Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
              Formulation Development and Device Options for the Subcutaneous Injection of Spiegelmer Drug Product Solution
              • Stefan Vonhoff - Vice President CMC, NOXXON Pharma AG
              15:50 - 16:3040 mins
              Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
              Drug Product Development and Industrialization for Peptides and Oligos: A CDMO Perspective
              • Umberto Romeo - R&D Manager, Corden Pharma
              16:15 - 16:4530 mins
              Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
              Formulation and Process Parameter Development for the Terminal Sterilization of Antisense Oligonucleotide Drug Products
              • Lani Hack - Engineer II, ASO Formulation Development and Manufacturing, Biogen
              16:30 - 17:0030 mins
              Workshop 4: Accelerating Oligonucleotide and Peptide Drug Development
              Closing Remarks and Discussion
                16:45 - 17:0015 mins
                Workshop 3: Drug Product Development Strategies for Oligonucleotides and Peptides
                Concluding Remarks and Discussion
                  17:00 - 17:055 mins
                  Close of Workshops
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