8:15 am Morning Coffee & Networking
8:45 am Chair’s Opening Remarks
Advancing Coating for Targeted, Stable & Permeating APIs
9:00 am Optimizing Polymer Coatings to Enhance GI Tract Penetration
Synopsis
• Profiling degradation strategies to improve predictability of polymer coatings
• Creating solid dosage formulations for controlled and delayed release
• Investigating the uses of pH-dependent interocoatings and highlighting their unreliability
9:30 am Targeting the Brain With Novel Nanoparticle Formulation
Synopsis
• Reviewing animal study results showing high bioavailability with novel nanoparticles
• Achieving tissue-specific targeting in the brain with single-layer targeted nanoparticles
• Exploring the promise of liposomes and addressing stability issues
10:00 am Ensuring Reliable Release With Both Polymer & Starch Coatings
Synopsis
• Precision targeting of peptides to the lower GI tract, specifically colon
• Application of stabilization and permeability enhancement technology
• Sharing ex vivo human GI model data and in vivo rodent PK/PD data from protein therapeutics
10:30 am Morning Break & Networking
Informed Formulation Strategy to Increase Peptide Permeability & Efficacy
11:30 am Roundtable Discussion: Adapting Formulation Approaches for Larger Peptides
Synopsis
• Proposing best practices when formulating for oral delivery of larger APIs
• Addressing secondary structure and folding challenges for larger peptides
• Exploring nanobody scale applications in autoimmune diseases, cancer diagnostics, and biosensors
12:00 pm Overcoming Challenges in Formulation of Peptides in Sterile Suspension
Synopsis
• Advantages of particulate suspensions
• Challenges in scaling from the research lab to pilot manufacturing
• Challenges in aseptic formulation and filling
12:30 pm Networking Lunch
Going Beyond Permeation Enhancers for Double Digit Bioavailability
1:30 pm Navigating the Possibilities of Traditional Permeation Enhancers
Synopsis
• Recounting the toxicity, variability and success of commonly used permeation enhancers including SNAC and C10
• Employing surfactant-based fluidization of membranes to enhance permeability
• Extrapolating the potential of second and third-generation permeation enhancers
2:00 pm Enhancing Bioavailability With Orally Delivered Peptide-Toxin Conjugates
Synopsis
• Leveraging single lipid membrane trafficking with bacterial toxins bound to glycosphingolipids
• Penetrating epithelia in the GI tract and achieving intracellular delivery of oral peptides
• Challenging single digit bioavailability and avoiding toxicity when targeting GLP-1 and GLP-2
2:30 pm Afternoon Break & Networking
Future Capabilities of Advanced Peptide Therapeutics
3:00 pm The State of Play in Oral Insulin Formulation
Synopsis
• Optimizing oral insulin formulations for cost efficiency and patient compliance
• Overcoming stability challenges to ensure a long shelf life
• Navigating regulatory considerations for cost-efficient oral insulin products
3:30 pm Optimizing Formulation With Speed: The Applications of Robotic Screening
Synopsis
• Streamlining formulation with informed data on the target tissue
• Advancing screening processes for thousands of excipient and coating combinations
• Assessing novel peptides and formulation approaches for various targets