8.00 am Check In & Morning Coffee
8:50 am Chair’s Opening Remarks
Elevating Patient Centric Peptide Formulation & Delivery Considerations to Develop Peptide Drugs Using a Human-Kind Approach
9:00 am Industry Leaders Panel Discussion: Starting With End Goals in Mind – Defining Patient-Centric Peptide Drug Delivery & Formulations to Improve Patient Adherence & Patient Outcomes
Synopsis
- Using patient population characteristics to define optimal and impactful peptide therapeutic formulation and modes of administration
- Considering age-appropriate formulations, drug dosing, ability to self-administer, disease characteristics, disease severity, patient experience of treatment and other factors
- Balancing unmet patient needs with commercial value and differentiation of peptide therapeutic product formulation and delivery
Modifying Peptide Structure & Biochemistry to Intentionally Design Peptides With Characteristics More Amenable to Desired Formulation Requirements
9:30 am Exploring D-VITylation Technology & Development of EXT608 as a Once Weekly Long-Acting PTH Peptide Hormone
Synopsis
- Prolonging half-life of therapeutic peptides
- Discussing advantages of vitamin D covalent attachment over existing fatty acid technologies
- Sharing preclinical and early clinical data to demonstrate safety and effectiveness of EXT608 in hypoparathyroidism
10:00 am Translational Pathway of MA-[D-Leu-4]-OB3, a Synthetic Peptide Leptin Mimetic: Enhancing Efficacy by Increasing Bioavailability & Improving Pharmacokinetics
Synopsis
- Outlining how to increase aqueous solubility: C-terminal amide substitution
- Increasing resistance to proteolysis: Alanine scan and D-amino acid substitution
- Reviewing how to increase membrane permeability: N-terminal myristoylation
10.30 am Structured Speed Networking
Synopsis
This informal session provides the perfect opportunity to connect with industry front-runners and key opinion leaders in the peptide-based drug formulation and delivery field. Establish meaningful connections to build upon at the rest of the conference and gain exclusive first-hand insights into the latest research and developments driving progress in the space.
11.00 am Morning Coffee Break
Predicting Translatability of Discovery & Preclinical Systems Into Humans to Accelerate the Pace of Peptide Formulation & Delivery Innovation
11:30 am From Bench to Preclinical & Clinical Translation of Oral Peptides – Are We There Yet?
Synopsis
- Leveraging in vitro assays for developing oral peptides
- Applying ex vivo and in vivo models to assess oral peptide delivery and clinical relevance
- Investigating absorption modelling for oral peptide formulations with permeation enhancers
Investigating Advanced Oral Formulations of Peptide-Based Drug Products to Strive for Double-Digit Bioavailability
12:00 pm Enhanced Oral Delivery of Exenatide: Optimizing Lipid-Based Formulations & Enteric Protection
Synopsis
- Showcasing in vitro and in vivo data from healthy volunteers to highlight the consistent and effective delivery of the payload to the small intestine using Capsugel® Enprotect® capsules, regardless of dosing conditions
- Designing advanced lipid-based formulations with permeation enhancers to improve exenatide’s resistance to proteases and enhance its intestinal absorption as a model GLP-1 receptor agonist peptide
- Tailoring the enteric properties of Capsugel® Enprotect® capsules to the specific requirements of lipid-based formulations and permeation enhancers through our proprietary bilayer manufacturing technology
12.30 pm Lunch & Networking Break
1:30 pm Advancing Oral Peptide Delivery Through Formulation Strategies
Synopsis
- Discussing formulation screening approaches
- Highlighting optimal pre-clinical testing
- Developing formulation strategies to increase permeability
2:00 pm Exploring Solid & Liquid Formulations for Oral Peptide Delivery
Synopsis
- Optimizing SNAC-based peptide formulations to achieve higher bioavailability
- Demonstrating mechanistic understanding of the in vivo behaviours
- Sharing preclinical and clinical data in dogs and humans, and discussing translatability challenges
2:30 pm Impact of Absorption Region on Permeation Enhancer-Based Oral Peptide Delivery: A Case Study
Synopsis
- Reviewing the challenges associated with effective oral peptides delivery
- Evaluating physiological aspects of the gastrointestinal tract, highlighting the advantages and limitations for oral absorption of peptides
- Exploring strategies and challenges for peptide targeted delivery, and analyzing preclinical data following targeted oral administration of a peptide
3.00 pm Afternoon Networking Break & Scientific Poster Session
Synopsis
Want to share your work but not ready for the big stage just yet? The Scientific
Poster Session is prime time to share your work with peers and get their thoughts on
how you can optimize your peptide therapeutic composition and mode of delivery, whilst
building connections for potential collaborations.
3:30 pm Exploring Advanced Formulations for Oral Delivery to Enhance Peptide Bioavailability
Synopsis
- Exploring innovations in encapsulation technology for oral delivery of peptides
- Discussing the key parameters influencing the rational design for oral delivery of APIs
- Investigating the physical and chemical stability of the encapsulation system and the impact on peptide release and functionality
Breakout Roundtable Discussions
4:00 pm Uncover the story behind the leaps and setbacks from the innovators of the peptide-based drug formulation and delivery space. Each roundtable will be hosted by a leader who will share a challenge, question or case study to discuss:
Considerations & Challenges for
High Concentration Subcutaneous
(SC) & Multi-Dose Peptide Injectables
Chen Liang, Senior Scientist,
Novo Nordisk
Discovering Considerations for
Scaling Up Manufacturability
of Novel, Non-Standard Peptide
Formulations
Speaker to be announced
Refining Analytical Development
Methods to Establish Peptide Drug
Product Stability & Efficacy
Dhanashree Surve, Assistant
Scientist, University of Miami
Miller School of Medicine