Main Conference Days

8.00 am Check In & Morning Coffee

8:50 am Chair’s Opening Remarks

  • Riet Dams Global Head of Pharmaceutical Product Development & Supply, Johnson & Johnson

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

  • Zhigao Niu Innovation Lead & Senior Scientist , Novo Nordisk
  • Peter Knauer Vice President of CMC , Xeris Pharmaceuticals
  • Riet Dams Global Head of Pharmaceutical Product Development & Supply, Johnson & Johnson

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

  • Tarik Soliman Founder & Chief Executive Officer, Extend Biosciences

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

  • Patricia Grasso Professor of Medicine, Neuroscience & Experimental Therapeutics, Albany Medical College

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

  • Vincent Jannin Director, R&D & Head of Innovaformâ„¢ Accelerator, Lonza

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

  • Ruzica Kolakovic Senior Principal Scientist, Drug Product Development Scientific Integrator, Johnson & Johnson

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

  • Zhigao Niu Innovation Lead & Senior Scientist , Novo Nordisk

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

  • Siyuan Huang Senior Director – Product Delivery, CMC Project Management, Eli Lilly

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

5:00 pm Chair’s Closing Remarks & End of Conference Day One

  • Riet Dams Global Head of Pharmaceutical Product Development & Supply, Johnson & Johnson