Manufacturing & Analytical Characterization
Anuji Abraham, PhD
Associate Scientific Director
Bristol-Myers Squibb Company
New Brunswick, New Jersey
Oral administration of peptides has posed challenges in research and development due to factors such as digestion and limited absorption in the gastrointestinal tract. However, recent advancements, such as Novo Nordisk's development of Rybelsus, have demonstrated the potential for oral delivery of peptides.
The approval of Rybelsus provides an alternative treatment option for individuals with type 2 diabetes who prefer oral medication over injectable formulations. This once-daily oral tablet offers the convenience of oral administration while providing the benefits of GLP-1 receptor agonists in managing blood sugar levels. Additionally, other oral peptides have entered late-stage clinical trials, such as JNJ-2113 from Johnson & Johnson for plaque psoriasis and MK-0616, an investigational oral PCSK9 inhibitor for hypercholesterolemia.
In the session on oral peptide delivery with permeation enhancers, the latest advancements, innovations, and future directions in this field would be covered. Here is a brief description of what could be included in this session:
1. Advancements in Permeation Enhancer Selection and Development:
• Discussion on the latest developments in selecting and developing novel permeation enhancers for oral peptide delivery.
• Exploration of innovative techniques and strategies to enhance the efficacy, safety, and stability of permeation enhancers.
2. Formulation Technologies for Oral Peptide Delivery:
• Presentation of cutting-edge formulation technologies used in oral peptide delivery, including nanoparticles, liposomes, microparticles, and prodrug approaches.
• Showcase of industrial applications and successes in formulating peptides with permeation enhancers for oral delivery.
3. Case Studies and Success Stories:
• The approval and commercial success of Rybelsus (oral semaglutide) is indeed a significant and encouraging development for oral peptide delivery. Rybelsus is the first oral GLP-1 receptor agonist approved by the FDA in 2019 for the treatment of type 2 diabetes.
• The commercial success of Rybelsus is particularly encouraging as it indicates the acceptance and demand for oral peptide delivery in the market. This success not only benefits individuals with type 2 diabetes but also opens up possibilities for the development of other oral peptide-based therapies.
• Showcase of real-world case studies and success stories from industry leaders in the development and commercialization of oral peptide delivery systems with permeation enhancers.
• Highlighting unique formulation approaches, clinical outcomes, and patient acceptance.
4. Industrial Scale-Up and Manufacturing Considerations:
• Insights into the challenges and considerations involved in scaling up the production of oral peptide formulations with permeation enhancers.
• Discussion on manufacturing processes, optimization strategies, and quality control measures for industrial-scale production.
5. Emerging Trends and Future Outlook:
• Discussion on emerging trends, challenges, and opportunities in the field of oral peptide delivery with permeation enhancers.
• Exploration of future directions, potential collaborations, and technologies on the horizon.
Overall, the session would provide a comprehensive overview of the latest advancements, successful case studies, formulation technologies, manufacturing considerations, and future trends in the field of oral peptide delivery with permeation enhancers.
Hot Topic Speaker: Stephen T. Buckley, PhD (he/him/his) – Novo Nordisk A/S
Hot Topic Speaker: Filippos Kesisoglou, Ph.D. (he/him/his) – Merck & Co., Inc.
Hot Topic Speaker: Siyuan Huang, PhD (he/him/his) – Eli Lilly and Company