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This Workshop will explore the evolution of GLP-1 therapeutics, research into new modalities to treat Diabetes, the future of the GLP-1 market, and innovation in GLP-1 agonists. Each session will offer scientific insights that executives at both large and small pharmaceutical firms can use as they evaluate the future business direction of diabetes therapeutics. 

 

Date: May 13-14, 2025

Time: 10:30-12:15pm ET; 1:00-3:00pm ET (each day)
 

May 13 - Day 1

Get inside the business of one of the currently most impactful and important drug categories and indications – GLP-1 therapeutics for the treatment of diabetes and obesity. On Day 1 we will review the drug class, the scope of the market and what it may still hold in terms of business opportunities. We will look ahead into new modalities in development and get some insight into the complexities of the rapidly expanding space of compounded GLP-1s.
 

May 14 - Day 2

On Day 2 we examine some key hurdles for the development of modalities in this drug class, look further on the horizon of innovation within and beyond the GLP-1 drug class by also discussing issues like patient adherence as well as the role of biomarkers in the discovery of diabetes and obesity treatments.

 

Pricing:

Members:  One Day $400 USD - Full Day $800 USD

Non-Members: One Day $750 USD - Full Day $1100 USD

This course will provide a detailed overview of the quickly growing and diversifying class of oligonucleotide drugs and their conjugates. While RNA-based therapeutics development has been around for more than 20 years, the product class did not see the kind of growth reflective of its therapeutic potential until recent years when key stability and delivery challenges were addressed by new scientific and technology approaches. This course will cover a broad range of topics related to chemistry, manufacturing, and controls (CMC) aspects of oligonucleotide drugs and their conjugates.

Course objectives:

  • Provide an overview of the product class and the different types of RNA-based therapeutics that have been developed
  • Review the overall manufacturing process approaches and associated control strategies
  • Discuss key raw material considerations and challenges
  • Review conjugation options and strategies
  • Consider regulatory approaches, both in terms of licensure pathways and product quality/manufacturing considerations
  • Discuss challenges associated with product complexity and gaps in existing regulatory guidance
  • Discuss phase-appropriate analytical and product-characterization approaches
  • Review approaches to specification-setting for key product quality attributes

Stats Snax discusses basic statistical concepts that apply to the pharmaceutical industry using examples from CMC development areas. Designed for non-statisticians, you will learn foundational concepts that CMC statisticians encounter in their daily interactions with clients.

 

If you have ever wondered, “What is a p-value?” or “How is expiry determined?” – This series is for you!

 

Learning Objectives:

  • Foundational statistical concepts
  • How the topic can be used in daily pharmaceutical operations
  • Proper application of statistical concepts, and common misapplication (as appropriate)
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