Conference Day Two - Thursday, May 1, 2025

7:00 am Registration & Coffee

7:50 am Chair’s Opening Remarks

Manufacturing Morning: Scaling up Peptide Manufacturing & Logistics for Effective Distribution of GLP-1s

8:00 am Roundtable: Early Considerations for Manufacturing GLP-1s to Streamline Processes & Reduce Delays

Synopsis

  • Ensuring the build of a resilient supply chain to minimize disruption and ensure on time delivery of GLP-1s to patients
  • Discussing the importance of process optimization in reducing cost of goods and scaling up GLP-1 manufacturing processes
  • Identifying and mitigating potential risks throughout the manufacturing and distribution process ahead of time to overcome challenges pre-emptively 

8:30 am Accelerating method Development and Manufacturing of GLP-1 Analogs with LC-UV/MS

Synopsis

  • GLP-1 manufacturers need to meet regulatory standards while maintaining product safety and productivity
  • Orthogonal mass information increases efficiency in informed decisions making in method development and reduces errors
  • LC-UV/MS workflow provides critical insights on GLP-1 identification and impurities/degradants detection

Uncovering the Next Frontier of GLP-1 Based Therapeutics: Novel Strategies for Enhanced Therapeutic Impact

9:00 am RJx-01 & Muscle Quality Protection

9:30 am Advancing GLP-1 Clinical Trials with Quantitative MRI: Multi-Organ and Body Composition Imaging for Deep Phenotyping

Synopsis

  • Beyond weight loss: Using quantitative MRI to track fat distribution and body composition changes in GLP-1 clinical trials
  • Multi-organ insights: Leveraging MRI to phenotype metabolic diseases by assessing liver, kidney, heart, and muscle health
  • Enhancing trial outcomes: Integrating quantitative MRI with traditional biomarkers for deeper patient insights and optimized clinical trial design

10:00 am Session Reserved for Umed

10:10 am Leveraging Gene Therapy Approaches to Promote Durable Weight Loss & Overcome Challenges in Patient Adherence

  • Jay Caplan Co-founder & President, Fractyl Health

Synopsis

  • Advancing incretin-based therapies designed to be a one-time therapy for long-term remission of type 2 diabetes
  • Permanently altering metabolic hormone response in pancreatic islet cells
  • Uncovering strategies to maintain body composition and glycemia after semaglutide withdrawal

10:40 am Morning Refreshments

11:10 am TrialReady: A Real-Time Continuous Symptom Monitoring Platform to Improve GLP-1 Study Adherence, Reduce Trial Risk Metrics, and Track Multimodal Changes in Physiological Endpoints

Synopsis

  • Review multidomain patterns of GLP-1 associated symptoms
  • Introduce TrialReady as the only platform to monitor GLP-1 associated symptoms in real time
  • Discuss behavioral characterization tools to improve adherence and reduce dropout

11:20 am Preventing Professional & Duplicate Participants from Entering GLP-1 Clinical Trials: It’s Not A Matter of If there will be Duplicates. Rather, How Many…

Synopsis

  • Enhancing Patient Safety, Data Quality, and Study Integrity
  • Current trends we are seeing within the GLP-1 space related to duplicate & professional participants and ways to mitigate this risk
  • Why do participants dual enroll? The "participant personas" identified by Verified Clinical Trials
  • How prevention of professional & duplicate participants (vs detection) can save time and money, reduce dropout rates, can reduce placebo response / strengthen efficacy, and make you more competitive

11:30 am Examining the Genetic Risk Factors in the Efficacy of GLP-1 Agonists

Synopsis

  • Understanding how patient variability affects the response to GLP-1 therapeutics
  • Exploring the resistance that can be seen to slowed gastric emptying
  • Genetic effects on incretin signaling 

12:00 pm Novel Peptide Based Therapy to Increase GLP-1 levels Naturally

Synopsis

  • GLP-1 levels Naturally
  • AI based peptide discovery platform developed to create specific potent activating peptide based therapeutics
  • The peptides cause increase in the level of GLP1 in the same pathway used by natural intake of food
  • This approach cause release of GLP-1 to blood stream with less side effects and high satiety feeling

12:30 pm Bioassays and Metabolic Assays for Evaluating GLP-1, GIP, and Glucagon Therapeutics

Synopsis

  •  Measuring Drug Activity – Functional bioassays quantify potency and efficacy of GLP-1, GIP, and glucagon receptor agonists
  • Metabolic Insights – Lipid and glucose assays assess drug effects on fat storage, breakdown, and insulin sensitivity
  • Optimizing Therapeutic Development – Integrated assay strategies provide a comprehensive view of incretin-targeting drug mechanisms

12:40 pm Lunch & Networking

Turbocharging GLP-1 Durability & Patient Support to Drive the Long-Term Maintenance of Weight Loss

1:40 pm xRNA-encoded GLP1 agonist: the Goldilocks solution for safe, durable and titratable therapy

Synopsis

  • xRNA is a synthetic, chemically decorated version of mRNA with longer duration of effect
  • We developed xGLP-1, an xRNA version to introduce GLP-1 peptides, while optimizing the sequence, chemistry and payload to boost in vivo potency and durability by several orders of magnitude
  • Two routes of administration support the opportunity for possible self-administration and various combination therapies

2:10 pm Panel Discussion: Navigating Best Practices to Promote Patient Adherence to GLP-1s for Good Quality, Durable Weight Loss

Synopsis

  • Discussing the value of support in lifestyle choices to support the healthy and productive administration of GLP-1s – should it be compulsory to provide lifestyle management programs along with GLP-1 therapeutics
  • Understanding financial barriers to adherence such as changing insurance landscape for weight loss drugs
  • Highlighting the importance of education and support to ensure that GLP-1s are given to suitable patients

Assessing GLP-1s as a ‘Do it All’ Product & Future Directions Beyond Obesity & Metabolism Indications

3:10 pm Advancing the Use of GLP-1s in Neurodegenerative Disease

  • Adam Bell Vice President - Translational Development & Regulatory Affairs, Neuraly

3:40 pm Chairs Closing Remarks

3:50 pm End of Conference Day Two