View From the Summit Archives - Summit Clinical Research Defining the Future of Therapeutically Focused Research Thu, 08 May 2025 21:27:21 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.1 https://summitclinicalresearch.com/wp-content/uploads/2021/12/cropped-summit_site_icon-32x32.png View From the Summit Archives - Summit Clinical Research 32 32 Summit Clinical Research at the 2025 EASL Congress in Amsterdam https://summitclinicalresearch.com/summit-easl-2025-conference/?utm_source=rss&utm_medium=rss&utm_campaign=summit-easl-2025-conference https://summitclinicalresearch.com/summit-easl-2025-conference/#respond Thu, 08 May 2025 20:13:34 +0000 https://summitclinicalresearch.com/?p=11549 The post Summit Clinical Research at the 2025 EASL Congress in Amsterdam appeared first on Summit Clinical Research.

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Summit Clinical Research is proud to announce our participation in the 2025 EASL Congress in Amsterdam, Netherlands, from May 7-10, 2025. As leaders in liver disease research, Summit will present groundbreaking findings focused on Metabolic Dysfunction-Associated Steatohepatitis (MASH), liver fibrosis, and innovative treatment approaches.

Our team, including esteemed scientists and leadership, will showcase cutting-edge research through oral presentations, poster sessions, and a symposium, discussing advancements in MASH, liver fibrosis, and novel non-invasive biomarkers. These presentations reflect Summit’s commitment to advancing the understanding of liver diseases and improving patient outcomes.

What You Can Expect from Summit at EASL 2025:

Oral Presentations:
  • Efruxifermin Improves Fibrosis in MASH Cirrhosis Patients (SYMMETRY Trial)
  • Sustained Improvements in Biomarkers with Survodutide in MASH and Fibrosis
Poster Presentations:
  • Non-invasive Markers to Predict Biopsy Response in MASH and Fibrosis Patients
  • General Characteristics of Patients Prescribed Resmetirom
  • Resmetirom Treatment Improvements in Liver Stiffness and Fibrosis Biomarkers for MASH Cirrhosis
Symposium:
  • Is Liver Biopsy Still Required in Clinical Trials for MetALD and ALD?

Key Topics We’re Focusing On

Our presentations at EASL 2025 will cover a range of critical topics that are transforming the landscape of liver disease research:

  • MASH and Fibrosis Treatment: We will delve into promising therapies like survodutide and efruxifermin, which are showing potential in improving liver fibrosis in patients with MASH.
  • Non-invasive Biomarkers: We’ll present research on the role of non-invasive markers in predicting biopsy responses, providing alternative methods for monitoring liver disease progression.
  • Patient Demographics: Our research includes an analysis of racial and ethnic demographics in MASH clinical trials, shedding light on how diverse patient populations respond to treatments.

Meet Our Leadership

In addition to our scientific team, Brandon Early, President, David Rosa, Director of Business Development, and Michelle Mazuranic, Vice President of the Center of Learning, will be attending the conference. They will be available to discuss Summit’s capabilities in clinical research, patient recruitment, and our innovative approaches to clinical trials in liver disease.

Why Connect with Summit at EASL?

Summit Clinical Research has a long-standing commitment to advancing liver disease research. Our team’s participation in EASL 2025 is an opportunity to engage with industry leaders, share our latest findings, and collaborate on advancing liver health. Whether you’re a researcher, healthcare professional, or industry partner, we welcome the opportunity to connect with you and discuss the latest advancements in clinical research.

If you’re attending EASL 2025, we invite you to schedule a meeting with Brandon, David, or Michelle to learn more about Summit’s work in liver disease research and our role in shaping the future of clinical trials.

Looking Ahead

We are excited to contribute to the conversation at EASL 2025 and look forward to connecting with like-minded professionals who are equally passionate about improving outcomes for patients with liver diseases like MASH. Together, we can continue to drive innovation and make meaningful strides in the fight against liver fibrosis and metabolic liver diseases.

Stay tuned for updates during the conference, and be sure to follow our social media channels for live insights from the event.

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Summit Clinical Research Expands Global Reach and Trial Portfolio https://summitclinicalresearch.com/summit-clinical-research-expands-global-reach-and-trial-portfolio/?utm_source=rss&utm_medium=rss&utm_campaign=summit-clinical-research-expands-global-reach-and-trial-portfolio Wed, 19 Mar 2025 19:07:20 +0000 https://summitclinicalresearch.com/?p=11197 The post Summit Clinical Research Expands Global Reach and Trial Portfolio appeared first on Summit Clinical Research.

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Summit Clinical Research continues strong growth, surpassing 120 sites in the Summit network, and over 60 trials. We continue our growth across multiple continents with presence in North America, Latin America, and Europe.

  • 8 Countries are now part of the Summit Clinical Research network.
  • The countries contain over 120 sites, adept in hepatology, obesity, and Alzheimer’s disease trials.
  • Cumulatively we’ve executed trials with over 70 sponsors.

We are grateful for our clinical trial sponsors, sites, and patients for their continued trust in Summit.

Summit began in the hepatology area and established a reputation for executing high-volume trials while maintaining a keen focus on data quality. Today, our services stretch beyond hepatology:

  • Hepatology trials such as MASH and MASLD continue to be a key component to our trials.
  • Given the high volume of screen failures in MASH, we support obesity trials to offer patients various options.
  • We’ve expanded in Alzheimer’s disease to capitalize on the overlapping procedural load.

We look forward to supporting your trials. Reach out to learn more!

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2024 End of Year Report https://summitclinicalresearch.com/2024-end-of-year-report/?utm_source=rss&utm_medium=rss&utm_campaign=2024-end-of-year-report Wed, 19 Mar 2025 16:21:42 +0000 https://summitclinicalresearch.com/?p=11178 The post 2024 End of Year Report appeared first on Summit Clinical Research.

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All pathology results have been resulted.

All screening windows have closed.

And eligible patients from 2024 have been randomized.

Even though it’s already the beginning of March, we’re excited to dive into some of the learnings from Summit Clinical Research in 2024.

As many of you may know 2024 was incredibly challenging for the Summit family with the passing of our co-founder, Dr. Stephen A. Harrison. Despite our sadness we are excited about the ways that we are investing in Dr. Harrison‘s legacy. Dr. Harrison never slowed down in life and would surely want to honor this momentum as caretakers of the companies he founded. We are eternally grateful to our families, our friends, site staff, and employees for the support you’ve shown us. We look forward to sharing more with you this year.

In contrast, 2024 was also a monumental year with the launch of the first US FDA-approved MASH drug, Rezdiffra® (resmetirom) from Madrigal. Summit Clinical Research was honored to play a large role in the development of this new drug. This launch is an exciting moment for the patients who may benefit from this treatment. It’s also an important pivot point for drug developers as they seek to understand the impact, if any, on their development plans. We expect to see further development of Rezdiffra in new patient populations for label expansion, and to better understand the experience of this drug in the real world offering important insights into liver and metabolic disease.

Figure 1

Summit Clinical Research initiated 15 new trials in 2024 bringing our total to 71 clinical trials since company inception in 2018 (Figure 1). These trials certainly bring new treatment options to patients in their respective disease states. They also create potential competition among drug developers and this topic is one of our most common points of engagement with sponsors in the metabolic and liver disease space. Given the breadth and depth of Summit’s involvement with these trials we have key insights to aid in site selection, site engagement, patient enrollment, patient retention, and overall trial success.

Though Summit experienced a 14% percent growth in new trials from last year, and not represented in the image, this count of new trials is lower than industry expectations. Anecdotally, these shifts appear to be delayed starts rather than cancellations, and 2025 is already off to a busy start with new trials. We’re tracking a few key trends in this “stutter step” we saw for new trial starts in 2024:

  1. Harrison’s untimely passing: Dr. Harrison was an accelerant for the entire therapeutic area. He acted as KOL and/or medical advisor for myriad sponsors; he helped sponsors network with Summit sites; he encouraged Summit sites to expand and grow (such as Pinnacle Clinical Research growing to 11 locations); he connected sponsors with Summit Clinical Research to execute the best trials; and he laid the foundation for innovation in the MASH space for Summit to perpetuate.
  2. Commercial launch of Rezdiffra: the US FDA approval of Rezdiffra (resmetirom) is monumental, and along with the adoption of the new drug is the requisite shifting of other development programs as sponsors figure out what, if anything, will happen to their programs. This launch also brings added visibility to the MASH disease area which has a halo effect to other MASH development programs with the hope that prescribers and patients are more aware of the disease.
  3. Adoption of GLP-1: Recent estimates are 1 in 8 patients in the US are using a GLP-1 treatment. These treatments have shown weight loss efficacy for some patients and also are studied across the metabolic spectrum including Type 2 Diabetes, MASH, and now Alzheimer’s Disease. These drugs offer compelling combination opportunities in these diseases. However, drug developers must navigate how to evaluate the efficacy of their drugs against GLP-1, as well as determine how to consider GLP-1 exposure at the patient level.

As we face this challenging landscape together, what challenges and opportunities do you see? Get in touch with Summit…

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