Tag: DIA

Author: Collin Labar, Life Sciences and Data Strategy Executive

In the past year, leading pharmaceutical companies have invested more than 10 billion dollars in M&A and licensing deals focused on MASH (Metabolic Dysfunction-Associated Steatohepatitis). This marks a dramatic shift in how the industry views this chronic liver disease, once considered too risky and poorly understood to justify major investment.

Today, MASH is among the most dynamic and competitive therapeutic areas, with multiple late-stage therapies in development, strong regulatory tailwinds, and a significant global burden of disease. The race to capture this market has begun in full force.

Key MASH Transactions from the Past 12 Months

The scale of recent transactions speaks volumes about the momentum building around MASH:

• Novo Nordisk agreed to acquire Akero Therapeutics for up to $5.2 billion, including $4.7 billion upfront. Akero’s lead candidate, efruxifermin, is in late-stage trials and viewed as one of the most promising assets in the space.
• Roche announced its acquisition of 89bio for up to $3.5 billion, securing rights to pegozafermin, a Phase 3-ready FGF21 analog.
• GSK acquired efimosfermin from Boston Pharmaceuticals in a licensing deal worth $1.2 billion upfront and up to $800 million in milestone payments.
• A VC syndicate entered a licensing and spinout arrangement for NGM Biopharma’s MASH asset (NGM313) valued at approximately $608 million in total deal consideration.
• Eli Lilly formed a strategic collaboration with OliX, a company focused on cardiometabolic and MASH-relevant RNA programs. While the financials were not publicly disclosed, the deal represents Lilly’s ongoing push into the metabolic space.

Together, these transactions reflect a clear strategic shift. The MASH opportunity is no longer theoretical – it is real, immediate, and massive.

Real-World Data Is Becoming a Strategic Necessity

With multiple therapies expected to launch within a narrow timeframe, clinical differentiation may not be enough. Commercial success will increasingly depend on how well companies understand the real-world MASH population.

Real-world data (RWD) drawn from electronic health records, imaging reports, pathology summaries, and provider notes is already playing a crucial role in helping life sciences teams:

• Accurately size the eligible patient population
• Identify undiagnosed or misdiagnosed MASH patients
• Characterize disease severity and fibrosis progression
• Map the patient journey from NAFL to cirrhosis
• Understand comorbid conditions such as type 2 diabetes, obesity, and cardiovascular disease
• Demonstrate real-world treatment patterns and gaps in care

Why Unstructured Data Matters

The challenge with MASH is that many of the most important clinical details are not captured in structured data fields. ICD codes for MASH and fibrosis stages are underused or inconsistently applied. As a result, structured data alone often misses key insights.

Unstructured clinical text, like biopsy reports, radiology findings, physician narratives, and progress notes can provide critical signals:

• Fibrosis scores (F1 to F4) and steatosis grades
• Mentions of fatigue, abdominal discomfort, or weight changes
• Documentation of lifestyle factors such as alcohol consumption or diet
• Descriptions of patient-reported symptoms and longitudinal progression

Extracting and analyzing this data with natural language processing and AI tools enables a far more complete picture of the MASH patient population.

Looking Ahead

As more therapies reach the market, the ability to capture and interpret real-world signals will become a key source of competitive advantage.

• Companies that can integrate both structured and unstructured data will be better positioned to:
  Support value-based contracts and payer negotiations
• Identify subpopulations for label expansion
• Conduct robust post-marketing surveillance
• Understand treatment patterns across diverse care settings
• Demonstrate real-world outcomes that matter to clinicians, regulators, and patients alike

Clinical trial data may be the foundation for approval, but real-world data will be essential for differentiation, adoption, and long-term success.

Author: Omer Dror, CEO & Co-Founder

When founding Latica, I was constantly haunted by the questions: How can data help bring truly impactful treatments to market faster while ensuring their long-term success and positive outcomes? How do we leverage data to accelerate progress in healthcare? I naturally believe the answer lies in the data, but what I’ve come to know is that in many cases, pulling together real-world data (RWD) from seemingly disparate fields like dermatology, gastroenterology, and otolaryngology can tell a more accurate story.

The Immunological Connection: Why These Fields Hold the Key

The success of this approach lies in the surprising interconnectedness of chronic illnesses, revealing a common thread – immunology and the resulting inflammation. Disruptions in the immune system play a significant role in the development of conditions like psoriasis, inflammatory bowel disease (IBD), and chronic rhinosinusitis (CRS). This overlap presents a golden opportunity: by collecting longitudinal RWD – patient data gathered over an extended period – we can identify shared biomarkers and treatment targets across these conditions.

The Financial Burden of Autoimmune Diseases

The economic impact of autoimmune diseases is staggering. According to the American Autoimmune Related Diseases Association (AARDA), the annual direct healthcare costs associated with autoimmune diseases exceed $100 billion in the United States alone. This figure likely underestimates the true cost, as it only accounts for seven of the more than 100 known autoimmune diseases. When considering all autoimmune conditions, the total annual cost could potentially reach $300 billion.

Let’s break down the costs for some specific autoimmune and allergic/inflammatory conditions:

1. Rheumatoid Arthritis (RA): The annual direct cost of treating RA in the US is estimated at $10.9 billion, with indirect costs totaling $8.4 billion. Some studies suggest the total cost could be as high as $16 billion to $47.6 billion annually.
2. Psoriasis: With approximately 9 million affected individuals in the US, the annual cost of psoriasis treatment ranges from $51.6 to $63.2 billion. Monthly costs for topical treatments can average upwards of $600, while annual biologic costs can range from $40,000 to $50,000 per patient.
3. Multiple Sclerosis (MS): The estimated annual cost for MS treatment in the US is $63.3 billion.
4. Inflammatory Bowel Disease (IBD): Including both Crohn’s disease and ulcerative colitis, IBD affects an estimated 3 million Americans, with total annual U.S. costs exceeding $28 billion. Hospitalizations, surgeries, and long-term medication use all contribute to this high burden.
5. Asthma: Often under-appreciated in the autoimmune context, asthma affects over 25 million Americans. Annual direct and indirect costs top $80 billion, driven by emergency care, medication, and lost work/school days. Asthma also frequently overlaps with CRS and atopic conditions, making cross-specialty data even more vital.

Beyond the Finish Line: The Untapped Value of Post-Approval RWD

The traditional drug development model often overlooks a crucial phase: what happens after a drug receives FDA approval? This is where RWD shines. Here’s why:

Unveiling the Real-World Picture: Clinical trials offer a controlled environment, but they don’t capture the complexities of real-world use. RWD paints a more holistic picture, revealing how patients respond to treatments in their everyday lives, including potential side effects and long-term efficacy.

Precision Medicine Takes Flight: Imagine tailoring treatment plans not just to a primary condition, but to a patient’s unique profile across specialties. Diverse RWD empowers this kind of personalized approach, potentially leading to improved outcomes and reduced healthcare costs.

The Economic Impact of Early Diagnosis and Treatment

Early diagnosis and treatment of autoimmune diseases can significantly reduce healthcare costs. For example, studies have shown that RA patients miss an average of 7.92 work days per year compared to 4.34 days for individuals without RA. By identifying and treating these conditions earlier, we can potentially reduce both direct medical costs and indirect costs associated with lost productivity.

Turning the Tide: Overcoming Challenges

Of course, there are challenges. Integrating data across specialties, ensuring patient privacy, and utilizing notes that contain crucial insight into the patient experience, disease severity, and clinical outcomes require focused efforts. However, the potential rewards far outweigh the hurdles.

The Future is Connected: Seizing the Opportunity

By embracing RWD we can unlock a new era of post-approval success. Imagine a future where data is used for precision targeting of patients most likely to respond to a given treatment and clinical pathways are continuously refined based on real-world data, leading to better patient outcomes, less switching of treatments, and reduced cost. This is the power of connecting data, and those who recognize its potential will be at the forefront of the next wave of medical innovation.

The call to action is clear: Let’s leverage the power of RWD to bridge the gap between approval and long-term success. Together, we can ensure that our innovations not only reach the market faster but also deliver on their promise to improve patients’ lives in the long run while potentially reducing the enormous financial burden of autoimmune diseases on our healthcare system.

Reference Sources

General Cost of Autoimmune Diseases: The American Autoimmune Related Diseases Association (AARDA) reports that the annual direct healthcare costs associated with autoimmune diseases exceed $100 billion in the U.S. This figure is likely an understatement, as it only accounts for seven of the more than 100 known autoimmune diseases, with the total costs potentially reaching $300 billion annually.

Rheumatoid Arthritis (RA): The direct cost of treating RA in the U.S. is estimated at $10.9 billion, with indirect costs totaling $8.4 billion. Some estimates suggest that the total cost could range between $16 billion and $47.6 billion annually.

Psoriasis: The annual cost of psoriasis treatment is estimated to range from $51.6 billion to $63.2 billion. Monthly costs for topical treatments can average upwards of $600, while annual biologic treatment costs range from $40,000 to $50,000 per patient.

Multiple Sclerosis (MS): The estimated annual cost for MS treatment in the U.S. is approximately $63.3 billion.

Economic Impact of Early Diagnosis and Treatment: Studies have shown that patients with RA miss an average of 7.92 workdays per year compared to 4.34 days for individuals without RA, highlighting the indirect costs associated with lost productivity.

Author: Collin Labar

Looking Ahead to Fall 2024 🍁 Life Science Events

Fall is not just the season of football, cooling temperatures, and everything Pumpkin Spice-related. It is a time of discovery in the Life Science and MedTech world. Conferences like MedTechX, ARS 2024, HLTH, DIA Real-World Evidence, and ISPOR Europe draw the brightest minds – researchers, data scientists, informaticists, market access experts, and medical affairs teams – eager to explore the cutting-edge technologies that will revolutionize the way we develop, launch, and monitor therapies.

At Latica, we’re particularly excited about the role Artificial Intelligence (AI) and Large Language Models (LLMs) are playing in this transformative journey. These technologies are fueling significant advancements in real-world data analysis, a crucial aspect of drug development and post-market surveillance.

As we head towards these industry gatherings, here’s what we at Latica are excited about:

• Poster Presentations: Partnering with industry leaders, we’ll be showcasing insightful research based on real-world data that has only recently been available via Latica Technology.
• Real-World Data Research Collaboration: We’re looking forward to collaborating with partners to define innovative research projects for 2025 that leverage Latica’s extensive RWD dataset. Our platform and partnerships create a unique data resource powered by over 175 million real-world patient encounters and millions of valuable unstructured data points, providing a powerful platform for groundbreaking discoveries.

Ready to Leverage Real-World Data for Success?

Latica offers a comprehensive solution for harnessing the power of real-world data.

We’d love to meet you at one of these industry events for coffee and data-driven conversations.

Connect with us on LinkedIn or use the Contact Us link to learn more about how to achieve breakthrough results and develop impactful research for future events. 

Don’t miss the opportunity to revolutionize your approach to medical activities, drug development, and market access this fall! 🍁🍂🎃 🏈