Fall into Innovation: Lynx.MD Gears Up for Life Science – MedTech Conference Season

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 Lynx.MD, 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 Lynx.MD 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 Lynx.MD Technology.
  • Real-World Data Research Collaboration: We’re looking forward to collaborating with partners to define innovative research projects for 2025 that leverage Lynx.MD’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?

Lynx.MD 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! 🍁🍂🎃 🏈

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

The Common Factor Between Gastroenterology, Dermatology and ENT/Allergy Diseases

Author: Dr. Robert Eisdorfer, Lynx.MD chief medical officer and co-founder


The Shared Language of Immunology

At first glance, Gastroenterology, Dermatology, and ENT/Allergy appear to have little in common. As a cornerstone of Lynx.MD’s data and analytics strategy, further explanation should be helpful.

People with seemingly unrelated diseases can have similar experiences because of one common factor: excessive type 2 inflammation, which in itself is part of a normal immune response to allergens and infections. However, when it goes into overdrive, it can contribute to inflammatory diseases such as asthma, atopic dermatitis (eczema), chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis (a chronic and progressive digestive disease), or even certain environmental allergies. Treatments directed at certain interleukins (ie. IL-12, IL-23 etc)work in a variety of disease states including:

  • Asthma
  • Atopic Dermatitis (AD) 
  • Nasal Polyps (NP), or Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) 
  • Eosinophilic Esophagitis (EoE) 
  • Prurigo Nodularis (PN)
  • Certain Food Allergies

Other types of inflammation result in diseases like IBD and psoriasis, and again treatments overlap specialty disciplines. 

From a real-world data (RWD) perspective, large data sets plus predictive analytics and machine learning should enable crucial insights. The correct drug at the right time and dose for each patient, and evaluation of response and natural history in people with more than one disease (ie. eosinophilic esophagitis and asthma). 

Large data sets have already provided insights into the natural history of crs with np, selection and dosing of biologics in different pt populations in IBD. Using LLM’s, images, and videos, along with longitudinal real world data will provide increased understanding of multiple inflammatory and immunologic diseases.

Explore Real-World Data With Lynx.MD

Explore how Lynx.MD’s AI-powered platform can revolutionize your approach to life science research with domain expertise in gastroenterology, otolaryngology, dermatology, and more.

Contact us today to learn about our data resources and industry-leading platform.

About the Author

Dr. Robert Eisdorfer, Chief Medical Officer and co-founder of Lynx.MD is a Gastroenterology Specialist with over 38 years of experience in the medical field. He is passionate about advancing medicine and improving patient outcomes through the application of meaningful medical research and technology. Dr. Eisdorfer works with healthcare organizations around the world to provide strategic guidance for the consideration and adoption of new technology solutions.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

From a Small Startup to a Data-Rich Dream Job: My Journey as a Bioinformatics Data Scientist

Author: Yael Silberberg, VP Data Science, Lynx.MD

Overcoming the Challenges of Traditional Data

As a bioinformatics data scientist, I’ve spent years in the trenches of medical research. One of them was working at a small startup that aimed to find the best treatments for cancer based on biopsy results. In that role, the process was meticulous and slow—each study required us to carefully design a protocol, recruit patients with specific indications, and wait for months to determine whether the treatment was effective. We collected data painstakingly, one patient at a time, over long periods. This is still the case for many diagnostic startups and even large pharmaceutical companies, where every new patient adds a valuable data point, but progress is often measured in small, incremental steps.

A Paradigm Shift: The Power of Pre-Existing Data

When I moved to my new role, the first thing that blew my mind was the sheer volume and accessibility of the data. All the information we had slowly accumulated in my previous job—biopsy images, treatment plans, patient responses—was already here, waiting to be analyzed. And not just for a few patients, but for thousands, across a wide range of indications. It felt like stepping into a researcher’s dream.

While retrospective data should never fully replace the rigor of prospective data, where hypotheses are tested in real time, the ability to rapidly generate and test new hypotheses using pre-existing data is a game-changer. Instead of waiting for months or years to gather enough data to draw meaningful conclusions, I can now leverage vast datasets that span different providers, countries, indications, and populations. The potential to validate findings across multiple datasets, in a fraction of the time it would take in a traditional research setting, is nothing short of revolutionary.

The Impact on Medical Research

This transition has opened my eyes to the incredible possibilities that come with having access to such rich, diverse datasets. Here are just a few ways in which this data is transforming the research landscape:

  1. Accelerating Hypothesis Generation and Testing: In the traditional research model, formulating and testing a hypothesis could take years. With the data now at our disposal, hypotheses can be generated and tested almost as quickly as we can code. This rapid iteration process allows us to explore a wide array of potential treatments and diagnostic markers, refining our understanding at an unprecedented pace.
  2. Enhancing the Power of Retrospective Analysis: While prospective studies remain the gold standard, retrospective analysis using large datasets offers a powerful complement. By analyzing existing data, we can identify patterns and correlations that might not be apparent in smaller studies. Finding new biomarkers that were not even collected in traditional studies. This can inform the design of future prospective studies, making them more focused and effective.
  3. Validating Across Diverse Populations: One of the biggest challenges in medical research is ensuring that findings are applicable across different populations and centers. With access to data from multiple providers and countries, we can validate our hypotheses in diverse patient populations. This not only increases the robustness of our findings but also ensures that treatments are more universally effective.
  4. Streamlining Phase 4 Clinical Studies: Traditionally, Phase 4 clinical studies, which assess the long-term side effects of new drugs, are lengthy and resource-intensive. By leveraging existing data, we can conduct these studies more efficiently, monitoring patient outcomes over extended periods and identifying long-term adverse effects more quickly and without opening a new study, only by analyzing the data that is collected anyway in the clinics .

Challenges and Opportunities

Of course, there are many challenges that come with working with such vast datasets. Data quality, integration across different sources, and ensuring patient privacy are just a few of the hurdles we face. However, these challenges are far outweighed by the opportunities. Having access to this data is the dream of any researcher, offering a chance to make meaningful discoveries that can transform patient care.

The Dream of Every Researcher Reflecting on my journey from a small startup to my current role, I can’t help but feel a sense of excitement and possibility. The transition has not only expanded my access to data but has also broadened my perspective on what’s possible in medical research. The ability to work with such a rich, diverse dataset is something I could only dream of in my previous roles, and I am eager to see how this data will continue to drive innovation and improve patient outcomes in the years to come.

About the Author

In addition to her work with Lynx.MD, Yael is also the Director of Computational Biology at Point6 Bio, where she has been leading research since March 2024. With over a decade of experience in data science and bioinformatics, Yael has held senior roles at Pyxis Diagnostics, including VP of Data Science, and at BiomX Ltd, where she served as Head of Data Science. Her expertise spans big data analytics, computational biology, and bioinformatics, honed through her academic journey at Tel Aviv University, where she earned a PhD in Bioinformatics.

Explore how Lynx.MD’s AI-powered platform can revolutionize your approach to life science research. Contact us today to learn more about our data resources and industry-leading platform.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

Learn from Israeli Healthcare’s Real-World Data Initatives

Author: Lynx.MD

The Israeli healthcare system is leading medical research and innovation through partnerships with Lynx.MD, a medical data intelligence platform. Israel’s biggest healthcare providers: the Government Medical Centers Division of the Israeli Ministry of Health and Clalit Health Services are advancing key strategic data initiatives and leverage secure real-world data sharing to improve patient outcomes.

Unlocking the Power of Real-World Data for Strategic Initiatives

For years, fragmented healthcare data systems and privacy concerns hampered efforts to use real-world data for strategic initiatives. Lynx.MD’s platform bridges this gap. By providing a secure and controlled environment for anonymized data sharing, Lynx.MD empowers healthcare providers to:

  • Fuel Medical Research and Development: The Kineret Project exemplifies this. Lynx.MD integrates with a vast database of patient information, allowing researchers to mine valuable insights for developing new treatments and improving healthcare delivery.
  • Enhance Population Health Management: Clalit Health Services, through its partnership with Lynx.MD, can leverage real-world data to identify at-risk populations and tailor preventive care programs. This proactive approach improves overall population health outcomes.
  • Optimize Clinical Decision-Making: Access to anonymized patient data through Lynx.MD empowers clinicians to make data-driven decisions at the point of care, potentially leading to better treatment plans and improved patient outcomes.

Measurable Results: A Win for All

The partnerships between Lynx.MD and the Israeli healthcare providers have yielded demonstrably positive results. Both Clalit Health Services and the Government Medical Centers Division have leveraged the platform to:

  • Increase Internal Research Projects: The secure and user-friendly platform has streamlined internal research efforts, enabling healthcare providers to initiate and complete a significantly higher number of in-house research projects.
  • Scale Up External Research Partnerships: Lynx.MD has facilitated a dramatic increase in the number of external research partnerships for both providers. The platform allows both provider organizations to securely partner with life science and academic researchers to securely access anonymized data, accelerating collaboration and innovation.

Secure Real-World Data Sharing: A Key to Success

The foundation of these successful partnerships lies in Lynx.MD’s secure real-world data sharing capabilities. 

  • Data Anonymization: Patient privacy remains paramount. In the case of Kineret and Clalit, they are taking the lead on all de-identification of data before granting permissioned researchers to work with the data. For other Lynx.MD partners the Lynx.MD platform ensures sensitive data is anonymized before being accessed protecting patient identities while enabling valuable research and analysis.
  • Granular Access Control: Healthcare providers retain complete control over their data. The Lynx.MD platform allows the provider organization to grant granular access permissions to researchers and institutions, ensuring data is used only for approved purposes.
  • Robust Security Protocols: Lynx.MD adheres to the strictest security protocols, safeguarding sensitive healthcare data and ensuring compliance with regulations.

A Bright Future for Healthcare

The collaborations between Lynx.MD, the Israeli Ministry of Health, and Clalit Health Services create opportunities to advance healthcare discovery informed by real-world data. By addressing strategic data initiatives and leveraging secure real-world data sharing, these partnerships pave the way for a future filled with groundbreaking discoveries, improved population health management, and ultimately, better patient outcomes.

Meet Your Strategic Data Goals

Contact Lynx.MD today to discuss how our industry-leading platform can support your strategic data initiatives and clinical research goals.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

Real-World Data’s Role in Advancing MASH Treatment

Author: Collin Labar

The recent market entry of Madrigal Pharmaceuticals Rezdiffra1, a groundbreaking treatment for metabolic dysfunction-associated steatohepatitis (MASH), marks a significant milestone in gastroenterology care. While this achievement is undoubtedly a testament to the power of pharmaceutical innovation, it also underscores the critical role of technology and real-world data (RWD) in accelerating drug development and optimizing patient outcomes.

As a healthcare data technology company, we are excited to see how advanced technologies and RWD have enabled the rapid progression of Rezdiffra from the clinical trial phase to market approval. These tools have been instrumental in enhancing our industry understanding of MASH and other gastrointestinal diseases, paving the way for developing new and effective therapies. Much of the value is contained in the data itself, and emerging technologies now allow for the rapid extraction of real-time clinical outcomes locked in physician notes, procedure reports, imaging, lab results, and pathology data. 

The Journey Ahead: Market Surveillance and Real-World Evidence

According to BioPharma Dive Rezdiffra has made a remarkable entry into the market, generating $14.6 million in U.S. sales within its first months. This performance has exceeded Wall Street analysts’ expectations and set the stage for potential European commercialization. The drug’s approval is based on its efficacy in improving liver fibrosis and resolving MASH in patients with moderate to advanced liver fibrosis, without requiring invasive liver biopsies for diagnosis.

As Rezdiffra, or any new drug, becomes more widely available, it is essential to closely monitor its performance in the real world to fully understand its impact on patient outcomes. This is where technology and RWD will continue to play a pivotal role.

  • Real-world evidence generation: By leveraging robust data collection and analysis platforms, we can gather comprehensive information on treatment patterns, patient adherence, and real-world effectiveness. This data will be invaluable in identifying potential safety concerns, optimizing treatment strategies, and demonstrating the long-term value of therapeutics after entering the market.
  • Patient experience monitoring: Technology can be used to capture patient-reported outcomes and feedback in real-time, providing insights into the overall treatment experience. This information can help identify areas for improvement in care delivery and patient support services.
  • Identifying emerging trends: Advanced analytics can be applied to RWD to uncover new insights into MASH disease progression, patient populations, and treatment response. These findings can inform future research and development efforts.
  • Data-driven decision making: Real-world evidence is increasingly informing regulatory decisions and post-market surveillance. Given the large number of people waiting for this first-in-class option, it will inform patient selection for treatment.

By harnessing the power of technology and RWD, the industry can continuously monitor, refine understanding, and optimize the care provided to MASH patients. This data-driven approach will not only ensure the successful commercialization of Rezdiffra but also drive innovation in gastroenterology and other MASH-focused therapies.

 Contact us today to explore how Lynx.MD’s AI-powered platform can revolutionize your approach to life science and MedTech research.

  1. Note: This blog post is for informational purposes only and does not constitute any endorsement or affiliation with any specific pharmaceutical company or treatment. It is intended to provide general industry insights on the use of technology and real-world data in the healthcare and pharmaceutical research lifecycle.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

Claims Generate Claims. Lynx.MD Generates Answers.

Author: Lynx.MD

Real-World Evidence For MedTech and Life Sciences

The post-FDA approval environment is undergoing a transformative shift, driven by the increasing importance of real-world evidence (RWE). While randomized controlled trials (RCTs) have been foundational in drug and device development, their limitations in capturing real-world patient experiences have become increasingly apparent. RWE, derived from real-world healthcare data, offers a vital perspective on product performance in the market, empowering medical affairs and market access teams to make informed decisions that benefit patients.

To fully realize the potential of RWE, it is essential to look beyond traditional structured data sources. While valuable, structured data such as electronic health records (EHRs) and claims databases often fall short of capturing the nuances of real-world clinical practice. The untapped wealth of unstructured data, including clinical notes, imaging reports, and patient-generated health data, holds the key to unlocking a deeper understanding on how well therapies perform after receiving FDA approval and in-market.

Here’s how RWE unlocks this potential:

Beyond Structured Data: The Power of Unstructured RWE

Unstructured data offers a rich, narrative-based perspective on patient experiences, treatment decisions, and outcomes. By leveraging advanced analytics and natural language processing (NLP), organizations can extract valuable insights that are often hidden within the text of clinical records. These insights can be used to:

  • Enhance Product Understanding: Unstructured data provides a deeper understanding of how products are used in real-world settings, including off-label use, treatment patterns, and patient adherence.
  • Identify Safety Signals: Early detection of adverse events can be facilitated by analyzing unstructured data for patterns and trends.
  • Inform Product Development: By understanding patient experiences and unmet needs, companies can identify opportunities for product improvement and innovation.

Driving Market Access and Medical Affairs Success

For market access teams, unstructured RWE can be used to:

  • Develop Compelling Value Propositions: Demonstrate real-world effectiveness and impact on cost of care to build robust value propositions for payers and healthcare providers. Uncover evidence of improved patient outcomes, quality of life, and resource utilization to differentiate the product.
  • Optimize Pricing and Reimbursement Strategies: Inform pricing and reimbursement strategies by demonstrating the product’s real-world value and impact on cost of care. Utilize unstructured data to quantify cost-effectiveness and support negotiations with payers.

Medical affairs teams can leverage unstructured RWE to:

  • Enhance scientific understanding: Delve deeper into product mechanisms of action, safety profiles, and real-world effectiveness through in-depth analysis of unstructured data.
  • Inform medical strategy: Identify emerging trends, unmet medical needs, and opportunities for clinical development by analyzing real-world clinical practice.
  • Support evidence generation: Generate high-quality real-world evidence publications to strengthen the product’s scientific foundation and inform healthcare decision-making.
  • Optimize medical communications: Tailor messaging and materials to address healthcare provider needs and concerns based on insights from real-world data.

Overcoming Challenges and Maximizing RWE Potential

To fully realize the benefits of unstructured RWE, organizations must invest in advanced analytics capabilities, data privacy and security measures, and skilled personnel. Collaboration between market access, medical affairs, and data science teams is essential for successful RWE initiatives.

By embracing the power of unstructured data, the pharmaceutical and medical device industries can unlock new opportunities for post-approval success, improve patient outcomes, and strengthen their market positions.

Harnessing the Power of AI and Machine Learning 

While unstructured data offers a goldmine of insights, manually analyzing it can be time-consuming and resource-intensive. This is where the Lynx.MD platform comes in. With Lynx.MD artificial intelligence (AI), natural language processing (NLP), and computer vision, deep insights can be extrapolated efficiently from complex data sources. 

  • AI and NLP can automate the extraction of key data points from unstructured sources like physician notes, PDFs, procedure/pathology reports, and patient surveys. This data can then be used to build robust value propositions for payers and healthcare providers. Imagine AI automatically highlighting sections of clinical notes that discuss improved patient outcomes or cost savings, or pathology finding, empowering teams to focus their efforts on these impactful areas.
    • In a recent Lynx.MD use case, a drug manufacturer needed to identify patient care flow and unmet needs using information that could only be obtained from clinical notes. Lynx.MD’s AI was able to determine whether specific assessments were performed and what factors led to drug switches, providing crucial insights for the manufacturer’s strategy
  • Computer vision can analyze medical images to quantify disease progression and assess treatment efficacy in real-world settings. This data can be used to support product claims and demonstrate real-world value.
    • Lynx.MD’s AI and computer vision has been instrumental in gastrointestinal health care. Analyzing colonoscopy imaging and associated reports to detect adenomas can only be done effectively with AI and computer vision. Lynx.MD’s advanced algorithms can extract these critical insights, enabling researchers to improve early detection rates and treatment outcomes

The Future of Medical Affairs and Market Access

The future of healthcare hinges on understanding the real-world impact of treatments. By harnessing the combined power of traditional data, rich patient experiences, and cutting-edge AI, medical affairs and market access teams can revolutionize how they assess medical devices and therapies.

Lynx.MD leverages advanced AI/ML and Computer Vision to break down data silos by providing a comprehensive platform that captures the full patient experience through both structured and unstructured data. This empowers medical affairs and market access teams to accelerate the delivery of life-changing treatments while optimizing for patient care.

Explore how Lynx.MD’s AI-powered platform can revolutionize your approach to life science research. Contact us today to learn more about our data resources and industry-leading platform.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

175 Million Reasons to Be Excited: How Real-World Data Can Revolutionize Life Sciences

Author: Lynx.MD

The life sciences industry struggles to reconcile its innovative spirit with the slow, data-starved reality of bringing new treatments to patients. Traditional clinical trials, hampered by limited data access and restrictive settings, often lack the diversity and real-world experience needed to deliver unbiased results.

This is what Lynx.MD and our healthcare ecosystem have optimized a solution for. Imagine having access to anonymized information from over 175 million patient interactions, analyzed and enriched by the power of Artificial Intelligence (AI) and computer vision. This enables us to extract deeper insights from various sources, including electronic health records (EHRs), imaging, labs, videos, and more.

That’s the potential that researchers unlock with the Lynx.MD platform. With new data added daily, this rich tapestry keeps growing.

Lynx.MD goes beyond outdated data methods to supercharge life science and medtech research with real-world data (RWD):

  • Closing the Knowledge Gap: Real-world data can provide insights into how patients actually respond to treatments in their everyday lives, not just in a controlled setting. This can help bridge the gap between clinical trial data and real-world effectiveness.
  • Improved Trial Design: By analyzing RWD, researchers can predict and identify patient populations most likely to benefit from a new treatment, leading to more targeted and efficient clinical trials. This can save time and money, ultimately getting effective therapies to patients faster. Similarly, real-time access to unstructured data allows us to identify patients who meet technical inclusion / exclusion criteria on the spot, supporting site selection and patient recruitment
  • Unearthing Hidden Patterns: RWD allows researchers to analyze vast datasets, uncovering patterns and relationships that might be missed in smaller, controlled trials. This can lead to discoveries about drug interactions, treatment side effects, and even the identification of entirely new indications for existing medications.
  • Enhanced Patient Safety: By monitoring real-world use of medications and devices, researchers can proactively identify potential issues. This allows for quicker interventions when needed.
  • Personalized Medicine: RWD can be used to develop personalized medicine approaches by tailoring treatments to individual patients based on their unique genetic makeup, medical history, and lifestyle factors.

Data quality and standardization are important considerations, and patient privacy and ethics are paramount. However, the potential benefits of real-world data to improve healthcare for all are undeniable.

Here are some exciting possibilities for the future:

  • Faster development cycles for new drugs and devices
  • More effective and personalized treatments for patients
  • A more proactive approach to patient safety
  • A deeper understanding of disease progression and treatment response

The future of life sciences is awash with data. By harnessing the power of real-world data, researchers and developers can unlock a new era of medical discovery, ultimately leading to better health outcomes for all.

Explore how Lynx.MD’s AI-powered platform can revolutionize your approach to life science research. Contact us today to learn more about our data resources and industry-leading platform.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

Beyond the Lab: Real-World Data is Vital to Medical Affairs And Market Access

Author: Lynx.MD

The secure sharing of real-world data (RWD) has emerged as a pivotal factor driving innovation and improving patient outcomes across the healthcare industry. For MedTech, life sciences, and biopharma companies, leveraging RWD can significantly enhance medical affairs and market access strategies, ultimately leading to more effective and cost conscious treatments and therapies. Let’s look at how secure data sharing can revolutionize these sectors, focusing on the critical roles of medical affairs and market access.

The Importance of Real-World Data

Real-world data encompasses information collected outside of traditional clinical trials, including electronic health records (EHRs), clinical notes, imaging, claims data, patient registries, and wearable devices. This data provides a comprehensive view of patient health and treatment outcomes in real-world settings, offering insights that are often not captured in controlled clinical environments.

Enhancing Medical Affairs

Medical affairs teams play a crucial role in bridging the gap between clinical research and clinical practice. They are responsible for ensuring that healthcare professionals have access to the latest scientific evidence and that patient care is informed by the most current data. Secure sharing of RWD can significantly enhance the capabilities of medical affairs teams in several ways:

  1. Improved Evidence Generation: By accessing diverse and comprehensive datasets, medical affairs teams can generate robust real-world evidence (RWE) that complements findings from randomized controlled trials (RCTs). This evidence can provide a more accurate picture of how treatments perform across different patient populations and in various clinical settings.
  2. Enhanced Communication with Healthcare Professionals: RWD allows medical affairs teams to provide healthcare professionals with up-to-date, evidence-based information about the safety and efficacy of treatments. This can improve clinical decision-making and patient outcomes by ensuring that practitioners have access to the most relevant data.
  3. Support for Post-Market Surveillance: Continuous monitoring of treatment outcomes through RWD can help identify potential safety issues and adverse events more quickly than traditional methods. This proactive approach to pharmacovigilance can enhance patient safety and ensure that treatments remain effective over time.

Facilitating Market Access

Market access teams are responsible for ensuring that new treatments and therapies are available to patients as quickly and efficiently as possible. Secure sharing of RWD can play a critical role in facilitating market access by:

  1. Demonstrating Value to Payers: Payers, including insurance companies and government health programs, require robust evidence of a treatment’s value before agreeing to cover it. RWD can provide compelling evidence of a treatment’s real-world effectiveness, safety, and cost-effectiveness, helping to secure reimbursement and market access.
  2. Supporting Health Technology Assessments (HTAs): HTAs are used by payers and regulatory bodies to evaluate the clinical and economic value of new treatments. RWD can enhance HTAs by providing additional data on treatment outcomes, patient quality of life, and healthcare resource utilization, leading to more informed decision-making.
  3. Accelerating Regulatory Approvals: Regulatory agencies, such as the FDA and EMA, are increasingly recognizing the value of RWD in supporting regulatory submissions. By providing real-world evidence of a treatment’s safety and efficacy, companies can expedite the approval process and bring new therapies to market more quickly.

Ensuring Data Security and Privacy

While the benefits of RWD are clear, it is essential to address the challenges associated with data security and privacy. Ensuring that patient data is protected and used ethically is paramount. Several strategies can help achieve this:

  1. Data Anonymization and Tokenization: Techniques such as anonymization and tokenization can protect patient identities while allowing researchers to analyze data. These methods ensure that sensitive information is not exposed, reducing the risk of data breaches.
  2. Secure Data Collaboration Platforms: Platforms, like Lynx.MD, enable secure data sharing and collaboration between stakeholders. These environments allow multiple parties to analyze data without directly accessing raw patient information and PHI, ensuring that data privacy is maintained.
  3. Compliance with Regulations: Adhering to data protection regulations, such as HIPAA in the United States and GDPR in Europe, is crucial. Companies must implement robust data governance frameworks to ensure compliance and maintain trust with patients and healthcare providers.

Lynx.MD CTO, Ofir Farchy, addressed these concerns and more in his article for MedCity News, outlining best practices for secure data collaboration in the healthcare sector.

Secure sharing of real-world healthcare data holds transformative potential for these sectors. By enhancing medical affairs and market access capabilities, real-world data drives innovation, improves patient outcomes, and ensures new treatments reach those in need. 

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

Fresh from DIA 2024: How Real-World Data is Supercharging Medical Affairs

Author: Collin Labar

Dia Logo

Just got back from the whirlwind that is DIA! As a Business Development Lead in the healthcare data space, it’s always an energizing experience to connect with industry leaders and get a pulse on the latest trends. This year, one theme dominated conversations: real-world data (RWD) and its transformative impact on medical affairs.

It’s no secret that clinical trials, while crucial, have limitations. They’re expensive, time-consuming, and often lack the real-world context of how patients actually use our products. But DIA buzzed with dicussion about RWD, a treasure trove of information waiting to be tapped. Electronic health records, claims data, wearable devices – it’s all there, waiting to tell a more complete story.

Security First: Keeping Patient Data Safe

Now, data privacy is paramount. Security is at the forefront of every conversation. Stringent regulations like HIPAA are in place, and secure cloud platforms with robust access controls anonymize data while facilitating collaboration between healthcare providers and companies. Think of it like a high-security library – knowledge is shared, but patient confidentiality remains sacrosanct.

The Medical Affairs Game Changer

This secure access to RWD has the potential to unlock a treasure chest of possibilities for medical affairs teams. Here’s what excites me the most:

  • Identifying Unmet Needs: Imagine analyzing claims data and discovering a higher-than-expected complication rate with a specific device. This intel can inform design modifications and future clinical trials, ultimately leading to safer and more effective products. 
  • Speaking the Payer’s Language: Traditionally, value communication meant bombarding doctors with clinical trial data. But with RWD, we can show the real-world value proposition. Did our new device significantly improve patient outcomes? Can we demonstrate cost savings in a real-world setting? This data empowers us to have impactful conversations with payers, potentially leading to faster market access and wider adoption. Faster adoption means more patients benefiting from the latest advancements.
  • Precision Medical Affairs: Gone are the days of one-size-fits-all messaging. Analyzing electronic health records, lab notes, images, scans and more, allows us to identify patient subgroups who benefit most. We can then develop targeted resources for healthcare providers, leading to more informed treatment decisions. It’s about tailoring care, not just promoting products.

The Numbers Don’t Lie: The ROI of RWD

This isn’t just about innovation, it’s about ROI. Studies suggest RWD can cut clinical trial costs by 20% and increase the probability of favorable reimbursement decisions by 10-15%. McKinsey projected that an average top-20 pharma company could recoup more than $300 million annually by adopting advanced RWE analytics alone. That’s real money saved and more resources allocated to developing life-changing technologies.

The Future is Now: AI and the Power of Insights

But the sheer volume of RWD presents a challenge – analysis. That’s where the true potential for AI, machine learning, and computer vision exist. These technologies can automate data cleaning, identify trends, and unlock hidden patterns within massive datasets.

Imagine using AI to analyze X-rays and identify patients who might benefit from a new surgical device based on specific anatomical features. This not only saves us time but also allows us to uncover groundbreaking insights that could improve patient care.

The Next Chapter: A Data-Driven Medical Affairs Revolution

DIA left me with a sense of optimism. The use of RWD is revolutionizing medical affairs, paving the way for:

  • Predictive Analytics: AI can analyze historical data to predict treatment outcomes and identify high-risk patients. This empowers healthcare providers to personalize treatment plans, ultimately leading to better patient outcomes.
  • Engaging Patients on Their Terms: RWD can inform personalized communication channels for patients. Think about targeted educational messages and support groups delivered directly to patients using our specific treatment.

Real-world data, when used responsibly and securely, holds the key to unlocking a future where medical innovation thrives, fueled by the power of real-world information. It’s a future where the patient experience informs how we develop more effective treatments, get them to patients faster, and ultimately, improve lives. And that’s why I’m so excited to be a part of this transformative journey.

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.

Media Alert: Lynx.MD Leveraged for Study on Infliximab Optimization for IBD to be Presented at Crohn’s & Colitis Congress

Study real-world outcomes of IBD infliximab patients with the Anser TDM Test: Presentation by Prometheus using the Lynx GI data library

Lynx.MD, a provider of a comprehensive medical data intelligence platform, is honored to support our partner, Andrew Shim, Medical Affairs, Prometheus Laboratories Inc, poster presentation at the upcoming Crohn’s & Colitis Congress 2024 demonstrating the potential of therapeutic drug monitoring (TDM) to positively impact patient outcomes with infliximab dose optimization.

Poster Session:  Comparing Real-World Outcomes… Using TDM vs. Unoptimized Control Group 

Presenter:  Dr. Andrew Shim, Prometheus Laboratories Inc., University of Minnesota

When:  Friday, January 26th, 7:00 PM – 8:00 PM Pacific

Venue:  Bellagio, Las Vegas

Key points of interest:

  • Large-scale study conducted in real-world community-based practices.
  • TDM-guided infliximab optimization linked to reduced rates of IBD-related surgery compared to standard dosing.
  • Findings add to growing evidence supporting personalized, TDM-driven treatment for improved outcomes and reduced healthcare costs.

This study was made possible through a powerful collaboration between Prometheus Laboratories Inc. and Lynx.MD, a leading real-world medical data platform. Leveraging Lynx.MD‘s rich repository of de-identified clinical data within the Lynx.MD Trusted Data Environment, Prometheus researchers gained unparalleled access to real-world treatment patterns and outcomes in a diverse patient population. This unique partnership exemplifies the power of data-driven research in advancing personalized medicine and ultimately improving patient lives.

Don’t miss this opportunity to learn more about this potentially transformative approach to IBD care at the Crohn’s & Colitis Congress. Attend Dr. Shim’s presentation to discover how data-driven insights can inform IBD treatments.

Additional Information:

#CCCongress24

About Lynx.MD

Lynx.MD offers a secure, SaaS medical intelligence platform for sharing real-world clinical data, accelerating research and development, and providing transformative analytics. With the Lynx Trusted Data Environment (TDE), organizations can collaborate with internal and external developers, data scientists, and researchers to build the next generation of data-informed applications, therapies and care options.