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The Fit-for-Purpose Gap: What RWD Still Gets Wrong

In this session, industry experts Dr. Radek Wasiak and Isabella Even-Chen break down the critical "Fit-for-Purpose Gap"—the misstep of assuming a single, generalized dataset can satisfy every study design, regulatory requirement, or health economics endpoint.

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Clinical

The Fit-for-Purpose Gap: What RWD Still Gets Wrong

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From Clinical Data to Actionable Assets for Pharmaceutical R&D

Precision in Human Biological Samples: Leveraging Regulatory Rigor and Deep Data for Advanced Disease Research

Filling the Gap: Integrating Patient-Generated Data into Real-World Evidence

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Regulatory Evolution in Substantial Evidence: The FDA’s One-Trial Pathway and the Strategic Implications for Biopharmaceutical Development

The Science of the "Gut Feeling": Why Techs are a Lab's Best Diagnostic Tool

Differentiating Between CROs, CDMOs and CMOs: How Each Plays a Role in Drug Development

Understanding Biological Material Licensing for Preclinical Research

Tissue 2 Target

Enhancing Diversity in Clinical Trials: The Role of Systematic Literature Reviews in FDA's DEI Initiatives

From Development to Delivery: Prioritizing Market Access in Biotech and Pharma

Academy of Surgical Research Series 2023

FDA Issues Draft Guidance Recognizing the Role of Real-World Evidence in Learning More about Populations Underrepresented in Clinical Trials for Drugs and Biological Products

The Future of Diversity in Clinical Trials: Real-World Evidence

Chronological Age vs Biological Age: Can Aging be Reversed?

The Need for Speed: Accelerating Bioluminescence Imaging Research

Japan's Thriving Research Scene

Supplier Spotlight: Invicro

Supplier Spotlight: Crown Bioscience

Brain-Derived Tau in Blood: the Future of Alzheimer’s Disease Diagnosis?

Podcast Q&A: Social Media Data: Opportunities and Insights for Clinical Research

Industry Insights with Chris Rand from Aurora Scientific

Fright or Delight? Dopamine-Mediated Fear Response in the Amygdala

Translational Research for Basic and Clinical Research: The World's First NASH to Liver Cancer model-STAM-and Its Clinical Relevancy.

From Behind the Microscope to Under It: A Researcher's Experience Participating in a Clinical Trial

Supplier Spotlight: Cresset Discovery

Supplier Spotlight: BioChain

Supplier Spotlight: Eurofins Discovery

Translational Applications of MiniPDX: An In Vivo Organoid Assay in New Drug R&D [Webinar Recap]

Biomarkers Before the Assay: Sample Strategy and Signal Integrity

From Clinical Data to Actionable Assets for Pharmaceutical R&D

Beyond Exposure: Integrating PK/PD for Translational Predictive Power

Advancing ADC Development: Leveraging AI and Translational Preclinical Models to Improve Clinical Predictability

Using ALS Patient-Derived Motor Neurons to Study TDP-43 Mislocalization

Transcranial Focused Ultrasound Neuromodulation of the Default Mode Network in the Treatment of Depression and Promotion of Wellness

Artificial Intelligence in Preclinical Research: Pathology, Biospecimens, and Model Selection

Network meta-analysis and its role in evidence-based decision-making

Biomarkers from Bench to Bedside: Tools, Targets, and Translational Insights

Breaking the Bottleneck: Harnessing Proteomics Services to Overcome Challenges in Clinical Research

Addressing Orphan and Rare Diseases - A Cutting Edge Conversation

Joint Clinical Assessment 2025: Pioneering Pathways for Oncology, Advanced Therapies & Rare Diseases

RWE reality check: Routine patient health records and regulatory requirements

Migraine: Past, Present, and Future

Pathophysiology of Endometriosis: Current Concepts and Clinical Translations

Indirect Calorimetry for Rodent Research: New Approaches to Enhance Translational Value

Licensing Biological Materials: Crucial Considerations for Preclinical Researchers

Spatial Biology and the Gastrointestinal Tract: Unveiling Cellular Landscapes and Disease Mechanisms

Meeting Ethical & Regulatory Requirements When Using Human Biological Specimens

From Bench to Clinic: Decoding the IND Roadmap for Innovative Cell and Gene Therapies

The Role of Advanced De-Identification in AI-Driven Healthcare

Survival Analysis for Immature Data: A Review of Techniques and Lessons Learned

Market Access - Transforming BioTech Commercial Decisions?

Illuminating Immunohistochemistry: From Biomarker to Clinical Trial Assay

The Translational Utility of Ultrasound and Photoacoustics in Head and Neck Oncology

Delphi Panels: What Are They Good For?

Unraveling European Animal Welfare Legislation for Biotech & Pharma

Patient Voices Matter: Transforming Industry-Sponsored Real-World Evidence with Patient-Centric Approaches

Understanding Animal Welfare Best Practices in Asia Pacific for Biotech & Pharma

Updates in Chronic Traumatic Encephalopathy (CTE)

Strategies to Optimize Commercialization of Oncology Treatments for Younger Adults

Navigating Animal Welfare Legislation in North America: Insights for Biotech & Pharma

Compensatory Mechanisms in Parkinson's Disease

Navigating the Clinical Outcomes Maze: An Overview of Clinical Outcomes Assessments and Why Training Matters

EU HTA Joint Clinical Assessments: Navigating Potential Challenges Ahead of 2025

Cell & Gene Therapies - Beginning with the End in Mind

From Models to Heartbeats: Computational Design of Vagus Nerve Stimulation for Cardiac Health

Bridging the Gap: Strategies for Patient-Centered Real-World Evidence in Rare Diseases

Implantable Circuit-Specific Treatments for Autonomic Dysfunction

Integrating Patient Engagement and Trainee Development in Pre-Clinical Research

Voices to Trials: Engaging Patients in Clinical Trial Design

Partnering with Disease Registries: The Value and Impact for Real-World Evidence Generation

Minimizing the Impact of Cross-Cultural Differences in COA Translations

Transforming clinical research: Scaling real-world data across diseases with expert-led AI

Improving Patient Outcomes: AI-Based Phenotyping for Diagnosis, Treatment, and Clinical Trials

Clinical Trial Innovation: How Healthcare Technology is Evolving

COMPLi HBS Legislation Series: France

Notice of Pre-Application Webinar for RFA-AG-24-009, "Alzheimer's Disease (AD) and AD-Related Dementias (ADRD) Real-World Data Platform (U54 Clinical Trial Optional)"