Clinical Research Focus. 37th Edition

Reflections from JPM 2025: A CEO’s Perspective on Biopharma’s New Era       

Having just returned from the 2025 JP Morgan Healthcare Conference, I am energized by the transformative developments shaping the biopharma industry. With over 8,000 professionals in attendance and more than 500 companies presenting, the conference underscored the resilience, creativity, and forward-thinking mindset driving the sector today.

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FDA Issues Draft Guidance for AI-Enabled Medical Devices

The FDA has released comprehensive draft guidance to support the development and lifecycle management of AI-enabled medical devices, emphasizing transparency, bias mitigation, and safety. This marks a significant step toward aligning innovation with regulatory standards to ensure patient safety and effective healthcare solutions.

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Choosing the Right Endpoints in Oncology Trials

Endpoints are the backbone of successful oncology trials, guiding both clinical decisions and regulatory approvals. Are you selecting the most meaningful endpoints for your studies? Check out our latest video, where we break down key oncology endpoints and provide practical tips on how to choose the right ones for your trial’s phase and objectives. Whether you’re navigating early-phase studies or preparing for pivotal trials, this simple guide is designed to streamline your endpoint selection process.

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NIH Study Links SARS-CoV-2 Infection to Increase in ME/CFS Cases

A new NIH-funded study reveals that SARS-CoV-2 infection significantly raises the risk of developing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Findings show that 4.5% of post-COVID participants met ME/CFS criteria, compared to just 0.6% of non-infected participants. The study underscores the link between infections and chronic conditions, highlighting the urgent need for further research into Long COVID and ME/CFS.

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The Optimus Revolution: Four Years of Progress in Oncology Drug Development

The FDA’s Project Optimus has redefined dose optimization in oncology. After years of collaboration and research, the finalized August 2024 guidance will transform clinical trial designs and drug development, prioritizing better patient outcomes, reduced toxicity, and more personalized therapies. This marks a pivotal moment for biopharma companies, pushing innovation in response to evolving regulatory expectations.

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Medtronic Rolls Out Adaptive Brain Stimulation for Parkinson’s Following EU Approval

Medtronic has introduced the first closed-loop deep-brain stimulation therapy for Parkinson’s disease after securing CE mark approval in Europe. This breakthrough technology uses BrainSense algorithms to provide real-time, self-adjusting neuromodulation for improved motor symptom control. With over 40,000 patients already benefiting from the technology, this milestone represents a significant advance in brain-computer interface innovation.

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Serbia is a Rising Star in Clinical Research

Regulatory timelines for clinical trials in Serbia have fluctuated in recent years, creating challenges for some biopharma companies. However, recent trends indicate a significant reduction in approval timelines, sparking optimism among sponsors and stakeholders. This positive shift reflects Serbia’s commitment to fostering a more efficient and research-friendly regulatory environment

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Abelacimab Shows Breakthrough Potential in Atrial Fibrillation Treatment

The AZALEA-TIMI 71 Phase II trial demonstrated that the Factor XI inhibitor abelacimab significantly reduces bleeding risk compared to rivaroxaban, the standard anticoagulant. The trial showed up to a 69% reduction in bleeding events and a near elimination of gastrointestinal bleeding, marking a major advancement in the safety profile of atrial fibrillation treatments.

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New Breakthrough in BRAF-Mutant Colorectal Cancer Treatment

A Phase 3 trial revealed that a combination of encorafenib, cetuximab, and chemotherapy significantly improves response rates and survival outcomes for patients with BRAF V600E-mutant metastatic colorectal cancer. This novel regimen demonstrated higher objective response rates and more durable effects compared to standard treatments, potentially redefining first-line therapy for this patient population.

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Neomorph and AbbVie Partner on $1.6B Molecular Glue Degrader Deal

Neomorph has secured a $1.6 billion partnership with AbbVie to develop molecular glue degraders—an emerging class of small molecules designed to target previously “undruggable” proteins in oncology and immunology. This collaboration, which includes option fees, milestone payments, and royalties, underscores AbbVie’s commitment to advancing protein degradation technology for immune disorders and cancer therapies.

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