Nageatte Ibrahim, Author at Arc Nouvel

16 Jul

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The Missing Majority: Why Older Adults Remain the Weakest Link in Oncology Trial Evidence

Over the past decade, oncology has achieved a level of biological precision that would have been difficult to imagine even twenty years ago. Molecular stratification has redefined disease taxonomy, biomarker-driven therapies have reshaped treatment algorithms, and adaptive trial designs have...

16 Jun

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GLP-1 Receptor Agonists and Cancer: Separating Signal from Noise

The GLP-1 and cancer debate is increasingly being discussed not only as a safety question, but also as a prevention and pharmacovigilance question. Recent academic studies are examining whether glucagon-like peptide-1 receptor agonists are associated with cancer risk among adults...

02 Apr

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Oncology Trial Recruitment in the Age of AI: Strategic Insights for Clinical Development Leaders

Over the past decade, oncology drug development has undergone a profound scientific transformation. Biomarker-driven therapies, adaptive designs, and tissue-agnostic indications have expanded what is clinically possible. Yet the operational engine of clinical trials, patient identification and enrollment, has not evolved...

26 Mar

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AI-Generated Control Arms in Clinical Trials: Evidence, Opportunities, and Strategic Considerations

Clinical trials are undergoing structural change. As therapies become more targeted and patient populations more fragmented, the traditional randomized controlled trial (RCT) is increasingly difficult to execute. This is particularly true in oncology, rare diseases, and precision medicine, where eligible...

03 Mar

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FDA Project Optimus: The “Right Dose” in Oncology Drug Development

Oncology drug development is undergoing a fundamental methodological transformation. With the launch of Project Optimus in 2021, the U.S. Food and Drug Administration (FDA) formally signaled that the historical paradigm centered on identifying the maximum tolerated dose (MTD) is no...

23 Jan

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Cancer Vaccines in the Checkpoint Era: Neoantigens, mRNA, and Phase 3 Progress

Cancer vaccines have been pursued for decades, yet repeated late-stage disappointments led many to doubt whether therapeutic vaccination could ever deliver meaningful clinical benefit. Those disappointments were not only about antigen choice, they were also about immune context: many early...

16 Jan

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Why Cancer Drugs Fail FDA Approval: How Clinical Trial Teams Can Prevent Rejection Early

In oncology drug development, FDA rejection is often perceived as a late-stage failure, an FDA Complete Response Letter (CRL) that arrives after many years of pre-clinical development, years of intense clinical work, heavy capital investment, and deep, persistent patient needs....

14 Jan

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6 Oncology Drugs Likely to Receive FDA Approval in 2026: A Clinical and Regulatory Analysis

Each year, the oncology development landscape becomes noisier. Late-stage assets are promoted aggressively, conference headlines amplify early signals, and investor narratives often blur the line between promise and probability. After more than 12 years leading global clinical programs across major...

23 Sep

Announcement
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Arc Nouvel Showcases Innovation at BioTechX USA in Philadelphia

Arc Nouvel Debuts in Philadelphia at BioTechX USA with an Exhibitor Booth featured in the Start-Up Zone of the conference as well as presenting a poster. It was wonderful to connect with so many companies and colleagues in the business. We are looking...

08 Sep

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She’s Gone and Done It: The Inspiring Journey of Dr. Nageatte Ibrahim

At the crossroads of medicine, science, and innovation stands Dr. Nageatte Ibrahim—a physician, scientist, and global leader whose work has reshaped the fight against cancer. Best known for her role in the development of Keytruda, one of the most groundbreaking...

Nageatte Ibrahim

The Missing Majority: Why Older Adults Remain the Weakest Link in Oncology Trial Evidence

GLP-1 Receptor Agonists and Cancer: Separating Signal from Noise

Oncology Trial Recruitment in the Age of AI: Strategic Insights for Clinical Development Leaders

AI-Generated Control Arms in Clinical Trials: Evidence, Opportunities, and Strategic Considerations

FDA Project Optimus: The “Right Dose” in Oncology Drug Development

Cancer Vaccines in the Checkpoint Era: Neoantigens, mRNA, and Phase 3 Progress

Why Cancer Drugs Fail FDA Approval: How Clinical Trial Teams Can Prevent Rejection Early

6 Oncology Drugs Likely to Receive FDA Approval in 2026: A Clinical and Regulatory Analysis

Arc Nouvel Showcases Innovation at BioTechX USA in Philadelphia

She’s Gone and Done It: The Inspiring Journey of Dr. Nageatte Ibrahim

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