Articles Archives - Arc Nouvel

26 Feb

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Who is Arc Nouvel: Dr. Vivian Li on Strategy, Risk, and Value in Clinical Development

Across the drug development lifecycle, including pre-IND readiness, early clinical transitions, manufacturing evolution, and regulatory engagement, biotech and pharmaceutical companies turn to Arc Nouvel for specialized guidance. In oncology and beyond, the firm’s clients are often navigating early clinical decisions...

26 Feb

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Who is Arc Nouvel: Dr. Robert Charnas on Regulatory Strategy, Patient-Focused Development, and the Discipline to Stop

Arc Nouvel is a boutique consulting firm that supports pharmaceutical, biotechnology, and investment clients with end-to-end clinical development solutions, strategic consulting, operational support, and executive coaching across early- to late-phase programs. But the firm’s real advantage lies in the experience...

24 Feb

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Who Is Arc Nouvel? A Conversation with Dr. Gavin Liu on Cell Therapy CMC Strategy and GMP Manufacturing

Arc Nouvel works with biotechnology and pharmaceutical companies at inflection points, pre-IND preparation, early clinical transitions, manufacturing evolution, and regulatory engagement. At these moments, scientific promise alone is not enough. What determines whether a therapy advances efficiently or stalls under...

17 Feb

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Rethinking the “Dark Side” With Dr. Ildikó Csíki

For decades, medicine has told itself a story. It is a story with moral clarity: white coats and academic halls represent purity of purpose, while industry, pharmaceutical companies, biotech startups, commercialization offices, lurks somewhere in the shadows, necessary but suspect....

12 Feb

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FDA Accelerated Approval in Oncology: A Strategic Guide for Biopharma

The development of oncology therapeutics is often marked by biological complexity and long timelines required to demonstrate definitive clinical benefit. To address situations in which patients cannot wait for traditional outcome data, the U.S. Food and Drug Administration (FDA) established...

02 Feb

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Rethinking the “Dark Side”: Interview with Dr. Scott Pruitt

For decades, a familiar phrase has echoed through academic hallways and hospital corridors whenever a physician-scientist announces a move into industry: “going to the dark side”. The words are often delivered with a wry smile or a half-joking warning, but...

27 Jan

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Cancer Vaccine CMC Strategy: FDA Expectations for Manufacturing and Regulatory Readiness

Cancer vaccine manufacturing companies engaging the FDA must demonstrate a clear, phase-appropriate CMC strategy that supports both clinical development and eventual licensure. FDA expectations for cancer vaccines, particularly personalized and combination products, extend beyond early IND readiness into manufacturing controls,...

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...

21 Jan

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Who Is Arc Nouvel?

From Merck to Modern Oncology Drug Development: Insights from Eric Rubin, MD Arc Nouvel works with biotech and pharmaceutical companies navigating early and complex decisions in oncology drug development. However, a more important question often emerges: who stands behind Arc...

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....

Articles

Who is Arc Nouvel: Dr. Vivian Li on Strategy, Risk, and Value in Clinical Development

Who is Arc Nouvel: Dr. Robert Charnas on Regulatory Strategy, Patient-Focused Development, and the Discipline to Stop

Who Is Arc Nouvel? A Conversation with Dr. Gavin Liu on Cell Therapy CMC Strategy and GMP Manufacturing

Rethinking the “Dark Side” With Dr. Ildikó Csíki

FDA Accelerated Approval in Oncology: A Strategic Guide for Biopharma

Rethinking the “Dark Side”: Interview with Dr. Scott Pruitt

Cancer Vaccine CMC Strategy: FDA Expectations for Manufacturing and Regulatory Readiness

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

Who Is Arc Nouvel?

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

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