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M. Nielsen Hobbs

Interim Editor-in-Chief, Pink Sheet

Washington, DC

Nielsen has been covering the pharmaceutical industry most of his life, reporting on everything from ANDAs to Zika vaccines. He strongly believes that the user fee system needs to stop using Roman numerals. His favorite stories are ones that help readers understand the personalities and policies that dictate whether their regulatory strategy succeeds or fails. A regular contributor to the Pink Sheet podcast, he also creates infographics and editorial feature images for articles. Before joining Pink Sheet he worked for Congressional Quarterly. Nielsen frequently moderates webinars and panels at industry conferences, and enjoys discussing R2-D2 almost as much as he enjoys talking about 351(k).

Latest From M. Nielsen Hobbs

Clinical Trial Diversity Action Plan Waivers Will Be ‘Very Rare,’ US FDA Official Says

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Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

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Pink Sheet Podcast: BIOSECURE Act Advances, Trial Diversity Sticks, Platform Principles Without Designation

Pink Sheet editors and reporter consider the implications of the BIOSECURE Act as it advances through a House committee, whether industry would improve clinical trial diversity with tougher enforcement of the regulation, as some have suggested, and the FDA’s use of platform technology ideas for gene therapies not participating in the program.

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As Biosecure Bill Moves Forward, Clock Ticking For Industry To Move Away From Chinese CDMOs

Pink Sheet infographic details the timeframes and potential extensions under the House version of the bill, which just cleared committee.

Legislation Manufacturing

BIO Seeks ‘Substantial Runway’ To Shift Away From China As Momentum For Manfacturing Bill Grows

Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.’

Manufacturing Lobbying

What’s The Key To Successful R&D With Artificial Intelligence? ‘Bilingual’ Scientists

Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.

Artificial Intelligence Clinical Trials
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