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Simon Fleming

Veteran of the pharmaceutical industry, fluent in all aspects of clinical trial management, including business development, strategic operations, process improvement, technology implementation and finance. Special focus on global quality management, data management, biostatistics and statistical programming operations.

• Read: Clinical Trial Trends: Non-malignant Hematology

  Clinical Trials

  Clinical Trial Trends: Non-malignant Hematology

  Jan 13, ‘25 | 4 min read

  • 

    Jen Vance

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• Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

  Translational Research - Regulatory - Assays - Gene Therapies

  Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

  Jan 07, ‘25 | 11 min read

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  • Deborah P.

    Maham A.

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• Read: Top Clinical Research Organizations for Rare Diseases in 2025

  Clinical Trials - Rare Diseases

  Top Clinical Research Organizations for Rare Diseases in 2025

  Jan 03, ‘25 | 8 min read

  • 

    Rob Maiale

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• Read: Clinical Trial Trends: Late Phase Oncology

  Clinical Trials - Oncology

  Clinical Trial Trends: Late Phase Oncology

  Dec 12, ‘24 | 5 min read

  • 

    Natacha Grand

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• Read: Clinical Trial Trends: Antibody-Drug Conjugates

  Clinical Trials - Oncology

  Clinical Trial Trends: Antibody-Drug Conjugates

  Dec 10, ‘24 | 5 min read

  • 

    Natacha Grand

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• Read: The BIOSECURE Act’s Impact May Outlive the Bill Itself

  Manufacturing

  The BIOSECURE Act’s Impact May Outlive the Bill Itself

  Dec 10, ‘24 | 1 min read

  • 

    Anshul Mangal

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• Read: Clinical Trial Trends: Early Phase Rare Oncology 

  Clinical Trials - Oncology - Rare Diseases

  Clinical Trial Trends: Early Phase Rare Oncology 

  Dec 03, ‘24 | 5 min read

  • 

    Robert Bauer

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• Read: Custom FSP Models That Help Biotechs Scale Smarter

  Clinical Trials

  Custom FSP Models That Help Biotechs Scale Smarter

  Dec 01, ‘24 | 7 min read

  • 

    Nithiya Ananthakrishnan

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• Read: Chevron Deference: A New Era for Biotech

  Manufacturing

  Chevron Deference: A New Era for Biotech

  Nov 20, ‘24 | 1 min read

  • 

    Anshul Mangal

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