プロフィール詳細

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Dr. Richmond B.に依頼

Germany

Forensic Clinical Auditor (PhD) | Oncology & Rare Disease Catalyst Risk | FDA "Red Team" Specialist

プロフィール概要

Dr. Richmond T. Bergner is a forensic clinical auditor and biopharmaceutical strategist with 5 years of experience specializing in "Red Team" due diligence for institutional investors. Unlike generalist scientific consultants who provide high-level overviews, Dr. Bergner executes rigorous, negative-diligence audits to identify structural trial failures, regulatory disconnects, and statistical artifacts before they impact market capitalization. Dr. Bergner's objective is to move the investment thesis from the "Inside View" (management narrative) to the "Outside View" (statistical reality), providing a specific Probability of Success (PoS) vs. Market Implied Probability assessment. His proprietary diligence framework focuses on three core pillars of risk: - Statistical Forensics & "Kill Sheets": Auditing Kaplan-Meier curves for informative censoring imbalances and scrutinizing interim analyses for "p-hacking" or improper alpha spending functions. - Regulatory "Kill Factors": Evaluating assets against evolving FDA standards, specifically FDORA compliance for confirmatory trials and the realistic application of regulatory flexibility in single-arm rare disease studies. - Commercial Reality & SOC Drift: Modeling "Standard of Care Drift" to determine if a pipeline asset will be commercially obsolete upon launch due to competitor velocity or payer friction. Active Catalyst Coverage & Forensic Audits: Pharming Group (Leniolisib): PDUFA audit focusing on payer friction in rare immunology label expansion. Aquestive Therapeutics (Anaphylm): Regulatory precedent analysis regarding FDA posture toward non-injectable delivery systems. REGENXBIO (RGX-121): CMC (Manufacturing) risk assessment and "Commercial Readiness" audit for gene therapy site activation. Merck (Keytruda/Ovarian) & Lantheus (PDUFA) : Reference Class Forecasting and competitive moat analysis . Dr. Bergner is available for deep-dive consultations to stress-test investor conviction, identify "Bear Case" risks, and refine position sizing based on calculated risk/reward scenarios.

専門分野

• ★ Investment Management
• ☆ Drug Development
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Regulatory Affairs

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing, Translation

Research Market Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis, Data Visualization, Text Mining & Analytics, Data Mining, Data Processing, Data Insights

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support

職務経験

Imperial College London

- 現在

Medical Science Liaison

CSL

3月 2024 - 12月 2025

Key Account Manager

Merck KGaA Group

3月 2022 - 2月 2024

Co-Founder and Lead Scientist

Cancer2Life

3月 2018 - 2月 2022

Therapy Area Specialist

AstraZeneca

4月 2020 - 9月 2020

Postdoctoral Researcher

Imperial College London

5月 2016 - 10月 2019

学歴

PhD in Clinical Medicine Research

Imperial College School of Medicine - United Kingdom

10月 2012 - 9月 2016

MRes Clinical and Experimental Medicine (Drug Discovery)

University College London, University of London - United Kingdom

9月 2011 - 9月 2012

BSc (Hons) Biomedical Science

London Metropolitan University

9月 2008 - 7月 2011

認定資格

• Certified Pharmaceutical Consultant (recognized under Section 75, German Medicines Act, AMG)

  German Government

  9月 2020 - 現在

出版物

JOURNAL ARTICLE

Onida, S., Lees, H.J., Bergner, R., Shalhoub, J., Holmes, E., Davies, A.H.(2025). 1H Nuclear Magnetic Resonance Spectroscopy Reveals Changes in Metabolic Phenotype Associated with Disease Stage in Patients with Chronic Venous Disease . European Journal of Vascular and Endovascular Surgery. 69. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 325-333.

Bergner, R.T., Onida, S., Velineni, R., Spagou, K., Gohel, M.S., Bouschbacher, M., Bohbot, S., Shalhoub, J., Holmes, E., Davies, A.H.(2023). Metabolic Profiling Reveals Changes in Serum Predictive of Venous Ulcer Healing . Annals of Surgery. 277. (2). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString E467-E474.

Onida, S., Tan, M.K.H., Kafeza, M., Bergner, R.T., Shalhoub, J., Holmes, E., Davies, A.H.(2019). Metabolic Phenotyping in Venous Disease: The Need for Standardization . Journal of Proteome Research. 18. (11). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 3809-3820.