Andrew Michael

About Andrew Michael

MD who chose the industry path and spent the last decade learning clinical development from the inside out.Most physicians in drug development came up through residency and clinical practice. I came up through the operational trenches: monitoring sites, reviewing safety data, working alongside investigators, CROs, and sponsors across 20+ global trials. Then I added the medical layer - SAE review and causality discussions, protocol input, IND-enabling activities.I understand both the science and the operational machinery that makes trials actually run.Recent work- Moderna Phase 3 mRNA vaccine subjects), unblinded monitoring across top-enrolling global sites- OncoC4, Medical Safety Officer on CTLA-4 checkpoint inhibitor program- UroGen, joined pre-IND, contributed to IND-enabling activities for rare disease oncology program- First-in-Human GLP-1 receptor agonist development (Regor)- Led GxP remediation of 49 SOPs ahead of FDA BIMO inspectionWhat I bring:→ Medical judgment grounded in hundreds of SAE reviews and direct investigator collaboration→ Operational fluency across sponsors, CROs, and sites→ Therapeutic depth: oncology, immuno-oncology, vaccines, metabolic disease→ A builder\'s mindset, founded FreeGCP.com to modernize clinical research trainingExploring Medical Director and Clinical Development roles in oncology or metabolic disease.

Experience

1. Principal Medical Consultant

   Pacific Clinical Research Pcr

   Dec 2016 — Present · San Diego, CA, US

   Independent consulting practice providing medical monitoring, clinical development strategy, and regulatory support to biotech sponsors and CROs.Selected engagements:MODERNA (20••••25)Phase 3 mRNA seasonal influenza vaccine trial — subjects globally. Medical oversight and unblinded monitoring. Responsible for 3 of the top 10 recruiting sites worldwide.REVOLUTION MEDICINES (2025)Led GxP remediation of 49 SOPs across clinical operations, pharmacovigilance, and quality systems ahead of FDA BIMO inspection. Delivered on accelerated timeline.ADAGENE (20••••24)Phase 1b/2 immuno-oncology trial — anti-CTLA-4 antibody in combination with pembrolizumab for advanced solid tumors. SAE review and reconciliation across 6 US sites.IMMUNOGEN (20••••23)Phase 1/2 antibody-drug conjugate trial in CD123+ acute myeloid leukemia and hematologic malignancies. Medical data oversight for 2 US sites.REGOR (2020)First-in-Human Phase 1 GLP-1 receptor agonist program. Single ascending dose study in healthy subjects. Site initiation and monitoring.Additional experience with Pfizer (COVID-19 pivotal vaccine trial), Compass Pathways (psilocybin therapy), Portola, Aptinyx, Promedior, and others across oncology, CNS, and rare disease.Core activities across engagements- Medical monitoring and medical data review- SAE/AE review, causality assessment, and narrative development- Protocol development input and amendment support- Cross-functional collaboration with biostatistics, regulatory, and pharmacovigilance- IND application contributions

Education

• Ross University School of Medicine

  Doctor of Medicine (MD)

  2008 — 2012

• California State University, Bakersfield

  Bachelor of Science - BS, Biology

  2007

• Stanford University Graduate School of Business

  Innovation and Entrepreneurship

  2019

Skills

• Medicine
• Checkpoint Inhibitors
• Medical Monitoring
• Clinical Team Leader
• Health Education
• Life Sciences
• Protocol Development
• Oncology
• Adverse Events
• Pharmacology
• Start-Ups
• Clinical Supervision
• Cloud Applications
• Data Management
• Regulatory Affairs
• Disease Management
• Hospitals
• Clinical Operations
• Infectious Diseases
• Research
• Medical Devices
• Clinical Research
• Healthcare Information Technology (Hit)
• Clinical Trials
• CRO Management
• Electronic Data Capture (Edc)
• Wearable Devices
• Patient Safety
• Biotechnology
• SEO
• Crispr
• Good Clinical Practice (Gcp)
• Marketing
• Project Management
• Immunotherapy
• Team Building
• Wearable Computing
• Project Planning
• Clinical Data Management
• Clinical Development