Jenna Brager, PhD, RN, MS

Vice President of Drug Development for MyMD Pharmaceuticals, Inc.

November 21, 2022

Operational management prior to implementing a Phase 1/Phase 2 trials focuses on pre-clinical work (toxicology) and submission of an investigational new drug (IND) applications.
The personnel needed to execute these essential studies includes:

  • Site Head
  • Senior Director, Safety Evaluation
  • Executive Director(s) of PK and Biostatistics
  • Director of Operations
  • Associate Director, Regulatory
  • Study specific Director
  • Supervisor (Toxicology Services)
  • Executive Director (Veterinarian)
  • Report Coordinator
  • Quality Assurance Auditor

Moving from a pre-clinical focus to submission of a complete IND application requires an additional set of individuals including:

  • Medical Writers (support protocol/IB and IND)
  • Regulatory Lead/Officer
  • Publishing Lead

Transitioning from pre-clinical management and IND submissions to managing clinical trials, of whatever size and complexity, requires a tremendous amount of effort that oftentimes goes unrecognized. For example, a Phase 1 clinical trial at minimum requires the following:

  • Project Lead
  • Clinical Project Manager
  • Site Activation Manager
  • Therapeutic Medical Advisor or Medical Monitor
  • Pharmacokinetics Lead
  • Data Team Lead
  • Project Management Analyst
  • Statistical Lead
  • Clinical Research Associate (unblinded; pharmacy)
  • Clinical Research Associate (blinded; clinical conduct)
  • External Vendors including but not limited to central lab and support staff (lab directors and managers)
  • Manufacturing (Director, Assistant Director(s), Assistant Stability Manager, Project Manager
  • Clinical Staff (Investigator(s), Research Staff
  • Institutional Review Board (IRB)
  • Consultants including but not limited to a Medical Monitor, Internal Medical Writer, Pharmacology/Toxicology Expert, Neurologist, Toxicologist, CMC Expert

Shifting from a Phase 1 to a Phase 2 trial includes a similar set of personnel from a Phase 1 trial with the addition of new roles due to complexity (multi-site, sample size, and staffing):

  • Clinical Project Manager
  • Senior Biostatistician, ECD BIOS (programming)
  • Senior Biostatistician(s)
  • Regulatory Affairs Specialist/ Regulatory Lead
  • Senior Director, Clinical Pharmacology
  • Project Coordinator
  • Safety Lead
  • Senior Director, Medical
  • Clinical Services, Site Payments
  • Site File Specialist
  • Clinical Trial Manager
  • Project Manager
  • Project Manager
  • Contract Senior Clinical Research Associate, Clinical Monitoring
  • Associate Director, Data Management
  • Senior Lead Clinical Data Manager
  • Associate Director of Regulatory Affairs and Drug Development
  • Senior Manager, Regulatory Affairs
  • Director, Medical Writing
  • Medical Writers (1 and 2)
  • Institutional Review Board
  • External Vendors including but not limited to central lab and support staff (lab directors and managers)
  • Clinical Staff (Investigator(s), Research Staff
  • Institutional Review Board (IRB)
  • Consultants including but not limited to: Medical Monitor, Internal Medical Writer, Pharmacology/Toxicology Expert, Neurologist, Toxicologist, CMC Expert
  • Manufacturing (Director, Assistant Director(s), Assistant Stability Manager, Project Manager

Well-designed and executed trials are more complex and labor-intensive than one might realize. As one can see, clinical trials require a tremendous amount of investment in human capital which demands expertise across numerous domains (manufacturing, pre-clinical, clinical trial management, regulatory and medical oversight). Successful implementation is dependent on strong communication across all channels of development.

References

  1. Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). https://doi.org/10.1186/1745-6215-11-78

Dr. Jenna Brager, PhD, RN, MS, is the Vice President of Drug Development at MyMD Pharmaceuticals. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.

Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email jbrager@mymd.com.

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