MJB Pharma Consulting, Inc. Information

With 20 years of drug discovery and development experience, Michael Bargfrede (Principal) provides high-quality clinical PK/PD noncompartmental analyses (NCA) and interpretation to support real-time decision making at every stage of your programs development. MJB Pharma Consulting will support you through the dynamic landscape of drug development, adapting to your business needs and providing quick, thorough turnarounds of analyses for dose escalation meetings, unexpected adverse events, or whatever the challenges of drug development throws at you. Reporting options that range from PK memos to submission ready PK reports and scientific manuscript preparation. Michael’s experience spans many therapeutic areas including oncology, gastrointestinal, inflammation, CNS and immunology as well as small molecule, monoclonal antibody and antibody drug conjugate therapeutic applications. Services include: • PK & PD Noncompartmental Analysis (NCA) • Rapid turnaround times for NCA • Outputs in CDISC SDTM formats • Final analysis using actual collection times • Full PK reports • PK Simulations • Generation of Tables, Figures and Listings (TFLs) • Dose proportionality assessments • Manuscript/Presentation preparations • Data Management • Allometric Scaling • Clinical Pharmacology Project Management