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    Magic Wand Research, LLC (Clin PK Services):

Clinical Pharmacokinetics and Pharmacometrics

OUR VISION:

To provide excellent and rapid PK services and Clinical Pharmacology Lead Services for the Pharma, Biotech, and Medical Device industries in a fraction of a FTE salary.

Per-project or retainer services are provided directly to the company or trough CROs.

OUR SERVICES:

PK ANALYIS & PHARMACOMETRICS SERVICES

  • PK analysis - conducting non-compartmental analysis (required for all Phase-I/II studies), compartmental and population PK and PK/PD analysis using the gold standard software. Data interpretation for CSR and as rapid-turnaround for dose escalation decisions.
  • Serve as the client interface with PMX vendors - supporting the client with all the required interactions with PMX vendors: vendor selection process, analysis plan development, review and provide feedback during the model development and simulation process, critical review of PMX report and writing the Discussion section.
  • First in Human (FIH/FIM) dose selection – integrating pharmacology, toxicology, in-vitro, and animal model data (internal and competitor information) to come up with an agile dose escalation scheme
  • Full PK support – serve as a protocol PK scientist from the study design concept, trough protocol writing, data analysis, to CSR writing. Present PK aspects in Early/Full Development team meetings and governance meetings

CLINICAL PHARMACOLOGY LEAD SERVICES

  • Early Development Team leader for pre-Phase 2b assets. Lead cross-functional development teams with responsibilities to develop and execute the Clinical Pharmacology plans (CDP).
  • Study Director for required Ph-I/II studies - in-charge of all scientific and operational aspects of the clinical study
  • Consulting in preparations and representation for regulatory interactions: regulatory document preparation (briefing books, NDA and sNDA Biopharmaceutics and Clinical Pharmacology Summaries), participation in face-to-face and teleconference meetings with regulators and in preparing responses to Health Authority written questions

ADDITIONAL SERVICES

  • Lectures and courses
  • Compound/ pipeline evaluation for financial purposes (due diligence, VC investments)
  • Connecting, building an asset file, and representing biotech/ small pharma companies to the relevant people/ departments in large pharma companies