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Huston Associates, LLC

Scientific & Market Driven Biopharmaceutical Development Planning and Execution
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Huston Associates, LLC
Over 30 years of biopharmaceutical and device development experience
15 Years as Huston Associates providing the means to take drugs and devices from research and development, through regulatory approvals, to commercialization.
Company history
Founded in August 1999
Clients have ranged from start-up to mid-tier pharmaceutical companies
Various client responsibilities including interdisciplinary project team management, partnership alliances, representation to federal regulatory (FDA) and granting agencies (DoD and TATRC), FDA and EMA regulatory submissions, clinical trials designs and operations.
On-site training (Clinical & Regulatory Development)
Program Chair - UC, Santa Cruz Clinical Trials Design and Management
Instructor, Clinical Trials Designs at UC, Santa Cruz - Regulatory and Clinical Management Certificate Programs
Instructor and program advisory board at UC, Berkeley Extension
  • Biologics for pain and inflammation
  • Small molecules for neurologic indications, oncology, and anti-infectives
  • Drug/device combinations for diagnostics, ex-vivo tissue processing, and drug delivery
  • Gene therapy for hematologic and neurologic indications



Select Huston Associates' Achievements

  • Six INDs, including 4 in eCTD format and submission
  • 2 NDAs and 1 MAA approved
  • Regulatory Defense - preparations and FDA meetings
  • Several Phase 1 - 3 clinical trials - designs, planning, and execution
  • Alliance and project management for 8 partnerships
  • Refined clinical trial processes and selection of safety database systems
  • Managed multi-year federal awards totaling over $40 million

Industry experience prior to establishing Huston Associates, LLC - Click here

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