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BIOPHARMA’S HAP TEAM

BioPharma’s HAP team consists of a core team of abuse potential specialists that have been involved in the very
first human abuse potential studies conducted under GCP in the early 2000s, and prior to the introduction of the
FDA Guidances on Abuse Potential and Abuse Deterrent Assessment.

Medical Director and Principal Investigator – 15 years of research experience in HAP and Abuse Deterrent Assessment.

Dr. Isabella Szeto MD, CCFP, FCFP, CPI, Principal Investigator – 13 years of clinical research experience with 200+ studies.

Dr. John Oldenhof, MSc, PhD, VP of Clinical Pharmacology – 18 years of experience having overseen 250+ early phase and HAP and Abuse

Deterrent Assessment studies

Shein Nanji, Manager of Subject Recruitment with over 10 years of experience building a robust database of recreational drug user.

Service Detail

Dr. Oldenhof’s 18 year tenure in clinical pharmacology has largely been dominated by his work on the design and execution of HAP programs to support the FDA’s mandate for assessing the abuse potential of novel chemical entities and abuse deterrence for tamper-resistant technologies. His published work and experience includes the development of novel methodologies, innovative study designs and direct collaboration with the US Food and Drug Administration (FDA) to advance human abuse potential studies and pharmacometrics analyses.

  • Regulatory consultation

  • Protocol design and development

  • Clinical study execution

  • Recreational drug user recruitment

  • Data Management

  • Biostatistical analysis, including Statistical Analysis

  • Plan (Development)

  • Interpretation and report writing

  • Ancillary services are also provided through our

    preferred partners

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