Community Spotlight

From First-In-Human to Human Abuse Potential:
Diverse Topics Are on the Table for the Clinical Pharmacology (CP) Community

Beatrice Setnik
CP Community Chair
Vice President
Scientific and Clinical Strategy, Early Phase
Syneos Health


he CP Community is devoted to helping clinical pharmacologists and other early phase clinicians and scientists to collaborate more effectively. It provides educational opportunities in multiple formats to enhance understanding of the complexities of Clinical Pharmacology as it applies to the diverse disciplines involved in the entire life-cycle of product development, and especially early development and translational research. Our core group meets quarterly to ensure timely discussion of topics at upcoming DIA meetings related to the progressive field of clinical pharmacology.

Our objectives are to:

  • provide a dynamic forum to discuss relevant topics in clinical pharmacology through the sharing of knowledge, expertise, and experience;
  • exchange information and discuss current issues related to national and international regulatory guidances, as they apply to clinical trial methodology;
  • support educational exchanges at the DIA by delivering workshops, symposia and other forums focused on topics related to clinical pharmacology;
  • publish position papers on current issues, new regulations, emerging trends, and technology evolution; and
  • influence the regulatory environment as it pertains to clinical trial methods in all phases of drug development.

At the DIA 2018 Global Annual Meeting in Boston, our CP Community held several discussions on first-in-human clinical trials and the evolving methodologies for these studies following the revised European Medicines Agency (EMA) guidance. Even though the new EMA rules are not reflected in current regulatory guidances in North America, it is important to take them into consideration when building protocols for new trials taking place in the US and Canada as well as elsewhere. In recent experience, IRBs have provided feedback to sponsors that is highly consistent with EMA guidelines for first-in-human trials. Many professionals in attendance provided excellent feedback based on their experiences in this area.

Our community is currently working on opinion pieces on various aspects of clinical trial methods. The community is also actively working on an exciting program for next year’s Global Annual Meeting, which will include topics in human abuse potential evaluation and other areas of clinical pharmacology.

Professionals in the CP Community have wide variety of backgrounds. The majority have industry experience within a CRO or Sponsor organization, some within academia or regulatory agencies, and many have multiple perspectives. Most work primarily in applied CP and have various academic trainings, including as physicians, nurses, academics, pharmacists, and in other scientific disciplines, though all are considered clinical pharmacologists. Formal training in clinical pharmacology curricula, however, is not a prerequisite and we warmly welcome any professional interested in this field to join our community.

If you are interested in joining, please contact Beatrice Setnik at and visit our community website.