In his current role with Certara, Dr. Heller provides consultancy services to pharmaceutical and biotech companies for non-clinical and clinical DMPK/ADME studies. This includes acting as project lead or strategic consultant to design and manage IND and NDA-enabling ADME programs for drug metabolism, PK, DDI, and radiolabel studies, project management, vendor management, report review and preparation, gap analysis, allometry, as well as conducting human radiolabel dosimetry estimations. In addition, Dr. Heller may serve as a virtual project team representative.

Dr. Heller has over 25 years’ experience providing scientific/technical leadership, consultancy, and operational CRO management to enable ADME and bioanalytical services, with depth in radiolabel studies from in vitro, non-clinical to clinical hAME studies and dosimetry.