In his current role with Certara, Dr. Heller provides consultancy services to pharmaceutical and biotech companies in the areas of non-clinical and clinical DMPK/ADME studies, including 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 conduct human radiolabel dosimetry estimations. In addition, Dr. Heller may provide an operational role as a virtual project team representative.

Dr. Heller has over 20 years’ experience providing scientific/technical leadership, consultancy and operational CRO management to enable a platform of ADME and bioanalytical services, with depth in radiolabel studies from in vitro, non-clinical to clinical hAME studies and dosimetry.