Harald Reinhart, M.D. has been a successful leader in the pharmaceutical industry for over 25 years. He has led projects from research to lifecycle management, with an emphasis on smart, innovative and streamlined clinical development.
With a science background and a solid understanding of new technologies, he has guided numerous programs from research to the Proof-of-Concept stage, establishing meaningful criteria for target profiles (TPP) and GO/NO GO decisions for full development.
As a global project manager and leader of several high-profile projects, his teams executed numerous Phase 2 and 3 studies that led to NDAs and SNDAs. Under his leadership, several drugs achieved Health Authority approval, including Cipro®, Precose®, Coartem®, Cubicin®, Sebivo®, Osphena®, and Famvir®.
His clinical expertise was a critical success factor in interactions with Health Authorities (FDA, EMA, others) when solutions for risk / benefit issues, guideline questions, or non-standard approaches were needed. He successfully managed inter-company collaborations for several compounds.
As a consultant his expertise is sought in the strategic alignment of programs, the evaluation of drug candidates for development, and for Due Diligence and inlicensing assessments. He and the team at AllphasePharma is helping advance specialty drugs and antibiotics for MDR infections for which unorthodox solutions are required.