By Julie Rosenberg, MD Biopharma startups often need senior-level expertise as they navigate the drug development process. However, hiring a full-time executive can be financially out of reach. These companies...
The client was preparing to start a major submission for a marketing authorization in a rare disease and was faced with critical timelines and a complex development program. They needed their Clinical Submission Team Lead to be decisive yet adaptive during what was expected to be a challenging submission process.
In the dynamic landscape of Biotech, Pharma, and life sciences, Biopharma consultants play a pivotal role in driving success for Pharmaceutical companies, healthcare providers, and other key stakeholders. As a...
A global pharmaceutical company had over 4 active INDs, with more than 20 clinical studies in phase 2 and phase 3 in oncology indications. Full-service CROs were utilized for each program, but after turnover at both the client company and the CROs, a decision was made to reassign the studies to a central, US based staff. This new study allocation lead to a lack of continuity, internally and externally, and the new team was having trouble getting up to speed on the clinical status of the programs. In parallel, a business decision was made to internalize data management operations.
