Improving Patient Health And Safety

A rapidly expanding biotech company was concerned about the strategy and execution of the CMC section for its CAR T-cell therapy program. An experienced CMC program management consultant took the lead in creating a product development plan (PDP). Collaborating closely with the product team lead, cross-functional team members, and relevant vendors, the consultant developed and maintained the plan. Upon completion, the program manager played a crucial role in implementing processes and tools for risk assessment and mitigation, strategic planning, cross-functional communication, and scheduling across the program.

Review other key activities completed by the expert program manager and the outcome of this case study by downloading the PDF below.