To create a project management system to support the early development phase of an emerging biotech company as they prepared their first IND. Tailoring the support to provide a framework that would accelerate their program without adding paperwork and red tape was essential. The projects objectives were to prepare and submit an IND and initiate the proof of concept study immediately following IND allowance. In addition to the activities & deliverables of the 3-functional area leads, those of external consultants, a contract manufacturing organization (CRO) and contract research organization (CRO) also had to be include in the integrated development plan.
The solution included project management process sized for an ultra-small, company, thus abridged versions of a project charter, communication plan and other standard tools were created and completed within the first two weeks. Given the geographic distribution and travel schedule of the team, weekly project team meetings were organized and conducted primarily via web-based platform. These meetings were structured with agendas, minutes and review of action items. Creation of an initial project schedule was followed by integrating the project schedules of the two main vendors. Regular project meetings with the CRO & CMO were also established.
The team’s appreciation of the inter-relationship of the deliverables and the impact of changes prepared the them for negotiations on the timing of activities and outputs from vendors. This yielded an integrated plan with realistic deliverable dates. Roles and responsibilities were defined. Identification of risks and challenges along with impacts and contingency planning, when possible, were elaborated. Early success included on-time submission of RMAT (regenerative medicine advance therapy) and preparations for FDA meeting.