Case 1: Small Biotech Company

CSTI Case Study: Portfolio Management

Company: Small BioTech Company
CSTI Objective: Establish infrastructure to manage entire portfolio of research and development assets.

SITUATION

  • Sponsor had 3 assets in development and an ever-increasing number of assets in the research phase transitioning to development
  • Portfolio cost forecast, timelines, and resource needs could not be accurately defined
  • Technical personnel were working on advancing research and development efforts but were uncoordinated and communicated infrequently
  • Major fund-raising effort underway
  • Team structure and function was inconsistent among the assets
  • Communication between technical personnel and management was inconsistent and disparate.
  • Timelines were deteriorating and the suitability of data and data reporting quality was questionable

SOLUTION - CSTI Development Management Services

  • Created uniform operating infrastructure for the management of development assets including:
  • Defined the development team structure and personnel competencies for all technical personnel within the following sub-teams: clinical and medical, regulatory, pre-clinical CMC, and commercial as well as the project team lead
  • Prepared full plans for each development asset through commercialization with documented milestones, timelines, deliverables, decision points, and contingency plans
  • Created uniform infrastructure for the management of research assets including deliverables, and key criteria for advancing asset to a candidate for clinical development
  • Significantly improved and formalized communication within the teams and between the teams and management
  • Established system to code and manage costs which included forecasting, invoice validation, and variance tracking. Successfully managed vendor performance to contract and budget using this system
  • Drove implementation of established infrastructure through team training and oversight
  • Implemented and refined all operations to align with changes within the Sponsor organization

RESULTS

  • CSTI processes and expertise enabled the submission of two IND applications within 8 months
  • Upcoming milestones and data assessments were transparent to all stakeholders and this facilitated efficient progression to follow-on efforts with minimal impact on the timeline, budget and quality of data
  • The flexible cost forecasting model facilitated adjustment of the timing of the implementation of planned efforts to align with changes to forecasted cash in-flows
  • Project forecast enabled securing of Venture Capital funding