Consider a biopharma company's journey
Multiple phases of rapid growth
- Clinical trials
- NDA submission
- FDA approval
- Additional pipeline assets
Significant challenges and risks
- R&D productivity & disruptive technologies
- Compliance/regulatory
- cGMP manufacturing and supply chain
- Cash flow
Substantial dependence on suppliers
- R&D: CRP, PV, lab services and supplies
- Tech Ops: CRO, CDMO, quality, product development
- Commercial: Medical education, KOL/Ad Board, media
- Administrative: Legal, consultants, IT, HR services
Now consider some supplier risks and costs...
Supply Risk:
- Will you outgrow your current CRO capability?
- Can your pharmacovigilance supplier support your growth?
Finance Risk
- Do you have internal audit issues related to the supplier contracting and payment processes?
- Is your finance staff overworked trying to manage the supplier master data file?
Operational Structure
- Are departments adding headcount to their staff to manage suppliers?
Cost Management
- Is there a “new normal” to frequently revise budgets due to growing supplier spend and unexpected invoices?
Enterprise Risk
- Are there enterprise risk factors (pandemics, global unrest, sustainability, etc.) which should be included in the supplier and category management process?