Business Plan Development for Early Stage Specialty Pharma Company
Case Study
Scenario:
- Newly incorporated specialty pharma company needs business plan and commercialization strategy for two novel lead drug candidates targeting different cardiovascular indications.
Background:
- Company founded by ex pharma researchers with strong IP position on a series of compounds with novel pharmacokinetic properties to overcome commonly seen adverse events and efficacy limitations of lipid lowering and antihypertensive therapies
- Company needed business planning and development support, and requested assistance with the writing of a business plan
- Company was seeking to raise VC funding prior to commencement of pre-clinical development
Objectives:
- Develop and write business plan
- Refine business strategy
- Explore options for conducting IND enabling pre-clinical studies
- Develop outlicensing goals and strategy
- Conduct market opportunity assessment and competitive analysis
- Explore risks, revenue, and profit opportunities for clinical development and outlicensing of lead candidates
Approach:
- Review literature, secondary data and syndicated market reports
- Identify opportunities and resources to support pre-clinical development
- Define target market, value proposition, current competitors and key competitive drugs in development
- Develop target product profile and commercial needs for clinical development
- Construct early stage demand projections and financial projections based on target product profile, risk, and anticipated market scenarios
- Write draft of business plan for management review
Key Outcomes:
- Developed and wrote business plan
- Identified clinical development consulting partner, made introductions, and managed interactions between partner and company
- Identified potential pharmacogenomics partner for possible collaboration in the development of a complementary diagnostic test to support commercialization of one of lead candidates.
- Developed patient Rx demand and financial NPV models to evaluate changing assumptions and “what if scenarios”
Impact:
- Business plan provided foundation for developing investor presentation and operational plans
- Company was able to raise venture capital funding in the midst of a challenging economic climate
