Avoid the line with Build-to-Suit
  
Advance assets in a risk-mitigated and separate clinical and non-clinical infrastructure to avoid being a part of the masses once concepts are proved and assets advanced.

Build-to-Suit

  
Prevail acts as a single source of responsibility for both clinical and financial outcomes. Our build-to-suit approach prompts companies to evaluate their development strategies from taking into consideration the most efficient and cost-effective way of advancing a clinical asset to executing a clinical plan that maximizes the asset’s unlocked value. This comprehensive approach links the business strategy to the clinical asset. Other benefits include:
 
  • Project financing from Prevail Partners
  • Achieving your specific financial and control objectives as determined by your long term clinical development strategy 
  • Leveraging Prevail’s industry-leading norms for clinical development performance and outcomes (e.g., guaranteed database lock within 48 hours of receiving last patient data) 
  • Maximizing selection and oversight of qualified and experienced consultants and others 
  • Transforming clinical development from a fixed to a variable cost 
  • Enable ongoing, vital input from current or prospective strategic partners (licensees, investors, payers) through a patented collaboration platform during the clinical studies
  • Risk mitigation achieved by committing to a smaller, controlled spend until a Projected Outcome Analysis (POA) merits ramping or expanding the study -- the POA continually analyzes in real-time, patient-by-patient results compared against projected results that are modeled on historical data trends and metrics 
  
  
Engaging the industry’s shortcomings by working with biotechs and pharma to streamline innovation to strategic partners and a faster monetization, thereby strengthening the early-stage ecosystem of product candidates and bolstering research and development pipelines. Stretch your capital. Jumpstart a future clinical program. Allocate your resources to other priority projects and leave the heavy lifting to us. The Built-to-Suit program drives value from non-priority or under-resourced clinical assets by providing financing and flexible, turnkey services and information technologies to manage the entire development process or leave you to do whatever part of the process you prefer. 
Ideal Situations
A  clinical program that you own and is not currently funded due to other corporate priorities, but which could create substantial value if successfully advanced in the clinic. The Build-to-Suit program will maximize value inflections.  
A third-party clinical asset that you would like to in-license due to its valuation and long-term potential upside, but its current stage of development could be a potential drag on your short-term valuation. Placing the asset in a spin company and having it built-to-suit enables you to create long-term value without a disproportionate short-term cost.   
Case History
Pivotal Phase III trial of Tyvasco for United Therapuetics, after it was given an off-balance-sheet opportunity and put into LungRx
  • “One of the largest trials of an add-on therapy in pulmonary arterial hypertension,” Tyvaso website
  • “With [Prevail], we launched this trial on time, after a very short start-up period,” LungRx press release
  • “We believe that the [Prevail] system which UTHR has employed for TRIUMPH-1 will allow for more rapid turnaround in data,” C.E. Unterberg, Towbin analyst report
  • United Therapeutics’ market value jumped about $300 million based on the reported results.