Patent Strategy

At the early stage of a virtual biotech, most of the company value is based on the strength of its patents so a strong portfolio which includes composition-of matter and method-of-use claims that cover the product to be commercialized in the territories of interest is essential. B4D’s highly experienced management team helps clients avoid pitfalls such as maintaining an expensive patent portfolio which may not be useful to cover the commercial product, or which may not be sufficiently broad in terms of territories in order to attract partners or investors. We can work with in-house legal counsel or directly with patent agents in various jurisdictions for patent review and management, strategy development and procurement.

 

Business Plan

B4D develops the Business Plan starting with a rigorous scientific assessment of the product and any available preclinical and clinical data. The company conducts an assessment of market size, competitive landscape and product pipeline, patents, regulatory pathway, development timelines and cost estimates, sales/licensing revenue forecasts in the territories of interest and identifies potential commercialization partners.

 

Clinical/Regulatory

One of the challenges of a start-up company is selecting appropriate CROs for the work and ensuring that they have access to all the information needed to achieve the company’s objective. B4D provides expertise needed to problem-solve and make decisions based on results obtained in the outsourced studies. Clients benefit from access to B4D’s core team and their strong network within North America and Europe based on 25+ years of clinical development experience.

 

Business Development/Licensing

We develop out-licensing strategies taking into consideration the preferred stage of development and territories for partnering. We also execute the strategy including:

  • Preparation of all promotional materials (non-confidential and confidential dossiers, presentations, licensing term sheets)
  • Development of the target deal structure and terms, based on a detailed valuation of the technology and industry comparables
  • Identification of suitable partners, negotiating and closing deals

 

Funding Assistance

The most promising model for virtual biotechs focusses on a single asset with a strong patent position which has been well characterized in the preclinical setting. In this model the company raises sufficient funding to advance the product to the clinic and establish proof of concept. At this point the company can explore options for partnering or acquisition by Pharma or biotech, or possibly an IPO if market conditions allow. Our team has success in raising funding through nondilutive and equity financings. We can assist companies in the preparation of the Prospectus and “Road Show” and other elements needed to support financing.

 

Virtual Company Management

The B4D team is a highly experienced and innovative management team with expertise in identifying attractive drug candidates, target indications, designing and managing outsourced clinical development programs and negotiating licensing deals. B4D provides a flexible cross-functional team which can be brought in part-time initially, and increased as the project advances. This model overcomes the excessive burn rates experienced by traditional pharmaceutical/biotech companies that are associated with expenditures unrelated to actual asset development.