The Spencer Fane Britt & Browne LLP Life Sciences Practice assists multinational corporations, private research institutes, university systems, start-up companies, and individual entrepreneurs in coordinating the legal, business, and scientific aspects of the commercialization process. Our attorneys and consultants focus on the five core areas of both law and business encountered by most clients in commercializing a life sciences technology:

• Intellectual property protection, opinion drafting, and transactional due diligence
• Technology licensing
• Investment funding
• Regulatory compliance and standardization
• Post-market compliance and product marketing

The Life Sciences Practice focuses on the legal aspects of the commercialization process in a manner designed to bring biotechnologies, pharmaceuticals, medical devices and therapies to market. We integrate these traditionally stand-alone legal and business practices into a multi-disciplinary, multi-office practice. Unlike the traditional model in which a client is required to seek a different group of business consultants or attorneys to implement each of the five core steps of biocommercialization (i.e., "pushing" the technology through the process), the Life Sciences Practice provides these capabilities in one organization to assist innovators in "pulling" their technologies through the process.

Our attorneys and scientific advisors have decades of experience not only in the law, but in industry and academic research as well. As a multi-practice law firm, our Life Sciences attorneys work closely with other Spencer Fane practice groups including international, financial services, litigation, antitrust and unfair competition, real estate, non-competes and trade secrets, labor, employee benefits, bankruptcy and environmental.

A commercialization strategy that coordinates the five core steps of the process, as well as the numerous entities involved, enhances each successive step of the biocommercialization process. As depicted in the figure above, an innovator will seek numerous ways to protect its intellectual property to provide a vehicle to license, fund, and market the technology. Rather than merely capturing that technology as a single "snapshot" that might not relate to predicted market conditions, the Life Sciences Practice assists its clients by developing intellectual property strategies that are informed by events downstream (e.g., competitive intelligence from a licensing review, technology funding information from an investor, technology standards information from a regulatory consultant, reimbursement information from a marketing consultant, and so on) that enhance the potential for increased license revenue, funding, regulatory approval, sales revenue, and reaching the market more efficiently.

The Life Sciences Practice works within a framework that includes service providers associated with the life sciences commercialization process. As depicted above, Contract Research Organizations and Contract Manufacturing Organizations hired by innovators to conduct pre-clinical and clinical trials providing proof of concept, safety, and efficacy data can be involved in a commercialization strategy. The Life Sciences Practice leverages information provided by the CROs and CMOs throughout the intellectual property and product lifecycle to better protect what is predicted to be successful on the market. In addition, investor information is leveraged at an earlier stage to better protect currently under-valued and more "disruptive" aspects of the innovation.

Information provided by regulatory consultants, statisticians, and clinicians regarding regulatory compliance and standardization by international standards organizations can be leveraged at an earlier stage to protect what is better predicted to reach the market. Finally, strategic consultants brought in to assist with reimbursement, branding, market placement, post-market compliance and other issues related to acceptance of a life sciences technology in the marketplace can provide information at an earlier stage to better protect what is predicted to be sold on the market. These core business and legal elements of the biocommercialization process have been distilled into a unified process for assisting our clients at every stage.