Putting It All Together: A Biotechnology, Pharmaceutical and Medical Device Commercialization Overview

I am often asked to advise 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. Each project I encounter is unique and exciting, which is the nature of pharmaceutical, medical device and biotechnology commercialization. What I have learned over my career is that five core areas of law, science and business are almost always encountered by clients in commercializing a life sciences technology:

1. Intellectual property protection, opinion drafting, and transactional due diligence
2. Technology licensing
3. Investment funding
4. Regulatory compliance and standardization
5. Post-market compliance and product marketing

In my law practice, I study whether the strategic leveraging of these core disciplines can enhance the market entrance and penetration of client technologies. I've learned that by integrating traditionally stand-alone legal, scientific and business practices present in the ecosystem surrounding client technology in a multi-disciplinary fashion, my clients can increase the number of therapeutics, diagnostics and medical devices being sold in the market.

To escape the traditional model in which a client is required to seek a different group of business consultants, scientists and attorneys to implement each of the five core steps of biocommercialization (i.e., "pushing" the technology through the process), I seek to provide innovators the information to "pull" technologies through the process. Essentially, this site intends to provide information often used by executives, attorneys, scientists, consultants, contract researchers and contract manufacturers to empower inventors in bringing pharmaceutical, medical device and biotechnology innovations to market.

An intellectual property strategy that coordinates the five core steps of the process, as well as the numerous entities involved in the commercial ecosystems surrounding client technologies, enhances each successive step of the biocommercialization process. As depicted in the figure above, an innovator typically seeks numerous ways to protect its intellectual property to provide a vehicle to license, fund, and market the technology. Simply put, an invention that cannot be licensed, funded (i.e., is it "investable"?) or regulated stands little chance of entering the market.

Rather than merely capturing that technology in a single "snapshot" that might not relate to eventual market conditions, a question that should be asked by every life sciences innovator is whether an intellectual property strategy that is 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) can be developed to enhance the potential for increased license revenue, funding, regulatory approval, sales revenue, and reaching the market more efficiently.

This site provides a framework whereby service providers associated with the life sciences commercialization process (the commercial 'ecosystem') are involved in pulling an innovation to market:

1. At the earliest possible moment, hit-to-lead studies and pre-clinical trials that provide proof of concept, efficacy data, and perhaps safety data, are leveraged using information provided by CROs and CMOs throughout the intellectual property and product lifecycle to better protect what is predicted to be successful on the market.
2. Investor information is leveraged at an earlier stage to better protect currently under-valued and more "disruptive" aspects of the innovation.
3. 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.
4. 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 can be distilled into a unified process for assisting innovators no matter what stage of the commercialization process they may find themselves.

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