“From Concept to Miracle…The Lawyer’s Role in Florida’s Bioscience and Technology Industry”
The 21st Century is said to be the century for innovations in bioscience and nano-technology innovation; the dawn of a new industrial revolution. Florida is well-known as a state for new beginnings and entrepreneurship. The State is expected to be a cutting-edge leader in this exciting and rapidly developing science frontier.
Florida has become a rapidly growing center for biotechnology and medical research and development. The State is steadily gaining national recognition as an important center for discoveries in its scientific and medical communities.
In its June, 2012 BioPulse article A Snapshot of the Bioscience Industry, BioFlorida (“Florida’s bioscience industry association… represent(s) and advocate(s) for the state’s biotechnology, pharmaceutical and medical device industries”) reported that:
“While other states are seeing a decline in biotechnology investment and entrepreneurship, the biotechnology industry in Florida continues to grow, with venture capital investments surging by 200 percent(.)”
In recent years, Florida has succeeded in attracting and relocating premier research institutions, including:
• Max Planck Florida Institute for Neuroscience: “a study conducted by Enterprise Florida anticipates that the research organization will support the creation of more than 1,800 jobs, both directly and indirectly, over the next two decades, and generate more than $2 billion in economic activity.”
• Vaccine and Gene Therapy Institute of Florida: “the Florida-funded expansion of Oregon Health & Science University’s highly successful Vaccine and Gene Therapy Institute, focused on vaccine development with a special focus on vaccines and therapeutics that protect the aging population, which is the most vulnerable to disease.”
• Torrey Pines Institute for Molecular Studies: “conducting basic research to advance the understanding of human disease and the improvement of human health, Torrey Pines’ scientists conduct research in fields associated with a wide variety of major medical conditions, and new methods for drug discovery.”
• Sanford-Burnham Institute for Medical Research: “conducts world-class collaborative research dedicated to finding cures for human disease, improving quality of life; its Orlando facility focusing on diabetes and obesity.”
• Scripps Research Institute of Florida: “cutting edge facilities for researchers who conduct studies at the forefront of basic biomedical science, drug discovery, and technology development.”
A State-wide supporting infrastructure includes state-of-the-art university laboratories, hospitals, and research centers and the State’s 12 research parks, including:
• Florida Innovation Hub of the University of Florida: “will provide its resident companies with office space, laboratories, conference rooms, and other resources…to enable the advancement of their technology and marketing strategies….”
• Lake Nona Science & Technology Park: “this 600-acre site will be home to University of Central Florida’s new College of Medicine and Health Sciences Campus, Burnham Institute for Medical Research’s East Coast Campus, a University of Florida Research Center, Orlando VA Medical Center, and Nemours Children’s Hospital and Research Campus.
• Tradition Center for Innovation: “research and office park focused on immunology, medical devices, health care and clinical trials, and life sciences.”
• University of Miami Life Science and Technology Park: the complex “provides first-class facilities in an urban park setting in order to promote research, inspire collaboration between the University and private and public enterprise, deliver economic benefits to the local community and bring meaningful medical and technological advances to the world.”
To these may be added several business incubators supporting Florida’s growing number of startup companies.
Many scientists are entrepreneurs. They seek to develop proprietary and patentable life science-related products and medical devices. Their research initiatives lead to collaborations with like-minded colleagues; to financial arrangements with angel investors, venture capital, and private equity firms; and to strategic alliances, joint ventures, or mergers or acquisitions with more viable industry partners. Ultimately, that idea (the subject of interesting research, clinical study, and regulatory concern) reaches full commercialization and is subject to capital markets interest. Moreover, the idea or concept is eventually transformed into a universally available life-science miracle product or device.
“At each of the major junctures on the road to decipher the human genome, there were multiple issues, those that were legal-regulatory in nature and those of intellectual property, geopolitical divisions, and the maturity of information technology, personnel, and public relations, with which researchers and developers had to contend.” (Bryan Bergeron and Paul Chan, Biotech Industry: A Global, Economic, and Financing Overview John Wiley & Sons, 2004 (Kindle Edition Locations 1706-1707)
The road from basic research to commercialization may be long and tortuous. It can be a formidable affair. Financial and general management practices do not always equate with scientific methods; regulatory and legal compliance requirements can constrain clinical studies and medical procedures.
Business creation in the life sciences, as in other for-profit endeavors, catapults the entrepreneur into unfamiliar territory. Territory, where risk mitigation is critical and “timing everything.” Financial consultants, business advisors, and lawyers; each has a role in this mitigation process. It may not “take a village,” but it does require a multi-disciplinary and professional, team-oriented approach.
The business lawyer’s role, as confidant and counselor, is pivotal: whether the client’s “sounding board;” reviewing the impact of business or strategic plans; expressing opinions relating to governance or other corporate actions; negotiating contentious commercial or financial issues; securing patents; or doing deals. This is especially true when advising science and technology-oriented firms engaged in entrepreneurial business and financial transactions.
“A lawyer…is a representative of clients, an officer of the legal system, and a public citizen having special responsibility for the quality of justice. As a representative of clients, a lawyer performs various functions. As an adviser, a lawyer provides a client with an informed understanding of the client’s legal rights and obligations and explains their practical implications. As an advocate, a lawyer zealously asserts the client’s position under the rules of the adversary system. As a negotiator, a lawyer seeks a result advantageous to the client but consistent with requirements of honest dealing with others. As an evaluator, a lawyer acts by examining a client’s legal affairs and reporting about them to the client or to others.”
Lawyers shape relationships; a critical role often forgotten. For example, a successful transaction attorney is a “deal maker; not deal breaker.” Good transaction lawyers will not make “mountains out of molehills.” Counsel understands that the client will be living with deal results perhaps for years; while he or she moves on to the next case or transaction.
Good corporate lawyers focus core disciplines in business and finance. And, have a “familiarity with many apparently unconnected areas of legal practice;” including securities, antitrust, intellectual property, real property law and litigation. Such counsel, especially if engaged at an early stage, is well-positioned to help a bioscience, technology, and other industry entrepreneur initially create a viable business platform and thereafter, help navigating the legal “rocks and shoals” of the free enterprise system.
Carl H. Perdue, JD, LLM – Of Counsel
chp@assoulineberlowe.com
In Miami: 305-567-5576
In Broward: 954-929-1899
In Palm Beach: 561-361-6566
ERIC N. ASSOULINE, ESQ.
ASSOULINE & BERLOWE, P.A.Intellectual Property, Labor & Employment Law, Bankruptcy, Commercial Litigation, and Corporate Law
Miami · Ft. Lauderdale · Boca Raton
Photo is from . . . New York’s Hall of Science from the World’s Fair exhibit in Flushing, Queens.
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