Today’s innovation-driven global economy accelerates the biotechnology revolution.  Advances in biological sciences give all people – scientists and non-scientists alike – a better understanding of the world in which we live. That understanding doesn’t always result in easy choices but often underscores complex ethical and social choices involving human health, food production, and protections for the environment.  The impact of biotechnology’s far-reaching innovations have generated widespread interest, as well as concern, in what this revolution has created to date – and what lies ahead.
So, what is biotechnology?  Biotechnology refers to the use of living systems to develop products as new scientific discoveries allow for better understanding of fundamental life processes at the cellular and molecular level. By making precise genetic modifications that were not possible using traditional methods, biotechnologists improve selected attributes of microbes, plants, or animals for human use. According to my research, biotechnology in its simplest form has been around for millennia – dating back to when our ancestors used innovative ways to grow certain types of plants and breed animals. Rudimentary processes, for sure, but the modifications represented biotechnological innovation.  In recent times, biotechnology is synonymous with terms like genetically engineering foods and genetically modified organisms.
Why biotechnology – and why now?  Many reasons exist, but my answer is – in a word – money.  Sustainable economic growth is one of the big challenges in the 21st century, so the effort to tackle this global challenge requires progressive and often controversial action. The science behind biotechnology is complex and multi-layered, with misconceptions arising over its impacts and implications. As a non-scientist, I understand biotechnology today as being able to change a single gene – plucked from a strand of thousands – as compared to traditional breeding which involves a random mixture comprised of many genes.

Though I may not fully understand biotechnology’s science part, I clearly understand biotechnology’s money part.  Which is to say that biotechnology is a very large global business. According to Research & Markets, worldwide biotechnology businesses recorded revenues of $281.7 billion in 2011, with 10% annual growth achieved from 2007-2011.  To underscore the appeal biotechnology has to investors, Ernst & Young reported in its 2012 Beyond Borders publication that biotechnology companies headquartered in the US and Europe raised US$33.4 billion in 2011.  Approximately one-half of that number represented “innovation capital” – that is, investments made by private equity investors that accelerate the research, development, and commercialization of biotechnology-related products and applications.  Clearly, investors see profits in biotech’s future.

Where is biotechnology’s present and where does innovation occur today?  Biotechnology has a global footprint with no stronger footing then here in the United States.  The US is the world leader in biotechnology with seemingly every sector of the domestic economy – from agriculture to engineering to manufacturing to healthcare – involved. Because of the role biotechnology plays in the US economy, much innovation emerges from university laboratories and from innovation-focused companies that emphasize research and development.

Biotechnology innovations are not centered in only the developed world. Indeed, countries from the developing world are involved in the research, development, and commercialization of new products made possible by biotechnology innovations.  For example, India’s biotechnology industry has taken advantage of modifications in the country’s intellectual property laws to invent around existing patents.  The innovative systems and processes that resulted have reduced marketplace prices of biotech-inspired healthcare products, making them affordable to hundreds of millions of Indian citizens.  Given that much of India’s population cannot afford imported biological products produced in the developed world, innovative problem solving – and the products that result from the process – serves as a life-saving example of Indian biotech ingenuity at work.

Turning closer to home, biotechnology is a major player in Florida. From Pensacola to Miami, innovative and successful biotech companies continue to transform the state into a hotbed of innovation, discovery, and commercialization.  Headquartered here in the heart of Florida are biotech companies that lead their sectors and have transformed the industry – and the region. Leading companies include AGTC, Banyan Biomarkers, and Xhlale with scores of other Gainesville area companies delivering innovative products and selling life-changing solutions.

Biotech companies perform important, game-changing work. Banyan Biomarkers is in the business of “innovating diagnostics for the detection of brain injury and disease” and directs its research involving the company’s proprietary biomarkers at treatments for stroke, liver disease, Alzheimer’s, Parkinson’s, and depression.  According to Jackson Streeter, CEO of Banyan Biomarkers, “Innovation in biotechnology involves a breakthrough at the scientific bench that improves the lives and health of patients at the bedside.” Streeter’s connecting the “bench-and-bedside” illustrates the power of biotech innovations – and serves to remind us of biotechnology’s impact on our lives.

Another industry leading company is AGTC, headquartered in Alachua.  AGTC is no stranger to innovation, nor is the company’s CEO, Sue Washer.   AGTC is developing cures for rare lung and eye diseases by utilizing a highly specialized team of physicians and researchers.  The company’s innovative approach involves the use of leading-edge techniques to develop treatments involving the replacement of broken genes with normal functional genes.

I asked Washer for her definition of innovation in biotechnology.  Her answer is both comprehensive and insightful:  “Innovation in biotechnology means using what we know about how living organisms work to make products more effective, safer, and targeted to individual patients’ needs.  Innovation can also be applied to how we develop products and get them to the market.”

Getting products to market is the mark of excellence of the most innovative of companies.  That’s because innovation is not so much about the idea but nearly all about how effectively the company (or entrepreneur) can execute the commercialization plan.  Again, Washer’s comments ring true about what it takes to successfully bring innovation to the market:  “Working collaboratively with regulators, developing novel and more specific testing methods, virtually anything we can do to speed up the time it takes for patients to receive treatment.”

Serial innovator and successful entrepreneur, Richard Allen, is the CEO of Gainesville-based Xhale. Innovation is at the core of the company, as witnessed by Xhale’s goal of “breathing new life into medicine.”  Xhale is a medical technology innovator, developing products that transform healthcare and save lives. The company is a world leader in the use of sensors and is focused on innovative patient-centric monitoring solutions.

As do Streeter and Washer, Allen has his finger on the pulse of what is innovation – and what makes for successful innovative outcomes.  Allen defines innovation as “the creation of novel methods or technologies that address previously unmet healthcare-related needs. If innovation is a subset of creativity… in medical technologies, innovation is creativity focused on some unmet need – a cure or treatment for a previously unaddressed disease or condition, or a more efficacious or cost-effective way to treating a disease or condition – but something truly novel.”

These leaders of innovative companies have demonstrated that biotechnology will continue to have a significant impact on our lives today and into the future.  Like any progressive solution, biotechnology solves problems and produces value – both tangible and intangible – while creating both positive and negative effects.  Whether friend or foe of biotechnology’s innovations and applications, the voices on both sides grow louder and more passionate every day.

And the debate is fierce.  Critics dispute biotechnology’s outcomes and call for an immediate end to GMOs, genetically engineered crops (“Frankenfoods”) and the adoption of organically grown foods and non-engineered crops and feedstocks. Their concerns involve losses of biodiversity and long-lasting harmful effects on the environment. Proponents of biotechnology’s impact cite raised living standards, improved quality of life in both developed and developing countries, and the unleashing of a concentrated effort to combat hunger, control disease, and reduce environmental degradation on a global scale.

Regardless of one’s position on biotechnology’s impact, the public’s voice will continue to be heard.  That’s because social media’s expansive and intrusive reach gives most people a digital soapbox from which to voice their opinions.  And we usually do.  But the goal is not to talk, but to act, which is why for real progress to be made on finding common ground in the biotech debate, collaboration between opponents and proponents is necessary. This collaboration can lead to important decisions being made in which benefits are maximized and risks are minimized.  Easier said than done on all counts, but it is worth noting that nothing in life is completely risk-free.

That is why the path forward requires collaboration involving interested parties.  This collaboration can result in placing a series of “tripwires” that monitor whether or not the products of modern biotechnology are as safe – or safer – than those produced with traditional methods. Choosing which monitoring mechanisms are best is a difficult task.  That is why an open discussion involving the economic, ethical, moral, scientific, and social issues associated with biotechnology must be an ongoing one.  That conversation is not an easy one, yet most people do have a choice; it may not be an easy choice, but it’s a choice nonetheless. And policy makers can – and should – put in place safeguards and regulations that protect the public’s safety, privacy, and confidentiality.

Biotechnology’s potential to create positive and negative impacts around the world is enormous.  Biotech innovations will continue to raise a host of social, economic, ethical, and legislative concerns across the globe.  A question I struggle with is “Who has access to biotechnology’s power and how does acting on this access affect society as a whole?”  No easy answer there.  Combine that difficult question with a paralyzing concern of many:  Biotechnology’s advancements could increase the probability of biological warfare – with speculation that today’s biotechnologists will have similar impacts on the world as nuclear physicists did in the mid-20th century.

To achieve the promise while avoiding the calamity, biotech’s ongoing revolution requires strong, ethical, and visionary leadership.  This committed leadership is as much top-down as it is bottom-up and involves key players in the revolution. Which is why academic, business, community, government, regulatory, and scientific leaders must step up locally and globally in answering the questions, addressing the concerns, fulfilling the promise, and protecting the public when it comes to biotechnology’s place in the world today – and in the foreseeable future.