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A Brave New World

by Keith Barber

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Seven people flipped a symbolic switchin a parking lot adjacent to Building91, an old manufacturing facility forRJ Reynolds in the northern district ofdowntown Winston-Salem, and a 30-foot bannerunfurled that proudly proclaimed, “WakeForest Biotech Place, Opening 2012” during aspecial ceremony on June 4. The unfurling ofthe banner was followed by a fireworks display.People in attendance clapped and cheered inthe scorching 90-degree heat. For the electedofficials and VIPs in attendance, the ceremonymarked a pivotal moment in the city’s economichistory. Gov. Beverly Perdue was one of those peoplewho flipped the switch to officially begin therenovation of a 242,000 square foot facilityto become the home of the Piedmont TriadResearch Park’s new northern campus.Perdue praised the leadership exhibited bycity officials and Wake Forest University inhaving a vision and never wavering from it.She placed the groundbreaking ceremony inhistorical perspective. “The world’s changed around us and manyother states that are so troubled haven’t changedwith the times and the thing I think that’sgiven North Carolina this defining moment inAmerican history is we’ve had leaders like theones here who have just demanded that peoplechange — that’s hard,” Perdue said. “Now, wehave a new brand. We’ll never forget where wecame from but we now at least have a bit ofhint about where we’re going that looks powerfulfor North Carolina.” It is somehow fitting that the expansion ofWinston-Salem’s emerging biotech industrywill be on property donated by the industry thatbest represents the city’s economic past — RJReynolds. Just two weeks ago, the companyannounced that it would cease operations at itsWhitaker Park plant by the middle of next year.As big tobacco falls by the wayside, along withthe textile and furniture industry, the biotechindustry represents the city’s best hope of buildinga 21st century economy, Perdue said. Thegovernor lavished praise on city and communityleaders for finding a way forward. “What this community has done rather thanhanging its head after all the economic losseswas to come together and figure what theground was going to be for the 21st centuryand that’s why you see something marveloushappened this morning,” Perdue said. “The jobgrowth is exponential. There could be hundredsof thousands of jobs here in the next century.Who knows what will happen? But againyou’ve just got to start it and they’ve started ittoday.” The good doctor The man who started it all, Dr. AnthonyAtala, was also in attendance on June 4. Atalaand his team of researchers and scientists werethe first in the world to successfully implant alaboratory-grown organ into a human. Dr. George Weightman, a former major generalin the US Army and chief operating officerof the Wake Forest Institute for RegenerativeMedicine, explained that city leaders recruitedAtala from Harvard University six years agoafter he successfully implanted a “neo-bladder”into human patients. Part of the city’s recruitmentpackage included a promise to build astate-of-the-art research facility, which is nowknown as Piedmont Triad Research Park, orPTRP.“The intent was they wanted to have a newindustry start here,” Weightman said. “[Atala]would be the magnet to draw in a lot of otherbiotech industries into the PTRP, so that wasthe concept.”The concept has proven to be enormouslysuccessful, Weightman said.Atala came to Winston-Salem in 2004 with20 people, including three faculty members and17 staff members from Harvard. Atala and hisscientists moved into the research park facilitiesin 2006. Since that time, the faculty and staffof the Wake Forest Institute for RegenerativeMedicine, or WFIRM, has grown to more than250. In addition, six or seven different start-upcompanies have been spawned by Dr. Atala’sdiscoveries and proprietary technologies.Spinouts utilizing the technology developedby Atala’s team of researchers and scientistsinclude Tengion, a clinical-stage biotechnologycompany; KeraNetics, a biomaterials companyfocused on creating keratin-based productsfor use in areas of regenerative medicine; andCBDI, a manufacturer of bioreactors. Therefore, the addition of more than 240,000square feet of laboratory space in the northerndistrict facility is vitally important to the continuedsuccess of WFIRM, said Weightman.“This is extremely important because of allthe infrastructure that you need to make surethat science and technology can advance sowe can deliver these technologies all the waythrough,” Atala added.Atala characterized the support he’s receivedfrom Wake Forest and the city of Winston-Salem as “truly amazing.” He acknowledgedthe fact that regenerative medicine has thepotential to be the biggest economic driver inthe area, but emphasized that he is first andforemost a man of science. “I think that anytime you bring researcherstogether that are geared toward clinical translation,chances are you will have increased activityin that area,” Atala said. “The work we do atthe institute are geared toward bringing technologyfrom the bench to the bedside. Our missionbeing a medical center and a research institution,our mission is to really bring technologies to our patients so we can make them better.”

And as researchers continue their work toward developing lab-grown organs and tissues for people, the economic opportunities for start up companies grow exponentially. It’s comparable to a chemical chain reaction that begins with a desire to improve patients’ lives, Atala said.

“Our mission is to develop transformational technologies,” he said. “If the technology is needed, then you need someone to manufacture it. If you need someone to manufacture it, you need someone to invest in it. Then you need to put up a facility to produce it. If you need a facility to produce it, then you need employees and then you create jobs.”

A mayor’s vision

The series of events that led to the unveiling of the northern campus of the Piedmont Triad Research Park began back in the early 2000s when Winston-Salem city officials studied 108 comparable metropolitan areas to identify strategies for improving the city’s quality of life.

While reviewing the data, Mayor Allen Joines noticed a disturbing trend. Winston- Salem’s job growth rate was dipping compared to the average job growth rate of cities of similar size. And 17 of the metro areas were enjoying a job growth rate that was twice that of the city. Those 17 cities had one thing in common.

“What set them apart was this: Each one of them had identified a single economic driver or magnet, and had been ruthless in supporting it, and this magnet had been a huge driver for their economy,” Joines said.

City officials determined that if they wanted to achieve the status of a high-performing metro area, they would need to create about 30,000 new jobs in the next 10 to 12 years. So elected officials and community leaders began the process of trying to identify an economic driver that could create 30,000 new jobs, one that would be unique and couldn’t be duplicated by other cities in the region.

The city narrowed the list until it arrived at its answer: regenerative medicine.

Atala said the city’s timing could not have been any better.

“We started working in this field 20 years ago, and it took us a whole nine years from conception to actually placing a product in a patient — almost a decade just to create a technology we can put into patients,” Atala said. “In the next few years, you will really see an explosion of technologies going into patients. The number is going to go up exponentially.”

Due to the vision of people like Joines, Winston-Salem could become a biotech hub on a global scale. Atala’s research team has so many new replacement parts for the human body currently in the pipeline that are ready to go into patients, which is a far cry from 10 years ago when only one technology was ready.

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Winston-Salem has been able to boast for the past four years that it has the largest stand-alone regenerative medicine complex in the country. This spring, the city hosted the first international regenerative medicine conference ever and formed a national regenerative medicine foundation. In addition, city and community leaders have started a venture-capital fund to assist start-up companies spun out from the proprietary technology created by Atala and his team.

“Dr. Atala takes his research so far down the road before it really launches so that a lot of the hard research work has been done before it’s time to go out and try to spin,” Joines noted.

Financial experts project that it would take only $4 million to start a spin-out company working with Atala’s proprietary technology as compared to four or five times that much for ordinary spin-out ventures.

All of this adds up to additional investment and new high paying, high-skilled jobs, Joines said. It will also mean a great number of jobs for high school graduates and graduates of two-year community college programs, Joines said. Forsyth Tech will open a building within the northern campus of Piedmont Triad

Research Park to begin training the workforce for WFIRM and the spin-out companies that are created in the next decade.

The beginning of construction on the northern campus of PTRP marks a seminal moment in Winston-Salem’s history, a moment that happened only because of the dedicated work of scores of community leaders and elected officials, Joines said.

Through a shared vision, city leaders have built the foundation of a vibrant downtown area that includes the research park and BB&T Ballpark. Joines said there is still much work to be done for Winston-Salem to achieve the status of a top-performing city, but the opening of Wake Forest Biotech Place in 18 months has accelerated the city’s job-growth potential and future economic prospects.

“It will create a whole new atmosphere in that northern section that I believe will foster additional investment in that area,” Joines said. “We’re certainly not where we want to be but there is a pretty strong momentum.”

For humanity

“We are witnessing today a miracle of sorts,” said Wake Forest president Nathan Hatch to the audience at the June 4 event. “A worn-out industrial plant turning into a modern biotech laboratory — that is amazing. It’s all the more remarkable given the straitened economic times in which we are living. It is testimony to a shared vision of excellence and a sense of renewal that is very evident in this whole community.”

Hatch reminded the guests in attendance that the university’s motto is pro humanitate, or “for mankind,” and Wake Forest’s investment in the downtown research park fulfills its stated mission.

James R. Berens, president of Wexford Science Technology, talked about his company’s role in helpig institutions utilize their research activities as a catalyst for economic development in creating knowledge-based communities during the unveiling ceremony. Berens outlined Wexford’s long-range goal of creating a knowledge-based community in downtown’s northern district. Wexford hopes to eventually develop the 800,000 square feet of industrial space in the northern district that remains untouched, Berens said.

A knowledge-based community centers on research activities, so the core facilities in the new biotech park will contain spaces for small and growing research and development companies. Spaces will be built for private industry that come to the research park to collaborate with Atala’s scientists.

The $87 million facility will house spaces dedicated to workforce training. There will also be retail spaces, conference centers and fitness centers. The biotech park will include community collaborative spaces, which will offer a wide range of programs and activities that will educate, inform and entertain. A number of elements are critical to the creation of a knowledge-based community — an outstanding research institution, leadership, vision and public support. Wake Forest Biotech Park fulfills all those criteria, Berens said.

“As you look at the cost to revitalize the north district, the cost is immense,” Berens said. “Without public support this is a project that would just never happen.”

The new research park is the recipient of financing from federal, state and local governments, he added.

The majority of Dr. Atala’s work is also funded by federal grants, Weightman said.

Two-thirds of WFIRM’s funding comes from the National Institutes of Health and a third comes from the Department of Defense. With regard to acquiring grants, Atala and his team of researchers enjoys a phenomenal track record. In 2006, the Institute for Regenerative Medicine was working with $6 million in grant money. This year, WFIRM has attracted $60 million in grant funding.

The Department of Defense’s interest in regenerative medicine led to the formation of the Armed Forces Institute for Regenerative Medicine or AFIRM. Weightman explained that the Pentagon implemented AFIRM after looking closely at the injuries suffered by soldiers serving in Afghanistan and Iraq. The Department of Defense partnered with a number of institutions like Wake Forest to provide funding over a five-year period for institutes to produce organs and body parts that can go directly to wounded soldiers.

This deadline-oriented funding has created a push for research institutions to bring products to the clinical trial stage more rapidly, Weightman said. The military is interested in regenerative medicine as it relates to five areas: healing of wounds, burn therapy, digit and limb reconstruction, cranial and facial reconstruction, and compartment syndrome, which occurs when trauma to an area builds up pressure and kills the tissue in that part of the body.

As a retired Major General, Weightman was brought into WFIRM specifically to help administer the AFIRM program. Weightman said the military applications of Atala’s proprietary technology has led to another platform for the institute’s extensive research.

The Army informed its partner institutions that it needed to know if their soldiers are infected when they are treated at a field hospital. Traditionally, the only way to check for infection in a soldiedr is to swab the wound with a culture, and then wait 48 hours for the result. However, in 48 hours, a wounded soldier has typically been airlifted to a military hospital in Europe or America.

So WFIRM’s scientists began looking at the common gene makeup of the top 32 different bacteria that populate wounds as a way to address the diagnostic problem.

“We can put that on a ray and a PCR machine, which most hospitals have. We can put a sample in there and tell you in three hours if a person is infected and what they’re infected with,” Weightman said. “So before that patient ever leaves that hospital and is evacuated, the Army can have that information.”

The high-tech diagnostic platform should lead to a partnership with an outside firm to commercialize the technology, Weightman said. Yet another example of how biotechnology can spur economic development and job growth. Another area for commercialization and economic investment are scaffolds — biodegradable materials that provide the “skeleton” for the organ or body part created in the laboratory.

“That whole field of biomaterials is another significant area that we’re starting to partner with various companies to find out what the best combination of materials is for a particular tissue,” Weightman said. “As we ramp up what we’re ready to throw onto biomaterials under the scaffolds, the intent is those companies will come.”

In addition, the institute has developed a bio-printer, which uses ink-jet technology to reproduce skin cells for burn victims. The military is highly interested in using this technology to help soldiers who suffer serious burns in combat.

Still, Atala remains a man of science. It is Weightman’s job to handle the business development side. That’s why he’s added intellectual property and regulatory affairs departments: to expedite the science to the point that the institute can hand it off to a large pharmaceutical firm like Pfizer.

Despite the tremendous strides made by Atala and his researchers, regenerative medicine is still an evolving science, Weightman said.

“Regenerative medicine is like genomics was 20 years ago,” he said. “Remember when they cracked the human genome? Everybody was expecting gene therapy for your particular illness in five years. We’re just barely getting to that point now — 15 or 20 years later.

“I think the same thing is going on in regenerative medicine,” he continued. “People think, ‘When can you grow my finger?’ or, ‘When can you get me a new kidney?’ or whatever body part is wearing out. I think we’re still a ways away from that so we’re kind of in the period of setting people’s expectations about what’s doable today versus when can we actually see that.”

The future of regenerative medicine remains bright and the biotech industry’s potential in the Piedmont Triad appears limitless. And Winston-Salem stands at the forefront of the biotech industry in North Carolina.

“The things that are going on here around basic biosciences, research and discovery are critical to America’s future, to the globe’s future and it’s all started here in Winston- Salem,” Perdue said. “This is a blueprint for America and it’s a good blueprint for North Carolina.”

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