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Industry & the Professions Since 1942
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November
2004 Cover Story
Below, Novozymes
workers produce enzymes used in baking, textiles, detergents and other
everyday products. Photo
courtesy Novozymes A/S.
Right, Dr. Leslie Alexandre, president and CEO of the N.C.
Biotechnology Center.
Photo by Tom Edwards,
New Image Studio
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Biotech Behemoth?
Making us a world leader in the
exploding industry is an ambitious
goal that all starts in the classroom
By Allan Maurer and Jill R.
Aitoro |
Learn more about biotech:
What makes us think
we can be No. 1?
Grant boosts
biotech at Forsyth Tech
|
The
heavy weight of North Carolina’s grand scheme to become the nation’s
No. 1 state for biomanufacturing rests in large part on the slender
shoulders of Dr. Leslie Alexandre, who might weigh 100 pounds dripping
wet. As the president and CEO of the N.C. Biotechnology Center, state
officials have handed her a 10-year plan to create tens of thousands of
new jobs and billions in new investment by biotech firms that officials
fondly hope to attract here.
Alexandre, 46, may be small in stature but she’s no lightweight. Since
she took the helm at the Biotech Center in 2002, succeeding the
legendary Charles Hamner, the state leapfrogged Maryland to move from
fourth to third nationally in the biotech industry, according to Ernst
& Young’s 2004 Global Biotechnology Report.
And although she’s definitely a product of the Left Coast (her
master’s and doctoral degrees are from UCLA), she’s proved she can
hold her own with the good ol’ boys in the General Assembly. She
marched into the legislature this summer and said the Biotech Center
needed a major new appropriation to accomplish its mission, and walked
out with $5 million. The Durham-based center used part of that money to
open satellite offices in Asheville and Winston-Salem to encourage
biotech growth outside the Triangle and Charlotte.
She concedes that much about the state’s lofty goals for biotech are a
bit sketchy and hard to explain to laymen, but she says there’s no
confusion about her main objective. “There are many jobs directly and
indirectly involved in the life sciences,” Alexandre says. “From a
business perspective, every biomanufacturing job creates two or three in
the community that support it. So you might have 200 jobs in a facility
and 600 to support them. That’s why the Biotech Center was created –
to stimulate new jobs in the life sciences. That’s what the strategic
plan is about.”
Or as her boss, Gov. Mike Easley, once said when asked what biotech was
all about: “It’s about $20 an hour.”
It’s unclear whether Alexandre will achieve her Herculean task, but
she’s already chalked up a few successes, such as Merck’s decision
earlier this year to spent $300 million building a vaccine manufacturing
plant in Durham that will create at least 200 new jobs. Using her
multiplier, that means Durham can expect 600 other new jobs will be
created in the region to support the Merck plant.
Competing with Brains, Not Brawn
Alexandre’s bible these days is a 106-page strategic plan entitled
“New Jobs Across North Carolina,” which could be condensed as
follows: Making the state a major national force in biotech is the
surest way to transform the state from its Old Economy reliance on
textiles, tobacco and furniture to a New Economy world typified by
high-paying “knowledge industry’ jobs.
Presented to the governor as the year began, the plan outlines 10 years
of strategic moves intended to swell the 34,000 biotech related jobs in
the state currently to 48,000 by 2013 and to 125,000 by 2023. Achieving
that goal won’t be cheap; the price tag is placed at $640 million in
investments by state and local governments.
The centerpiece of the strategic plan, and the piece with the highest
cost, is an effort to create a workforce trained in the specific skills
needed by biotech companies. “We have a recognized high caliber
workforce and we’re investing in the training for them to work in
these government-regulated manufacturing companies, from entry-level to
Ph.Ds,” Alexandre says.
She adds: “We’re making the investment so state workers can compete
successfully in a knowledge-based economy, so they are able to compete
with brains, not just brawn.”
The state’s first step toward the goal of a workforce trained in
biotech already is showing promising results. BioWork, a 128-hour
introductory course offered to community college students, was developed
by the Biotech Center in conjunction with major industry players in the
state. It prepares students for entry-level jobs in pharmaceuticals or
biomanufacturing. Several classes of BioWork graduates have entered the
workforce, and industry leaders are taking notice.
“We’re seeing the
training,” says Williams. “We’re at the point right now of adding
250 jobs to this site in support of a new product. More and more people
come in with resumes that show training through the BioWork program.”
On average, it takes about four and a half months of training for
someone new to manufacturing to be attractive as a new hire, Williams
says.
Novozymes, a maker of enzymes used in a variety of products and among
the first biotech players in North Carolina, played a significant role
in developing the Biowork curriculum. Experts from Bayer, Biogen Idec,
Diosynth, Wyeth, GlaxoSmithKline and DSM Catalytica also contributed. In
addition, biotech companies outfit the labs where courses are taught,
and even provide some of the instructors — people who have an industry
perspective and can go in and develop the skills of prospective new
employees in the biomanufacturing area. Parts of the course are even
used as training exercises within the industry.
Higher Levels of Learning
Although it was regarded as a key step in the right direction, it became
clear early on that BioWork was only step one. Higher level biotech jobs
require specialized knowledge in a complex, complicated industry that is
heavily government regulated, says Mark Paige, vice president of
Novozymes and chairman of the N.C. Biomanufacturers Forum.
A primary reason for that is what’s called Good Manufacturing
Practices (GMP), Uncle Sam’s regulatory rulebook for biomanufacturing,
which runs to hundreds of pages. Mistakes in biomanufacturing can be
potentially disastrous to the public health and a company’s economic
health, as witnessed by the recent flap over flu shots. When British
regulators discovered contaminated batches of vaccine at
California-based Chiron’s UK plant, about half of the vaccine needed
for millions of Americans went down the drain.
“We wanted to provide an
environment for people to gain the skills needed by biomanufacturing
companies — from the discipline required in a GMP environment for
record keeping, to the sterile handling of material, to fermentation and
downstream processing techniques,” Paige says.
“What we hope our
initiatives will do is not only create programs, but also provide
focus,” Paige adds. “So if you are a cell biology major or even a
biochem major, you may have an opportunity to take a set of courses
while fulfilling that degree to position you perfectly for a career in
biomanufacturing.”
Biogen Idec’s Williams adds, “We like to see other biomanufacturing
companies here primarily because the training improves and we all
benefit.” Biogen Idec’s RTP facility started with a workforce of one
or two eight years ago and will reach 700 by the end of this year.
“Our ultimate goal is to find people coming off the street with skills
in biomanufacturing,” Williams says. “But that may not be realistic
right away. What we can do is influence training in the area, so that
eventually we will have a larger workforce to draw from.”
Central to those goals is a unique collaborative effort between
industry, government and academia.
The idea for considerably expanding the training programs that began
with BioWork evolved from the 2003 creation of the Biomanufacturing and
Pharmaceutical Training Consortium, composed of N.C. State, N.C. Central
University and the Community College System. The intent was to develop
initiatives that would provide more in-depth, hands-on training for
students interested in biomanufacturing. Funding came from a $60 million
grant from the Golden LEAF Foundation. The N.C. Biosciences Organization
(NCBIO), a statewide industry trade association, kicked in an additional
$4.5 million in equipment, professional services and other forms of
training support.
Golden LEAF, charged with spurring economic development in the state’s
more rural western, eastern, and northern counties, likes the idea that
biomanufacturers want to be near biotech centers such as the Research
Triangle, but locate their actual facilities in those more rural areas.
See related story, page 16.
“These groups really stepped up to the plate, supporting initiatives
that will be very important to the state over the next 20 years,” says
Ken Tindall, senior vice president for business development at the
Biotech Center. “We’re putting in place something that is not
available anywhere else in the country and likely the world.”
Going Beyond BioWork
While BioWork was a good start at training entry-level workers, the
industry urged Alexandre and other state leaders to raise the
educational bar. That led to BioNetwork, the education and training
program through the community college system and two large-scale
facilities on the campuses of N.C. State and N.C. Central universities.
Using $8.7 million of the total $60 million in Golden LEAF funding,
BioNetwork will provide development centers and training facilities to
select community colleges throughout the state.
To some extent, Paige says, the BioWork program acted as a test run for
the more expansive BioNetwork program. “The community colleges were
far more prepared to move quickly by augmenting existing programs,” he
says. “They’ve gotten a number of their proposals funded, and are in
the process of implementing them.”
BioNetwork just last month began spending its $8.7 million allocation
for its first two years, says Susan Seymour, who was named director of
the program in March.
“As this industry evolves
into manufacturing, two-thirds of its workforce will be trained at the
community college level,” she notes. “We need to educate and train
6,000 workers over the next three years, 2,000 a year at all levels. Top
industry leaders in the state tell us, ‘Hey, we’re swapping out
employees.’ BioNetwork
allows us to create centers to jumpstart this training.”
BioNetwork consolidates programs among all the community colleges, but
some have been doing biotech training for quite a while. Alamance
Community College, for instance, has had a biotechnology program for 18
years and is often consulted about curriculum. Eighty percent of its
students land jobs in the industry or regional research universities
before graduation, with starting salaries ranging from $28,000 to
$34,000.
“They’ve been doing hands-on training for a long time,” Seymour
says. “BioNetwork was created to leverage the resources of all the
community colleges and connect them together.”
Seymour points out that the community college system is one of the
world’s largest educational systems with 560,000 enrollments last
year. “We’re building on our strengths, on the way we develop
partnerships and relationships with industry, providing free custom
training programs,” she says.
Central Carolina Community College in Sanford, for instance, is
partnering with Wyeth’s expansion program, providing “a state
supported boot camp for their new hires,” Seymour says. “They signed
a lease for a training facility around the corner from the campus and
six to 12 new hires at a time go through BioWork and learn business
through a game that teaches them the basics of what it takes to make a
profit.” The boot camp reduces the time it takes new hires to settle
in from 18 months to six months, Seymour says.
Thus far, BioNetwork leaders have met with architects to discuss its six
planned centers and have submitted purchase orders for equipment.
Enrollment in BioNetwork programs has jumped significantly, Seymour
adds. She says it will be six months to a year before the BioNetwork
programs are fully up and running, and even then they’ll remain
flexible to industry needs.
Academia Takes the Pledge
The two planned major facilities are also making progress, though more
slowly given the massive construction associated with both. The
Biomanufacturing Research Institute & Training Enterprise Center,
with $19.1 million of the allotted funding, will be a 65,000-square-foot
research facility situated next to N.C. Central’s Science Complex in
Durham. It will be equipped with the latest in biomanufacturing
technology as well as laboratories, lab support areas, administrative
offices, classrooms, and an auditorium. Its doors are scheduled to open
in fall 2006.
At $36 million, the Biomanufacturing Training and Education Center (BTEC)
on N.C. State’s Centennial campus is the most ambitious of the
projects. The 94,000-square-foot facility will focus on mammalian cell
line development, product testing, process development and cell culture
processing. It will include bioprocessing spaces, clean rooms,
laboratories and classrooms.
The goal of N.C. State’s center is two-fold. First, the training fills
the gap between fundamental skills and what biomanufacturing companies
need for their specific processes. “In this industry there is a tight
juxtaposition between science and technology, with many aspects just not
taught,” Kilpatrick says. In exchange for that gap training, an
explicit agreement ensures that industry companies will hire directly
out of the program. “It’s frustrating to train students in the
biological sciences, only to have 30 to 40 percent of them go out of the
state to find jobs, because local companies want experienced engineers.
This provides a contract to prevent that from happening,” he says.
The second goal of the center is for new faculty hires to develop future
technologies for biomanufacturing industry, such as high cell density
bioreactors and transgenic processing equipment. “Why take it on if
there is no future technology component? We as a university are happy to
contribute to a training and educational mission as long as there will
be a promise of technological development in return,” says Peter
Kilpatrick, a professor of chemical engineering at N.C. State who will
become director of the Biomanu-facturing Training and Education Center.
Construction of the center begins next year and should be completed in
2006.
A curriculum committee comprised of members from the different
educational entities and from industry shapes content for the evolving
programs. They’re answering questions such as, will there be a new
degree program at the university and community college level? Or will
there be a concentration, a specialization track within a major, or a
certification program? They also want to ensure that programs work
together logically rather than conflict with each other.
“If you are developing your skills in a community college setting and
ultimately end up in the center for a capstone educational experience,
you need coordination among the educational institutions,” Paige says.
“The curriculum has to fit together in a seamless flow to allow the
student to build skills throughout the program.”
Perhaps most important for biomanufacturing is the ability to stay on
top of the needs in the industry and accommodate them. To keep the
dialogue going, the Biotech Center formed the Bioprocess/Process
Development Intellectual Exchange Group. Leaders in industry and
academia meet on a regular basis throughout the academic year to discuss
issues faced by biomanufacturing at the state and national levels, and
to attend presentations, participate in panel discussions and take
advantage of networking opportunities.
All of this — from the consortium, to grant funding, to training
programs and facilities, to ongoing industry awareness — reflect a
commitment that keeps North Carolina moving forward. But additional
commitments probably will be necessary to stay ahead in the highly
competitive biotech arena.
“Any manufacturing is capital intensive,” Caldwell says. “It’s
going to take cash and it’s going to take courage to invest that cash
to get this moving quickly.”
What
Makes Us Think We Can Be No. 1?
Below:
Biogen Idec workers examine products at the company's RTP plant.
 North
Carolina competes against nearly every other state and several nations
for each plum biotechnology-related manufacturing plant or research
facility it lands. So far it has done so with enviable success, climbing
to third in national rankings as a biotech hot spot, after California
and Massachusetts, and it wants to be No. 1 in biomanufacturing.
Is that goal realistic? Just what makes North Carolina such an ideal
place for biotechnology-related manufacturing?
The state has all the right elements to come out ahead, says Leslie
Alexandre, president and CEO of the N.C Biotechnology Center, even
against stiff competition from nearly every other state and other
nations.
“The state has an incredibly broad and deep array of natural resources
that lend themselves to applications of the life sciences that have
commercial potential,” she says.
North Carolina’s diverse environments stretch from forested western
mountains to the ocean-kissed coast. Its regions continuously rank high
in national surveys of the best places to work, live, raise a family or
build a company. The state’s natural resources, including cheap land,
fit many of the biomanufacturing industry’s needs.
The diversity of the state’s geography speaks directly to the scope of
its opportunities in bioscience-related manufacturing, says Alexandre.
State Commerce Secretary Jim Fain agrees. “With products in
agriculture, forestry, health care, and the environment, biotechnology
is a natural fit for North Carolina,” he says.
Plus, biotech is just what the doctor ordered for a state that’s lost
160,000 traditional manufacturing jobs, officials say. “Here’s a
state that’s been hammered by the downturn of the economy,” says
Peter Kilpatrick, chairman of the Department of Chemical Engineering at
N.C. State and director of the soon-to-be erected Biomanufacturing
Training and Education Center (BTEC). “We’ve suffered greatly in the
traditional manufacturing industries and are left to figure out a way to
come back. Biomanufacturing will provide the state with an incredible
amount of potential.”
Also, biomanufacturing companies prefer to locate near an area such as
Research Triangle Park, with its already thriving biotech industry and
major research universities, where they can find qualified executives,
scientists, and labor. But they tend to locate their actual
manufacturing plants outside urban areas. That means biomanufacturing
fits in with the state’s intent to attract new industry to all parts
of North Carolina, including rural counties.
Novozymes, for instance, located its Franklinton plant on what used to
be a soybean field. The rural area provides space for loading docks,
storage bins, and a formidable facility, as well as the isolation
necessary for manufacturing to go full out, all the time.
“Manufacturing in general is 24/7, 365 days a year,” says Mark
Paige, vice president of Novozymes and chairman of the N.C.
Biomanufacturers Forum. “Shut down fermentations, and lose tons of
money,” he explains succinctly.
But those factors alone do not account for North Carolina’s head start
in the race to become No. 1. Any state that has an plenty of empty
ground can support bricks and mortar, says Bill Caldwell, vice president
of drug discovery at biopharmaceutical company Targacept Inc. in
Winston-Salem. “What makes this an exciting and viable area is the
commitment of our leaders to make it happen.”
That continuing commitment of more than two decades helped create the
state’s already envied status in biotech. It fostered a strong
statewide biomanufacturing base on which to build, with 14 existing
plants that include GlaxoSmithKline, Diosynth, Biogen Idec, Novozymes
and Wyeth. Merck, Alphavax, and Pittsboro-based Biolex are opening new
plants and Biogen Idec is expanding.
North Carolina’s biomanufacturing companies alone currently employ
4,700 people, while 259 other life science related companies employ a
total of 34,612, according to the Biotech Center’s database, which is
being constantly updated. “We’re excited because the things the
state has done the last few years position it as a recognized global
leader in biomanufacturing,” says Alexandre.
What is it that makes biomanufacturing attractive not just to North
Carolina, but also to every other state and to nations from Ireland to
Singapore? Jobs.
“When you talk about
biomanufacturing, you talk about the end products,” says Glen
Williams, general manager and senior director of manufacturing at Biogen
Idec. The company, formed in 2003 from the merger of Biogen Inc. and
IDEC Pharmaceuticals Corp., develops, manufactures, and markets novel
therapies, specializing in products to combat multiple sclerosis. Biogen
Idec operates three licensed, dedicated biological bulk-manufacturing
plants, including one of the world’s largest cell culture facilities
in Research Triangle Park. “Biotechnology is the umbrella,” Williams
says, “which includes various components that work together to
eventually result in a product produced through biomanufacturing.”
Those products, whether they are life saving drugs or enzymes or
contract research, sell worldwide. Biomanufacturing is a “cluster”
industry that sells its products outside the region and redistributes
the income through its payroll. That money in turn goes to retail
stores, grocers, and automobile dealers, who then have to hire more
help. A study conducted by the Biotech Center shows that for every job
in biomanufacturing, about three more are created.
Jobs emerge in all the businesses that support the biomanufacturing
plant: the shipping, packaging, and distribution companies, the
equipment and raw materials producers. Also worth noting is that it
takes about three years to build a biomanufacturing plant, says Ken
Tindall, senior vice president for business development at the Biotech
Center, and costs upwards of $1,000 a square foot. That’s a huge boost
to the construction industry.
While biomanufacturing is not likely to directly replace all the jobs
lost in North Carolina’s aging industries, the jobs it promises are
high paying. An entry-level position in biomanufacturing pays about
$26,000 a year, Tindall says. That’s for a person who does not
necessarily have a degree, he adds. Depending on the company and the
individual’s path upward, that salary may double in five years. Merck
has said jobs at its planned vaccine plant in Durham should start at
about $700 a week. The average salary in the industry is over $68,000.
High paying jobs increase the industry’s cluster effect.
Biomanufacturing also is a young industry that’s growing rapidly, says
Alexandre. With more than 370 biotechnology-based drugs, vaccines, and
products in the U.S. pipeline, the industry estimates it will need to
build $3.3 billion worth of manufacturing facilities in the next three
or four years. Because a patent on a new drug is generally granted at
the very beginning of a 10- to 12-year development cycle, companies have
only a few years to make their money back once the U.S. Food and Drug
Administration grants approval. That means biomanufacturers often have
to build and hire trained workers quickly.
“Biomanufacturing is one of few industries that has continued to grow
over the last several years,” says Jose Juves, Biogen Idec’s
associate director of public affairs. In North Carolina, a Research
Triangle Regional Partnership study showed that during the economic
downturn of the last few years, the medical, pharmaceutical, biotech
sector was the only one that saw growth.
“There are always bumps in the road,” Juves says, “and it goes up
and down with the economy like everything else, but there is a lot of
potential that just doesn’t exist in almost any other area.” Great
products will still come out of traditional pharmaceuticals, he says,
but biomanufacturing is a newer industry that has yet to see some of its
greatest breakthrough products and processes.
Given such factors, the long-term goal for the state is to encourage not
only biomanufacturing in the area, but also nationwide recognition that
could attract associated industries and keep those secondary jobs in
state. “Right now, I’m spending some of my dollars to manufacture
drugs for our clinical trials outside of North Carolina,” says
Targacept’s Caldwell “I have to go elsewhere for some of what’s
needed, and I don’t want to. I would rather spend the dollars here so
that they can serve local economic development. So yes, we’re talking
job creation; but we’re also talking about keeping financial resources
here to support our economy.”
$5
Million Grant Boosts Biotech at Forsyth Tech
The
U.S. Department of Labor gave North Carolina’s biotechnology training
efforts a booster shot just ahead of the state’s homegrown BioNetwork.
Forsyth Technical Community College in Winston Salem received a $5
million grant from the Labor Department to develop curricula and
training models for biotechnology workers.
The school is one of five premier community colleges deemed national
“biotechnology centers of excellence,” receiving the grants. Each of
the five community colleges focuses on a different aspect of
biotechnology curriculum development aimed at preparing workers.
Forsyth’s efforts target biotech research and development in the
Southeast. Together, the five community colleges will establish the
National Center for the Biotechnology Work Force.
In 2003, Forsyth received an earlier $754,146 grant from the Department
of Labor for its biotechnology program. The NC State Board of Community
Colleges approved its associate degree program in biotechnology in 2002.
Forsyth Tech will also co-manage the North Carolina BioNetwork
Pharmaceutical Manufacturing and Training Center in Winston-Salem, one
of five statewide. It focuses on training support for the pharmaceutical
industry in the state.
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