Biotech: Finding The DNA For Success

The integration of artificial intelligence within life sciences is making drug discovery and development more innovative, less labor intensive and more cost-effective, says Deloitte’s annual global outlook.

By the BF Staff
From the March/April 2020 Issue

The integration of artificial intelligence within life sciences is making drug discovery and development more innovative, less labor intensive and more cost-effective, says Deloitte’s annual global outlook.

According to Deloitte’s 2020 Global Life Sciences Outlook, the biotech sector is at an inflection point. To prepare for the future and remain relevant in the ever-evolving business landscape, biopharma and medtech organizations will be looking for new ways to create value and new metrics to make sense of today’s wealth of data, the report overview says.

As data-driven technologies provide biopharma and medtech organizations with treasure troves of information, and automation takes over some mundane tasks, new talent models are emerging based on purpose and meaning. The integration of artificial intelligence (AI) and machine learning approaches within life sciences is making drug discovery and development more innovative, time-effective and cost-effective, the Deloitte report states.

Gene therapies, intelligent drug discovery and development, consumer wearables and telemedicine are drivers transforming the life sciences sector. While advances in technology appear to drive more efficiency, biopharma and medtech leaders should look to more deeply understand ways to increase value and meaning for workers, patients and ecosystem partners. Cultivating human strengths—for probing data, curating information and asking the right questions—can help humans work with technology to think exponentially. In order to be successful, leaders should look at how jobs can be redesigned around human-machine collaboration—that enhance workers’ capabilities and augment human abilities.

BIOTECH IS SHINING BRIGHT IN THE VALLEY OF THE SUN

With a vibrant downtown, a large population of highly trained and educated young people entering the workforce, a great startup ecosystem, as well as multiple highly accredited universities and research institutions, biotech is at the pulse of this growing metropolis.

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Barrow Neurological Institute breaks ground on Phoenix research facility. (Photo: Barrow Neurological Institute)

“We have been a real hub for innovative companies who are doing cutting-edge innovations from areas of fighting cancer to medical devices to neurological research,” said Phoenix Mayor Kate Gallego.

Phoenix has developed as an innovative biotech hub due to the incredible growth of the city and a robust pipeline of talent churned out by three top ranking universities and research institutions—Northern Arizona University, the University of Arizona and Arizona State University (ASU)—which are all located in downtown Phoenix.

“ASU in particular is the top university in the country for producing college graduates,” said Gallego. “We have a great well-educated population, we tend to be a younger city, and the campuses are great in bringing together people from diverse backgrounds. That’s what we often call creative hubs in our downtown where different people can come together to solve problems.”

For Phoenix, growth in the bioscience and healthcare industry means stable, quality jobs for residents and new people moving there. The Greater Phoenix area is now the fastest growing county in the U.S and Phoenix is the fastest growing city in the nation.

In the City of Phoenix alone, over the next 18 months, 17 bioscience and healthcare organizations are building new primary bioscience and healthcare facilities with an investment in excess of $3 million. These facilities will expand bioscience and healthcare facilities by over 4.1 million square feet and more than 7,000 health care and bioscience jobs will be created with a payroll in excess of half a billion dollars per year.

“We understand that the ecosystem can’t thrive if it doesn’t have all of the pieces in place,” said Mayor Gallego. “We are looking across the skillset—everything from big data which is becoming so central to healthcare to engineers and neuroscientists. We work with our universities and have a successful community college system here. They have been investing in innovations to try to support a technician workforce, as well as healthcare professionals that are a key part of biotech.”

One of the latest biotech investments is Maryland-based Wexford Science & Technology who is building a $77 million research center on the north side of the Phoenix Biomedical Campus in downtown Phoenix. ASU, which will anchor that facility, is investing $40 million in tenant improvements.

The Wexford building will be 200,000 square feet and is designed to grow private sector investment in bioscience and health technology in Phoenix. ASU will lease approximately 112,000 square feet—half of the building—for 15 years with three five-year options. The remainder will be occupied by private-sector companies.

“Wexford is a bioscience focused real estate investor that creates very cutting-edge spaces where entrepreneurs’ thrive,” said Mayor Gallego. “They know it’s not just about four walls, but how to define spaces that create community and collaborations.”

Overall, the Phoenix Biomedical Campus is 30 acres with a capacity of 6 million square feet. To date, 1.6 million square feet have been building, housing ASU, University of Arizona and the Translational Genomics Research Consortium (TGEN).

“TGEN are an incubator for a lot of smaller companies and they have been lead on a lot of research and bio health initiatives,” said Mayor Gallego. “They have partnered with downtown universities on research.”

Arizona’s health care employers are also growing faster than their national counterparts and faster than other types of Arizona businesses.

Mayo Clinic, which serves more than 100,000 patients each year and has more than 7,000 employees, is in the midst of one of its largest capital expansions in history.

In April 2019, Mayo Clinic and ASU broke ground on a new 150,000-square-foot collaborative facility that will feature a MedTech Accelerator, biomedical engineering and informatics research labs, nursing programs and an innovative education zone.

“We are undertaking our largest capital expansion in Mayo’s 130 year history—and we are doing that right here in Arizona,” said Dr. Richard Gray, CEO of Mayo Clinic in Arizona. “This latest project will expand our clinical operations and invest in an integrated research and educational building on our campus.”

The new facility will foster a relationship between ASU and Mayo Clinic that leads to better solutions, outcomes and learning environments through intensified research, clinical expansion and development of innovative clinical approaches to medicine and health care.

ASU and Mayo Clinic formalized their relationship in 2016 with the announcement of the Mayo Clinic and ASU Alliance for Health Care. Over the years, the nation’s most innovative university and the world leader in patient care and research have partnered on programs that range from nursing to medical imaging to regenerative and rehabilitative medicine to wearable biosensors.

“We are planning a significant technological revolution for Mayo Clinic and our ongoing digital transformation,” said Dr. Gray. “We see Phoenix as an ideal place to grow our digital footprint.”

The new facility, scheduled to open in late 2020, will be owned and operated by the university and will connect to Mayo Clinic via a desert pathway. It is the first of several buildings planned to dot the surrounding landscape in the coming years and represents a cooperative effort not only of Mayo Clinic and ASU, but of the city of Phoenix and state of Arizona, as well.

The MedTech Accelerator will promote innovative collaborations by providing medical device and health care IT early-stage companies with personalized business development plans. Once construction of the new building is complete, it will be housed on the second floor, helping entrepreneurs accelerate to market and investment opportunities.

“I’ve been excited about Phoenix and the attractiveness and opportunities here for a very long time,” said Dr. Gray. “In the last decade or so we’ve really become such a vibrant city and growing place for biotechnology. The growth of ASU and the number of engineers they produce each year, along with other terrific educational institutions, has provided a worker pipeline to allow tech and especially biotech to grow.”

Phoenix is also home to the world-renowned Barrow Neurological Institute—one of the best neurology and neurosurgery care centers in the nation.

In November 2019, Barrow broke ground on its new Neuroplex research facility, a 130,050-square-foot, five-story building that will help the institute further research and medical innovation.

The facility will be located adjacent to the Dignity Health St. Joseph’s Hospital and Medical center campus in downtown Phoenix.

“The Neuroplex is a way to re-envision neurosciences care—bringing everybody together and making the patient experience as important as the operating room,” said Dr. Lawton, president and CEO of Barrow Neurological Institute.

The expansion will include 30,000 square feet of research space, increasing Barrow’s laboratory capacity by 50 percent. The Neuroplex, which is set to open in late 2020, will serve as the new home for outpatient clinics for neurosurgical, epilepsy, neuro-oncology and endocrinology clinics. It will also house an ambulatory surgical center and outpatient surgical suites for modern and less invasive surgeries that do not require hospitalization.

In addition to neuroscience, Barrow is leading the way in innovative areas like genomics and robotics. It has revolutionized the way surgery is performed on the spine—developing a first-of-its-kind robot to perform back surgeries. The technology is now being used in hospitals throughout the country and is expected to become the future surgical method for spine surgery.

“We have really great leading institutions in Phoenix like ASU and Barrow that attract great minds and great people,” said Dr. Barrow. “Phoenix has a nice combination of affordable lifestyle, attractive geography and a bright future where the population is growing. This brings together all the things you need for success.” [This section was written by Jenny Vickers.]

HUDSONALPHA INSTITUTE: BOOSTING ENTREPRENEURSHIP

How might DNA predict which patients will benefit most from new classes of drugs as treatment? How can the identification of genetic markers in human DNA lead to detecting cancers more rapidly? How can reference genomes improve crop breeding and prepare us for tomorrow’s challenges?

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More than 40 bioscience companies have chosen to establish a presence on the campus of the HudsonAlpha Institute for Biotechnology (aerial view, above), taking advantage of proximity to cutting-edge research. (Photo: HudsonAlpha Institute of Biotechnology)

At the HudsonAlpha Institute for Biotechnology, scientists tackle these and other questions on the forefront of genomics daily. More than 40 bioscience companies have chosen to establish a presence on the HudsonAlpha campus, taking advantage of proximity to this cutting edge research and the state’s growing biotech workforce.

Alabama, known historically as an agricultural economy, makes a perfect home for the HudsonAlpha Genome Sequencing Center (HGSC). The HGSC is a world leader in plant genomics, helping inform smarter breeding of crops ranging from peanuts to cotton to cacao, using some of the most advanced sequencing techniques available today.

Led by two of the most cited researchers in the world—Jane Grimwood, PhD, and Jeremy Schmutz—the HGSC has produced more than half of the world’s high-quality plant reference genomes. These genomes allow scientists and plant breeders alike to hone in on the traits that make great crops. Plant breeding often requires waiting for a crop to reach maturity to see if it has retained desirable traits from the previous generation. By sequencing plant genomes and comparing them against a reference, scientists can confirm whether traits were passed on far earlier in the process, saving years if not decades. This genetically enhanced breeding speeds crop development and helps to secure a stronger future for agriculture, as it aims to keep up with surging demand and a changing climate.

All of this is made possible by long-read sequencing that sets the industry standard for depth of coverage, elevating the HGSC and HudsonAlpha among its peers. It’s not just genetics; it’s some of the most advanced genetics on the planet.

Even with agriculture going strong, the broader economy of Alabama has transformed itself over the past 70 years. The state has quietly capitalized on a business-friendly environment to become a leader in aerospace, automotive, advanced manufacturing and bioscience. HudsonAlpha’s Educational Outreach team plays its part by developing the talent that these future-facing industries demand. Led by Neil Lamb, PhD, the Institute prepares students to fill the growing need for laboratory technicians, quality control specialists, genetic counselors and other roles in life sciences organizations.

Education programs at HudsonAlpha train future scientists through hands-on classroom modules, digital learning materials and in-depth camp experiences for educators and students. BioTrain interns gain skills and knowledge that prepare them for the workforce as well as related higher education coursework. Simultaneously, interns improve their professional skills through weekly lunch seminars that focus on learning to work in a professional setting and dealing with workplace values such as punctuality, respect and time management.

HudsonAlpha was founded as a nonprofit to combine the power of academic research with the resources of the commercial sector. Since its founding more than a decade ago, the mission of the Institute has been to bring discoveries to market more quickly, and HudsonAlpha has already completed a number of successful tech transfers in pursuit of that goal.

Associate Companies on the HudsonAlpha campus are encouraged to participate and take advantage of “the Business of Biotech”—a series of entrepreneurial and commercialization support programming focused on the needs of early-stage biotech companies as they look to grow. These efforts also help accelerate new therapeutics, medical devices, diagnostics and other innovations. VP for Economic Development Carter Wells leads the team providing these incubation-like resources for life sciences companies of all stages and sizes.

Companies can lease co-working style desks, as well as premier lab and office space with flexibility for scaling on campus. Larger companies may find a site along the double helix park.

The Institute’s 152-acre biotech campus offers room to grow and access to quality resources, including top talent and a ready workforce, continuous knowledge sharing and funding sources for intellectual property—all in a collaborative community of bioscience enterprises.

DELAWARE: LEGACY OF TRANSFORMATIVE ACHIEVEMENTS

Innovation is the catalyst for virtually every industry in Delaware, from farming to pharma and beyond. DuPont’s more than 200-year legacy has supported Delaware’s rise as a global force in science, technology and engineering. Delaware-based Incyte ranks seventh among Forbes Magazine’s World’s Most Innovative Companies, continuing the tradition. With success following success, science and technology companies are growing and locating in Delaware.

Here are just some of the reasons why—Delaware:

  • Ranks sixth on the U.S. State Innovation Index
  • Ranks fourth for highest concentration of PhDs employed in health, science and engineering
  • Ranks seventh on the Milken Institute’s 2018 State Technology and Science Index
  • Ranks 2 in lowest cost for doing business

Today, chemical manufacturing is the largest manufacturing industry in Delaware—generating $6.4 billion in economic activity—and accounts for one-third of all Delaware manufacturing exports. The state’s position as a leader in advanced chemicals is supported by a deep talent pool, with the highest concentration of chemical engineering jobs in the country. It is also served by a top-tier talent pipeline from the University of Delaware’s graduate chemical engineering program, which ranks among the nation’s top 10, according to U.S. News & World Report.

Delaware’s bioscience companies—spanning pharmaceuticals, agriculture, chemicals and medical devices and diagnostics—are leaders in moving cutting-edge technology from lab to market. Leading pharmaceutical companies are headquartered in the region, where firms collaborate with research and medical institutions to develop and commercialize innovative drugs, diagnostics and devices. The number of life sciences firms in the state has grown by more than 60 percent during the last decade, drawing on an existing pool of highly trained and specialized workers. Delaware’s location within a two-hour drive of more than 100 colleges and universities offers an ongoing abundance of human resources for these businesses.

Other resources include the exciting, new Delaware-located facilities that will support continued bioscience advances well into the 21st century. These include the recently completed $156 million Biopharmaceutical Innovation Building at the University of Delaware’s Science, Technology and Advanced Research (STAR) Campus in Newark.

Solenis is a $3 billion global producer of specialty chemicals for water-intensive industries, including the pulp, paper, oil and gas, chemical processing, mining, biorefining, power and municipal markets. The company’s product portfolio includes a broad array of process, functional and water treatment chemistries as well as state-of-the-art monitoring and control systems. These technologies are used by customers to improve operational efficiencies, enhance product quality, protect plant assets and minimize environmental impact.

With roots in Delaware going back 100 years and its new global headquarters in Wilmington, the company employs 5,200 professionals in 120 countries spanning five continents and operates 40 manufacturing facilities strategically located around the world. When Solenis entered what leadership calls “a growth mode” in 2018, the number of locations where it could have achieved its goals of increasing capacity and adding jobs were considerable.

Solenis chose to expand in Delaware and worked with Delaware Prosperity Partnership toward the eventual move of its worldwide headquarters in early 2020. The existing but redeveloped 90,000-square-foot office space currently houses executives, global managers and departments such as human resources, marketing, information technology and customer service.

“More than 200 employees have relocated to the building, and there’s ample room to facilitate the growth we expect,” said Senior Vice President and Chief Financial Officer Philip M. Patterson Jr. “We are working to retain, recruit and add employees to enhance our value proposition and better serve our customers.”

Helping Solenis reaffirm its commitment to Delaware were the amenities promised by the site and the state’s performance-based incentives. Delaware Prosperity Partnership helped the company secure more than $3.9 million from the State of Delaware toward its move into new headquarters in the Avenue North complex, an upscale mixed-use campus that combines office, commercial, residential and hotel uses. Designed for sustainability and employee well-being, the two-story building houses a comfortable, collaborative workspace featuring automatic lighting adjustment, wellness rooms, a fitness center and plenty of natural light.

“Solenis, a global leader in specialty chemicals, plays an important role in Delaware’s economy and our rich history of innovation,” said Gov. John Carney. “Choosing Delaware for their next phase of growth and development benefits our economy and our communities, and underscores Delaware’s prominence in the specialty chemical sector. And this confirms again that Delaware remains a great place for companies of any size to put down roots, grow and create jobs.”

A smaller, newer endeavor which has done just that is the privately held, clinical-stage biopharmaceutical company Prelude Therapeutics. The four-year-old startup conducts research focused on key drivers of cancer cell growth, survival and resistance. Two clinical trials are in progress, with more pre-clinical development candidates in the pipeline.

Also based in Wilmington, Prelude began operations with a handful of employees and has grown to employ more than 30—drawing international attention for its innovative discoveries and attracting top pharmaceutical and biotech talent to Delaware along the way. While splitting operations between Delaware Innovation Space and nearby office space, Prelude outgrew those locations quickly and sought to grow—choosing to do so remaining in Delaware. Working with Delaware Prosperity Partnership, Prelude applied for and received $834,090 in performance-based grants for job growth and capital investment.

As a result, Prelude’s team will expand to a projected total of 81 employees by 2022. The roughly four-dozen new positions will include professional scientists and skilled associates and add approximately $5.5 million to the company’s annual payroll. Prelude also plans to invest $5 million in expanded lab and office space in the Wilmington area.

“Prelude’s decision to expand in Delaware,” the governor noted, “reaffirms that our state is a great place for business of all sizes to put down roots, grow and create good-paying jobs.”

Incyte also is in the process of expanding its campus. In September 2019, the company was approved for an expansion project for a new six-story building that will include lab and office space on its campus in Delaware. This expansion intends to allow Incyte to bring employees currently in Chadds Ford, PA, to Wilmington on one campus. The construction on this project is expected to take approximately two years.

In October of 2019, the company announced that it had entered into an agreement with Wilmington Friends School Inc., to purchase the lower school property on the school’s campus in Wilmington. This acquisition, once final, will provide Incyte with a long-term opportunity to expand its global headquarters campus in Wilmington.

RHODE ISLAND IS READY FOR CELL AND GENE THERAPY PRODUCTION

The cell and gene therapy industry is continuing to grow at a rapid pace. By 2024, this industry is projected to reach more than $6 billion in revenues and the FDA reports more than 900 active investigational new drug applications for clinical studies in gene therapy. Commercial success of cell and gene therapies hinges on effective, scalable production.

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Amgen Rhode Island’s conventional manufacturing plant is adding a next-generation biomanufacturing plant in 2020. (Photo: Rhode Island Commerce Corporation)

A cell and gene therapy company must decide whether or not to build its own manufacturing facility. If choosing to build, the space needs to be flexible enough to accommodate increases in production scale, future pipeline, and technological advances. The company also would need assurance the surrounding area has the highly-skilled talent necessary for production.

Another option is to utilize contract manufacturers, which already have space, equipment and trained staff. But demand by other cell and gene therapy companies, many requiring specialized expertise and methodologies, is causing a backlog, slowing production time considerably. Coupled with the well-documented viral vector shortage, it is clear some companies may need to take on manufacturing.

As companies move from solely producing treatments for rare diseases, which have lower demand due to small patient populations, toward finding therapies for more common conditions that affect millions, like Alzheimer’s or Parkinson’s, the ability to scale quickly will become even more crucial. With a proven history in manufacturing and forward-thinking government agencies ready to support this industry, Rhode Island is the ideal place to establish manufacturing and production facilities.

Throughout history, Rhode Island has been at the forefront of advancing American industries. From the Slater Mill leading to the American Industrial Revolution in the late 1700s to the Corliss steam engine, Rhode Island has been and remains a global manufacturing leader. The state is adept at helping to scale production in ways that can reduce costs, by investing in resources to support companies and simultaneously facilitating innovation.

For cell and gene therapy manufacturing in particular, Rhode Island is already building support infrastructure for the development of manufacturing facilities. This doesn’t always mean new construction. In 2018, Rubius Therapeutics, a clinical-stage biopharmaceutical company developing cell therapies, announced it would establish a manufacturing facility in Smithfield, Rhode Island. Rubius is investing $155 million over five years in an adaptive reuse of an existing 135,000-square-foot building to create a facility that will allow the company to manufacture in a way that is compliant with Current Good Manufacturing Practice regulations, and eventually for commercialized production. At this facility, Rubius will produce large quantities of the company’s Red Cell Therapeutic product candidates, as well as necessary lentiviral vectors.

Rubius is not alone in taking advantage of what Rhode Island has to offer. Amgen, a multinational biopharmaceutical company, recently broke ground on its 120,000 square-foot, next-generation biomanufacturing plant in West Greenwich, Rhode Island. The first facility of its kind in the U.S., it will not only take half the construction time, it also reduces operating costs by half and increases sustainability by reducing the amount of used and emitted water, energy and carbon.

Both Amgen and Rubius were able to take advantage of Rhode Island’s flexible and powerful tax incentive programs that support job creation and infrastructure development. Rubius was also a recent recipient of a site readiness grant that allows it to explore options for further development.

Another key reason why both Rubius and Amgen chose Rhode Island is access to a highly skilled workforce. Across the biotechnology industry, there is a need for qualified manufacturing workers. Rhode Island has taken on the challenge to ensure that the more than 1.6 million people in the greater Providence metro area have the advanced skills necessary to support the innovative work happening in the life sciences industry today and in the future.

A great example of this investment in workforce development is Amgen’s use of the state’s Real Jobs RI program, which creates demand-driven, public-private partnerships to meet businesses’ needs. Instead of training a few dozen process technologists for the next-generation plant, Amgen works with Real Jobs RI on custom workforce solutions, including convening educators from public colleges and universities like University of Rhode Island and the Community College of Rhode Island to create coursework and leveraging learnings from Amgen’s next-generation biomanufacturing plant in Singapore. Each year, Amgen reevaluates and the programs are adjusted to prioritize resources toward what is most needed in the coming year.

Rhode Island is committed to the future of the cell and gene therapy industry, investing in cutting-edge programs that support the growing bioscience innovation ecosystem. The Rhode Island Cell Therapy Training Institute (RI-CTTI) within the Rhode Island CAR-T Design and Development Center, for instance, will be formed by the University of Rhode Island and Roger Williams Medical Center with support of the state through the Innovation Campus program. The Center provides state of the art cell therapy manufacturing capacity for multiple CAR-T cell trials, and the specific goal of RI-CTTI is to train nursing students on the unique process of treating patients using cancer immunotherapy, including key topics such as CAR-T production and administration.

As the cell and gene therapy industry grapples with scalability concerns, states will vie for the opportunity to court this multibillion-dollar industry. Companies choosing a state partner should consider how the state invests in the necessary resources and programs to support growth, innovation and discovery of more advanced therapies. Rhode Island offers all of this and a proven track record of manufacturing success.

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