Life Sciences Hubs: Good Genes, GREAT Growth

Billions in private equity and public funding are flowing into the life sciences sector, which is front and center in the battle against the COVID-19 pandemic.

By the BF Staff
From the January/February 2001 Issue

The life sciences industry has been a bright spot in the U.S. economy, with private investors putting more than $16 billion to work in the first half of 2020. That is in addition to a steady stream of government funding, with the National Institutes of Health ramping up grants from $11 billion in 1994 to $39.1 billion in 2019, according to Roger Humphrey of NAIOP, the commercial real estate development association.

In addition to the ongoing development and production of COVID-19-vaccines, related therapeutics and antibody tests, Humphrey says that contributing factors to this influx of funding include an aging U.S. population that demands life-sustaining and life-extending care, wellness-conscious millennials in their peak earning years driving personalized treatment, and a prescription drug market on track to reach $1 trillion by 2022.

“To capture funding and reap the huge rewards of being first-to-market, life sciences companies must fend off fierce competition from large, established businesses and start-ups alike. Increasingly, that means creating a work environment that encourages innovation and productivity while remaining flexible to meet new and evolving demands,” Humphrey said in a post on NIAIOP’s website.

Here’s a detailed look at two of the leading life sciences hubs that have attracted world-class biopharma players to their locations.

LIFE SCIENCES GROW AT HUDSONALPHA

Locating on the HudsonAlpha campus in Alabama offers life sciences companies of any stage or size access to the cutting edge of biotechnology and flexibility to grow. Since nonprofit HudsonAlpha has a mission to foster the success and growth of bioscience companies, it is neither an ordinary incubator nor landlord. More than 45 life sciences companies currently reside on campus, taking advantage of its collaborative culture and its proximity to on-site cutting-edge research and world class sequencing capabilities.

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Aerial of the HudsonAlpha campus. (Photo: HudsonAlpha)

Fostering success of biotechs of all sizes and stages was the vision of co-founders Jim Hudson and the late Lonnie McMillian, and became a mission of the nonprofit institute more than 10 years ago. Their passion for helping innovative biotech entrepreneurs have the resources and support network necessary to get from “bench to bedside” continues on the growing biotech campus.

Collaboration and the flexibility to grow have proven key components of success at HudsonAlpha. Superior shared spaces and full services leases make locating at HudsonAlpha the first of many simple choices that allow biotech management teams to spend their time and effort on and in the business.

The Institute’s 152-acre biotech campus, located in an Opportunity Zone, 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.

The coronavirus disease (COVID-19) outbreak continues to present enormous challenges for global health. While the world pursues its fight against the novel coronavirus, researchers and private industry have banded together in order to slow the spread of the virus and develop new tests and treatments for COVID-19. Now, more than ever, it is evident that collaboration is necessary to overcome current challenges and nowhere is as uniquely qualified to help foster these collaborations than Huntsville’s HudsonAlpha Institute for Biotechnology.

The strength of HudsonAlpha lies in the culture of collaboration and a unique structure that encourages entrepreneurship. That strength is currently being demonstrated through the research and development of diagnostic and treatment tools to combat COVID-19 across HudsonAlpha’s campus of 16 research laboratories and 45 biotech companies.

“I am in frequent contact with scientists here on the HudsonAlpha campus and we are working to find solutions for COVID-19,” said Rick Myers, PhD, HudsonAlpha president and science director. “We are fortunate to have leaders right here on our campus involved in the fight against this disease.”

At the outset of the COVID-19 pandemic, the companies residing on HudsonAlpha’s biotech campus have increased laboratory testing capacity, launched point-of-care testing diagnostics, advanced early stage antibody treatments for immune response, provided researchers with critical reagents for COVID-19 projects and researched personal protective equipment sterilization methods for the reuse of PPE equipment.

Eurofins Diatherix, a diagnostic testing laboratory, released its COVID-19 panel in mid-March and immediately began working with physicians and hospitals to test symptomatic patients. Since launching, Eurofins Diatherix has increased its testing capacity by more than 50% by adding to their workforce and expanding into and repurposing lab and office space at HudsonAlpha. Eurofins Diatherix recently received Emergency Use Authorization (EUA) for its COVID-19 panel and have provided diagnostic test results to hundreds of thousands of people nationwide.

“We appreciate that HudsonAlpha removed many obstacles that have allowed Eurofins Diatherix to scale up capacity for large volumes of COVID-19 testing,” said Jen Cart, CEO of Eurofins Diatherix. “Their swift accommodation of our needs demonstrated the incredible support and true purpose of the HudsonAlpha’s mission for collaboration and connectivity.”

Associate companies are also able to leverage the collective community of HudsonAlpha when needed. transOMIC Technologies is a critical vendor of reagents to researchers working on COVID-19 therapies. Recently, transOMIC lost operation of key equipment, threatening production of their test kits. Within an hour, transOMIC was able to meet the delivery commitments thanks to the multiple offers of assistance from other associate companies and non-profit labs on the HudsonAlpha campus.

“Thanks to HudsonAlpha and the collaborative community, we were able to continue production with minimal down-time and continue to provide products to researchers working on COVID-19 projects,” said transOMIC CEO, Blake Simmons.

HudsonAlpha has advocated for the associate companies on campus throughout this crisis and as local, state and federal policies are updated, many within the Institute work daily with the associate companies on funding options, best practices on workplace safety and on return-to-work planning.

Sameer Singhal, President/CEO of CFD Research, one of the associate companies that has been with HudsonAlpha since inception, said, “As a resident associate company on the campus, we appreciate having HudsonAlpha’s economic development team provide us useful resources during the pandemic and sharing best practices for returning to work.”

More than 45 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. To date at least 10 companies at HudsonAlpha are working on COVID-19 related projects, including some companies working for others during this peak demand pandemic era.

The biotech campus at HudsonAlpha is within Cummings Research Park, the second largest research park in the United States, which co-locates Fortune 500 companies with local and international businesses specializing in a range of high-tech industries.

WORLD-CLASS GENE THERAPY IN NORTH CAROLINA

Sanford and Lee County, NC have garnered international attention in recent months for major location decisions by Pfizer, Inc. and Astellas Pharma, two of the leading global players in gene therapy manufacturing.

In August, 2019, Pfizer announced an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, NC. This facility will support Pfizer’s continuing investment in gene therapy research and development, while expanding the company’s presence in North Carolina, where there are currently more than 3,600 Pfizer colleagues, including 650 in Sanford. The expanded facility is projected to add approximately 300 new jobs.

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Central Carolina BioWork is collaborating with industry and academic partners with NIIMBL support to create a direct path to short-term biotech manufacturing training for the military community. (Photo: Central Carolina Community College (CCCC))

In addition to its gene therapy operations, colleagues at Pfizer’s Sanford facility also manufacture components for the company’s vaccine portfolio, including Prevnar 13 and several vaccines currently in Pfizer’s research pipeline.

By expanding its manufacturing footprint in Sanford, Pfizer expects to strengthen its ability to produce and supply both clinical- and commercial-scale quantities of critical, potentially life-changing gene therapy medicines to patients living with rare diseases around the world. Specifically, the new facility would help advance Pfizer’s work in manufacturing highly specialized, potentially one-time gene therapies that use custom-made recombinant adeno-associated virus (rAAV) vectors.

“At Pfizer, our purpose is breakthroughs that change patients’ lives,” said Angela Hwang, Group President, Pfizer Biopharmaceuticals Group. “We’re excited to build this new state-of-the-art facility in Sanford because it will have the potential to help us develop novel methods to deliver transformative treatments to patients.”

“This investment will further strengthen Pfizer’s leadership in gene therapy manufacturing technology,” said Mike McDermott, President, Pfizer Global Supply. “The expansion of the Sanford site is expected to create hundreds of highly skilled jobs, which would increase Sanford’s high-tech manufacturing environment and is part of our overall plan to invest approximately $5 billion in U.S.-based capital projects over the next several years.”

In February 2020, following fast on the heels of Pfizer’s announcement, Bay Area unicorn Audentes Therapeutics announced it would be investing $109 million to build a new 135K SF, state-of-the-art gene therapy manufacturing facility in Sanford, NC. Fresh off the news of its acquisition in January, 2020, by Tokyo-based Astellas Pharmaceuticals, Audentes is focused on developing innovative AAV-based genetic medicines. The company plans to create over 200 new jobs in Lee County.

“Our investment in large-scale manufacturing has always been a cornerstone of our strategy to develop and ultimately deliver our important genetic medicines to patients as rapidly as possible. This new facility in Sanford will support the next phase of our growth as we establish a robust, global supply chain and expand our therapeutic and geographic scope as a part of the Astellas group of companies,” stated Natalie Holles, President and Chief Executive Officer of Audentes. “We are excited to join the vibrant biopharmaceutical research and manufacturing community that the state of North Carolina has established.”

Speed to market was a primary factor in Audentes’ decision to locate in Sanford and Lee County. They purchased a newly constructed 117K SF industrial building in shell condition on one of sixteen NC Dept. of Commerce certified sites situated in Sanford’s Central Carolina Enterprise Park (CCEP), a mere 15 minutes from the I-540 loop around Raleigh. This Class A industrial facility, part of an ongoing building program by premier Southeastern builder Samet Corporation and other local investors, gained the company a critical 12-18 month advantage in speed to market, at significantly lower cost than other counties in the Research Triangle region. Samet currently has a second shell building nearing completion in CCEP, and site design is well underway for a third.

The abundance of existing life sciences talent was another critical factor driving Audentes’ site selection decision. Companies like Pfizer, Seqirus, Ajinomoto, Grifols and Novo Nordisk employ thousands within less than 45 miles of the site. As North Carolina Commerce Secretary Anthony M. Copeland said of the decision, “Audentes Therapeutics is joining one of the nation’s top life science clusters. North Carolina has the largest biomanufacturing workforce in the nation and a growing concentration of gene therapy scientists, researchers and workers.”

North Carolina leaders recognize that life sciences are transforming the world. Vaccines prevent disease. Gene therapies and precision health data cure them. Advances in agriculture feed the planet. With the ever-expanding life sciences ecosystem has come significant public investment in support of the industry. The NC Biotechnology Center is a non-profit, public-private partnership supported by the N.C. General Assembly. Its mission is to transform North Carolina and its life science technology-based economic development through innovation, commercialization, education, and business growth.

Anchored by three globally-renowned research universities, and bolstered by the award-winning North Carolina Community College System, Lee County’s region also features multiple world-class educational programs tailored specifically to meet the needs of Biopharma manufacturers.

The NC State BTEC (Biomanufacturing Training and Education Center) is a unique, cross-disciplinary instructional center that provides educational and training opportunities to develop skilled professionals for the biomanufacturing industry and create the best-trained, most industry-focused workforce possible. NC State BTEC operates under the auspices of North Carolina State University’s College of Engineering on NC State University Centennial Campus. BTEC’s two facilities feature more than $12.5 million of industry-standard equipment and a simulated cGMP (current Good Manufacturing Practice) pilot plant facility capable of producing biopharmaceutical products using cell growth and expression, recovery, and purification processes using aseptic practices.

Central Carolina Community College is now offering Bioprocess Technology and BioWork programming. The BioWork industry credential provides a foundation for a career as a Bioprocess Technician with local and regional biopharmaceutical companies. Offering credit for BioWork creates a clear, seamless path into the new Bioprocess Technology degree program. Central Carolina’s AAS in Bioprocess Technology curriculum is designed to prepare individuals to work as process operators in biological products manufacturing facilities.

Central Carolina Community College is participating in a National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) program to train military veterans for biotech manufacturing jobs. Participants include the North Carolina Biotechnology Center, Pfizer Inc., Wake Technical Community College, Gaston College, Durham Technical Community College, and Merck Inc.

Dr. Lisa Smelser, CCCC lead biotech instructor, said: “Central Carolina BioWork is honored to collaborate with industry and academic partners with NIIMBL support to create a direct path to short-term training for our military community. Military members have skills and aptitude that are well-matched for careers in the biopharma industry.”

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