Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
GSK Expansion, Ebola R&D Enhance State’s Focus on Growing Biopharma via Vaccine Development
When leaders gather next month at the Tech Council of Maryland’s first-ever summit focused on building the vaccine development segment of the state’s biopharma industry, they’ll have plenty of reason to celebrate as well as plan ahead.
The most obvious reason occurred earlier this month, when GlaxoSmithKline (GSK) said it would create one of its three Vaccine Development Centers in Rockville, MD. GSK will add 600 jobs to the 400 it already bases in Maryland—in part by shifting positions now based in Philadelphia and Cambridge, MA.
“When GlaxoSmithKline gave us all a big present here and said that they were doing this expansion, it really was proof to me that we’re right. This is an attractive place to set up the right research and development programs, because the pieces of the puzzle you need to do that are here,” Philip Schiff, the Tech Council’s CEO, told GEN.
Those pieces, he said, go beyond Maryland’s location as home to the NIH and FDA. The state has a strong biopharma talent pool thanks to universities such as Johns Hopkins—the nation’s top recipient of NIH grants among academic institutions—and the University of Maryland system—as well as an industry presence that has grown to more than 500 companies, more than half in Montgomery County.
Eager to build on Maryland’s strengths, Schiff and the Council are working to help the state’s biopharma cluster grow by 2023 to third-highest in the U.S., behind only Boston-Cambridge, MA, and the San Francisco Bay Area. Earlier this year, GEN’s annual List of Top 10 U.S. Biopharma Clusters ranked Maryland and the rest of the DC metro area at number five. Boston/Cambridge topped the list, followed by the Bay Area, New York/New Jersey, and San Diego.
That list also cited two longstanding challenges to biopharma development in Maryland: A smaller workforce and weaker capital attraction than its higher-ranked rivals. Yet Gaithersburg-based Vaxin—which relocated from Alabama in 2012—won $16 million from four VC sources (Novartis Venture Fund, HealthCap, Truffle Capital, and Redmont Capital) in February, when it agreed to acquire Immune Targeting Systems for $16 million.
Telling the Story
Schiff cites forecasts that vaccine sales will outpace sales growth for the overall biopharma industry—the conclusion of separate reports in recent years by EvaluatePharma and the World Health Organization. And he says Maryland’s key challenge is less about what’s in the state than what people hear about it.
“We don’t tell the story very well,” Schiff said. “People don’t really understand what’s here, and what are the assets, and why Maryland. GSK figured it out. But I want other people to figure it out, and continue to build this cluster.”
Maryland will take its next step forward in biocluster building on May 7-8, when the Tech Council hosts The Atlantic Vaccines and Immunotherapeutics Summit at the Bethesda (MD) North Marriott Hotel & Conference Center. BIO President and CEO Jim Greenwood will join speakers from Maryland companies, schools, and government agencies, with opening remarks by U.S. Rep. Chris Van Hollen (D-MD).
Schiff says the Summit was not a response to GSK or other vaccine-related developments, but was in planning stages for about a year.
“We sat down with a new strategic plan, and started looking at what really makes up life sciences in Maryland: Why are we so unique? What’s successful? And what do we need to do to make it top-notch?” Schiff recalled. “One of the things that became very apparent to us is that the vaccine industry, the research and development here is unique. There are a unique set of assets here. There are things going on that make it very successful.”
According to the council, more than 45 companies with a Maryland presence are conducting some 160 clinical trials related to vaccines and immunotherapeutics. A key reason why is the federal government’s ramp-up of funding and research for Ebola vaccine development since last fall.
Baltimore-based Profectus BioSciences, for example, has reported receiving a combined $37.4 million in funding from three federal agencies toward its VesiculoVax™-vectored Ebola vaccine. On April 8, Profectus hailed successful results for the vaccine, saying it protected non-human primates against the Makona strain of Ebola virus (also called Ebola Guinea) linked to the West African outbreak.
Vaccines are among the biologics developed by AstraZeneca’s MedImmune subsidiary. MedImmune announced plans in November for a $200+ million expansion of its Frederick, MD, manufacturing center that will bring 300 new jobs, boosting its workforce there to 930, when completed in mid-2017.
A smaller but also growing vaccine developer, Emergent BioSolutions, won a $31 million contract last month from the U.S. Biomedical Advance Research and Development Authority (BARDA) toward advanced development of the next-generation anthrax vaccine candidate NuThraxTM.
Emergent is expanding its East Lombard Street manufacturing site in Baltimore—one of two company facilities in the city—which will double from its current 58,000 square feet, and add 158 jobs over the next four years. Construction is “going to be substantially complete the end of next year, and we’ll be in production in 2017,” Daniel J. Abdun-Nabi, Emergent’s president and CEO, told GEN.
Between that expansion, and plans to hire 133 over five years at its new Gaithersburg, MD, headquarters, Emergent’s workforce is set to swell to more than 700 from the current 425, Abdun-Nabi said.
“Maryland has tremendous resources in terms of talent, infrastructure capabilities, academic institutions and research universities, and close ties to the customer, whether it’s BARDA or NIH, or FDA. It’s got all the makings for a fairly incredible biotech hub. For us to be the center of that really makes an awful lot of sense,” Abdun-Nabi said.
Yet challenges remain: Maryland’s costs and taxes exceed those of competing states—something Abdun-Nabi hopes will change under new Governor Larry Hogan (R).
Last month, Emergent said it manufactured a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ), as a heterologous “boost” to GSK’s experimental Ebola vaccine, under agreements with GSK, NIH’s National Institute of Allergy and Infectious Diseases (NIAID), and the University of Oxford. The MVA was produced at Emergent’s Bayview campus in Baltimore, established by BARDA as one of three Department of Health and Human Services' Centers for Innovation in Advanced Development and Manufacturing (CIADM) nationwide.
Emergent previously showed its partners it could quickly scale up production of MVA tuberculosis vaccine on a cell line instead of in eggs, Abdun-Nabi said: “Within 90 days from getting our hands on the construct, we had it produced, released, and ready to go into the clinic.”
HHS committed $222 million to the CIADM at Bayview, which like the other two centers is designed to enable flexible development and production of medical countermeasures—such as at least 50 million doses of pandemic flu vaccine within four months of strain identification.
GSK’s GlaxoSmithKline Biologicals unit manufactures ChAd3-EBOV, which was co-developed by NIAID and Okairos, a drug developer acquired by GSK in 2013. In January, GSK shipped the first doses of the vaccine to Liberia for a Phase III trial, following promising Phase I results.
GSK signaled its intent to grow in vaccines last year, when it agreed to acquire Novartis’ non-flu vaccine business for up to $7.1 billion plus royalties, part of a set of company-reshaping deals that also involved Eli Lilly.
Not surprisingly, GSK cited proximity to government agencies that fund vaccine R&D—including NIH and BARDA—in its decision to expand in Rockville.
“This location will also enable our research teams to collaborate with critical US bio-scientific and policy vaccine leaders, particularly in GSK’s emerging focus in biodefense and medical counter measure innovation, as well as leaders on global health from around the world,” a company spokeswoman, Melinda Stubbee, told GEN.