Frederick County, Maryland is Emerging as a Life Science Risk Management Hub
April 23, 2019
The BioHealth Capital Region (BHCR) recently showcased its strength as a national biopharma cluster (ranked #4 in the U.S. according to GEN’s latest rankings) at the BHCR Forum held at AstraZeneca’s Gaithersburg, MD site in early April.
Among a number of notable takeaways, the BHCR’s regenerative medicine industry is quickly becoming a powerful sub cluster within the wider BHCR hub. Companies like Frederick, MD’s RoosterBio, Inc. and Theradaptive, as well as Osiris Therapeutics, who was recently acquired for $660.5M, have made the BHCR a major hub for regenerative medicine.
However, the regenerative medicine hub is not the only developing segment in the region. Another life science-related industry is quietly taking shape within the BHCR: Frederick County Maryland’s emerging life science risk management segment is developing rapidly.
Biorisk mitigation, regulatory compliance, accreditation and validation are critical factors to biopharma GMP, quality assurance/control and the subsequent delivery of efficacious and safe medicines to patients in need.
Risk management companies to watch like A2LA, VaLogic, and Inspirion Biosciences–in addition to the recent Thermo Fisher Scientific, Inc.’s expansion that houses its cyber security arm–are recent examples of a sub cluster gaining traction within Frederick.
Let’s take a look a closer look at three growing biopharma risk management companies–as well as Thermo Fisher’s cybersecurity center–that are reshaping Frederick’s life science industry portfolio.
A2LA was founded in 1978 as a non-profit membership society. The company is the 5th largest accreditation body of its type in the world and is one of only a handful of similar organizations in the U.S. A2LA has approximately 70 employees on site with over 200 assessors operating throughout the U.S. The company’s international business is expanding considerably as it works with foreign companies seeking accreditation to do business in the U.S.
A2LA’s mission is “Providing independent, world-class accreditation and training programs that inspire confidence in the quality of services and acceptance of results from accredited organizations.” The privately-held company is led by industry veteran Lonnie Spires, who is president and CEO. The organization provides third-party accreditation services from ISO/IEC lab testing and calibration to CLIA (clinical laboratory improvement amendments) for clinical testing labs and ISO/IEC accreditation for reference material producers. Any A2LA accreditation is valid across the globe. A2LA also provides cybersecurity accreditation via its Cybersecurity Inspection Body Program and delivers critical training that empowers companies to maintain accreditation, including courses on quality principles, GMP/GLP, management systems and internal auditing.
Founded in 2002, VaLogic is a life science-focused risk management services and GMP consulting organization. The organization is led by founder and president Bill Robertson, who has expanded VaLogic’s services during his tenure to help “…over 300 biopharma companies advance their development and commercialization of life-enhancing therapeutics.” VaLogic assists life science organizations with risk mitigation across a wide range of inflection points, including product development, ground-up new facility and renovation/expansion builds, general facility management and GMP operations. The company’s mission is to reduce overall risk, speed up production development timelines and secure the supply chain.
The company has two software products–VaLogic LogiPoint™, a 24/7 monitoring and analytics solution, and VaLogic Logical™, which provides the resources and infrastructure to create a world-class cGMP calibration, compliance and validation program. VaLogic also offers expert facility prequalification readiness services, including integrated commissioning and qualification, Q9 quality risk management, ISPE/PDA, EMA/MHRA, ISO and ISE.
In 2010, the company opened a 6,000 SF office in Frederick, which they expanded to 15,000 SF in 2017 to accommodate its growing staff and expanding client portfolio.
Founded in 1999, Inspirion Biosciences is a global biorisk management organization that “provides critical solutions covering the entire spectrum of your laboratory lifecycle from design, commissioning and start-up, through operations, laboratory relocation and decommissioning to address, identify and solve safety and security risks at each step before they arise.”
The organization works with academic research labs, biotech incubators, healthcare facilities, federal government programs, commercial facilities and the insurance industry, among others. Inspirion is a global company that has worked with clients across 30 countries.
CEO/owner and risk management expert Dr. Craig Reed has spearheaded the company’s growth, overseeing approximately 50 Cooperative Bioresearch Projects (CBRs), 200 Biosafety & Biosecurity Threat & Vulnerability Assessments (T&VA) in 10 countries and the program management of six different U.S.-funded engagement programs valued over $70M. Inspirion has assisted the U.S. Centers for Disease Control and Prevention, the U.S. Department of Energy, the U.S. Department of State, among other agencies, and has served as an advisor to the White House.
According to a 2016 Frederick New Post (FNP) story, Inspirion seeks to increase awareness about the precarious nature of the biorisk compliance environment. Reed estimates that there are over 300,000 biosafety level 1 through 4 labs in the U.S. alone and only about 500 American Biological Safety Association (ABSA) certified professionals to manage biorisk for them. That means there is one credentialed biorisk safety professional for every 600 biosafety level 1 through 4 labs in the U.S., which is a cause for concern and action. All of Inspirion’s staff are ABSA certified as Registered Biological Safety Professionals (RBPs) and/or as Certified Biological Safety Professionals (CBSPs).
Reed believes that this disconnect should concern all federal, state and local government officials and any organization that operates a biological laboratory. Reed feels that ongoing growth of molecular biology and recombinant genetic technology is “outstripping our scientific infrastructure” and making work safety and risk management more important than ever.
Reed sees Frederick, MD as place that could become a center for stronger biorisk management and regulation. In the same FNP article referenced earlier, Reed stated, “We need to be advancing these issues of laboratory safety and security. It will tell others that this is the place to come for the bioscience industry.”
Thermo Fisher Scientific–Cyber Center of Excellence
In late October 2018, Thermo Fisher Scientific, Inc., announced a 290,000 SF site expansion in Frederick, MD that will house its new business center and biorepository while also serving as the North American hub for the company’s life science business. Interestingly, the site expansion included its Cybersecurity Center of Excellence, which will house the organization’s cybersecurity arm. Cybersecurity risk management is a growing concern in healthcare and the life science industry.
A developing cybersecurity talent base spurred on by burgeoning cyber programs at Mount St. Mary’s University, Hood College and Frederick Community College is a primary reason Thermo Fisher located its cyber unit in its Frederick facility.
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According to Thermo Fisher’s official press release about the Frederick facility expansion, U.S. Senator Ben Cardin, Ranking Member of the Senate Committee on Small Business and Entrepreneurship stated, “Thermo Fisher’s expansion in Frederick County helps continue the emergence of this community as a regional leader in biotechnology, and will provide real-world progress in fighting complex diseases and bolstering our cybersecurity. By deepening its investment in Frederick, Thermo Fisher is building the local economy and providing Marylanders with the high-quality jobs and 21st century research tools we need to stay one step ahead.”
With a strong foundation of growth-stage life science risk management companies, including those addressing emerging cybersecurity risk management needs, Frederick is poised to add yet another powerful component to its rapidly growing life sciences industry.