Georgia Bio Sign-on to State Medical Technology Alliance HHS & CMS Letter

Georiga Bio sign-on to the State Medical Technology Alliance (SMTA) letter to U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid. Please see the language below.


The Honorable Alex M. Azar II
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

The Honorable Seema Verma
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244


Dear Secretary Azar and Administrator Verma:

As members of the State Medical Technology Alliance (SMTA), we are state and regional life sciences associations representing biotechnology, medical device companies, universities, research institutions, and venture capital firms across the country, all dedicated to developing and delivering life-enhancing and life-saving products, we write to express our strong support for your leadership in the U.S. Department of Health and Human Services’ (HHS) efforts to provide coverage for transformative medical devices that are approved as breakthrough devices by the FDA.

The COVID-19 pandemic highlighted the need for our nation’s health care system to better align care for patients.  We commend HHS for taking swift action to create appropriate waivers and incentives across different health care stakeholders to better address this devastating disease.  Providing patients with access to breakthrough devices would further this push to align care for patients by promoting innovation and providing patients with the latest in life-changing medical technology.

The medical technology industry is an important and thriving sector in the U.S. economy, creating jobs in all 50 states and representing a sizable portion of the nation’s Gross Domestic Product.  The industry is responsible for about 1.9 million jobs in the U.S. and an economic output of approximately $381 billion annually.

Access to state-of-the art medical technology and diagnostics can help to improve care and patient outcomes, and CMS has acknowledged the value of breakthrough products by including a Breakthrough Product Pathway for new technology add-on payments (NTAP) in the Final Rule on the FY 2020 Inpatient Prospective Payment System. 

We commend HHS and CMS for these efforts and urge you to take the next step by providing coverage for all medical devices that are approved and cleared as FDA-designated breakthrough in all settings.  Providing this needed certainty will help ensure the next round of truly life-changing innovation can get to the patients who need them as quickly as possible.

As members of the SMTA, we look forward to working with the Administration to finalize this critical effort.



Sincerely,


Arizona BioIndustry Association (AZBio)

Biocom: Life Science Association of California

BioFlorida

BioForward Wisconsin

BioOhio

Bioscience Association of West Virginia (BioWV)

BioUtah

California Life Sciences Association (CLSA)

Colorado BioScience Association (CBSA)

Florida Medical Manufacturers Consortium (FMMC)

Georgia Bio

Healthcare Institute of New Jersey (HINJ)   

Illinois Biotechnology Innovation Organization (iBIO)

Indiana Health Industry Forum (IHIF)

Indiana Medical Device Manufacturers Council (IMDMC)

Iowa Biotechnology Association (IowaBio)

Kentucky Life Sciences Council

Life Sciences Pennsylvania

Life Science Tennessee

Life Science Washington

Massachusetts Medical Device Industry Council (MassMEDIC)

Medical Alley Association

MedTech Association New York

Michigan Biosciences Industry Association (MichBio)

Mississippi Biotechnology Association

Missouri Biotechnology Association (MOBIO)

NCBIO

SCBIO

Southeast Life Sciences

Texas Healthcare & Bioscience Institute (THBI)

April 16, 2026
[Seattle, WA] April 15, 2026 – Apprenti, the leading national intermediary for Registered Apprenticeship (RA), is proud to announce the formal approval and filing of the National Biomanufacturing Technician Standards with the U.S. Department of Labor (USDOL). Crafted under the strategic guidance of the Apprenti Life Science Advisory Board—which includes leaders from Pfizer, Merck, Thermo Fisher, and Biogen—these standards were developed in close partnership with the Life Sciences Workforce Collaborative (LSWC) and InnovATEBIO as part of a high-impact NIIMBL project. This approval represents a foundational shift for the industry, moving away from a fragmented, state-by-state approach to a scalable, consistent model for developing biomanufacturing professionals at sites across all 50 states. The national standards provide a “plug-and-play” framework that ensures a technician trained in Massachusetts or North Carolina meets the same rigorous, industry-vetted benchmarks as one in Ohio or Missouri. The foundational development of these national standards was informed by existing Life Science RA programs from organizations across the country, including: MassBioEd, Oregon Life Sciences, National Center for Therapeutics Manufacturing (NCTM), BioSTL, Wistar Institute, North Carolina Life Sciences Apprenticeship Consortium (NCLSAC) and others. A National Engine for Talent: The filing of these standards is a cornerstone of NIIMBL’s efforts to strengthen domestic biomanufacturing capabilities and develop the workforce of the future. Beyond the standards themselves, the project is delivering a suite of resources and tools—including a comprehensive Employer Toolkit and specialized screening rubrics—that state-based organizations and employers can leverage to implement RA programming for their most in-demand roles. “These national standards set the stage for a sustainable, skills-first pipeline that mirrors the rigor of the industry’s most complex manufacturing processes,” said Daniel Weagle , Director of Life Science Business Development at Apprenti. “By providing a unified approach, we are empowering national employers to scale their workforce development efforts strategically and accessibly.” The Value Proposition of Registered Apprenticeship For Life Science employers, the Registered Apprenticeship model offers a compelling business case rooted in cost-effectiveness and long-term stability: High Retention: RA programs boast exceptional retention rates—historically as high as 89% to 90%—as apprentices are trained within a company’s specific culture and protocols from day one. Cost Efficiency: Research indicates that for every dollar spent on apprenticeship, employers see an average return of $1.47 in increased productivity and reduced recruitment costs. Inclusive Innovation: The model expands access to untapped talent pools, including non-degreed individuals and career-switchers, ensuring the biomanufacturi ng workforce reflects the demographics of the communities it serves. As the global biopharmaceutical market is projected to exc eed $570 billion by 2032, this pa rtnership between Apprenti, NIIMBL, and industry leaders ensures that the U.S. workforce is not just prepared for the future of manufacturing, but is actively driving it. This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB21H086). About Apprenti: Apprenti is a 501(c)(3) nonprofit organization and a U.S. Department of Labor recognized Intermediary. Apprenti designs and delivers scalable Registered Apprenticeship (RA) programs in high-demand industries. By adapting the proven apprenticeship model, Apprenti helps employers meet workforce needs while training the next generation of skilled professionals. Apprenti’s programs are industry-recognized, federally approved, and supports employers across the country. Since launching in 2015, Apprenti has partnered with employers, government agencies, and education providers to create new apprenticeship pathways. About NIIMBL The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of industry standards, and educate a world-leading workforce. Media Contact: Dan Maiese, Communications Manager, dmaiese@niimbl.org , 302-831-3824 About the Life Sciences Workforce Collaborative (LSWC) The Life Sciences Workforce Collaborative (LSWC) is a national nonprofit coalition of state, regional and national life science associations and institutes who are working together to build a competitive, and future-ready life sciences workforce. Originally founded in 2012 as the Coalition of State Bioscience Institutes (CSBI), LSWC connects industry, academia, and government partners through data-driven insights, best practice sharing, and collaborative programs. Learn more at www.LifeSciencesWorkforce.org About InnovATEBIO InnovATEBIO is a National Center for Biotechnology Education, working to advance the education of highly skilled technicians for the nation’s biotechnology workforce. Toward this goal, InnovATEBIO provides leadership in biotechnology technician education, including support for development and sharing of best practices and emerging technologies in biotechnology workforce development. Read LSWC's full announcement here.
April 4, 2026
April 2, 2026- WASHINGTON, D.C. – John F. Crowley, President and CEO of the Biotechnology Innovation Organization (BIO) , released the following statement on Section 232 Pharmaceutical Proclamation. “A thriving American biotechnology ecosystem is essential to growing the U.S. economy, strengthening national security, and improving the health and well‑being of everyday Americans. While we appreciate the Administration’s recognition of the need for tariff exemptions for certain critical biotech products, the reality is that any tariffs on America’s medicines will raise costs, impede domestic manufacturing, and delay the development of new treatments - all while doing nothing to enhance our national security. “U.S. biotech companies have been eager to expand investments here at home, but tariffs, along with an uncertain policy environment and efforts to force “most‑favored nation” schemes, work directly against that goal. The risks are especially acute for small and mid‑size biotech companies, which develop more than half of all FDA‑approved medicines yet often lack the capital to build dedicated manufacturing facilities as they weather an industry defined by high costs, long development timelines, and significant risk. “The fact is: tariffs divert scarce resources away from research and development, weaken American biotech against China’s rising industry, and ultimately, harm health and economic wellbeing of Americans. “We stand ready to work with the Administration on a long‑term strategy that encourages biotechnology investment, reduces the time, cost, and uncertainty of developing new medicines, expands U.S. biomanufacturing capacity, and ensures American innovation is fairly valued overseas. Tariffs and MFN are not the answer." Source - https://www.bio.org/press-release/bio-statement-section-232-pharmaceutical-proclamation
April 1, 2026
Atlanta, GA (April 1, 2026) – Georgia Life Sciences (GLS) is proud to announce that Saisurya Lakkimsetti, a junior at Lakeside High School in Columbia County, has been named the winner of the 2026 Georgia BioGENEius Challenge. The Georgia BioGENEius Challenge took place, as part of the statewide Georgia Science and Engineering Fair (GSEF) at the Classic Center in Athens, Georgia. Forty-seven students from across Georgia competed for this year’s title and cash prize. Jaehyeon Lee, an 11th-grade student from Walton High School, was named runner-up in this year’s competition. The Georgia BioGENEius Challenge recognizes outstanding high school students who are conducting innovative biotechnology research with real-world applications. This year’s top projects, presented in the Global Healthcare Challenge track, demonstrated exceptional scientific rigor and forward-thinking potential in addressing critical healthcare challenges. Saisurya’s research focuses on identifying potential inhibitors for Endocan, a protein known to play a role in glioblastoma tumor growth. Using advanced computational modeling techniques—including AlphaFold and molecular docking tools—she screened thousands of small molecules to identify compounds that may block tumor-promoting signaling pathways. Her work identified several promising candidates that could serve as a foundation for future drug development targeting glioblastoma. Jaehyeon’s project investigates how varying glucose concentrations affect regeneration in planaria, modeling impaired wound healing in diabetic conditions. By testing graded glucose environments and measuring regeneration indicators such as growth and differentiation, Jaehyeon demonstrated that lower glucose levels enhance regeneration while higher levels inhibit healing. The study establishes a model to better understand hyperglycemia’s impact on diabetic wound healing. “The work by these students is a powerful example of the innovation and determination we see in Georgia’s next generation of life sciences leaders,” said Maria Thacker Goethe, President and CEO of Georgia Life Sciences. “The BioGENEius Challenge is critical because it provides students with a platform to apply cutting-edge science to real-world problems, while also strengthening the future workforce that will drive breakthroughs in healthcare, biotechnology, and beyond.” The Georgia BioGENEius Challenge is part of Georgia Life Sciences’ broader commitment to advancing workforce development and fostering innovation across the state’s rapidly growing life sciences ecosystem. Judging the 2026 Georgia BioGENEius Challenge: Ian Biggs; Ralph Cordell, CDC; Alex Harvey, ViaMune; Jamie Graham, Smith Gambrell Russell; and Evan Scullin, LuminiSci.
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