Stay informed. Stay Connected. - BioLink

Stay Informed. Stay Connected.

BioLink delivers the latest news, events, and insights from the world of life sciences in Michigan and across the United States. From groundbreaking research to policy updates and emerging trends, BioLink informs you about the industry's innovations and growth.

Share your news with us and we will share it in BioLink and on MichBio's social media channels. Reach over 17,000 people in the Bio-Industry.

U-M's Accelerate Blue Foundry Opens Applications for Second Cohort

Calling all entrepreneurs! Innovation Partnerships at the University of Michigan has opened applications for the second cohort of the Accelerate Blue Foundry, a program that connects innovators with U-M technologies to launch the next wave of startups. Participants receive mentorship, funding support, and the chance to pitch for at least $50,000 in seed investment from the Accelerate Blue Fund.

Applications close November 5, 2025.

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NSF Expands Testing and Development Capabilities with Acquisition of Cambium Analytica

NSF, a global public health and safety organization headquartered in Ann Arbor, has announced the acquisition of Cambium Analytica, a Traverse City–based analytical testing and development company serving the natural food, beverage, and dietary supplement industries.

The move strengthens NSF’s Food and Nutrition division, expanding its expertise in testing, product development, and regulatory compliance amid growing consumer demand for health-focused, high-quality products. The acquisition aligns with NSF’s strategic push for global growth, innovation, and integrated solutions that span the entire product lifecycle—from concept to market readiness.

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U-M BME's Team SafeSpike Wins in 2025 NIH DEBUT Challenge

A team of University of Michigan Biomedical Engineering students—Team SafeSpike—has earned top honors in the 2025 NIH Design by Biomedical Undergraduate Teams (DEBUT) Challenge, winning the $15,000 HIV/AIDS Prize for their innovative needle safety device.

Their invention, SafeSpike, is designed to prevent accidental needle stick injuries with an intuitive, spring-loaded protective mechanism suitable for both clinical and home use. The project emerged from U-M’s senior BME capstone course led by Dr. Melissa Wrobel, where students tackle real-world healthcare challenges through stakeholder engagement and hands-on prototyping.

Outperforming 123 teams from 67 universities, Team SafeSpike impressed judges with its simplicity, user-focused design, and market feasibility—earning national recognition and a spot at the 2025 Biomedical Engineering Society (BMES) meeting in San Diego.

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TrialAssure unveils Advanced AI Architecture to Boost Transparency and Reliability

TrialAssure, a Canton-based global leader in clinical trial transparency and data sharing, has introduced new enhanced architectural techniques across its AI-powered platforms—LINK AI®, ANONYMIZE®, and REGISTRY®—to improve accuracy, visibility, traceability, and control for pharma and biotech users.

The upgrade enables a more structured way for AI to interpret and retrieve information from source documents, giving users clearer insight into how outputs are generated and reducing the “black box” challenge common in AI tools. The new framework allows users to trace AI responses back to specific document sections, improving confidence, compliance, and efficiency in regulatory and clinical documentation workflows.

“This advancement raises the standard for how AI can operate transparently in highly regulated environments like life sciences,” said Zach Weingarden, Director of AI Technology & Applications at TrialAssure.

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Cayman Chemical and Curapath Partner to Expand Access to PEG-Free Shielding Lipids

Cayman Chemical (Ann Arbor) has partnered with Curapath (Valencia, Spain) to make PEG-free shielding lipids—including Curapath’s proprietary polysarcosine (pSar) and polyamino acid–based lipids—more widely available to researchers developing lipid nanoparticles (LNPs) for drug delivery, gene therapy, mRNA vaccines, and biologics.

The collaboration provides a non-toxic, non-immunogenic, and biodegradable alternative to PEGylated lipids, addressing growing concerns about PEG-related immune reactions. Through Cayman’s global distribution network, Curapath’s next-generation materials will be accessible in both R&D and GMP quality, supporting safer and more effective LNP formulations.

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MichBio Submits Comments to the U.S. Department of Commerce opposing Potential Tariffs on Medical Devices

The U.S. Department of Commerce’s new Section 232 investigation into medical device imports has raised significant alarm across the nation’s medtech sector. While intended to assess potential national security risks, the proposed trade restrictions could instead harm a thriving, innovation-driven industry that supports millions of American jobs and ensures patient access to life-saving technologies.

In formal comments submitted on October 16, 2025, MichBio urged the Department to recognize that tariffs would raise healthcare costs, threaten R&D investment, and undermine domestic innovation—including Michigan’s own robust medtech ecosystem of manufacturers, suppliers, and innovators.

“The dominance of U.S. medtech is an asset to our national security and economic resilience,” said Stephen Rapundalo, PhD, MichBio President and CEO. “We urge the Department to avoid actions that could disrupt this uniquely American success story.”

Rather than imposing tariffs, MichBio advocates for policies that strengthen the medtech supply chain through targeted investment, workforce development, and public-private partnerships—building resilience without sacrificing affordability or access.

Senate Advances Revised BIOSECURE Act— Implications for Biotech and Biopharma

On October 9, 2025, the U.S. Senate approved an amendment to include a retooled BIOSECURE Act in its version of the National Defense Authorization Act (NDAA). While the legislation still must be reconciled with the House version, this move signals renewed momentum behind a national effort to restrict federal engagement with biotechnology and pharmaceutical firms linked to potential foreign security risks.

The updated Senate draft addresses earlier industry concerns by removing the fixed list of “companies of concern” and tying future designations to the Department of Defense’s evolving “1260H” list of Chinese military companies. It also narrows the scope of restricted technologies and clarifies certain waiver and transition provisions.

If enacted, the BIOSECURE Act would:

Prohibit federal agencies and contractors from purchasing or using biotech equipment or services from designated entities
Require OMB and DoD to maintain and update a national security risk list
Set timelines and limited exceptions for transition and compliance

While intended to safeguard national interests, the proposal raises concerns about supply chain disruption, research delays, and compliance uncertainty across biotech, biopharma, and CDMO sectors. For Michigan’s life sciences community—particularly companies engaged in federally funded R&D—these changes could reshape vendor relationships, sourcing strategies, and future partnerships.

MichBio is closely monitoring the legislation’s progress and will continue engaging with BIO and federal partners to ensure Michigan’s biosciences ecosystem is informed and represented as policy evolves.

October GBG Report is Now Available—Member Exclusive

The October GBG Report from G2G Consulting is out now with 137 active federal funding programs supporting biosciences innovation — from AI and biomanufacturing to therapeutics and rare disease research.

Available exclusively to MichBio members (log in to access).
Not yet a member? Reach out to learn how to join and start receiving these monthly funding insights.

ACCESS THE OCTOBER REPORT

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