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SSTI Profile: BHI’s Rich Bendis on Building and Scaling Innovation Ecosystems

By News

The article below was originally developed by the State Science & Technology Institute (SSTI), a national nonprofit organization that works with states, regions, and practitioners to strengthen science, technology, innovation, and entrepreneurship as drivers of economic prosperity.

Founded in 1996, SSTI serves as the most comprehensive resource for technology-based economic development, offering research, advisory services, and convenings that support the growth of competitive innovation ecosystems. Through its nationwide network of policymakers and practitioners, SSTI provides unique insight into best practices and emerging trends, helping communities design and implement strategies that translate research and innovation into sustained economic impact.

This profile of Rich Bendis reflects SSTI’s long-standing focus on how regional leadership, public-private collaboration, and innovation intermediaries can shape durable, globally competitive biohealth and technology clusters. Rich Bendis was one of the original Board members of SSTI.

How to transform from “flyover” to biotech cluster

Richard Bendis has significant experience building biotech clusters in formerly “flyover” regions (e.g., places that lack the infrastructure to support tech-based entrepreneurs and companies). Around 2009-2010, he was giving a presentation at the National Academy of Sciences in Washington, D.C., on how to build these regions around an industry-driven private-public partnership. After the talk, someone from Johns Hopkins approached him and said they had been trying—with little success—to build a biotech cluster in Maryland. They asked him to come to Montgomery County, Maryland, the epicenter of the region’s life sciences industry.

Bendis accepted the challenge and began working as a consultant for Montgomery County. He created an advisory board that considered forming an organization to foster greater interaction among academia, government, and industry in the region. The group asked Bendis to serve as the interim CEO of a new organization that would serve as an innovation intermediary in the region. Bendis founded BioHealth Innovation, Inc. (BHI) in 2011; Bendis created the term “BioHealth” for BioHealth Innovation as a more relevant term than biotechnology or biosciences due to the convergence of technology and the life science industry. BHI held its first board meeting in January 2012. The board continues to be industry- led, and market-driven.

Bendis presented recommendations on how to get everyone engaged and told them they would need three years of funding to keep going and meet their goals. He also told the group, “Everybody has to step up to the table.” At first, there was dead silence. Bendis pressed, saying, “Who is going to be engaged first?” The first person to commit was Montgomery County’s County Executive, who offered $500,000 per year for three years.

“Once he made the commitment, industry and academia followed,” said Bendis. “But it took government to take the initiative. So, you never know where the champion is going to come from. But it is necessary to identify a respected regional leader that can help mobilize all of the other partners.”

The organization’s geographic scope quickly expanded from Montgomery County to the surrounding area. “Medimmune (now AstraZeneca) said, ‘we don’t care where anybody is from,” Bendis recalled. “(They weren’t worried) about state borders, county borders, city borders, rivers or bridges,” said Bendis. “(They just wanted) to see the whole ecosystem working together.” Then, the president of Johns Hopkins said that if they included Baltimore—located in Baltimore County—in a regional initiative, the university would join and become active on the board. The Montgomery County Executive did not hesitate to accept Johns Hopkins’ proposal, saying, “If that’s what it’s going to take to get this going, then let’s do it.”

“That’s the kind of support you need,” said Bendis.

The next step was to create a brand for the region. People were calling the region the DMV for D.C., Maryland, and Virginia, which suggested “Division of Motor Vehicles” more than “biotech cluster.” Medimmune/AstraZeneca pushed for a brand comparable to Route 128 in Boston, the Research Triangle, Austin, Texas, and Silicon Valley.

One negative outcome of having no brand was that they were missing out on higher ratings in Genetic Engineering & Biotechnology News’ (GEN) annual Top 10 U.S. Biopharma Clusters list. When the publication started ranking the Maryland area, it ranked only a five-mile stretch on Interstate 270. Thus, the area struggled to achieve a top- 10 ranking. Other clusters, such as Boston/Cambridge, the San Francisco Bay Area, and New York/New Jersey, get credit for activity beyond specific city or state borders.

They decided to call their newly conceived geographic area the “BioHealth Capital Region.” “I came up with the term ‘BioHealth’ to merge the technology and life science industries in our name,” said Bendis. “And Capital, because we need money and capital, but we’re also in the Nation’s Capital, so you can go either with an ‘A’ or an ‘O,’ and then ‘Region,’ because there was not a history of the region working together across the Potomac.”

Medimmune/AstraZeneca spearheaded the branding effort. They paid their public relations firm to host a series of meetings over six months to determine whether the regional effort would benefit from having a brand. They concluded that it would.

The first order of business after deciding to create a brand was to gain a better understanding of the region’s challenges. Bendis led a gap analysis, speaking with nearly 100 people across 55 organizations. The most significant gap they identified was a lack of support for commercialization. “A lot of these people were researchers at academia, or they had spun out of NIH, or they were creating their own company, but they didn’t have a lot of business experience,” said Bendis. “So, one of the major gaps was how to get commercialization of business expertise to these people when they need it.” To fill this gap, BHI created the Entrepreneur-in-Residence program.

The gap analysis had revealed that at NIH, there was a 60-person technology transfer office that was not proactive about engaging with investors or industry. Bendis suggested they bring in an entrepreneur-in-residence (EIR). This person would be someone who understands the industry, marketing, investment, and the needs of strategic partners. NIH agreed to the concept but did not have the funds to support such a person. Bendis said BHI would fund the first one. The program, said Bendis, “took off from there.” NIH has 27 individual institutes, and several asked whether they could have an EIR as well. As a nonprofit, BHI couldn’t fund multiple EIRs, but it offered to help recruit EIRs if the institutes could find the funding The National Heart, Lung, and Blood Institute (NHLBI) contracted for the second EIR. “They were very proactive about wanting to have commercialization for their … small business innovation research programs…. They were making investments in these companies, and these companies didn’t have a lot of business or commercialization expertise.” The institute provided funding, and BHI did the recruiting, kept the EIRs on its payroll, and helped manage their work.

Now, BHI has 33 EIRs located nationally in addition to servicing NIH. It is the exclusive provider of EIRs to ARPA-H-funded companies. Additionally, they have a contract with Montgomery County for the Montgomery County Executives-in-Residence program, which provides life-sciences-specific services to selected local companies. And they have recently contracted BioHealth-managed EIRs to support commercialization for companies located at BARDA’s SPARK Accelerator in
Washington, D.C.

The BHI gap analysis also found that many early-stage entrepreneurs in Maryland and the BioHealth Capital Region (BHCR) were applying for SBIR grants but had a below-average success rate. Moreover, no one in the region was providing support for these companies. In response, BHI developed an internal team of analysts to support early-stage entrepreneurs who wanted to submit proposals. So far, BHI has helped more than 200 companies, with a 46% success rate and over $100 million of SBIR awards for their clients. BHI provides these services at minimal cost to companies; if the company is successful, BHI gets a success fee. BHI uses this money to help support other companies.

BHI also works directly with the region’s university technology transfer offices. BHI has worked with several universities and currently has a contract with Georgetown University to provide EIRs and analysts to the recently launched Georgetown Tech Ventures (GTV). They are helping to evaluate GTV’s technology pipeline, determine which innovations have commercial potential, and
develop strategies for what to do with those technologies.

To unite the region, BHI offers events that bring biohealth leaders together to learn about emerging trends within their industry. The BioHealth Capital Region Forum, offered in partnership with Medimmune/AstraZeneca in Gaithersburg, MD. They held the first forum 12 years ago in an amphitheater provided by the company. The event grew larger every year until the COVID pandemic, when they went hybrid. Now, US Pharmacopeia in Rockville, MD, provides space for the event. They
charge no registration fee, and in 2025, they had 46 sponsors who provided $230,000 to support the forum. Seven hundred fifty people attended, from throughout the U.S. and from Estonia, Finland, and Sweden, and other international locations.

Another event during the Forum is the Crab Trap Competition. “It’s like a shark tank but with crabs, crabs being Maryland-centric,” said Bendis. They also offer an investment conference. About 33 companies give quick pitches to showcase their companies. On the third day, they have one-on-one company-investor meetings.

“Another thing we do to get people engaged is a podcast I created called BioTalk,” said Bendis. “It could be about entrepreneurs, industry, government, academia, NGOs, venture capitalists, or those engaged in the biohealth industry. And that helps spread the word for the region. And also helps spread the word for some of the companies that we showcase on the podcast.” They’ve been producing the podcast for about eight years.

One indicator of success, to Bendis, would be that people understand the region’s vibrancy. That they are perceived in this way is illustrated by their rise in GEN’s Top 10 ratings.

One of the goals for the BioHealth Capital Region was to improve its ranking to number three. They have accomplished that goal. From 2016 through 2021, they ranked as low as sixth. By 2022, one year ahead of their goal, BioHealth Capital Region ranked number three, and they have maintained that ranking through 2025.

“BioHealth Innovation has been successful due to the public-private partnership of its mission and governance, as well as being blind to artificial geographic boundaries,” said Bendis. “The goal now is to maintain our number three ranking,”

GEN’s criteria for the rankings are NIH funding, number of patents, lab space, value of venture capital deals, and number of industry jobs in the region. In 2018, their second year after GEN ranked them as BioHealth Capital Region, they had:

  • $1.456 billion in NIH funding
  • 4,943 patents
  • $22.5 million sq ft. of lab space (According to Rockville, MD-based Scheer Partners, which measures the entire region, vs. JLL’s 9.5 million for “suburban Maryland”)
  • $944.07 million for VC deals
  • 41,322 jobs (according to JL63L)/63,287 (according to Battelle)

This year, 2025, the GEN metrics for the region are:

  • $3.639 billion in NIH funding (a 16% drop from last year)
  • 9,141 patents (highest number in the nation)
  • 35.8 million sq. ft. of lab space (according to JLL)
  • $1.387 billion for VC deals (53% drop from 2024)
  • 133,743 jobs (Government cuts helped shrink employment 1.8% this year, according to JLL data)

The growth since 2018 is clear, despite some drops in numbers since last year, which, according to GEN, were mainly due to the government’s funding cuts and the elimination of government jobs heavily concentrated in this region. But GEN suggests these are temporary setbacks, citing some significant growth for the region’s bio industry in the past year, including:

  • A recently opened $300 million AstraZeneca cell therapy manufacturing facility in Rockville, MD
  • A $286 million biosafety testing facility opened in October by MilliporeSigma
  • 4MLK, a 250,000-square-foot multitenant lab-office building completed in Januaryby the University of Maryland, Baltimore, and developer Wexford Science + Technology

BHI recently posted a “Top 10 BioHealth Capital Region Stories of 2025” article on their website which also included AstraZeneca Expands Virginia Investment to $4.5 Billion, and Samsung Biologics Establishes U.S. Manufacturing Footprint in Maryland.

BHI’s Top 10 BioHealth Capital Region Stories of 2025

The BioHealth Capital Region closed out 2025 with clear evidence of strength and momentum. While life sciences companies across the country navigated capital constraints, policy uncertainty, and global market shifts, the BHCR region continued to grow. Major manufacturers expanded their U.S. footprints, new facilities came online, research institutions deepened their role in advanced technologies, and investment flowed across companies at every stage. Taken together, these stories show a region that did more than hold its ground. It advanced, adapted, and continued to lead.

The BioHealth Capital Region Maintains a Top 3 National Ranking
For the third consecutive year, the BioHealth Capital Region earned a Top 3 position in GEN’s U.S. Biopharma Cluster Rankings. The region led the nation in biotechnology-related patents and ranked third in both NIH funding and lab space, maintaining strong performance despite economic pressure across the sector. Continued infrastructure investment and new facilities across Maryland and Virginia underscore long-term stability and competitiveness.
https://biohealthinnovation.org/the-biohealth-capital-region-maintains-top-3-spot-in-gens-2025-u-s-biopharma-cluster-rankings/

Lilly Commits $5 Billion to New Manufacturing in Virginia
Eli Lilly announced plans to build a $5 billion manufacturing facility in Goochland County, Virginia, marking its first fully integrated U.S. site dedicated to the manufacture of active pharmaceutical ingredients and drug products for bioconjugates and monoclonal antibodies. The project will create more than 650 permanent jobs and support advanced manufacturing using AI, automation, and digital systems.
https://biohealthinnovation.org/lilly-announces-plans-to-build-5-billion-manufacturing-facility-in-virginia/

AstraZeneca Expands Virginia Investment to $4.5 Billion
AstraZeneca increased its planned investment in a new Albemarle County manufacturing facility to $4.5 billion, expanding the site’s scope to include antibody drug conjugates alongside metabolic and oncology products. The project is expected to create approximately 3,600 direct and indirect jobs and will anchor a broader $50 billion U.S. manufacturing and R&D commitment.
https://biohealthinnovation.org/astrazeneca-plans-to-increase-investment-and-scope-of-its-virginia-manufacturing-facility-to-4-5-billion-creating-3600-new-jobs/

Nearly $3 Billion Invested in Montgomery County Companies
Montgomery County companies attracted $2.9 billion in investment during 2024 across mergers, acquisitions, venture capital, and private funding. Life sciences accounted for more than half a billion dollars, reinforcing the county’s role as a regional anchor for biohealth innovation. Over 100 deals reflected strength across companies of all sizes.
https://biohealthinnovation.org/mcedc-nearly-3-billion-invested-in-montgomery-county-maryland-companies-in-2024/

Merck Breaks Ground on $3 Billion Manufacturing Center in Virginia
Merck began construction on a $3 billion pharmaceutical manufacturing Center of Excellence in Elkton, Virginia. The project will expand small molecule manufacturing and testing capabilities while supporting more than 500 permanent roles and thousands of construction jobs. The investment builds on Merck’s long-standing presence in the region and its broader U.S. manufacturing strategy.
https://biohealthinnovation.org/merck-breaks-ground-on-3-billion-center-of-excellence-for-pharmaceutical-manufacturing-in-elkton-virginia/

AstraZeneca Opens $300 Million Rockville Manufacturing Hub
AstraZeneca unveiled its new $300 million Rockville Manufacturing Center, focused on cell and gene therapies for oncology clinical trials. Built using advanced digital tools, the facility reflects continued confidence in Montgomery County at a time of broader federal funding uncertainty. The site is expected to begin delivering therapies to patients in the near term.
https://biohealthinnovation.org/wbj-astrazeneca-unveils-300m-rockville-investment-a-boost-for-moco-amid-federal-cuts/

Samsung Biologics Establishes U.S. Manufacturing Footprint
Samsung Biologics announced the acquisition of the former Human Genome Sciences facility in Rockville, Maryland, securing its first U.S.-based manufacturing site. The transaction adds 60,000 liters of biologics capacity to Samsung’s global network, retains more than 500 skilled jobs, and strengthens domestic supply chain resilience.
https://biohealthinnovation.org/samsung-biologics-expands-u-s-manufacturing-capabilities-with-strategic-acquisition-of-human-genome-sciences-from-gsk/

USP Opens Advanced Technologies Laboratory in Maryland
The U.S. Pharmacopeia launched a new Advanced Technologies Laboratory in Rockville to support the adoption of advanced manufacturing, real-time quality monitoring, and alternative API production methods. The lab is designed to accelerate scalable solutions that strengthen medicine supply chains and support domestic manufacturing efforts.
https://biohealthinnovation.org/usp-announces-new-advanced-technologies-laboratory-in-maryland-to-accelerate-and-scale-pharmaceutical-manufacturing-innovations/

Northern Virginia Launches Its First Innovation District
With support from GO Virginia, Northern Virginia launched its first Innovation District focused on life sciences, aerospace, defense, and semiconductor industries. Led by George Mason University in partnership with Prince William County and the City of Manassas, the district aims to accelerate research translation, company formation, and workforce development.
https://biohealthinnovation.org/george-mason-is-part-of-northern-virginias-first-innovation-district-launched-with-transformational-grant-from-go-virginia/

Where Human and Artificial Intelligence Converge
The 2025 BioHealth Capital Region Forum brought together more than 750 attendees for two days of programming focused on AI, quantum technologies, advanced manufacturing, and investment. The week highlighted the region’s leadership across research, commercialization, and capital formation, while reinforcing its position as a Top 3 U.S. biopharma cluster.
https://biohealthinnovation.org/where-human-and-artificial-intelligence-converge-a-recap-of-the-2025-biohealth-capital-region-forum/

Looking ahead to 2026, the BioHealth Capital Region enters this year with depth across research, manufacturing, talent, and capital. Projects announced over 2025 are moving into execution, partnerships are strengthening, and the region’s role in national health security and innovation continues to expand. The trajectory is clear, and the foundation is strong. What comes next will build on a year that demonstrated both toughness and ambition.

Looking to partner with Rich and BHI? Email Rich at rbendis@biohealthinnovation.org today!

BHI EIR Insights: 7 Tactics to Optimize Launch Messaging – Part IV

By News

by Jonathan Kay, MPP, Managing Partner, Health Market Experts & BioHealth Innovation, Inc. Entrepreneur-in-Residence

In our last three posts of this series, we discussed:

  1. Test, Don’t Guess
  2. Know Your Stakeholders
  3. Listen First

The next step is to develop clear, purposeful, and actionable messages with structure.

Lesson 4: Consider Message Anatomy

A structured framework for message development ensures that your communication is consistent, credible, and compelling. The anatomy of a message consists of 3 components:

  • Themes
  • Purpose
  • Proof Points

Themes might include safety, effectiveness, value, convenience, trust, quality of life, etc. Each theme can have many messages used in different contexts and for different targets

Purpose is the job the message is trying to accomplish. A message might be trying to raise awareness, build or restore trust, demonstrate competitive advantage, etc.

Proof points are the snapshots of evidence that support the message and help achieve the purpose. Proof points could come from clinical data, expert testimonials, survey data, outcomes, or success stories.

Additional useful tips:

  • Focus on benefits, not only features of a product or service
  • After writing messages, ask, “What could make this more persuasive?”
  • Ask yourself, “Does the message support the value proposition?”

For example, consider a novel biologic therapy taken at home one time per day rather than three times per day – or instead of a once-a-week infusion in a center. With that information, we can write many messages focused on the theme of convenience.

A basic message: “This product is to be taken once per day.”

Now, how can this message do more?

A stronger message: “This product is more convenient because you only need to take it once per day.”

And how can this message do more?

A closer to optimal message: “The convenient once-a-day regimen is shown to improve patient adherence and outcomes.”

Can this message work harder? Will the message get the job done and achieve the result we want? Recall, we test messages with real stakeholders to predict what will work best

Effective message development almost always comes from input and vetting across disciplines.

Collaborate with marketing, sales, commercialization, market access, medical affairs, policy, and public affairs teams when developing messages. And as needed, seek legal review. Take an interdisciplinary approach to get input and alignment across departments resulting in unified launch communications.

If your organization is preparing to launch a new business or brand, connect with us (message me on LinkedIn) or visit https://www.healthmarketexperts.com/ to learn more about how we can help you with messaging and commercial strategy to set your business and brand on a path of success.

Written by a human. This post expands on content I previously wrote as a blog at Catalant and delivered in guest lectures at Rutgers Business School.

Visit https://www.linkedin.com/in/jonathan-kay-healthcare/ to connect with Jon on LinkedIn.

BHI’s Top 10 BioHealth Capital Region Stories of 2025

By News

The BioHealth Capital Region closed out 2025 with clear evidence of strength and momentum. While life sciences companies across the country navigated capital constraints, policy uncertainty, and global market shifts, the BHCR region continued to grow. Major manufacturers expanded their U.S. footprints, new facilities came online, research institutions deepened their role in advanced technologies, and investment flowed across companies at every stage. Taken together, these stories show a region that did more than hold its ground. It advanced, adapted, and continued to lead.

The BioHealth Capital Region Maintains a Top 3 National Ranking
For the third consecutive year, the BioHealth Capital Region earned a Top 3 position in GEN’s U.S. Biopharma Cluster Rankings. The region led the nation in biotechnology-related patents and ranked third in both NIH funding and lab space, maintaining strong performance despite economic pressure across the sector. Continued infrastructure investment and new facilities across Maryland and Virginia underscore long-term stability and competitiveness.
https://biohealthinnovation.org/the-biohealth-capital-region-maintains-top-3-spot-in-gens-2025-u-s-biopharma-cluster-rankings/

Lilly Commits $5 Billion to New Manufacturing in Virginia
Eli Lilly announced plans to build a $5 billion manufacturing facility in Goochland County, Virginia, marking its first fully integrated U.S. site dedicated to the manufacture of active pharmaceutical ingredients and drug products for bioconjugates and monoclonal antibodies. The project will create more than 650 permanent jobs and support advanced manufacturing using AI, automation, and digital systems.
https://biohealthinnovation.org/lilly-announces-plans-to-build-5-billion-manufacturing-facility-in-virginia/

AstraZeneca Expands Virginia Investment to $4.5 Billion
AstraZeneca increased its planned investment in a new Albemarle County manufacturing facility to $4.5 billion, expanding the site’s scope to include antibody drug conjugates alongside metabolic and oncology products. The project is expected to create approximately 3,600 direct and indirect jobs and will anchor a broader $50 billion U.S. manufacturing and R&D commitment.
https://biohealthinnovation.org/astrazeneca-plans-to-increase-investment-and-scope-of-its-virginia-manufacturing-facility-to-4-5-billion-creating-3600-new-jobs/

Nearly $3 Billion Invested in Montgomery County Companies
Montgomery County companies attracted $2.9 billion in investment during 2024 across mergers, acquisitions, venture capital, and private funding. Life sciences accounted for more than half a billion dollars, reinforcing the county’s role as a regional anchor for biohealth innovation. Over 100 deals reflected strength across companies of all sizes.
https://biohealthinnovation.org/mcedc-nearly-3-billion-invested-in-montgomery-county-maryland-companies-in-2024/

Merck Breaks Ground on $3 Billion Manufacturing Center in Virginia
Merck began construction on a $3 billion pharmaceutical manufacturing Center of Excellence in Elkton, Virginia. The project will expand small molecule manufacturing and testing capabilities while supporting more than 500 permanent roles and thousands of construction jobs. The investment builds on Merck’s long-standing presence in the region and its broader U.S. manufacturing strategy.
https://biohealthinnovation.org/merck-breaks-ground-on-3-billion-center-of-excellence-for-pharmaceutical-manufacturing-in-elkton-virginia/

AstraZeneca Opens $300 Million Rockville Manufacturing Hub
AstraZeneca unveiled its new $300 million Rockville Manufacturing Center, focused on cell and gene therapies for oncology clinical trials. Built using advanced digital tools, the facility reflects continued confidence in Montgomery County at a time of broader federal funding uncertainty. The site is expected to begin delivering therapies to patients in the near term.
https://biohealthinnovation.org/wbj-astrazeneca-unveils-300m-rockville-investment-a-boost-for-moco-amid-federal-cuts/

Samsung Biologics Establishes U.S. Manufacturing Footprint
Samsung Biologics announced the acquisition of the former Human Genome Sciences facility in Rockville, Maryland, securing its first U.S.-based manufacturing site. The transaction adds 60,000 liters of biologics capacity to Samsung’s global network, retains more than 500 skilled jobs, and strengthens domestic supply chain resilience.
https://biohealthinnovation.org/samsung-biologics-expands-u-s-manufacturing-capabilities-with-strategic-acquisition-of-human-genome-sciences-from-gsk/

USP Opens Advanced Technologies Laboratory in Maryland
The U.S. Pharmacopeia launched a new Advanced Technologies Laboratory in Rockville to support the adoption of advanced manufacturing, real-time quality monitoring, and alternative API production methods. The lab is designed to accelerate scalable solutions that strengthen medicine supply chains and support domestic manufacturing efforts.
https://biohealthinnovation.org/usp-announces-new-advanced-technologies-laboratory-in-maryland-to-accelerate-and-scale-pharmaceutical-manufacturing-innovations/

Northern Virginia Launches Its First Innovation District
With support from GO Virginia, Northern Virginia launched its first Innovation District focused on life sciences, aerospace, defense, and semiconductor industries. Led by George Mason University in partnership with Prince William County and the City of Manassas, the district aims to accelerate research translation, company formation, and workforce development.
https://biohealthinnovation.org/george-mason-is-part-of-northern-virginias-first-innovation-district-launched-with-transformational-grant-from-go-virginia/

Where Human and Artificial Intelligence Converge
The 2025 BioHealth Capital Region Forum brought together more than 750 attendees for two days of programming focused on AI, quantum technologies, advanced manufacturing, and investment. The week highlighted the region’s leadership across research, commercialization, and capital formation, while reinforcing its position as a Top 3 U.S. biopharma cluster.
https://biohealthinnovation.org/where-human-and-artificial-intelligence-converge-a-recap-of-the-2025-biohealth-capital-region-forum/

Looking ahead to 2026, the BioHealth Capital Region enters this year with depth across research, manufacturing, talent, and capital. Projects announced over 2025 are moving into execution, partnerships are strengthening, and the region’s role in national health security and innovation continues to expand. The trajectory is clear, and the foundation is strong. What comes next will build on a year that demonstrated both toughness and ambition.

From Can to Should: Reassessing Viability in 2026

By EIR Insights, News

Last year, I wrote a LinkedIn Article titled To be or not to be: Just because you CAN, doesn’t mean you SHOULD.” The point was straightforward. Passion and good science are not enough. They never really were. That post was a reaction to what I was seeing across early-stage biotech and MedTech at the time. The environment has not eased since then. If anything, the bar has moved higher.

The requirements for viability are more stringent today than they were even a year ago. Early-stage capital remains difficult to access, particularly at the seed and Series A stages, unless a company has human proof of concept. Angel investors want de-risking. Most venture funds will not underwrite the earliest technical risk. Government funding used to fill that gap. The uncertainty around the reauthorization of innovation investment programs has made it harder to hit commercially meaningful milestones at exactly the stage when companies need that support most. Until policy catches up, founders are forced to seek private capital that is increasingly selective and unforgiving.

This shifts the question founders need to ask themselves. It is no longer whether an idea is interesting or even whether it addresses an unmet need. The question is whether the idea can survive the current validation threshold. That threshold is no longer defined by enthusiasm or momentum. It is defined by evidence, timing, and a clear path to value creation that stands up to scrutiny.

Commercial realism remains the most common failure point. Founders and CEOs are almost always optimistic about their opportunity, and they should be. If the CEO is not the champion, no one else will be. The problem arises when optimism replaces rigor. Market size is often overstated. Competitive dynamics are underestimated. Pricing and reimbursement assumptions are built on hope rather than data. Real market assessments require primary customer discovery paired with precedent sales data, both top-down and bottom-up. They also require discipline about who the customer is and where adoption will realistically occur.

Differentiation has also changed. Incremental improvements used to matter. Slight changes in dosing or convenience could be enough in some cases, but that still holds only if the market signals that it values those changes. In many therapeutic and digital health categories, that bar has risen. The existence of a standard of care, even an imperfect one, changes everything. Workarounds that are cheaper and good enough are formidable competitors. A fourth- or fifth-line product rarely succeeds just because the total addressable market is significant. Investors are not persuaded by big numbers without a sophisticated explanation of what portion of that market is reachable and why.

Health economics can no longer be an afterthought. Payers are not focused on novelty. They are focused on sustainability. Cost effectiveness, total cost of care, and system-level impact matter early, not late. Clinical development strategies that ignore this reality tend to produce assets that struggle to gain traction even if they reach approval.

Manufacturing and supply chain considerations are now decisive factors in viability. Fully burdened cost modeling should be mandatory, not optional. Many promising concepts fail when exposed to the realities of sourcing, scale-up, tech transfer, and CDMO capacity. Lead times for specialized reagents, limited suppliers, geopolitical pressures, and competition from larger customers all introduce risks that can derail timelines and margins. Profitability estimates that are not grounded in real quotes and realistic assumptions are unreliable. A product that cannot be manufactured profitably at scale is not a product. It is an experiment.

Intellectual property expectations have also hardened. Venture investors continue to favor novel chemical entities with enforceable composition-of-matter claims. Method-of-use claims and simple repurposing strategies remain difficult to defend commercially. Off-label use, generic substitution, and payer resistance erode value quickly. Repurposing can be both capital and clinically efficient, but unless there is a credible way to lock the market through delivery technology, owned chemistry, or a pricing model that holds, it is rarely attractive to institutional capital. The irony is that some of the most efficient paths to patient benefit struggle the most under current investment models.

Clinical adoption risk extends far beyond efficacy. I look at alternatives already in use and ask who they fail and why. I look at early predictors of response and whether patient selection is feasible. I look at whose pain point is being addressed and whether that aligns across providers, patients, payers, and regulators. Evidence requirements vary by stakeholder, and the costs and time required to satisfy them must be modeled honestly. I also look closely at who makes the buying decision and how the product would be sold. Adoption fails as often for psychological and behavioral reasons as it does for scientific ones.

Deciding whether to move forward, pause, or walk away requires discipline. Founders need to evaluate unmet need, solution fit, market opportunity, IP defensibility, validation requirements, development and manufacturing plans, regulatory and reimbursement pathways, financial models, and exit logic together. Weaknesses in any one area can undermine the entire effort. The willingness to stop is not a sign of failure. It is a sign of judgment. In this environment, the threshold for validation is higher across the board, even in areas that remain attractive to pharma and investors.

This is where an experienced, external perspective matters. A short, focused conversation can surface gaps that would otherwise take years and significant capital to discover. Stress-testing assumptions early saves time, money, and energy. Not every idea should become a company. Not every asset belongs in a pipeline. The goal is not to build something at all costs. The goal is to build something that has a real chance of reaching patients and creating value along the way.

Being in the business of innovation means living with uncertainty and learning constantly. It also means making hard calls sooner rather than later. Just because you can still does not mean you should. The difference between the two has never mattered more.

BHI EIR Insights: 7 Tactics to Optimize Launch Messaging – Part III

By News

by Jonathan Kay, MPP, Managing Partner, Health Market Experts & BioHealth Innovation, Inc. Entrepreneur-in-Residence

In our last two posts of this series, we discussed:

  • Tactic #1: Test, Don’t Guess (i.e., adopt a data-driven mindset)
  • Tactic #2: Know Your Stakeholders (i.e., avoid a one-size-fits-all approach)

Insight 3: Listen First

Once you have determined who to speak to, it’s time to focus on how to speak to them.

Recall, we talked about the need to be precise and purposeful:

  • Who is the message for?
  • What information do they need?
  • Will the message fulfill its purpose?
  • Will the message influence opinions and motivate behavior?

To answer those questions, we listen.

Listening to your target audience can take many forms:

  • Customer feedback (e.g., customer satisfaction, CRM, or the sales team) 🔁
  • Online (e.g., social media and, increasingly, seeing what AI “says”)  📊
  • Customer discovery / research (e.g., stakeholder interviews and surveys) 📝

Listening produces the raw material for developing messages that we test before launch.

During a commercial strategy and segmentation engagement for implantable cardiac devices, we listened to C-level leaders in marketing and sales and field representatives; we searched online; and we conducted original interviews and surveys with a wide range of target audiences to anticipate their response.

All audiences needed to hear about safety, efficacy, and value. However, when we tested messages, the cardiac subspecialists responded more favorably to different messages than the general cardiologists; likewise, physicians with a high volume of complex procedures needed messages tailored to their case mix.

Key takeaways?

1. Listen.

2. Test.

3. Optimize.

Health Market Experts works with clients in health and life sciences to develop and implement data-led strategies that maximize the success of their businesses and brands.

We uncover how different audiences think, what they value, and how to tailor messages accordingly. If your organization is preparing to launch a business, brand, or campaign, connect with us or visit https://www.healthmarketexperts.com/ to learn more about how we can help you execute your launch plan that sets you apart.

Written by a human. This post expands on content I previously wrote as a blog at Catalant and delivered in guest lectures at Rutgers Business School.

Visit https://www.linkedin.com/in/jonathan-kay-healthcare/ to connect with Jon on LinkedIn.

Building a Life Sciences Innovation District in Prince William County on BioTalk

By BioTalk with Rich Bendis Podcast, News

This episode of the BioTalk with Rich Bendis Podcast brings together leaders from industry, academia, and economic development to unpack the vision behind a new life sciences Innovation District anchored in Prince William County. With introductions to NAUGEN, George Mason University’s Institute for Biohealth Innovation, and the Prince William County Department of Economic Development, setting the stage for how each organization contributes to the district’s foundation. The guests discuss the life science assets, research strengths, and translational capabilities that define the district and explain why it is well-positioned to support biotechnology and advanced R&D companies.

The podcast explores how the partnership between Prince William County, George Mason University, and the City of Manassas came together, outlining the distinct roles each plays in advancing a shared strategy. The episode also introduces the NISA program, detailing how it supports companies seeking a soft-landing pathway into the district, the types of organizations best suited for the program, and the facilities, talent, and collaborative resources participants can access both immediately and over time.

Listen now via your favorite podcast platform:
Apple: https://apple.co/4p94Dqe
Spotify: https://bit.ly/3Y7dJZw
iHeart Podcasts: https://ihr.fm/3KLV7v4
Amazon Music Podcasts: https://amzn.to/4pajS1P
YouTube Music Podcasts: https://bit.ly/4phRV8I
TuneIn: https://bit.ly/44GoG7Y

Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com).

Jaehan Park is Founder and CEO of NAUGEN, a global innovation accelerator advancing novel technologies across life sciences and deep tech. With more than 25 years of experience in strategy and business development, he has led collaborations spanning cancer immunotherapy, vaccines, and biologics with global pharmaceutical companies and academic institutions. He leads the NISA Program in partnership with George Mason University and serves as a Mentor-in-Residence at KIC DC, supporting international startups entering U.S. markets.

Amy Adams is Executive Director of George Mason University’s Institute for Biohealth Innovation, where she advances biohealth research and innovation across more than 300 faculty and thousands of students. Her work focuses on partnerships, shared research infrastructure, and building hubs that connect academia with industry. She is co-leading the development of the Innovation District anchored at Mason’s SciTech campus and serves on the boards of BioHealth Innovation and the Association of University Research Parks.

Christina Winn leads the Prince William County Department of Economic Development, guiding investment, business growth, and redevelopment efforts across one of Virginia’s largest counties. She is overseeing the development of a research-driven Innovation District in partnership with George Mason University and the City of Manassas, supported by a GO Virginia grant. Her career includes leading large-scale economic development initiatives that have driven significant capital investment, job creation, and national visibility for the region.

Samsung Biologics Expands U.S. Manufacturing Capabilities with Strategic Acquisition of Human Genome Sciences from GSK

By News

INCHEON, South Korea, ROCKVILLE, Md. and LONDON Dec. 21, 2025 /PRNewswire/ — Samsung Biologics (KRX: 207940.KS), a leading contract development and manufacturing organization (CDMO), today announced that its wholly owned U.S. subsidiary, Samsung Biologics America, has entered into a definitive agreement to acquire 100% of Human Genome Sciences from GSK (LSE/NYSE: GSK). This strategic move secures Samsung Biologics’ first U.S.-based manufacturing site, a significant expansion of the company’s global footprint and its long-term commitment to the U.S. market.

Located in Rockville, Maryland, the facility sits at the center of one of the key U.S. bio-clusters and encompasses two cGMP manufacturing plants with a combined 60,000 liters of drug substance capacity, supporting both clinical and commercial production from small to large scale. Existing products will continue to be manufactured at the site, and Samsung Biologics plans to make additional investments to expand the site’s capacity and upgrade technology to further support a more resilient U.S. supply chain for critical biologic medicines.

 

Under the terms of the agreement, with closing anticipated toward the end of Q1 of 2026, Samsung Biologics will acquire the Rockville assets for USD 280 million. The company will also retain more than 500 employees at the site to ensure operational continuity and stability. By integrating this facility into our global network, Samsung Biologics will provide clients with flexible, multi-site options in both the U.S. and Korea to ensure that live-saving therapeutics are reliably available to American patients.

Samsung Biologics has established a proven track record of operational and construction excellence through on-time completion of its Bio Campus I and II, and also recently secured land for Bio Campus III, which will house distinct R&D and manufacturing programs for new modalities. With 785,000 liters of capacity across five plants, the industry’s leading capacity, Samsung Biologics continues to advance its diversified portfolio spanning monoclonal antibodies, antibody-drug conjugates (ADCs), mRNA, organoid-based services, and next-generation therapies.

“This landmark acquisition is a testament to our unwavering commitment to advancing global healthcare and bolstering our manufacturing capabilities in the U.S. The investment will enable us to deepen our collaboration with federal, state, and local stakeholders to best serve our customers and partners while ensuring a reliable and stable supply of life-saving therapeutics,” said John Rim, CEO and President of Samsung Biologics. “This marks an important step forward in our mission to achieve a better life through biomedicines, and we look forward to building on the legacy of this facility as we welcome experienced colleagues to the Samsung Biologics family and continue delivering innovative solutions that make a meaningful impact.”

Regis Simard, President, Global Supply Chain, GSK, said: “Today’s agreement to divest the Rockville manufacturing site to our valued long-term partner, Samsung Biologics, will secure the manufacture of two important medicines on US soil for US patients and further build GSK’s supply chain resilience. Along with GSK’s recent commitment to invest $30bn in R&D and manufacturing in the US over the next 5 years, this deal enables us to further focus on building the agility, capacity and capability needed in our manufacturing network to deliver the next generation of specialty medicines and vaccines. I am confident in a positive partnership and future for the Rockville site.”

About Samsung Biologics

Samsung Biologics (KRX: 207940.KS) is a leading contract development and manufacturing organization (CDMO), offering end-to-end integrated services that range from late discovery to commercial manufacturing.

With a combined biomanufacturing capacity of 785,000 liters across Bio Campus I and II, Samsung Biologics leverages cutting-edge technologies and expertise to advance diverse modalities, including multispecific antibodies, fusion proteins, antibody-drug conjugates, and mRNA therapeutics.

By implementing the ExellenS™ framework across its manufacturing network with standardized designs, unified processes, and advanced digitalization, Samsung Biologics ensures plant equivalency and speed for manufacturing continuity.

Samsung Biologics also operates commercial offices in Korea, the U.S., and Japan. Samsung Biologics America supports clients based in the U.S. and Europe, while its Tokyo sales office serves the APAC region.

Samsung Biologics continues to invest in new capabilities to maximize operational and quality excellence, ensuring flexibility and agility for clients. The company is committed to the on-time, in-full delivery of safe, high-quality biomedicines, as well as to making sustainable business decisions for the betterment of society and global health.

For more information, visit https://samsungbiologics.com/

Media Contact at Samsung Biologics:

Claire Kim, Senior Director cair.kim@samsung.com

SOURCE Samsung Biologics

Entrepreneurs in Residence Call: Biohealth Commercialization Leaders with AI and Quantum Experience

By News

BioHealth Innovation is expanding its Entrepreneurs in Residence (EIR) network and is seeking experienced leaders at the intersection of biohealth and advanced technologies, including artificial intelligence and quantum computing.

This call is for seasoned operators with a strong commercialization background. Ideal candidates have taken innovations from concept through market entry, licensing, spinout, or acquisition, and understand the realities of regulatory pathways, customer discovery, fundraising, and scale. Experience working with startups, academic technologies, government labs, or early-stage venture-backed companies is essential. EIRs serve in a part time advisory role with BHI, working flexibly alongside other professional commitments while contributing hands on commercialization expertise.

We are particularly interested in EIRs who can translate AI and quantum capabilities into practical biohealth applications, including drug discovery, diagnostics, clinical research, manufacturing, data analytics, and health system innovation. The role requires comfort working across technical, business, and stakeholder environments.

EIRs work closely with entrepreneurs, researchers, and partners across the BioHealth Capital Region and nationally. Engagements may include advising project teams, supporting partner initiatives, guiding commercialization strategy, and mentoring founders navigating early growth decisions.

This is an opportunity to contribute deep expertise to high-potential biohealth innovations while remaining connected to a collaborative, mission-driven ecosystem.

Interested candidates should contact BHI Founder, President, and CEO, Rich Bendis at rbendis@biohealthinnovation.org, with a summary of their background, commercialization experience, and areas of technical focus.

 

BHI EIR Insights: 7 Tactics to Optimize Launch Messaging – Part I

By EIR Insights, News

by Jonathan Kay, MPP, Managing Partner, Health Market Experts & BioHealth Innovation, Inc. Entrepreneur-in-Residence

Healthcare is complicated. Communicating effectively doesn’t need to be.

For a new medical technology, biologic, pharmaceutical, or digital health solution, a critical element of go-to-market strategy (GTM) and initial commercial success is messaging.

But messaging often doesn’t get the attention it deserves.

GTM messaging could include messages to any: physicians, hospital administrators, policy makers, patients, caregivers, payers, and more.

This post kicks off our 7-part series on Optimizing Launch Messaging 🚀, where we will share 7 valuable tactics to help achieve your goals related to access, commercial success, and improved patient outcomes.

Tactic 1: Test, Don’t Guess

The first step to optimizing launch strategy is embracing a data-driven mindset:

Healthcare markets are complex in so many ways. Think of the scientific, clinical, regulatory, reimbursement, and competitive landscape. Testing in a complex and changing environment helps minimize risk and maximize potential.

Companies run clinical trials to test the impact of a therapy. Similarly, commercial teams should test their launch communications to ensure they are effective and safe. That is, are the messages clear, credible, and persuasive? Do the messages avoid unintended consequences?

Why test messages? We test messages to:

  • Understand unmet needs
  • Assess competitive differentiators
  • Understand which messages resonate and why
  • Learn how to motivate appropriate behavior

Do you have a positive example from when you tested messages in advance of using them? Share your thoughts below!

At Health Market Experts, we make corporate and brand messaging more efficient and effective. If your organization is preparing to launch a product or a campaign, connect with us to learn more about how we can help you develop and execute your launch plan and maximize success. Ask us about message awareness and attribution, too.

This post was written with NI not AI (written by a human using natural intelligence).

This post expands on content I previously wrote as a blog at Catalant and delivered in guest lectures at Rutgers Business School.

Visit https://www.linkedin.com/in/jonathan-kay-healthcare/ to connect with Jon on LinkedIn.

Strengthening Virginia’s BioHealth Future with Secretary of Commerce and Trade Juan Pablo Segura on BioTalk

By BioTalk with Rich Bendis Podcast, News

Secretary Juan Pablo Segura joins BioTalk for a conversation about Virginia’s growing position in the biohealth economy and the statewide strategy behind it. He outlines the significance of the new partnership with AstraZeneca, Lilly, and Merck, including up to $120 million in private investment to create a workforce development center and expand the Commonwealth’s life sciences capacity. Segura talks through how Virginia approaches company recruitment, what investors are responding to, and why the state is seeing increased interest from biomanufacturing and advanced R&D companies. He also discusses Virginia’s use of public-private partnerships to accelerate industry growth, strengthen the talent pipeline, and support emerging hubs across the Commonwealth. The conversation closes with a look at Virginia’s role in the BioHealth Capital Region and how the regional identity helps amplify the state’s message as it continues building a competitive biohealth ecosystem.

Listen now on your favorite podcast platform:
Apple: https://apple.co/3M2UNbB
Spotify: https://bit.ly/4izRPYa
iHeart Podcasts: https://ihr.fm/3Ktc0u5
Amazon Podcasts: https://amzn.to/3K5kkjN
YouTube Music Podcasts: https://bit.ly/4owIZfc
TuneIn: https://bit.ly/4ptw26O


Editing and post-production work for this episode was provided by The Podcast Consultant (https://thepodcastconsultant.com).

Juan Pablo Segura is the Secretary of Commerce and Trade for the Commonwealth of Virginia. He leads 13 agencies focused on economic growth, business development, and industry expansion across the state. Before entering public service, Segura spent his career building companies in the digital health sector, most notably as a founder of Babyscripts, a widely adopted maternity care platform. His work has been recognized by Startup Health, CTIA, EY, and the White House. He is a CPA and a graduate of the University of Notre Dame, and he lives in Henrico, Virginia with his family.

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