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Don’t Miss the Region’s Flagship BioHealth Event: Register Now for BHCR Week 2026

By News

Registration is open for the 12th Annual BioHealth Capital Region Week, taking place September 15–17, 2026, at US Pharmacopeia (USP) in Rockville, Maryland.

BioHealth Capital Region Week brings together leaders from industry, academia, government, investment, economic development, research institutions, emerging companies, and regional partners for three days of programming focused on the future of the region’s biohealth ecosystem.

This year’s theme, “Growing the BioHealth Capital Region of Tomorrow,” reflects the need for stronger collaboration, commercialization, investment, infrastructure, and innovation as the region continues to build on its position as one of the nation’s leading biohealth clusters.

Attendees can register now for the BioHealth Capital Region Forum and the BioHealth Capital Region Investment Conference, and emerging companies can also apply for the Crab Trap Competition, all through the event site:

Register and apply here: https://eventmobi.com/website/BHCR2026

BioHealth Capital Region Forum: September 15–16

The BioHealth Capital Region Forum will feature two days of panels, keynote conversations, regional updates, networking, and ecosystem-building discussions.

The agenda is coming together with conversations focused on the issues shaping the next stage of growth for the region, including:

  • The BioHealth Capital Region’s national ranking and competitiveness
  • Regional standards, quality, regulatory science, and life sciences measurement leadership
  • Onshoring, domestic medicine production, and supply chain resiliency
  • Biotech company growth across the BioHealth Capital Region
  • Computational health, AI, data, and decision-making
  • Infrastructure, facilities, financing, construction, and demand
  • Quantum in biohealth and future computational capabilities
  • Universities and innovation districts as drivers of regional growth
  • Commercialization talent, fractional leadership, and company-building support
  • Market opportunities for breakthrough medical innovation
  • Public-private partnerships and investment funding to grow the biohealth economy

The Forum will also include networking breaks, receptions, and opportunities to connect with leaders from across Maryland, Washington, D.C., Virginia, and beyond.

Crab Trap Competition: September 16

The Crab Trap Competition returns as part of BioHealth Capital Region Week, giving emerging biohealth companies the opportunity to pitch live in front of investors, judges, industry leaders, and regional partners.

Crab Trap is designed for companies developing promising technologies across biotech, medtech, diagnostics, digital health, AI-enabled health, and other areas of life sciences innovation. Selected finalists will gain visibility, feedback, and connections that can help support their next stage of growth.

Companies interested in competing should apply now through the BHCR Week event site.

BioHealth Capital Region Investment Conference: September 17

The BioHealth Capital Region Investment Conference will take place on September 17 and is designed to connect companies with investors, strategic partners, economic development leaders, and regional resources.

Companies seeking capital, visibility, and strategic connections should register early and complete as much of their profile as possible. Strong profiles help support better engagement, better visibility, and more productive company-investor connections before and during the event.

Investors are also encouraged to register now to identify promising companies, review profiles, and participate in conversations around the next generation of biohealth opportunities.

Registration for the Investment Conference is separate from Forum registration.

Thank You to Our Sponsors

BioHealth Capital Region Week remains free to attend thanks to the support of our sponsors. That is one of the things that makes this event different from many other industry conferences. Sponsor support helps ensure entrepreneurs, researchers, students, companies, investors, public-sector partners, and regional leaders can participate without cost barriers.

Every dollar raised goes toward producing the event and supporting the programming, visibility, logistics, and convening power that make BHCR Week possible.

Thank you to this year’s current sponsors and partners:

Alexandria Real Estate Equities
BioHealth Innovation, Inc.
BlackBird Labs
BrainBox, Inc.
Emmes
FNIH
George Mason University
George Washington University
Henry Jackson Foundation
Johns Hopkins University
Maryland Department of Commerce
Mirecule
Kelly Services
KPMG
Montgomery County Economic Development Corporation (MCEDC)
NIH Federal Credit Union (NIHFCU)
The NIH Office of Technology Transfer (OTT)
Noble Life Sciences
PIC MC
Precigen
PWC
Rose Li Associates
Rothwell, Figg, Ernst & Manbeck, P.C.
Scheer Partners
TEDCO
United Therapeutics
University of Maryland BioPark
University of Maryland Institute for Health Computing (UM-IHC)
US Pharmacopeia (USP)
Venable
VIPC
Virginia Bio
WellDoc
Women in Bio

Organizations interested in joining this group as sponsors are encouraged to contact BioHealth Innovation.

Sponsorship provides visibility across BioHealth Capital Region Week, including recognition through event materials, signage, the registration site, BHI communications, and onsite programming. Sponsors also gain access to the invite-only VIP Leadership Dinner, a smaller and more focused setting that brings together senior executives, investors, speakers, public-sector leaders, university partners, and key opinion leaders for high-value relationship building.

If you’re interested in joining your peers as a sponsor, email Rich Bendis at rbendis@biohealthinnovation.org AND Andy Eckert at aeckert@biohealthinnovation.org.

Register Now

BioHealth Capital Region Week is one of the region’s most important annual gatherings for biohealth leaders, entrepreneurs, investors, researchers, and ecosystem partners.

Register now for the Forum and Investment Conference, and apply for the Crab Trap Competition here:

https://eventmobi.com/website/BHCR2026

USP Invites Public Comment on Product-Specific Emerging Standards for Biologics

By News

Opportunity to Comment on Product-Specific Emerging Standards for Biologics 

Advancing efficiency and alignment in biologics development, through product-specific methods, to support broader availability of biologics, including biosimilars, for patients

The U.S. Pharmacopeia (USP) has announced the publication of a set of product-specific emerging standards for biologics, now available for public comment through the Emerging Standards Platform. The initial set of emerging standards includes analytical methods for epoetin, interferon beta 1a, rituximab, and bevacizumab, along with accompanying physical reference standards. USP invites manufacturers, regulators, academia, healthcare providers, and other stakeholders to review the methods, share practical feedback, and submit input, including alternative methods, through the Emerging Standards Platform. Please consider providing your input. Input received during this stage will inform how these concepts evolve.

These emerging standards are being introduced in advance of any formal compendial consideration to enable early stakeholder feedback. The newly released emerging standards for biologics are designed to be flexible by offering multiple methods to assess quality attributes rather than a single approach. These emerging standards do not include product specifications, leaving those determinations to the reviewing regulator. 

This approach relies on engagement from regulators, manufacturers, and other stakeholders—utilizing emerging standards, sharing experience, and contributing feedback that helps ensure these tools are relevant, usable, and meaningful. “Biologic therapies require approaches that are scientifically rigorous, workable in real-world settings, and that account for the complexity of biologics, which is why we are publishing these for stakeholder comment for early engagement and feedback,” says Diane McCarthy, Ph.D., Vice President, Global Biologics at USP. “These product-specific emerging standards are designed to focus on analytical methods and system suitability tests and criteria, supporting consistent assessment of assay performance, and efficiency in how analytical evidence is generated and assessed.”

The development of these emerging standards for biologics follows the adoption of a Resolution in 2025 by the USP Convention to develop standards and tools to advance access to biologic and biosimilars therapies to patients around the world. As an independent, non-profit organization, the Convention is USP’s largest governing body, comprised of more than 450 stakeholder organizations across healthcare, government, industry, academia, and patient advocacy. Resolutions from the Convention direct USP’s work over five-year cycles. “Pharmacopeias around the world are already advancing standards for monoclonal antibodies and other therapeutic proteins, creating a clear opportunity for greater global convergence and harmonization,” explains Sara Radcliffe, Head of Global External Affairs for Biologics, USP. “As pharmacopeias move forward with product specific standards, aligning quality expectations across jurisdictions has become increasingly important for regulators and manufacturers alike.” 

In recent years, regulators have integrated scientific advances into review frameworks, including expanding utilization of analytical evidence with less reliance on clinical data. A lack of common expectations across the globe on appropriate methods and analytical performance can create inefficiency and inconsistency both in product testing and in interpretation of resulting data. The emerging standards published today aim to provide these tools. “As regulators increasingly rely on analytical data to evaluate biologics, establishing shared approaches to assessing quality becomes critical,” says Fouad Atouf, Ph.D., Chief Science Officer at USP. “Publicly available standards and tools can help reduce uncertainty, streamline development and review, and support broader availability of quality biologic therapies for patients. We look forward to active stakeholder engagement and input.”

USP’s emerging standards for biologics are intended to enable alignment with regulatory frameworks, support more efficient regulatory reviews, enable regulatory convergence across regions, help reduce duplication for manufacturers, and facilitate market access to affordable biologics, including biosimilars, for patients around the world. We look forward to working together in collaboration with stakeholders to achieve these important goals. 

About USP

USP is a private, non‑profit scientific organization that collaborates with stakeholders around the world to develop public quality standards and solutions that support quality across the development, manufacturing, and delivery of regulated health products; strengthen regulatory systems; enhance supply reliability; and support the adoption of innovation. Used in more than 150 countries, USP standards and solutions play a critical role in increasing the availability of quality medicines, dietary supplements, and food ingredients worldwide.

Registration Now Open for the 2026 BioHealth Capital Region Forum and Investment Conference

By News

Registration is now open for the 12th Annual BioHealth Capital Region Forum and BioHealth Capital Region Investment Conference, taking place September 15th, 16th, and 17th, 2026, at US Pharmacopeia (USP) in Rockville, Maryland.

This year’s BioHealth Capital Region Week theme, “Growing the BioHealth Capital Region of Tomorrow,” reflects the region’s continued focus on collaboration, commercialization, investment, and leadership during a time of change and opportunity across the biohealth ecosystem.

The BioHealth Capital Region Forum will be held September 15th and 16th and will bring together leaders from industry, academia, government, investment, and entrepreneurship for two days of high-level discussion, regional updates, thought leadership, and networking. The Forum continues to serve as a central gathering point for the people, companies, institutions, and public-sector partners helping shape the future of biohealth across Maryland, Washington, D.C., Virginia, and beyond.

Attendees can expect conversations focused on the region’s growth, the future of biohealth innovation, investment trends, commercialization pathways, infrastructure, talent, artificial intelligence, public-private collaboration, and the forces shaping the next chapter of the BioHealth Capital Region.

Register for the Forum here:
https://bit.ly/BHCRWEEK2026

Important Registration Note: Attendees who want to participate in both the BioHealth Capital Region Forum and the BioHealth Capital Region Investment Conference must register for each event separately.

The Investment Conference uses a separate registration process because it is designed around company-investor engagement. Companies seeking investment and investors looking to meet with emerging biohealth companies are asked to provide additional information that helps support company visibility, investor review, partnering, and more targeted connections throughout the day.

The BioHealth Capital Region Investment Conference will take place on Thursday, September 17th. This focused program brings together investors, entrepreneurs, emerging biohealth companies, strategic partners, and ecosystem leaders for a day centered on capital formation, company presentations, networking, and meaningful business development opportunities.

Companies developing new technologies across therapeutics, diagnostics, medical devices, digital health, AI-enabled biohealth, research tools, and other areas of life sciences innovation are encouraged to register. Investors looking to connect with promising companies from across the region and beyond should also sign up through the Investment Conference registration page.

Register for the Investment Conference here:
https://bit.ly/BHCRIC2026

Applications are also now being accepted for the BioHealth Capital Region Crab Trap Competition, which returns as part of BioHealth Capital Region Week. The Crab Trap Competition highlights promising early-stage biohealth companies and gives selected entrepreneurs the opportunity to pitch live in front of experienced investors, industry leaders, subject matter experts, and regional ecosystem partners. The BioHealth Capital Region Crab Trap Competition will take place on Wednesday, September 16th.

Five finalists will be selected to present during BioHealth Capital Region Week. Each finalist will deliver a seven-minute company presentation, followed by a three-minute question-and-answer session with the judges. Prize details, including cash and services, will be announced soon.

Apply for the Crab Trap Competition here:
https://bit.ly/CrabTrap2026

BioHealth Capital Region Week continues to be one of the region’s most important gatherings for advancing collaboration, showcasing innovation, and connecting the people and organizations building the future of biohealth. Whether you are an entrepreneur, investor, researcher, executive, public-sector leader, service provider, or ecosystem partner, this is a key opportunity to be part of the conversation and the connections that will shape what comes next.

Register now and join us September 15th, 16th, and 17th at USP in Rockville, Maryland.

BioHealth Capital Region Crab Trap Competition Now Accepting Applications

By News

Applications are now being accepted for the BioHealth Capital Region Crab Trap Competition, returning as part of the 12th Annual BioHealth Capital Region Week, taking place September 15, 16, and 17, 2026, at US Pharmacopeia in Rockville, Maryland. Apply today at https://bit.ly/CrabTrap2026.

The Crab Trap Competition highlights promising early-stage biohealth companies developing new technologies, products, and solutions across therapeutics, diagnostics, medical devices, digital health, research tools, and other areas of life sciences innovation. Each year, the competition gives selected entrepreneurs the opportunity to present their companies in front of experienced investors, industry leaders, subject matter experts, and regional ecosystem partners.

Five finalists will be selected to pitch live during BioHealth Capital Region Week. Each finalist will deliver a seven-minute company presentation, followed by a three-minute question-and-answer session with the judges. The format gives entrepreneurs a focused opportunity to explain the problem they are solving, the strength of their technology, market opportunity, commercialization strategy, management team, funding progress, and key milestones.

The competition is open to companies preparing for growth, investment, strategic partnerships, or broader market engagement. Applicants should be ready to provide materials that may include a technology overview, market description, intellectual property landscape, competitive advantage, management structure and experience, funding to date, company milestones, financial plan, executive summary, and company presentation deck.

Prizes for this year’s competition are currently being finalized and will be announced soon. As in past years, the prize package is expected to include a combination of cash awards and professional services designed to support the winning company’s continued progress.

The Crab Trap has become a signature platform for showcasing emerging biohealth companies from across the region and beyond. Previous participants and winners include companies such as Perfusion Medical, Linshom Medical, Luminoah, Neuroene Therapeutics, Nanochon, BrainScope, Floreo, LifeSprout, and Sonavex. These companies reflect the range of innovation represented through the competition, from medical devices and digital health to tissue engineering, neurological technologies, respiratory monitoring, surgical tools, and therapeutic platforms.

For entrepreneurs, the Crab Trap offers more than a pitch opportunity. It provides visibility within one of the nation’s leading biohealth hubs, direct exposure to investors and strategic partners, and a chance to connect with leaders who can help advance promising companies toward their next stage of growth.

Companies interested in competing are encouraged to apply now at https://bit.ly/CrabTrap2026. Finalists will be selected in advance of BioHealth Capital Region Week and invited to present live during the Crab Trap Competition on September 16, 2026.

GEN Names BioHealth Capital Region a Top 3 U.S. Biopharma Cluster for Fourth Year in a Row

By News

The BioHealth Capital Region, spanning Maryland, Virginia, and Washington, D.C., has once again been named one of the nation’s Top 3 biopharma clusters by Genetic Engineering & Biotechnology News (GEN), marking the region’s fourth consecutive year in the Top 3.

GEN’s 2026 “Top 10 U.S. Biopharma Clusters” ranking was authored by Alex Philippidis, Senior Business Editor at GEN, who has long tracked the growth, competition, and evolution of life sciences ecosystems across the country. Philippidis will return to the BioHealth Capital Region Forum this year to discuss GEN’s updated Top 10 list, the movement within the national rankings, and what the latest findings suggest about the future of U.S. biopharma innovation.

In the 2026 ranking, GEN places the BioHealth Capital Region at No. 3 nationally, behind only Boston/Cambridge and the San Francisco Bay Area. The full article is available here: https://www.genengnews.com/topics/drug-discovery/top-10-u-s-biopharma-clusters-2026/

The recognition reinforces the region’s standing among the country’s strongest life sciences ecosystems and reflects the depth of its research institutions, federal assets, industry base, talent, lab infrastructure, and commercialization capacity.

Recognition carries special meaning for a region that set a public goal years ago to become a Top 3 biopharma cluster. Reaching that milestone was significant. Maintaining it for four consecutive years shows that the BioHealth Capital Region has moved beyond aspiration and into sustained national leadership.

GEN’s annual ranking evaluates U.S. biopharma clusters using five core indicators: NIH funding, venture capital funding, patents, lab space, and jobs. In the 2025 ranking, the BioHealth Capital Region ranked first nationally in biotechnology-related patents and third in both NIH funding and lab space, helping secure its Top 3 position despite broader economic and industry headwinds.

For the BioHealth Capital Region, this continued recognition by GEN is a proof point for the power of regional collaboration. Maryland, Virginia, and Washington, D.C. each bring distinct strengths to the ecosystem, but the region’s national competitiveness is strongest when those assets are connected. The presence of NIH, FDA, NIST, USP, major research universities, leading health systems, established biopharma companies, emerging startups, investors, and commercialization partners gives the region a differentiated role in advancing biohealth innovation.

“Being ranked Top 3 by GEN for the fourth year in a row is a moment to celebrate across the entire BioHealth Capital Region.” Said Rich Bendis, Founder, President and CEO of BioHealth Innovation, Inc. “Congratulations to the many partners across Maryland, Virginia, and Washington, D.C. who have helped make this possible, including our companies, universities, federal institutions, economic development organizations, investors, entrepreneurs, and ecosystem leaders. This recognition reflects years of collaboration and a shared commitment to growing one of the nation’s leading biohealth clusters.”

The 2026 GEN ranking also comes at an important moment for the industry. Cluster development is being shaped by national trends, including renewed capital activity, increased merger and acquisition activity, a revived IPO market, and continued investment in U.S.-based biomanufacturing. Those trends are highly relevant to the BioHealth Capital Region, where research strength, proximity to federal labs, manufacturing growth, and translational support continue to define the ecosystem’s value.

GEN’s 2026 Top 10 also showed movement among several other regions compared with 2025. The Top 3 remained unchanged, with Boston/Cambridge, the San Francisco Bay Area, and the BioHealth Capital Region holding their positions. Greater Philadelphia moved from No. 7 in 2025 to No. 5 in 2026, while North Carolina moved from No. 8 to No. 7. Chicagoland moved from No. 10 to No. 9. San Diego shifted from No. 5 to No. 6, Los Angeles/Orange County moved from No. 6 to No. 8, and Seattle moved from No. 9 to No. 10.

The full GEN 2026 Top 10 includes:

  1. Boston/Cambridge, MA
  2. San Francisco Bay Area
  3. BioHealth Capital Region, Maryland, Virginia, and Washington, D.C.
  4. New York/New Jersey
  5. Greater Philadelphia
  6. San Diego
  7. North Carolina
  8. Los Angeles/Orange County, CA
  9. Chicagoland
  10. Seattle

For the BioHealth Capital Region, the fourth consecutive Top 3 ranking in GEN is both a recognition and a call to action. It confirms that the region has the assets, talent, and infrastructure to compete with the largest life sciences hubs in the country. It also underscores the need to keep building: more company formation, more access to capital, more lab and manufacturing capacity, more workforce development, and more collaboration.

BioHealth Innovation Welcomes Caroline Popper and Julie Wilkinson as Entrepreneurs-in-Residence

By News

BioHealth Innovation, Inc. (BHI) is pleased to announce the addition of Caroline Popper and Julie Wilkinson as Entrepreneurs-in-Residence (EIRs). Together, they bring decades of experience across medical technology, diagnostics, digital health, commercialization strategy, FDA pathways, manufacturing, corporate development, and venture-building.

Popper is a business leader, physician, and lawyer with more than 30 years of experience in medical technology, diagnostics, and the life sciences. Her work has focused on technologies and services that improve healthcare efficiency, with a growing emphasis on the intersection of healthcare, biology, technology, and artificial intelligence.

She has held operational and strategic roles at BD and bioMérieux, served as Chief Business Officer of MDS Proteomics, founded Popper and Company, and co-founded The Sherpanis with Julie Wilkinson. She also served as Chief Commercial Officer of Johns Hopkins Precision Medicine and led commercialization activities for the Johns Hopkins Applied Physics Lab Healthcare Mission Area. She currently serves as co-chair of the American Bar Association Healthcare Section AI Task Force.

Wilkinson is a scientist, C-level executive, and entrepreneur with more than 30 years of experience advancing MedTech innovations through FDA clearance and GMP manufacturing across medical devices, digital health, and in vitro diagnostics. She has led R&D efforts at major health technology companies, including Abbott, Beckman Coulter, and Agilent, and founded and grew a life science service company from zero to $10 million before a successful exit.

Her expertise spans FDA product development pathways, MedTech technology readiness, investor diligence, product-market fit, value proposition development, business model design, and commercialization strategy. She was also part of the $2 billion RADx Tech NIBIB initiative, which helped create U.S. manufacturing capacity for COVID-19 tests, and has led company teams through FDA authorization and manufacturing scale-up for new diagnostics.

“Caroline and Julie bring the kind of hands-on operating experience that is invaluable to entrepreneurs and early-stage companies,” said BHI President and CEO, Rich Bendis. “Their combined expertise in diagnostics, MedTech, FDA strategy, commercialization, manufacturing, AI, and venture-building will strengthen BHI’s ability to support innovators as they move from promising technologies to market-ready solutions.”

“Caroline and I are very excited to join the BHI Entrepreneur-in-Residence team and support our capital region entrepreneurs as they accelerate the transformation of innovative ideas into market-ready products. Turning an idea into a successful commercial product takes far more than funding and determination, it requires the collaboration of experienced experts working together as an active team. The Entrepreneur-in-Residence program led by Rich Bendis exemplifies that collaborative approach and provides entrepreneurs with the strategic support needed to move innovation forward,” said Julie Wilkinson, New Entrepreneur-in-Residence, BioHealth Innovation.

As Entrepreneurs-in-Residence, Popper and Wilkinson will work with BHI and its partners to help emerging companies evaluate technology readiness, refine commercialization strategies, navigate regulatory and development milestones, assess market opportunities, and build stronger pathways toward investment, partnership, and growth.

Their addition reflects BHI’s continued commitment to expanding its EIR network with leaders who have deep technical expertise, operating experience, and a strong understanding of what it takes to move biohealth innovations from concept to commercialization.

Organizations and Institutions interested in EIR support through BHI are encouraged to contact Rich Bendis, President and CEO of BioHealth Innovation, at rbendis@biohealthinnovation.org.

About BioHealth Innovation, Inc.

BioHealth Innovation, Inc. (BHI) is a nonprofit innovation intermediary that accelerates the commercialization of promising biohealth technologies. BHI works with entrepreneurs, startups, research institutions, federal laboratories, universities, investors, and industry partners to help move science from discovery to market.

Through its Entrepreneurs-in-Residence program, non-dilutive funding support, international soft-landing services, and commercialization expertise, BHI helps companies and innovators strengthen business strategies, pursue funding, connect with partners, and navigate the path toward growth. BHI is also a founding member and manager of the BioHealth Capital Region brand, supporting the continued development of Maryland, Washington, D.C., and Virginia as one of the nation’s leading life sciences clusters.

AI in Grant Writing: Where it Helps and Where it Hurts

By EIR Insights, News

By Catherine Leasure, Ph.D., BHI Life Sciences Business Strategist – If you’ve written a grant recently, you’ve probably wondered whether AI could make the process easier. Maybe you’ve already tried it. The honest answer is that AI can help, but how much depends entirely on what you bring to it. When you know what you’re doing, it gets you to a solid draft faster. However, without a strong grasp of the process behind it, it can produce polished-sounding text that misses the mark in ways that aren’t always obvious until a reviewer or experienced grant writer points them out.

Where AI Earns Its Keep

The tasks where AI performs best are the ones that are time-consuming but relatively mechanical. Generating a document outline that accounts for both grant requirements and your specific project content is a good example. What might take an hour of cross-referencing a funding opportunity announcement can be done in minutes with the right prompt. From there, AI can help turn that outline into a working first draft and translate dense technical language into plain descriptions for non-specialist reviewers, which is particularly useful when generating ancillary documents like abstracts or project summaries that need to be accessible to a broad audience.

AI also shines in the later stages of drafting. Grant applications are long documents, and inconsistencies are easy to overlook when you’ve been working on the proposal for weeks or months. Terminology that shifts between sections that were written by different people, early claims that aren’t fully supported later in the document, and overly wordy sentences are all the kinds of issues that AI excels at catching and fixing. It can also serve as a compliance checker, making sure required sections are present and that the structure of your application matches what the solicitation requires.

None of this replaces the thinking that goes into a competitive application. But it does free up time and mental energy for the parts that require it.

Where AI Falls Short

The same confidence that makes AI useful in the drafting process can work against you when the content and strategy require nuance. AI can misrepresent novel technologies, fabricate citations, or produce technically plausible descriptions that are subtly wrong (this is called hallucinating). For early-stage companies with innovative science, this is a real risk. AI can only work with what you give it. If you’re not providing detailed, accurate information about your technology and approach, it will fill in the gaps on its own, and not always correctly. You need someone who actually understands the technology both guiding the prompts and reviewing anything AI generates before it goes into your final draft.

Beyond accuracy, there’s a layer of strategic knowledge that AI doesn’t have access to. It can’t tell you how a program officer has been framing their priorities in recent conversations, what a review panel tends to weigh most heavily, or whether your project is actually a good fit for a particular solicitation before you invest time writing your proposal. That kind of information comes from reaching out to and meeting with program officers before you submit. These conversations can reshape an application in ways that no AI tool can replicate.

Then there’s the writing itself. Even the best prompts can produce text that experienced reviewers recognize immediately: sentence structures like “it’s not X, it’s Y,” excessive adjectives, and the overuse of certain punctuation are all patterns that show up repeatedly in AI-generated text. Beyond the stylistic tells, AI tends toward a kind of confident vagueness that sounds thorough but doesn’t actually say much. In competitive grant programs, that kind of generic writing loses. If AI contributes to any part of your draft, it’s the grant writer’s job to make sure the final product sounds like it was written by a real person. Reviewers who are engaged with your writing are more likely to be engaged with your science.

Finally, using AI to write your grant poses a potential confidentiality risk that often goes overlooked. When you paste proprietary information about your technology into a public AI tool, that content may be used to train the model, and there is no guarantee it will stay private. Details about your innovation could potentially surface in someone else’s results! Treat any public AI tool the way you would any other unsecured channel: don’t put anything in that you wouldn’t be comfortable sharing publicly.

Agency Guidance on AI Use

Some funding agencies have begun addressing AI use in applications directly. NIH, for example, recently issued guidance stating that applications that are substantially developed by AI will not be considered original ideas of the applicant, and that the NIH employs AI detection tools to identify AI-generated content (NOT-OD-25-132). Applications found to be in violation post-award can face serious consequences, including cost disallowance, grant suspension, or termination. The NSF has taken a slightly more lenient approach, requesting that proposers disclose whether AI tools were used when preparing an application. The NIH and the NSF are not alone in scrutinizing AI use, and it is reasonable to expect other agencies to follow suit as AI use becomes more widespread.

The Bottom Line

AI is a useful tool in the grant writing process, but it works best as a starting point, not a final product. The applications that score well aren’t necessarily the ones with the smoothest prose, they’re the ones that demonstrate a clear understanding of the funding landscape, make a compelling scientific case, and show reviewers that the team behind the project knows what they’re doing. That requires expertise that no prompt can substitute for.

Used effectively, AI can get you to a better draft faster. But knowing how to use it thoughtfully, and knowing when not to rely on it, is itself a skill.

Work with Us

At BHI, we work with clients from the earliest stages of identifying the right funding opportunity through grant submission, including helping determine where AI can speed up the process and where it needs to be set aside in favor of human expertise. Our grant writers have supported over 200 applications, helping clients secure $66M in non-dilutive funding. If you’re working on a grant application and want to make sure you’re using every tool available without sacrificing the quality of your submission, we’d love to talk.

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

By EIR Insights, News

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

To recap, the first 5 posts of our series covered:

  1. Test, Don’t Guess: Adopt a data-driven mindset about messaging impact
  2. Know Your Stakeholders: Avoid a one-size-fits-all approach
  3. Listen First: What are  your stakeholders saying and how?
  4. Message Anatomy: Ensure messages get the job done
  5. Measuring Success: Define metrics of success upfront

Insight 6: Just Start

It’s true we want to pursue all 5 tactics above. But that doesn’t mean we always can.  Sometimes clients or would-be clients insist:

  • Time is too limited, so they can’t test
  • The target audience is rare or ultra rare, so they can’t test

🛑 Hold on! Don’t skip testing even in these situations. As the saying goes, Don’t let perfect be the enemy of the good.(That’s typically attributed to surgeons!🥼)

Real-world problems require real-world problem-solving. To know in advance how well your messages will perform, ask real-world stakeholders. Even if time is extremely limited. Even if audiences seem too hard-to-reach. (We can help you in both cases. While we encourage clients to have a launch runway and notify us in advance, typically we can line up test audiences in a day or two, or faster!)

Testing messages BEFORE launch can improve early uptake 📈, increase commercial success, and save time and budget later. It can help you avoid unnecessary stress.

✅ Rather than skip testing, “just start” testing by modifying the ideal and going with what is realistic. Here are a few ideas:

  • Fewer interviews
  • Shorter survey
  • Leverage Gen AI (more to come in Tactic #7)
  • Plan ahead: put message testing in your launch plan

When a client was preparing to launch a genetic marker for a rare disease, they approached us to test physician ad concepts and messages. They faced two familiar constraints in biotech launches:

  1. Limited time
  2. A small, hard-to-reach physician population

One more traditional approach might have been to test messages → share feedback with client and creative agency → agency modifies concepts → ideally we test again to optimize. Instead, we compressed the process and reduced the timeline by days, possibly a week. (How great would it be to save a week when getting ready for launch?)

How did we do that?

  • We reduced the number of stakeholder interviews.
  • We prioritized metrics like stopping power, visceral response, clinical credibility
  • Importantly, we invited the agency into the testing process.

Bringing the agency in allowed for agile development. As the interviews progressed, the concepts evolved, and we moved closer and closer to optimal with each next test.

The results were telling, actionable, and valuable even with a small sample. We confirmed a key hypothesis, which added confidence to the commercial strategy. We also revealed confusing language about the biomarker that we easily fixed to avoid encountering post-launch confusion, questions, and delayed product adoption.

The key takeaway: When launching a business or a brand or a campaign, perfect conditions are rare. But even limited testing can uncover powerful insights, reduce risk, and strengthen confidence before your message reaches the market.

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.

Thanking Jarrod Borkat and Rachel Rath for Their Service on the BioHealth Innovation Board

By News

BioHealth Innovation extends its sincere thanks to Jarrod Borkat, Chief Commercial and Strategy Officer at On Demand Pharmaceuticals, and Rachel Rath, Head of JLABS @ Washington DC, for their dedicated service on the Board of Directors.

Throughout their tenure, both leaders brought a steady, thoughtful presence to the board and helped strengthen the organization’s role within the BioHealth Capital Region. Their perspectives, grounded in deep industry experience and regional engagement, supported informed decision-making and reinforced a shared commitment to advancing innovation across the ecosystem.

Jarrod Borkat’s career spans senior commercial, strategy, and partnership roles across the biopharmaceutical sector. His experience building large-scale collaborations among industry, academia, and government brought practical insight to board discussions, particularly around commercialization pathways and cross-sector engagement. His long-standing involvement in the region reflects a consistent belief in collaboration as a foundation for sustainable growth.

During his time with MedImmune and AstraZeneca, Jarrod played a key role in advancing the BioHealth Capital Region (BHCR) brand and strengthening its national profile. He was also a strong advocate for BioHealth Innovation expanding its footprint into Washington, DC, and Virginia, helping foster a more integrated regional ecosystem. In addition, he served on the Board’s Executive Committee, where his strategic perspective supported organizational growth and transition.

Rachel Rath provided a complementary lens shaped by her leadership at one of the region’s most active innovation platforms. Her work evaluating and accelerating early-stage companies, along with prior experience supporting national health security and clinical research initiatives, informed the board’s understanding of emerging technologies and the needs of founders navigating complex development environments.

“Jarrod and Rachel have been exceptional board members and trusted partners,” said Rich Bendis, Founder, President, and CEO of BioHealth Innovation. “Their leadership, insight, and commitment to the BioHealth Capital Region have made a lasting impact. We are grateful for their service and for the time and expertise they so generously shared.”

BioHealth Innovation wishes both leaders continued success and looks forward to their ongoing contributions to the region’s innovation community.

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.

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