Testimony of Michelle Dennis, Heartland BioWorks Tech Hub — Fueling Innovation: The Role of Small Businesses in America's Bioeconomy

Summary

Written testimony of Michelle Dennis, Regional Innovation Officer of the Heartland BioWorks Tech Hub, before the U.S. Senate Committee on Small Business and Entrepreneurship on April 7, 2026, at a hearing titled Fueling Innovation: The Role of Small Businesses in America's Bioeconomy. It describes BioWorks as a tech hub designated and funded by the U.S. Economic Development Administration through the CHIPS and Science Act, focused on Indiana's biotech and biomanufacturing sector. It lists barriers facing biotech small businesses, including high capital requirements, long regulatory pathways and limited access to specialized infrastructure. It states that BioWorks distributes grants of about $500,000 to help early-stage innovators use Indiana labs and contract manufacturers, and refers to a $1 billion investment in Indiana life sciences announced by Governor Braun.

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                             Testimony of Michelle Dennis
              Regional Innovation Officer, Heartland BioWorks Tech Hub
Hearing Titled Fueling Innovation: The Role of Small Businesses in America’s Bioeconomy
            U.S. Senate Committee on Small Business and Entrepreneurship

                                          April 7, 2026


Chair Ernst, Ranking Member Markey, and Distinguished Members of the Committee:

Thank you for the opportunity to provide this testimony. As Regional Innovation Officer, I lead
the Heartland BioWorks Tech Hub (BioWorks), designated and funded by the U.S. Economic
Development Administration (EDA) through the CHIPS and Science Act. With a focus on
Indiana, the BioWorks mission is to support and grow Indiana’s biotech and biomanufacturing
sector, aiming to ensure that biotech invented in the U.S. is scaled and made in U.S. In
operational terms, one of our key objectives is to connect U.S. innovators and startups with
Indiana scale-up and manufacturing infrastructure—largely housed in small-to-midsized
operations. With that, I deal directly with a host of biotech and biomanufacturing companies
from startups to global leaders. This has helped me gain a deep understanding of both the
immense challenges biotech small businesses face, as well as the opportunities that exist through
coordination and federal support.

Indiana has been a quiet driver in life sciences for decades, largely bedrocked by global leaders
in biotechnology – Eli Lilly & Co. (world’s largest pharma company, exceeding $1T market
cap), Elanco (3rd largest animal health company in the world), and Corteva (world’s largest pure-
play ag company) – having their headquarters in the state. These biotech powerhouses are
supported by innovation churning out of Indiana’s three R1 universities and the world’s largest
medical school. Yet, despite this monumental momentum in biotech, Indiana, like many of our
Midwest peers, has lacked the critical resource-intensive pieces needed to create a viable – let
alone thriving – ecosystem that spurs innovation, small business growth, and ultimately global
competitiveness.

It is widely understood that the U.S. is getting outpaced by our adversaries when it comes to
biotech innovation, biomanufacturing and supply chain security, and biodefense. This is despite
the fact that our east and west coasts have been doing biotech innovation, and doing it well, for
years. Winning the global biotech race requires that new innovators and additional regions step
up. We cannot solely rely on the conventional innovation regions nor the typical Fortune 100
companies to secure our global competitiveness in biotech.

Startups and small businesses are the primary engines of innovation in biotechnology, often
pioneering breakthrough therapies, diagnostics, and platforms that larger entities are slower to
pursue. They play a critical role in translating early-stage scientific discoveries into real-world
applications, while also driving competition, job creation, and regional economic growth.
However, specific to biotech, the barriers to success are near-insurmountable:
   • high capital requirements (hundreds of millions of dollars),
   • long and uncertain regulatory pathways,
   • limited access to specialized infrastructure, and
   • challenges in attracting sustained investment through lengthy development timelines (10-
       15 years).

Addressing these challenges takes an all-hands approach and the coasts have shown that this
works, but we need more of it. This is where federal support and programs like the Tech Hubs
and BioWorks come in. For years, Indiana has been bootstrapping its biotech innovation network
in a determined attempt to smooth the pathway to startup success for its innovators. Now,
through BioWorks coordination and EDA funding, we are overcoming longstanding biotech
innovation hurdles, while growing our state’s biomanufacturing sector.

BioWorks coordinates the region’s strong contract development and manufacturing organization
(CDMO) capacities and capabilities and robust pilot-scale lab infrastructure and funnels US
innovators to these resources. By driving connections to existing – largely untapped – Indiana
commercialization resources, we help secure and accelerate domestic biotech startup success. We
also distribute grants (~$500,000 per grant in nondilutive funding) to help early-stage innovators
fund their utilization of Indiana labs and CDMOs. Through this networked approach, BioLaunch
catalyzes biotech innovation, supports new and existing companies in Indiana and beyond, and
accelerates the US production of innovative bioproducts—creating a nexus where next-
generation bioproducts are discovered, made, and distributed in the US. And, this is achieved
through coordination of existing state resources, as opposed to investing millions of dollars in
constructing new, purpose-built facilities.

We have awarded grants to both in-state and out-of-state innovators developing new therapeutics
and biomanufacturing innovations that will now scale up in Indiana because of BioWorks. These
awardees are gaining access to state-of-the-art infrastructure, technical expertise, and start-up
mentorship that helps accelerate commercialization timelines, reduce costs, and mitigate risk. At
the same time, connecting early-stage startups with our scale-up resources creates a business
pipeline for these small-to-midsize operations. It also enables them to engage with the latest
biotech coming down the pipeline, allowing them to ensure their manufacturing processes are
capable of keeping up with innovation. Through our coordinated approach, this infusion of
federal dollars is enabling BioWorks to achieve our aggressive goal: biotech invented in the U.S.
is made in Indiana.
Admittedly, we do not address all barriers to biotech startup success. The capital requirements
are still overwhelming large. However, VC follows where there are proven nexuses of activity.
By creating a legitimate innovation ecosystem in the Midwest, Indiana will no longer be a
flyover state for investors. This still leaves the regulatory challenges. However, this is an ideal
opportunity for further federal partnership. This isn’t just a case of us or other regions needing
more VC activity. It’s a case of multiple stakeholders rallying to make the biotech
commercialization process faster, cheaper and thus more attractive to investment.

Complementary efforts by other critical Indiana life sciences entities who are testifying today,
including the Indiana University Launch Accelerator for Biosciences, who is leveraging
significant philanthropic support to dive into Indiana labs and pull vital biotech innovations into
higher TRLs, and BioCrossroads, who is engaging and supporting Indiana’s biotech sector, are
demonstrating that progress builds on momentum. Capitalizing on the work of BioWorks,
IULAB, BioCrossroads, and others, Governor Braun recently announced an unprecedented $1
billion investment in Indiana life sciences over the next ten years.

BioWorks, through our many partners across Indiana, is helping de-risk early-stage science,
expanding access to critical infrastructure, and attracting private investment that might otherwise
bypass nascent markets. We are creating a replicable model of foundation-setting that will enable
biotech innovations to get out of the lab and turn into the small businesses we need. Through
continued federal support, partnership, and alignment, groundbreaking discoveries can be
translated into new companies, high-quality jobs, and globally competitive industries rooted in
communities across the country.

Recognizing the potential for federal partnership, there are already grassroots efforts underway.
BioWorks is leading a working group of the biotechnology-related EDA Tech Hubs to share data,
best practices, and exemplary programs. These regional hubs are located in the Midwest or other
burgeoning regions and thus share similar innovation challenges and opportunities. Leveraging
the power of our federal programs, we are working together to support our communities’ startups
and industry and collectively maximize the impact of our programs. With further federal support,
we can do so much more, driving the nation’s global dominance in biotechnology


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