Precision Medicine: Why Delaware Is A Burgeoning Hub for it

ORIGINAL SOURCE: Delaware Business Times

Delaware has long been recognized as a leader in the life sciences, with major institutions such as the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) making their home in the First State.

In the emerging field of precision medicine — which “takes into account individual variability in genes, environment and lifestyle for each person” to treat and prevent disease, according to the Precision Medicine Initiative — Delaware has also earned recognition. In October 2023, the U.S. Department of Commerce’s Economic Development Administration Tech Hubs program designated the Greater Philadelphia Region Precision Medicine Tech Hub — a region that includes Delaware.

Beyond the importance of the regional hub announcement, Delaware already has a robust record in the development of precision medicine at all levels — from research and development to manufacturing protocols to clinical education and the discipline’s application in practice at medical facilities in Delaware. Read on for three stories of Delaware companies leading the way at the intersection of precision medicine research and technology.

BioCurie
Named in honor of scientist Marie Curie, Wilmington-based startup BioCurie is developing the first AI-driven software platform to transform cell, gene and nucleic acid therapy (CGT) production. These advanced therapies are difficult and costly to develop and manufacture, creating a major pain point in the biopharmaceutical industry. BioCurie’s patent-pending software platform will enable biopharma companies and contract manufacturers to predict optimal manufacturing conditions — drastically improving the speed, quality and cost of these lifesaving therapies.

Dr. Irene Rombel, CEO and co-founder, saw the unmet need in the industry, and seized the opportunity to solve it by harnessing data and AI before it was “cool.” She joined forces with Chief Scientist and Co-Founder Professor Richard Braatz from MIT, a world leader in AI for biomanufacturing, who shared her vision. With the help of funding from an Encouraging Growth, Development and Expansion (EDGE) Grant from the State of Delaware, they developed the first prototype of their software platform. BioCurie is currently in contract with a top 25 pharmaceutical company and will launch the first AI-driven software product for gene therapy production in 2025.

“We are transforming the current labor-intensive hit-or-miss approach to CGT manufacturing to a new data-driven paradigm, with the goal of ‘right first time,’” says Rombel. “Patients’ lives depend on it.”

Rombel believes that Delaware is a prime spot for the company to prosper. “Delaware has the distinct advantage of being a small business-friendly state where we have access to key decision makers,” says Rombel. “Our location also gives us the benefit of proximity to NIIMBL, the largest consortium for innovating biomanufacturing, as well as being part of the greater Philadelphia region, home to many CGT companies and future customers.”

In addition, BioCurie can tap into talent at the University of Delaware (UD) and Delaware Technical Community College. Rombel is committed to giving back and recently participated in a popular workshop on “AI’s Role in Transforming Science and Innovation” at UD. “By working closely with academia,” she says, “we will help ensure that we’re inspiring and training our future workforce for exciting careers in the TechBio industry.”

ChristianaCare’s Gene Editing Institute

Having worked in the precision medicine space for more than three decades, Dr. Eric Kmiec at ChristianaCare’s Gene Editing Institute has seen the concept of gene editing morph from merely a concept into clinical reality. As the Executive Director and Chief Scientific Officer, Kmiec believes that the gene editing tool known as CRISPR technology — originally used to help sickle cell anemia patients — has the potential for a much broader application in oncology and even cardiovascular disease.

“All patients are different genetically and we know that cancer functions at the genetic level. We have to target the gene to solve the problem,” explains Kmiec.

ChristianaCare’s patient-centric approach, addressing health disparities among different ethnic and socioeconomic groups, wants all patients regardless of their background to have access to CRISPR technology. The Institute is particularly focused on using CRISPR technology for head, neck, esophageal and lung cancer. These cancers disproportionately affect those who smoke, use tobacco and drink alcohol excessively. While cancer treatments such as immunotherapy, radiation and chemotherapy are effective, they are harsh and some patients even decide
to halt treatment.

Chemotherapy resistance is generally controlled, at least partially, at the genetic level. By exploiting what CRISPR does naturally, which is in effect cut or splice DNA, scientists can disable certain cancer-specific genes that are preventing available therapies from working effectively. This approach can enhance the effect of standard-of-care chemotherapies so that lower doses can be given.

Kmiec believes that having the Gene Editing Institute embedded within the ChristianaCare health system in Delaware is a great advantage for its research. In fact, the National Institutes of Health often include Delaware as a model in population health studies, especially in health disparities, because its population diversity and healthcare-access issues are reflective of broader national concerns.

“We don’t only want to be using CRISPR technology on people who can afford it. We want everyone to have access to it,” Kmiec says. “We’ve gone through the hype of when CRISPR was first introduced, but now with the emergence of CRISPR being used in vivo, directly delivering it into tumors, it is an exciting time to be researching it.”

Innovative Precision Health

Clinical trial recruitment is a challenging and costly endeavor for pharmaceutical companies as they hope to bring a drug to market. But Newark-based startup Innovative Precision Health is hoping to streamline that process for pharmaceutical companies and research organizations.

The company has a database of 160 million patients in the U.S., and of that number, 60 million have seen a doctor within the last two years. By analyzing the database, the company is able to pinpoint which patients meet very stringent clinical trial criteria.

“We use a fine-tooth comb to streamline the process, by using AI, which results in saving the pharmaceutical companies money and time. The process before was time-consuming, as researchers often spent long periods analyzing doctors’ notes, which can now be done in seconds using our complex algorithms and tools,” says Sury Gupta, the vice president of engineering at Innovative Precision Health. The company is focused primarily on qualifying patients for trials in the neurology, cardiology and gastroenterology space.

Gupta believes Delaware is a prime spot for the startup. “It is on the up and up, and we are part of the ecosystem that the University of Delaware has built around the south side. Our location in the [FinTech Innovation Hub] building is critical and it is a very supportive community, plus we have access to talented data scientists at the university.”