Inside Caleo Biotechnologies’ Founder & CEO’s Mission to Transform Drug Development From Montgomery County, MD

With a PhD in biomedical engineering and more than 14 years of experience in disease modeling and tissue engineering, Samaneh Kamali, CEO and co-founder of Caleo Biotechnologies, has spent her career working at the intersection of science and application. Her focus has been on developing human-relevant systems to better understand complex diseases, particularly inflammatory and fibrotic conditions.

Over her years of working in science, she noticed a persistent and costly gap in drug development. Too often, therapies that show promise in early preclinical testing fail later in clinical trials. The reason, she explains, is not always the science itself, but the models used to test it.

“Existing systems don’t always capture patient biology with enough accuracy,” Kamali notes. “That disconnect can lead to decisions based on incomplete or misleading data.”

Caleo Biotechnologies was founded to close that gap. Instead of building another incremental model, the company is focused on developing what it calls decision-grade systems, which are platforms designed to more closely emulate real patient biology and generate data that directly informs clinical pipelines.

A Platform Built for Precision

At the core of Caleo Biotechnologies’ work is its Organ-Dish platform, which uses patient-derived, immune-competent 3D models to evaluate therapies earlier and with to evaluate therapies earlier with stronger alignment to clinical outcomes.. The company’s goal is clear: help drug development teams make better and more accurate decisions before entering the clinic. By standardizing these complex biological systems into a scalable, microplate-based workflow, Caleo Biotechnologies is positioning itself as a critical partner for drug developers looking to reduce risk and improve patient outcomes.

That approach is already gaining traction. The company has moved beyond early validation and is now actively engaging with pharmaceutical and biotech partners. “Our focus is centered on execution, growing partnerships, broadening application areas, and consistently delivering data that supports real development decisions,” Kamali says. Additionally, the company has recently received funding and support from TEDCO, MSCRF and Montgomery County’s Technology Innovation Fund. Kamali has also been invited to present at multiple pitch events and forums across the DMV region.

Operating at the Cutting Edge of Life Sciences

For a company operating at the cutting edge of life sciences location is key, and Kamali found a strong fit in Montgomery County.

“What prompted our move to Montgomery County was the strength of its biotech ecosystem and the practical support it offers to early-stage companies,” explains Kamali. “The region brings together access to talent, proximity to leading institutions, and a strong network for collaboration and hiring.”

Equally important was the practical infrastructure available to early-stage companies. From lab space at the Germantown Innovation Center to funding opportunities like the Montgomery County Technology Innovation Fund, the region offered Kamali the resources needed to grow her company quickly from concept to execution. Organizations like MCEDC have also played a role in helping Kamali build connections across the ecosystem through introductions, increasing visibility, and opening doors to strategic partnerships. According to Kamali, that connectivity has been valuable as she and her team continue to build collaborations and grow the company. Today, CaleoBio maintains a growing presence in Montgomery County, with a core team of three supporting laboratory operations locally and additional team members across Maryland focused on business and commercialization efforts.

Leading By Example

As Kamali continues to scale her company, she believes that as a CEO in a highly technical space, visibility and showing others what’s possible without compromising your vision is crucial. “Seeing women lead companies, make strategic decisions, and operate at the intersection of science and commercialization helps normalize that path for others,” explains Kamali. “Beyond that, it’s about being accessible, sharing experiences, supporting others coming up in the field, and creating environments where strong, diverse talent can grow and lead.”

According to Kamali, Montgomery County has long been supportive of women founders. “The County has been intentional about supporting diverse founders through targeted programs and resources, which helps address some of the traditional barriers to access,” notes Kamali. “In practice, the opportunity is to build and scale companies within a supportive and connected environment, while contributing to a more diverse biotech ecosystem.”

From its base here Montgomery County, Maryland, Caleo Biotechnologiesis not only scaling its platform and partnerships but also contributing to a broader life sciences ecosystem where innovation and collaboration drive progress and help create technologies making a real-world impact.