What was behind your transition from a history degree to immunology and ultimately to becoming the CEO of Biological Dynamics?
My journey began with a fascination for the development of things, be it historical events or biological processes. My initial research focused on gastrointestinal tract hormones, exploring their roles as neurotransmitters and their impact beyond just the pancreas and stomach. This curiosity led me to the Salk Institute in San Diego, California, where I delved into immunology alongside Nobel Prize winners like Francis Crick and Gerry Edelman. At Harvard Medical School, I collaborated with Nobel laureate Baruj Benacerraf, furthering my understanding of the immune system. My career has been a narrative of unfolding important biological stories, such as the exploration of genetics through tools like sequencing and PCR and the integration of these discoveries into clinical care. These experiences have been instrumental in shaping my role at Biological Dynamics, where we deliver an understanding of exosome mysteries and their clinical applications.
Could you explain the historical background and the technological evolution of Biological Dynamics?
Biological Dynamics was founded on technology developed in Mike Heller's lab at UC San Diego (UCSD). This technology, based on Alternating Current Electrokinetics (ACE), aimed to replace centrifuges and gels for isolating biomolecules in fluids. In 2010, with the initial papers published, UCSD licensed the technology to Biological Dynamics for clinical and basic applications. The company's early years focused on refining the technology and understanding how to manipulate the amplitude and frequency of the current to alter the collection of materials. Around 2015-2016, our focus shifted to studying cell-free DNA in various biological fluids. I briefly left the company—but remained on the board—for a leadership role at the public company Natera around 2016-2017. I found significant progress when I later returned to Biological Dynamics to helm the company as CEO. The team discovered that by tweaking the ACE technology, they could isolate extracellular vesicles, particularly exosomes, which carry rich information from their origin cells. Using our proprietary ExoVerit platform, we can enrich these exosomes and analyze their DNA, RNA, and proteins.
This breakthrough led to the development of cost-effective, rapid methods for disease detection, including a panel for early-stage pancreatic cancer detection with over 90% sensitivity and early work in Alzheimer's disease diagnosis using plasma exosomes.
We know that the diagnosis of pancreatic cancer is especially problematic. Can you elaborate on your progress in early-stage diagnosis?
Our primary focus at Biological Dynamics is on early-stage cancer diagnostics, particularly for pancreatic and other cancers, where early detection drastically improves life expectancy. For instance, detecting pancreatic cancer in stage one offers an 80% chance of a five-year survival, compared to just 10% if detected later.
Our goal is to harness the information from exosomes to make significant advances in early detection, which is beneficial for patients and healthcare providers and aligns with our business strategy. We have published several peer-reviewed papers on early-stage pancreatic cancer, demonstrating the potential of our proprietary technology in changing the prognosis of this traditionally hard-to-diagnose cancer.
What we have developed at Biological Dynamics is a simple, automated tool that, within a few hours, allows the study of exosomes and their relationship with early stages of cancer cell development. Our technology could be deployed in hospital labs, for example, and could reduce the sample-to-result time from days to hours. This tool has significant implications beyond just cancer research and diagnostic assay development. For instance, brain tumors and neurodegenerative diseases like Alzheimer's can now be studied through blood tests, thanks to the ability of exosomes to cross the blood-brain barrier. This capability opens up new avenues for studying brain-related conditions and developing liquid biopsies that inform physician decision-making in a less invasive, more effective manner.
When can patients expect to access your technology for cancer diagnostics?
We are currently distributing our ExoVerita Pro instrument in research settings, with a wider launch planned for 2024. Our platform enriches exosomes for further research, aiding in understanding their role in various cancers.
Can you discuss the company's plans for expansion and funding strategies?
Biological Dynamics has been fortunate to receive substantial investment from Dr. Irwin Jacobs, a co-founder and former chairman of Qualcomm and retired UCSD professor. As we launch the ExoVerita Pro instrument and generate revenue, we plan to attract additional investment from strategic and venture partners. This funding will help us expand our instrument sales and further develop assays and applications for our technology. Our strategy involves proving the utility of exosomes in both research and clinical settings, demonstrating a complete solution from discovery to clinical application.
What is the primary challenge your company aims to overcome in the next few years?
Our foremost challenge in the coming years is to solidify the role of exosomes in early disease detection and other clinical applications. While we have conducted several public, peer-reviewed validation studies, there is a need for more comprehensive data to establish the clinical validity of exosomes across various disease states. Our goal is to demonstrate the efficacy of our tool in isolating and analyzing exosomes, thereby proving their critical role in research and in early diagnosis, potentially altering the course of disease management and patient outcomes.
