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By Steven Surdez

AMPEL Biosolutions (AMPEL), located in Charlottesville, Virginia is a leading personalized precision medicine company developing tools that can help autoimmune and inflammatory disease patients improve their quality of life. AMPEL is one of the exciting companies that have emerged from the Charlottesville (CVille) biohub clustered around the University of Virginia (UVA).

AMPEL’s Genomic Platform (AGP) is a revolutionary blend of bioinformatic tools, RNA analytics, and machine learning algorithms (AI/ML) that analyzes gene expression. AGP helps drug developers better identify, analyze, predict and prioritize targets for drug development while also empowering healthcare providers to better serve their patients. AMPEL testing tools can help providers better assess disease status and tailor treatments to a patient’s unique, dynamic genomic profile.

The company just recently announced the development of CovGENE, a new blood test that quickly determines whether a COVID-19 patient will have a mild, moderate, or severe outcome; this groundbreaking new blood test will help determine the necessary treatments and medicines to reduce the chances of hospitalization due to COVID-19. AMPEL also has two new product launches on the horizon in late 2022/2023 and a deep, promising product pipeline.

These are exciting times for the AMPEL team. BioBuzz thought it was a great time to catch up with AMPEL’s Co-founder, President, and Chief Scientific Officer Dr. Amrie Grammer to discuss her founder’s journey and AMPEL’s promising future.

Tell our audience about your career journey and how you came to found AMPEL?

AMPEL was founded in 2013, but the planning for the company really started in the 2000s while I was at the National Institutes of Health (NIH) with my Co-founder Dr. Peter Lipsky, who is now AMPEL’s CEO/CMO. This was around when the human genome was being sequenced. Dr. Lipsky and I have been colleagues for over 30 years. 

I was exposed to the NIH’s Office of Entrepreneurship at that time and this really opened my mind to taking the science I’d been working on my whole career and transforming it into a mission to bring a commercial product to the market. That’s where AMPEL really started.

Back in the early 2000s, the research community didn’t really know how many genes there were, and by the middle of that decade we knew there were around 20,000 genes. And recently, in the last six months, the Human Genome Project was fully completed. 

When we started AMPEL we quickly realized that the majority of the analytic tools based on the human genome were focused on oncology. So, when we had the information from the human genome project and greater computational power was available to us, we decided to go beyond oncology and develop a platform focused on autoimmune and inflammatory diseases. 

The biggest reason that drug trials fail is that there’s a percentage of patients in the trial that don’t have the capacity to respond to the drug being tested. So, AMPEL is asking and answering the question: Is the pathway present that the drug is targeting?

We looked at all 20,000 genes and grouped the genes following an extensive R&D process and over 80 peer-reviewed publications. We then identified the pathways that the cells are using to communicate with each other. We initially built our platform with Lupus in mind and validated it with pharma collaborations from target screening and preclinical models all the way through Phase 3 clinical trials and real time selection or enrichment during the entry phase of clinical trials. 

Fast forward to today and we are a rapidly growing precision medicine company with a platform technology in RNA analytics and gene expression (what happens when the gene “opens up” and genes get turned off and on) and we’ve validated it in revenue-generating collaborations with 15 pharmaceutical companies so far. We also have about 10 other potential products in our pipeline. For drug developers, our platform provides an end-to-end solution.

Our platform essentially helps companies make faster, more informed drug development decisions while also helping physicians find the right drug for the right person at the right time.

How does AMPEL’s Genomic Platform work?

What gives us the potential to rapidly bring all these products to market is our platform technology, AGP®. This platform hosts the tools that look at what happens when your body gets a signal and your DNA opens up and each of these 20,000 genes get switched on and off. We use our RNA analytical tools to identify all 20,000 genes that are off and on; we separate these into cell type, function, and pathway and compare them to our database of more than 15,000 autoimmune and normal patient gene expression profiles. We use AMPEL’s artificial intelligence and machine learning capabilities to make a prediction about the severity of a patient’s disease and what cell types and pathways are present, providing decision support for treatments physicians are prescribing every day.

AGP® is technology agnostic, meaning it can work with any customer’s setup for analyzing RNA such as RNASeq, PCR, Nanostring and other standard technologies that detect RNAs. AMPEL’s genomic platform does not require manufacturing like some other precision medicine kits out there on the market. Our precision medicine products are ordered by a doctor like any standard test and blood is drawn into a standard, off the shelf tube designed for RNA isolation. It’s then sent to the Research DX/Pacific Bio lab. The results, which are a summary of the RNAs present in the sample, then get uploaded to our platform via the cloud. Our AI and machine learning algorithms then generate a report that gets sent back to the doctor.   

AMPEL’s Precision Medicine report provides decision support to physicians and patients for evidence-based drug prescription decisions.

Why is this important? 

We all know prescribing the right drugs can be trial and error; it’s an iterative process. For those with minor illnesses, the consequences of getting the wrong drug is likely minor. But for those suffering from Lupus, for example, this trial and error process can lead to organ damage and be life threatening.

It takes Lupus patients about five years on average to get the right drug regimen, if they do at all. Better evidence-based and faster decisions about drug regimens and can mitigate flare ups and limit the worst impacts of Lupus.

AMPEL’s genomic platform can help Lupus patients, and potentially other autoimmune and inflammatory disease patients in the future, get the right drug at the right time much more quickly than before. 

What are some of the exciting, upcoming milestones for AMPEL and what are your target markets?

We just recently announced a validation study for CovGENE®, a groundbreaking blood test for COVID-19 patients that can predict disease severity. This is a validation study in collaboration with my alma mater, the University of Virginia. We hope to co-develop this product and bring it to the market by early 2023.

We are also very excited about several upcoming product launches. 

We anticipate launching our first product, LuGENE this fall. LuGENE is a CLIA-validated blood test for Lupus that can help understand where a patient is in their disease progress. LuGENE is the culmination of 30 years of passionate Lupus research by myself and Dr. Lipsky and our scientific team.

After that we anticipate launching DermaGENE, a skin biopsy test for Psoriasis, Atopic Dermatitis, Scleroderma, and Lupus.

AMPEL employs about 25 staff at the moment. We’re always looking for excellent talent and we will be recruiting across the country.

Our primary customers for these products will be pharma companies, large hospital systems and physicians, in addition to concierge medical practices that might be interested in a potential AMPEL blood test called WellGENE®, which will help individuals proactively measure their level of inflammation and help monitor their health. We hope to launch WellGENE® within the next three years.

How could advancements in precision medicine like AGP® change the healthcare system for the better?

The bottom line is that platforms like AGP® and other precision medicine tools will increase the likelihood of clinical trial success and help doctors identify the right, stable drug regimen for their patients more efficiently and quickly.  

Streamlining the drug development process and preventing disease progression will not only improve patient’s lives but will also drive down healthcare costs and reduce the burden on the system overall.

How has the Charlottesville, Virginia life sciences ecosystem supported AMPEL’s journey to where it is today?

The Virginia and Charlottesville life sciences community has been extremely supportive. 

Successful life sciences company leaders from the region have been very generous with their time helping entrepreneurs like myself and emerging companies like AMPEL. CVilleBioHub, of which AMPEL is a founding member, Venture Central and Virginia Bio are all critical parts of the hub’s support system.

Expanding out from there, I feel strongly that Maryland, DC and Virginia are stronger when we work together. We’ve worked with BioHealth Innovation, the Office of Entrepreneurship at the NIH and the Coalition for 21st Century Medicine in Arlington, Virginia. (AMPEL was elected to the Coalition in 2022.) The Society for International Business Fellows, which is out of Atlanta but has a strong presence in Virginia, has provided mentorship and business support to us as well.

We founded AMPEL in Charlottesville purposefully. We are very proud to be a home grown Virginia company. 

This is a very strong life sciences hub that’s getting stronger and is being more widely recognized across the country. We are thrilled to be a contributing part of this growing ecosystem.

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