From Lab to Launch by Qualio

Today we’re catching up with Dr. Heather Underwood, CEO of EvoEndo. EvoEndo recently completed an $8.4 million Series A financing round on the heels of 510(k) FDA clearance in early 2022. We first spoke with Dr. Underwood in June of 2021. In this episode, we chart a course through her accomplishments, lessons learned through the FDA clearance process, working with CROs, and hear firsthand about th...

Today we speak with developer turned health-tech founder Gulé Sheikh. We discuss her innovations and entrepreneurship at a leading tele-health company, her experience in technology, and the importance of representation.  In the early 20th century, women led computer programming and made huge contributions to the field. From Ada Lovelace’s algorithm and Grace Hopper’s pioneering work on COBOL to Wo...

Non-invasive ventilation (NIV) is a life-saving tool used throughout ICUs to manage respiratory failure. The traditional form of non-invasive ventilation, a tight-fitting mask placed over a patient's nose and mouth, comes with significant drawbacks. What if there was an option to treat patients with respiratory failure that improved outcomes while reducing the likelihood for invasive intubati...

The average cost of developing a new drug is estimated at over $2 billion. Roughly 10% of pre-clinical drugs ever make it to human trials. And each year, $50 billion is “misspent” in the trial & error method of research and development. An AI-enabled “decision engine” could help researchers find cures to rare diseases, bridge the translational gap between animal models to human systems, and mo...

What if you started a company like Roche (est. in 1896) from the ground up? How would you approach drug development differently given enabling technology available today? That's the question Diego Rey and the other founders of Endpoint Health asked.  Diego Rey is a co-founder and Chief Scientific Office of Endpoint Health, which is flipping the traditional drug development model on its head w...

What’s the background of a Noble Prize winner in chemistry, where are the next innovations in science, and how do you say “asymmetric organocatalysis”? Find out the answers on this week's episode as we chat with David MacMillan.  From food production to industrial manufacturing, catalysts are all around us and play an outsized role in our lives. It’s estimated that 90% of all commercially pro...

Today, we have Lyn Yaffe joining us. Lyn is the Co-founder, Chairman, and CEO of EPR-Technologies. EPR Technologies is a biomedical spinoff of the Safar Center for Resuscitation Research, University of Pittsburgh. EPR Technologies is committed to the preservation of human life through rapid profound hypothermia, by pursuing techniques and patented products for emergency preservation and resuscitat...

Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn’t limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting...

Adopting EU MDR is either going to make or break some regulatory teams. With some major updates to EU MDR in the past couple years, the need for innovation and efficiency has never been greater for med device companies.  We love hearing stories where experts in different industries come together to solve a massive problem and unlock potential for life-saving products. That's the story behind...

One of the primary issue plaguing R&D for new drugs is the experimental discovery (trial & error) process. Success rate is very low and capital intensive and takes a long time to market. NOVA’s mission is to instill an engineering mindset into drug R&D (model, simulate, predict) to help companies design more targeted trials. Imagine having 78,000 trial patients in a phase II clinical t...

Stress is part of life but a dysregulated stress system should not be. Unfortunately, many children experience stress so frequently that it becomes toxic. This not only impairs their executive brain function but also creates a dysregulated stress system which makes them magnitudes more likely to suffer from health problems later in life. To make matters worse, a dysregulated stress system is not e...

Today's show we chat with Courtney Brown from Australia about her role as CEO of The Millennial Group  since its founding in 2008. She shares her perspective on how to harness remote/digital talent to achieve lasting change. She also shares her work as a Contributing Expert of Digital Health Technical Advisory Group for the World Health Organization. With decades of experience across customer...

Did you know that hearing loss is one of the largest areas of unmet need in medicine? It affects approximately 466 million people worldwide, including 48 million people in the United States.  Today's guest Laurence Reid, CEO of Decibel Therapeutics dives deeper into meeting that unmet need. Decibel has architected a whole platform to restore hearing and balance loss. With several treatments i...

Today's episode we explore the ins and outs of market access strategy with Dinesh Kabaleeswaran,  Sr. Dir. of Insights and Advisory at MMIT. Learn more about how to improve market access strategy with better data, payer and buyer insights, and what the medical device side of life sciences can learn from pharma's approach and speed to market access.  About Dinesh: Dinesh Kabaleeswaran lea...

We're excited to have, from all the way in Switzerland, Tanja Dowe the CEO of Debiopharm Innovation Fund on the show. Tanja has a background in microbiology and biochemistry and is an expert in business models and market requirements for life science companies.  We’re going to learn from her experience in acquisitions, investments, and commercialization of life science companies across Europe...

Today we're talking to Robert Niichel the CEO of SmartTab, which is creating ingestible capsules for drug delivery of biologics and targeted medications. Think of a pill you take that tells medications where to deliver their remedy. It's like an Uber driver or GPS for drug therapy.  About SmartTab: SmartTab is developing an advanced platform of ingestible capsules for oral drug delivery...

Today's guest is Ian Chan the co-founder and executive chairman of Abpro. Abpro is improving the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies. Ian explains how their technology is "future proofing" antibodies.  Recently, Abpro announced its ABP 310 COVID antibody retains neutralization activity against the SARS-CoV-2 Omicron va...

This past year—much like the year before—has put increasing pressure on professionals working in life sciences and healthcare. We hear the inspiring and sobering stories from those on the front lines of life sciences who are making a real difference to save lives.  To celebrate the strong tailwinds behind us and the people who helped pave this road to success – notably amid an ongoing pandemic – Q...

You may have heard the adage, "an ounce of prevention is worth a pound of cure." Today's guest Joseph Mocanu, PhD shares how companies and entrepreneurs across the world are overcoming barriers to bring an ounce of prevention to emerging markets and rural communities. His company, Verge HealthTech Fund focuses on seed stage healthcare technology companies relevant to emerging market...

It's not hard to find someone who has been affected by diabetes and the rising cost of insulin. In fact, today's guest says that 1 in 10 people in the US today have diabetes and that figure is expected to rise to 1 in 5 by the end of the decade.  That means there's going to be a large increase in the demand of insulin and therefore production.  Cameron Owen co-founder and CEO of rBi...

Most likely everyone reading this has been affected by cancer or knows someone who has had cancer.  Using natural cell degradation, today's guest and the team at Arvinas are treating previously undruggable diseases like cancer and Parkinson's. Their goal is to cure cancer or at a minimum, reduce it to a disease where you take your medication and continue living a full life without the te...

Today's guest, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the medical device industry as a design engineer and regulatory affairs executive. John is an entrepreneur and expert in medical device design and commercialization. Prior to creating Kapstone, John was a founding member of Altiva Corporation, a spinal implant company that was sold to Ex...

Today's guest, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell isolation and recovery. It's a field that few are as passionate about and dedicated to improving as much as Andrew and VitaCyte.  Insights from the discussion :  VitaCyte was started to better understand the mechanism by which enzymes work cooperatively to connective tissue and...

Typically, it takes several months for third-parties and consultants in the life sciences industry to get data back to pharma companies with payer research. Today's guest is Baiju Aurora, CEO of Market Access Transformation (MAT) is shrinking getting payer response research to a few days.  Baiju has led the MAT team for more than five years and their first product, Rapid Payer Response, provi...

To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the end patient to the investors benefit.  A Harvard study on quality found that a “company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.”  In this epi...