From Lab to Launch by Qualio – Détails, épisodes et analyse

Today, we're thrilled to talk to husband-and-wife dream team, Laurie & John Masiello. The Masiellos have been launching and scaling life science companies together since 1984. After merging their first company, Masy BioServices, with a North Carolina CDMO in 2021, the Masiellos struck again, forming Predictive Monitor in 2022. 

Their debut product, OverShield, combines IoT sensor technology with AI and data analysis to offer a powerful early warning system for controlled GMP chambers, from freezers to cold and stability rooms. The couple’s mission centers around harnessing Pharma 4.0 technology to maximize equipment uptime, improve operational efficiency, and protect life-saving biopharmaceutical products.

Hear Laurie & John walk us through their incredible shared journey and industry insights as they prepare to celebrate their 50th wedding anniversary.

https://www.linkedin.com/company/predictive-monitor-llc/

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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Today we’re talking to Mohan Uttarwar, an accomplished entrepreneur and innovator with extensive expertise in life sciences and precision diagnostics, as he walks us through his fascinating journey from an Indian village without electricity to the bleeding edge of Silicon Valley tech innovation.

Mohan's work focuses on addressing unmet needs in oncology and personalized medicine, and he’s particularly focused on the development of next-generation diagnostic tools, specifically in the areas of liquid biopsy and multi-omics. 

Based in Cupertino, California, Mohan is the co-founder and CEO of OneCell Diagnostics, now 1Cell.AI. 1Cell’s AI-powered cancer diagnostics promise 90% faster detection of cancers, and 80% more accurate therapy response plans.

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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We made a bonus episode of From Lab To Launch to mark a special occasion: the launch of Qualio's fourth annual life science quality trends report in March 2025.

Our very own Kat and Clive dug into the report and its fascinating findings to see how life science quality teams are spending their time, what they're planning for 2025, and what headaches and frustrations they're looking to conquer this year.

Join us and dive into our report - and read the full thing at reports.qualio.com!

Note: the audio in this episode has been made using artificial intelligence

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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Andy Levien, President and CEO of ArcScan talks to Robert about expanding his medical device company internationally and into China.  

ArcScan was founded in February 2007 in Golden, Colorado. Their product, the ArcScan Insight® 100 is the leading, very high frequency ultrasound device that images the entire anterior segment of the eye, including behind the iris; areas that cannot be seen with even the newest models of optical technology

And because the system is not handheld, diagnostic measurements have never been this precise. ArcScan’s many innovations have led to a number of issued and pending ArcScan patents. Due to the success of accommodating intra-ocular lenses and the ever-growing refractive surgery market, intelligent imaging and precise measurements are more necessary than ever before. 

Show notes:

• https://arcscan.com/
• https://www.linkedin.com/in/andrewlevien/ 

About Andy
Andy Levien was appointed President and CEO of ArcScan in April 2012, and currently holds this position today. Before that he served as President and Global VP Operations of Norgren and President of Norgren Fluid Controls, a pneumatics and industrial controls company. Prior to that he held SVP and General Manager roles at Emerson Electric Co., an electrical equipment  and industrial instruments manufacturer.

ArcScan was founded in February 2007 in Golden, Colorado. The original machine, the Artemis 2, was eventually rebranded and became the ArcScan Insight® 100. The ArcScan Insight® 100 is the leading, very high frequency ultrasound (VHFU) device that images the entire anterior segment of the eye, including behind the iris; areas that cannot be seen with even the newest models of optical technology. And because the system is not handheld, diagnostic measurements have never been this precise.

ArcScan’s many innovations have led to a number of issued and pending ArcScan patents. Due to the success of accommodating intraocular lenses and the ever-growing refractive surgery market, intelligent imaging and precise measurements are more necessary than ever before.

Apply to be on From Lab to Launch here.
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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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Dr. Amy Beckley, founder and CEO of MFB Fertility and inventor of the Proov fertility test joins the show to talk about her journey as a scientist going through infertility herself to searching for answers and inventing a solution.   

Amy Beckley, had trouble conceiving for over three years, she did what many women do: saved up thousands of dollars and pursued in-vitro fertilization treatment. After being blessed with a son, Amy knew she wanted to continue to grow her family. What she didn’t know was how well she could handle the physical and emotional challenge of another round of IVF. 

With a PhD in Pharmacology and expertise in hormone signaling, she began tracking her own hormone levels at home. In doing so, she started to suspect that she had a problem with ovulation —which was causing her to lose pregnancy after pregnancy. 

Empowered by this knowledge, she went to her doctor and got a prescription for hormone supplements. With these supplements, she was able to conceive without the help of IVF, and maintain a healthy pregnancy. After her daughter was born, her mission was clear—to empower women with vital knowledge that could help in their ability to conceive. She founded MFB Fertility, Inc. and invented the Proov test in her own basement, which now allows women to confirm successful ovulation by tracking PdG in just five minutes, at home. 

Show notes:

• https://proovtest.com/
• https://www.forbes.com/sites/alicebroster/2020/07/02/air-force-invests-13-million-to-help-military-couples-conceive/?sh=2df266de4cb3
• https://www.linkedin.com/in/amybeckley/
• https://www.today.com/video/how-the-pandemic-is-impacting-family-planning-and-ivf-102026821986
• https://www.titan100.biz/amybeckley

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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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Today we're excited to have Laura Araujo, Vice President of Quality at 4G Clinical share her insight into quality management. 

4G Clinical’s focus and mission is to bring crucial medicines to those who need them faster. 4G Clinical delivers modern, flexible and validated randomization and trial supply management solutions to Pharma and CROs faster than anyone else in the world. 

Laura has over 30 years of experience in Quality Assurance and Technology, holding various positions in Software Development, Quality Assurance, Software Auditing, and Technology Management. She has had positions in, or related to, the pharmaceutical industry for 25 years, including owning and running her own consulting firm for 10 years. During our conversation today, we talk about 4G Clinical and what they have accomplished, especially during the pandemic, Laura’s experience of working as a consultant, switching career paths and entering the Quality space, and much more!

Show Notes:

• https://www.4gclinical.com/home
• Laura Araujo on LinkedIn

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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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Today we welcome Mr. Assaf Barnea to the show. He is a former pro basketball player in Europe and currently the CEO of Sanara Ventures, a healthcare innovation fund backed by Phillips and Teva Pharmaceuticals investing in digital health and medical device technologies.

Sanara invests primarily in early stage digital health and bio convergence companies. He offers his insight and outlook on bio convergence in the future.

Assaf also shares experiences as the co-founder of the World Bank’s International Finance Corporation’s Tech Emerge Initiative, which is a unique acceleration platform that connects healthcare startups from around the world with leading corporations and hospitals in emerging economies. He talks about the work done in India, Brazil, and now Africa. Truly inspiring and life-changing work. 

In his career, Mr. Barnea co-founded CardioSense, a medtech startup company, served as CEO of Kinrot Ventures spearheading its acquisition by Hutchison Water in 2012. He spearheaded business development at Mekorot, Israel’s national water company, where he oversaw the establishment of WaTech, the Entrepreneurship & Partnership Center for Water Technologies, where he received the Cleantech Group’s Innovation Hero Award.

A unique highlight in Assaf’s story is basketball. At New Jersey’s Seton Hall University he and his team won the Big East championship against Georgetown in 1991 playing against Dikembe Mutombo and Alonzo Mourning. He played professionally in Europe for years and shares some parallels between athletic prowess and entrepreneurship.

We’re excited to have him share his perspective and advice for entrepreneurs on today’s show.

Show Notes:

• www.SanaraVentures.com
• https://www.techemerge.org/
• Assaf on LinkedIn

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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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It only takes one ground-breaking MedTech startup to change a product category forever. Back in 2006, serial entrepreneur Steve Kelly partnered with MIT researchers to take an anti-bleeding gel product to market. The biodegradable gel was a significantly better option for many hemostat applications, compared to alternatives like bandages, surgical clamps, tissue adhesives, vasoconstrictors, and cauterization. Today, topical hemostatic agents are considered the most efficient, effective, and safe option to stop bleeding in many patients and conditions.

Winning medical device startups have a few factors in common, according to McKinsey research. First, they all have an idea that can provide consistently superior experiences to all users, including patients, caregivers, and clinicians. They will also “reimagine processes to dramatically reduce costs and accelerate decision making.” The most successful MedTech companies manage to get closer to the patient by providing an innovation that’s better, cheaper, safer, more convenient, or somehow just a better option.

In order to get close to the patient, MedTech startups need to achieve velocity in the early stages to provide proof-of-concept, secure funding, and demonstrate clinical safety for regulatory approval. There’s no room for mistakes or delays in a hyper-competitive market space. A strong baseline of compliance is crucial from day one to ensure there are no barriers to obtaining FDA approval or a CE Mark.

That's one of the reasons we exist. Qualio is quality management software for the life sciences ecosystem. 

1. ABLE HUMAN MOTION
2. DAY ZERO DIAGNOSTICS
3. GARWOOD MEDICAL DEVICES
4. X-COR THERAPEUTICS
5. FLATIRON HEALTH

If you can think of any other innovative companies that we should feature on from lab to launch, Let us know by filling out this form:
https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewform

See interviews and episodes on https://www.qualio.com/from-lab-to-launch-podcast.

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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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What if incurable diseases like HIV, cancer, PKU, and epithelial solid tumors were completely curable? We're closer than you might think. Really close. 

In fact, Jeff Galvin and his team at American Gene Technologies™ (AGT) have been advancing the research and application of viral vectors for several years with some incredibly exciting breakthroughs on the horizon (hint: curing HIV could be just a few years away). 

In case you didn't know already, viral vectors is a relatively new technology where you can crack open any virus, scoop out the malevolent code and replace it with code to attack the root drivers of what are today incurable diseases. Essentially this creates a "stealth bomber" benevolent virus in your body. The future of this treatment could "send radiation and chemotherapy the way of bloodletting and leeches" as Jeff says in this podcast. 

Jeff has a contagious energy for gene technology and a grand vision of the future of curing the incurable.

If you want to get a peak at how gene technology could quite literally change the world (and soon!) listen to what Jeff has to say.

Enjoy!

About Jeff Galvin

Jeff Galvin is the CEO and Founder of American Gene Technologies™ (AGT). He earned his BA degree in Economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH.

Show notes:

• Jeff's LinkedIn
• Jeff on Twitter: @jeffreygalvin
• https://www.americangene.com/
• Press Release about AGT's FDA approval to continue HIV cure program
• AGT on LinkedIn
• AGT on Twitter - @americangene
• AGT on Facebook - @amerigene
• AGT on Instagram - @americangenetechnologies

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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

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Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part is, it's all non-dilutive funding. 

For example, the NIH's Small Business Innovation Research (SBIR) program alone awards $1B each year. That's more annual funding than any VC! And that's just one of many SBIR programs available from US Federal agencies. 

Ram May-Ron, managing partner at FreeMind Consultants walks through the enormity and approachability of these federal non-dilutive programs. 

FreeMind Group helps life science organizations secure non-dilutive funding from US federal agencies and private foundations.

FreeMind started in 1999 and has grown into the largest consulting group of its kind. With experience in seeking funding from nearly all NIH Institutes, Department of Defense, NSF, FDA, BARDA, etc., as well as private foundations, they’ve helped clients garner over 1.5 billion dollars to date. Awards range from $150,000 to $150,000,000 per project. 

If funding is on your mind - you need to consider what Ram has to say here. 

Show notes:

• https://www.freemindconsultants.com/
• Ram on LinkedIn
• NIH.gov

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Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez