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TitreDateDurée
Labor of love with Laurie & John Masiello, co-founders of Predictive Monitor10 Nov 202500:25:52

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

Music by keldez

Rural India to Silicon Valley: an entrepreneur's journey with Mohan Uttarwar, co-founder & CEO of 1Cell.AI27 Oct 202500:29:38

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

Music by keldez

Special episode! Digging into Qualio's 2025 quality trends report26 Mar 202500:15:53

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

Music by keldez

Expanding Med Device Distribution Internationally and in China with Andy Levien CEO at ArcScan12 May 202100:21:05

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:


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.
Music by keldez

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

Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility27 Apr 202100:17:31

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:

Music by keldez

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

Defining Quality: The Role, Responsibilities, and Industry with Laura Araujo from 4G Clinical21 Apr 202100:20:27

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:

Music by keldez

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

Lessons from Bringing New Tech to Developing Countries and Pro Basketball with Assaf Barnea, CEO of Sanara Ventures14 Apr 202100:17:56

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:

Music by keldez

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

5 Innovative Med Device Startups to Watch31 Mar 202100:09:09

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.

Music by keldez

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

Curing Incurable Diseases with Jeff Galvin of American Gene Technologies25 Mar 202100:26:03

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:

Music by keldez

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

How to Get Non-Dilutive Funding via Federal Agencies with Ram May-Ron, Partner at FreeMind Group17 Mar 202100:20:31

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:

Music by keldez

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

Awakening Millions with Brain-Computer Interfaces with Andreas Forsland, CEO of Cognixion10 Mar 202100:20:59

Imagine if Stephen Hawking couldn't communicate. The world's understanding of theoretical physics would be greatly limited. There are roughly half a billion people like Stephen Hawking who are just waiting for an awakening. They could communicate and contribute if they only had the technology to do so. 

Helping these people with either motor or cognitive limitations be able to communicate is part of the big mission of Andreas Forsland, Founder and CEO at Cognixion. 

Andreas has a robust background in hardware, software, and design. That background all converged when his mother was in the hospital struggling to communicate to healthcare providers. The idea for Cognixion was then born. 

Cognixion is a digital health startup based in Santa Barbara, California and Toronto, Ontario. Cognixion builds accessible and affordable neuroprosthetic software and wearables that use biometric sensors and machine learning in new ways to help people with complex disabilities use their face, eyes and brain as a direct control interface for mobile and augmented reality accessibility. 

Imagine controlling Alexa with your brain. Mind blown!

Cognixion is the "Tesla of Neurotech" and is recognized as a top 21 neurotech startup to watch, and is focused on scaling up the transformation of over 100 million lives and translating universal design approaches for everyone by focusing on the most challenging human interaction needs. 

Show notes:

Music by keldez

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

How to Maintain and Improve Your Quality Management While Working Remotely03 Mar 202100:22:24

Today, we're introducing a new type of episode called Quality Quick Tips.  

Periodically we'll focus on specific aspects of quality management since we love to nerd out on all things quality and compliance. Call us weird. Call us what you want, but quality management is what we love to do. And we do it well ...so why not have some fun along the way! 

Today, two of Qualio's QA experts, Kelly and Ezra talk about how to maintain and improve your quality management while working remotely. It was a conversation that they had in the midst of the COVID 19 pandemic, but it still applies today.  

As many organizations are still adjusting to a new normal of remote quality work, they cover important aspects like what questions to ask to better evaluate and prioritize tasks, the what and how to communicate about quality issues, how to manage remote audits, the importance of documentation all of these changes that are happening. Internal and external factors and a lot more. Building and improving a culture of quality at your company can be done either remote or in person, and this episode can help you show how that's done. 

Music by: keldez

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

Quality Management Fundamentals in Aerospace, Life Sciences, and Antarctica with Gene Vought from Cirris Systems24 Feb 202100:19:54

Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, especially with continuous audits from partners, but Gene Vought makes it look easy.

Gene is a quality manager at Cirris and has been with the company for over 25 years. Cirris designs manufacturers, worldwide sales, service, and technical support for cable testing equipment for manufacturers of cable assemblies, wire harnesses, custom fixtures, and other interconnection products.

Ambition and a desire to serve customers have placed cable testers in the hands of thousands of customers on every continent, even including Antarctica. People all over the world rely on Cirris when they test cables that helped drive cars, heal patients, defend soldiers and even launched satellites into space.

Gene has an impressive track record and background, and we're really excited to have the opportunity to speak with him today. I think you'll really enjoy this episode because we talk about his experience in the aerospace industry,  his experienced at Cirris and the life sciences industry and his role as a quality manager and how important that is to the success of the company.

Also kind of fun what he enjoys to do outside of work. Hope you enjoy.

Show notes:

Music by keldez

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

Mind the gap! Advancing transplantation with Tina Liedtky, President of the Transplant Diagnostics Division, Thermo Fisher Scientific12 Mar 202500:20:06

As the organ transplant list continues to grow, experts in the transplant diagnostics industry are looking for ways to address the supply and demand challenges within the field. 

New tactics, like retransplantation and xenotransplantation, and new testing methods, such as HLA testing and transplant diagnostics, are being explored to boost transplant success rates and ensure more patients get the lifesaving transplants they need. 

As President of Thermo Fisher Scientific’s transplant diagnostics division, Tina Liedtky is at the cutting edge of meeting this challenge. 

She’s also passionate about addressing health equity issues, such as ingrained biases regarding gender and race, to help bridge the transplantation gap.

Tina joined Meg for a fascinating discussion about the future of transplantation, closing 'the gap', and Thermo Fisher's recent award.

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

Improving Patient Safety at The Point of Care with Joan Melendez of Xcelrate UDI17 Feb 202100:23:27

Did you know about $6 billion is spent each year in medical device recall management?

Having a product recall is probably a medical device companies, worst nightmare, but once something gets recalled, the communication between the FDA and manufacturers and healthcare facilities, all involved in the workflow of that product ,often break down or are slow to respond. This results in patients becoming highly at risk. 

To solve this, Joan created Xcelrate UDI with a goal to improve patient safety at the point of care, by leveraging the power of the unique device identification system for medical devices and biological tissues. 

Xcelrate UDI uses innovative barcode scanning technology to capture the data required by the FDA and digitally document. The patient health record with precision and accuracy.
Joan has over 25 years building and optimizing healthcare applications specializing in perioperative, anesthesia, and trauma workflows.

She shares some great insights with us today by starting a couple of, with a big mission. And it was an 800% increase in recalls in recent years, a byproduct of companies increasingly moving faster in this space over time, there has never been a more important time than now to focus on quality and alerting and patient safety.

Show notes:

Music by keldez

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

Funding and Scaling Your Med Device Startup with Jen Baird, CEO of Fifth Eye10 Feb 202100:26:42

Getting funding and scaling a medical device business alone is challenging. But challenges don't deter entrepreneurs like Jen Baird. From being disregarded at first from VCs  simply because she was a woman, to then selling her company for $205M,  to today scaling a med device startup with a denovo FDA application, Jen has done it all! If that's not impressive enough, she takes time to write her insights as a startup CEO in her personal blog. 

Jen has founded and led multiple healthcare ventures. Her most successful company to date was Accuri Cytometers which Jen led from inception to global commercialization. She raised over $30 million in angel and venture capital financing, developed a product and achieved more than $12 million in annual sales in just five years. In 2011, Accuri was sold to Becton Dickinson for $205 million, which is a 10X revenue multiple and Jen generated, or a 5X return for her investors. 

Most recently, Jen raised an $11.5 million Series A to found and build Fifth Eye, a medical device software company that detects hemodynamic status from a single streaming lead of ECG. Her career also includes stints in commercial banking, management consulting, and several other previous startups. Jen graduated at the top of her class with a master's in management, from Northwestern University's Kellogg graduate school of management and earned a BA in organizational psychology from the University of Michigan. 

For everyone who's listening and in the trenches of building a life sciences company, Jen has been there many times and has had some incredible exits. 

I hope you enjoy listening and learning from her wisdom and experience. 

Show notes:

Music by keldez 
Jen's Photo credit Leisa Thompson

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

Reducing Patient and Nurse Injuries with Charleen Solomon from AriseQ202 Feb 202100:23:36

Did you know nurses are required to turn and change bed-bound patients every two hours?  The primary reason for this protocol is to help patients avoid pressure ulcers. At first glance, that seems like a straightforward and quick task. But it's actually quite a challenge, especially when nurses are short-handed. The traditional approach of turning patients is time consuming and prone to injuring nurses. 

The problem has serious financial healthcare costs as well with $250 billion spent each year on nursing injuries and pressure ulcers. 

Charleen Solomon, a nurse herself, thought of a solution one day when her sweater got caught in the door of her car. Her back was aching from turning a hospice patient that day and her 2nd shift was about to start when she had a lightning moment of inspiration to what would lead to her Q2 Solution. 

Charleen shares her journey from prototyping with fellow nurses, selling her house to have capital, seeking investment (and being rejected 200 times), to finding the right manufacturer, to a very successful product today with contracts with some of the biggest in healthcare. 

She knew the product worked from first-hand experience. Her tenacity, purpose, and gratitude are inspiring for any entrepreneur starting their own life science company. 

Notes:


Music by keldez

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

Lessons from Building an Open Source Quality Community with Gill Berry27 Jan 202100:27:57

Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded PerCen Technologies in response to challenges she felt were not addressed in Healthcare. It’s aim is to use scientific knowledge and the latest technologies to compliment clinical evidence based practice. PerCen Technologies is supported by the first national Health Innovation Hub of Ireland. 

We love seeing healthcare innovation coming out of Ireland, so we had to talk to Gill.  ;) 

Gill shares her takeaways after co-founding one of the first open source efforts in response to the Covid19 pandemic, the Open Source ventilator project and the Open Source Volunteers Extended network. She managed over 1,000 STEM  professional volunteers, academic institutions, SME’s and Multi-National’s and facilitated 30 projects with a transfer of knowledge and skills. 

It’s amazing what can be accomplished when we network, open source ideas, and collaborate together. Gillian’s story and lessons learned about the power of a network are certainly inspiring and applicable today.

Enjoy!

Show notes

Music by keldez

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

How AI is Revolutionizing Healthcare Products and Access with Sam Dribin20 Jan 202100:21:46

For the first time in healthcare, human ambition and technology are starting to intersect and AI is one of the main drivers. Listen in on this episode with Sam Dribin to learn about how AI is evolving to improve healthcare results. 

 Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support radiology.

Sam has a diverse background in technology including Biotech software development with expertise in the technical issues facing healthcare and life science companies and laboratories.

For the last five years, he’s been on the forefront evolving artificial intelligence with solutions that are focused on AI-based mammography to improve cancer detection. 

We’ve known Sam and CureMetrix for some time as a customer of Qualio, but today he shares his insight into how AI can impact healthcare such as reducing false-positives and increasing access to healthcare everywhere.

Show notes: 

Music:
keldez

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

Unlock Funding with IP and Focusing Your Purpose. The inspiring story behind HAI Solutions with Nick Perrenoud.13 Jan 202100:24:51

The story behind HAI Solutions is so inspiring and similar to many life science entrepreneurs who start their companies after personal (and occasionally tragic) experiences.

Nick Perrenoud is one of those entrepreneurs. He's the co-founder of HAI Solutions and led the development and patent for a solution to protect patients from the accidental or negligent contamination of IV anesthesia medications.

Nick learned the importance of protecting patients with sterile IVs, not only as a nurse anesthetist, but also when caring for his adopted son who required IVs for seven years and spent nearly three years in the hospital to, to central line infections. 

He shares many useful insights for any medical device entrepreneur such as how securing patents has helped with fundraising, focusing on your purpose, and being patient-driven. 

Enjoy!


Show notes: 

Music:
keldez

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

Spearheading the Life Sciences Industry with Claire Bonaci from Microsoft 06 Jan 202100:23:50

Listen to this chat between Qualio CEO, Robert Fenton and Claire Bonaci from Microsoft about how the life science industry is evolving.  We cover a wide of topics and trends based on her expertise and how she aspires to inspire young women interested in STEM and leadership roles.


Guest Bio:
Claire currently serves as Sr. Director of the Pharma sub vertical of the US Health & Life Sciences department at Microsoft. She works in partnership with US life science companies, pharma, and health organizations to create innovative Microsoft solutions specific to the company’s issues affecting their patients and their business.

She brings with her an expertise in the clinical trial and pharmaceutical industry, having been a global study lead on oncology clinical trials at a large pharmaceutical company prior to joining Microsoft. She has deep understanding of the clinical trial value chain and the complex nuances that biotechnology and life science companies experience. She is passionate about the many services and innovations Microsoft has to offer to reduce time to market for new drugs and provide better outcomes to patients.

Claire is also the producer and host of the Confessions of Health Geeks podcast, an industry focused podcast on the biggest trends and pain points in health and life sciences. Claire also has a passion for inspiring young women to be interested in STEM and leadership roles in STEM related fields. 


Show notes: 


Music by keldez

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

Global Opportunities from Starting a Med Device Company in a Pandemic with Meow-Ludo. 30 Dec 202000:21:38

Our guest today is Meow-Ludo. He’s an emerging technology evangelist and Chief Scientific Officer at Moth Diagnostics, a company formed in response to the covid pandemic. 

Meow has a background in solving problems using biotechnology and helped found the biohacker movement in Australia. This culminated in the establishment of BioFoundry, Australia's first open access molecular biology lab, with Moth Dx co-founder Adrian Pearce.

Meow has also run for federal parliament with the science party and flux party, advocating for data driven policy and technological improvements to democracy. He is perhaps most well known for one of the world's first cyborg law cases, fighting for the right to use an implanted travel card in his hand that gained worldwide attention.

Lots of takeaways from today’s show. One in particular about having a global mindset. Hope you enjoy. 

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

Giving back to those on the Frontlines of Healthcare with Robert Fenton and Mark Ryle22 Dec 202000:43:29

2020 has been an unprecedented year. In times like these, mission-driven companies should challenge themselves to stay focused on their immediate goals while not losing sight of their bigger vision. In an effort to reinforce our mission and demonstrate our values, Qualio is committing to what we call 1% For All Life. Starting this year, Qualio will donate 1% of our annual revenue to improving healthcare access for vulnerable populations.

Qualio's mission is to enable organizations to launch and scale life-saving products. While this supports our core belief that everyone deserves to live a long, happy, and healthy life, we are now expanding our mission by supporting organizations that ensure underserved communities receive the healthcare they need. 

Increasing the quantity and quality of treatment options does little to help those who cannot easily access the existing healthcare system. I saw this first hand while working as a pharmacist in large urban centers, rural communities, and drug addiction services in Ireland's largest prison. It became clear to me that the ability to access quality healthcare has an enormous impact on people's lives, and that we all have an opportunity to make a difference here.

After months of living through a global pandemic, we feel privileged to be able to give something to those that need better healthcare access. Here is where our donations will go in 2020:

To all our wonderful teammates, customers, and partners - thank you from the bottom of our heart for making all of this possible.


Show notes:

Music by keldez

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

From Hippie to Med School to Entrepreneur with Dr. Hana Solomon, MD16 Dec 202000:19:34

If you have a nose, you should check out this episode.

Dr. Hana Solomon, MD shares her journey from hippie to single-mother to med school to entrepreneur. She's the founder of BeWell Health and inventor of Nasopure, the most comfortable nose wash in the world.

She shares her wisdom to avoid "stupid business mistakes" such as acquiring the right type of patent for your product (e.g., design vs. utility patent)  and being financially braver to go bigger sooner.

Dr. Hana talks about little things, each of us can do to improve our health. Also at the end, she kindly offers a coupon code to get a discount on her nose wash product.

Guest bio:
Dr. Hana Solomon, MD graduated from the University of Missouri Columbia School of Medicine in 1986 and completed the university's pediatric residency program in 1989. For 20 years Dr. Hana has practiced pediatrics at the Solomon Family Medical Clinic in Columbia, Missouri.

Her articles have been published in the Wall Street Journal, Medscape's webmd.com, About.com, Natural Apathy Digest and other health-related publications. Dr. Hana started BeWell Health in January, 2001. The company's flagship product, Dr. Hana's Nasopure nasal wash systems have helped millions to maintain nasal and sinus health naturally.

Links:

Music by keldez

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

The predictive power of biomarkers with Mark Roskey, CSO of Quanterix11 Feb 202500:16:55

As more preventative approaches to health are set to take center stage, some diseases can’t be prevented but can be managed more proactively. Blood-based biomarkers, such as p-tau217, hold great promise for earlier, more proactive detection and monitoring of diseases such as Alzheimer’s, and it’s here that Quanterix plays a critical role.

Their Simoa digital health platform serves as the backbone for the majority of p-tau217 tests on the market today, reducing reliance on costly PET and CSF testing and streamlining the diagnostic journey for Alzheimer’s disease.

Mark has been a leader in the biotech space for over 2 decades, with a string of leadership roles before he joined Quanterix in 2014 and became their CSO in 2022.

Mark joined Meg on From Lab To Launch to discuss the exciting predictive power of biomarker technology, and what the future holds for spotting and treating diseases early.

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

4x cancer survivor to CEO/Founder. The power of patient-led solutions with Cinde Dolphin.09 Dec 202000:21:23

What if the next time you went to the receive healthcare at a clinic or hospital, you came out with an idea to improve the patient's experience? That's what Cinde Dolphin did.

She's a 4x cancer survivor and CEO/founder of KILI Medical Drain Carrier. Between surgeries, she went to a dollar store to begin prototyping a device that would improve her experience as a patient.

Her nurse team loved it. Her doctors loved it. What followed was her journey into entrepreneurship in life sciences.

Cinde shares her with story, which is an inspiring one, from patient to founder.

Guest Bio:
Cinde Dolphin is the CEO and founder of KILI Medical Drain Carrier. She's also a member of the Academy of Oncology Nurse and Patient Navigators. She likes to challenge the status quo. She's a four time cancer survivor and she's been through nine surgeries. 
Her malady was a catalyst to create a simple, yet elegant solution to manage post-op drains and improve upon the 50 year old conventional protocol, which involved attaching drains using safety pins. 
Cinde enjoys speaking to the medical community, as well as to the general public about the importance of patient innovations or from their experience, the insights they gain, create solutions, which help others with the same medical issues that they suffered. These former patients are determined that others will not have to contend with the problems that they had, and she believes truly in paying it forward. 

Links: 

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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

Insights from Biotech Pioneer and Investor Ron Shigeta03 Dec 202000:22:49

Ron Shigeta is a serial entrepreneur & startup biotech pioneer. He’s also been a serial founder having run startups in AI drug tox detection & synthetic biology. Ron holds a PhD in Chemistry from Princeton University, where he spent his academic research career focusing on secondary metabolic biosynthesis, diabetes, genomics, genetics, structural biology and systems biology.  

As an entrepreneur, investor, scientist, and mentor Ron shares some great insights to anyone who wants to contribute to life sciences. 

Some takeaways:

  • Starting a biotech company today is much easier and cheaper than at any other time
  • Advice to founders to gain relevancy and trust from investors and get funding
  • Biotech investments now are where software was 2+ decades ago

Links:

Music by keldez



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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Trailer24 Nov 202000:00:45

Welcome to the From Lab to Launch podcast by Qualio. Discover inspiring stories from those on the front lines of life sciences. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls.

Episodes are about 30 minutes and published each week on all major podcast players. 

Tune in and leave inspired to bring your life saving products to the world.

If you want to be a guest on the show, fill out this brief application: https://forms.gle/Yp7uKnSXTCPtTdRcA.

Music credit:

  • Keldez

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

Advancing Pathology using AI with Joseph Mossel Co-founder & CEO of Ibex19 Nov 202400:28:37

In this episode of From Lab to Launch by Qualio we interview Joseph Mossel, CEO and co-founder of Ibex Medical Analytics. Joseph shares his journey from computer science to leading a transformative AI-driven company in pathology. Founded in 2016, Ibex aims to provide accurate, timely, and personalized cancer diagnoses using AI technology. Joseph discusses the challenges and insights from deploying AI in clinical settings, the importance of partnerships, and the company's vision for the next few years. Tune in to learn how Ibex's innovations are reshaping cancer diagnostics and making a significant impact on patient outcomes.

https://ibex-ai.com/ 

https://www.linkedin.com/in/yossimossel/ 


00:00 Introduction to the Podcast
00:26 Meet Joseph Mossel, CEO of Ibex
01:14 The Founding and Vision of Ibex
05:59 Ibex's AI Technology and Its Impact
07:41 Challenges and Overcoming Them
09:54 AI in Cancer Diagnostics
15:12 Future of AI in Pathology
17:15 Partnerships and Collaborations
19:58 Advice for Labs and Entrepreneurs
23:29 Ensuring AI Reliability and Quality
25:48 Fun and Final Thoughts

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

The future of clinical trials with Sarah Englert, Senior Director of Innovation & Program Management at Thermo Fisher Scientific21 Oct 202400:25:45

Earlier this year, Thermo Fisher Scientific opened its first clinical trial Innovation Lab in Center Valley, Pa., designed to foster a culture of collaboration by providing a dedicated space for industry partners to come together, share ideas and co-create solutions for the industry’s biggest challenges. 

The global clinical trial market was valued at over $80 billion in 2023, and that’s projected to grow by 6.5% every year until 2030. But alleviating innovation silos is the only way to move the clinical trial industry forward and tackle its current challenges. 

And it’s here that Senior Director of Innovation & Program Management Sarah Englert's mission is focused...

https://www.linkedin.com/in/sarah-blake-englert-70557421/

https://www.thermofisher.com/us/en/home.html

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

The future of protein manufacturing with Kerry Love, co-founder of Sunflower Therapeutics07 Oct 202400:19:55

Today we welcome Kerry Love, the co-founder of Massachusetts-based (and wonderfully named) Sunflower Therapeutics. Established in 2018, Sunflower is dedicated to advancing biologic medicines and enhancing global vaccine accessibility through cutting-edge protein manufacturing technologies.

As a women-owned organization, Sunflower has a stellar team of scientists and engineers renowned for their expertise in perfusion fermentation, purification process development, biopharmaceutical manufacturing, and quality management. Their mission-driven approach revolves around simplifying bioproduction complexities with their modular, automated, and fully integrated platform. This transformative technology empowers innovators to swiftly manufacture critical biologic products precisely where they're needed most.



https://www.linkedin.com/in/kerry-love-1a197811/ 

https://sunflowertx.com/ 

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

Revolutionizing kidney health with Salvatore Viscomi, CEO of Carna Health24 Sep 202400:25:38

Carna Health is focused on applying technology to revolutionize kidney care by unlocking the early detection and management of chronic kidney disease (CKD). They provide clinical-grade software as medical devices that deliver instant health metrics, such as creatinine, eGFR, and uACR levels, from small patient samples. Their platform integrates with existing healthcare systems and electronic healthcare records, promoting proactive and patient-centric care underpinned by accurate, real-time patient data.

CEO and co-founder Salvatore Viscomi, MD, joined Meg to talk about the Carna Health mission, where current kidney care is going wrong, and what the future holds for kidney patients.

More about Dr. Viscomi:

Dr. Viscomi is the CEO and co-founder of Carna Health, a Boston-based SaMD company focused on revolutionizing how chronic kidney disease is spotted and treated early.


https://carna.health/ 

https://www.linkedin.com/in/salvatore-viscomi/

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

Pioneering in Genetic Research with Dr. Jonathan Hill of Wasatch Biolabs10 Sep 202400:29:47

Dr. Jonathan Hill, VP of Science and Technology and co-founder of Wasatch Biolabs joins the podcast today to talk about the future of genetic testing technology.

Dr. Hill shares his journey in genetics, starting from his undergraduate days to co-founding multiple biotech companies. They discuss the cutting-edge genomic and bioinformatic methods being developed at Wasatch Biolabs, including targeted DNA methylation sequencing and its significant implications for personalized medicine and early disease detection. Dr. Hill also elaborates on the integration of lab work and data analysis in genetic research, partnerships in diagnostic advancements, the role of AI in the future of genetic testing, and the importance of quality management in product development. Additionally, he speaks about the challenges faced in implementing these technologies and how they are being addressed. The conversation concludes with Dr. Hill's vision for the future of genetic testing and his approach to preparing students for the industry’s evolving landscape.

00:00 Introduction to the Episode
00:25 Meet Dr. Jonathan Hill
01:45 Dr. Hill's Journey in Genetics
03:27 Understanding DNA Methylation Sequencing
06:15 Applications in Personalized Medicine
15:06 Challenges in Implementing Assays
18:40 Future of Genetic Testing Technology
23:14 Importance of Collaborations and Partnerships
26:58 Fun and Personal Insights
27:43 Conclusion and Contact Information

More about Dr. Hill:
Dr. Hill is the VP of Science and Technology and a co-founder of Wasatch BioLabs, a biotechnology company committed to transforming the field of diagnostics. The company delivers reliable laboratory services, offering transparent testing and accurate results for biotech firms, patients, and research institutions.

https://www.wasatchbiolabs.com/ 

https://www.linkedin.com/in/jonathon-t-hill/ 

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

Sepsis Detection Made Rapid and Accurate with Dr. Rolland Carlson CEO of Immunexpress29 Aug 202400:28:34

Join us with guest Dr. Rolland Carlson, CEO of Immunexpress to talk about the transformative work happening in sepsis diagnosis.

Dr. Carlson discusses the importance of rapid sepsis diagnosis. The episode covers challenges faced during product development, regulatory achievements, and future plans for sepsis diagnostics. Dr. Carlson also shares advice on ensuring product quality and navigating FDA clearances.

00:00 Introduction to From Lab to Launch
00:25 Meet Dr. Rolland Carlson, CEO of Immunexpress
01:31 Challenges and Innovations in Sepsis Diagnosis
03:01 Impact of COVID-19 on Clinical Trials
04:17 The Vision Behind Septicite Rapid
05:17 Technical Insights into Sepsis Diagnosis
14:00 Regulatory Achievements and Quality Management
16:58 Integrating Septicite Rapid in Clinical Workflows
24:00 Future Innovations in Sepsis Diagnostics
25:34 A Personal Note from Dr. Carlson
26:29 Conclusion and Farewell


https://immunexpress.com/ 

https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/ 

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

Continuing Early Cancer Detection with David Suhy Co-founder of Earli12 Aug 202400:29:34

In this episode we bring David Suhy, co-founder and Chief Scientific Officer at Earli back to the podcast. David shares the heartfelt founding story of Earli, the company's mission to make cancer a benign experience by catching it early, and their unique approach utilizing synthetic promoters for early cancer detection and treatment.

He discusses challenges faced in clinical trials, the importance of quality and safety in research, and provides advice for other startups in life sciences. David also talks about the recent advancements at Earli, their funding journey, and offers valuable insights on navigating the dynamic field of scientific innovation.

The episode concludes with a light-hearted discussion about David's passion for making pizzas in his backyard wood-fired oven.

00:00 Introduction and Podcast Overview
00:37 Guest Introduction: David Suhy from Earli
01:19 The Founding Story of Earli
04:24 Earli's Unique Approach to Cancer Detection
06:33 Challenges and Innovations in Cancer Treatment
10:06 Clinical Trials and Lessons Learned
15:30 Funding and Financial Strategies
18:56 Future Plans and Developments
21:14 Quality and Safety in Research
23:43 Advice for Entrepreneurs and Scientists
25:27 Fun Facts and Closing Remarks

https://www.earli.com 

https://www.linkedin.com/in/davidsuhy/ 

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

The magic formula of population-based predictive analytics with Dr. Terrance Govender, VP of Medical Affairs at ClinIntell13 Oct 202500:18:16

Today on From Lab To Launch, we’re excited to welcome Dr. Terrance Govender, the VP of Medical Affairs at ClinIntell.

ClinIntell, based in Tampa, Florida, supports healthcare executives and leaders in accurately capturing the true severity of their inpatient population using population-based predictive analytics. 

The results for their customers? More accurate, trustworthy performance data and clinical condition reporting, that can be easily shared and used to drive continuous improvement activities.

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

Innovative Approaches to Medication-Assisted Addiction Treatment with Dr. Joshua Lee31 Jul 202400:32:29

This episode we're joined by Dr. Joshua Lee, a clinician, researcher, and professor specializing in medication-assisted treatment (MAT) for alcohol and opioid use disorders. Dr. Lee discusses his extensive research on medications such as naltrexone and buprenorphine, their significance in treating substance use disorders, and the transformative potential of telemedicine platforms like Oar Health. He highlights the underutilization of effective medications in primary care, the barriers to accessibility, and the enduring stigma associated with addiction. The conversation also touches on emerging trends and the future of addiction treatment.

Dr. Lee's Bio
Joshua specializes in medication-assisted treatment of alcohol and opioid use disorders. He conducts clinical trials and treats patients struggling with addiction as a primary care physician. As a Professor at NYU Grossman School of Medicine, he leads the Addiction Medicine Fellowship and conducts research focused on justice and community outcomes. 

https://www.oarhealth.com/
https://med.nyu.edu/faculty/joshua-d-lee
https://x.com/drjoshuadlee

00:00 Introduction and Podcast Overview
00:38 Introducing Dr. Joshua Lee
01:20 Clinical Trials and Medication Insights
03:46 Challenges in Alcohol and Opioid Treatment
08:50 Telemedicine and Its Impact
11:59 Addressing Misconceptions and Barriers
19:35 Success Rates and Future Trends
30:14 Fun Personal Question

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

Combatting the Opioid Crisis with Technology with Justin Zenanko CEO of SynerFuse16 Jul 202400:21:10

In this episode we're joined by Justin Zenanko, CEO and co-founder of SynerFuse to discuss groundbreaking technique combining spinal fusion and direct nerve stimulation to treat chronic low back pain, aiming to eliminate the need for postoperative opioids. Justin delves into the inspiration behind the technology, its clinical results, and the company's approach to quality and regulatory management. He also provides insights on raising funds in a competitive market and the potential future applications of SynerFuse's technology.

Justin's Bio
Justin Zenanko, CPA, MDiv, is the president, CEO, and co-founder of SynerFuse, Inc., a Minnesota-based company innovating the spine industry with its integrated approach which combines spinal fusion and direct nerve stimulation to address the chronic low back pain that is unaddressed in about 40% of the 500,000 traditional spinal fusion surgeries that take place annually in the US alone. The SynerFuse approach aims to eliminate the post-surgical need for addictive opioids. 

Link to SynerFuse website: https://www.synerfuse.com/

00:00 Introduction and Welcome
00:41 Meet Justin Zinenko: From CPA to MedTech Innovator
03:16 The Birth of SynerFuse: Combining Spinal Fusion with Nerve Stimulation
05:29 Clinical Results and Patient Success Stories
08:46 Quality and Regulatory Approaches in MedTech
10:29 Future Applications and Innovations
14:59 Advice for Aspiring Entrepreneurs
17:51 Fun Insights and Closing Remarks

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

Epilepsy Breakthroughs and Beyond with Jason Tardio and Toshiya Nishi from Ovid Therapeutics28 Jun 202400:23:58

**UPDATE** Since this episode was recorded, Takeda announced the results of the phase 3 soticlestat trials, which did not meet their primary endpoints.

We welcome Dr. Toshiya Nishi and Jason Tardio from Ovid Therapeutics. Dr. Nishi, with over 20 years of experience in drug discovery, discusses his role in the development of soticlestat and ongoing research on KCC2 activators for neurological disorders. Jason Tardio, Ovid's COO, shares insights on the company's focus on rare neurological disorders, including epilepsy, and its strategic initiatives for advancing treatments. Listen to their inspiring journey from the inception of Ovid Therapeutics to its current breakthroughs, and their perspectives on fostering a quality-driven and risk-tolerant culture in drug development.



https://ovidrx.com/


00:00 Introduction and Welcome
00:40 Meet the Guests: Dr. Toshiya Nishi and Jason Tardia
02:04 The Journey of Ovid Therapeutics
03:58 Discovering Saticklistat: A Serendipitous Breakthrough
08:35 Strategic Initiatives and Future Directions
13:48 Collaboration and Culture at Ovid Therapeutics
17:38 Ensuring Quality in Drug Development
21:50 Personal Insights and Closing Remarks
24:07 Conclusion and Farewell

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

Pioneering Viral Diagnostics with Dr. Nigel McCracken COO of Virax Biolabs18 Jun 202400:26:07

Join us as we discuss viral diagnostics and pharmacology with Dr. Nigel McCracken, Chief Operating Officer of Virax Biolabs. Dr. McCracken shares his expertise in drug development, focusing on oncology and infectious diseases, and discusses the company's pioneering work in detecting immune responses and diagnosing viral diseases. The conversation covers the impact of technology advancements in the past decade, the introduction of the Immune Select Profile in the Virax Immune T Cell Diagnostic Platform, and the evolving landscape of viral diagnostics post-COVID-19. Dr. McCracken also shares insights on maintaining high-quality standards in R&D and offers advice for aspiring professionals in the fields of drug development and diagnostics.

https://www.viraxbiolabs.com/

00:00 Introduction and Welcome
00:40 Meet Dr. Nigel McCracken
01:29 Nigel's Journey in Pharmacology
05:08 Innovations at Virax Biolabs
09:05 Impact of COVID-19 on Viral Diagnostics
12:53 Ensuring Quality in Diagnostics
16:37 Future Trends in Viral Diagnostics
20:20 Advice for Aspiring Researchers
23:13 Nigel's Personal Insights
24:20 Conclusion and Farewell

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

Lowering Anxiety using Smart Weight Technology with Marna Pacheco Founder of CapeAble Weighted Products30 May 202400:22:37

Join us in this inspiring episode of From Lab to Launch as we sit down with Marna Pacheco, the innovative founder of CapeAble Weighted Products. Marna turned a personal challenge into a pioneering enterprise that integrates fashion with function, providing therapeutic weighted products to those in need, from individuals with autism to medical patients across various settings.

You'll learn:

  • Marna shares her journey from designing a unique weighted cape for her daughter to founding CapeAble.
  • Insight into the smartweight technology that sets CapeAble products apart in efficacy and style.
  • Discussion on how CapeAble's products are making a significant impact in the medical field through non-pharmaceutical interventions.
  • CapeAble's expansion into medical applications.

https://www.capeable.com/

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

Transforming Neuropsychiatric Therapeutics with Dr. Sam Clark, CEO of Terran Biosciences15 May 202400:23:29

This episode of the From Lab to Launch podcast, brought to you by Qualio, features Dr. Sam Clark, CEO of Terran Biosciences. With a background in neurosciences from MIT and an MD and PhD from Columbia University, Dr. Clark shares his journey from academia to leading a pioneering company in neuropsychiatric therapeutics. He discusses the challenges and innovations in the development and supply of GMP psychedelic compounds, highlighting how these substances are making significant strides toward transforming mental health treatment.

Dr. Clark also explores Terran Biosciences' approach to overcoming drug development hurdles, emphasizing quality management and patent strategies to ensure the delivery of affordable, effective treatments. His insights offer a glimpse into the future of psychedelics in mainstream medicine and the broader implications for treating various disorders beyond mental health.

https://terranbiosciences.com/ 

Dr. Sam Clark's LinkedIn: https://www.linkedin.com/in/sam-clark-md-phd-133139199/ 


00:00 Welcome to From Lab to Launch!
00:40 Introducing Dr. Sam Clark and Terran Biosciences
01:23 Dr. Clark's Journey: From Academia to Neuropsychiatric Therapeutics
02:48 The Renaissance of Psychedelic Therapeutics
04:36 Challenges and Innovations in Drug Development
08:36 Quality Management at Terran Biosciences
10:23 The Future of Psychedelics in Mainstream Medicine
12:46 Expanding Beyond Neuropsychiatry: Terran's Broader Impact
14:02 Navigating Innovation and Ethics in Patenting
17:48 Advice for Aspiring Scientists and Innovators
20:42 Dr. Clark's Personal Inspirations and Closing Thoughts
22:21 How to Follow Dr. Clark and Terran Biosciences
23:00 Wrapping Up and How to Engage with From Lab to Launch

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

Treating Neurodegenerative Diseases with Rob Etherington, CEO of Clene Nanomedicine24 Apr 202400:26:09

Listen in on our conversation with Rob Etherington, CEO of Clene Nanomedicine, a company pioneering nanotherapeutics for neurodegenerative diseases like ALS, multiple sclerosis, and Parkinson's.

Rob discusses Clene's unique approach to improve mitochondrial function through a novel nanotherapeutic called CNM-au8, which has shown promising outcomes in clinical trials. He highlights the challenges in drug development, including funding and FDA approval processes, and underscores the importance of resilience, continuous learning, and strategic partnerships in advancing biotech innovations. The episode also touches on Rob's personal philosophy on leadership and the importance of women in leadership roles.

https://clene.com/
https://www.linkedin.com/in/rob-etherington-431718/ 

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

Saving Lives by Cancer Prediction and Detection with Dan Lunz, CEO of Previse27 Mar 202400:25:17

Today we interview with Dan Lunz, co-founder and CEO of Previse, an innovative medical solutions company specializing in cancer prevention and early detection. Lunz talks about his journey from being a Marine to leading a pioneering medical company. He discusses the scientific technology behind Previse, which started out as research for predicting esophageal cancer in patients with Barrett's esophagus. Lunz also shares about the company's current fundraising activities, commercialization plans, compliance with regulatory standards, and long-term goals for cancer detection. He hints at exciting future announcements about Previse's new developments, tests, and pipeline technologies.

https://previsedx.com/ 

https://www.linkedin.com/in/danlunz/ 


00:43 The Journey of Previse: Aiming for Early Cancer Detection
05:24 The Previse Technology: A New Approach to Cancer Detection
07:45 The Impact of Previse in the Medical Field
10:13 Fundraising and the Future of Previse
14:51 Navigating the Regulatory Landscape
18:02 Balancing Innovation and Compliance
21:15 Long-term Goals and Future Developments

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

The Power of Effective Writing in the Life Sciences Industry with Pam Hurley, Founder of Hurley Write13 Mar 202400:22:59

In this episode we welcome Pam Hurley, the founder and president of Hurley Write Inc., who specializes in professional writing and communication training. Pam discusses how proper writing can lead to more effective professional communication in life sciences, and how precision and confidence in writing can help professionals achieve their goals. 

She highlights the importance of clear and concise communication, especially in regulatory submissions, research publications, or internal communications. Delving into the common writing challenges, Pam mentions the lack of understanding of the outcome and disregarding reader's readability and understanding as some. She concludes by highlighting the crucial role of effective writing in business and organizational decision-making and shares tips for enhancing writing skills.

LinkedIn.com/in/Hurleywrite

https://www.hurleywrite.com/ 


00:40 Meet the Guest: Pam Hurley
02:14 Pam's Journey into Professional Writing
04:06 The Impact of Effective Writing in Life Sciences
08:15 Common Writing Challenges in Professional Settings
16:16 The Role of Writing in Decision Making
17:50 The Future of Writing: AI and Beyond
19:12 Pam's Favorite Writers and Reading Habits
21:42 Closing Remarks and Contact Information

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

Advancing Cancer Diagnostics with Mark McDonough, CEO of Chromacode26 Feb 202400:20:35

In this episode we interview Mark McDonough, the CEO of ChromaCode. The episode explores McDonough's journey to ChromaCode, from his early career as a naval officer to his roles at various medical and diagnostic companies. Under McDonough's leadership, ChromaCode has excelled in creating a high-definition PCR platform which enables fast, accurate, and affordable cancer diagnosis. The platform is particularly beneficial as it requires less patient tissue, provides rapid results, and has a lower cost than traditional diagnostic methods. McDonough also discusses the importance of partnerships in their go-to-market strategy and shared his insights on hiring and team development in today's competitive market. Looking ahead, ChromaCode expects to become a leader in developing innovative products for disease diagnosis, with a focus on patient-centered outcomes.

https://www.chromacode.com/ 

https://www.linkedin.com/in/mark-mcdonough-b1055216/ 


00:00 Introduction to the Podcast
00:40 Meet the Guest: Mark McDonough, CEO of ChromaCode
01:47 Mark's Journey to ChromaCode
06:05 Insights on Leadership and Building High Performing Teams
08:10 ChromaCode's Innovative Approach to PCR Testing
10:36 ChromaCode's Contribution to Precision Medicine
13:50 The Importance of Partnerships in ChromaCode's Strategy
16:33 Future Prospects for ChromaCode
18:27 Getting to Know Mark: Personal Interests
19:13 Closing Remarks and Contact Information

About Mark McDonough
Mark has over 25 years of experience helping build high growth HealthCare organizations. He is passionate about his team, his customers, and the patients that he and they are privileged to help serve. He most recently was the CEO of Pierian (now Velsera) which he led to a successful sale to Summa Equity, a private equity firm, in 2022. Prior to Pierian, he led CombiMatrix for five years, culminating in a sale to Invitae in 2017. Over his career, Mark has held various executive and commercial positions, and served as a US Naval Officer.

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

The proof is in the protein with Dr. Jonathan Usuka, CEO of Sapient29 Sep 202500:16:44

If you’ve been following From Lab to Launch for a while, you may remember a previous conversation with Sapient’s Chief Scientific Officer, Dr. Mo Jain, a couple years back. We’re thrilled to build on that conversation with Dr. Jonathan Usuka, the CEO of Sapient. 

Sapient is one of the largest capacity biomarker discovery labs in the world, and their mission is to accelerate drug development and improve patient outcomes through biomarker-guided therapeutics. By combining high-resolution biomolecular data with advanced computational approaches, Sapient is helping sponsors and researchers unlock new therapeutic targets and navigate complex biology at unprecedented speed and scale.

With more than 25 years of experience at the intersection of business, science, and technology, Jonathan has led innovation strategies across drug development, diagnostics, and AI-driven discovery. From streamlining therapeutic pipelines to pushing the boundaries of integrated diagnostics, his work is helping reshape how biopharma organizations bring life-changing therapies to patients.

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

Unlocking Longevity using ESS60 with Chris Burres Co-Founder of MyVitalC23 Jan 202400:27:15

Join us as we dive into the world of groundbreaking scientific discovery with Chris Burres, a renowned Chief Scientist. In this episode, Chris unveils the mysteries of a unique, soccer ball-shaped molecule that could be the key to unlocking secrets of health and longevity.

Discover how this extraordinary molecule, small enough to hold any atom from the periodic chart, might revolutionize our understanding of wellness and aging. Chris shares insights into the foundational principles that drive this innovative research and the potential life-changing benefits it holds.

Furthermore, hear firsthand the compelling success stories and testimonials from users of "MyVitalC." These narratives not only shed light on the practical implications of Chris's work but also illustrate the profound impact this discovery could have on our daily lives.

Whether you're a science enthusiast, a health and wellness aficionado, or simply curious about the latest in scientific breakthroughs, this episode promises to offer a fascinating blend of scientific exploration and real-world applications. Tune in to get a glimpse into the future of health science with Chris Burres guiding the way.

https://www.myvitalc.com/

More about Chris Burres
Chris Burres is the Co-Founder of MyVital-C as well as the co-owner of SES Research Inc. and he runs a podcast about SEO marketing which is really popular. Chris is also a health expert specializing in ESS60, a Nobel Prize-winning molecule with exceptional antioxidant properties. He’s been on numerous health and wellness podcasts sharing how ESS60 can revolutionize health and wellness.

https://www.linkedin.com/in/chrisburres

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

Innovative Lab Spaces and Cleanrooms on Demand with Azzur Group's Ravi Samavedam09 Jan 202400:18:05

In this episode of "From Lab to Launch" by Qualio, Meg welcomes Ravi Samavedam, the Chief Innovation Officer of Azzur Group. With over two decades of experience as a seasoned biochemical engineer, Ravi is a driving force behind Azzur's groundbreaking approach to lab spaces and cleanrooms.

Discussion Highlights:
Ravi delves into Azzur Group's evolution since its formation in 2010, emphasizing its roots in equipment and facilities for the biopharma industry. The conversation unfolds with a focus on Azzur's revolutionary "Cleanrooms on Demand" concept, drawing parallels to Legos for its flexibility and efficiency. Ravi explains the benefits of licensing lab space, offering a hybrid model that accelerates time-to-market for biotech and pharma companies.

The conversation explores how Azzur ensures GMP compliance in multiproduct facilities, emphasizing quality systems and strict agreements. Ravi elaborates on Azzur's one-stop-shop approach, providing a range of services under one roof, from testing labs to consulting. The discussion touches on the lab space shortage, both pre- and post-COVID, and the potential implications for the industry.

Ravi shares insights into emerging trends, expressing particular excitement for the potential decentralization of cell therapy manufacturing near hospitals. The episode concludes on a lighter note as Ravi reveals his personal interest in geography.

Connect and Learn More:
For those intrigued by Azzur Group's innovative solutions, virtual facility tours and more content can be found on their YouTube channel. Additionally, the Azzur website offers a wealth of information, including recent articles and client testimonials. Listeners are encouraged to explore further at Azzur Group's Website and YouTube Channel.

This episode provides a comprehensive understanding of Azzur Group's transformative contributions to the biotech and pharma sectors, offering a glimpse into the future of flexible and efficient lab spaces.

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

Transforming Healthcare Access: Navigating Challenges and Unlocking Data with Particle Health's Troy Bannister07 Dec 202300:23:21

In this episode, Meg is joined by Troy Bannister, the co-founder and chief strategy officer at Particle Health. Particle Health is a company revolutionizing the accessibility, sharing, and utilization of healthcare data to simplify navigation for patients and healthcare providers. Troy shares his inspiration behind starting Particle Health and dives into the challenges and strategies the company employed to navigate regulatory compliance and foster successful partnerships in the highly regulated healthcare industry.

The conversation delves into the importance of caring passionately about the mission, overcoming setbacks, and the role of partnerships in achieving Particle Health's mission. Troy provides insights into the evolving landscape of healthcare data sharing, emphasizing the potential for emerging trends and technologies to democratize healthcare data, leading to increased innovation and benefits for individuals.

This episode provides valuable insights into the challenges, strategies, and future trends in healthcare data access and innovation, making it a must-listen for those interested in the intersection of technology and healthcare. Connect with Troy on LinkedIn for further discussions and updates.

https://www.particlehealth.com/ 

https://www.linkedin.com/in/troy-bannister-259a3235/ 

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

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