In this episode of From Lab To Launch, Meg is joined by Dr. Les Enterline, Senior VP and Global Head of Functional Service Partnerships at PPD, part of Thermo Fisher Scientific.

With decades of experience across clinical research, Les is helping redefine how biopharma companies structure and scale their development teams through what’s known as the FSP model: a flexible outsourcing approach that’s gaining traction as sponsors face increasing pressure to deliver trials faster, more efficiently, and with more adaptive designs.

As clinical complexity grows and internal teams get stretched thin, FSPs are helping organizations scale specialized expertise while maintaining oversight, quality, and operational control. Under Les’ leadership, PPD has become one of the industry leaders in offering hybrid and fit-for-purpose models that blend the best of traditional CRO services with strategic resourcing.

In today’s conversation, we’ll explore how functional partnerships are evolving, how sponsors are rethinking outsourcing to meet modern challenges, and where the future of trial delivery is headed.

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

Nora Khaldi is a mathematician with a Ph.D. in Molecular Evolution and Bioinformatics, and her years of research have focused primarily on protein evolution and comparative genomics.

Throughout her career, Nora’s ambition has been to disrupt the status quo in areas that have been void of technology by introducing new ways of thinking, big data, and new algorithms.

In 2014, she founded Nuritas, a Dublin-based biotech company that counts U2’s Bono and The Edge among its investors. Nuritas has combined life science, nature and artificial intelligence to develop its unique Magnifier Discovery platform and to identify, unlock, clinically test and patent peptides, turning them into powerful and precise ingredients that elevate natural efficacy and make our everyday products healthier, safer, greener and more efficacious.

nuritas.com

linkedin.com/company/nuritas/

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

On today’s episode, we’re changing course a little. Instead of interviewing a life science company leader, we’re speaking to someone who empowers them and helps their companies to grow!

Elizabeth Chabe is the CEO of High Touch Group, a marketing consultancy firm specializing in life science clients. Her science marketing playbook, The Giant’s Ladder, is a #1 bestseller, and her work has been featured in The New York Times, Entrepreneur and CNBC, among others.

[email protected]

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

Today we’re excited to welcome Navin Dewagan, the CEO of Boston-based Digital Health Solutions.

Digital Health Solutions acts as the innovation partner for medical device and healthcare firms. Navin and his team help healthcare solution providers accelerate their medical products to market by leveraging years of domain expertise in IoT and cloud development, cybersecurity, mobile development and embedded software development for healthcare applications. 

Digital Health Solutions offers end-to-end software product expertise, from ideation to design & development, re-engineering, testing and verification & validation. Plus, with a range of services that’s close to our heart at Qualio, the team offers comprehensive quality and compliance support to help customers meet the complex regulatory demands of standards like IEC 62304, ISO 13485 and ISO 14971.

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

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

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

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

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

In this episode, Meg speaks to Ilya Burkov, the Global Head of Healthcare & Lifesciences Growth at Nebius AI.

Nebius AI’s goal is simple: to provide the cloud infrastructure that will be the groundwork of the AI revolution we can all see happening in front of us. Nebius’ suite of tools helps life science companies gather data and then train, fine-tune and launch their AI models into the world.

Ilya’s role is to oversee and drive the adoption of this cloud AI technology within the life science and healthcare sectors, placing him at the cutting edge of this next wave of industry change.

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

When we think of medical devices and how they’re built, 3D printing isn’t necessarily the first thing that comes to mind. But Boston Micro Fabrication is at the cutting edge of an exciting development in how life-saving devices are prototyped and created. 

With the news that the FDA is pivoting away from animal testing towards 3D organoids, and with the growing need to produce miniature, intricate and high-quality devices at speed, BMF’s nanometer-precise microArch 3D printing technology is opening the door to new possibilities - allowing the rapid production of equipment like stents, endoscopes, and even needles. A BMF-built catheter recently featured in a nature.com scientific report, delivering 183x higher drug concentrations for liver cancer treatment than would otherwise have been possible.

We were thrilled to talk to the CEO of BMF, John Kawola, about the company's exciting work.

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