From Lab to Launch by Qualio

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

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

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

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

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

**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

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

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

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

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