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

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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

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

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