From Lab to Launch by Qualio

Mental health issues have been on the minds of many as athletes are under tremendous pressure to perform perfectly at the Olympics, and Filament Health is on a mission to get safe, natural psychedelics into the hands of everyone who needs them as soon as possible. 

Today's guest is Ben Lightburn, CEO and Co-Founder of Filament Health, an exclusively natural psychedelic drug development company. Ben talks about rapidly discovering and extracting natural pharmaceuticals. 

Ben is an entrepreneur specializing in the research, development, and commercialization of novel extraction technologies. He applies his background in botanical extraction to this emerging class of medicines. 

Filament Health is building a platform to support the treatment of mental health conditions through GMP-compliant and FDA-approved psychedelic extracts from lab-grown and regeneratively harvested plants. 

Key Takeaways:

• Insights on building a core team comfortable with operating in a startup environment
• Approach to patenting and clinical trial process, as well as regulations for psychedelics
• Common misconceptions about natural pharmaceuticals

Show Notes: 

Filament Health

Filament Health - About Us

Filament Health - Our Technology

Good Manufacturing Practice (GMP)

U.S. Food and Drug Administration (FDA)

FDA - Breakthrough Therapy

U.S. Drug Enforcement Administration (DEA)

Health Canada

Mazza Innovation

Application to be on the show: From Lab to Launch

Qualio

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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Have you ever wondered why so many new biotech companies don't survive the first valley of death, which is the launch? Very likely it's the lack of access to labs, specialized equipment, advisors, and resources. 

Today's guests Shawn Carbonell, MD, Ph.D., and Brent Witgen, Ph.D., co-founders of Brazen Bio. Recently, Brent and Shawn launched Brazen Bio to help biotech founders advance human health. 

Brazen Bio is building a turnkey incubator program with state-of-the-art laboratory access, including specialized equipment, technical support, expert advisors, and housing accommodations.

Based in Los Angeles, Brent and Shawn are planning to run the first cohort of founders through the accelerator incubator program this year.

Key Takeaways:

• Biotech startups fail due to unmet needs; Brazen Bio can help resolve those needs for biotech founders
• Brazen is actively recruiting underrepresented founders with a goal to launch 100 companies in the next 10 years. 
• Access to state-of-the-art equipment, labs, and advisors should enable more startups to and innovation in the industry
• First cohort for Brazen Bio is this year. 

Show Notes: 

Brazen.bio

Employees at Brazen Bio

Invest in Brazen Bio

BioLabs LA at the Lundquist Institute

WeWork

IndieBio

Y Combinator

Amazon Web Services (AWS)

Stripe

HubSpot

Application to be on the show: From Lab to Launch

Qualio

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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Today’s guest is Rob Crowder, Head of Product at Nutromics in Australia, which has a booming life science community. Nutromics is a medical device company with a hardware and software component that includes a wearable micro-needle biosensor and software companion. 

Nutromics’s vision is a world with zero preventable deaths due to a lack of timely biological data, and it’s mission is to revolutionize health care through real-time molecular monitoring. 

Maybe one day, everybody will be wearing biosensors and have real time data from a molecular-level information superhighway.

Rob is a former GM of a Medtech product development company and has worked with more than 100 companies on feasibility, design, and commercialization of novel products. 

Key Takeaways:

• How to approach the challenges of developing hardware and software products
• How to have the right mindset as a product leader
• How to balance quality and product development velocity

Show Notes: 

Nutromics

Application to be on the show: From Lab to Launch

Qualio

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

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

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

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Today’s guest is Dr. Heather Underwood, CEO of EvoEndo. She talks about launching the first unsedated single-use endoscope to market.

Heather joined EvoEndo in 2019 after completing the Stanford Biodesign Fellowship for medical device innovation. She completed her PhD at the University of Colorado (CU) - Boulder's ATLAS program, where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship Grant and Gates Grand Challenges Grant to support her research. 

Heather has spent the past 10 years founding and leading medical device startups, non-profit life science organizations, and innovative academic initiatives, including co-founding Inworks at CU Denver.

EvoEndo was co-founded in 2017 by Dr. Joel Friedlander, a pediatric gastroenterologist, and the interdisciplinary aerodigestive medicine team at Children’s Hospital of Colorado. 

EvoEndo’s mission is to make endoscopies safer for patients by eliminating the need for general anesthesia while reducing the complexity and cost of endoscopy for physicians and hospitals. EvoEndo’s system combines sterile, single-use, flexible endoscopes with virtual reality (VR) based patient distraction to allow the procedure to be performed safely in children and adults without anesthesia or sedation. 

Key Takeaways:

• How EvoEndo’s products allow for more frequent monitoring and faster results for patients and healthcare providers
• Tips for the journey on FDA submissions
• How to fundraise while building relationships and trust with your investors 

Show Notes: 

EvoEndo Website 

EvoEndo on LinkedIn 

Dr. Heather Underwood on LinkedIn 

EvoEndo Raises $10.1 Million to Make Unsedated Transnasal Endoscopy a Reality for Patients and Physicians 

FDA - 510(k) Submission Process

Application to be on the show: From Lab to Launch

Qualio

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

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

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

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Today’s guests are Greg Yap and Jean-Paul (JP) Sanday from Menlo Ventures where fundraising is the #1 priority for almost every founder in life sciences.

Menlo’s 5 P framework for investing: Program, Platform, Portfolio, Partnerships, and People. 

Greg invests in teams trying to solve major problems in life science and health care, with a special interest in novel therapeutic platforms, digital health, and transformative technologies. 

JP focuses on vertical SaaS and enterprise software. He is excited about the future of work, infusing lives with intelligent automation, and democratizing data analytics. JP’s favorite part of his job is partnering with passionate founders to build a business that matters. 

These relationships are informed by JP’s own experience as an executive in hyper-growth companies, where he learned the critical role that culture plays in setting up a company for success. His conversations often focus on the “job” a product is hired to do, and he firmly believes customer retention is the best way to build a lasting company.

Key Takeaways:

• Founders: Know the difference between a platform company and product company
• Capital: If you want to raise capital, approach investors in an altruistic and human way
• Value Chain: Life sciences has evolved and the future outlook of regulated industries is how most countries adopt the most-stringent regulations

Show Notes: 

Greg Yap

Greg Yap’s Email

Greg Yap on LinkedIn

JP Sanday

JP Sanday’s Email

JP Sanday on LinkedIn

Menlo Ventures 

Sparta Systems

Roche

FDA - Classify Your Medical Device

European Union - Medical Device Regulation (EU MDR)

Benchling

Recursion Pharmaceuticals

Cofactor Genomics

Application to be on the show: From Lab to Launch

Qualio

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

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

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

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Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in privacy.

Sidekick Health was founded by two doctors, who worked for years treating patients with lifestyle-related illnesses. They explored ways to prevent chronic illnesses, help patients manage them, and improve their quality of life. Sidekick Health combines strong clinical validation with gamification, behavioral economics, and artificial intelligence (AI) to deliver engaging and personalized patient experience.

Previously, Kristinn worked as a consultant focusing on General Data Protection Regulation (GDPR) before joining Sidekick Health in November 2019. Since then, he has focused on registering Sidekick Health as a manufacturer of medical devices. In doing so, Kristinn has gotten involved more with quality matters. 

Sidekick Health’s platform is rated in the top 0.1% in quality by ORCHA, which has more than 30,000 users and clinical validation and successful customer launches across multiple therapeutic areas – ranging from type 2 diabetes to ulcerative colitis.

Key Takeaways:

• How to enter new markets
• Why quality is important for Software as a Medical Device (SaMD) companies
• How to scale your business while keeping culture top of mind 

Show Notes: 

Kristinn Gylfason on LinkedIn

Sidekick Health

General Data Protection Regulation (GDPR)

FDA - SaMD 

FDA - Classify Your Medical Device

Pfizer

ORCHA

eHealth Award 2020

No Rules Rules

Application to be on the show: From Lab to Launch

Qualio

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

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

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https://forms.gle/uUH2YtCFxJHrVGeL8

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Today’s guest is Lisa Helmonds, Vice President of Quality Services and Operations at MWA Consulting, which helps companies bring life-saving products to market and scale successfully. 

Lisa has more than 30 years of training in the areas of manufacturing and quality assurance for the pharmaceutical, biotechnology, and medical device industries. Also, she has extensive "good practice" (GxP) knowledge of quality guidelines and regulations. She works with several startups and established companies to implement or improve quality systems and procedures.

Lisa understands the challenges that industries deal with today. She describes a day-in-the-life of a quality consultant, innovations, and advice to life science entrepreneurs everywhere. Lisa has seen it all and offers some useful takeaways from her insights. 

Show Notes: 

Lisa Helmonds on LinkedIn

MWA Consulting

BioMarin

Genentech

U.S. Food and Drug Administration (FDA)

FDA - Form 483 Warning Letter or Inspection Observation

FDA - Guidance Documents

Application to be on the show: From Lab to Launch

Qualio

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

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

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

Show notes:

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

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

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

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

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

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

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

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

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

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

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

Show notes:

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

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

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

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

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

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

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

Show Notes:

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

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

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

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

Music by keldez