From Lab to Launch by Qualio

Today we're talking to Robert Niichel the CEO of SmartTab, which is creating ingestible capsules for drug delivery of biologics and targeted medications. Think of a pill you take that tells medications where to deliver their remedy. It's like an Uber driver or GPS for drug therapy. 

About SmartTab: SmartTab is developing an advanced platform of ingestible capsules for oral drug delivery of biologics and targeted medications. The platform is intended to replace both traditional coated capsules and injections. We're on a mission to provide novel administration routes and effective therapies that improve patient lives. 

About Robert:
Robert Niichel has 20+ years of experience in Pharmaceutical Research and Development, holding numerous pharma delivery system patents issued and pending in the United States and Globally. Niichel started SmartTab in 2016 as an evolution of his prior startup company which brought pharmaceutical technologies into the sports nutrition and consumer healthcare space.

Resource links: 

http://smarttab.co/

https://www.linkedin.com/in/robert-niichel-54a48038/

https://www.linkedin.com/company/veloce-corporation

https://twitter.com/Veloce_SmartTab

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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Today's guest is Ian Chan the co-founder and executive chairman of Abpro. Abpro is improving the lives of mankind facing severe and life-threatening diseases with next-generation antibody therapies. Ian explains how their technology is "future proofing" antibodies. 

Recently, Abpro announced its ABP 310 COVID antibody retains neutralization activity against the SARS-CoV-2 Omicron variant, which is exciting. 

You’ll hear the full story coming up but first some quick takeaways you’ll get from today’s conversation:

• How Abpro is cutting the time to generate antibodies for testing from 1 year to 2 months. 
• What all founders should focus on to facilitate fundraising - what Ian calls “first-class science”
• Unique challenges a company faces when it’s in high-growth mode and how to prepare. 

More about Ian he co-founded Abpro with his brother, Dr. Eugene Chan, who is the CEO. Not everyone goes into business with family but they’ve done it successfully a few times actually. Ian received an AB from Brown University and MBA from Harvard University.

Show notes:

https://abpro.com/

Abpro Reports Its ABP 310 COVID Antibody Retains Neutralization Activity Against the SARS-CoV-2 Omicron Variant

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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This past year—much like the year before—has put increasing pressure on professionals working in life sciences and healthcare. We hear the inspiring and sobering stories from those on the front lines of life sciences who are making a real difference to save lives. 

To celebrate the strong tailwinds behind us and the people who helped pave this road to success – notably amid an ongoing pandemic – Qualio is donating for the 2nd year in a row 1% of annual revenue. We call this initiative 1% For All Life. Every year we will continue to support organizations that ensure underserved communities receive the healthcare they need.

At Qualio, we share a core belief that everyone deserves to live a long, happy and healthy life. We are continuing our work to extend this mission by supporting organizations that align with our shared values. 

After nearly two years in a global pandemic, we feel strongly that we must continue to support better healthcare access to underserved communities. Here is where our donations will go as 2021 comes to an end:

• Saint Francis Foundation: Community Crisis Response Fund (COVID-19)
• Gates Philanthropy Partners: the Must-Solve Problems fund with the hope of supporting their efforts to drive healthcare innovation, eradicate disease, and reduce inequity in the world.

Learn more about why we’ve made this pledge and hear from Saint Francis Foundation’s President, Mark Ryle on their inspiring work in this episode of the From Lab to Launch podcast.

Links:

• https://www.saintfrancisfoundation.org/
• https://sfcommunityhealth.org/program/hhome/
• Find service opportunities near you: https://www.volunteermatch.org
• 1% for All Life 2020 article

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

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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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You may have heard the adage, "an ounce of prevention is worth a pound of cure." Today's guest Joseph Mocanu, PhD shares how companies and entrepreneurs across the world are overcoming barriers to bring an ounce of prevention to emerging markets and rural communities. His company, Verge HealthTech Fund focuses on seed stage healthcare technology companies relevant to emerging markets. 

He explains how each of us can get involved and be part of the solution to bridge the gap in life sciences between human capital and healthcare access. We each can make a difference.  

Joseph Mocanu is the Founder of Verge HealthTech Fund. Prior to this, Joseph was a scientist researching new cancer therapies, a medical device entrepreneur, and a management consultant for Oliver Wyman where he led life sciences and digital health across Asia. He has 19 scientific publications, 3 patents, and has made investments in 23 healthcare technology companies to date. Joseph has a PhD from the University of Toronto, and an MBA from the Richard Ivey School of Business.

Show notes:

• Verge HealthTech Fund: https://www.vergehc.com/
• Joseph on LinkedIn: https://www.linkedin.com/in/jmocanu/
• Other podcasts from Joseph: https://www.podfol.io/profile/joseph-mocanu/
• Qualio: qualio.com

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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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It's not hard to find someone who has been affected by diabetes and the rising cost of insulin. In fact, today's guest says that 1 in 10 people in the US today have diabetes and that figure is expected to rise to 1 in 5 by the end of the decade. 

That means there's going to be a large increase in the demand of insulin and therefore production. 

Cameron Owen co-founder and CEO of rBio joins the show to talk about how rBio is addressing this problem. 

rBio is a synthetic biology company developing new strains of microbes to produce insulin at much greater yields than current technology offers. By harnessing these advancements in biology, rBio's mission is to reduce the cost of insulin from the production and supply chain standpoint. Cameron shares his lessons learned from launching rBio just before the pandemic, his thoughts on raising capital, quality management, product development, and his passion for how biology (which he argues is the greatest technology on earth) can solve any problem we face in society today. 

His passion and excitement for biotechnology and its applications is contagious.

Show notes

• https://www.rbio.online/
• Email: [email protected]  
• Cameron's LinkedIn: https://www.linkedin.com/company/rbio/

About Cameron: 
Cameron Owen is the co-founder of rBio, a synthetic biology company developing new strains of microbes to produce insulin. rBio is harnessing advancements in biology to reduce the cost of insulin, while bringing pharmaceutical supply chains back to the United States. 

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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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Most likely everyone reading this has been affected by cancer or knows someone who has had cancer.  Using natural cell degradation, today's guest and the team at Arvinas are treating previously undruggable diseases like cancer and Parkinson's. Their goal is to cure cancer or at a minimum, reduce it to a disease where you take your medication and continue living a full life without the terrible side effects of today's treatments. 

Dr. Ian Taylor, Chief Science Officer at Arvinas, explains how his team is accomplishing this with PROTAC. Arvinas is a clinical-stage biopharmaceutical company focused on developing new therapeutics for cancers and other difficult-to-treat diseases.

If you are hoping for another treatment for cancer besides historical approaches (like chemotherapy), you need to listen to what Dr. Taylor has to say. It's innovating and extremely exciting. 

More about Dr. Ian Taylor:
Dr. Taylor came to the company after nearly 10 years at Pfizer Oncology, most recently as an Early Development Team Leader. In this role, Dr. Taylor was responsible for leading a cross-functional drug development team that conducted Phase 1 and Phase 2 clinical trials for multiple assets in several cancer indications. His initial role at Pfizer Oncology was as Senior Director of Translational Oncology. In this role, he was responsible for directing translational science activities, which included designing and executing translational research plans and leading companion diagnostic partnerships for programs in both preclinical and clinical (Phase 1 -3) stages. Prior to Pfizer, Dr. Taylor worked at Bayer Healthcare, Pharmaceuticals, holding positions of increasing responsibility, including Vice President of Cancer Biology. In this position, he led the department responsible for all biology aspects of small molecule drug discovery of cancer therapeutics in the mechanistic areas of signal transduction, cell cycle regulation, angiogenesis and apoptosis. During his tenure, the Cancer Biology group delivered numerous molecules to the Development organization. He also started and led the Biomarker group, which contributed to the development of sorafenib. Dr. Taylor earned his B.A. from Bowdoin College and his Ph.D. in Molecular Biology and Genetics from Harvard University. He also completed his postdoctoral training in the laboratory of Dr. Harold Varmus at the University of California, San Francisco and the National Institutes of Health (NIH).

Show notes

• https://www.arvinas.com
  
  
• Arvinas treatment pipeline: https://www.arvinas.com/pipeline-programs/pipeline
  
  
• Be a guest on the show: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewform

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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, John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the medical device industry as a design engineer and regulatory affairs executive. John is an entrepreneur and expert in medical device design and commercialization.

Prior to creating Kapstone, John was a founding member of Altiva Corporation, a spinal implant company that was sold to Exactech, Inc. in 2008. His experience also includes AcroMed Corporation, DePuy AcroMed, and the Cleveland Clinic Foundation.

John received his BSME from Cornell University and MBA from the Weatherhead School of Management. He has designed and managed development for dozens of commercialized products, is an inventor on over 20 patents and patents pending, and has authored multiple industry articles. John enjoys spending time on his farm in Asheville, NC with his large family.

Insights from the discussion: 

• Don’t sacrifice your best idea for your first idea, spend more time in ideation phase than in the product development cycle
• How to make marketing/sales/product and quality the offense and defense strategies of the same team
• As a founder/entrepreneur you need to seek work life rhythm, not balance 

About Kapstone Medical: 

The Kapstone Medical Mission is to Inspire, Equip and Guide. Kapstone Medical partners with physician inventors and manufacturers to develop and commercialize new medical devices. We do this by providing services for design, prototyping, patenting, quality systems, and regulatory approvals. Kapstone Medical provides product development, quality management, and project management solutions to clients who value the knowledge, depth of experience, and resources that a highly capable outsource partner has to offer.

Show notes:

Website: https://www.kapstonemedical.com/

LinkedIn: https://www.linkedin.com/in/johnkapitan/

John's email: [email protected]
Call Kapstone Medical: (714) 843-7852

Be a guest on the show: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewform

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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, Andrew Breite, Director of Quality at VitaCyte, discusses VitaCyte's contributions to cell isolation and recovery. It's a field that few are as passionate about and dedicated to improving as much as Andrew and VitaCyte. 

Insights from the discussion: 

• VitaCyte was started to better understand the mechanism by which enzymes work cooperatively to connective tissue and different cells for things like basic cell signaling research, preparing cells for sale, and even clinical therapies like islet transplantation. 
• VitaCyte’s mission is to make reagents more suitable for and compatible for the cells of interest, and to move the overall field forward in terms of understanding how this process work.
• VitaCyte is different than others because they have a fundamental drive to understand how these reagents work, and how they will ultimately contribute to the quality of the cells that are recovered for specific applications. 

About Andrew Breite:

Andrew was originally trained as an analytical protein biochemist. His professional roles have focused primarily on purification process optimization, assay development and product development. Andrew now serves as the Dir of Quality Assurance for a purified enzyme reagent product portfolio at VitaCyte. He has served in numerous roles during his more than 10 years at VitaCyte and helped develop the quality management system from the ground up.

About VitaCyte: 

VitaCyte’s co-founders, Bob McCarthy and Francis Dwulet, were key contributors to the development of the first commercial, purified collagenase-protease enzyme mixture used to prepare cells for subsequent transplantation. This improved tissue dissociation enzyme reagent contributed to success of the “Edmonton Protocol,” the first report of successful treatment of adult patients with Type 1 Diabetes where 7 of 7 patients were “insulin independent” one year after islet transplantation. Prior to the introduction of this purified enzyme reagent, most laboratories performing this clinical research procedure were spending significant amounts of time qualifying collagenase lots for their effectiveness to isolate human islets. Once a lot was selected, the lot qualification procedure was repeated within a year, often because of the instability of the enzymes in storage.

VitaCyte was initially funded by receiving NIH NIDDK Small Business Innovation Research (SBIR) awards, a state of Indiana 21st Century Fund award, and several state of Indiana SBIR matching awards.

The VitaCyte team’s curiosity about improving the state of cell isolation/recovery leads us to seek new solutions that reflect our mission to manufacture and support product/services that improve customer productivity. We encourage dialogue with our users who, in turn, stimulate us to develop new or improved products; to collaborate with lead users to develop a deeper understanding of how enzymes release cells from the extracellular matrix; and to engage others at scientific meetings to discuss their concerns about using enzyme to recover cells from tissue or after in vitro culture.

Show notes:

Website: https://www.vitacyte.com/

LinkedIn: https://www.linkedin.com/in/andrewbreite/

Edmonton Protocol: https://www.sciencedirect.com/topics/medicine-and-dentistry/edmonton-protocol

Be a guest: https://docs.google.com/forms/d/e/1FAIpQLSeEU7Owi8VDv30hzmWbj4JsXPKyfsWvKXHMeghEAyirAbR18A/viewform

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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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Typically, it takes several months for third-parties and consultants in the life sciences industry to get data back to pharma companies with payer research. Today's guest is Baiju Aurora, CEO of Market Access Transformation (MAT) is shrinking getting payer response research to a few days. 

Baiju has led the MAT team for more than five years and their first product, Rapid Payer Response, provides pharma companies payer research in only a few days from their payer network. 

Baiju’s career has spanned pricing, market access, health economics, and outcomes research for bio pharma, medical device, and diagnostics companies.

Key Takeaways:

• Embrace unexpected clients
• Industry trends in pharma, including consolidation, execution, and how faster market research can propel pharma companies forward
• Consider building a company with profitability first in mind rather than scale and growth

Show Notes: 

Market Access Transformation (MAT) - Rapid Payer Response

Baiju Aurora on LinkedIn

The Physician Payments Sunshine Act

Food Safety Preventive Controls Alliance (FSPCA)

General Data Protection Regulation (GDPR)

European Pharmaceutical Market Research Association (EphMRA)

U.S. Food and Drug Administration (FDA)

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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To be truly successful, quality must go beyond just meeting compliance requirements. When quality is a core practice at a company, everyone from the end patient to the investors benefit. 

A Harvard study on quality found that a “company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.” 

In this episode 5 quality management experts who work closely with entrepreneurs and startups discuss how to define a quality culture at your company and help everyone on your team strive to improve it. 

Guest in the discussion are:

• Meg Sinclair, Sr. Quality Specialist at Qualio
• Laura Araujo, VP of Quality at 4G Clinical
• Kelly Stanton, Dir. of Quality at Qualio
• Devon Campbell, Founder of Prodct LLC
• Christie Johnson, Founder of Kasota Engineering LLC (recently joined Product)

The content for this episode comes from a webinar about quality culture. A link to the full webinar can be found below.

Show Notes: 

The Quality Culture Playbook: How to build a quality culture (full webinar)

Prodct LLC

4G Clinical

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

Music by keldez