36 episodes

Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA

From Lab to Launch by Qualio Qualio

    • Science
    • 4.5 • 8 Ratings

Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA

    Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio

    Scaling insulin production with Cameron Owen, CEO/co-Founder of rBio

    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: cameron@rbio.online  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. 
    Music by keldez

    • 25 min
    Treating previously undruggable diseases with Dr. Ian Taylor, CSO at Arvinas

    Treating previously undruggable diseases with Dr. Ian Taylor, CSO at Arvinas

    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
    Music by keldez

    • 29 min
    What all medical device founders should know with John Kapitan, CEO of Kapstone Medical

    What all medical device founders should know with John Kapitan, CEO of Kapstone Medical

    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 cycleHow to make marketing/sales/product and quality the offense and defense strategies of the same teamAs 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: jkapitan@kapstonemedical.com
    Call Kapstone Medical: (714) 843-7852

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

    Music by keldez

    • 34 min
    Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

    Improving the State of Cell Isolation & Recovery with Andrew Breite from VitaCyte

    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

    Music by keldez

    • 18 min
    Reducing Time to Market for Pharma Companies with Rapid Payer Response and Baiju Aurora, CEO of MAT

    Reducing Time to Market for Pharma Companies with Rapid Payer Response and Baiju Aurora, CEO of MAT

    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 clientsIndustry trends in pharma, including consolidation, execution, and how faster market research can propel pharma companies forwardConsider 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


    Music by keldez

    • 35 min
    How to build a quality culture in startups. Panel discussion with 5 quality experts.

    How to build a quality culture in startups. Panel discussion with 5 quality experts.

    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 QualioLaura Araujo, VP of Quality at 4G ClinicalKelly Stanton, Dir. of Quality at QualioDevon Campbell, Founder of Prodct LLCChristie 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

    Music by keldez

    • 40 min

Customer Reviews

4.5 out of 5
8 Ratings

8 Ratings

Glizy345 ,

Amazing podcast

Love listening to these podcasts - awesome insights into the life sciences world.

darknight_39 ,

Good guests and stories

Interesting to hear the backstories of how companies got started and are solving problems. Good format overall and interesting guests. Rob’s accent is fun to listen to too.

Patient Engagement ,

4x cancer survivor to CEO/Founder

Robert Finton is an excellent host and provides en excellent platform to explore new ways of addressing Life Sciences. It’s obvious he does his homework prior to the interview, and brings thoughtful and critical questions to the recording.
More podcasts like this can make a difference in the future of medical care.

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