Explore every episode of From Lab to Launch by Qualio
Dive into the complete episode list for From Lab to Launch by Qualio. Each episode is cataloged with detailed descriptions, making it easy to find and explore specific topics. Keep track of all episodes from your favorite podcast and never miss a moment of insightful content.
Rows per page:
50
1–50 of 113
Pub. Date
Title
Duration
04 Feb 2022
Changing the Game for Drug Delivery with Robert Niichel, CEO of SmartTab
00:20:35
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.
European Market Strategy, Acquisitions and Disrupting the Drug Discovery Value Chain with Tanja Dowe from Debiopharm Innovation Fund
00:22:31
We're excited to have, from all the way in Switzerland, Tanja Dowe the CEO of Debiopharm Innovation Fund on the show. Tanja has a background in microbiology and biochemistry and is an expert in business models and market requirements for life science companies.
We’re going to learn from her experience in acquisitions, investments, and commercialization of life science companies across Europe and some recent investments in the US.
About Debiopharm Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to improve patient outcomes and quality of life in oncology and bacterial infections. Our main activities include drug development, drug manufacturing and digital health investment.
About Tanja Dowe Mrs. Dowe graduated from the Helsinki University of Technology (now Aalto University) where she obtained an MSc in Microbiology & Biochemistry in 2000. Tanja has always been interested in diagnostic and smart data solutions for precisions medicines. She has held several managing positions and has 18 years of experience in building business strategies, analyzing markets, in-/out-licensing and business acquisitions with more than 80 life sciences companies. She has strong knowledge in business models and market requirements necessary to commercialize innovations in the life science markets. Prior working at Debiopharm, Tanja was the Managing Partner of Innomedica Ltd, a leading European strategy consulting company in life sciences. She joined Debiopharm Innovation Fund S.A. in 2016.
Rethinking Your Market Access Strategy with Dinesh Kabaleeswaran, Sr. Dir. of Insights and Advisory at MMIT
00:20:26
Today's episode we explore the ins and outs of market access strategy with Dinesh Kabaleeswaran, Sr. Dir. of Insights and Advisory at MMIT. Learn more about how to improve market access strategy with better data, payer and buyer insights, and what the medical device side of life sciences can learn from pharma's approach and speed to market access.
About Dinesh: Dinesh Kabaleeswaran leads MMIT's Advisory & Insights teams, which provide market access context and a market research narrative for MMIT's data and technology products. Dinesh has more than seven years of managed care experience, advising large biopharmaceutical clients on pre- and post-launch strategies across oncology, non-oncology and immunology therapeutic areas. Dinesh holds a master’s in bioengineering from the University of Pennsylvania.
About MMIT MMIT is regarded as a trusted go-to-market partner that identifies barriers to patient access and helps coordinate major stakeholders to move therapies from pipeline to prescription—answering the “what” of how payers cover therapies and the “why” behind those decisions. MMIT’s product portfolio has been built by listening to our clients, and with expert teams of pharmacists, clinicians, data specialists and market researchers who provide foresight, clarity and confidence. This is the hallmark of who we are and who we will always be.
Restoring Hearing Loss with Novel Therapeutics with Laurence Reid CEO of Decibel Tx
00:28:17
Did you know that hearing loss is one of the largest areas of unmet need in medicine? It affects approximately 466 million people worldwide, including 48 million people in the United States.
Today's guest Laurence Reid, CEO of Decibel Therapeutics dives deeper into meeting that unmet need. Decibel has architected a whole platform to restore hearing and balance loss. With several treatments in their pipeline now, one in phase 1 clinical trials, they’re making great progress. Learn more about how Decibel started, current pipeline, and the future of biotech industry.
About Laurence Reid, Ph.D. Laurence joined Decibel in January 2020. He previously served as an entrepreneur in residence at Third Rock Ventures, where he focused on novel drug discovery and development opportunities. Before that, Laurence was CEO of Warp Drive Bio, a small molecule company focused on novel oncology and antibiotic drug discovery based on natural products, until its merger with Revolution Medicines in 2018. Prior to that, he was the senior vice president and chief business officer of Alnylam Pharmaceuticals, where he was responsible for the company’s business development, finance and legal functions. Before coming to Alnylam, Laurence was the chief business officer at Ensemble Discovery, where he led the company’s strategic planning and corporate development efforts. Laurence previously spent ten years at Millennium Pharmaceuticals in a range of general management and business development positions. In addition to his professional interests, Laurence is a board member of the Possible Project, a board member of Garuda Therapeutics and board advisor to Life Science Cares. He earned his Ph.D. from King’s College London and his B.A. from Cambridge University.
About Decibel Despite the overwhelming burden of hearing loss and balance disorders, the search for therapeutics to treat these conditions remains one of the largest areas of unmet needs in medicine. At Decibel, we are exclusively focused on discovering and developing transformative treatments to restore and improve hearing and balance. We have assembled a highly experienced scientific team and built a unique platform to achieve this goal.
Harnessing Digital Talent to Solve Crises with Courtney Brown from WHO & The Millennial Group
00:12:05
Today's show we chat with Courtney Brown from Australia about her role as CEO of The Millennial Group since its founding in 2008. She shares her perspective on how to harness remote/digital talent to achieve lasting change. She also shares her work as a Contributing Expert of Digital Health Technical Advisory Group for the World Health Organization. With decades of experience across customer, cyber, risk, marketing, technology & digital transformation within financial services, government and health organisations, Courtney has some great pointers if your company has any digital assets.
About Courtney: Courtney Brown started her career within Australia’s first digital banking proposition, ING Direct. She is dynamic and performance oriented, always seeking to exceed expectations through accountable delivery. Passionate about a legacy for the next generation and those yet to come, her drive is to disrupt systems and business models whilst also advising Boards and Executives for how to prepare for the future. This future where IT security is like currency and where distributed ledgers and open-source systems will be the way Millennials will soon demand to work.
Reporting to a Board of Medical Practitioners from the age of 25, Courtney has an entrepreneurial mindset having established and grown digital sales within numerous organisations. She has an advanced understanding of governance, commercial strategy, financial services compliance and will always remain an advocate for the customer of today and the customer of the future.
She performs at her best when facilitating negotiations of difficult conversations. Or, to develop the best strategy considering all risks and angles. Her management approach is stewardship. The Millennial Group’s immense talent pool as a collective has no organisational structure and she encourages collaborations across borders and with partners to tackle emerging and known technology challenges.
Helping boards to communicate the ‘why’ for adoption of emerging tech and the need to be the leader or first follower rather than the disrupted is why Millennial came about.
And having returned to Sydney after years abroad and interstate, Courtney is preparing to deliver value back to her hometown and the Australian economy. It is her belief that from afar Australia can become an economic powerhouse leveraging our distance and destination draw cards for collaborative success.
About Millennial Group Operating for 11 years we are a collective of digital specialists. As independent contractors we come together for meaningful work, creating meaningful impact. App developers, web developers, full stack integration & analysis to boost your platform capability. We are most passionate about distributed ledger technology & with these finite skills can support your organisation to maintain a digital edge.
Empowering parents & caregivers to identify toxic stress in children with Bryon Bhagwandin CEO of Recalibrate Solutions
00:32:11
Stress is part of life but a dysregulated stress system should not be. Unfortunately, many children experience stress so frequently that it becomes toxic. This not only impairs their executive brain function but also creates a dysregulated stress system which makes them magnitudes more likely to suffer from health problems later in life.
To make matters worse, a dysregulated stress system is not easily identifiable in today's healthcare especially for a child. In America alone, 16% of infants and children are at risk for stress related illnesses. Their stress lies under their skin.
How do we find those kids? Today’s guest is Dr. Bryon Bhagwandin, the Co-Founder and CEO at Recalibrate Solutions is solving for that. His team at Recalibrate Solutions is empowering physicians to eliminate toxic stress from the lives of children by monitoring stress system development with a 5-minute, disposable, saliva cortisol test.
If you are a parent or caregiver, you'll want to tune into what they're up to at Recalibrate. If you want to get involved as an investor, please visit their website or contact Dr. Bryon on LinkedIn.
About Bryon Dr. Bhagwandin is the Co-Founder and CEO at Recalibrate Solutions. He has served as an executive for multiple start-up companies. He has spent more than 20 years in medical product development, and possesses a remarkable combination of technical expertise, leadership, and business acumen. He has been awarded two degrees in physics and a Ph.D. in biomedical engineering. Dr. Bhagwandin has led multiple product development teams, successfully creating diagnostic, therapeutic, and drug-device combination products.
Dr. Bhagwandin understands the unique business challenges that must be navigated by medical device companies – design-controls, quality-system compliance, internal review boards, clinical testing, regulatory submissions, insurance codes, reimbursement models, hospital purchasing-cycles, and marketing through scientific research and peer review publications – a truly unique space. For more information about Dr. Bhagwandin, please visit https://www.linkedin.com/in/bryonbhagwandin/
About Recalibrate Solutions Decades of research has linked exposure to childhood adversity to a range of long-term negative outcomes, including the famous large-scale ACEs study which reported in 1998 that exposure to childhood adversity dramatically increases the risk for 7 out of 10 of the leading causes of death in America. The effects of stress exposure can begin to accumulate in the womb, and early childhood stress in particular, can have serious long-term effects including for achievement, depression, addiction, risk-taking and suicidality.
Today, there are no accessible, cost-effective, tools available that can readily be deployed to monitor stress system development. Envision the day when monitoring the health of a child's stress response system is an integral part of evaluating child development.
Our assessment tool is a five-minute, disposable, saliva based, cortisol test that can be conducted using 2-3 drops of saliva.
Using AI & Virtual Patients to Make Clinical Trials Safe, Affordable, and Scalable with François-Henri Boissel CEO of Novadiscovery
00:19:27
One of the primary issue plaguing R&D for new drugs is the experimental discovery (trial & error) process. Success rate is very low and capital intensive and takes a long time to market.
NOVA’s mission is to instill an engineering mindset into drug R&D (model, simulate, predict) to help companies design more targeted trials. Imagine having 78,000 trial patients in a phase II clinical trial compared to the usual 150 patient trials. Using AI and mechanistic modeling is becoming a trend. In fact, the model-informed drug development pilot program by the FDA is one of the most successful trials by the FDA.
Today's guest François-Henri has been the CEO of Novadiscovery (NOVA) since its founding in 2010. NOVA is a leading health tech company which has developed a hybrid approach combining mechanistic models & artificial intelligence to de-risk research programs and optimize clinical development. Essentially simulating clinical trials with virtual patients - called in silico, which has really taken off in the last few years.
About François-Henri Boissel: François-Henri holds an MSc in Management from ESSEC Business School. Prior to founding NOVA, he spent four years with investment bank Lehman Brothers in London and Tokyo where he has developed an expertise in financial engineering, deal structuring & execution. François-Henri has participated in securitization deals across a wide range of assets representing total completed financings in excess of $500 million USD in Europe and Asia.
As NOVA’s cofounder and CEO since 2010, François-Henri has honed a variety of skills ranging from corporate structuring to business development and people management.
About Novadiscovery: Nova accelerates and de-risks clinical development. Bringing speed and efficiency gains to pharmaceutical and biotech companies.
Modernizing the EUMDR Clinical Evaluation Report Process with Ethan Drower Co-founder of CiteMed
00:19:59
Adopting EU MDR is either going to make or break some regulatory teams. With some major updates to EU MDR in the past couple years, the need for innovation and efficiency has never been greater for med device companies.
We love hearing stories where experts in different industries come together to solve a massive problem and unlock potential for life-saving products. That's the story behind CiteMed where a software engineer and regulatory veteran came together to help med device companies with EU MDR and keep their products and new products in the market.
Ethan Drower, co-founder of CiteMed made a streamlined process for a med device company’s clinical evaluation report documentation - which some medical writers spend hours even whole careers on. CiteMed's approach is modern and efficient. He’ll explain more the backstory and process in the show.
CiteMed's top goal is to help companies get their medical products to market as quickly as possible all while maintaining state-of-the-art compliance with the European Commission regulations. Check out CiteMed's EU MDR templates and content on their website below.
If EU MDR is on your mind, you’ll get a lot from what Ethan and the team at CiteMed is doing.
About Ethan Drower and CiteMed: Ethan Drower is the Co-Founder and Operating Partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies' Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. Ethan as a software engineer and his partner, a veteran in the regulatory space, started CiteMed to deliver a high volume of beautifully written and formatted Literature Reviews on timelines that will enable companies to meet their EU MDR goals.
Accelerating Medtech's time to market with a modern regulatory strategy with James Gianoutsos, Founder of RimSys
00:22:56
Regulatory landscape is growing increasingly complex with new European Union Medical Device Regulations and In Vitro Diagnostic Regulations. In fact, research from MedTech Europe predicts that as many as 76% of products will be withdrawn from the market as a result and the complexity isn’t limited to just our friends in Europe. The US, Australia, Canada, China, and many more countries are adapting their regulatory approach. The only thing that doesn’t change is change itself - applies both in life and regulatory.
Today we’re going deeper into how to modernize regulatory affairs, specifically for medtech. James Gianoutsos is the Founder & President of RimSys - a regulatory information management platform that centralizes regulatory activities in the cloud. From product documentation to streamlined submissions to monitoring market status, RimSys can save RA teams hours and hours. Any life sciences founder listening in can learn from James's experience jumping into entrepreneurship from his career in Quality/Regulatory and how to get to market faster utilizing digital technologies.
Enjoy!
About James Giantoutsos James Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants. James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
About Rimsys Rimsys was founded in 2017 by regulatory affairs professionals who asked the simple question: “Isn’t there a better way to do this?” Like all RA teams, they spent hours looking for information, manually managed global product registrations, and struggled to keep up with changing regulations and standards. The Rimsys Platform is designed specifically to help medtech companies address these challenges, and confidently establish global regulatory compliance.
The History and Innovation of CPR and EPR with Lyn Yaffe, CEO of EPR Technologies
00:33:25
Today, we have Lyn Yaffe joining us. Lyn is the Co-founder, Chairman, and CEO of EPR-Technologies. EPR Technologies is a biomedical spinoff of the Safar Center for Resuscitation Research, University of Pittsburgh. EPR Technologies is committed to the preservation of human life through rapid profound hypothermia, by pursuing techniques and patented products for emergency preservation and resuscitation (EPR) to save a life when standard cardiopulmonary resuscitation (CPR) fails.
In the past decade, Lyn has been actively involved in research and development programs related to patient/casualty monitoring strategies, emergency hypothermia and rapid cooling techniques for point-of-injury care to induce ultra-profound cooling and temporary suspended animation (EPR), and semi-automated to automated, rapid vessel access techniques for therapeutic hypothermia, and a range of automated needle/catheter guidance and placement technologies.
About Lyn Yaffe Lyn Yaffe, M.D., was instrumental to the development of the concept of EPR during the research and development work at the Safar Center of Resuscitation Research, University of Pittsburgh, School of Medicine. Lyn has been dedicated to the concept and knowledgeable with regard to its emergency life-saving utility and potential applications in the field of resuscitation. Given the complexities of the EPR procedure and the demanding setting in which it will be used, these points take on special importance in this regard. Lyn and his team are therefore the best group to bring EPR forward successful development and product commercialization. Lyn completed undergraduate education at the Johns Hopkins University, School of Arts and Sciences, majoring in biophysics, in 1968. He received his M.D. degree at the University of Maryland, School of Medicine, in 1972, and completed pathology and research post-graduate training at Columbia University, New York, NY, with additional molecular biology research experience at the Roche Institute of Molecular Biology, in 1978. In the past decade, Lyn has been actively involved in research and development programs related to (1) patient/casualty monitoring strategies, (2) emergency hypothermia and rapid cooling techniques for point-of-injury care to induce ultra-profound cooling and suspended animation (EPR), and (3) semi-automated to automated, rapid vessel access techniques for therapeutic hypothermia, and a range of automated needle/catheter guidance and placement technologies.
About EPR-Technologies Our Vision is that EPR is the next emergency life-saving “Standard of Care” procedure following failure of CPR on any victim of cardiac arrest. And that every victim is able to come home from the hospital and live a normal life.
Catalyzing Chemical Reactions & Scientific Collaboration with Nobel Laureate David MacMillan
00:16:24
What’s the background of a Noble Prize winner in chemistry, where are the next innovations in science, and how do you say “asymmetric organocatalysis”? Find out the answers on this week's episode as we chat with David MacMillan.
From food production to industrial manufacturing, catalysts are all around us and play an outsized role in our lives. It’s estimated that 90% of all commercially produced chemical products are reliant on catalysts at some point in the manufacturing process. Many of these reactions aren’t sustainable. When studying as a post-doc at Harvard, David MacMillan had a eureka moment that led to groundbreaking research for green chemistry with his innovative organocatalysis.
David also works to catalyze human connections and accelerate scientific advancement through his work at the Princeton Catalysis Initiative. His insights into catalyzing cross-field collaboration are sure to inspire!
About David MacMillan David MacMillan is a Nobel laureate, the James S. McDonnell Distinguished University Professor of Chemistry at Princeton University, and director of the Princeton Catalysis Initiative, which accelerates research collaboration between scholars at Princeton and industry. He conceptualized and pioneered the field of asymmetric organocatalysis, and in 2021, he was named a co-recipient of the Nobel Prize in Chemistry for his work in the field.
Along with numerous awards and commendations, Professor MacMillan has been elected a Fellow of the Royal Society and a member of the American Academy of Arts and Sciences.
Princeton Catalysis Initiative PCI catalyzes collaborations between molecular, physical, biological, and social scientists who conduct high-impact research across disparate fields of study. By creating a new mechanism conducive to interdisciplinary research, PCI unites historically distinct areas to unleash new thinking, novel technologies, and ground-breaking applications.
Rebuilding Biopharma & Personalized Precision Medicine with Diego Rey Cofounder of Endpoint Health and YC Grad
00:18:09
What if you started a company like Roche (est. in 1896) from the ground up? How would you approach drug development differently given enabling technology available today? That's the question Diego Rey and the other founders of Endpoint Health asked.
Diego Rey is a co-founder and Chief Scientific Office of Endpoint Health, which is flipping the traditional drug development model on its head with a precision-medicine approach. In the past, biopharma companies would start with a molecule and then see where it can be used. Endpoint thinks differently. They are using deep patient insight from the patient’s biology, molecules, digital patient data and the latest in AI technology to create precision-first therapies. Pretty cool and unique approach especially for those who have traditionally been overlooked by generic drugs.
We’re excited to have Diego on to talk more about their approach, the future of precision medicine, and his inaugural work with Y Combinator’s life sciences startups.
About Diego Diego Rey, PhD, is a co-founder, board member, and Chief Scientific Officer of Endpoint Health, a Precision-First™ biopharma company where he employs his background in building multidisciplinary technical teams to create and develop the core technologies that enable Endpoint Health to deliver therapeutics and diagnostics to improve patient care.
Diego holds a PhD in Biomedical Engineering from Cornell University with minors in Biophysics and Applied Engineering Physics and a BS in Electrical Engineering from the University of California at Santa Barbara. Prior to Endpoint Health, during his PhD Diego co-founded GeneWEAVE Biosciences that was acquired by Roche where he was Head of Research for the Roche GeneWEAVE Division. After Roche Diego joined Y Combinator as YC’s first life sciences Visiting Partner.
About Endpoint Endpoint Health is a precision-first™ therapeutics company that building a new kind of biopharma. By rewriting the molecule-first drug development model, Endpoint aims to deliver precision therapies that have the potential to improve outcomes for patients with immune-driven illnesses. Their vision is a world in which all patients get the best treatment possible for their unique biology and disease.
How Artificial Intelligence Can Accelerate Drug Discovery and Bridge the Translational Gap with Jo Varshney of VeriSIM Life
00:17:04
The average cost of developing a new drug is estimated at over $2 billion. Roughly 10% of pre-clinical drugs ever make it to human trials. And each year, $50 billion is “misspent” in the trial & error method of research and development. An AI-enabled “decision engine” could help researchers find cures to rare diseases, bridge the translational gap between animal models to human systems, and move faster in drug development reducing associated R&D costs.
Today on the show we chat with Jo Varshney, the founder of VeriSIM Life, about the AI-enabled technology that is cutting the time for drug development in half. Searching for a drug candidate for bone cancer led Dr. Varshney to tackle the challenges of better predicting outcomes, improving methods for drug discovery, and building models closer to human systems.
About Jo Varshney and VeriSIM Life Dr. Jo Varshney is a multi-disciplinary and celebrated leader in veterinary & human health development. She is the founder and CEO of VeriSIM Life, which is building AI-enabled biosimulation technology to empower researchers to predict how potential drug candidates will interact in animal models. Dr. Varshney holds a Ph.D. in Comparative Oncology and Genomics from the University of Minnesota, a Master's Degree in Translational Pathobiology & Bioinformatics from Penn State University, and a Doctorate of Veterinary Medicine from the College of Veterinary Science & Animal Husbandry. She serves as a Scientific Advisor at SVAI, a San Francisco-based non-profit organization promoting education and cooperative research at the intersection of computational and life sciences.
The Benefits of Helmet-Based Ventilation with Aurika Savickaite
00:23:32
Non-invasive ventilation (NIV) is a life-saving tool used throughout ICUs to manage respiratory failure. The traditional form of non-invasive ventilation, a tight-fitting mask placed over a patient's nose and mouth, comes with significant drawbacks. What if there was an option to treat patients with respiratory failure that improved outcomes while reducing the likelihood for invasive intubation?
Today on the show, we speak with Aurika Savickaite about an FDA-approved alternative—helmet-based ventilation—that improves patient outcomes with its future forward design, has already been used in Italian hospitals for over 20 years, and played a significant roll in saving the lives of COVID patients.
About Aurika Savickaite and HelmetBasedVentilation.com Aurika Savickaite is the founder of HelmetBasedVentilation.com, a Registered Nurse, Vision Circle member at Space for Humanity, and holds an MSN from Rush University College of Nursing. Aurika studied the benefits of helmet-based ventilation and played an integral role in a three-year trial at the University of Chicago that successfully tested the helmet ventilator. Her Master's capstone project at Rush focused on non-invasive positive pressure ventilation based on her experience with the helmet. She is a passionate advocate for improving patient outcomes and founded HelmetBasedVentilation.com, a MedTech startup with the aim of training healthcare professionals on this technology, sharing knowledge, and contributing to the fight against COVID.
Entrepreneurship and Representation in Healthcare Technology with Gulé Sheikh
00:18:10
Today we speak with developer turned health-tech founder Gulé Sheikh. We discuss her innovations and entrepreneurship at a leading tele-health company, her experience in technology, and the importance of representation.
In the early 20th century, women led computer programming and made huge contributions to the field. From Ada Lovelace’s algorithm and Grace Hopper’s pioneering work on COBOL to World War II codebreaking at Bletchley Park and Katherine Johnson’s calculations critical to NASA spaceflights. Yet, when Gulé started her career 23 years ago, she was one of only 5 women in a class of 300 Computer Programming graduates. Gulé went on to found a successful health-tech company which she scaled 1000% and sold in 2019 after 7 years of running it. Join us as Gulé reflects on her experience in the tech industry.
About Gulé Sheikh Gulé Sheikh is a technologist by trade and former executive that founded the health-tech company eazyScripts, a top telemedicine software provider focused on the virtual care space. She developed the only proprietary algorithm for price transparency at the point of care in the US. She was interviewed by Melinda Gates as one of the few health-tech startup owners that raised over $2MM in the Midwest. Gulé is a passionate technologist with 22+ years in IT, and is now the Senior Strategic Success Manager in Healthcare at Salesforce.
Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo
00:15:42
Today we’re catching up with Dr. Heather Underwood, CEO of EvoEndo. EvoEndo recently completed an $8.4 million Series A financing round on the heels of 510(k) FDA clearance in early 2022. We first spoke with Dr. Underwood in June of 2021. In this episode, we chart a course through her accomplishments, lessons learned through the FDA clearance process, working with CROs, and hear firsthand about the challenges she’s tackled as Chief Executive of a medical device startup ready to revolutionize clinical endoscopy practice with a safer, faster, cost-effective alternative.
About EvoEndo EvoEndo, founded in 2017 by Dr. Joel Friedlander (Chief Medical Officer), is making unsedated transnasal endoscopy a reality. General anesthesia has been the standard of care for pediatric patients undergoing endoscopies. This can be a traumatic experience, especially for patients with chronic health conditions who may require the procedure several times a year. But EvoEndo’s single-use small-diameter device for unsedated transnasal endoscopy is ready to transform this medical necessity. The company received 510(K) clearance from the FDA in February of 2022 and is poised for a commercial launch of its innovative product.
About Dr. Heather Underwood Dr. Heather Underwood joined EvoEndo as CEO in 2019 after completing the Stanford Biodesign Innovation Fellowship for medical devices.
Dr. Underwood completed her Ph.D. at the University of Colorado 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 a Gates Grand Challenges grant to support her research. She has spent the last 10 years founding and leading medical device startups, non-profit life science organizations, and innovative academic initiatives.
Saving Lives and Early Cancer Detection with David Suhy of Earli
00:29:47
Can a chemical found in citrus fruit curb cancer and save lives through early detection? Today on the show, we'll talk about the possibilities with Dr. David Suhy, Cofounder and Chief Medical Officer of Earli. Earli was founded with the mission to make cancer a benign experience by catching and curing it early.
According the the American Cancer Society, 40% of people will be diagnosed with cancer at some point in their lifetime. And a third will die from it. What if there was a way to detect and confirm the presence of cancer by inducing synthetic biomarkers? You could catch cancer when it's most treatable and save countless lives. Learn more about this exciting technology and get inspired by David's insights.
About David Suhy Dr. David Suhy is the Chief Scientific Officer and Cofounder of Earli. He is a gene therapy expert, experienced in bio ventures both private and public. He has led gene therapy ideas from inception through Phase 2 clinical trials, and is recognized as a leader that science teams love to work with.
Before Earli, he was the CSO at Benitec Biopharma where he oversaw development paths for products in or near term clinical studies, including Hepatitis C Virus (HCV), Head and Neck Squamous Cell Carcinoma (HNSCC), and Oculopharyngeal Muscular Dystrophy (OPMD). He developed the first non-withdrawable, systemic RNAi compound used clinically in human subjects. He previously held scientific leadership roles at Tacere Therapeutics, Takara Bio, Anatara and PPD. He earned his PhD in Biochemistry, Molecular Biology and Cell Biology from Northwestern University and completed his post doctoral training at Stanford University.
He's a father to three teenagers, and he loves making pizza in his large wood-fired oven in his backyard. David is married to a neuroscientist, Dr. Joyce Suhy, who knows the risks of science, and is convinced that with David’s passion, Earli will accomplish its purpose.
About Earli Earli was founded in June of 2018 by Dr. Sam Gambhir, Cyriac Roeding and Dr. David Suhy. Earli is developing a technique, originally from Stanford University, to trigger the production of synthetic biomarkers as a means to detect, target and destroy cancer cells. Earli is currently enrolling for their clinical trial in Australia.
Building a Digital Health Startup with Shuo Qiao of Moving Analytics
00:25:30
Today on the show we're joined by Shuo Qiao, Co-founder and Chief Technology Officer of Moving Analytics. We discuss his career path and how it earned him a spot on the Forbes 30 Under 30 list, his interest in computer science, and crossing paths with his future business partner. Dive into funding strategies, the rise and global impact of telehealth, and the future of digital health tech on this episode of From Lab to Launch.
About Shuo Qiao Shuo Qiao is the Co-founder and Chief Technology Officer of Moving Analytics. Shuo earned his bachelor's degree in computer science degree from Beijing Jiaotong University and the top engineering university in India, the Indian Institute of Technology Madras. In 2013, he moved to the US to pursue his master's degree in computer science from the University of Southern California. He’s now the Co-founder and Chief Technology Officer of Moving Analytics, a digital health company that reduces the chance of a heart attack through digital cardiovascular disease prevention programs.
About Moving Analytics Moving Analytics is a digital health company with the mission to conquer cardiovascular disease as the leading cause of death by empowering people with tools to adopt healthy lifestyles. They work with a multidisciplinary team of cardiologists, nurses, nutritionists, and exercise physiologists to create personalized rehab programs for heart attack patients which they can access anywhere through their mobile phones.
Home testing for everyone, everywhere with Paul Chapman of Domus Diagnostics
00:24:46
We all experienced the importance of at-home testing from the Covid19 pandemic and today's guest is helping bring rapid, affordable, and accurate tests to everyone including traditionally underserved areas.
Dive into how Domus Diagnostics got started, the importance of Nucleic Acid Testing, and getting started with clinical trials to get FDA clearance with Kelly and Paul on this episode of From Lab to Launch.
About Paul Chapman From sales representative to CEO, Board Member and Angel Investor, Paul Chapman has over 25 years of international business leadership experience in Molecular Diagnostics, Point of Care Diagnostics, Medical Devices and Life Sciences. He is skilled at change agent and is a creative, action-oriented leader with a broad base of international Diagnostic, Medical Device and Life Sciences executive experience. Whether creating a new business or optimizing existing business models, Paul has created significant value by focusing on development of a high-performance culture through professional "A+" teams that he helps build.
About Domus Diagnostics Domus Diagnostics seeks to create tests for infectious diseases that are affordable, user-friendly, accurate, and rapid enough to address the needs raised by current and future public health crises. All this not only in the US but in every global market including underserved areas - talk about a big vision!
Marketing Must Knows for Healthcare Companies with Justin Crawmer & Scott Miscall of Webtek Interactive
00:24:18
Are you a life sciences start-up founder and want to bring your business to market, but don't know how? Marketing is something that is ever-evolving but should be part of every business' strategy. In today's episode, you will dive into marketing strategies, testing, industry regulations, and more in the healthcare sector with Jason and Scott from Webtek Interactive. Webtek Interactive is a full-service marketing agency that works with enterprise clients. They specialize in digital strategy for companies in the Healthcare and wellness space.
About Justin Justin’s background is in marketing online businesses and technical sciences. He’s consulted with over 300 businesses worldwide and worked in-house for companies like CHG Healthcare Services and Skullcandy.
About Scott Scott is an entrepreneurial Kiwi with 20 years of experience in organic search marketing. Beyond partnering with healthcare companies, Scott’s interest in the life sciences extends into biohacking and life extension.
About Webtek Successful marketing in today’s ever-changing, online landscape requires multidisciplinary skill, proven strategy, and perfectly executed development. Luckily, we’ve got the team and the tools for the job. (In fact, this is kind of our whole deal.)
We’re a full-service digital marketing agency with offices in Salt Lake City, UT, and Austin, TX. Your goals are our goals, and with our decades of expertise, we’ll help you meet them. We handle the complicated stuff—all you have to focus on is minding your business (we’ll mind it, too).
Finding Root Causes of Conditions by Looking at Genetics with Dr. J Dunn
00:31:01
Ever wondered about your genes and overall health? In today's episode, we will talk about just that. with Dr. J Dunn. We go over wholistic kinesiology and wholistic methylation. For over 30 years, she has practiced natural medicine, researched, and taught her groundbreaking techniques to hundreds of individuals who, like her, are on a quest to find an alternative solution to allopathic medicine.
Dr. Dunn began her career in the Natural Health Industry after a long bout of ill health, which drove her to seek out alternative healing methods. The results she experienced piqued her interest in Kinesiology, and she decided to study and learn this amazing technique herself. She eventually developed her own technique, combining anatomy, physiology, emotional work, bodywork, and nutrition to create Wholistic Kinesiology.
Her philosophy is to treat the person as a whole being, not just a collection of parts and symptoms.
Product and Software Development for MedTech Solutions with Piotr Zajac, CEO of Untitled Kingdom
00:15:41
What does the future of med tech look like? Piotr Zajac of Untitled Kingdom is tackling just that with his team and company. As they say, equality starts with technology. On today's episode, we chat with Piotr Zajac, CEO of Untitled Kingdom. His company is a known and collaborative partner specializing in software development and product development services.
Professionally, Piotr is the President of the Entrepreneurs' Organization and the guardian of Untitled Kingdom's mission to positively impact users' health and lives. Privately, he's a music connoisseur who just completed his term as President of the Wieniawa Community Band, a new father, a happy husband, and dog owner of a Polish greyhound named Argus.
How CiteMed is Helping Medical Device Companies Bring Their Launches to Market Faster with Co-Founder, Ethan Drower
00:36:09
Today, we are chatting with Ethan Drower, co-founder and operating partner of CiteMed, which is revolutionizing the European Union Medical Device Regulation (EU MDR) process. Literature Search and Review is the cornerstone of medical device companies' Clinical Evaluation Report, and CiteMed has made this process more streamlined and optimized than ever. The CiteMed team was formed to deliver a high volume of beautifully written and formatted Literature Reviews on timelines that will enable companies to meet their EU MDR goals. CiteMed's top goal is to help companies get their medical products to market as quickly as possible, all while maintaining state-of-the-art compliance with the European Commission regulations.
Testing a Gene Therapy to Cure HIV & Fundamentally Change Healthcare with Jeff Galvin of American Gene Technologies®
00:38:54
Today, we are excited to chat with Jeff Galvin, CEO of American Gene Technologies®. We are so glad to have Jeff back on the show, we first spoke with him last March to learn about American Gene Technologies and what they were working on. I am excited to hear all the updates and accomplishments since we last chatted. Jeff is the CEO and founder of American Gene Technologies® (AGT).
He earned his BA degree in Economics from Harvard and has more than 30 years of business and entrepreneurial experience including founder or executive positions at various Silicon Valley startups. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH and the incredible projects he was working on in gene and cell therapy. Jeff has contagious energy for gene technology and the future of curing for the incurable like HIV, cancer, and PKU.
Using Advanced AI to Curate Individualized Cancer Treatments with Navid Alipour, CEO of AI Med Global
00:27:42
Today, we are chatting with Navid Alipour. Navid is the founder and CEO of AI Med Global. Navid believes that with consistent advancements in the healthcare industry, the best care is even more accessible than ever before. When treating cancer, Oncologists are attempting to match the best course of treatment to the individual but every cancer is as unique as the patient!
His company, AI Med Global is making curated medicine accessible to cancer patients all over the world. By utilizing genetic information and a cleverly programmed AI, the technology behind CureMetrix and CureMatch are saving lives and improving healthcare.
Listen in this chat with Navid to learn more about how advanced AI is allowing curated individualized treatments for cancer and other exciting progress in the AI and medical industry.
More about Navid: Navid Alipour is the Chief Executive Officer at AI Med Global, a company focused on Artificial Intelligence Technology that improves healthcare and helps save lives. AI Med Global is a roll-up of two companies Navid cofounded, CureMetrix and CureMatch. He is also a founder of AI focused VC fund, Analytics Ventures. Through the founding of multiple Artificial Intelligence (AI) companies, Navid is a long-time entrepreneur in the AI space with an emphasis on the convergence of AI and the life sciences, which is also called Wellness Science. He seeks to identify scientists and domain experts in their respective fields to that are solving massive pain problems to take to market, by building companies from inception. While he is a VC and part of the founding of Analytics Ventures, he considers himself an entrepreneur at heart.
Revolutionizing Cell Separation with Dr. Brandon McNaughton, CEO of Akadeum Life Sciences
00:25:04
Today we are chatting with Dr. Brandon McNaughton, CEO and Co-founder of Akadeum Life Sciences. Brandon is an award-winning inventor and scientist with over 15 years of experience working with magnetic beads and nanoparticles. His experience includes the development of new types of particles, separation, and biosensors. Brandon brings previous startup experience in the life sciences and venture capital. He is also a recognized expert in customer discovery and in using human-centered design for high technology applications.
Before Akadeum, he served as entrepreneur in residence for Detroit Innovate, an early-stage venture fund facilitated by Invest Detroit. He also founded and served as chief technology officer of venture capital-backed startup Life Magnetics. He earned a Ph.D. in applied physics from the University of Michigan.
About Akadeum At Akadeum, we seek to improve human health by enabling better processes. Our platform technology is broadly applicable, but we are particularly focused on process improvements in the areas of cell therapy manufacturing, clinical diagnostics, and cell & molecular research.
Akadeum is revolutionizing the way separations are performed, including cell separation, nucleic acid extraction, chemical separation, and so much more. The power of our platform is that we’ve developed an elegant and easy-to-use technology that can enable faster, more accurate, and scalable workflows to solve the problems of tomorrow.
How to get to market faster with medical device outsourcing with Jeff Barrett, CEO of J-Pac Medical
00:30:37
We're excited to dive into the world of full-service medical outsourcing with Jeff Barrett, President and CEO OF J-Pac Medical. Jeff Barrett has more than 25 years of experience building high-growth medical product-based companies. He leads the advancement of J-Pac’s growth strategy, pursuing opportunities to further drive adoption of the company’s offerings and optimizing capabilities to better serve customers.
Prior to joining J-Pac Medical, Barrett held CEO positions at GI Supply and Optim LLC and Vice President of Operations roles at Haemonetics and Aspect Medical Systems. He is also a successful entrepreneur. By applying his operational and engineering aptitude, Barrett founded Eggrock Modular Solutions, which became a disruptive business in the building technology industry. Barrett has proven expertise building and managing high performance management teams, developing and implementing optimized operating infrastructure and manufacturing processes, and both improving existing product pipelines and growing new ones.
Barrett holds an MBA from Boston University’s Graduate School of Management, a B.S. in industrial engineering, and a B.A. in economics from Rutgers University.
About J-Pac Medical J-Pac Medical has a 40-year track record of building industry partnerships based on trust, transparency, technical expertise and quality work above all else.
To learn more about our journey to becoming the unique full-service medical outsourcing provider we are today, read our company history here.
How Dogs Can Be Used in Research and Science with Kayla Fratt Co-Founder of K9 Conservationists
00:16:05
We’re going to deviate from our typical life sciences for just a few moments just for fun to talk about dogs. We’ve heard about dogs using their olfactory system to detect biologic changes related to disease. Having a bit of a soft spot for dogs ourselves here at Qualio, when our friend Kayla Fratt reached out to be on the show, we thought it’d be fun to hear about her work in ecology and in the field doing conservation work.
Kayla is the founder of K9 Conservationists and Journey Dog Training. She trains dogs to detect data for researchers, agencies, and NGOs. Along with the rest of the K9 Conservationists team, Kayla travels the world collecting data with her dogs and offering support to conservation detection dog programs. As a dog lover myself I'm thrilled to chat with Kayla today and how dogs are leaving their “paw prints” on the world.
About Kayla Kayla Fratt is the founder of K9 Conservationists and Journey Dog Training. With her nonprofit K9 Conservationists, Kayla trains dogs to detect data for researchers, agencies, and NGOs. Along with the rest of the K9 Conservationists team, Kayla travels the world collecting data with her dogs and offering support to conservation detection dog programs. Her other business, Journey Dog Training, provides the financial stability and freedom to pursue the nonprofit. Journey Dog Training offers free and low-cost behavior advice to owners struggling with their pet’s behaviors.
Engineering quality in organizations to better meet patient needs with Matt Wictome from Datod Consulting
00:22:08
We've know many who have or had the job title of "Quality Engineer" however many outside the industry may not consider "quality engineers" to be actual engineers in the traditional sense (like mechanical engineering) - Matt Wictome's children think this way. But Matt explains how quality really is an engineering function because processes, products, and companies are being built or fixed—just as a mechanical engineer may build or fix an airplane.
Tune into this episode to learn more about how quality can be a central part of meeting patient needs.
About Matt and Datod Consulting Matthew P. Wictome, PhD, is Managing Director and founder of Datod Consulting. Datod specializes in building better and more effective Quality organizations. Over the past thirty years he has worked closely with a wide range of companies implementing impactful change to better serve the customer, benefit the shareholder, and improve regulatory compliance. As well as holding qualifications in lean & Six Sigma he is an ISO 13485 Quality System lead auditor. He holds a PhD and graduate degree in Biochemistry and an Executive Masters in Strategy, Change and Leadership with the University of Bristol. He is passionate in designing and implementing quality systems that are effective, efficient and outcome driven. His interests include how organizations function in the real world and the role of organizational culture has on the management of quality.
Datod's mission is to be the go-to partner for medical device companies who want to transform their Quality organizations to better serve their patients and grow their businesses.
From Emergency Medicine to Disrupting EHR Technology with Dr. Brian Fengler, Co-founder of EvidenceCare
00:19:54
Dr. Brian Fengler joins us on the show to talk about the latest in healthtech and innovating EHR technology to save lives in fewer clicks.
Brian is the Co-Founder and Chief Medical Officer of EvidenceCare (recently named as an Inc. 5000 Fastest-Growing Company), a company that provides a clinical decision support system (CDSS) that’s uniquely integrated with the Electronic Health Record (EHR) to optimize clinician workflows.
Dr. Fengler authored a treatment protocol for Pulmonary Embolisms when he was a resident at The University of Virginia. Despite being an expert in the field, he encountered a challenge while treating a 36-week pregnant patient suffering from a massive pulmonary embolism. Like 80% of healthcare decisions, he had to make a snap decision based on a quick internet search. Even though he was able to save both the mother and the unborn baby, he realized there was a gap in evidence-based information available to providers when they need it the most.
Looking to fill the gap in 2014, Brian founded EvidenceCare with Co-Founder, Jim Jamieson, to create software that would help physicians make better decisions for their patients and hospital. Before EvidenceCare, he was an Assistant Professor of Emergency Medicine at St Thomas Midtown and Rutherford Hospitals, one of the Founding Physicians and Managing Partners of Physicians Urgent Care, and a partner-owner of the Middle Tennessee Emergency Partners physician group. Dr. Fengler is now revolutionizing decision support at the bedside by providing what clinicians need to give better, evidence-based care.
Today, Brian shares more about his journey starting a healthcare tech company, EHR innovation, optimizing clinical workflows, and how the healthcare system can and should be improved.
Modernizing the Lab with Nathan Clark Cofounder of Ganymede
00:25:40
What does a modern lab look like? How much manual data processing will take place? Hopefully very little if Ganymede continues to make an impact.
Today Nathan Clark, Co-founder of Ganymede, one of the fastest-growing software startups in biotech joins to talk about how to automate and integrate basically everything in a lab. Before Ganymede Nathan was a product manager at Benchling which is another darling startup in biotech we’ve had our eyes on. You can read his full bio in the show notes but we’re excited to have him on today to talk about how the lab of the future will look and much much more.
About Nathan Clark Nathan Clark is the Co-Founder of Ganymede.bio, one of the fastest-growing software startups in biotech. Ganymede is the modern, cloud-native, data platform for life sciences companies, and it’s focused on integrating physical lab instruments with digital workflows. Prior to Ganymede, Nathan was the product manager at Benchling for Machine Learning and Insights Analytics. He also has a background in financial technology and trading, and notably launched affirm.com/savings.
About Ganymede Ganymede is the only whole-lab automation and data integration platform. Connect any lab instrument with any app or pipeline, all in one simple low-code platform.
Taking Diagnostic to the Future with Mehdi Maghsoodnia CEO of 1Health
00:17:56
Today we’re talking to Mehdi Maghsoodnia, Co-founder of 1Health which is a personalized precision medicine powered by a lab testing platform that connects labs, clinicians and consumers. Listen to get more details about how 1Health is bringing diagnostic to the modern age. We love the mission of 1Health which is to bring advanced diagnostics to market faster and to make them more accessible, affordable and simple. Love that and it’s similar to our mission at Qualio.
About Mehdi Maghsoodnia Mehdi is an industry fellow at UC Berkeley where he teaches innovation and entrepreneurship. He earned his Bachelor's at UC Berkeley and his MS from Stanford with an emphasis in AI and Machine learning.
Unlocking Scientific Data with Mike Tarselli at TetraScience
00:22:50
Today we’re talking to Michael Tarselli Chief Scientific & Knowledge Officer of TetraScience. Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. You can read the full bio in the show notes.
TetraScience is bringing the future of scientific data to today and has built the largest integration network of lab instruments, informatics applications, CRO/CDMOs, analytics, and data science partners, creating seamless interoperability and an innovation feedback loop that will drive the future of life sciences and the delivery of life-saving therapeutics.
More about Mike Tarselli Chief Scientific & Knowledge Officer of TetraScience, Mike Tarselli, explores the Tetra Scientific Data Cloud™ through knowledge capture, GxP compliance, and use case research. Previously, Mike was the Scientific Director for SLAS, a global professional society dedicated to lab automation and an Associate Director at Novartis building an external scientific collaboration platform. Mike received his Ph.D. from UNC Chapel Hill, completed postdoctoral work at Scripps Research, and his MBA through Quantic School of Business & Technology.
What all MedTech Founders Should Know with Duane Mancini CEO of Project MedTech
00:25:12
On the show today we have Duane Mancini, CEO & Managing Partner of Project MedTech and proud to be a “nerd” of the MedTech industry. Duane has extensive experience in go-to-market strategy including regulatory & reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design & execution. With all of the complexities of running a Medtech company and taking a product to the market, Duane partners with start-ups to develop strategies and milestones.
He runs the Project MedTech podcast series which has over 120 episodes. We’re excited to jump more into the medtech world and what companies need from inception to market.
Getting Treatments to Patients Faster by Focusing on Your Strengths with Keith Woods
00:20:21
There’s no question that 2022 was a tumultuous year for biotech companies. As 2023 is underway, we're talking to Keith Woods, former COO and current strategic advisor on the Commercial Committee of the argenx Board of Directors (from 3/13 on), a biotech company whose strong earnings come amid a downturn for the wider market and especially the biotech industry in 2022.
While other companies continue to face challenges in this climate, this biotech is hitting its stride – argenx has managed rapid growth, and a successful drug launch.
One major factor driving argenx’s success: argenx’s seasoned COO Keith Woods and his management philosophy of sustainable growth.
More about Keith Keith is was COO since 2018 and is currently a strategic advisor on the Commercial Committee of the argenx Board of Directors (from 3/13 on). He comes with 25+ years of leadership experience in the biopharmaceutical industry, with the likes of Alexion, Roche, and Amgen. He has sage advice to offer about navigating market downturns, while still managing to grow and scale sustainably. **UPDATE** After recording this interview Keith transitioned from COO to Advisor on the argenx Board of Directors. https://www.globenewswire.com/news-release/2023/03/02/2618906/0/en/argenx-Announces-Planned-Transition-of-Chief-Operating-Officer.html
About argenx The team at Argenx has created an antibody innovation ecosystem where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways and differentiated therapeutic antibodies. We’ll get more into their discoveries, culture, and how our listeners can bring about innovation by focusing more and more on patients.
Programming Humanity into AI to Improve Clinical Trials with Chuck Rinker CEO of PRSONAS
00:35:27
Chuck Rinker, CEO of PRSONAS, a self-proclaimed Human-AI Innovator, joins the podcast to discuss programming humanity into AI and revolutionizing the clinical trial industry through their iHealthAssist product.
Chuck has gone from developing black-ops military tech and NASA/space-borne avionics through gaming to the creation of nuMedia Innovations and the patented technologies behind it including the Digital Personality Engine that brings human engagement to self-service solutions for airports, hospitals, and commercial markets. Listen how this applies to the healthcare and life science industries.
More about Chuck My professional career has taken me from developing black-ops military tech and NASA/space-borne avionics through gaming, including directing the NCAA / Madden series of games for EA Sports. This lead to the creation of nuMedia Innovations and the patented technologies behind it. Our premier offering is the PRSONAS™ Digital Personality Engine bringing human engagement to self-service solutions for airports, hospitals, and commercial markets.
About PRSONAS Since inception, the team at PRSONAS have worked passionately to implement their vision of a digital workforce - empowering companies and organizations to automate the mundane, freeing time for human innovation. Leading international innovators such as Google for Entrepreneurs, Silicon Valley Open Doors, and FGNoviteiten Juryprijs have recognized us for our efforts.
Enabling the next generation of biomarker discovery with Dr. Mo Jain CEO of Sapient
00:27:05
Today we’re excited to have Dr. Mo Jain, CEO of Sapient. Dr. Jain or Mo as he prefers to be called is a physician-scientist with nearly 20 years of expertise in physiology, biomedicine, engineering, computational biology, and mass spectrometry-based metabolomics. Sapient is one of the largest capacity biomarker discovery labs in the world and well on its way to transform biomedicine forever. For all of our science and bio nerds, you'll sure be fascinated by the insights from Mo.
About Mo Jain - Dr. Jain is a physician-scientist with nearly 20 years of expertise in physiology, biomedicine, engineering, computational biology, and mass spectrometry-based metabolomics. Prior to founding Sapient, he formed and was director of Jain Laboratory at the University of California San Diego (UCSD). There he led a multi-disciplinary research team of chemists, engineers, mathematicians, epidemiologists, and physicians to develop next-generation rapid liquid chromatography-mass spectrometry (rLC-MS) systems to probe the non-genetic landscape of disease across population-scale human studies. His work was supported by the National Institutes of Health Outstanding New Environmental Scientist (ONES) Program grant and over $30M in federal, foundation, and industry funding. Dr. Jain founded Sapient in 2021 as a spinout of Jain Laboratory to expand upon the mission of accelerating human discovery and drug development through the nexus of high throughput analytical mass spectrometry, computational biology, and population-scale clinical studies. As CEO, he develops and directs the organization’s strategy and guides Sapient’s scientific, business, and technical operations.
Dr. Jain has held faculty positions at UCSD since 2013, most currently as a Professor of Medicine and Pharmacology. He obtained his MD and PhD from Boston University School of Medicine, and subsequently performed clinical residency and fellowship training in Internal Medicine, Cardiology, and Preventative Cardiology at Brigham and Women’s Hospital, Harvard Medical School. His postdoctoral work was performed at the Broad Institute and Massachusetts General Hospital in the HHMI laboratory, developing methods for large scale, mass spectrometry-based metabolomics and integrative computational analysis to define the role of bioactive metabolites in human disease.
Ernie Wallerstein, Jr. CEO of Mental Health Technologies
00:31:34
Today we’re excited to have with us Ernie Wallerstein, Jr., President and CEO of Mental Health Technologies or MHT. Ernie founded MHT back in 2018 and before that spent his career in big and startup tech companies. You can read his full bio in the show notes.
Mental Health Technologies is a cloud-based platform for testing and screening patients for behavioral health disorders. It aids professionals in addressing the growing challenge in providing services for mental health and substance abuse. By focusing on ease-of-use for both patients and providers, objective data collection, and enhanced billing practices, MHT’s goal is to horizontally integrate the entire mental health process for healthcare professionals.
About Ernie Ernie Wallerstein is of Cuban decent and has over 30 years of executive management and sales experience in software and cloud computing. Prior to founding MHT in 2018, Ernie was the president of Americas, for Enghouse Interactive, a publicly traded telecommunications company. Prior to Enghouse, Ernie Wallerstein held management positions in a tech start-up that went public as well as the SVP of Sales in a $500M+ company that was sold to private equity. Ernie enjoys golfing and spending quality time with his family and friends. But most of all Ernie is proudest of his two sons, Eric who lives in Manhattan and writes for the Wall Street Journal and Nicholas who is a sophomore at Marquette University.
Pioneering Treatment of HIV with Dr. Marcus Conant CMO of American Gene Technologies
00:28:25
Today on the show we welcome Dr. Marcus Conant, chief medical officer of American Gene Technologies. Dr. Conant was one of the first physicians to treat AIDS in San Francisco while running the inpatient dermatology service at the University of California San Francisco. Before anyone recognized the virus or understood that it was about to become a global epidemic, Dr. Conant took the lead in forming the Kaposi’s Sarcoma Research & Education Foundation in 1982, which later became the San Francisco AIDS Foundation. He’s dedicated much of his career to fighting for an end to HIV.
Full bio Marcus A. Conant, MD
Chief Medical Officer at American Gene Technologies
Marcus A. Conant, MDis a physician who treated thousands of HIV patients in the early 80s while running the inpatient dermatology service at the University of California San Francisco. Before anyone recognized the virus or understood that it was about to become a global epidemic, he took the lead in forming the Kaposi’s Sarcoma Research & Education Foundation in 1982, which later became the San Francisco AIDS Foundation. Marcus conducted early clinical trials, persevering despite seeing 94% of patients die during the epidemic’s first years. His clinical experience sensitized him to the suffering caused by the disease. As a physician with a holistic perspective, his work expanded beyond the strictly clinical, to include education, research, and advocacy. Marcus is currently a clinical professor emeritus at the University of California Medical Center in San Francisco. He has published more than 70 articles on the treatment of AIDS, testified in front of Congress multiple times, and is a powerful advocate for the LGBTQ community.
Solving hypertension with Dr. Jay Shah from Aktiia
00:29:33
Hypertension affects almost half of all American adults and over 1 billion people globally.
Dr. Jay Shah is Chief Medical Officer of Aktiia, a transformative company empowering providers and patients to greatly improve the diagnosis, monitoring, and treatment of hypertension.
Jay joined us to share how he plans to tackle this massive problem in public health.
More about Dr. Jay Shah Dr. Shah has 15+ years of medical expertise and 11+ years of leadership experience. He has brought his experience and expertise to the Swiss startup Aktiia, to change the paradigm of how the world’s most common disease – hypertension – is understood and managed. Also an angel investor and advisor, he is passionate about applying technology to solve practical problems in medicine and believes strongly in the power of positive thinking and collaboration.
The physical effects of psychological trauma: with Dr. Eugene Lipov and Jamie Mustard
00:48:49
Is psychological trauma really just in the mind? Research suggests it isn't.
Today we’re interviewing two innovators on the front lines of life sciences and co-authors of a recent book.
Dr. Lipov has been called the “Einstein of modern anesthesiology” He’s a renowned board-certified pain specialist and a huge proponent of the stellate ganglion block, a minimally invasive procedure that has been proven effective in treating PTSD symptoms.
Jamie Mustard is an artist and a renowned strategic consultant. He is the author of the bestselling book “The Iconist: The Art and Science of Standing Out." Beginning as a child and then into adulthood he suffered years of trauma at varying levels before stumbling across Dr. Lipov and the Dual Sympathetic Reset Procedure or DSR.
Today we’re going to dive into their groundbreaking revelation that psychological trauma manifests as a physical injury that can be seen and monitored on a brain scan, and their revolutionary approach to resetting the sympathetic nervous system that has helped countless patients suffering from chronic pain, anxiety, PTSD, and other related conditions.
Special Episode Welcoming New Podcast Host Meg Sinclair
00:14:59
We're welcoming a new host to From Lab to Launch! Kelly hands the baton over to Meg Sinclair. Listen in on their conversation about all things podcasting for life sciences, quality and transitioning over the podcast.
A little about our new host. Meg has over 10 years of experience in Quality Assurance, Regulatory Affairs and Compliance across a range of industries - from non-profits to medical device start-ups. Like many other Quality professionals who start out in another field or department, Meg found Quality after starting her career in Public Health, but her career path has always been about improving the lives of others which aligns with Qualio’s vision. Meg started with us in 2020 building out our own Quality System to achieve our ISO 9001 certification, followed by ISO 27001 certification in 2022. Meg was also an instrumental part of the Qualio Plus program, where we provide the necessary procedures and advisory level guidance to our customers as they’re coming onboard with Qualio.
Amazing biotech at high school incubators with Dr. Linnea Fletcher
00:24:10
Dr. Linnea Fletcher is a true pioneer at bridging biotech and education. On the show she explains how high school biotech incubators got started and how others can get involved. She also shares more about the upcoming innovATEBIO conference.
Dr. Fletcher she simultaneously joined the first National Science Foundation-funded National Biotechnology Education Center, Bio-Link, and received her first NSF-funded Advanced Technological Education grant to start Biotechnology high school programs in Texas. In 2015, she received an Emerging Technology Fund grant to build a Bioscience Incubator at ACC and several Wagner Peyser grants to equip it. Today, the incubator is full of start-up companies and students interning or working for these companies.
About innovATEBIO www.innovATEBIO.org InnovATEBIO, the National Biotechnology Education Center funded by NSF (National Science Foundation). The center was funded 4 years ago at 7.5M for 5 years to coordinate over 134 two-year biotechnology programs and their educational partners for the purpose of creating a biotechnology workforce focusing on technician education. Every senior scientist needs 5 to 7 technicians for R&D, biomanufacturing and quality assurance and regulatory matters. (National Science Board report 2019). At the moment, there is not enough technicians being produced to meet the needs of the US biotechnology industry.
About Dr. Fletcher https://innovatebio.org/iab-leadership Dr. Linnea Fletcher enjoys all forms of exercise but especially biking, hiking, and swimming. Her favorite pastimes are family events in the outdoors and travel. She received her Ph.D. in microbiology from the University of Texas at Austin, did two postdocs one at the Southwestern Medical Center and another in the Biochemistry Department at the University of Texas. She joined Austin Community College as a Department Chair in Biology and started the Biotechnology Program in 1999. At the same time, she joined the first NSF Funded National Biotechnology Education Center, Bio-Link and received her first NSF funded ATE grant to start Biotechnology high school programs in Texas. She worked as an NSF Program Officer from 2008 to 2010 and was involved setting up the first Vision and Change Meeting. Once back on the job as Biotechnology Department Chair in 2015, she received an Emerging Technology Fund Grant to build a Bioscience Incubator at ACC and several additional grants to equip it. Today the incubator is full of startup companies and students interning or working for these companies. She was PI of the AC2 Bio-Link Regional Center, and is now the PI of InnovATEBIO, the NSF funded National Biotechnology Center. Combining economic development with educational opportunities is her passion. She is also PI and Co-PI on several other grants associated with the work of the center. Linnea Fletcher believes the best way to engage educate students is to involve them in industry projects from high school on –and show them that their education has a purpose and matters—involvement in startup companies does this!
Tackling Aging with Dr. Carl Giordano Chief Science Officer at Rebesana
00:29:37
Dr. Carl Giordano joins us on From Lab To Launch!
Carl is the co-founder and Chief Science Officer at Rebesana, a company dedicated to healthy aging and longevity. After years of studying science-backed research on health and aging, orthopedic spine surgeon Carl developed a proprietary supplement to target health on a molecular level.
That supplement, backed by scientific publications, delivers a direct signal to cellular pathways in order to maintain health, longevity, and an athletic lifestyle as we age. The secret to slowing aging and extending our lives is closer than we think.
Outcome-Driven Innovation® with Tony Ulwick, CEO of Strategyn
00:24:11
Today we have Tony Ulwick on the show. Tony is the pioneer of Jobs-to-be-Done Theory, the inventor of the Outcome-Driven Innovation® (ODI) process, and founder of strategy and innovation consulting firm, Strategyn. He has applied his ODI process at some of the world's leading companies and across nearly all industries to inform breakthrough innovations - achieving a success rate that is 5 times better than the industry average.
Philip Kotler calls Tony "the Deming of Innovation" and credits him with bringing predictability to innovation. Published in Harvard Business Review and MIT Sloan Management Review, Tony is also the author of best sellers What Customers Want and Jobs-to-be-Done: Theory to Practice.
He is eager to continue sharing insights that will inspire leaders of organizations, executive teams, and innovators to change the way the world innovates.
The Moneyball for Injuries with Dr. Phil Wagner CEO & Founder of Sparta Science
00:19:23
Dr. Phil Wagner is the CEO & Founder of Sparta Science, a Movement Health Intelligence company dedicated to helping the world move better.
Founded in 2014, Sparta Science applies modern data science techniques that advance industry best practices and optimize how organizations assess, understand, and improve health & well-being.
With 4 patents, several more pending, and over 20 published, peer-reviewed research studies, Sparta Science continues to advance the Movement Health technology industry.
You may not know this but musculoskeletal issues are by far the largest diagnosis in America yet get a fraction of our healthcare budget. This is exactly what Phil and his team is working on - how to optimize human movement and injury risk mitigation. Any of us who have been to physical therapy for example, can learn something new today.
Treating Cancer using Targeted Radiotherapeutics with Jack Hoppin and John Babich of Ratio Therapeutics
00:27:18
Today we have Dr. Jack Hoppin CEO of Ratio Therapeutics and Dr. John Babich Chief Science Officer of Ratio Therapeutics. The team at Ratio Therapeutics is developing a suite of innovative technologies to develop best-in-class targeted radiotherapeutics for the treatment of cancers. They just recently opened a 19,000-square-foot headquarters and R&D facility in Boston to continue their exciting innovation.
We’ll dive into how Ratio started, their growth, and what you can learn from their journey from Lab to Launch.
Regulatory and quality expertise for solving customer problems with David R. Schoneker from Black Diamond Regulatory Consulting
01:03:28
On the podcast today we have David Schoneker who is currently the President of Black Diamond Regulatory Consulting, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries.
The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns. With over 45 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University’s School of Pharmacy in their RA/QA Masters Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements. Prior to this, Dave was the Global Regulatory Director of Strategic Relationships at Colorcon, Inc.
Revolutionizing Healthcare Supply Chains with Luká Yancopoulos, CEO of Grapevine Technologies
00:27:24
In this episode of "From Lab to Launch" by Qualio, host Meg welcomes Luca Yancopoulos, the CEO of Grapevine Technologies. Grapevine Technologies is a platform that revolutionizes the healthcare supply chain by connecting buyers with trusted wholesale suppliers, offering lower prices and a seamless online ordering process.
Luca's passion for improving healthcare supply chain inefficiencies was sparked when he founded a medical supplies distribution company, Pandemic Relief Supply (PRS), during the COVID-19 pandemic, which delivered over $20 million in critical supplies.
During the podcast, Luca discusses the impact of COVID-19 on healthcare supply chains, highlighting the outdated practices and inefficiencies in the industry. He explains how Grapevine Technologies aims to address these issues by providing a marketplace for medical practices and hospitals to connect with suppliers and optimize their supply chain.
Luca also shares insights into the challenges and opportunities in the healthcare supply chain industry for 2024 and beyond, emphasizing the increasing demand for change and transparency.
Listeners can find more information and updates on Grapevine Technologies by visiting their website (www.gograpevine.com) and following them on LinkedIn.
Eliminating Misdiagnosis of Sepsis with Greg Bullington, CEO of Magnolia Medical Technologies
00:26:06
Sepsis is often misdiagnosed, with approximately 40% of positive sepsis blood tests being incorrect. This leads to patients receiving unnecessary treatments, extended hospital stays, and risks associated with inaccurate diagnoses.
In this episode, Greg Bullington CEO of Magnolia Medical Technologies discusses the mission and innovations of Magnolia Medical Technologies, which is focused on improving the accuracy of sepsis diagnosis and reducing the overuse of antibiotics. Greg and his team have developed a technology to improve the accuracy of sepsis diagnosis and significantly reduce false positives.
The conversation touches on the challenges of bringing innovations to market, the importance of building a quality culture within the organization, and the future of blood culture testing. Greg emphasizes the need for evidence and the delivery of lower costs and better outcomes to gain support in the healthcare industry. He also discusses the role of non-dilutive funding sources and collaborations with key opinion leaders to drive innovation.
Magnolia Medical Technologies aims to continue solving the sepsis misdiagnosis problem and expand its reach. The company's vision includes developing additional solutions to improve diagnostic accuracy in various medical testing areas. Greg envisions a future with broader adoption of their technology, significantly reducing sepsis misdiagnosis and improving patient outcomes.
Guest Speaker Bio: Greg Bullington is the co-founder and CEO of Magnolia Medical Technologies. Greg is an accomplished leader with a wide range of experience, having worked with senior executive teams in over 50 companies, ranging from Fortune 500 corporations to venture-backed startups. He's also an expert in intellectual property with numerous patents to his name. Greg's mission with Magnolia Medical Technologies is to eliminate the misdiagnosis of sepsis, a condition caused by blood infections and a leading cause of death, costs, and readmissions in hospitals nationwide.
This podcast episode provides valuable insights into the mission, innovations, and future goals of Magnolia Medical Technologies in the field of sepsis diagnosis. Listeners interested in healthcare innovation and improving patient outcomes will find this episode informative and engaging.
Navigating Talent Management Challenges in Life Sciences with Darwin Shurig CEO of Surig Solutions, Inc.
00:35:22
In this podcast episode, host Meg interviews Darwin Shurig, the founder and CEO of Shurig Solutions, Inc. (SSI), a talent management and executive recruiting firm. Darwin is a seasoned entrepreneur and talent management expert who has built a successful firm partnering with clients to fulfill their talent needs and strategically support initiatives. He also emphasizes the importance of hiring and retaining high-performing teams in life sciences.
Episode Highlights:
In the ever-evolving world of talent management, Darwin sheds light on the current trends and challenges associated with recruiting top talent, particularly in the medical device and pharmaceutical industries. He emphasizes the critical importance of leadership, mission alignment, and the right talent as key factors contributing to a company's success.
Discussing the significance of retaining top talent, Darwin offers recommendations for organizations looking to keep their best employees. He stresses the importance of understanding a company's mission and creating a clear distinction between cultural fit and technical skills. He also highlights the need to focus on employee engagement, career growth opportunities, and providing a clear path for advancement.
Darwin explains how he initiated various educational initiatives at SSI, such as the SSI Educational Webinar Series and the SSI Executive Conversations Podcast. These platforms serve as valuable resources for professionals in the life sciences industry, offering insights, knowledge, and opportunities to interact with industry experts.
The conversation delves into the impact of COVID-19 on talent management and recruitment strategies. Darwin discusses how remote work, decision-making agility, and the cost of hiring have been affected. He emphasizes the increasing importance of autonomy for younger generations entering the workforce.
Darwin emphasizes that attracting talent in the life sciences industry is always a challenging endeavor, with roles in clinical, regulatory affairs, scientific development, quality, and leadership positions being particularly demanding. He anticipates a growing need for commercial talent as well, driven by the burgeoning cell and gene therapy sector.
Guest Speaker Bio: In this episode, we are joined by Darwin Shurig, the founder and CEO of Shurig Solutions, Inc. (SSI), a seasoned entrepreneur and talent management expert. Darwin has established a thriving executive recruiting firm that collaborates with clients to meet their crucial talent requirements, align strategic goals, and connect top performers with exceptional companies in the life sciences industry.
Where to Learn More: To access more content from Darwin Shurig and SSI, you can visit their website at www.shurigsolutions.com. You can also tune in to the SSI Executive Conversations Podcast, available on various platforms including Spotify, Apple Podcasts, and their YouTube channel. For direct inquiries or contact, reach out to SSI at 317-983-HIRE or through their website.
Transforming Healthcare Access: Navigating Challenges and Unlocking Data with Particle Health's Troy Bannister
00:23:21
In this episode, Meg is joined by Troy Bannister, the co-founder and chief strategy officer at Particle Health. Particle Health is a company revolutionizing the accessibility, sharing, and utilization of healthcare data to simplify navigation for patients and healthcare providers. Troy shares his inspiration behind starting Particle Health and dives into the challenges and strategies the company employed to navigate regulatory compliance and foster successful partnerships in the highly regulated healthcare industry.
The conversation delves into the importance of caring passionately about the mission, overcoming setbacks, and the role of partnerships in achieving Particle Health's mission. Troy provides insights into the evolving landscape of healthcare data sharing, emphasizing the potential for emerging trends and technologies to democratize healthcare data, leading to increased innovation and benefits for individuals.
This episode provides valuable insights into the challenges, strategies, and future trends in healthcare data access and innovation, making it a must-listen for those interested in the intersection of technology and healthcare. Connect with Troy on LinkedIn for further discussions and updates.
Innovative Lab Spaces and Cleanrooms on Demand with Azzur Group's Ravi Samavedam
00:18:05
In this episode of "From Lab to Launch" by Qualio, Meg welcomes Ravi Samavedam, the Chief Innovation Officer of Azzur Group. With over two decades of experience as a seasoned biochemical engineer, Ravi is a driving force behind Azzur's groundbreaking approach to lab spaces and cleanrooms.
Discussion Highlights: Ravi delves into Azzur Group's evolution since its formation in 2010, emphasizing its roots in equipment and facilities for the biopharma industry. The conversation unfolds with a focus on Azzur's revolutionary "Cleanrooms on Demand" concept, drawing parallels to Legos for its flexibility and efficiency. Ravi explains the benefits of licensing lab space, offering a hybrid model that accelerates time-to-market for biotech and pharma companies.
The conversation explores how Azzur ensures GMP compliance in multiproduct facilities, emphasizing quality systems and strict agreements. Ravi elaborates on Azzur's one-stop-shop approach, providing a range of services under one roof, from testing labs to consulting. The discussion touches on the lab space shortage, both pre- and post-COVID, and the potential implications for the industry.
Ravi shares insights into emerging trends, expressing particular excitement for the potential decentralization of cell therapy manufacturing near hospitals. The episode concludes on a lighter note as Ravi reveals his personal interest in geography.
Connect and Learn More: For those intrigued by Azzur Group's innovative solutions, virtual facility tours and more content can be found on their YouTube channel. Additionally, the Azzur website offers a wealth of information, including recent articles and client testimonials. Listeners are encouraged to explore further at Azzur Group's Website and YouTube Channel.
This episode provides a comprehensive understanding of Azzur Group's transformative contributions to the biotech and pharma sectors, offering a glimpse into the future of flexible and efficient lab spaces.
Unlocking Longevity using ESS60 with Chris Burres Co-Founder of MyVitalC
00:27:15
Join us as we dive into the world of groundbreaking scientific discovery with Chris Burres, a renowned Chief Scientist. In this episode, Chris unveils the mysteries of a unique, soccer ball-shaped molecule that could be the key to unlocking secrets of health and longevity.
Discover how this extraordinary molecule, small enough to hold any atom from the periodic chart, might revolutionize our understanding of wellness and aging. Chris shares insights into the foundational principles that drive this innovative research and the potential life-changing benefits it holds.
Furthermore, hear firsthand the compelling success stories and testimonials from users of "MyVitalC." These narratives not only shed light on the practical implications of Chris's work but also illustrate the profound impact this discovery could have on our daily lives.
Whether you're a science enthusiast, a health and wellness aficionado, or simply curious about the latest in scientific breakthroughs, this episode promises to offer a fascinating blend of scientific exploration and real-world applications. Tune in to get a glimpse into the future of health science with Chris Burres guiding the way.
More about Chris Burres Chris Burres is the Co-Founder of MyVital-C as well as the co-owner of SES Research Inc. and he runs a podcast about SEO marketing which is really popular. Chris is also a health expert specializing in ESS60, a Nobel Prize-winning molecule with exceptional antioxidant properties. He’s been on numerous health and wellness podcasts sharing how ESS60 can revolutionize health and wellness.
Advancing Cancer Diagnostics with Mark McDonough, CEO of Chromacode
00:20:35
In this episode we interview Mark McDonough, the CEO of ChromaCode. The episode explores McDonough's journey to ChromaCode, from his early career as a naval officer to his roles at various medical and diagnostic companies. Under McDonough's leadership, ChromaCode has excelled in creating a high-definition PCR platform which enables fast, accurate, and affordable cancer diagnosis. The platform is particularly beneficial as it requires less patient tissue, provides rapid results, and has a lower cost than traditional diagnostic methods. McDonough also discusses the importance of partnerships in their go-to-market strategy and shared his insights on hiring and team development in today's competitive market. Looking ahead, ChromaCode expects to become a leader in developing innovative products for disease diagnosis, with a focus on patient-centered outcomes.
00:00 Introduction to the Podcast 00:40 Meet the Guest: Mark McDonough, CEO of ChromaCode 01:47 Mark's Journey to ChromaCode 06:05 Insights on Leadership and Building High Performing Teams 08:10 ChromaCode's Innovative Approach to PCR Testing 10:36 ChromaCode's Contribution to Precision Medicine 13:50 The Importance of Partnerships in ChromaCode's Strategy 16:33 Future Prospects for ChromaCode 18:27 Getting to Know Mark: Personal Interests 19:13 Closing Remarks and Contact Information
About Mark McDonough Mark has over 25 years of experience helping build high growth HealthCare organizations. He is passionate about his team, his customers, and the patients that he and they are privileged to help serve. He most recently was the CEO of Pierian (now Velsera) which he led to a successful sale to Summa Equity, a private equity firm, in 2022. Prior to Pierian, he led CombiMatrix for five years, culminating in a sale to Invitae in 2017. Over his career, Mark has held various executive and commercial positions, and served as a US Naval Officer.
The Power of Effective Writing in the Life Sciences Industry with Pam Hurley, Founder of Hurley Write
00:22:59
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.
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
Saving Lives by Cancer Prediction and Detection with Dan Lunz, CEO of Previse
00:25:17
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.
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
Treating Neurodegenerative Diseases with Rob Etherington, CEO of Clene Nanomedicine
00:26:09
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.
Transforming Neuropsychiatric Therapeutics with Dr. Sam Clark, CEO of Terran Biosciences
00:23:29
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.
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
Lowering Anxiety using Smart Weight Technology with Marna Pacheco Founder of CapeAble Weighted Products
00:22:37
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.
Epilepsy Breakthroughs and Beyond with Jason Tardio and Toshiya Nishi from Ovid Therapeutics
00:23:58
**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.
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
Pioneering Viral Diagnostics with Dr. Nigel McCracken COO of Virax Biolabs
00:26:07
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.
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
Combatting the Opioid Crisis with Technology with Justin Zenanko CEO of SynerFuse
00:21:10
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
Innovative Approaches to Medication-Assisted Addiction Treatment with Dr. Joshua Lee
00:32:29
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.
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
Continuing Early Cancer Detection with David Suhy Co-founder of Earli
00:29:34
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
Sepsis Detection Made Rapid and Accurate with Dr. Rolland Carlson CEO of Immunexpress
00:28:34
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
Pioneering in Genetic Research with Dr. Jonathan Hill of Wasatch Biolabs
00:29:47
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.
Revolutionizing kidney health with Salvatore Viscomi, CEO of Carna Health
00:25:38
Carna Health is focused on applying technology to revolutionize kidney care by unlocking the early detection and management of chronic kidney disease (CKD). They provide clinical-grade software as medical devices that deliver instant health metrics, such as creatinine, eGFR, and uACR levels, from small patient samples. Their platform integrates with existing healthcare systems and electronic healthcare records, promoting proactive and patient-centric care underpinned by accurate, real-time patient data.
CEO and co-founder Salvatore Viscomi, MD, joined Meg to talk about the Carna Health mission, where current kidney care is going wrong, and what the future holds for kidney patients.
More about Dr. Viscomi:
Dr. Viscomi is the CEO and co-founder of Carna Health, a Boston-based SaMD company focused on revolutionizing how chronic kidney disease is spotted and treated early.
The future of protein manufacturing with Kerry Love, co-founder of Sunflower Therapeutics
00:19:55
Today we welcome Kerry Love, the co-founder of Massachusetts-based (and wonderfully named) Sunflower Therapeutics. Established in 2018, Sunflower is dedicated to advancing biologic medicines and enhancing global vaccine accessibility through cutting-edge protein manufacturing technologies.
As a women-owned organization, Sunflower has a stellar team of scientists and engineers renowned for their expertise in perfusion fermentation, purification process development, biopharmaceutical manufacturing, and quality management. Their mission-driven approach revolves around simplifying bioproduction complexities with their modular, automated, and fully integrated platform. This transformative technology empowers innovators to swiftly manufacture critical biologic products precisely where they're needed most.
The future of clinical trials with Sarah Englert, Senior Director of Innovation & Program Management at Thermo Fisher Scientific
00:25:45
Earlier this year, Thermo Fisher Scientific opened its first clinical trial Innovation Lab in Center Valley, Pa., designed to foster a culture of collaboration by providing a dedicated space for industry partners to come together, share ideas and co-create solutions for the industry’s biggest challenges.
The global clinical trial market was valued at over $80 billion in 2023, and that’s projected to grow by 6.5% every year until 2030. But alleviating innovation silos is the only way to move the clinical trial industry forward and tackle its current challenges.
And it’s here that Senior Director of Innovation & Program Management Sarah Englert's mission is focused...
Advancing Pathology using AI with Joseph Mossel Co-founder & CEO of Ibex
00:28:37
In this episode of From Lab to Launch by Qualio we interview Joseph Mossel, CEO and co-founder of Ibex Medical Analytics. Joseph shares his journey from computer science to leading a transformative AI-driven company in pathology. Founded in 2016, Ibex aims to provide accurate, timely, and personalized cancer diagnoses using AI technology. Joseph discusses the challenges and insights from deploying AI in clinical settings, the importance of partnerships, and the company's vision for the next few years. Tune in to learn how Ibex's innovations are reshaping cancer diagnostics and making a significant impact on patient outcomes.
00:00 Introduction to the Podcast 00:26 Meet Joseph Mossel, CEO of Ibex 01:14 The Founding and Vision of Ibex 05:59 Ibex's AI Technology and Its Impact 07:41 Challenges and Overcoming Them 09:54 AI in Cancer Diagnostics 15:12 Future of AI in Pathology 17:15 Partnerships and Collaborations 19:58 Advice for Labs and Entrepreneurs 23:29 Ensuring AI Reliability and Quality 25:48 Fun and Final Thoughts
The predictive power of biomarkers with Mark Roskey, CSO of Quanterix
00:16:55
As more preventative approaches to health are set to take center stage, some diseases can’t be prevented but can be managed more proactively. Blood-based biomarkers, such as p-tau217, hold great promise for earlier, more proactive detection and monitoring of diseases such as Alzheimer’s, and it’s here that Quanterix plays a critical role.
Their Simoa digital health platform serves as the backbone for the majority of p-tau217 tests on the market today, reducing reliance on costly PET and CSF testing and streamlining the diagnostic journey for Alzheimer’s disease.
Mark has been a leader in the biotech space for over 2 decades, with a string of leadership roles before he joined Quanterix in 2014 and became their CSO in 2022.
Mark joined Meg on From Lab To Launch to discuss the exciting predictive power of biomarker technology, and what the future holds for spotting and treating diseases early.
Mind the gap! Advancing transplantation with Tina Liedtky, President of the Transplant Diagnostics Division, Thermo Fisher Scientific
00:20:06
As the organ transplant list continues to grow, experts in the transplant diagnostics industry are looking for ways to address the supply and demand challenges within the field.
New tactics, like retransplantation and xenotransplantation, and new testing methods, such as HLA testing and transplant diagnostics, are being explored to boost transplant success rates and ensure more patients get the lifesaving transplants they need.
As President of Thermo Fisher Scientific’s transplant diagnostics division, Tina Liedtky is at the cutting edge of meeting this challenge.
She’s also passionate about addressing health equity issues, such as ingrained biases regarding gender and race, to help bridge the transplantation gap.
Tina joined Meg for a fascinating discussion about the future of transplantation, closing 'the gap', and Thermo Fisher's recent award.
Special episode! Digging into Qualio's 2025 quality trends report
00:15:53
We made a bonus episode of From Lab To Launch to mark a special occasion: the launch of Qualio's fourth annual life science quality trends report in March 2025.
Our very own Kat and Clive dug into the report and its fascinating findings to see how life science quality teams are spending their time, what they're planning for 2025, and what headaches and frustrations they're looking to conquer this year.
Join us and dive into our report - and read the full thing at reports.qualio.com!
Note: the audio in this episode has been made using artificial intelligence
Welcome to the From Lab to Launch podcast by Qualio. Discover inspiring stories from those on the front lines of life sciences. 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.
Episodes are about 30 minutes and published each week on all major podcast players.
Tune in and leave inspired to bring your life saving products to the world.
Insights from Biotech Pioneer and Investor Ron Shigeta
00:22:49
Ron Shigeta is a serial entrepreneur & startup biotech pioneer. He’s also been a serial founder having run startups in AI drug tox detection & synthetic biology. Ron holds a PhD in Chemistry from Princeton University, where he spent his academic research career focusing on secondary metabolic biosynthesis, diabetes, genomics, genetics, structural biology and systems biology.
As an entrepreneur, investor, scientist, and mentor Ron shares some great insights to anyone who wants to contribute to life sciences.
Some takeaways:
Starting a biotech company today is much easier and cheaper than at any other time
Advice to founders to gain relevancy and trust from investors and get funding
Biotech investments now are where software was 2+ decades ago
4x cancer survivor to CEO/Founder. The power of patient-led solutions with Cinde Dolphin.
00:21:23
What if the next time you went to the receive healthcare at a clinic or hospital, you came out with an idea to improve the patient's experience? That's what Cinde Dolphin did.
She's a 4x cancer survivor and CEO/founder of KILI Medical Drain Carrier. Between surgeries, she went to a dollar store to begin prototyping a device that would improve her experience as a patient.
Her nurse team loved it. Her doctors loved it. What followed was her journey into entrepreneurship in life sciences.
Cinde shares her with story, which is an inspiring one, from patient to founder.
Guest Bio: Cinde Dolphin is the CEO and founder of KILI Medical Drain Carrier. She's also a member of the Academy of Oncology Nurse and Patient Navigators. She likes to challenge the status quo. She's a four time cancer survivor and she's been through nine surgeries. Her malady was a catalyst to create a simple, yet elegant solution to manage post-op drains and improve upon the 50 year old conventional protocol, which involved attaching drains using safety pins. Cinde enjoys speaking to the medical community, as well as to the general public about the importance of patient innovations or from their experience, the insights they gain, create solutions, which help others with the same medical issues that they suffered. These former patients are determined that others will not have to contend with the problems that they had, and she believes truly in paying it forward.
From Hippie to Med School to Entrepreneur with Dr. Hana Solomon, MD
00:19:34
If you have a nose, you should check out this episode.
Dr. Hana Solomon, MD shares her journey from hippie to single-mother to med school to entrepreneur. She's the founder of BeWell Health and inventor of Nasopure, the most comfortable nose wash in the world.
She shares her wisdom to avoid "stupid business mistakes" such as acquiring the right type of patent for your product (e.g., design vs. utility patent) and being financially braver to go bigger sooner.
Dr. Hana talks about little things, each of us can do to improve our health. Also at the end, she kindly offers a coupon code to get a discount on her nose wash product.
Guest bio: Dr. Hana Solomon, MD graduated from the University of Missouri Columbia School of Medicine in 1986 and completed the university's pediatric residency program in 1989. For 20 years Dr. Hana has practiced pediatrics at the Solomon Family Medical Clinic in Columbia, Missouri.
Her articles have been published in the Wall Street Journal, Medscape's webmd.com, About.com, Natural Apathy Digest and other health-related publications. Dr. Hana started BeWell Health in January, 2001. The company's flagship product, Dr. Hana's Nasopure nasal wash systems have helped millions to maintain nasal and sinus health naturally.
Global Opportunities from Starting a Med Device Company in a Pandemic with Meow-Ludo.
00:21:38
Our guest today is Meow-Ludo. He’s an emerging technology evangelist and Chief Scientific Officer at Moth Diagnostics, a company formed in response to the covid pandemic.
Meow has a background in solving problems using biotechnology and helped found the biohacker movement in Australia. This culminated in the establishment of BioFoundry, Australia's first open access molecular biology lab, with Moth Dx co-founder Adrian Pearce.
Meow has also run for federal parliament with the science party and flux party, advocating for data driven policy and technological improvements to democracy. He is perhaps most well known for one of the world's first cyborg law cases, fighting for the right to use an implanted travel card in his hand that gained worldwide attention.
Lots of takeaways from today’s show. One in particular about having a global mindset. Hope you enjoy.
Giving back to those on the Frontlines of Healthcare with Robert Fenton and Mark Ryle
00:43:29
2020 has been an unprecedented year. In times like these, mission-driven companies should challenge themselves to stay focused on their immediate goals while not losing sight of their bigger vision. In an effort to reinforce our mission and demonstrate our values, Qualio is committing to what we call 1% For All Life. Starting this year, Qualio will donate 1% of our annual revenue to improving healthcare access for vulnerable populations.
Qualio's mission is to enable organizations to launch and scale life-saving products. While this supports our core belief that everyone deserves to live a long, happy, and healthy life, we are now expanding our mission by supporting organizations that ensure underserved communities receive the healthcare they need.
Increasing the quantity and quality of treatment options does little to help those who cannot easily access the existing healthcare system. I saw this first hand while working as a pharmacist in large urban centers, rural communities, and drug addiction services in Ireland's largest prison. It became clear to me that the ability to access quality healthcare has an enormous impact on people's lives, and that we all have an opportunity to make a difference here.
After months of living through a global pandemic, we feel privileged to be able to give something to those that need better healthcare access. Here is where our donations will go in 2020:
Spearheading the Life Sciences Industry with Claire Bonaci from Microsoft
00:23:50
Listen to this chat between Qualio CEO, Robert Fenton and Claire Bonaci from Microsoft about how the life science industry is evolving. We cover a wide of topics and trends based on her expertise and how she aspires to inspire young women interested in STEM and leadership roles.
Guest Bio: Claire currently serves as Sr. Director of the Pharma sub vertical of the US Health & Life Sciences department at Microsoft. She works in partnership with US life science companies, pharma, and health organizations to create innovative Microsoft solutions specific to the company’s issues affecting their patients and their business.
She brings with her an expertise in the clinical trial and pharmaceutical industry, having been a global study lead on oncology clinical trials at a large pharmaceutical company prior to joining Microsoft. She has deep understanding of the clinical trial value chain and the complex nuances that biotechnology and life science companies experience. She is passionate about the many services and innovations Microsoft has to offer to reduce time to market for new drugs and provide better outcomes to patients.
Claire is also the producer and host of the Confessions of Health Geeks podcast, an industry focused podcast on the biggest trends and pain points in health and life sciences. Claire also has a passion for inspiring young women to be interested in STEM and leadership roles in STEM related fields.
Unlock Funding with IP and Focusing Your Purpose. The inspiring story behind HAI Solutions with Nick Perrenoud.
00:24:51
The story behind HAI Solutions is so inspiring and similar to many life science entrepreneurs who start their companies after personal (and occasionally tragic) experiences.
Nick Perrenoud is one of those entrepreneurs. He's the co-founder of HAI Solutions and led the development and patent for a solution to protect patients from the accidental or negligent contamination of IV anesthesia medications.
Nick learned the importance of protecting patients with sterile IVs, not only as a nurse anesthetist, but also when caring for his adopted son who required IVs for seven years and spent nearly three years in the hospital to, to central line infections.
He shares many useful insights for any medical device entrepreneur such as how securing patents has helped with fundraising, focusing on your purpose, and being patient-driven.
How AI is Revolutionizing Healthcare Products and Access with Sam Dribin
00:21:46
For the first time in healthcare, human ambition and technology are starting to intersect and AI is one of the main drivers. Listen in on this episode with Sam Dribin to learn about how AI is evolving to improve healthcare results.
Sam Dribin is the Chief Technology Officer for CureMetrix, an AI company focused on solutions that support radiology.
Sam has a diverse background in technology including Biotech software development with expertise in the technical issues facing healthcare and life science companies and laboratories.
For the last five years, he’s been on the forefront evolving artificial intelligence with solutions that are focused on AI-based mammography to improve cancer detection.
We’ve known Sam and CureMetrix for some time as a customer of Qualio, but today he shares his insight into how AI can impact healthcare such as reducing false-positives and increasing access to healthcare everywhere.
Lessons from Building an Open Source Quality Community with Gill Berry
00:27:57
Gillian Berry is a qualified clinical nurse specialist and founder of PerCen Technologies. She founded PerCen Technologies in response to challenges she felt were not addressed in Healthcare. It’s aim is to use scientific knowledge and the latest technologies to compliment clinical evidence based practice. PerCen Technologies is supported by the first national Health Innovation Hub of Ireland.
We love seeing healthcare innovation coming out of Ireland, so we had to talk to Gill. ;)
Gill shares her takeaways after co-founding one of the first open source efforts in response to the Covid19 pandemic, the Open Source ventilator project and the Open Source Volunteers Extended network. She managed over 1,000 STEM professional volunteers, academic institutions, SME’s and Multi-National’s and facilitated 30 projects with a transfer of knowledge and skills.
It’s amazing what can be accomplished when we network, open source ideas, and collaborate together. Gillian’s story and lessons learned about the power of a network are certainly inspiring and applicable today.
Reducing Patient and Nurse Injuries with Charleen Solomon from AriseQ2
00:23:36
Did you know nurses are required to turn and change bed-bound patients every two hours? The primary reason for this protocol is to help patients avoid pressure ulcers. At first glance, that seems like a straightforward and quick task. But it's actually quite a challenge, especially when nurses are short-handed. The traditional approach of turning patients is time consuming and prone to injuring nurses.
The problem has serious financial healthcare costs as well with $250 billion spent each year on nursing injuries and pressure ulcers.
Charleen Solomon, a nurse herself, thought of a solution one day when her sweater got caught in the door of her car. Her back was aching from turning a hospice patient that day and her 2nd shift was about to start when she had a lightning moment of inspiration to what would lead to her Q2 Solution.
Charleen shares her journey from prototyping with fellow nurses, selling her house to have capital, seeking investment (and being rejected 200 times), to finding the right manufacturer, to a very successful product today with contracts with some of the biggest in healthcare.
She knew the product worked from first-hand experience. Her tenacity, purpose, and gratitude are inspiring for any entrepreneur starting their own life science company.
Funding and Scaling Your Med Device Startup with Jen Baird, CEO of Fifth Eye
00:26:42
Getting funding and scaling a medical device business alone is challenging. But challenges don't deter entrepreneurs like Jen Baird. From being disregarded at first from VCs simply because she was a woman, to then selling her company for $205M, to today scaling a med device startup with a denovo FDA application, Jen has done it all! If that's not impressive enough, she takes time to write her insights as a startup CEO in her personal blog.
Jen has founded and led multiple healthcare ventures. Her most successful company to date was Accuri Cytometers which Jen led from inception to global commercialization. She raised over $30 million in angel and venture capital financing, developed a product and achieved more than $12 million in annual sales in just five years. In 2011, Accuri was sold to Becton Dickinson for $205 million, which is a 10X revenue multiple and Jen generated, or a 5X return for her investors.
Most recently, Jen raised an $11.5 million Series A to found and build Fifth Eye, a medical device software company that detects hemodynamic status from a single streaming lead of ECG. Her career also includes stints in commercial banking, management consulting, and several other previous startups. Jen graduated at the top of her class with a master's in management, from Northwestern University's Kellogg graduate school of management and earned a BA in organizational psychology from the University of Michigan.
For everyone who's listening and in the trenches of building a life sciences company, Jen has been there many times and has had some incredible exits.
I hope you enjoy listening and learning from her wisdom and experience.
Improving Patient Safety at The Point of Care with Joan Melendez of Xcelrate UDI
00:23:27
Did you know about $6 billion is spent each year in medical device recall management?
Having a product recall is probably a medical device companies, worst nightmare, but once something gets recalled, the communication between the FDA and manufacturers and healthcare facilities, all involved in the workflow of that product ,often break down or are slow to respond. This results in patients becoming highly at risk.
To solve this, Joan created Xcelrate UDI with a goal to improve patient safety at the point of care, by leveraging the power of the unique device identification system for medical devices and biological tissues.
Xcelrate UDI uses innovative barcode scanning technology to capture the data required by the FDA and digitally document. The patient health record with precision and accuracy. Joan has over 25 years building and optimizing healthcare applications specializing in perioperative, anesthesia, and trauma workflows.
She shares some great insights with us today by starting a couple of, with a big mission. And it was an 800% increase in recalls in recent years, a byproduct of companies increasingly moving faster in this space over time, there has never been a more important time than now to focus on quality and alerting and patient safety.
Quality Management Fundamentals in Aerospace, Life Sciences, and Antarctica with Gene Vought from Cirris Systems
00:19:54
Cables are everywhere, quite literally. Quality management for a cable testing company can be challenging, especially with continuous audits from partners, but Gene Vought makes it look easy.
Gene is a quality manager at Cirris and has been with the company for over 25 years. Cirris designs manufacturers, worldwide sales, service, and technical support for cable testing equipment for manufacturers of cable assemblies, wire harnesses, custom fixtures, and other interconnection products.
Ambition and a desire to serve customers have placed cable testers in the hands of thousands of customers on every continent, even including Antarctica. People all over the world rely on Cirris when they test cables that helped drive cars, heal patients, defend soldiers and even launched satellites into space.
Gene has an impressive track record and background, and we're really excited to have the opportunity to speak with him today. I think you'll really enjoy this episode because we talk about his experience in the aerospace industry, his experienced at Cirris and the life sciences industry and his role as a quality manager and how important that is to the success of the company.
Also kind of fun what he enjoys to do outside of work. Hope you enjoy.
How to Maintain and Improve Your Quality Management While Working Remotely
00:22:24
Today, we're introducing a new type of episode called Quality Quick Tips.
Periodically we'll focus on specific aspects of quality management since we love to nerd out on all things quality and compliance. Call us weird. Call us what you want, but quality management is what we love to do. And we do it well ...so why not have some fun along the way!
Today, two of Qualio's QA experts, Kelly and Ezra talk about how to maintain and improve your quality management while working remotely. It was a conversation that they had in the midst of the COVID 19 pandemic, but it still applies today.
As many organizations are still adjusting to a new normal of remote quality work, they cover important aspects like what questions to ask to better evaluate and prioritize tasks, the what and how to communicate about quality issues, how to manage remote audits, the importance of documentation all of these changes that are happening. Internal and external factors and a lot more. Building and improving a culture of quality at your company can be done either remote or in person, and this episode can help you show how that's done.
Awakening Millions with Brain-Computer Interfaces with Andreas Forsland, CEO of Cognixion
00:20:59
Imagine if Stephen Hawking couldn't communicate. The world's understanding of theoretical physics would be greatly limited. There are roughly half a billion people like Stephen Hawking who are just waiting for an awakening. They could communicate and contribute if they only had the technology to do so.
Helping these people with either motor or cognitive limitations be able to communicate is part of the big mission of Andreas Forsland, Founder and CEO at Cognixion.
Andreas has a robust background in hardware, software, and design. That background all converged when his mother was in the hospital struggling to communicate to healthcare providers. The idea for Cognixion was then born.
Cognixion is a digital health startup based in Santa Barbara, California and Toronto, Ontario. Cognixion builds accessible and affordable neuroprosthetic software and wearables that use biometric sensors and machine learning in new ways to help people with complex disabilities use their face, eyes and brain as a direct control interface for mobile and augmented reality accessibility.
Imagine controlling Alexa with your brain. Mind blown!
Cognixion is the "Tesla of Neurotech" and is recognized as a top 21 neurotech startup to watch, and is focused on scaling up the transformation of over 100 million lives and translating universal design approaches for everyone by focusing on the most challenging human interaction needs.
How to Get Non-Dilutive Funding via Federal Agencies with Ram May-Ron, Partner at FreeMind Group
00:20:31
Over $50B (with a B!) is available each year to life science companies from federal agencies. The best part is, it's all non-dilutive funding.
For example, the NIH's Small Business Innovation Research (SBIR) program alone awards $1B each year. That's more annual funding than any VC! And that's just one of many SBIR programs available from US Federal agencies.
Ram May-Ron, managing partner at FreeMind Consultants walks through the enormity and approachability of these federal non-dilutive programs.
FreeMind Group helps life science organizations secure non-dilutive funding from US federal agencies and private foundations.
FreeMind started in 1999 and has grown into the largest consulting group of its kind. With experience in seeking funding from nearly all NIH Institutes, Department of Defense, NSF, FDA, BARDA, etc., as well as private foundations, they’ve helped clients garner over 1.5 billion dollars to date. Awards range from $150,000 to $150,000,000 per project.
If funding is on your mind - you need to consider what Ram has to say here.
Curing Incurable Diseases with Jeff Galvin of American Gene Technologies
00:26:03
What if incurable diseases like HIV, cancer, PKU, and epithelial solid tumors were completely curable? We're closer than you might think. Really close.
In fact, Jeff Galvin and his team at American Gene Technologies™ (AGT) have been advancing the research and application of viral vectors for several years with some incredibly exciting breakthroughs on the horizon (hint: curing HIV could be just a few years away).
In case you didn't know already, viral vectors is a relatively new technology where you can crack open any virus, scoop out the malevolent code and replace it with code to attack the root drivers of what are today incurable diseases. Essentially this creates a "stealth bomber" benevolent virus in your body. The future of this treatment could "send radiation and chemotherapy the way of bloodletting and leeches" as Jeff says in this podcast.
Jeff has a contagious energy for gene technology and a grand vision of the future of curing the incurable.
If you want to get a peak at how gene technology could quite literally change the world (and soon!) listen to what Jeff has to say.
Enjoy!
About Jeff Galvin
Jeff Galvin is the CEO and Founder of American Gene Technologies™ (AGT). He earned his BA degree in Economics from Harvard in 1981 and has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies, including one in the medical-technology arena that was sold to Varian, the leading maker of linear accelerators used in cancer therapy. Following his startup experience, he retired to become an Angel Investor in real estate and high tech. He came out of retirement to found and fund AGT after meeting Roscoe Brady at NIH.
It only takes one ground-breaking MedTech startup to change a product category forever. Back in 2006, serial entrepreneur Steve Kelly partnered with MIT researchers to take an anti-bleeding gel product to market. The biodegradable gel was a significantly better option for many hemostat applications, compared to alternatives like bandages, surgical clamps, tissue adhesives, vasoconstrictors, and cauterization. Today, topical hemostatic agents are considered the most efficient, effective, and safe option to stop bleeding in many patients and conditions.
Winning medical device startups have a few factors in common, according to McKinsey research. First, they all have an idea that can provide consistently superior experiences to all users, including patients, caregivers, and clinicians. They will also “reimagine processes to dramatically reduce costs and accelerate decision making.” The most successful MedTech companies manage to get closer to the patient by providing an innovation that’s better, cheaper, safer, more convenient, or somehow just a better option.
In order to get close to the patient, MedTech startups need to achieve velocity in the early stages to provide proof-of-concept, secure funding, and demonstrate clinical safety for regulatory approval. There’s no room for mistakes or delays in a hyper-competitive market space. A strong baseline of compliance is crucial from day one to ensure there are no barriers to obtaining FDA approval or a CE Mark.
That's one of the reasons we exist. Qualio is quality management software for the life sciences ecosystem.
Lessons from Bringing New Tech to Developing Countries and Pro Basketball with Assaf Barnea, CEO of Sanara Ventures
00:17:56
Today we welcome Mr. Assaf Barnea to the show. He is a former pro basketball player in Europe and currently the CEO of Sanara Ventures, a healthcare innovation fund backed by Phillips and Teva Pharmaceuticals investing in digital health and medical device technologies.
Sanara invests primarily in early stage digital health and bio convergence companies. He offers his insight and outlook on bio convergence in the future.
Assaf also shares experiences as the co-founder of the World Bank’s International Finance Corporation’s Tech Emerge Initiative, which is a unique acceleration platform that connects healthcare startups from around the world with leading corporations and hospitals in emerging economies. He talks about the work done in India, Brazil, and now Africa. Truly inspiring and life-changing work.
In his career, Mr. Barnea co-founded CardioSense, a medtech startup company, served as CEO of Kinrot Ventures spearheading its acquisition by Hutchison Water in 2012. He spearheaded business development at Mekorot, Israel’s national water company, where he oversaw the establishment of WaTech, the Entrepreneurship & Partnership Center for Water Technologies, where he received the Cleantech Group’s Innovation Hero Award.
A unique highlight in Assaf’s story is basketball. At New Jersey’s Seton Hall University he and his team won the Big East championship against Georgetown in 1991 playing against Dikembe Mutombo and Alonzo Mourning. He played professionally in Europe for years and shares some parallels between athletic prowess and entrepreneurship.
We’re excited to have him share his perspective and advice for entrepreneurs on today’s show.
Defining Quality: The Role, Responsibilities, and Industry with Laura Araujo from 4G Clinical
00:20:27
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!
Empowering Women With Personal Fertility Knowledge with Dr. Amy Beckley of MFB Fertility
00:17:31
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.
Expanding Med Device Distribution Internationally and in China with Andy Levien CEO at ArcScan
00:21:05
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.
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.
Apply to be on From Lab to Launch here. Music by keldez
Succeeding in Quality Consulting with Lisa Helmonds, VP of Operations at MWA Consulting
00:19:18
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.
How to Maintain a Quality Culture during Explosive Growth with Kristinn Gylfason at Sidekick Health
00:22:09
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
Fundraising Fundamentals with Greg Yap and JP Sanday from Menlo Ventures
00:33:56
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
Enhance your understanding of From Lab to Launch by Qualio with My Podcast Data
At My Podcast Data, we strive to provide in-depth, data-driven insights into the world of podcasts. Whether you're an avid listener, a podcast creator, or a researcher, the detailed statistics and analyses we offer can help you better understand the performance and trends of From Lab to Launch by Qualio. From episode frequency and shared links to RSS feed health, our goal is to empower you with the knowledge you need to stay informed and make the most of your podcasting experience. Explore more shows and discover the data that drives the podcast industry.
