From Lab to Launch by Qualio

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.

Links: 

https://chemistry.princeton.edu/faculty/david-macmillan

https://pci.princeton.edu/

https://www.nobelprize.org/prizes/chemistry/2021/macmillan/facts/

https://en.wikipedia.org/wiki/Organocatalysis

Qualio Website

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

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

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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.

Links: 

 https://www.startengine.com/epr-technologies

 www.epr-technologies.com

Lyn Yaffe LinkedIn 

Qualio Website

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

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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.

Show notes
https://www.rimsys.io/
Rimsys Series A post
James Giantoutsos LinkedIn

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

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

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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.

Show Notes:
CiteMed website: https://citemedical.com/
CiteMed EUMDR resources: https://www.citemedical.com/learn-eu-mdr/
Ethan's LinkedIn: https://www.linkedin.com/in/ethandrower/

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

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

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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.

Show Notes:
FDA's Model-Informed Drug Development Pilot Program
Novadiscovery: https://www.novadiscovery.com/index.html
François-Henri's Linkedin: https://www.linkedin.com/in/fran%C3%A7ois-henri-boissel-54785717/

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

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

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

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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. 

Show Notes:
https://www.recalibratesolutions.com/about
How it works: https://youtu.be/FK8kdQWgFZU
Bryon' LinkedIn: https://www.linkedin.com/in/bryonbhagwandin/

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

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

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

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https://forms.gle/uUH2YtCFxJHrVGeL8

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Today's 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.

Show notes:
Millennial Group website: https://themillennialgroup.com.au/
Courtney's LinkedIn: https://www.linkedin.com/in/courtneybrowndigital/
Qualio
Previous episodes: https://www.qualio.com/from-lab-to-launch-podcast

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

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

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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.

Show notes

Decibel website: https://decibeltx.com/
Pictures of the inner ear: https://www.decibeltx.com/our-approach/

Qualio

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

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

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

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Today's 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.

Twitter: https://twitter.com/DineshKannanKa2
LinkedIn: https://www.linkedin.com/in/dineshkannan/

Recent articles by Dinesh:
The Power of Partnerships: Why Pharma Needs to Redefine its Role With IDNs (Drug Channels)
Market Access Speed Is the Next Critical Differentiator for Pharma Manufacturers (PharmExec) 

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.

MMIT website: Mmitnetwork.com
MMIT on LinkedIn: https://www.linkedin.com/company/mmit-managed-markets-insight-&-technology-/

Show notes
Qualio
Press Release: MMIT Announces Game-Changing Solution for Life Sciences Companies
MMIT's Reality Check series

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

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

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

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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.

Resource links: 

debiopharm.com

Tanja's LinkedIn

Debiopharm's investment in VeriSIM

VeriSIM Life website

Qualio

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

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

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

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

Music by keldez