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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https://forms.gle/uUH2YtCFxJHrVGeL8

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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
Pre

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

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

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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/

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

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https://forms.gle/uUH2YtCFxJHrVGeL8

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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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https://forms.gle/uUH2YtCFxJHrVGeL8

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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

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

Music by keldez

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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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

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

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

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

Resource links: 

http://smarttab.co/

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

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

https://twitter.com/Veloce_SmartTab

Qualio

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

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

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

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

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

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

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

Show notes:

https://abpro.com/

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

Qualio

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

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

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https://forms.gle/uUH2YtCFxJHrVGeL8

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

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

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

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

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

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

Links:

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

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

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

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

Show notes:

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

Music by keldez

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

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

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

Music by keldez