Vial, a next-generation contract research organization (CRO), created a Biotech-focused podcast called First in Human (FIH) that interviews industry leaders and investors to learn about their journey to in-human clinical trials. FIH features a wide range of industry leaders pushing the envelope of what we previously thought was possible. Our CEO and Co-Founder, Simon Burns, and team have facilitated diverse and eye-opening conversations with remarkable individuals transforming the biotech space.

Below, we highlight the top 10 insights from conversations with our expert FIH guests.

1. Mark Schwartz (Virgo, CEO & Co-Founder)

Real-World Data and Artificial Intelligence: The Future of GI Trials

Matt Schwartz is the CEO and Co-Founder of Virgo and was featured on Episode 5 of Fih Biotech Podcast. Schwartz, a biomedical engineer by training, previously worked as a product manager in minimally invasive spine surgery and robotic surgery spaces. He recognized the need for better data infrastructure to capture video from endoscopic procedures and founded Virgo in 2017. The company aims to help gastroenterologists record their own procedure videos at scale for research projects, training initiatives, quality improvement initiatives, and day-to-day care.

Schwartz discusses the challenges of conducting clinical trials in the gastrointestinal (GI) research space, with a particular focus on inflammatory bowel disease (IBD), due to their highly procedure-oriented nature. Although IBD has quite a widespread disease prevalence, he also highlights the difficulties of enrolling patients for these studies. However, despite these obstacles, Schwartz is hopeful for the future, expressing excitement about leveraging real-world data to improve study designs and applying innovative artificial intelligence (AI) tools to incorporate decentralized clinical trial principles. To end off, he emphasizes the future of clinical trials is focusing on optimizing Patient selection and meeting expected enrolment rates.

“I think it’s obviously really exciting…[GI is] just starting to get the attention it deserves from a technology perspective…there are definitely ways you can leverage real-world data potentially to just inform better trial design going forward…I love that people are pushing on it and look forward to seeing data proving that [AI is] viable…”

Listen to the full episode here.

Frank Watanabe (Arcutis Biotherapeutics, CEO & President)

A Gap in Derm Trials: Improving Therapeutic and Patient Diversity

Frank Watanabe, the CEO and President of Arcutis Biotherapeutics, was the guest on Episode 3 of FIH biotech podcast. Arcutis is a recognized leader in delivering innovative treatment to patients with a wide range of dermatological challenges, including atopic dermatitis, vitiligo, and plaque psoriasis. He attributed the company’s success to having a clear strategy and focusing on biologically validated targets, best-in-class molecules, and people with deep dermatology expertise. Watanabe expresses his commitment to serving the dermatology space, believing skin diseases are often downplayed and that dermatologists deserve a dedicated company to address their needs.

Watanabe offers an informative and engaging discussion on the current state and future of dermatology treatments, as well as insightful advice for biotech founders on navigating the challenges of the industry. In addition to highlighting the importance of developing drugs that are both effective and safe with reasonable pricing, the conversation covers promoting diversity in clinical trials. In particular, he emphasizes the need to enroll individuals from various ethnic groups to generate data that would help dermatologists make informed decisions regarding the efficacy of drugs for different skin types. Watanabe also advises biotech founders to prioritize spending on essential projects and to conserve cash, as well as potentially relying on down rounds, to weather the storm during a turbulent market.

“It’s a really exciting time to be a dermatologist or dermatology clinician…I think there is a real burgeoning now of the R&D in the dermatology space…These are large populations and so drugs need to be widely available…[and] doctors need information on how drugs treat different ethnic groups…Everything is impacted when you have a dermatologic disease and dermatologists and the people they treat deserve companies that are focused solely on serving them…”

Listen to the full episode here.

Sam Whitaker (Mural Health, Co-Founder & Co-CEO)

Driving Patient Engagement with a Next-Generation Payment Solution

For Episode 23 of FIH biotech podcast, we sat down with Sam Whitaker, Co-Founder and Co-CEO of Mural Health. Whitaker comes from a particularly unique background, having started his career in transactional finance before co-founding several successful fintech companies. In particular, he highlights the challenges of building a vertically integrated payments business in a regulated industry like clinical trials, where it can be difficult for companies to break through and compete with the market leader.

Mural Health is using payments to drive engagement with participants and deliver value to sponsors, with the aim of creating a next-generation participant payments solution that offers a high NPS experience. Whitaker believes that leveraging the payment touchpoint with the participant can help drive patient retention, adherence, and enrollment rates. As a second-time founder, he reflects on the advantages his experience and relationships in the industry provide, but also acknowledges the uncertainty and fear of failure that come with starting a new venture. The podcast is a must-listen for those who want to learn more about the clinical trial space and its payment ecosystem.

“[I] wanted to create a payments product that did something additional than just moving money and creating more value for a specific industry…This gives us an opportunity to use payments as a hook. You have their attention; now, can we do something more for them that will also have a positive impact on the study…We’ve built a tech product that is meant to deliver features and benefits to the participant. If we do a really good job, we’ll make their lives delightful.”

Listen to the full episode here.

Margo Georgidas (Montai Health, CEO & Co-Founder)

Anthromolecules: Using Nature to Innovate in Chronic Disease

On Episode 26 of FIH biotech podcast, we hosted Margo Georgidas, the CEO and Co-Founder of Montai Health. Margo’s background is in technology, she previously served as CEO of Ancestry.com and President of Google Americas. This background has enabled her to bring a unique perspective to the biotech industry. Montai Health is revolutionizing the approach to chronic disease treatment by unlocking the power of nature with digital technology to create new therapies rapidly and repeatedly.

Georgidas explains the company’s unique approach to creating human-centered solutions against chronic disease grounded in Anthromolecules: molecules that have co-evolved with humans for hundreds or even thousands of years. She believes this approach presents an opportunity to reduce the cost in the ecosystem by improving clinical trial failure rates and shortening the time to market for new drugs. Ultimately, Montai Health is committed to engaging with the healthcare community, from providers to patient advocacy groups, to improve both the patient experience and chronic health outcomes.

“[Chronic disease is] a huge societal problem…It’s trillions in healthcare costs and an unsustainable burden on our society… [Our approach is] grounded on a privileged molecular starting point which we call Anthromolecules…Technology is enabling us to transform our ability to access what the power is in this nature…As we think about all the ways in which we’ll build knowledge, we hope to take our technology to as many areas as possible.”

Listen to the full episode here.

Viswa Colluru, Ph.D. (Enveda Biosciences, Founder & CEO)

Unlocking Nature’s Potential: Leveraging AI in Natural Drug Discovery

Tune in to Episode 11 of FIH biotech podcast to learn more about Viswa Colluru (Ph.D.), Founder and CEO of Enveda Biosciences, who is pioneering the use of nature’s bioactive chemistry in drug discovery. Colluru’s background in biology and his experience at Recursion Pharmaceuticals has given him a unique perspective on the challenges of drug discovery. Enveda is a relatively new entrant into the biotech space looking to tap into nature’s power to find new naturally occurring medicines.

Colluru shares his insights on the challenges in the discovery of candidates that work in humans and the importance of exploring natural products. He also discusses the use of AI and machine learning to access untapped chemistry in natural products. Colluru also emphasizes that more diversity in founders and funders in this space can lead to different and innovative ideas, particularly in orphan diseases. However, this quest for innovation is often hindered by inefficiencies in clinical trial designs; therefore, he underscores the need for more objective measures to combat this challenge. Ultimately, Enveda’s thesis is that nature is the best source of bioactive chemistry on the planet, and Colluru is working to unlock its potential.

“…Over 50% of medicines come from nature, yet 95% of nature is a chemical mystery… Enveda said let’s bring AI and machine learning to solve this problem…Five years from now, I’m hoping we don’t talk about biotech and techbio as two different things, and we just talk about humanity…to find new medicines.”

Listen to the full episode here.

Aneesh Chopra (CareJourney, President)

Data Democratization and the Importance of Collaboration

In Episode 29 of FIH biotech podcast, Aneesh Chopra, former CTO of the United States and current President of CareJourney, emphasizes the importance of utilizing healthcare data assets to help individuals navigate the healthcare system. CareJourney uses linked longitudinal databases to identify, benchmark, and ultimately reduce waste and inefficiency in healthcare delivery. By focusing on improving the performance of health systems, pharmaceutical companies, and networks, Chopra highlights the benefits of value-based care and its potential to reduce costs and improve patient outcomes.

In addition to his expertise in value-based care, Chopra also discusses the significance of public/private collaboration in the digital era. He emphasizes the need for open innovation and democratization of data, where datasets held by the government can be made available for the private sector. Examples of this include the multi-billion-dollar weather economy and the development of The Cures Act healthcare IT internet-based interoperability standards. Overall, CareJourney’s focus is on improving the performance of health systems, pharmaceutical companies, and networks. Follow Aneesh Chopra on CareJourney to learn more about his insights on healthcare delivery reform and public/private partnerships.

“Healthcare data held by the government might be useful to complement the wide-ranging and long-standing data pipelines that have been supporting the pharmaceutical industry through commercial means… Where we are right now is actively seeking partners who wish to work with us in an open and collaborative spirit…My broad goal is to eventually cross the chasm with open APIs, so we can deliver that kind of personalized experience…We’re not there yet, but we’re pushing to bring that vision to life.”

Listen to the full episode here.

Ganesh Padmanabhan (Autonomous AI, CEO)

Remembering Patient Centricity: AI Applications in Healthcare Data

Tune into Episode 31 of FIH biotech podcast to learn how Ganesh Padmanabhan, the CEO of Autonomous AI, is revolutionizing healthcare data analysis by applying human-centric artificial intelligence to the problem. He has spent 15 years in big tech at Intel and Dell, and after a corporate career, he co-founded a company called Molecular, which is about aggregating data to ensure better AI experiences with data. After a change of control and an exit late in 2020, Padmanabhan founded Autonomize AI to help healthcare innovators advance on healthcare data faster, better, and in a more contextual fashion, putting patients in the center of it.

Their platform is designed to assist with patient recruitment and retention for clinical trials, protocol design, and patient engagement. One of the key concerns in healthcare is privacy, which is why Autonomize AI uses self-hosted models in secure HIPAA-compliant environments to address privacy concerns. The company believes that generative AI is transformative for every industry, especially for healthcare, and they are determined to build a series of tools to leverage the latest and most innovative solutions. In a world where technology is rapidly changing, Padmanabhan and Autonomize AI are committed to focusing on the customer and keeping patient-centric design principles at the forefront of their work.

“Healthcare has always been about patient centricity and making sure you’re doing things for the patient…[Applying] technology to improve the human condition is probably the ultimate calling for any technologist… We are building a series of tools…[leveraging] the most innovative solutions, but then keep in mind your patient-centric design principles… if you believe in technology driving the greater good, that everybody has a better quality of life over time.”

Listen to the full episode here.

David Berry, M.D., Ph.D. (Valo Health, Founder & CEO)

Streamlining Drug Development & Optimizing Trial Designs with AI

David Berry (M.D, Ph.D.), Founder and CEO of Valo Health, joins Episode 18 of FIH biotech podcast to provide a glimpse into Valo’s work, as well as share insights into the potential for technology to transform drug development and improve clinical trials. Dr. Berry’s educational background in biological engineering from MIT and Harvard Medical School, along with his experience at Flagship Pioneering, has led him to focus on creating an integrated end-to-end drug discovery and development capability anchored around human data. Valo’s approach to using AI has the potential to transform the pharmaceutical industry by reducing the cost and time of drug development and increasing the probability of success.

Dr. Berry highlights the company’s current clinical trials, including a ROCK-12 inhibitor for non-proliferative diabetic retinopathy, and a functional S1P1-biased agonist for heart failure. He also discusses the potential for technology to drive efficiency in clinical trials, particularly in identifying and enrolling the right patients for a study. Dr. Berry believes that by streamlining this process, drug development can be accelerated, and patients can receive the treatments they need in a timelier manner. The pharmaceutical industry has traditionally been recalcitrant to adopting new technologies, but companies like Valo are paving the way for a new era of drug development that is faster, more efficient, and ultimately benefits patients.

“There’s a tremendous opportunity to drive efficiency in clinical trials… we were able to use our computational tools to try to predict which patients are most likely to progress from one stage to the next stage of diabetic retinopathy… This allows us to start matching up drug to patient benefit in ways that are better for the patient, for the health system, and we’re very excited about that.”

Listen to the full episode here.

Alex Zhavornkov, Ph.D. (Insilico Medicine, CEO & Co-Founder)

Maximizing Patient Benefit: Biotechnology in Drug Development

Episode 7 of FIH biotech podcast features Alex Zhavoronkov (Ph.D.), the CEO and Co-Founder of Insilico Medicine, a next-generation drug discovery company that utilizes artificial intelligence and machine learning to accelerate drug development. With a background in computer science and experience in the semiconductor and biotech industries, Zhavoronkov developed Insilico Medicine, a next-generation drug discovery company, to address age-associated diseases. With its cutting-edge technology, his company has established partnerships with industry giants like Pfizer and Sanofi and has recently moved its first asset into clinical trials.

In addition to discussing various aspects of biotechnology, Zhavoronkov touches on the potential of dual-purpose therapeutics and reprogramming technology; although still early in their development, these therapeutics could maximize patient benefit and lead to the discovery of potentially blockbuster drugs. The conversation also emphasizes the importance of validation and commitment to delivering drugs to patients for success in the industry. In particular, Zhavoronkov states that the industry needs to focus on developing drugs that target multiple disease pathways and prioritize patient benefit. Although advancing the capabilities of exciting new technology is a priority, he highlights the importance of understanding disease biology in-depth, as well as using biomarkers in clinical trials to ensure the right patient population is targeted. Overall, the discussion underscores the need for innovation, collaboration, and a patient-centered approach in biotech research and development.

“It feels like we’re, in a moment right now. This is the computational bio moment…Insilico, in addition to our own drug discovery we make the tools that we use internally available for the entire industry…many other technologies are available that allow you for pretty effective and efficient [drug] retrosynthesis planning…in our case our fundamental value in the company is patient first, so we want to ensure that we maximize patient benefit.”

Listen to the full episode here.

Keith Flaherty, M.D. (Scorpion Therapeutics, Founder)

Overcoming Challenges in Clinical Trial Infrastructure

Keith Flaherty (M.D.), the founder of Scorpion Therapeutics, joins us as our featured guest in Episode 2 of FIH biotech podcast to delve into several key topics that are shaping the future of biotech, particularly in oncology. With over 22 years of experience at the forefront of targeted therapy in oncology, Dr. Flaherty discusses the need for better tools to help healthcare professionals monitor patient experience during therapy, the importance of ctDNA in cancer treatment, and the potential for small biotech companies to drive innovation in oncology.

First, Dr. Flaherty emphasizes that current monitoring methods are often inadequate and that there is a pressing need to find more accurate and efficient ways to track patient progress. Second, ctDNA is a promising component of cancer treatment and he discusses the many ways it can be used in diagnosis, monitoring, and guiding therapy decisions. Although, its applications still require more research and are not yet fully understood in the community. Lastly, Dr. Flaherty discusses the value of combining therapeutic development, diagnostics, and data management under one roof to help small biotech companies advance the field. He notes these companies were often more flexible and forward-thinking than their larger counterparts, as well as well-positioned to develop new effective cancer therapies that can improve patient outcomes. Dr. Flaherty’s detailed insights in this episode emphasize the need for the development of a new ecosystem in the drug development process that combines therapeutic and diagnostic development with data utilization.

“Biotech companies are the driver of innovation [in] oncology… [There] is critical information to guide drug development and execution of clinical trials. But the inefficiency of how that data is jailed up, I mean, in our incredibly antiquated systems on our end… we’re coming out of an era of just enormous inefficiency…we’re just really starting to have a view on how to create some real efficiency here.”

Listen to the full episode here.

Interested In Joining Our Biotech Podcast?

If you want to join these ten transformative influencers and many more in sharing biotech innovations with First in Human, contact us at [email protected]!