Xtalks Life Science Podcast

In this episode, Vera talked about how a couple of direct-to-consumer TV commercials have helped a medical device company, Axonics, establish its reputation in the non-drug incontinence therapy space. Around 87 million adults in the US and Europe have overactive bladder and it is estimated that an additional 40 million adults have fecal incontinence. Axonics offers innovative sacral neuromodulation (SNM) systems that are approved by the US Food and Drug Administration (FDA) for the treatment of bladder and bowel dysfunction. The team discussed Axonics Therapy and the occurrence of non-drug (medical device) TV ads.

This episode features an interview with Cody Simmons, CEO of DermaSensor, a health technology company that aims to launch the world’s first point-and-click skin cancer detection tool for primary care providers.

In this episode, Ayesha talked about new rules that the US Environmental Protection Agency (EPA is proposing for curbing ethylene oxide emissions from sterilization facilities. The agency says the new guidelines would help reduce emissions by 80 percent, which is particularly important for communities that live near sterilization plants and workers who work at them. Ethylene oxide is a known carcinogenic, with long-term exposure to the odorless, colorless gas being associated with cancers including breast cancer and myeloma among others. The gas is used to sterilize medical equipment as well as spices. Hear about the new proposed rules and industry reactions to them.

This episode features an interview with Wei-Li Shao, President of Omada Health.

Omada Health is a provider of virtual care solutions focused on common chronic conditions, including both type 1 and type 2 diabetes, hypertension and musculoskeletal. As a virtual-first chronic care provider, the company helps members make lasting changes to improve health and reduce care costs for organizations.

Wei-Li is a global executive leader with over 20 years of experience building and leading biopharmaceutical and diagnostic imaging businesses in the United States, New Zealand, China and Taiwan. He joined Omada Health in 2019 following an 18-year career as an executive at Eli Lilly and Company.

Hear more about Omada Health and its commitment to quality virtual care in this episode.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this episode, Xtalks’ senior editorial staff discuss how the pharmaceutical industry has changed – and stayed the same – in the last 2 decades. Sarah talks about the global value of the pharmaceutical industry in 2002 versus today and which companies made the top 3 based on revenue.

Sarah also shared the top-selling drugs in 2002, 2012 and 2022, and how much the industry as a whole has invested in R&D in those years. The team discusses the number of new drugs and biologics approved by the FDA each year, and debates whether the regulator will be able to keep up with growing submission numbers and the expectation of speedy approval decisions. 

The team also talked about the role of Xtalks in knowledge dissemination and facilitating meaningful conversations in the pharma industry through webinars, written content, videos and, of course, this podcast!

To read more, visit Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History. For a closer look at the stats discussed in this episode, check out this infographic.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Manu Garg, VP, Head of Healthcare Consulting at Definitive Healthcare. Sarah and Manu discussed the transformative role of healthcare commercial intelligence in the industry today, and how machine learning (ML) and artificial intelligence (AI) are changing care delivery for patients. 

As new drug development is increasingly focused on targeted therapies for rare diseases and other indications with limited patient pools, healthcare commercial intelligence can help companies find their target market and help direct resources. Manu explained how both large and small pharmas, biotechs and medtechs can benefit from Definitive Healthcare’s SaaS-based tools.

Manu explained how AI is helping to predict tumor mutations so that cell and gene therapies can be targeted to individual patient’s needs, realizing the true promise of “personalized medicine.” He also discussed why the healthcare sector needs to adopt new ways of using patient-generated device-based health data to bring care to patients when and where they need it.

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Howard Look, CEO and co-founder of Tidepool, a non-profit organization that has a range of software tools for people with diabetes and the clinics that serve them. 

Tidepool recently received US Food and Drug Administration (FDA) clearance of Tidepool Loop, an automated insulin dosing app meant for the management of type 1 diabetes in patients who are six years of age and older. Howard spoke about the FDA clearance and discussed how Tidepool Loop addresses an unmet need in the type 1 diabetes space.

Howard shared his story about his personal connection to diabetes and what prompted him to start Tidepool. He discussed his strategy for engaging stakeholders — the patients, health care providers, caregivers and payers — to pave the way for individuals with type 1 diabetes to access Tidepool Loop.

Hear more about Tidepool Loop and Tidepool’s continuing work in the diabetes management space.

Read more here:

Tidepool Loop Is FDA Cleared as an Automated Insulin Dosing App for Type 1 Diabetes

For more life science and medical device content, visit the Xtalks Vitals homepage.

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This episode features an interview with Diarmuid Flavin, Chief Operating Officer (COO) of Neuromod, a Dublin-based medical device company specializing in the treatment of tinnitus, a condition known as “ringing in the ears.” Tinnitus is believed to impact between 10 to 15 percent of adults worldwide.

In this episode, Ayesha talked about the FDA approval of Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy, a leading cause of blindness. The condition is an advanced form of dry age-related macular degeneration (AMD) for which there have been no treatment options up until this recent approval. Hear more about the drug, including some questions about its clinical benefit.

Ayesha also talked about the FDA’s emergency use authorization (EUA) of Lucira Health’s over-the-counter (OTC) combination COVID-19 and flu diagnostic that can be administered at-home. The molecular PCR test is the first at-home combination test that can differentiate and detect the Influenza A, B and SARS-CoV-2 viruses in 30 minutes or less. The editorial team discussed the utility of the test, including settings in which they may be useful in and whether they may even be needed at all.

Read the full articles here:

Apellis’ Syfovre Approved as First Treatment for Geographic Atrophy Despite Uncertain Clinical Benefit

FDA Authorizes First At-Home Combination COVID and Flu Test

For more life science and medical device content, visit the Xtalks Vitals homepage.

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In this week’s Xtalks Life Science podcast episode, Sarah spoke with Doug Biehn, Chief Commercial Officer at Cala Health, a bioelectronic medicine company that develops wearable neuromodulation therapies.

The company’s lead product, Cala Trio, was approved by the US Food and Drug Administration (FDA) in 2018 for transient relief of hand tremors in adults with essential tremor (ET).

Tune into the episode to learn more about Cala Health’s individualized prescription neuromodulation therapy. Doug discussed the day-to-day struggles of patients with ET and the challenges they face when seeking medication for their condition. Doug also shared the benefits of Cala Trio for the relief of hand tremors and how company is committed to ensuring all patients have access to this life-changing neuromodulation therapy.

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