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The Bio Report

The Bio Report podcast, hosted by award-winning journalist Daniel Levine, focuses on the intersection of biotechnology with business, science, and policy.

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FDA Wants Industry to Guard Against Cybersecurity Risks of Medical Devices

As medical device makers are building network connectivity and intelligence into their products, they are adding new vulnerabilities and risks as well. The U.S. Food and Drug Administration has just issued draft guidance for postmarket management of cybersecurity of medical devices. It follows previous guidance on premarket submissions for management of cybersecurity in medical devices. We spoke to Russell Jones, partner with Deloitte & Touche, cyber risk leader for the firm’s State of California Practice and co-leader of the firm’s medical device safety and security practice, about the FDA actions, how these connected devices can be exploited by hackers, and what medical device makers can learn from industries that have already faced these issues.


21 Jan 2016

Rank #1

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CrowdMed Enlists the Wisdom of Crowds to Solve Medical Mysteries

For many patients with rare and difficult to diagnose conditions, it can take many years and many doctors to find a correct answer. CrowdMed is trying to offering an alternative to patients by allowing them to tap the wisdom of crowds and letting medical detectives who sign on to the site try to find the right answer. We spoke to Jared Heyman, founder and CEO of CrowdMed, about the problem with the traditional way doctors diagnose patients, the wisdom of crowds, and the case for making medicine a team sport.


9 Jul 2015

Rank #2

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Jimmy Carter's Final Wish: Eradicating Guinea Worm

President Jimmy Carter, at a recent press conference discussing his cancer diagnosis and treatment, expressed his wish to outlive the last Guinea worm. The Carter Center, since 1986, has led a global effort to eradicate Guinea worm disease with great success and its goal is within reach. We spoke to Ernesto Ruiz-Tiben, director of The Carter Center’s Guinea Worm Eradication Program, about its efforts, the history behind it, and what lessons can be drawn in combating other public health threats throughout the world.


27 Aug 2015

Rank #3

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Enlisting the Immune System in the Battle Against Alzheimer's

Alzheimer’s disease is the sixth leading cause of death and it continues to rise. Today it is costing the U.S. healthcare system $200 billion a year and there are no therapies that prevent, halt, or reverse the disease’s progression. United Neuroscience is taking a new approach to the disease with its endobody vaccines, a class of synthetic biologics it is developing to treat Alzheimer’s and other CNS conditions. We spoke to Ajay Verma, chief medical officer of United Neurosciences, about Alzheimer’s, the company’s platform technology, and the promise of enlisting the immune system in the fight against CNS diseases.


8 Jun 2017

Rank #4

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Overcoming the Delivery Challenges of Gene Therapy

Gene therapy represents an expanding area of potential to correct and modulate the activities of genes driving diseases. One of the major challenges these groundbreaking technologies face, though, is delivering them to where they need to go within the body to be effective. Nanogenic Solutions believes its solved the problem with its LipTide technology that marries a payload carrying-lipid with synthetic peptides that target cell suface receptors and allow DNA or RNA into the cell. We spoke to Simon Newman, director of preclinical development for Nanogenic Solutions, about the challenges of gene therapy, the LipTide technology, and what it could mean for advancing a range of RNA and DNA therapies.


1 Jun 2017

Rank #5

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Why Big Pharma Hasn't Been Able to Fix Its Revenue Gap with M&A

It was an unprecedented year for M&A activity in the life sciences, but even though Big Pharma returned to dealmaking after largely spending 2013 on the sidelines, it’s been unable to close its growth gap through acquisitions. Specialty Pharmaceutical and Big Biotech have been building muscle and key acquisitions that could address growth for Big Pharma continue to be snapped up by competitors. We spoke to Jeff Greene, EY’s Global Life Sciences Transaction Advisory Services Leader, about his firm’s new M&A report, at what point the growing price of assets becomes too rich, and what the outlook is for 2015.


22 Jan 2015

Rank #6

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Should Investors Temper Their Enthusiasm for CAR-T Therapies

CAR-T cell immunotherapies seek to harness the body’s immune system to fight tumor cells. The promise of this new class of therapies has ignited investor’s imaginations, but a new report from EP Vantage argues that the enthusiasm that has driven valuations of CAR-T companies should be tempered by an eye towards the risks. We spoke to Jacob Plieth, report author and senior reporter for EP Vantage, about the promise of these therapies, what we know about their safety and efficacy, and why the muddy intellectual property landscape is a concern.


5 Feb 2015

Rank #7

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Why Life Sciences M&A Should Heat up This Year

A surge in merger and acquisition activity in the life sciences is expected this year, according to a new report from EY. The company annual M&A Firepower Report says increased competition, new sources of capital, and the change in U.S. corporate tax laws will drive greater dealmaking in the sector. We spoke to Jeff Greene, EY global life sciences transaction advisory services leader, about the report, the drivers of the activity, and why nontraditional players in the sector may be in a better position to make a splash in 2018.


11 Jan 2018

Rank #8

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Carrying Therapeutic Payloads Across the Blood-Brain Barrier

The blood-brain barrier provides essential protection against pathogens while allowing needed oxygen and nutrients to pass. However, one challenge it presents is getting therapeutics delivered to the brain and central nervous system. Bioasis Technologies has developed a way to attach fusion proteins to drugs to allow them to pass the blood-brain barrier. We spoke to Mark Day, CEO of Bioasis, about its platform technology, what is known about it from testing to date, and the potential therapeutic implications of being able to deliver drugs systemically that can reach the central nervous system and brain.


12 Jul 2018

Rank #9

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What a Decade of Investment Tells Us about the Health of Biotech

A detailed view of funding of emerging therapeutic companies over the past ten years shows despite a rebound in venture financing, companies continue to struggle to find early-stage money. Nevertheless, the report shows the overall health of investment in the sector is thriving. We spoke to Dave Thomas, senior director of industry research and analysis for the Biotechnology Industry Organization and co-author of the report, about BIO’s findings, what therapeutic areas attracted the most financing, and what impact the capital markets have had on partnering and licensing activity.


25 Jun 2015

Rank #10

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What's in Store for the Biotech Industry in 2015

As the biotech industry ramps up for the JPMorgan Healthcare conference, we continue our conversation with TheStreet.com’s Adam Feuerstein. In part two of our conversation, we look ahead to what’s in store for the biotech industry in 2015. We get Feuerstein’s thoughts on who and what to watch in the new year, what Big Pharma company may be the target of a takeover, and whether fights over drug pricing will put an end to biotech’s bull market.


31 Dec 2014

Rank #11

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Turning Cold Tumors Hot

One reason immunotherapies fail is because of the ability to tumors to alter the microenvironment in which they exist and hide themselves from detection by the immune system. In some indications, as few as 20 percent of patients benefit from checkpoint inhibitors. Oncolytics Biotech is developing pelareorep, an immune-oncolytic virus that activates the innate and adaptive immune systems, triggering inflammation in the tumor, and overexpressing checkpoints to increase the number of patients that can benefit from the use of checkpoint inhibitors. We spoke to Matt Coffey, president and CEO of Oncolytics Biotech, about Pelareorep, how it works to treat cancer, and why it can make checkpoint inhibitors more effective.


9 Jan 2020

Rank #12

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Regeneron Embraces Genetics as Fundamental to Drug Development

Drug discovery and development is a slow and costly process, but the Regeneron Genetics Center represents a drugmakers’ bet that harnessing large amounts of genetic data can point the way to better targets, greater success rates, and ultimately better drugs. We spoke to Aris Baras, vice president and head of the Regeneron Genetics Center ahead of the Precision Medicine World Conference 2017 in Silicon Valley about how large genetic studies are brining fundamental change to the drug development process, the approach Regeneron is taking, and why its becoming a necessary element of drug development today.


19 Jan 2017

Rank #13

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Our Annual Biotech Review/Preview with STAT's Adam Feuerstein

A holiday tradition at The Bio Report is to take a moment to reflect on the year past and look ahead to the new year with Adam Feuerstein, senior writer and national biotech columnist for STAT. We talked to Feuerstein about some of the highs and lows of the year in biotech, a few of the big stories he followed, and the big fourth quarter for biotech stocks. Feuerstein offers us a look at the best and worst CEO of 2019, the upcoming JPMorgan conference, and what to watch in 2020.Last week we released an additional episode of the podcast that featured the Himalayan Cataract Project (https://soundcloud.com/levine-media-group/an-effort-to-eradicate-preventable-blindness), which is working to eradicate preventable blindness throughout the world. There are 18 million people in the developing world who are unable to perform the tasks of daily living because of easily treatable cataracts that can be addressed with a fast and inexpensive procedure. We’re helping raise $100,000 through a GoFundMe Campaign (https://gate.sc/?url=https%3A%2F%2Fcharity.gofundme.com%2Fo%2Fen%2Fcampaign%2Fgiving-the-gift-of-sight-in-ethiopia-and-eritrea&token=26d7bc-1-1577387027965) to bring the organization back to Ethiopia and Eritrea, where on a recent trip to the region they performed 4,300 sight-saving surgeries. If you’d like to learn more, have a listen to the special episode in our feed. We’ll include a link at the bottom of this week’s episode to the campaign. Thanks to all who gave and if you haven’t, we encourage you to consider making a contribution to this cause.


26 Dec 2019

Rank #14

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The Year in Biotech and What to Watch in 2019

As the year draws to a close, we continue what’s become an annual tradition and look back on the year in biotech and ahead to the J.P. Morgan Healthcare Conference and beyond with Adam Feuerstein, senior biotech writer for STAT News. Adam tries to make sense of a puzzling year for biotech that seemed full of contradictions, offers some thoughts on the highs and lows of the past 12 months, and discusses what he’ll be watching for during the J.P. Morgan Healthcare Conference.


27 Dec 2018

Rank #15

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Biotech Industry Moves Towards a Patent Cliff

Scrutiny of drug prices around the globe is expected to exert growing pressure on the biopharmaceutical sector. EvaluatePharma, in its recently issued World Preview 2017, Outlook to 2022 says that despite consensus forecasts for worldwide drug sales hitting more than $1 trillion in 2022, it does reflect a drop from the same period last year. We spoke to Antonio Iervolino, head of forecasting for evaluate pharma, about the new report, the outlook for the sector and the potential for a new patent cliff with the advent of biosimilars.


13 Jul 2017

Rank #16

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Why the Diversity of Genomic Data Matters

The lack of diversity in genomic data has been an issue of growing concern. It threatens to limit the benefits from the massive investment that has been made to date to transform biomedical research, drug development, and the clinical care of patients. We spoke to Jonas Korlach, chief scientific officer of Pacific Biosciences, about the problem, how it’s being addressed, and the role advancing technology can play in gleaning greater insights from the genomes that are analyzed.


17 May 2018

Rank #17

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Why Biomarkers May Be the Key to Immuno-Oncology Success

Developers of cancer immunotherapies are in a race to find combinations that can distinguish their products for specific indications. Biomarkers, which have played an essential role in the development of targeted therapies, have proven a much more complex challenge in the realm of immuno-oncology. Nevertheless, biomarkers may be the key to winning the competitive battles in immuno-oncology. We spoke to Rachel Laing, managing partner of Bionest Partners, about the role for biomarkers in immuno-oncology, why immuno-oncology companies have much at stake in the hunt for biomarkers that can better select patients for their therapies, and the role biomarkers will play in the move toward real-time oncology.


10 May 2018

Rank #18

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Shaping the Emerging Bioeconomy

The ability to engineer biological systems to replace chemical processes is making the promise of the emerging bioeconomy a reality. Some of the leading industry players, though, see a growing need to have a voice in the policy arena and have formed the Bioeconomy Alliance to ensure the sector can flourish and realize its potential. We spoke to Jason Gammack, chief commercial officer of Inscripta and a founding member of the Bioeconomy Alliance, about how synthetic biology is reshaping the economy, why there is a need for this new organization, and the issues it will address.


7 Nov 2019

Rank #19

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Why Drug Companies May Soon Become Health Technology Companies

The convergence of technology and life sciences, changing consumer behavior, and increasing pricing pressures on drug and device makers are forcing these companies to rethink business models and how they derive value from their products, according to a new EY Progressions 2018 report. The report argues that life sciences companies will no longer be able to rely exclusively on product-centric innovations, which face diminishing returns as health systems wrestle with cost constraints. We spoke to Pamela Spence, EY global life sciences industry leader, about the report, what a growing trend in collaborations between technology and healthcare companies may say about where the industry is heading, and why the future of life sciences companies may be as health technology companies.


15 Mar 2018

Rank #20