The BioWorld Insider Podcast

Karen Carey, BioWorld managing editor and chief analyst, takes a look at the numbers from the first half of 2024. She finds the first six months to be healthy for the biopharma market while the rest of the year is populated with question marks that include the U.S. presidential election and potential interest rate cuts.

Two costs of developing drug candidates have been upended by new research from the Tufts University School of Medicine's Center for the Study of Drug Development. New data have produced some very different numbers than you might expect in the cost of a single day of a clinical trial and of missing a day to generate prescription drugs sales. The center's director, Ken Getz, spoke to the BioWorld Insider podcast about updating the outdated numbers and what it means for companies and investors.

Chris Barden, a co-managing partner at MPM Bioimpact who manages the firm's Bioimpact Equities and Oncology Impact funds, shares her insights into the upcoming American Society of Clinical Oncology (ASCO) conference in Chicago. She talks about the major trends in oncology, including development of antibody drug conjugates, which is currently the hottest area in cancer treatment. Another highlight she expects from ASCO will be development in radiotherapy treatments, particularly in prostate cancer. Bardon provides a guide for attendees to use in setting their schedules for the year's biggest cancer conference and what to watch for in the future.

A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O'Heeron offers insight into the company's unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren't attractive enough for Fibrobiologics' management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O'Heeron said was worth the effort. “We couldn't be more happy with the outcome,” he said.

BioWorld Managing Editor Karen Carey joins the podcast to talk about the numbers from the first quarter of 2024, along with a look back at some 2023 deals and indicators that signal better times are on the way. Financings for the quarter were better than expected, sporting some of the best numbers of the past 13 years. It's part of a larger trend, Carey says, of investors being a lot pickier about where they put their money and demanding better data. The result is a strengthened market and a better outlook.

In one of the biggest financings of the year so far, former Prometheus Biosciences Inc. CEO Mark McKenna helped raise $400 million to launch a new company, Mirador Therapeutics Inc. He didn't sit on the sidelines for long after Merck & Co. Inc. bought Prometheus for $10.8 billion in 2023. He recruited key Prometheus executives to focus on Mirador's genetic approach to drug discovery and precision medicine. McKenna said there was too much left undone to just hang back. In this BioWorld Insider episode, he talks about the new company and the multi-billion-dollar drugs that he believes provide sub-optimal efficacy compared to the tailor-made therapies he wants to develop. He also has deep insights into drug pricing and why the investment market is so tough on companies that don't have A-plus science and teams.

Because artificial intelligence is such a new technology it comes with a mountain of unknowns. Integrating it into a pharmaceutical company presents a unique series of challenges, as a new survey from Verix shows. The report is based on responses from directors, vice presidents and C-suite executives in sales, marketing and brand management at pharmaceutical companies in the U.S. that have more than $100 million in annual revenue. Doron Aspitz, the CEO of Verix, talked about the new findings with the BioWorld Insider podcast and the profound shift that executives face as the new technology takes over an entire industry. 

One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc. and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.

Google's Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Among the gems and eyebrow raisers is talk of dramatic reductions in the time it takes to identify the right molecule for development and how digital clinical trials in the not-too-distant future will substantially shrink study times. This episode also provides a preview of the annual Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a gold sponsor of the Oct. 4-6 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Penberthy.

Guests Karen Carey, BioWorld's managing editor, and Mike Ward, Clarivate's global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit.

A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. While the competition started at the beginning of the year with the launch of Amgen's Amjevita, the true test of the strength of the competition is taking place now as other adalimumab biosimilars hit the market. There are eight launching a challenge to Humira and all are likely to have a lower price tag than Humira's. Discussing the biosimilars landscape with BioWorld Staff Writer Lee Landenberger are BioWorld Regulatory Editor Mari Serebrov, who has written extensively about biosimilars and these launches, and also Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, which recently released its second quarterly report on biosimilar market penetration and pricing across various therapeutic spaces.  

Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.

It used to be a lot easier to find partners. After two years of strong dealmaking, the volume and value of partnerships slid in the first quarter of 2023. M&As also are down compared to prior years. But there are some reasons to be cheerful. Looking at first quarter numbers and surveying the big picture on this BioWorld Insider podcast are Karen Carey, BioWorld's managing editor and senior data analyst, along with Tim Shannon, a general partner at Canaan. Carey just wrote about biopharma deals and completed M&As in the first quarter. Shannon, who's been with Canaan since 2009, has a new fund sporting $850 million in new capital, including an oversubscribed $650 million fund for seed and series A financings. They both offer their insights into the first quarter's numbers and what may lie ahead. Hosted on Acast. See acast.com/privacy for more information.

It all goes to show how a good idea can't be kept down. Madam Curie started radiopharmaceuticals in the late 1800s and now it's a multibillion-dollar industry. BioWorld's seven-part series on a new era of radiopharmaceuticals reveals their increasing importance as part of cancer treatments because they have fewer side effects and cause far less damage to tissue than previously. The big idea is taking the hallmarks of two cancer therapies – radiology and chemotherapy – and merging them. That's what makes this evolving technology a disrupter. The series, led by BioWorld Staff Writer Tamra Sami, takes a close look at the different radiopharmaceutical moieties and the science behind them, the supply chain vulnerabilities, the regulatory landscape, the patient journey and therapies in the pipeline. Sami summarizes this special report in the latest edition of the BioWorld Insider Podcast. Hosted on Acast. See acast.com/privacy for more information.

As James Peyer, the CEO of Cambrian Biopharma Inc., watched his grandfather fail every cancer treatment and pass away, he also saw the structure of his future company being born. Waiting until people became sick was the wrong way to treat disease, he found. Instead, Cambrian was created to develop anti-aging therapies, a unique business model that fits the new field of geroscience. To do that, Cambrian became a biotech business, a VC fund and an incubator. Peyer spoke to the BioWorld Insider Podcast about his pipeline and how he goes about fundraising in a little understood field. Hosted on Acast. See acast.com/privacy for more information.

After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity.  Hosted on Acast. See acast.com/privacy for more information.

After many years of research and development, drug-induced weight loss has matured into a viable therapeutic option. But do the drugs directly help people become healthier or is it the weight loss? There are longstanding concerns that the health effects of weight might be overrated. And new studies show fitness improves health outside of weight. So, can a person still be considered healthy despite being over a “normal” weight? How will future medical science consider what is called the obesity epidemic? In this edition of the BioWorld Insider podcast, BioWorld Science Managing Editor Anette Breindl, discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness which in many ways goes against the mainstream health care state of mind about obesity. Download transcript

We wrapped up 2022 and are preparing for 2023 on this BioWorld Insider podcast. Staff writer Lee Landenberger talked to four CEOs, visionaries of companies producing new science and drug development. The CEOs offered their insights into what happened this year and looked at the challenges and opportunities for next year. Karen Zaderej, CEO of Axogen Inc., detailed a successful phase III study of its peripheral nerve repair product, Advance Nerve Graft, despite staffing challenges at hospitals. Sean Bohen, CEO of Olema Oncology Inc., whose company is developing therapies to treat women's cancers, reflected on how Olema overcame financing challenges.Rob Ross, the CEO of Surface Oncology Inc., spoke about how equity funding has dried up and has forced Surface to be creative in order to keep moving forward with its antibody against IL-27 to treat non-small-cell lung cancer.Rob Etherington, the CEO of Clene Nanomedicine Inc., revealed how his company will be leaning into strategic M&A and licensing opportunities to keep its multiple sclerosis candidate, which can improve function on top of standard-of-care MS drugs, moving forward. Hosted on Acast. See acast.com/privacy for more information.

An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Lanthier discussed challenges facing companies developing psychedelic treatments and how to overcome the one-size-fits-all, trial-and-error approach to mental health treatment that often seems stuck in the past. Hosted on Acast. See acast.com/privacy for more information.

BioWorld writers bring you the details of new R&D alliances, financings, IPOs and M&A every day. These stories are the heartbeat of the relationships between industry giants and their smaller, more innovative peers. But what's the top-line read for dealmaking these days? With nearly 1,000 biopharma deals completed through early August amid a volatile economic climate, there's a lot to talk about. Join the BioWorld Insider podcast as we talk with Senior Analyst Karen Carey, whose data-driven research delivers a detailed picture of the ups and downs. For starters, the sector has seen sharp declines this year in stocks and less money being raised. “What we are seeing seems to be a correction of the intense enthusiasm – the zeal for biopharma during 2020 and 2021 when nobody knew what was going on with COVID,” Carey said. Our GDPR privacy policy was updated on August 8, 2022. Visit acast.com/privacy for more information.

In Extending the human lifespan, a BioWorld special report, the team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing potential “Fountain of Youth” candidate drugs. In this episode of the BioWorld Insider Podcast, the team discussed the report's highlights and key takeaways. In what could be a holy grail for humanity, anti-aging drugs would simultaneously reduce the risk of multiple age-related illnesses in one. BioWorld found that investments in life-extending drugs and the number of clinical trials are on the rise. Can we hopscotch over the many diseases of aging? The impact could be staggering. Equitable access to drugs and therapies tackling aging could reduce health care costs in a major way and improve quality of life. See acast.com/privacy for privacy and opt-out information.

As multidisciplinary care extends survival and improves the quality of life for people with amyotrophic lateral sclerosis (ALS), can a host of new ALS drugs vying to slow its progression make a difference? A surprise extension of the U.S. FDA review for Amylyx Pharmaceuticals Inc.'s AMX-0035 to review new data, plus near-term readouts from a major ALS platform trial may soon provide answers. Join the BioWorld Insider podcast as we talk with executives from Amylyx and Clene Inc., and a key Penn State ALS expert on what the future of medicine may hold for ALS patients. See acast.com/privacy for privacy and opt-out information.

Could investments in biopharmaceutical companies in 2022 be as aggressive as 2021, which saw a record 1,968 biopharma deals worth about $213.5 billion? So far, 2022 may be the lowest financing year since 2017 overall. But, drilling down to venture capital, private companies raised $5.7 billion in Q1 through 129 transactions, making it the second-best first quarter in history with 2021 at the top. Apparently, investors and private companies have maintained their appetite into 2022. Simultaneously, deal volume is down but values are up, which means that biopharma executives are realizing they can gain access to innovative technologies for a lot less money through licensings and collaborations. BioWorld Senior Analyst Karen Carey explores the data with staff writer Lee Landenberger, explaining what happened in Q1 and where Q2 is headed. See acast.com/privacy for privacy and opt-out information.

The CDC's Advisory Committee on Immunization Practices (ACIP) always had a full schedule, but COVID-19 amped it up tremendously. Some public health policy observers wonder whether the increased responsibility meets the CDC's needs and if the CDC pays enough attention to the committee. William Schaffner, professor of preventive medicine in the Department of Health Policy as well as professor of medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine, joined ACIP in 1982. He has deep insight on how the committee works as the National Foundation for Infectious Diseases' liaison to ACIP. He joined BioWorld staff writer Lee Landenberger to talk about the committee and how it makes the big decisions that ultimately affect public health policy. See acast.com/privacy for privacy and opt-out information.

With the study of long COVID-19 continuing to evolve, the BioWorld team is taking a closer look at the condition -- a complex syndrome affecting more than 100 million people globally -- and what's being done about it. In this episode, BioWorld Senior Science Editor Anette Breindl and Staff Writer Lee Landenberger, fresh off writing a pair of detailed stories about these issues, join us to talk about how consensus around what long COVID is has emerged. Why is that consensus important and what sort of treatments are in the pipeline? Are patients moving closer to the center of the conversation as we continue to navigate this pandemic, which the World Health Organization reminded us recently is very much not yet over? Listen to find out! See acast.com/privacy for privacy and opt-out information.

The increasing use of artificial intelligence (AI) technologies across all stages of drug development is presenting interesting new challenges around the world. One key question of growing importance: Can an AI algorithm be an inventor? If so, can the AI system apply for or receive a patent? We spoke to Ryan Abbott, a professor of law and medicine, as well as the leader of the Artificial Inventor Project and Jim Belfiore, senior vice president of innovation at Clarivate, to learn more about the implications of these questions and how patent offices and courts are handling them so far. What's at stake in recognizing a more prominent role for AI in the innovation sphere? Could AI inventorship potentially create IP asset inflation? Listen to find out. See acast.com/privacy for privacy and opt-out information.

In another record year for biopharma fundraisings, more money than ever pulsed through the industry. The volume and value of pharma IPOs and venture capital financings are at their highest levels. Private financings for 2021 easily outdistanced those from 2020, much of it powered by SPACs. Where is it all going in 2022? Two experts joined BioWorld to share their thoughts. Kleanthis Xanthopoulos is a co-founder and executive chairman of Shoreline Biosciences. For more than 20 years he's been an executive, company founder, CEO, investor and board member in biopharma research. Also joining the discussion was Joe Hernandez, CEO and executive chairman of Blue Water Vaccines, who founded or led eight health care and pharmaceuticals companies. See acast.com/privacy for privacy and opt-out information.

The FDA's June 2021 approval of Aduhelm (aducanumab), the first plaque-targeting therapy, rattled the company, regulators and the market. BioWorld brought together two experts to get their thoughts as each is involved in developing vaccines or treatments for Alzheimer's or Parkinson's disease. Michael Agadjanyan is the president of Nuravax Inc., which is developing antibodies for preventing Alzheimer's and Parkinson's disease. We also spoke with Robert Glanzman, who is chief medical officer of Clene Nanomedicine Inc., which is developing a nanotherapeutic for Parkinson's disease. Both have strong views on Aduhelm. They also had a spirited debate on the science of curing dementia. See acast.com/privacy for privacy and opt-out information.

Complex manufacturing processes and supply chains have always been part of the biopharma industry story, with many people in more than a few nations typically involved along the way. While that observation applies to plenty of other areas of business, Paul Testa, executive vice president for operations and supply chain at Tokyo-based Kyowa Kirin, tells us about the crucial difference with medicine: “We can wait for toilet paper or building materials, but the patient cannot wait because their health care is at stake,” he said. Continuity, reliability of supply, business process and automation were all key priorities for him before the pandemic and haven't drastically changed since. But “there's an added layer of complexity with COVID and a lot of the intricacies of managing those details that we all deal with,” he said. How does the Japanese concept of 和 (wa) fit in? Listen to find out. See acast.com/privacy for privacy and opt-out information.

Amid industry's ongoing drive to speed drug discovery, clinical development and commercial success, government regulation can sometimes seem slow moving. But even a quick look at regulatory highlights from 2021 shows nothing could be further from the truth. From COVID-19 and cancer to Aduhelm and the broader health care ecosystem, so much has changed – and not just in the U.S. Join us for perspective on this fast-changing landscape from Peter Pitts, president of the Center for Medicine in the Public Interest, among other roles. “All of a sudden, everybody is a regulatory expert,” he said. Will free beer get us where we need to go? Listen to find out. See acast.com/privacy for privacy and opt-out information.

The COVID-19 pandemic is so all encompassing and complex, with dramatic details shifting almost hourly, that it can be easy to lose track of the big picture. And there are so many questions. Has industry pushed out vaccines too fast? Was there adequate testing? Did they take shortcuts? Why were governments pushing for boosters before the scientific data was available? We asked BioWorld's regulatory editor Mari Serebrov, who has covered the pandemic since the beginning, to help put it all into perspective. She has strong insights into vaccine development, including the handful of winners and quite a few failures in the more than 1,000 vaccines and therapeutics in the pipeline. Listen to the discussion on how industry has pushed out vaccines and drugs in this turbo-charged timeline. See acast.com/privacy for privacy and opt-out information.

A new pill, molnupiravir, from Ridgeback Biotherapeutics. and partner Merck & Co. could cut hospitalizations and deaths from COVID-19 in half. The companies are already seeking emergency use authorization in the U.S. and global governments are pledging to buy big lots of the medicine, pending regulatory approvals.But some people are already crying foul over the proposed price, $712 for a treatment, which includes twice daily doses for five days – because the U.S. government helped pay for the research. Molnupiravir was invented at Emory University and had partial funding and support from the U.S. government.Joseph Allen, executive director of the Bayh-Dole Coalition, joined the BioWorld Insider Podcast this week to explain how this scientific discovery may have never had a chance to move out of the university onto pharmacy shelves without the government's support of innovation. The cost of health care, including drugs, is an entirely separate topic and should be treated as such, he said. Allen explained that the Bayh-Dole Act, which then-Senator Joe Biden voted for in 1980, also has something called a march-in provision. In the absence of good-faith efforts being made to commercialize an invention discovered with government support, it enables the government to force licensing of the technology to another party. While some have argued the same mechanism could be used to set the price of federally funded medicines, Allen said that's never been the law's intention. However, the pricing saga plays out, the pill would be a far more convenient alternative to other currently used therapies which are injected.Listen to BioWorld Insider podcast to better understand the controversial story behind the story. See acast.com/privacy for privacy and opt-out information.

Cervical cancer is one of the leading causes of cancer morbidity and mortality in women worldwide. While widespread use of HPV vaccination is dramatically reducing the number of women developing the disease where vaccination is common, the global number of new cases is projected to climb over the next decade. Treatment options until now have been limited to surgery, chemotherapy, radiation, and immunotherapy. Recent data showed adding Keytruda to standard first-line chemotherapy improved survival, but there's still substantial need for new treatments. This week, one arrived: The Danish firm Genmab and its U.S. partner, Seagen, won accelerated FDA approval for the antibody-drug conjugate Tivdak (tisotumab vedotin). Join us as we talk about the approval and the future of Genmab with the company's president and CEO, Jan van de Winkel. See acast.com/privacy for privacy and opt-out information.

Rapid development of mRNA-based COVID-19 vaccines has drawn global attention. But could DNA-based vaccines work better in the long run?Recent emergency use authorization for Zydus Cadila's DNA-based COVID-19 vaccine made headlines worldwide, previewing what's possible. Now, join BioWorld Insider as we take a closer look at this type of vaccine with Lucio Rovati, CEO and chief scientific officer of Italy's Rottapharm Biotech. Together with another Italian firm, Takis Biotech, they recently announced phase I results of the first DNA vaccine candidate against COVID-19 to enter clinical development in Europe. The vaccine has potential as both an initial vaccine and as a third dose when the antibody response from other available vaccines decreases. See acast.com/privacy for privacy and opt-out information.

COVID-19's impact on clinical trials has been broad and varied. Recruiting disruptions, protocol changes and logistical challenges have forced both investigators and regulators to adapt. As the pandemic continues to shape how trials are run, key stakeholders are responding with new ideas to keep drug candidates on track. Join us as we talk to Laurie Halloran, president and CEO of Boston-based Halloran Consulting, about the way trial sponsors and regulators have managed through this time. Working with more than 750 clients, from startups to global drug developers over 23 years, Halloran has seen it all and shares some of the strategies companies are using to succeed. See acast.com/privacy for privacy and opt-out information.

Though Revolution Medicines Inc.'s RAS companion / SHP2 inhibitor RMC-4630 failed to show efficacy in two early-stage combination trials, the company is moving forward with the candidate, its lead asset, partnered with Sanofi SA. Mark Goldsmith, Revolution's president, CEO and chairman joined the BioWorld Insider Podcast to discuss the challenges and progress in other experiments. See acast.com/privacy for privacy and opt-out information.