The opioid crisis may not be front and center anymore, but it's raging still. A major problem is that overdose-reversal drugs don't last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm's candidate for a solution to the medical and societal problem. The NIH – which has been helpful to Elysium since the company's founding – the FDA, and others are working to advance a longer-lasting reversal agent. Experiments already done with approved reversers, as well as computer modeling that's been used by regulators previously, will help in the push, Sturmer said.

Starting with the Clear Outcomes study in 2023, which gave Esperion Therapeutics immediate success with more than 1 billion impressions globally, the company has been creating a pipeline to keep its positive momentum going. Esperion developed and is commercializing the only U.S. FDA approved oral, once-daily, non-statin medicines for primary and secondary prevention of cardiovascular disease in patients struggling with elevated LDL cholesterol. BioWorld Insider guest Sheldon Koenig, Esperion's CEO, views the company as a cardiometabolic drug developer that is working to treat and possibly cure primary sclerosing cholangitis so patients can avoid having to get a liver transplant. "All of us at Esperion believe that we are delivering medications and working on medications that are helping patients," Koenig said.

This podcast is sponsored by Esperion Therapeutics.

Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in this episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced "and that means we can potentially cure a disease rather than intervening in a disease." Zieler also shared his thoughts on creating sustainable health care in aging societies, the innovation cycle gap between the U.S. and Europe, and how collaboration between business and government is critical in forging ahead in this wide-ranging discussion.

Capricor Therapeutics Inc. just wrapped up a visit with the U.S. FDA and is prepping to file a BLA in October for its Duchenne muscular dystrophy treatment. Linda Marbán, Capricor's CEO, is the guest on the newest BioWorld Insider podcast and she talks about deramiocel (CAP-1002), the company's  allogeneic cardiac-derived cell therapy, for treating the rare disease and how the FDA has made strong efforts in helping lay the groundwork for deramiocel. Marbán has been working on the Duchenne treatment for many years and she has strong insights into how to tackle a rare disease development program and how the FDA has changed its ways over time to help out. She has been in the biopharma space for more than 20 years and also is a co-founder of Capricor. 

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.

Bioxcel Therapeutics Inc.'s phase III results in bipolar disorders or schizophrenia could bring Igalmi (BXCL-501) out of the clinic and into patients' homes for easier treatment. Vimal Mehta, Bioxcel CEO, talks about the potential with Lee Landenberger in the latest BioWorld Insider podcast.

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.

Guests BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, Samsung Bioepis vice president and head of U.S. market access, discuss the launch of biosimilars that are taking on a blockbuster.

Brad Holden, CEO of Resilient Lifescience, explains how the device works for overdoses as well as other potential applications for this new technology.

Karen Carey, BioWorld's managing editor and senior data analyst, and Tim Shannon, a general partner at Canaan, break down the numbers from first quarter of 2023.

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BioWorld Staff Writer Tamra Sami talks about the science behind radiopharmaceuticals, the supply chain vulnerabilities, the regulatory landscape, the patient journey and therapies in the pipeline.

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James Peyer, the CEO of Cambrian Biopharma Inc., talks about anti-aging therapies, a business model that fits the new field of geroscience.

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BioWorld Science Managing Editor Anette Breindl discusses her new analysis of multiple studies related to weight loss, metabolic health and fitness that in many ways go against mainstream theories about obesity.

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Guests Karen Zaderej, CEO of Axogen Inc., Sean Bohen, CEO of Olema Oncology Inc., Rob Ross, the CEO of Surface Oncology Inc., and Rob Etherington, the CEO of Clene Nanomedicine Inc., speak about adapting their companies to the market's new realities.

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James Lanthier, the CEO of Mindset Pharma Inc., talks about developing next-generation psychedelic medicines to treat neurological and psychiatric disorders.

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More and more, artificial intelligence is becoming inseparable from drug development. But it needs to be well integrated with the right people and support technologies in order to be successful, according to Josep Bassaganya-Riera, the founder and CEO of Nimmune Biopharma Inc. Nimmune has leveraged methods of AI-enabled drug discovery to develop a number of late-stage therapeutics using a strategic model Bassaganya-Riera first developed at Landos Biopharma Inc., a previous venture which was sold to Abbvie in 2024. As the founder of several other companies, Bassaganya-Riera has more than 20 years in the industry and he shared his insights and experience on the podcast about the crucial importance of getting technology and people in balance. The key, he said, is to have the right people in the same room interacting with each other and the technology.

BioWorld Senior Analyst Karen Carey chats about the collision of a volatile economic climate and big biopharma deals.

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Extending the human lifespan, a BioWorld special report, examines the companies developing "Fountain of Youth" drugs. In this episode, the writers discuss this scientific holy grail.

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Executives from Amylyx Pharmaceuticals Inc. and Clene Inc., along with a key Penn State ALS expert, discuss what the future of medicine holds for patients.

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BioWorld Senior Analyst Karen Carey explores the newest data and where it is leading.

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Infection control expert William Schaffner of the Vanderbilt University School of Medicine joins to discuss the CDC's Advisory Committee on Immunization Practices and how COVID-19 put the committee's schedule into overdrive.

Senior Science Editor Anette Breindl goes in depth about how long COVID-19 emerged and is being defined.

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Guests 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 plc, have a discussion about the brave new world AI is creating.

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A conversation with Kleanthis Xanthopoulos, a co-founder and executive chairman of Shoreline Biosciences, and Joe Hernandez, CEO and executive chairman of Blue Water Vaccines, who have founded or led eight health care and pharmaceuticals companies.

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Insights into the controversial drug come from guests Michael Agadjanyan, president of Nuravax Inc., which is developing antibodies for preventing Alzheimer's and Parkinson's diseases, along with Robert Glanzman, chief medical officer of Clene Nanomedicine Inc.

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Paul Testa, executive vice president for operations and supply chain at Tokyo-based Kyowa Kirin, on the dramatic importance of continuity, reliability of supply, business process and automation.

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 As pharma deals with the impact of NIH grant cuts and what could follow with the imposition of tariffs, Robert Williamson, CEO of Triumvira Immunologics Inc., and Hernan Bazan, CEO of South Rampart Pharma LLC, brought their extensive experience in the industry to the podcast. Their concerns include how tariffs will bring lower margins for U.S. companies, higher costs and eventually drug shortages. They also spoke about the impact on drug development as more than 90% of all drugs are NIH-supported and the challenges private investment faces as it steps in to fill the gap. "What we're doing by freezing the domestic biotech innovation and supply space, is that … we're gifting China this future leadership in the biotech space with some of these tariffs," Williamson said.

Peter Pitts, president of the Center for Medicine in the Public Interest, on how government regulation seems like a slow but in actuality moves more quickly than understood.

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BioWorld Regulatory Editor Mari Serebrov puts the pandemic and the science into perspective.

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Joseph Allen, executive director of the Bayh-Dole Coalition, explains how molnupiravir, from Ridgeback Biotherapeutics, and partner Merck & Co. Inc., may have never had a chance to move out of the university onto pharmacy shelves without the government's support.

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The approval of antibody-drug conjugate Tivdak (tisotumab vedotin) for treating cervical cancer and the future of Genmab A/S are the subjects with the company's president and CEO, Jan van de Winkel.

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An in-depth conversation with Lucio Rovati, CEO and chief scientific officer of Italy's Rottapharm Biotech as they tackle the new world of DNA vaccines.

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Laurie Halloran, president and CEO of Boston-based Halloran Consulting, shares her thoughts on the impact of COVID-19 on clinical trials.

Mark Goldsmith, Revolution Medicines Inc. president, CEO and chairman, talks about grappling with RAS mutations.

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Howard Fillit, founding executive director and chief science officer at the Alzheimer's Drug Discovery Foundation, shares his insights on the impact of financial investments driving these therapies.

Biopharma deal-making activity, a closely watched marker of industry health, was alive and well in the second quarter. BioWorld Senior Analyst Karen Carey sifts through the numbers.

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Michel Detheux, president and CEO of Iteos Therapeutics Inc., discusses what his company brings GSK in a massive new deal.

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The biopharma sector is still trying to get its wind and resume its once-powerful investment ways. Medical technology has sidestepped much of biopharma's issues by being more flexible along the development path, according to BioWorld MedTech Editor Annette Boyle in this edition of the podcast. This year's med-tech investment numbers have improved over those from last year and the year before by bringing in $2.76 billion by financing 56 transactions in January alone. Boyle described the current financing climate on the newest BioWorld Insider podcast and explained why the sector is performing well year to date.

Biogen's vice president of global and U.S. medical affairs for Alzheimer's disease offers insight into Aduhelm.

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Billion-dollar M&As are commonplace now, but not too long ago they were a rarity. So many have occurred in the past few years, they've become the norm. But were all these multi-billion-dollar mega mergers worth the money? Karen Carey, BioWorld's senior managing editor and chief analyst, crunched the numbers on 21 of the biggest M&As in a three-part BioWorld series and found very few have been, so far, good deals for the buyer. In this podcast, Carey sifts through the winners and losers and explains the analysis.

As a new BioWorld investigative report shows, decades of research excluding women from clinical trials and investment decisions made in male-dominated boardrooms have led to half the world's health needs being underserved. Of the drug development companies working on women's health solutions, the proportion of funding and partnering for the sector is quite small. But it's slowly growing, as is the depth of science. Karen Carey, BioWorld's managing editor and chief analyst, and the managing editor of Bioworld Science, Anette Breindl, join this episode of the BioWorld Insider podcast to talk about the business and the science of women's health.