The BioWorld Insider Podcast – Details, episodes & analysis

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.