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.

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As a new BioWorld new 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.

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Modifi Biosciences Inc. was recently acquired by Merck & Co. Inc. for $30 million up front. Modifi shareholders could receive milestones of up to $1.3 billion. It all happened in the dizzyingly short span of a little more than two years. Modifi’s founder, Ranjit Bindra, and a small group of advisers brought the company through preclinical work on DNA repair for treating glioblastoma and then twice faced running out of money and shutting down the company. Confounding the typical wisdom, Bindra and co-founder Kevin Rakin ended up putting the Merck deal together all by themselves. “People would actually ask, ‘Who is your banker that did the M&A deal?’ I said, ‘You're looking at them. It's me and Kevin Rakin.’ I learned a lot.”

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In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said.

Quantum computing could lead to more efficient drug discovery by identifying promising compounds faster, understanding their effects at the molecular level and then reducing the need for costly or time-consuming lab experiments.

Lipinska is one of the more than 100 experts who will evaluate the future of health care at the upcoming 2024 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 sponsor of the Oct. 28-30 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 Lipinska.

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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.

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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.

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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.

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