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BioWorld Insider Podcast
One-on-one with medical innovators
Breakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.
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.
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.
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.
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.
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.
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.
A new pill, molnupiravir, from Ridgeback Biotherapeutics, and partner Merck & Co. Inc., 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.