BioSpace

In this episode, Lori Ellis and Colin Zick spend a little time further discussing some of the points brought up in the Bioprocessing Summit last month. AI is a tool, a powerful one but a tool. Understanding this, they explore the connections between hammers, AI, The Planet of the Apes and monoliths.

In the end, it is all about compliance.

Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guest

Colin Zick, Partner, Fo...

A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. from China, and pharma companies exit the U.K. in droves. President Donald Trump is reportedly writing an executive order that would clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, while Sanofi, Merck and more ...

The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country’s health, saying the U.S. now has “the highest chronic disease burden of any country in the world.”

Looking back to l...

In this episode, Mike Garrett, CEO of Taconic Biosciences, discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment. He explains that investors now demand more robust translational data showing real potential to impact human health, rather than just basic in vitro results, forcing researchers to generate better evidence packages earlier in development.

This episode...

We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex’s new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis’ agreement with Arrowhead for neurodegenerative diseases such as Parkinson’s. 

But as we look ahead, Thursday’s Senate Finance Committe...

Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make...

Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.

While the 9.1% placebo-adjusted weight loss generated by Lilly’s orforglipron over 72 weeks was an efficacy...

While AI represents a significant advancement in efficiency for early-stage drug discovery, it won't dramatically change the 90% clinical trial failure rate. Most failures stem from fundamental gaps in biological understanding rather then the processes where AI is able to have the most impact.

The discussion highlights AI's strengths and ability to reduce preclinical costs. However, they caution that AI faces significant...

Three months after taking heat over an error-riddled first report, Health Secretary Robert F. Kennedy’s Make America Healthy Again Commission was due to submit a new strategy report to President Donald Trump last week. While the report is delayed—for disputed reasons— Politico obtained a draft copy, which homes in on creating a new vaccine framework and streamlining access to investigational drugs, specifically...

In this Denatured discussion, the conversation revolves around unpacking the patent policy changes that could make or break biotech companies. Guests Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck highlight critical issues posed by the Patent Office including recent changes to the Inter Partes Review (IPR) such as discretionary denial and a proposed patent property tax.

Cummings and Li also discuss how biopharma can w...

Vinay Prasad is back at the FDA as chief of the FDA’s Center for Biologics Evaluation and Research. Prasad’s return—which hit the news wires Saturday morning—came just 10 days after his unexpected exit on July 29, following blowback over the saga involving Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys, and a campaign by conversative personalities to oust the outspoken physician.

Elsewhere in ...

In this thought-provoking episode, Cresset Group’s CSO, Mark Mackey, and VP of AI, Mutlu Dogruel, dissect the emerging geopolitical battle for AI supremacy, revealing how China's DeepSeek model fundamentally disrupted the AI landscape by achieving GPT-4 level performance for just $6 million versus OpenAI's reported $100+ million investment.

The discussion exposes a critical divide in global AI governance: Europe's "regulatory fortr...

Center for Drug Evaluation and Research Head George Tidmarsh will oversee the Center for Biologics Evaluation and Research on an acting basis after Vinay Prasad’s abrupt departure hours after the recording of last week’s episode of The Weekly. While the situation is being billed as temporary, rumors are swirling that structural changes may be afoot at the FDA with Commissioner Marty Makary looking for better drug, biologi...

While AI excels at repetitive tasks like triaging medical information calls, document retrieval, and adverse event detection, the industry must address valid concerns from physicians (41% are excited but concerned, according to AMA studies) and patients who distrust AI systems.

In this episode, IQVIA’s Louise Molloy advocates for complete transparency, including clear disclaimers when AI generates or supports responses, arguing tha...

The Sarepta saga continued into another week as the FDA recommended that the voluntary hold on the company’s Duchenne muscular dystrophy gene therapy be lifted for ambulatory patients, after determining that the death of an 8-year-old Brazilian Duchenne patient who had received Elevidys’ was not caused by the drug.  Sarepta’s stock has swung wildly and its transparency questioned after it elected not to reveal the dea...

Just a few weeks ago, it seemed like Sarepta had weathered a spate of bad news, after two patients died from liver injuries from its Duchenne muscular dystrophy gene therapy Elevidys. Then came news of a third patient death. Last Wednesday, the company announced a major restructuring and 500-person layoff.  

Then, in just a few days time, Sarepta Therapeutics went from enjoying a notable stock bump in response to that corporate upda...

This episode continues the discussion regarding the rapid evolution of mRNA technologies since COVID-19. Guests discuss the improvements that have occurred within just a few years, which are making these therapies more reliable, cost-effective and viable for personalized cancer, rare disease chronic disease treatment.

Today’s episode is sponsored by Eclipsebio. From AI-ready datasets to sequencing validation, they drive RNA success.

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This episode focuses on how AI is transforming pharmacovigilance (PV) on a global scale, particularly focusing on the evolving role of local qualified persons for pharmacovigilance in the EU.

This episode is presented in partnership with IQVIA.

Host

⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guest

Disclaimer: The views expressed in this discussion by guests are their own an...

Up to 3,500 FDA staffers received their final walking papers Monday after the U.S. Supreme Court found last week that the government is “likely to succeed” in arguing that its overhaul of HHS is “lawful.” Meanwhile, FDA Commissioner Marty Makary floated policy changes for the agency, including a proposal to lower prescription drug user fees for the next iteration of the program, and one to offer speedier rev...