BioSpace

00:20:12

From Chat Bots to World Order: The Race for the 21st...

BioSpace ·

2025/08/07

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 fortress" approach with the AI Act creates strict but vague rules that

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00:26:29

FDA In Flux, Pfizer Talks to Trump on MFN, Merck Cuts...

BioSpace ·

2025/08/06

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, biologic alignment.Meanwhile, the agency has come under criticism for another recent

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00:22:59

We Don't Own Patient Data–We're Just Babysitting It

BioSpace ·

2025/07/31

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 that the industry serves as "custodians, not owners" of patient data

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00:19:17

Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s...

BioSpace ·

2025/07/30

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 death of a third patient—a participant in a trial of a gene therapy for limb girdle

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00:24:12

Sarepta’s Wild Week, CDER’s New Leader, FDA...

BioSpace ·

2025/07/23

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 update to its lowest price in nearly 10 years as it halts shipments of

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00:15:19

Why Countries Are Racing to Build mRNA Factories...

BioSpace ·

2025/07/22

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.Explore their solutions at ⁠https://eclipsebio.com/⁠.Host⁠⁠⁠⁠⁠⁠Lori

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00:13:07

AI Is Taking Over Drug Safety Monitoring–But There's...

BioSpace ·

2025/07/17

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.Host⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestAna Pedro Jesuíno, Global Head Local QPPV Network, IQVIADisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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00:25:46

FDA Layoffs, 200 Rejection Letters, User Fees and...

BioSpace ·

2025/07/16

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 reviews to companies willing to lower the cost of their drugs. Last week, the regulator opened

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00:08:35

Bonus Episode: Q2 2025 Job Market Update

BioSpace ·

2025/07/15

In this discussion, BioSpace’s vice president of marketing ⁠⁠Chantal Dresner⁠⁠ and careers editor ⁠⁠Angela Gabriel⁠⁠ take a look at job market performance in the second quarter of 2025. They discuss job posting trends, application rates and the most significant layoffs of 2025 so far, plus wider trends impacting biopharma including Massachusetts’ $30M tax incentives and factors affecting California’s success. Want to receive our latest quarterly job market reports as soon as they’re

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00:14:21

The mRNA Revolution You Haven't Heard About: From...

BioSpace ·

2025/07/10

This discussion focuses on how mRNA and self-replicating RNA (srRNA) technologies are expanding far beyond COVID vaccines into revolutionary therapeutic applications for cancer and rare diseases. It is clear that mRNA therapeutics offer three major application areas: infectious disease vaccines, therapeutic vaccines for oncology, and protein replacement for monogenic rare diseases.Today’s episode is sponsored by Eclipsebio. From AI-ready datasets to sequencing validation, they drive RNA success

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00:23:15

Second Half Milestones, KalVista’s Surprise Approval,...

BioSpace ·

2025/07/09

While most of the U.S. was celebrating the 4th of July holiday, President Donald Trump was busy signing the One Big, Beautiful Bill into law. This wide-ranging tax law has a few implications for the biopharma industry, including expanded IRA exemptions for orphan drugs. Looking ahead to the second half of 2025, BioSpace reviews some of the upcoming catalysts highlighted by Jefferies’ “Halftime Show” report,including a highly anticipated Phase III readout for Eli Lilly’s oral obesity candidate

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00:23:48

CAR T Expands, M&A Ticks Up, Two Psychedelics Read...

BioSpace ·

2025/07/02

The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be left up to the U.S. Preventive Services Task Force. The ruling thwarted a lawsuit brought by a group of insurance providers who challenged the Affordable Care Act’s requirement that they cover preventive medicines, such as HIV drugs, recommended by the task force. The high court also determined that members of this task force can be removed at will by

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00:24:30

Understanding the FDA's AI Guidance in Pharmacovigilance

BioSpace ·

2025/07/01

In this episode of Denatured, Archana Hegde from IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA's first draft guidance for AI in drug development, published in January 2025. Hegde explains that the vagueness of the current framework is like “a recipe with no pictures and mystery ingredients." During the discussion, she highlights areas of existing confusion.This episode is presented in partnership with IQVIA.Host⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠,

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00:33:16

FDA Churn Continues, RFK Faces Congress, Obesity...

BioSpace ·

2025/06/25

Robert F. Kennedy Jr. testified in front of the House Committee on Energy and Commerce Tuesday, where Democrats confronted the health secretary on hot button issues ranging from his recent overhaul over the CDC’s Advisory Committee on Immunization Practices (ACIP) committee, Kennedy’s recently published—and error-ridden—MAHA report, and his threat to ban government scientists from publishing in certain medical journals. Meanwhile, at the FDA, the mass exodus of senior leadership continues. On

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00:27:26

Navigating Funding Freezes and AI Frontiers

BioSpace ·

2025/06/19

Lori Ellis, head of insights at BioSpace, discusses some of the recent events and topics that are buzzing around BIO and DIA in 2025 with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors. They address funding, the partnering market, AI, and also the recent FDA and CGT roundtable discussion.HostLori Ellis, Head of Insights, BioSpaceGuests⁠⁠Peter Ronco⁠⁠, CEO, Emmes⁠Phil Vanek⁠⁠, Founder, Redline Bio Advisors; Chief

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00:20:02

Another Gene Therapy Death; Biopharma M&A Picks Up; a...

BioSpace ·

2025/06/18

This week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year’s BIO Conference in Boston. The half-team discusses this week’s biggest news: the death of another patient who took Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys. The patient was a non-ambulatory teenager who experienced acute liver failure after receiving the gene therapy, which is the same cause of death for an Elevidys patient reported in March. Sarepta announced that it was halting

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00:20:58

RFK Axes CDC Vaccine Advisors ; Metsera’s Weight Loss...

BioSpace ·

2025/06/11

This week the BioSpace team was sent into an after-hours scramble by the news that Health and Human Services Secretary Robert F. Kennedy Jr. had fired the remaining members of the CDC’s Advisory Committee on Immunization Practices. The secretary argued in an op-ed that accompanied the announcement that the “clean sweep” was necessary to “reestablish public confidence in vaccine science.” The move came amid heightening rhetoric from Kennedy about the safety of vaccines and sparked concerns that the

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00:15:09

AI's Role in Decoding the FDA's New Regulatory...

BioSpace ·

2025/06/05

In a dynamic regulatory environment, IQVIA’s Michelle Gyzen suggests that AI may be the best and only way to keep with changes that are happening daily–and sometimes hourly.In this discussion Lori and Michelle touch on the governance frameworks for cybersecurity, risk, and how AI transformation and integration is evolving to help regulatory professionals navigate the speed and complexity of global requirements.Host⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestMichelle Gyzen, Sr. Director,

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00:20:52

M&A Ticks Up, ASCO Excites and Vaccines Cause More Drama

BioSpace ·

2025/06/04

The words of the week so far in biopharma are “deals” and “cancer”—or, more specifically, money being invested in cancer and other key therapeutic areas. With the American Society of Clinical Oncology’s annual conference underway in Chicago, Bristol Myers Squibb got in the PD-1/PD-L1xVEGF game, paying potentially more than $11 billion to co-develop BioNTech’s solid tumor bispecific BNT327. Elsewhere, Sanofi nabbed the year’s second-biggest buyout, picking up Blueprint for $9.5 billion, expanding its

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00:20:13

COVID-19 Vaccine Overhaul, Rocket Grounded, ‘One...

BioSpace ·

2025/05/28

The name of the biopharma game this season is vaccines—and RFK Jr. wasted no time returning from Memorial Day Weekend before making news on this front, removing the COVID-19 vaccine from the list of recommended immunizations for healthy kids and pregnant women on Tuesday. This follows a rash of recent moves, including a new risk-based strategy for the approval of new COVID vaccines focused on adults over 65 and high-risk individuals six months to 64 years of age and a request that Moderna and

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