BioSpace

00:29:14

How Target Product Profiles Guide the Industry...

BioSpace ·

2025/05/22

Lori Ellis, head of insights and Ian Fisher, head of development of analytics at IQVIA, discusses the critical importance of Target Product Profiles (TPPs) for life sciences companies, especially during uncertain times with funding challenges. Fisher emphasizes that TPPs serve as strategic guiding light which help companies articulate their development goals and demonstrate value to potential investors and partners.This episode is presented in partnership with IQVIA.Host⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of

en

00:22:39

Pfizer’s $6B China Deal, Drug Pricing and FDA’s New...

BioSpace ·

2025/05/21

Pfizer stole the headlines this week with a pact worth up to $6 billion with Chinese biotech 3SBio for a PD-1/VEGF candidate just three months after inking a clinical trials collab for a similar drug with Summit Therapeutics. It’s the largest Chinese licensing deal in recent memory, as pharmas continue to turn to the country to fill their pipelines. Also on Tuesday, the Department of Health and Human Services offered a smidge more detail on President Donald Trump’s Most Favored Nation executive

en

00:31:06

Trump’s Drug Pricing Policy, Prasad’s CBER Nod,...

BioSpace ·

2025/05/14

President Donald Trump unveiled a sweeping drug pricing policy this week, seeking to lower drug prices in the U.S. by up to 80% through a reprisal of the Most Favored Nation rule he attempted to introduce in his first term. The rule would essentially link U.S. prices to those paid in other nations where medications are cheaper. Biopharma reaction was one of tentative relief, with BMO Capital Markets analysts suggesting the executive order had “more bark than bite.” Meanwhile, the Centers for

en

00:28:11

Eroding Immunity: Vaccine Hesitancy and Cynicism

BioSpace ·

2025/05/08

Paul Offit, MD, Director of the Vaccine Education Center at the Children's Hospital of Philadelphia and the Maurice R. Hilleman Professor of Vaccinology, Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania, identifies himself as a "vaccine skeptic"–someone who demands data and evidence–which he believes is the appropriate stance for medical professionals and regulators.After the Cutter incident in 1955, which resulted in 250 cases of polio caused by batches

en

00:24:16

Trump’s US Manufacturing Push, New Vaccine Policy,...

BioSpace ·

2025/05/07

In his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints. Bristol Myers Squibb CEO Christopher Boerner announced this week that the company will pump $40 billion into its stateside operations over the next five years, even as the pharma executes a massive

en

00:24:09

Tariffs Continue to Dominate Q1 Earnings, AACR...

BioSpace ·

2025/04/30

Policy issues—particularly tariffs—loom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizer’s call, CEO Albert Bourla called the Trump administration’s national security concerns “legitimate,” but objected to the proposed tariffs in general. Meanwhile, Novartis CEO Vas Narasimhan brushed off the tariff risk but expressed concern over President Donald Trump’s desire to bring back the ‘Most Favored Nations’ rule. Meanwhile,

en

00:10:34

Economic Challenges, Strategic Investments: Reshaping...

BioSpace ·

2025/04/24

This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine emphasizing the need for collaboration to improve women's health.This discussion features Lori Ellis, Martin Hadosi, and Melissa Laitner, who emphasize the need for collaborative effort across multiple sectors including industry, healthcare organizations, researchers, and patient advocacy groups. Regarding

en

00:18:16

Makary’s First Interview, US Manufacturing Push and...

BioSpace ·

2025/04/23

While much of the country was off celebrating Easter and Passover this weekend, the FDA—and its new leader Marty Makary—were busy making news. Makary, who was confirmed as FDA commissioner last month, gave his first major interview, where he unveiled a new regulatory pathway for rare disease therapies and addressed the “epidemic of distrust” he feels is imperiling the agency. Makary also shared his thoughts on the conflicts of interest he sees between the FDA and pharma industry, highlighting a new

en

00:21:00

Tariff Turmoil, FDA’s Future, Pfizer’s Obesity...

BioSpace ·

2025/04/16

It’s all about tariffs again this week. No sooner had Donald Trump announced that “major” tariffs on the pharmaceutical industry would be coming “very shortly”—sending stocks spiraling—the president announced a 90-day pause on most taxes for imports from countries not named China. But this respite was not to last. On Sunday, Secretary of Commerce Howard Lutnick told ABC News that tariffs would be coming for pharma in the next month or two, according to Leerink. A Federal Register Notice revealing

en

00:09:18

Bonus: Q1 2025 Job Market Update

BioSpace ·

2025/04/15

In this bonus episode, BioSpace’s vice president of marketing ⁠Chantal Dresner⁠ and careers editor ⁠Angela Gabriel⁠ take a look at job market performance in the first quarter of 2025. They discuss job posting trends, application rates and layoffs. Also discussed are recent decisions of the Trump administration and how they are impacting the workforces of the private sector, HHS and academia.Want to receive our latest quarterly job market reports? ⁠Subscribe⁠ to Career Insider for our job market

en

00:10:01

Breaking Down Barriers: The Nuanced Approach to...

BioSpace ·

2025/04/10

This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine examining the underrepresentation of women in clinical trials. They stress that rather than waiting for regulatory guidance, the industry should proactively improve trial accessibility and inclusivity, as there's mutual benefit in faster enrollment and more diverse participation.This episode is presented in

en

00:17:15

Tariff-Triggered Recession Fears, Fallout From HHS...

BioSpace ·

2025/04/09

Pushback against the Trump administration’s massive government cuts exploded this weekend across America—and biopharma is no exception. Taking a deep dive into the leadership cuts, we found that more than half of the senior FDA leaders from six months ago are no longer there, and that’s just the leadership. Across the Department of Health and Human Services, some 20,000 people will be leaving—of their own accord or otherwise—amounting to a 25% reduction in headcount that would leave HHS with around

en

00:17:34

FDA on Fire, Novo’s Mixed Bag of Semaglutide Cardio...

BioSpace ·

2025/04/02

Biopharma’s reaction to the forced resignation of venerable CBER director Peter Marks has been swift and furious, with former FDA Commissioner Robert Califf saying on LinkedIn that “the FDA as we’ve known it is finished.” Analysts, meanwhile, called Marks’ exit “arguably biotech investors’ greatest fear,” as company shares across the industry tumbled. Marks’ announcement added insult to injury for the agency, which was already reeling from the announced cuts of 10,000 employees across the

en

00:09:58

Balancing Protection and Inclusion: The Evolution of...

BioSpace ·

2025/03/27

Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives, National Academy of Medicine, join Lori Ellis, head of insights, to discuss the evolution of women's inclusion in clinical trials. They note that while overall representation has improved, significant challenges remain. They highlight how industry mindset has evolved from being protectionist to inclusion.This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking

en

00:19:23

Trump’s Pharma Tariffs, Monarez for CDC, Novo’s New...

BioSpace ·

2025/03/26

President Donald Trump doubled down on tariff threats targeting pharma, saying additional levies on pharmaceuticals will come “at some point,” per CNBC. Meanwhile, Johnson & Johnson became the latest big pharma to respond to Trump’s warning of potential tariffs if companies don’t reshore their manufacturing, announcing a massive $55 billion U.S. manufacturing and R&D investment. Not all companies are on board, however: AstraZeneca is looking eastward, pumping $2.5 billion into a new research

en

00:19:37

Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon...

BioSpace ·

2025/03/19

A patient with Duchenne muscular dystrophy taking Sarepta’s gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys’ label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited.Meanwhile, both AstraZeneca and Taiho Pharmaceuticals announced acquisitions worth up to $1 billion or more in two sizzling

en

00:12:56

A Conversation With Mark McKenna, CEO of Mirador

BioSpace ·

2025/03/18

On the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Mark McKenna, CEO of Mirador Therapeutics, a member of BioSpace’s NextGen Class of 2025. Their discussion here focused on the company’s two-pronged approach to developing therapies for inflammatory and fibrotic diseases, as well as the importance of operating under stealth at this time for the biotech.This is the second episode in a special series of The

en

00:16:00

“Perfect Patient” Industry Burdens; Exits and...

BioSpace ·

2025/03/13

Miruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this episode, she discusses the challenges of stringent inclusion and exclusion criteria of clinical trials. She also dives into her main takeaways from this year's JP Morgan Healthcare Conference and Scope Summit around exits and investment in women's health.Host⁠⁠⁠Lori Ellis⁠⁠⁠, Head of Insights, BioSpaceGuests⁠Miruna Sasu⁠, President and CEO, COTADisclaimer: The views expressed in this discussion by guests are their own

en

00:18:44

COVID Reflections, Novo’s Next-Gen Weight Loss...

BioSpace ·

2025/03/12

As we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market. Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though

en

00:15:36

Tariff Threat Continues, More Meetings Cancelled,...

BioSpace ·

2025/03/05

Donald Trump’s tariffs have headlined myriad news stories this week—including at BioSpace, where we reported Pfizer CEO Albert Bourla’s claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity. Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming

en

All Episodes

Similar Podcasts

Rabbit Hole of Research

Jotham Austin, II PhD, Nick Elizalde,...

La Science CQFD

France Culture

A Moment of Science

Indiana Public Media

Meteorology Matters

Rob Jones

The Deep Dive Lab: Unraveling Materials Science

Son Hoang