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.

Host

⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guest

Ian Fisher, Head of Development Analytics, IQVIA

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 order. A press release explained that drug prices will be tied to the lowest price in certain countries with a GDP at least 60% that of the U.S. and that the effort will focus on branded drugs.

Over at the FDA, the strategy around COVID-19 vaccines is evolving. According to an editorial published in the New England Journal of Medicine Tuesday by FDA Commissioner Marty Makary and CBER director Vinay Prasad, future COVID-19 approvals will focus on adults over 65 and high-risk individuals six months to 64 years old—a strategy they say will better align the U.S. with other high-income nations. This is also in sync with the Novavax approval, which came in Friday after a few delays.

Meanwhile, the FDA’s Oncologic Drugs Advisory Committee (ODAC) is currently in the midst of a two-day meeting, but acquiring the necessary expertise was “absolute chaos,” according to an agency insider who spoke with BioSpace. This is partly due to the decimation of an FDA office that includes staff responsible for screening scientific and therapeutic area experts for conflicts of interest.

Going back to last week—which seems like a year ago at this point—we were somewhat shocked to learn that the CEO of one of the world’s most valuable pharma companies is on his way out. Friday morning, Novo Nordisk announced that CEO Lars Fruergaard Jørgensen will be leaving the company after eight years at the helm. After peaking last June at about $155 apiece, the obesity leader’s shares are currently worth just $68. Novo said the decision for Jorgensen to leave was mutual, but Jorgensen was not made available to speak on a call following the announcement.

Finally, a couple of milestones are worth noting: First, the Alzheimer’s space got a big win on Friday when the FDA approved the first blood-based test for the disease—news that could be a boon to Eli Lilly’s Kisunla and Biogen & Eisai’s Leqembi. And second, a nine-month-old boy named KJ with a disease called CPS1 deficiency that affects just 1 in 1.3 million U.S. babies was treated with a single-use CRISPR treatment created just for him. It’s an incredible story that highlights just how far gene editing has come, but it also highlights a rare disease crisis, with these sorts of ultra- and nanorare diseases lacking the necessary financial incentive to motivate biopharma’s focus.

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 Medicare and Medicaid Services announced that among the next 15 drugs to undergo IRA-prescripted price negotiations could be drugs payable through Medicare Part B, and not just Part D, where the first two rounds have applied.

Into all of this action steps Vinay Prasad, the outspoken oncologist and hematologist who was named last week as the next director of the FDA’s Center for Biologics Evaluation and Research. While the S&P Biotech ETF fell by more than 5% upon the news, overall reaction was fairly measured, with cell and gene therapy executive Audrey Greenberg summing up Prasad’s selection as “anything but a status quo appointment.”

Over in the weight loss and obesity space, Eli Lilly can’t seem to lose. This weekend, Lilly announced full data from a head-to-head trial showing a “superior benefit-to-risk ratio” for its Zepbound over Novo Nordisk’s Wegovy. And last week, the Indiana-based pharma won a court battle against compounders when a judge sided with the FDA, stating that tirzepatide—the active ingredient in both Zepbound and diabetes sister drug Mounjaro—was no longer in shortage. Add on a presidential shoutout during Trump’s Monday press conference for its U.S. manufacturing investments, and it really was Lilly’s week.

Flying less high are some 2,000 Bayer employees who lost their jobs in the first quarter of 2025 as part of the company’s new operating model, which is intended to make Bayer “much more agile.” On a less direct flight is Galapagos, which reversed course on plans to spin out a portion of the company and find a new CEO. Instead, CEO Paul Stoffels will make a quicker exit and the Belgian biotech could sell off its cell therapy assets as it looks to build up a new pipeline in house, having abandoned the spinout idea altogether. Stay tuned.

Finally, in ClinicaSpace this week, we took a deep dive into the HIV treatment space, where companies like Gilead and Immunocore are targeting a cure, while the Trump administration slashes funding for HIV research.

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 of polio vaccine containing live polio virus given to the public, the FDA took up this mantle in evaluating vaccines. He warns that public discourse has moved dangerously past healthy skepticism into harmful cynicism, particularly through conspiracy theorists who dismiss scientific evidence by claiming researchers are "in the pocket of Big Pharma." This cynicism threatens public health as vaccine-preventable diseases like measles and pertussis are re-emerging due to declining vaccination rates, with polio potentially following if immunization continues to decrease.

Host

⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guests

Paul Offit, MD, Director of the Vaccine Education Center, Children's Hospital of Philadelphia; Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics, Perelman School of Medicine, University of Pennsylvania

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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, cancer conference season is in full swing, with the American Association for Cancer Research’s annual event continuing in Chicago. Merck, GSK, Boehringer Ingelheim, Roche and others have presented highly anticipated data from some of their cornerstone cancer drugs and other candidates.

Turning to the latest news out of the FDA, newly minted Commissioner Marty Makary gave his first two big press interviews last week, making statements that both jibed with and contradicted recent reporting. And in the midst of the ongoing Novavax vaccine saga, many have raised concerns that the FDA could become politicized under the watch of HHS Secretary RFK Jr.

Finally, check out this week’s BioPharm Executive stories, including a deep dive into the trend toward mining innovative therapies from China and BioSpace’s annual report on pharma CEO-to-employee pay ratios.

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 investment challenges, they acknowledge the current difficult economic environment affects all biomedical research, not just women's health specifically.

This episode is presented in partnership with ⁠DIA⁠, in support of their ⁠2025 Global Annual Meeting⁠ taking place June 15-19 in Washington DC.

Host

⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guests

⁠Martin Hodosi⁠, Partner, Kearney

⁠Melissa Laitner⁠, Director of Strategic Initiatives, National Academy of Medicine

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

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 directive to ban industry representatives from serving on the agency’s advisory committees—a move experts believe will have minimal impact in reducing COIs.

Makary also touched on vaccines and what he believes to be the cause of autism. On this, he was more restrained than his boss, HHS Secretary Robert F. Kennedy Jr., who continues to insist on re-investigating what he believes is a link between autism and vaccines. The interview comes as more former FDA officials sound the alarm about the changes happening within the agency.

Elsewhere on the policy front, President Donald Trump continues to threaten tariffs on pharma products. In response, two more companies, Roche and Regeneron, are committing billions of dollars to enhance their U.S. footprints. They join Novartis, J&J and Eli Lilly in this regard, with the latter additionally promising to manufacture its investigational oral obesity drug orforglipron in the U.S.

That announcement followed the news that orforglipron generated “injectable-like efficacy” in a Phase III diabetes trial. Lilly intends to submit for approval of the pill for weight management by the end of this year and diabetes in 2026. Not to be outdone, chief rival Novo Nordisk revealed Saturday that it has already filed for FDA approval of an oral formulation of its own blockbuster, semaglutide, for overweight and obesity.

Finally, make sure to check out this week’s edition of BioPharm Executive where we take a deep dive into another sizzling space—transthyretin amyloid cardiomyopathy (ATTR-CM)—and find out which pharma CEO has the biggest golden parachute.