Designating something "safe" in this industry means acceptable risk. AI can help us improve acceptable risks if it is used appropriately. However, industry experts must be thoughtful and responsible in their use of AI within clinical trials.

In the third episode of our mini series on artificial intelligence, our guests explore the challenges and benefits of integrating technology into the lives of patients.

Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guests

⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA

⁠⁠⁠⁠Moritz von Stosch⁠⁠⁠⁠ Chief Innovation Officer, DataHow

⁠⁠⁠Nindhana Paranthaman⁠⁠⁠, Executive Medical Director, Clinical Development, Summit Therapeutics

⁠⁠⁠⁠Paul Agapow⁠⁠⁠⁠, Head of Data Science, BioNTech

The cell and gene therapy sector may be on the road to recovery after being met with investment headwinds following the highs seen during the pandemic, according to data presented Monday at the 2024 Cell & Gene Meeting on the Mesa hosted by the Alliance for Regenerative Medicine. BioSpace News Editor Greg Slabodkin reports from Phoenix.

Last week, news broke that WuXi AppTec and WuXi Biologics, two companies named in the BIOSECURE Act, are looking to unload facilities in the U.S. and abroad as uncertainty looms over their U.S. business prospects.

As Eli Lilly resolves shortages of its GLP-1 blockbusters, the company remains confident in its massive lead, along with competitor Novo Nordisk, over other companies with weight loss drug candidates—GLP-1s or other modalities such as next-gen CB1 inhibitors—looking to compete in the lucrative space. Not only are both companies making deals to expand their pipelines beyond GLP-1s, Lilly and Novo are actively pursuing broader markets for their current diabetes and weight loss blockbusters.

Meanwhile, Big Pharma’s layoffs continue with announcements last week from Bayer, J&J and Pfizer.

Bristol Myers Squibb notched one of this year’s biggest approvals as the FDA greenlit Cobenfy, formerly KarXT, as the first novel treatment for schizophrenia in 35 years. Cobenfy’s origins go nearly as far back, beginning as an Alzheimer’s hopeful developed by current obesity rivals Eli Lilly and Novo Nordisk. On a lower note, Pfizer withdrew sickle cell medicine Oxbryta from the market, sending patients and advocates scrambling for more information.

In other news, Roche hosted a Pharma Day event where it touted the $850 million acquisition of a portfolio of CDK inhibitors from Regor Pharmaceuticals and projected $3.6 billion in annual sales from three Carmot Therapeutics-acquired obesity and diabetes drug candidates. For those companies not bringing in billions of dollars, royalty financing provides an attractive option. And news editor Greg Slabodkin gives a preview of the upcoming Meeting on the Mesa.

Plus, BioSpace looks at how the new abortion and IVF laws could impact women’s health research. With nearly a dozen abortion-related measures on state ballots this year, this will be an area to watch during next month’s elections.

Globalization, return on investment, diverse data sets undiscovered: this episode continues the exploration of AI. As we see the industry level out AI adoption, the future is still exciting and yet uncertain. With quantum around the corner, there are still challenges with AI at every turn.

Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guests

⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA

⁠⁠⁠⁠Moritz von Stosch⁠⁠⁠⁠ Chief Innovation Officer, DataHow

⁠⁠⁠Nindhana Paranthaman⁠⁠⁠, Executive Medical Director, Clinical Development, Summit Therapeutics

⁠⁠⁠⁠Paul Agapow⁠⁠⁠⁠, Head of Data Science, BioNTech

Novo Nordisk CEO Lars Fruergaard Jørgensen testified Tuesday in front of Sen. Bernie Sanders’ Senate health committee regarding the prices of Ozempic and Wegovy—with some interesting takeaways. Meanwhile, PhRMA scored a rare win as the Fifth Circuit Court of Appeals ruled in the trade group’s favor, sending its complaint against the Inflation Reduction Act (IRA) back to a lower Texas court. Looking ahead, 15 more drugs are expected to be negotiated under the IRA next year, including Novo’s Ozempic.

Last week, the Federal Reserve cut the federal interest rate by half a percentage point—a move that was expected and met with a collective shrug from the biotech market, with experts skeptical of its impact.

Elsewhere, the schizophrenia space is gearing up for an FDA decision on BMS’ KarXT. If approved, KarXT would be the first novel drug for the neuropsychiatric disease in decades. And on the obesity front, Novo’s oral cannabinoid receptor 1 drug elicited impressive weight loss in a Phase IIa trial, with some adverse events, and young startup Metsera touted robust Phase I data for its injectable GLP-1 candidate.

After their groundbreaking approval last year, infusions of Vertex and CRISPR Therapeutics’ and bluebird bio’s sickle cell gene therapies have begun, bringing hope to patients and the companies closer to realizing revenue. Meanwhile, bispecifics and anti-TIGIT therapies were all the rage at ESMO 2024 as BioNTech, GSK and iTeos, BMS and more reported positive results across multiple cancers.

Last week, Moderna announced it would slash its R&D budget by $4 billion as it targets 10 new approvals through 2027. Possibly boding well for this target, the biotech features prominently on our list of 5 late-stage mRNA vaccines to watch. Meanwhile, the oral obesity drug race continues to heat up, with Terns Pharmaceuticals, Roche and Novo Nordisk all reporting new data from their respective trials. And in the equally hot radiopharmaceuticals space, Sanofi inked a $110 million licensing deal with RadioMedix to develop a neuroendocrine tumor candidate.

Finally, BioSpace takes a deep dive into the HEALEY ALS Platform Trial, which has so far seen quick failures and small victories as leaders and early participants remain hopeful.

As 2024 closes, it is only right to discuss where we are when it comes to AI and where we will be in the future.

As technology continues to evolve and blend into science in 2025 and beyond, a practical approach to what it can and cannot do must be explored.

Additionally, how overpromising while underdelivering has affected investors' and the industry’s confidence in AI.

Host

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace

Guests

⁠⁠Mike King⁠⁠⁠, Senior Director of Product and Strategy, IQVIA

⁠⁠⁠⁠Moritz von Stosch⁠⁠⁠⁠ Chief Innovation Officer, DataHow

⁠⁠⁠Nindhana Paranthaman⁠⁠⁠, Executive Medical Director, Clinical Development, Summit Therapeutics

⁠⁠⁠⁠Paul Agapow⁠⁠⁠⁠, Head of Data Science, BioNTech

Summit Therapeutics made headlines this weekend at the 2024 World Conference on Lung Cancer, revealing that its bispecific antibody outperformed Keytruda in first-line non-small cell lung cancer. Meanwhile, bispecifics are one of several therapeutic classes on the agenda at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona later this week.

Last week, BioMarin held a public address intended to calm anxious investors after rounds of layoffs and pipeline changes—but many were left wanting. Also undergoing major upheaval is Lykos Therapeutics, which laid off 75% of its workforce after failing to secure approval for its MDMA-based post-traumatic stress disorder therapy and announced last week that CEO Amy Emerson is stepping down from her role. In Washington, D.C., Congress is back in session this week and wasted no time in reviewing the BIOSECURE Act, which passed a House vote on Monday.

And on the weight loss front, Terns Pharmaceuticals is moving ahead to Phase II after its investigational GLP-1 pill elicited positive results in Phase I, and Amgen is pushing MariTide into a broad late-stage development program that will test the obesity treatment in other weight-related conditions, such as heart, kidney and liver diseases.