Life sciences organizations are facing both intense pressure and extraordinary opportunity, according to Mark Sullivan, president of regulated industries at Salesforce. In a conversation with The Top Line’s Chris Hayden, Sullivan said companies too often operate in “survival mode,” focused on defending margins rather than leading innovation. But with the rise of AI and agentic technologies, he said, the industry is poised for a transformation that could reshape how drugs are developed, trials conducted and patient data used — all at greater speed and lower cost.

Sullivan emphasized that this new era requires rethinking how companies engage with stakeholders. Instead of distant, one-way interactions, he said, agentic AI enables dynamic, conversational relationships that improve satisfaction and generate actionable insights. Salesforce, he noted, is expanding beyond its CRM roots to help life science enterprises become “agentic” organizations — integrating secure, compliant AI systems across finance, HR and supply chains. With data security and trust at the core, Sullivan called on leaders to look beyond software replacement and pursue true digital transformation for the good of patients and the industry alike.

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The FDA made waves in early September when it announced a plan to publicly release complete response letters (CRLs) at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical transparency.”

At the same time, the FDA released 89 new CRLs, adding to the more than 200 that were previously made public in July and shedding more light on the agency’s often opaque review process. That earlier document dump, though, only included rejection letters for drugs that were eventually approved. Now, for the first time, the agency is releasing CRLs for unapproved drug candidates—including recent high-profile rejections such as Ultragenyx’s gene therapy for Sanfilippo syndrome type A, Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy and Replimune’s melanoma drug.

Publicly airing the rationale for rejecting drug candidates is a significant shift for the FDA and a potential cause for concern for the biopharma industry.

To unpack what the new policy means for drug developers, Fierce Biotech’s Darren Incorvaia sat down with Torrey Cope, a lawyer with Sidley Austin who represents and advises life sciences companies on issues related to the FDA.

To learn more about the topics in this episode:

• FDA releases ‘initial batch’ of more than 200 drug rejection letters

• FDA moves to publish drug rejection letters in real time, releases new batch including Replimune's high-profile snub

• FDA misinterpreted efficacy data that prompted DMD rejection, Capricor claims

• ‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

• 'Several concerning observations': FDA sheds more light on reasons it rejected drugs

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With a new president of U.S. pharma at the helm—and two key FDA approvals now in the books—Boehringer Ingelheim is sharpening its focus on the lucrative American market.

In this week’s episode of “The Top Line,” we dive into Boehringer Ingelheim’s latest regulatory successes, two crucial launches, and the German company’s expanding commercialization push in the U.S.

Fierce Pharma’s Fraiser Kansteiner sits down with Brian Hilberdink—who joined Boehringer as president of U.S. human pharma in February—to discuss his game plan to further unlock the American market and capitalize on key BI green lights in idiopathic pulmonary fibrosis and lung cancer.

To learn more about the topics in this episode:

• Boehringer Ingelheim breaks into oncology with FDA approval for lung cancer med Hernexeos
• Boehringer Ingelheim breathes new life into lung fibrosis field with FDA approval for Jascayd
• 'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline
• Chutes & Ladders—Boehringer snatches up LEO exec for US pharma team

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