Midyear Pulse Check: What's Shaping Biopharma In 2026?

By Tyler Menichiello, Chief Editor, Bioprocess Online

It’s that time of the year when industry outlooks start getting measured against reality. In that spirit, I gathered my fellow editors from across the Life Science Connect ecosystem to join me on a special episode of the “Better Biopharma” podcast for a midyear check-in and editorial roundtable. We compared notes from our different corners of the industry, reflecting on the year’s progress and offering predictions for what the rest of the year has in store. We also discussed some of the exciting projects that the team is working on.

As detailed below, we arrived at a few common themes that are shaping biopharma in 2026:

• AI is increasingly transitioning away from hype to actual implementation (although, there is still plenty of hype)
• The regulatory landscape in the U.S. is still in a prolonged period of instability and change*
• Geopolitical tensions across the globe continue to strain supply chains, which remain in flux
• Small- to mid-size biopharma companies are being made to operate with greater adaptability, which at this point in my career seems like par for the course.

This editorial roundtable features Katie Anderson, chief editor at Pharmaceutical Online; Jeff Buguliskis, Ph.D., deputy chief editor at Outsourced Pharma; Ben Comer, chief editor at Life Science Leader and host of “The Business Of Biotech” podcast; Ray Dogum, chief editor at Drug Discovery Online; Rachel Grabenhofer, chief editor at Clinical Supply Leader; Erin Harris, chief editor at Cell & Gene and host of Cell & Gene: The Podcast; Dan Schell, chief editor at Clinical Leader; and Anna Rose Welch, chief editor at Advancing RNA.

Watch the full editorial roundtable discussion here.

*This episode was recorded prior to Marty Makary’s resignation from the FDA. Check out the Bioprocess Online Editorial Advisory Board’s reaction to that announcement here.

Major Developments Across The Industry

• Regulatory Agencies Advance Guidance On AI
  • Pharmaceutical Online’s Katie Anderson highlighted the FDA and EMA’s joint release of guidelines and common principles for using AI in drug development.
  • We also discussed the agency’s modernization efforts as far as the launch of its internal AI tool, Elsa 4.0, and the Harmonized AI and Lifecycle Operations for Data (HALO) platform.
• Geopolitical Shifts Pressure Supply Chain Reshoring Efforts
  • Outsourced Pharma’s Jeff Buguliskis spoke to the effect of geopolitical friction and legislative pressure on U.S. supply chains. The industry is seeing a shift away from a hyper-globalized supply chain model, said Buguliskis, resulting in increased reshoring back to the U.S. For ADC companies who rely on multiple CDMO partners, this trend may result in seeking more localized, domestic supply chains, if not one-stop-shops.
• A Resurgence of Biotech IPO Activity
  • Life Science Leader’s Ben Comer shared some good news from this year’s J.P. Morgan’s Annual Healthcare Conference, reporting a “surprisingly” positive macro environment, despite the aforementioned political struggles. Comer noted that April had the most active IPO month in five years, with four companies raising over $1.5 billion in the biotech sector.
• New Approach Methodologies Are Gaining Traction
  • Drug Discovery Online’s Ray Dogum expressed enthusiasm in the growing space of new approach methodologies or NAMs, which are different forms of early-stage testing that include organoids and organ-on-chips. He believes that using these tools in conjunction with growing AI capabilities will unlock stronger computational analysis of and insights into preclinical data.
• CGTs Are Maturing
  • Cell & Gene’s Erin Harris expressed optimism in the direction the CGT space is heading. “We’re seeing a lot more focus on industrializing the field,” she said, specifically highlighting the growing role of AI in enabling tighter process control, automation, and modular manufacturing. She also noted a shift in the industry as the field continues to expand beyond traditional ex vivo towards more in vivo approaches, citing the approval of Regeneron Pharmaceuticals’ Otarmini as a defining moment for in vivo gene therapy.
• RNA Technology Expanding Into Therapeutic Areas
  • Advancing RNA’s Anna Rose Welch commented on a sort of transformation she’s witnessing in her space as mRNA technology moves beyond vaccine technology into more therapeutic applications. On the oligonucleotide side, she mentioned the ongoing struggle to define a CMC identity in terms of how these therapies are regulated. Notably, China’s National Medical Products Administration (NMPA) released guidance that mostly aligns with existing EMA guidance, despite several areas that suggest differences in opinion between the regulatory bodies.
• FDA’s Real-Time Initiatives And Adaptability In Clinical Supply
  • Clinical Leader’s Dan Schell talked about the value of the FDA’s real-time clinical trials initiative, which should greatly reduce the “dead time” spent on paperwork and data cleaning at the agency. It also benefits drug developers by expanding access to human-level data earlier in development, a point that Ray Dogum alluded to as well.
  • Clinical Supply Leader’s Rachel Grabenhofer emphasized “adaptability” as a core theme of 2026, with drug sponsors focused on testing AI tools for real-time supply forecasting and contingency planning.

To hear more about what my colleagues across the Life Science Connect publishing sphere are working on and what they hope to see throughout the remainder of 2026, listen to the full “Better Biopharma” roundtable episode on Bioprocess Online or wherever you get your podcasts. While you’re at it, subscribe to be notified about new episodes, released every other Wednesday.

If you’re a fan of the show, let us know what you’d like to see more of by taking this 60-second survey. Stay tuned for our year-end roundtable, where we’ll reflect on 2026 and share our predictions and hopes for 2027.