Hey there, and welcome to edition four of The Beghou Biopharma Review by Marc Iskowitz.
This may sound funny, but when I was a kid back in the ‘70s and ‘80s, I actually enjoyed going to the doctor. That’s because a visit to our pediatrician, Dr. Brown, felt less like a checkup and more like a catchup with a family friend. With his New England accent and dry humor, he always put us at ease.
These days, virtual care in many cases is replacing that old-school, brick-and-mortar medical encounter. And that has implications for pharma. As we mark the traditional end of summer here in the US, we’re looking back at a couple of trends that turn conventional approaches on their head and highlight pharma’s commercial evolution.
First, industry’s growing interest in direct-to-consumer (DTC) models is raising questions about the future of sales-rep roles and whether incentive compensation frameworks can keep up (they can, and we’ll explain how).
Second, the FDA’s launch of a generative AI tool called Elsa could fundamentally alter how regulatory filings are prepared and reviewed. It’s a big moment for regulatory affairs and for commercial teams.
My colleagues have been helping parse these shifts. We're also preparing a major “Commercialization That Works” report on how execs are altering plans and forecasts for these new realities, from top areas of investment to key factors for launch readiness (more on that below).
OK, let’s take stock of what’s changing, why it’s important and what it could mean going forward.
As pharma companies experiment with DTC sales models, some industry watchers are asking what happens to the sales rep.
Heavyweights like Eli Lilly, Pfizer and Roche have either launched their own platforms, struck deals with telehealth firms or are considering this approach. With DTC sometimes circumventing the usual gatekeepers, it’s natural to assume that incentive compensation (IC) plans might not be compatible. But Rohit Gupta, partner at Beghou, envisions the two coexisting.
“Rep activity and DTC are not in conflict,” Rohit notes. “When planned well, they can complement each other and work together to drive brand success.”
In other words, reps remain central to the commercial equation. And IC schemes, while they may need to be adjusted for fairness, can evolve right along with this trend. Read my full interview with Rohit here.
The FDA’s new generative AI tool, dubbed Elsa, is quietly ushering in a new era for regulatory submissions. Historically, filings have been dense, manual and narrative-heavy. But Elsa’s capabilities, which range from automated summarization and consistency checks to pattern recognition, suggest a shift toward intelligent, data-driven review and continuous submissions.
Pradeepta Mishra, VP of AI Innovation at Beghou, says this will raise the bar for submission quality and compress timelines. That means pharma companies may need to rethink how they prepare submissions. Expect a move toward data-first content, embedded metadata and AI-ready ontologies.
The payoff could come in the form of faster approvals and better compliance. Read Pradeepta's analysis in the publication Clinical Leader here.
The report mentioned above is based on our Commercialization That Works survey, which is now in the field, and seeks to canvas experienced biopharma commercial execs for best practices and benchmarks in a range of areas, from commercial ops and data/analytics to marketing and market access.
The research is designed to surface the true differentiators behind successful launches and sustainable commercialization overall, along with external factors that are top of mind for execs these days.
The full report is due out in October. But watch this space, as well as Beghou’s social channels, for a sneak peek at some of the themes emerging from the research beginning in late September.
GenAI adoption is often slowed by two things: tool overload and “black box” skepticism.
“Teams can easily be overwhelmed by a new system with a steep learning curve and too many bells and whistles, while opaque, complex tools can contribute to skepticism and confusion,” write Gupta and fellow Beghou partner Dan Schulman.
To help teams overcome these hurdles, Gupta and Schulman have outlined six change-management accelerators. Their approach treats this as a team-led transformation, not a tech rollout. Click here for a concise outline of the steps or here to watch their webinar.
Here's a look at what we’ve been up to at Beghou and what’s coming up next.
Feel free to write in with questions or feedback on any of these stories. I’d be happy to get our consultants’ take or send more resources your way.
Cheers,
Marc Iskowitz
Editorial Director, Beghou
P.S. Thank you for reading and to freelance writer Gowri N Kishore for helping me put this together.