How CMOs Are Fighting Back Against Declining ROI in Development: Part II
In Part 1 of our Chief Medical Officer 360 Summit takeaways, we unpacked the complex forces reshaping biotech in 2025 — from rising R&D spend and tightening regulations to the role of AI in streamlining trials. While challenges abound, so does opportunity.
In this second installment, Kevin Lee shares key insights from the event where biotech CMOs strategized on combatting declining returns on development. With rising clinical costs and mounting investor pressure, CMOs are leading the charge in transforming development processes.
The ROI Crisis: Framing the Challenge
Kenneth Getz of Tufts CSDD set the tone early with sobering data on how ROI has eroded across the decades:
Mean Peak Sales per Approval ($US Millions)
Total Global R&D Spend ($US Billions)
Mean Percent of Total Sales Invested in R&D
Return on R&D Investment
2000s
$757
$94.2
18.2%
12-15%
2010s
$816
$136.4
18.4%
9-11%
2020s
$396
$188.1
20.9%
3-5%
Despite record R&D investments, returns are dwindling — forcing leaders to rethink development from the ground up.
Investor Conversations: Data First, Buzzwords Last
Investors don’t just want compelling science — they want clarity, strategy, and a realistic path to market. CMOs are reframing their narratives to better resonate:
Ground your science in risk awareness — Highlight known target pathways, anticipated off-target effects, and adverse events.
Quantify your market — Total Addressable Market (TAM) should be real, not theoretical. Define your patient population with hard data.
Redefine “Me-Too” — Being first to market isn't the only path to success. Safer, faster-to-manufacture, or more cost-effective therapies can still win.
Investor Strategy Tip: Treat your therapeutic as a business case. Present it with a growth mindset, including clear mitigation strategies, market capture plans, and endpoint confidence.
Source: Biotech Investment Banking Keynote Led by Michael Meyers, Head of M&A at H.C. Wainwright & Co., LLC and Ed Tucker, CMO at Jasper Therapeutics
AI in Development: From Hype to Hard ROI
Top biotech teams are leveraging AI not as a novelty — but as a strategic engine for efficiency, speed, and smarter decision-making:
Multi-modal data integration unlocks deeper insights and precision medicine.
Verticalized AI platforms streamline fragmented processes across trials.
In an era where speed to data — and speed to decision — dictates survival, AI is becoming biotech’s greatest competitive lever.
Source: Utilizing AI to Streamline Clinical Development Panel including Jeff Humphrey, Mohammed Asmal, Scott Chetham, Gen Li, Peter Linde
The FDA: From Obstacle to Ally
The most successful CMOs don’t treat the FDA as a gatekeeper. They treat it as a partner.
“The FDA should be looked at as a collaborator, not an opponent.” – Norman Sussman, CMO, DURECT
Tactical collaboration tips:
Co-develop endpoints and trial designs. Engage early to avoid rework later.
Opt for facetime. In-person meetings at the FDA’s Silver Spring office foster trust and alignment.
Share transparently. Regulators don’t expect perfection — they expect context.
Building a development strategy with the FDA can mean fewer delays, faster approvals, and better long-term outcomes.
Source: Enhanced Strategic FDA Collaboration: Working with CDER and CBER Panel including Peter Francis, Richard Scranton, Harpreet Singh, Norman Sussman
Patient Organizations: The Most Underutilized Strategic Partner
Patient groups are more than advocacy voices — they’re vital collaborators in trial design, recruitment, and credibility.
Smart CMOs are:
Bringing them in earlyto shape inclusion criteria, endpoints, and study protocols.
Partnering on recruitment, tapping into patient networks to accelerate enrollment.
Sharing outcomes and value to build authentic trust and alignment.
“Partnering with patient organizations helps connect to diverse populations. Meet them where they are.” – Murray Abramson, Precision Biosciences
In an increasingly patient-centric world, these organizations are not optional. They’re essential.
Source: How to Better Partner with Patient Organizations Panel including Joseph Palumbo, Murray Abramson, Peter Schmidt, Laura Williamson
The Path Forward: Rethink. Rebuild. Reinvent.
The biotech model isn’t broken — it’s evolving. The CMOs thriving in this landscape are those embracing:
Investor fluency: Combining scientific rigor with market logic.
Smarter pipelines: Fueled by AI, adaptive trials, and integrated platforms.
Collaborative execution:Working hand-in-hand with regulators, patients, and partners.
These are the traits that separate reactive teams from revolutionary ones.
At GQR Life Sciences, we help biotech companies build talent infrastructures that reflect this new reality — placing high-impact professionals in Clinical Development, Medical Affairs, Regulatory, and Clinical Operations.
If you're a CMO ready to build a team that can thrive in this next chapter of biotech, we’re here to help.
