Page 145 - Binder2

Without this, the system risks flooding the market with
biologics that win the sprint—but fail the marathon.

4. Realigning Risk, Responsibility, and Reward

At the heart of this issue is misaligned accountability.

Right now:

• Developers are rewarded at launch
• Regulators judge based on early endpoints
• Payers absorb the cost of failure
• Patients bear the consequences of tolerization

That’s backwards.

We need a system that aligns risk and reward:

• If a therapy is likely to provoke immune rejection,
its price and positioning should reflect that risk
• If a biologic shows extended immune durability, it
should be rewarded—not just with market share, but
with structural advantages (accelerated review,
formulary access, pricing premiums)
• If a platform consistently avoids ADAs across
indications, that should become a competitive
differentiator

In short: what works longer should win faster.

143