---
id: "prereq-drug-pipeline"
type: "prereq"
source_timestamps: ["§ Past Successes", "§ 4. Extend AMC research investments beyond early-stage science."]
tags: ["regulatory", "pharma-industry"]
related: ["concept-traditional-amc-model"]
reason: "Necessary to understand why AMCs traditionally stop at early-stage science and why crossing into clinical development requires a new financial and operational model."
sources: ["tail2"]
sourceVaultSlug: "hbr-seg-tail2"
originDay: 2
articleStem: "hbr-tail-131-medical-drug-discovery"
sourceUrl: "https://hbr.org/2026/04/u-s-medical-centers-need-a-new-model-for-drug-discovery-and-development"
sourceTitle: "U.S. Medical Centers Need a New Model for Drug Discovery and Development"
---
# FDA Drug Approval Pipeline

The article assumes the reader understands the **standard phases of drug development**: basic science → early-stage translational → **Phase 1 / 2 / 3 clinical trials** → commercialization, and the **distinct financial and operational burdens of the later stages**.

**Why it's required:** without this, one can't see why AMCs traditionally stop at early-stage science ([[concept-traditional-amc-model]]) and why crossing into clinical development demands a new financial and operational model ([[concept-amc-strategic-financing]], [[claim-traditional-funding-insufficient]]).