This document summarizes highlights from a conference on applying Lean and Six Sigma concepts in life sciences R&D. It identifies some key prerequisites for establishing Lean Sigma in clinical operations, including having a compelling business case, leadership support, appropriate organizational structures and roles, and a methodology to assess benefits. The major challenges are noted as having sufficient organizational bandwidth to take on new projects and overcoming resistance to change. Effective strategies to address these challenges include gaining strong leadership backing, selecting high-impact projects, and ensuring tangible results that reinforce the value of Lean Sigma.