1. Introduction and Overview 2. Experimental and clinical trial protocol design and data analysis: Two Opposite yet complementary alternatives toward the goals of R&D 3. MAL-PD/CI approach for biomedical R&D in vitro and in animals 4. Implementation for MAL-PD Econo-Green R&D 5. Current Landscape of International FDA Drug Evaluation, Clinical Pharmacology, and Clinical Trials Guidance 6. The epothilone story: Experimental success and clinical failure 7. MAL-PD Advocacy: Public Hearing, Public Comments and Scientific Recommendations 8. Consensus from international FDAs on Definitions of "MAL-PD and "Synergism 9. Why MAL-PD Approach and the Traditional Approach are Opposite yet Complementary 10. Summary and examples of applications: Papers Using the MAL-PD/BD/CI/BI theory/method.. 11. Conclusions