1. Editor’s Commentary: Celebrating the Journal’s New Name— Therapeutic Innovation & Regulatory Science

   • J. Rick Turner

   Commentary 30 December 2012 Pages: 391 - 392

2. Associate Editor’s Commentary: The Tao of Biosimilars

   • Peter J. Pitts

   Commentary 30 December 2012 Pages: 393 - 396

3. Building Value Through Biomarkers: The “Smarter Development” Imperative

   • Brad Smith
   • Michael Stocum
   • Oren Cohen

   Commentary 30 December 2012 Pages: 397 - 403

4. FDA’s Flexibility in the Approval of Orphan Drugs

   • Anne Pariser
   • Larry Bauer

   Letter to the Editor 30 December 2012 Pages: 404 - 404

5. Development of Targeted Agents and Companion Diagnostics

   • Béatrice Gerard
   • Marie-Christine Bétard
   • Madlyn Denyer

   Companion Diagnostics 30 December 2012 Pages: 405 - 419

6. Some Thoughts on Challenges for Noninferiority Study Designs

   • David L. DeMets
   • Lawrence Friedman

   Statistics 30 December 2012 Pages: 420 - 427

7. Relative Efficiency of Unequal Versus Equal Cluster Sizes for the Nonparametric Weighted Sign Test Estimators in Clustered Binary Data

   • Chul Ahn
   • Fan Hu
   • Seung-Chun Lee

   Statistics 30 December 2012 Pages: 428 - 433

8. Testing Marginal Homogeneity in Matched-Pair Polytomous Data

   • Zhao Yang
   • Xuezheng Sun
   • James W. Hardin

   Statistics 30 December 2012 Pages: 434 - 438

9. Designing Phase 2 Trials Based on Program-Level Considerations: A Case Study for Neuropathic Pain

   • Nitin Patel
   • James Bolognese
   • Jose Pinheiro

   Clinical Trials 30 December 2012 Pages: 439 - 454

10. A Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions

    • Pankaj B. Desai
    • Christopher Anderson
    • William K. Sietsema

    Clinical Trials 30 December 2012 Pages: 455 - 463

11. Lessons Learned From a Direct Data Entry Phase 2 Clinical Trial Under a US Investigational New Drug Application

    • Jules T. Mitchel
    • Judith M. Schloss Markowitz
    • Dario Carrara

    Clinical Trials 30 December 2012 Pages: 464 - 471

12. A Patient-Focused Solution for Enrolling Clinical Trials in Rare and Selective Cancer Indications: A Landscape of Haystacks and Needles

    • Eric B. Lynam
    • Jiin Leaw
    • Matthew B. Wiener

    Clinical Trials 30 December 2012 Pages: 472 - 478

13. Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs

    • Andreas M. Vogel

    Regulatory Science 30 December 2012 Pages: 479 - 484

14. Outcome Measures in Study Registries: The Need for a Consistent Approach

    • Hans-Theo Forst
    • Robert Paarlberg

    Study Registries 30 December 2012 Pages: 485 - 492

15. Review of Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries

    • Edward Tabor

    Book Review 30 December 2012 Pages: 493 - 493

16. DIA 2012 48th Annual Meeting Student Poster Abstracts

    Abstracts 30 December 2012 Pages: 494 - 504