Commentary

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  • Coverage with evidence development (CED), rather than quality-adjusted-life-year (QALY) thresholds, offers the best way forward in balancing evidence-based policy for new oncology products with the needs of developers, payers, physicians and patients.

    • Joshua Cohen
    • William Looney
    Commentary
  • Efficiently generating evidence of clinical utility is a major challenge for ensuring clinical adoption of valuable diagnostics. A new approach to reimbursement in the United States offers a balance between evidence and incentives for molecular diagnostic tests.

    • Kevin A Schulman
    • Sean R Tunis
    Commentary
  • When faced with a competitive threat, two companies took diametrically opposite approaches. Both were ultimately successful, but Genzyme's decision proved to be the cleaner and cheaper option.

    • Brady Huggett
    Commentary
  • The NIH Roadmap Epigenomics Mapping Consortium aims to produce a public resource of epigenomic maps for stem cells and primary ex vivo tissues selected to represent the normal counterparts of tissues and organ systems frequently involved in human disease.

    • Bradley E Bernstein
    • John A Stamatoyannopoulos
    • James A Thomson
    Commentary
  • Epigenomics provides the context for understanding the function of genome sequence, analogous to the functional anatomy of the human body provided by Vesalius a half-millennium ago. Much of the seemingly inconclusive genetic data related to common diseases could therefore become meaningful in an epigenomic context.

    • Andrew P Feinberg
    Commentary
  • Comparative analysis of epigenomes offers new opportunities to understand cellular differentiation, mutation effects and disease processes. But the scale and heterogeneity of epigenetic data present numerous computational challenges.

    • Aleksandar Milosavljevic
    Commentary
  • One of the biggest gaps in our knowledge about epigenomes is how their interplay with cellular signaling influences development, adult cellular differentiation and disease.

    • Helai P Mohammad
    • Stephen B Baylin
    Commentary
  • As health biotech enterprises in emerging economies move from imitation to innovation, will they become less relevant to local global health priorities?

    • Rahim Rezaie
    • Peter A Singer
    Commentary
  • Orienting cancer drug discovery to the patient requires relating the genetic features of tumors to acquired gene and pathway dependencies and identifying small-molecule therapeutics that target them.

    • Stuart L Schreiber
    • Alykhan F Shamji
    • Bruce A Posner
    Commentary
  • By focusing on an unmet medical need, providing a cost-efficient solution and reinvesting the resulting revenues into R&D and state-of-the-art manufacturing, Shantha Biotechnics was able to build one of India's first biotech successes.

    • Justin Chakma
    • Hassan Masum
    • Peter A Singer
    Commentary
  • Restrictive licensing practices on DNA patents are stymieing clinical access and research on genetic diagnostic testing. Diagnostic companies, university tech transfer offices and their respective associations need to pay more attention.

    • Julia Carbone
    • E Richard Gold
    • Robert Cook-Deegan
    Commentary
  • Given the accumulation of DNA sequence data sets at ever-faster rates, what are the key factors you should consider when using distributed and multicore computing systems for analysis?

    • Michael C Schatz
    • Ben Langmead
    • Steven L Salzberg
    Commentary
  • By streamlining the qualification process for biomarkers, coordinated protocols recently implemented at the different regulatory agencies can facilitate progress and provide impetus to novel biomarker discovery and validation.

    • Federico Goodsaid
    • Marisa Papaluca
    Commentary
  • There is a paucity of biomarkers that reliably detect nephrotoxicity. The Predictive Safety Testing Consortium (PSTC) faced several challenges in identifying novel safety biomarkers in the renal setting.

    • Joseph V Bonventre
    • Vishal S Vaidya
    • Frank Dieterle
    Commentary
  • In 2008, Roche acquired Genentech, ending the most successful symbiotic business relationship the biotech/pharma sector has ever seen. Morphing biotech business models, pharma management's short-termism and dwindling investor patience means we'll never see the like of it again.

    • Christopher Scott
    Commentary