Unmet needs: Research helps regulators do their jobs

Changes in clinical trial length

(2015) Lisette Pregelj et al.   NATURE REVIEWS DRUG DISCOVERY

ClinGen — The Clinical Genome Resource

(2015) Heidi L. Rehm et al.   NEW ENGLAND JOURNAL OF MEDICINE

Cell-free DNA Analysis for Noninvasive Examination of Trisomy

(2015) Mary E. Norton et al.   NEW ENGLAND JOURNAL OF MEDICINE

Current situation on the availability of nanostructure–biological activity data

(2015) C. Oksel et al.   SAR AND QSAR IN ENVIRONMENTAL RESEARCH

Chromatin Changes at thePPAR-γ2Promoter During Bone Marrow-Derived Multipotent Stromal Cell Culture Correlate With Loss of Gene Activation Potential

(2015) Patrick J. Lynch et al.   STEM CELLS

Establishing Criteria for Human Mesenchymal Stem Cell Potency

(2015) Rebekah M. Samsonraj et al.   STEM CELLS

Incorporating patient-preference evidence into regulatory decision making

(2015) Martin P. Ho et al.   SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES

Enabling Consistency in Pluripotent Stem Cell-Derived Products for Research and Development and Clinical Applications Through Material Standards

(2015) Anna French et al.   Stem Cells Translational Medicine

Clinical applications of next generation sequencing in cancer: from panels, to exomes, to genomes

(2015) Tony Shen et al.   Frontiers in Genetics

Novel bioequivalence approach for narrow therapeutic index drugs

(2015) LX Yu et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

MSC-Based Product Characterization for Clinical Trials: An FDA Perspective

(2014) Michael Mendicino et al.   Cell Stem Cell

Improving the design of nutrition labels to promote healthier food choices and reasonable portion sizes

(2014) C A Roberto et al.   INTERNATIONAL JOURNAL OF OBESITY

Nano(Q)SAR: Challenges, pitfalls and perspectives

(2014) Ratna Tantra et al.   Nanotoxicology

Harmonizing standards for producing clinical-grade therapies from pluripotent stem cells

(2014) Peter W Andrews et al.   NATURE BIOTECHNOLOGY

Better standards sought for range of stem cells entering the clinic

(2014) Elie Dolgin   NATURE MEDICINE

Diagnostic Clinical Genome and Exome Sequencing

(2014) Leslie G. Biesecker et al.   NEW ENGLAND JOURNAL OF MEDICINE

Gene markers of cellular aging in human multipotent stromal cells in culture

(2014) Ian H Bellayr et al.   Stem Cell Research & Therapy

Automated microscopy as a quantitative method to measure differences in adipogenic differentiation in preparations of human mesenchymal stromal cells

(2013) Jessica L. Lo Surdo et al.   CYTOTHERAPY

ACMG clinical laboratory standards for next-generation sequencing

(2013) Heidi L. Rehm et al.   GENETICS IN MEDICINE

Implementing personalized cancer genomics in clinical trials

(2013) Richard Simon et al.   NATURE REVIEWS DRUG DISCOVERY

Global proteomic signature of undifferentiated human bone marrow stromal cells: Evidence for donor-to-donor proteome heterogeneity

(2013) Samuel T. Mindaye et al.   Stem Cell Research

Assessment of immunosuppressive activity of human mesenchymal stem cells using murine antigen specific CD4 and CD8 T cells in vitro

(2013) Cristina Nazarov et al.   Stem Cell Research & Therapy

Improved proteomic profiling of the cell surface of culture-expanded human bone marrow multipotent stromal cells

(2012) Samuel T. Mindaye et al.   Journal of Proteomics

Quantitative Approaches to Detect Donor and Passage Differences in Adipogenic Potential and Clonogenicity in Human Bone Marrow-Derived Mesenchymal Stem Cells

(2012) Jessica Lo Surdo et al.   TISSUE ENGINEERING PART C-METHODS

Applying quantitative structure–activity relationship approaches to nanotoxicology: Current status and future potential

(2012) David A. Winkler et al.   TOXICOLOGY

Microbial Genomics and Infectious Diseases

(2011) David A. Relman   NEW ENGLAND JOURNAL OF MEDICINE

Mesenchymal stem cell therapy: Two steps forward, one step back

(2010) James Ankrum et al.   TRENDS IN MOLECULAR MEDICINE