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The quest to transition from Sub Investigator to Principal Investigator

Monday, November 10, 2014 07:00 AM

Dr. Smith certainly is the most earnest and resourceful investigator I have encountered in my clinical research career.

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Cloud Pharmaceuticals ratifies board of directors

Friday, November 7, 2014 01:42 PM

Cloud Pharmaceuticals, a therapeutics company focused on cloud-based drug design and development, has ratified its board of directors. Members of the board include Cloud Pharmaceuticals chairman and CEO Ed Addison, chief scientific officer Shahar Keinan, Ph.D., and chief information officer Lawrence Husick. Other members of the board include:

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Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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BIND Therapeutics inks oncology agreement with Merck

Friday, November 7, 2014 01:25 PM

BIND Therapeutics, a Cambridge, Mass.-based clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins, has signed an R&D agreement with Merck, through a subsidiary, to discover and develop novel nanomedicines for oncology. This collaboration will leverage BIND's proprietary nanomedicine technology to create targeted Accurins based on novel, potent payloads from Merck's preclinical oncology portfolio.

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Study: Medication nonadherence a barrier to long-term health and public safety

Friday, November 7, 2014 01:22 PM

One out of four samples collected from patients with serious mental illness (SMI) did not contain the prescribed antipsychotic medication, according to clinical research from Ameritox's Ingenuity Health, a Baltimore, Md.-based provider of monitoring solutions to behavioral health clinicians. Coupled with nearly 40% of samples testing positive for illicit drugs or non-prescribed medications, the study illustrates the pervasiveness of medication nonadherence among those with SMI and highlights the potential barriers to long-term health and public safety.

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Leading BioSciences submits compassionate use IND for Ebola-related shock

Friday, November 7, 2014 01:03 PM

Leading BioSciences, a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock, has submitted an expanded access Investigational New Drug application (IND) with the FDA— also known as "compassionate use"—for its lead product LB1148.

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Lexicon expands management

Thursday, November 6, 2014 03:13 PM

Lexicon Pharmaceuticals has announced management additions directed toward the completion of phase III development and commercial preparations for telotristat etiprate in carcinoid syndrome and preparation for phase III initiation and commercial readiness for sotagliflozin (LX4211) in type 1 diabetes.

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Study: Large enterprises view business transformation as essential

Thursday, November 6, 2014 12:41 PM

Continual business transformation is crucial for companies to stay ahead of emerging players and maintain a competitive edge. From bringing new offerings to market to deploying IT systems to major capital expenditures, business transformation can take countless forms. Many large institutions, however, are struggling with their transformation efforts, according to a study from Oracle, a multinational computer technology corporation headquartered in Redwood City, Calif., and Forbes.

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Takara Bio selects Genedata software to automate, standardize NGS data analysis

Thursday, November 6, 2014 12:35 PM

Takara Bio, a global biotechnology company based in Shiga, Japan, has chosen Genedata Expressionist for Genomic Profiling as its key software platform for next-generation sequencing (NGS) data. Genedata, headquartered in Switzerland, is a provider of advanced software solutions for drug discovery and life science research.

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DaVita Clinical Research, St. Anthony Hospital collaborate

Wednesday, November 5, 2014 01:57 PM

DaVita Clinical Research (DCR), a Minneapolis, Minn.-based specialty CRO, now can offer its sponsors increased patient access, on-site ancillary services and specialty physician experience in key therapeutic areas through a partnership with St. Anthony Hospital in Lakewood, Colo. 

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November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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