DIA Biosimilars 2013

Duke University

International Stem Cell, Duke collaborate on Parkinson's disease

Friday, August 30, 2013 02:22 PM

International Stem Cell (ISCO), a California-based biotechnology company developing novel stem cell-based therapies, has entered into a master clinical research agreement with Duke University to conduct clinical trials research in Parkinson's disease using ISCO's neural stem cell product.

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Cenduit: Now with Patient Reminders

Nuevolution launches collaboration

Monday, August 12, 2013 01:12 PM

Nuevolution is collaborating with Duke University, the Howard Hughes Medical Institute and Lexicon Pharmaceuticals for the investigation of the biological mechanism of action of a specified GPCR drug target. The Principal Investigator for Duke University and the Howard Hughes Medical Institute is Robert J. Lefkowitz, a Duke faculty member, HHMI employee and Nobel Laureate in Chemistry 2012.

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CRF Health – eCOA Forum

Biogen Idec to discontinue development of ALS drug

Friday, January 4, 2013 10:29 AM

Weston, Mass.-based Biogen Idec has decided to discontinue development of dexpramipexole in amyotrophic lateral sclerosis (ALS), after top-line results of EMPOWER, its phase III trial, did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival.

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New executive committee named to CTTI

Friday, September 7, 2012 02:08 PM

The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

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Researchers call for pragmatic trials to better identify and treat statin-intolerant patients

Monday, December 12, 2011 09:13 AM

Next year marks the 25th anniversary of statins, best known as the blockbuster drug that carries low-density lipoprotein (LDL), often called “bad cholesterol,” out of the blood to help millions of people reduce the risk of heart attack and stroke and slow the progression of coronary artery disease.  

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GeoVax completes enrollment for HVTN 205 trial

Monday, October 3, 2011 11:05 AM

GeoVax Labs has completed enrollment for a phase IIa clinical trial testing its HIV/AIDS vaccine. The vaccine is being developed for use in uninfected people to prevent infection should they be exposed to the virus. The trial, designated HVTN 205, is being conducted by the HIV Vaccines Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. A total of 299 participants are enrolled in HVTN 205.

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CTTI report recommends risk-based monitoring

Monday, August 15, 2011 08:02 AM

Almost 90% of those conducting clinical trials within the commercial drug industry always perform on-site visits to their study sites. In contrast, about a third of academic, government or cooperative groups involved in research do. And yet, neither monitoring method is based on any evidence that it improves the quality of the data, as no such evidence yet exists.

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Duke University and the Wallace H. Coulter Foundation create $20 million endowment

Thursday, April 21, 2011 12:41 PM

Duke University and the Wallace H. Coulter Foundation have created a $20 million endowment to foster a research collaboration between bioengineers and clinicians with the goal of developing new technologies to improve patient care.

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Duke puts PI on leave, suspends enrollment in three studies

Monday, August 2, 2010 08:16 AM

A high-profile principal investigator in oncology at Duke University has been placed on administrative leave while the university investigates whether he lied about Rhodes Scholar status on several grant applications. The university has also suspended patient enrollment in three trials he was involved in. 

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CWWeekly

September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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