Thursday, May 5, 2016
The EMA has granted BioMarin‘s request for accelerated assessment for the planned cerliponase alfa Marketing Authorization Application (MAA). Accelerated assessments are granted on the grounds that a product may satisfy an unmet medical need and is of major interest from the point of view of therapeutic innovation and public health.
CROMSOURCE, an international CRO providing a comprehensive portfolio of services to the pharmaceutical, biotechnology and medical device industries, has appointed four senior executives to its management team. The appointments include Dr. Troy W. McCall as chief operating officer (COO), Debbie Kent as global head of TalentSource staffing solutions, Dr. Kerry Dyson as global head of Clinical Research Division and April McCall as vice president of Commercial Operations. Additionally, CROMSOURCE announced the expansion of its North American presence with the opening of an office in Research Triangle Park in North Carolina.
Montrium, clinical trial technology specialists and electronic content management software providers, have announced the commercial release of the eTMF Navigator, an interactive intelligence dashboard integrated into eTMF Connect. Armed with the right information, clinical teams can now drive improvements in their processes, and better manage their clinical trials.
PharmaSeek, an Investigative Site Network (ISN), is expanding the reach of its network by partnering with the Puerto Rico Consortium for Clinical Investigation (PRCCI). PRCCI is a newly established nonprofit government trust comprised of multiple clinical research sites throughout Puerto Rico. Through a collaborative network of investigators and the support of PharmaSeek, PRCCI hopes to promote and enhance clinical research and drug development in Puerto Rico.
Therabron Therapeutics, a clinical-stage biotechnology company dedicated to advancing a new standard in respiratory care, has received Fast Track designation from the FDA for rhCC10 (recombinant human Club Cell 10 kDa Protein), specifically for the prevention of chronic lung disease related to premature birth.
The Pulse on Patient Recruitment by Ashley Tointon
Patient centricity is a common phrase appearing in the patient recruitment field. Its message is “putting patients first,” which invites more patient input into the clinical trial process, and is one way pharmaceutical companies are actively becoming more patient-centric. Patient engagement can be enhanced by the development of relationships with patient advocacy groups (PAGs).
IRBs react to new model for registering proposed gene trials
On April 27, the National institutes of Health (NIH) enacted a new administrative model for the review of proposed human gene trials; the new guidelines upend a process that has been in place for more than 40 years. Predictably, reaction throughout the industry is mixed. Larger firms are adjusting quickly to the change and retooling their processes to comply with the new model. At the other end of the spectrum, some IRBs, including IntegReview, declined to comment on the changes, stating that the matter is still under internal review.
Clinical research in India: Despite setbacks, opportunity continues
India has 16% of the world’s population and accounts for 20% of the world’s disease burden, yet less than 1.4% of global clinical trials are conducted there. A series of blemishes in clinical research has shaken worldwide confidence—but experts say positive steps have been taken to bring hope for the future. The latest setback came in April from the World Health Organization (WHO), which sent a notice of concern to the Indian CRO Semler Research, alleging data manipulation in a number of bioanalytical studies uncovered during site visits in December and January. WHO said its findings question the validity of studies performed for 12 products and that companies including Mylan, Lupin, Micro Labs and others may need to repeat trials conducted by the CRO.
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