The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends, including study protocols, big data, mergers, and new technologies.
Otsuka Pharmaceutical has been an industry leader in TB drug development for over 30 years. The company is currently focused on MDR (multidrug-resistant)-TB, which refers to a form of the disease that is resistant to at least the two main first-line drugs available on the market.
In a recent clinical trial, many of the sites lacked proper personnel, training, and equipment. Learn how the company overcame these challenges to make the trial a success.
According to Roslyn F. Schneider MD, MSc, Global Patient Affairs Lead at Pfizer, patients can often have a feeling of being powerless, and be left with the impression they are there to serve the drug development process, and not the other way around. “There are times when it seems we are asking patients for their opinions simply so we can paste them in a pre-defined place in an existing system,” she says. “That is not how a company should be treating one of its most critical stakeholders. As an industry we need to continue to find new ways to incorporate participant feedback in a way that is good for patients, their families, and caregivers. This will be beneficial for our companies and societies as a whole since all of these stakeholders are very closely aligned.”
A promising new diet may work wonders for helping individuals lose weight and fight obesity. The trial will involve taking fecal matter from the digestive tracts of healthy and thin humans, which would then be freeze-dried and put in a pill. Individuals in the study would then ingest the pills. The research does have some validity. Researchers at the Massachusetts General Hospital in Boston have discovered the microbes in digestive tracts of healthy individuals are different from those in obese individuals.
At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. By Keith Howells
On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.
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You are constantly facing increased competition for the best studies, mountains of papers and spreadsheets, vast array of complex sponsor contracts to track, and pressure to watch the bottom line.
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
TiGenix (EURONEXT BRUSSELS: TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis.
Titan Pharmaceuticals, Inc. (
A Johns Hopkins expert in the drug treatment of HIV disease and AIDS is spearheading an international effort to radically shift the manufacturing and prescribing of combination therapies widely credited in the last decade for keeping the disease in check for 8 million of the 34 million infected people worldwide.
Oncos Therapeutics, the biotech company executing a clinical development program on its next generation oncolytic viruses, today announced the appointment of its Clinical Advisory Board (CAB).