How does a company evaluate a Contract Research Organization?

Nowadays, both large pharmaceutical and small biotech companies are much more likely to outsource projects to CROs than they might have been in the past. In the 2016 outsourcing survey done by Contract Pharma, 80 percent of 315 pharmaceutical executives who responded said that they would increase their use of outsourcing in order to “focus more on core competencies,” among other reasons, according to an article by Ray Tobey in The ClinSmart Blog.

Do People With Alzheimer's Know They Have Alzheimer's? Alzheimer's Talk Ep 2

Do people with Alzheimer's actually know they have Alzheimer's?  What are the different symptoms between mild to moderate to severe forms of Alzheimer's and dementia?  How close are we to a cure or better treatments?  Global Clinical Trials Principal Investigator, Jason Kellogg, MD shares his thoughts on Alzheimer's disease and the various clinical research being conducted on this all-too-prevalent condition.  

New biotech firm will focus on rare diseases

The major pharma company, Pfizer, has created a new independent company, SpringWorks Therapeutics, which will focus on the production of drugs aimed at rare diseases, which is not profitable for Pfizer itself. Some of these drugs, which the drug giant did not choose to move forward internally, are being repurposed by the new spinoff biotech company.

Clinical Trials System “Broken”?

An official at the Food & Drug Administration (FDA) described the clinical trials system as “broken.” Speaking at a workshop at the National Academies of Sciences, Engineering, and Medicine, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, cited the need for new ways to gather and use patient data, the use of master protocols and the development of new clinical trial networks.

How Do We Control Health-Related Smartphone Apps?

How Do We Control Health-Related Smartphone Apps?

Because the pancreas is buried deep in the body, pancreatic cancer is almost always fatal. Usually, it has metastasized before it is diagnosed. Now the University of Washington has developed a smartphone app that looks for pancreatic cancer using the phone’s camera and applying special formulas called algorithms. After one small clinical study, the app had nearly 90 percent success in diagnosing pancreatic cancer. More testing is necessary.

Sam Whitaker Joins Bracket as Chief Technology Officer

On September. 13, Bracket, a clinical trial technology and specialty services provider based in Wayne, Pennsylvania, announced the hiring of Sam Whitaker as chief technology officer (CTO). Whitaker’s responsibilities will include global product strategy, management and innovation, technology development and engineering, including architecture, user experience (UX), user interface (UI) and IT support functions.

People use social media in Alzheimer’s research

Social media consumers today can get a tremendous amount of health-related material online. More than 40 percent of people who use social media are estimated to be influenced by it in their choice of diet, exercise routine, finding a doctor, getting a second medical opinion or managing chronic illnesses. The sites can be professional; run by drug companies, professional associations or a group active in research for a particular disease; or they can be lay sites organized by patients themselves or family support groups.

Small CROS Feel the Squeeze

Small and medium sized contract research organizations (CROs) have experienced a period of aggressive acquisitions and mergers, reports Jason Monteleone in Pharma Finance. As the number of smaller firms diminishes, they face increased competition, with each other, as well as with the larger companies.

Facebook tells drug marketers about clinical trial strategy

Last Thursday, September 7, Facebook brought drug marketers together for a breakfast that promoted its “clinical trials strategy.” As Facebook was approaching an industry that is accelerating its digital advertising expenditures, the social media giant was also attempting to educate its marketers on how to target consumers for clinical trials.

First Gene Therapy, New Kind of Cancer Treatment Hits The Market

In a press release the Food and Drug Administration (FDA) has announced its approval of a chimeric antigen receptor (CAR) T-cell gene therapy for treatment of childhood and adolescent B-cell acute lymphoblastic leukemia (ALL) for patients up to 25. ALL affects blood and bone marrow cells and is the most frequent childhood cancer. According to the National Cancer Institute, there are 3,100 new cases per year.

What prompts FDA inspections?

What are the factors that cause the U.S. Food and Drug Administration (FDA) to inspect a clinical trial site, especially when the visit is unannounced? A blog by Michael Causey of the Association of Clinical Research Professionals sheds some light on this subject, which is dreaded by clinical trial sponsors, clinical investigators and institutional review boards, who struggle to understand the rationale behind the dreaded visits.

FDA criticized and defended over looser date requirements

Rigorous and lengthy research of candidate drugs, aimed at being maximally sure of their safety and effectiveness before their being released to the public, was once the norm. The downside was that drugs were kept from patients who would have benefitted from them. In recent years the Food and Drug Administration (FDA) has shifted emphasis in drug approval from prudence to speed, according to some critics.

Shire CFO Poulton departs for Indigo, agriculture startup

The announced departure of Jeff Poulton as chief financial officer of Shire plc, a biopharma company, quickly on the heels of the exit of former R&D chief Phil Vickers caused some talk on Wall street and decreased Shire’s shares. Poulton and various financial analysts are calling the move an attempt at garnering a better professional opportunity, while Ireland-based Shire revealed a plan to consolidate its U.S. operations down to two main sites — Cambridge and Lexington — in Massachusetts.

Pharmas will collaborate increasingly with third-party solution providers

Pharmas will collaborate increasingly with third-party solution providers

Ben Adams, writing in Fierce Biotech, in 2016, reported that Cutting Edge Information, a Research Triangle Park, North Carolina-based firm that serves the drug industry, has done a survey of major pharmaceutical and therapeutic device makers. It has found that while 17 percent of them currently outsource their clinical trials to contract research organizations (CROs), this number is expected to climb to 52 percent within a few years as a cost-cutting measure.