Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.
Though the announcement may seem recent, it was actually in October of last year when Vice President Biden boldly announced the “moonshot to cure cancer,” a personal passion fueled by his son’s death from the disease. Half a year later, this tall-order still has the industry – and world’s – attention, remaining the cause of consistent speculation and debate.
After the clinical tragedy in France in January, the French Health Ministry has found blame with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts. The EU has guidelines in place to ensure that does not happen again.
In May 2014, I interviewed Mithra Bindhu of India-based Asiatic Clinical Research to get an update on performing clinical trials in that country. The DCGI (Drug Controller General of India) had recently attempted to overhaul the entire system, which took a long time, complicated the process of conducting trials in India, and caused some sponsors to question the value of doing business there. Has the situation changed?
Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. By BARRY van der STRATE, PhD, Associate Director of Science, Large Molecules, PRA Health Sciences; CHAD BRISCOE, PhD Executive Director of Science & Innovation Bioanalytical Services, PRA Health Sciences
During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences