In an unprecedented move, John Hubbard, Ph.D., senior VP and worldwide head of development operations for Pfizer, announced the strategic partnering with two CROs, ICON and Parexel, as preferred clinical trial outsourcing providers. Hubbard sat down with me to discuss how the two-partner model evolved and how it is going to help spur innovation at the pharma giant.
Breast Cancer Vaccine Holds Promise For Several Players
I came across a headline in one of my news feeds announcing the FDA clearing the way for RXi Pharmaceuticals to move forward with plans for final-stage testing of a cancer vaccine. This might not seem like big news. As I read, however, I realized this is big news for several reasons, and holds promise for a variety of players.
Proof-Of-Principal Confirmed In FIH/SAD Study
A Top 50 biotechnology client needed a contract research organization clinical partner who could conduct a first-in-human/single-ascending-dose (FIH/SAD) study in healthy volunteers for an anti-inflammatory indication. The study evaluated whether the drug product was safe and well-tolerated at dose levels that inhibit >50% of the ex-vivo prostaglandin D2-induced eosinophil shape change in whole blood.
The India Opportunity
India provides a number of significant advantages for the outsourcing of clinical trials, because it offers a large patient population that facilitates faster recruitment, low trial cost per patient, a highly qualified professional medical community, plus global-quality hospitals and clinical research facilities.
Thursday, October 13, 2011
11:00 AM EST | 8:00 AM PST | 4:00 PM GMT
The U.S. Food and Drug Administration issued a final rule on September 28, 2010 that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. This webinar will discuss the operational changes you will need to implement to support the new rule. Click here to register.
The demand for eDiaries for the collection of Patient Reported Outcomes (PRO) data has increased, and so too have the questionnaire requirements. As a result, larger sized screens are required for certain site-based clinical trials.
Clinical Service: Pharmacovigilance
Norwich Clinical Services offers comprehensive pharmacovigilance services for premarketing product safety, postmarketing surveillance, and data analysis. Norwich pharmacovigilance comprises three units: drug safety and surveillance for all drug products, risk management strategy, and regulatory affairs.