When Measuring European Regulatory Approval, the Timestamp Matters

pharmaphorum recently published an article written by our Founder and CEO Yin Ho and Research Analyst Daniel Sanchez: "When Measuring European Regulatory Approval, the Timestamp Matters." The article looks at cycle times in regulatory decisions and how they are being measured in the US and Europe. A cycle time measures the time from the date of submission, through date of approval. We noticed that some of the analyses involving the European Medicines Agency (EMA)’s cycle time used an inappropriate endpoint, resulting in cycle times that looked two months shorter than they actually are.

Keeping the Fast Lane Open - DDN News Feature on Our FDA Breakthrough Designation Research

Drug Discovery News recently did a feature story, "Keeping the Fast Lane Open" that used our research and thinking from our three-part series "Life in the Fast Track." Since there has been a lot of discussion recently about the FDA’s new “Breakthrough Therapy” designation, we thought it would be interesting to look at some previous FDA fast lanes to see if they have actually made a difference in the speed and process of bringing drugs to market.

Pharmaceutical Trade Groups Endorse Data Sharing, with Conditions - Our CEO, Yin Ho, in Specialty Pharmacy Times

The trending topic of data transparency has been making news recently. The European Federation of Pharmaceutical Industries (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have agreed to make their clinical trial data more readily available for public inquiry. Our Founder and CEO, Yin Ho, was asked to comment on this recently, in a Specialty Pharmacy Times piece, "Pharmaceutical Trade Groups Endorse Data Sharing, with Conditions."

FierceBiotechIT Discusses Pfizer/Context Matters Collaboration on PRO Usage in Diabetes Clinical Trials Study

FierceBiotechIT recently wrote about our analysis of online data, researched by the team here at Context Matters in collaboration with Pfizer, that found only 7.4% (47 trials) of 650 Phase 3 and Phase 2/3 clinical trials for diabetes treatments included patient-reported outcomes.