FDA Seeks Help with AI
The US FDA recently published an interesting discussion paper, entitled Using Artificial Intelligence & Machine Learning in the Development of Drug and Biological Products. Here is a link to the…
The US FDA recently published an interesting discussion paper, entitled Using Artificial Intelligence & Machine Learning in the Development of Drug and Biological Products. Here is a link to the…
As we bring 2012 to a close, we're looking back at a few of the interesting events that took place. It was a challenge to whittle this down to a…
There are some very interesting data published yesterday on FDA approval statistics: It was in 1984 when FDA first added the 505(b)(2) pathway for drug approval, a hybrid between the…
The February, 2012 issue of Life Science Leader has a wide-ranging interview with G. Steven Burrill. It's an interesting, insightful read, and we can recommend the interview. Mr. Burrill makes…
UPDATE (21 February) - Here is a decent video interview of Rachel Sherman, head of the Office of Medical Policy for the FDA, on the Biosimilar guidelines: BioCentury This Week Today…
Last week, the NY Times published an interesting article on the cause of Alzheimer's Disease. The article describes experiments in a new mouse model which may confirm, once and for…
As 2011 draws to a close, here are a few thoughts on 2011 and 2012: Uncertainty - If there is one word that captures the mood of the year, it…
Lacerta Bio was privileged to give a short talk at the first (and hopefully annual) Drug Delivery Summit in London late last month. While lightly attended, the two-day conference brought…
Call us late to the party, but in August of this year, KPMG published Future Pharma: Five Strategies to Accelerate the Transformation of Pharmaceutical Industry... The entire report is available…
On the one hand, you hate to see talent leaving the US. But, you have to applaud their attitude: "Although we are comfortable in America, we often felt that something…