Introduction Part I of this article proposed a framework to help guide the discussion around repurposing, which we define very broadly. Now, in Part II, we extend the framework and…
Introduction Repurposing was at one time a very popular strategy, with some of the earliest blockbusters being novel formulations (usually new oral sustained release versions) of existing products. Generous regulatory pathways (like…
In every industry, revenue is driven by a simple equation: Revenue = (Price per Unit) × (Units Sold) For most sectors, both levers are available. A company can raise prices,…
How much does it cost to develop a drug?We still don't know. The most recent analysis on this subject was published earlier this year. In an excellent analysis, Sertkaya et al. analyzed…
This article was triggered by a beverage-induced discussion I had with Martin Eglitis at BIO-Europe earlier this month. In my licensing courses, I spend a bit of time talking about the probability…
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…
Of course we are being facetious when we use the word “scam.”But it nevertheless reflects the opinion of a major portion of the US population that have, shall we say,…
What will our industry and economy look like in the post-COVID-19 era?First of all, we would never recommend paying too much attention to anyone who knows precisely what the answer…
It is an interesting question. With so much information and mis-information coming at us, it is difficult to tackle this issue in a meaningful and insightful way. For those of you who are statistically…
Ophthalmology is changing. If we look back 5-10 years, topical formulations of novel or established drugs were the norm in ophthalmology product development. These days, we are seeing antisense, gene…