As every good regulatory person knows they should never plan any milestone or important events for December as that is when every filing MUST go in!  So, my good intentions of writing a blog in December were sidelined not only by work but by a pair of December birthdays, my daughter and myself, and then there was that little known holiday of Christmas.  It didn’t help that there were milestone events as well - my younger daughter turned 18, I turned 50 (more on that later), and my older daughter came home for Christmas, not only to celebrate, but also to deposit her belongings so she could go off to Havana, Cuba to do her semester abroad program.   

I spent the first week of December in Prague at the DIA EU EDM (could I use more acronyms?) and actually started a “Blague from Prague”, but like many other things that month, holiday cards included, I never finished this particular entry.  The subject of it, including an EU Update will be the subject of my next entry . . . really it will. 

In the short three months that have made up 2008, I have decided to tackle another subject near and dear to my heart, which is DDDD or D⁴ or more explicitly, Document and Data Due Diligence.  I actually think it might be my next line of work if the whole wine thing doesn’t work out (see My First Blog).  So what is it, or what should it be you ask…well in this world of in licensing, it is something I don’t feel is being performed by the correct people looking at the correct information. 

Typically, Due Diligence is done by a combination of lawyers, businessmen and occasionally regulatory types.  It is almost always comprised of looking at documentation of the milestone type:  business development plans, health authority briefing books or meeting minutes, high level summaries, the real impressive stuff.  All of which is well and good, but doesn’t touch on the nuts and bolts of regulatory documentation which will support marketing applications, which is why everyone is doing this!  What folks should be looking at are the manufacturing documents, the case report forms, the clinical study reports and the supportive documentation, all of which will comprise the filing.   

Last, and certainly NOT least, is someone needs to look at the data!  Someone needs to find and identify the data, and then have someone who knows what compliant data looks like, review the data.  Marketing applications, especially FDA New Drug Applications are data driven, so if the data is no good, your application goes nowhere! 

Sponsors need to know what it is they are purchasing and how much work is going to be needed to get it into shape.  If it is not “file able” they need to get a discounted purchase price or something, if it is in great shape and is already electronically available and ready to go, they should pay more. 

We are seeing small companies who have invested in doing their Investigational New Drug applications in eCTD format and data collection according to CDISC reap the benefits in $$$ during negotiations with larger pharmaceutical companies.  Companies who have been down this road before know that by standardizing the data, it will be easier to pool and pooling is what is required at the end.  Tremendous time saving can occur here as well, all of which ultimately equals $$$.  Companies also know that utilizing the eCTD from the IND stage through development will also result in time savings when it comes to putting the NDA together. So to all of you interested in Due Diligence, take the time to roll up your sleeves and really look under the hood of these drugs you are buying and if you need any help call me as I want to kick some tires in my next career!