Are we there yet – Where’s the GeneTox IG?!

This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko who leads the CDISC team developing the SEND standard for Genetic Toxicology. I asked him “What is the current scope and timeline of the SEND Genetox Implementation Guide?”, and here’s what he had to say: “Some context is in order first.  …

The standard for the altruistic exchange of nonclinical data

This will be my final blog post of 2021, as I’ll be taking a break over the festive season. The season of goodwill is very apt for what’s on my mind this week. Whether it’s media reports of how COVID-19 vaccines were collaboratively developed so rapidly; or the rise of consortia for exchanging pharmaceutical data …

The relative speed of SEND development

As we approach the holiday season and the eventual end of another year, I’m again thinking of how fast this year has passed. Also remembering childhood times when Christmas seemed to take forever to arrive. Now it seems I barely catch my breath and another year flies by. So yes, time is most definitely relative. …

FDA provides more detail on the Scope of SEND

This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the highlight of the week was the FDA public meeting. As …

What’s the deal with the eCTD Study Tagging File (STF), SEND and the Technical Rejection Criteria?

As you are probably aware, Instem recently acquired PDS Life Sciences and so I’ve been working very closely with my new colleague, Mike Wasko. Mike is a prominent figure within our industry, and this week as we were catching up, we started discussing the question: What is the relationship between the eCTD Study Tagging File …

Is SEND the key to unlocking Historical Control Data?

“You wait all day for a bus and then 3 come along at once.” It’s a phrase I used to hear a lot in my younger days when I would often ride public transport. There’s been some of that going on this week, though not with busses. For me, this week it’s been the role …