Spoiler Warning: This week’s blog post is even more self-indulgent than usual.
I’m recognizing two very significant anniversaries in my professional career. This month marks 25 years of working in the nonclinical space. September 1997 saw me take a programming job at a preclinical software vendor, fully in the expectation that it would be a temporary position for no more than two years, just to pay the bills until I became a rock star. I’m not being flippant. Through a combination of naivety and arrogance, I genuinely believed I was destined to a be a guitar hero. 25 years later, I’m still here so you can see how well that worked out for me.
In the context of SensibleSEND, the more significant anniversary is marking 10 years since I joined CDISC and was first exposed to SEND. So, it seems a good time to take a moment to see how much has been accomplished.
Thinking back to 10 years ago, while the FDA were making all the right noises about their enthusiasm for SEND, much of our industry never really believed SEND would be mandated for submission. Today, the inclusion of SEND datasets for submitted studies has just become business as usual, having been a requirement since 2016 for NDAs and 2017 for INDs.
Initially just covering general toxicology and carcinogenicity studies, we’ve seen SEND expand to cover cardio and respiratory safety pharmacology studies with the introduction of SEND 3.1.
My own involvement with SEND was triggered by the move to cover Developmental and Reproductive studies. It may have taken 10 years, but we are now only months away from these studies requiring SEND datasets for submission too, and I’m sure you are well aware of the upcoming requirement for SEND for CBER submissions.
So, for me it’s been 10 years. In any given year, we seem to make less progress than I would like. However, looking back over a decade, I see just how far we have come. SEND is now my full-time job. Even 10 years ago, I’m not sure how many of us would have imagined that SEND could be anyone’s full time job. Yet, today within nonclinical, it’s a serious career path. My organization, like many others, has entire departments dedicated to SEND. We have SEND experts, consultants, trainers and other service providers, for whom SEND is their full-time job.
I’ve often quoted the line “SEND has been the biggest change to our industry since the introductions of GLP”. Someone once said this to me, and looking back at my 25-year anniversary, this certainly rings true. So much has changed, so much is still changing and so here’s to the next 10 years.
‘til next time
Marc
Sensible SEND Blog 