The fda’s oversight relationship with biotech/pharma, and the proactive suggestions contained in the signals piece, remind me of the interaction between a salesperson and sales mgmt. during a 1st quarter territory/account planning review. During this session, it quickly becomes very obvious how prepared the salesperson is and what level of planning he/she is capable of. At the end of one of these meetings, it is usually clear to each participant whether the salesperson will survive another year or whether they should immediately begin to seek alternate employment.
The meetings will be voluntary, informal and interdisciplinary
Of course, in the world of sales, these meetings are not voluntary. However, the well-prepared salesperson welcomes the interaction since, for example, they can request additional support resources, while the ill-prepared seeks to avoid it.
But they profess to be puzzled by why biotechs do skimpy Phase II's. I don't think it's any mystery - money and time-to-market.
Also, (i) the inability to plan and think strategically and (ii) the continuing employment scam.
Just as many salespeople do not want to have their planning, or lack thereof, exposed to critical thought by mgmt., so, I suspect, a lot of biotech/pharma mgmt. would opt out of this voluntary review for fear of exposing a company weakness, or their own (unless,of course, failure to participate became equated with inadequacy).
I recall, with amusement (in hindsight), the conclusion of one of these ill-fated salesperson/mgmt. reviews. Representing mgmt. at the time, I was a bit concerned when one salesperson’s animosity gradually increased to an uncomfortable level. When he opened his briefcase with dramatic flair, I wondered whether a letter of resignation or a gun was about to appear. Fortunately, it was the former.
It will be interesting to see the industry’s reaction to the fda proposal. I suspect that the early participants will be those of talent since they will serve both the fda’s needs as well as their own.
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