Big changes, coming soon to a pharmaco near you! Nostrapharmus predicts big changes in the way R&D projects are selected, big changes in the role of the regulator. Very soon, a general adoption of risk management in regulation and in development investment will increase both flexibility and safety, and it will greatly enhance the industry's capacity to develop drugs for future need.
What's driving change?
The present, paper‑heavy system of regulation doesn't stop Serious Adverse Events (SAEs). And when things go wrong, tick the right boxes and your pharmaco's probably off the hook – legally, at least. But the public wants heads to roll. Who's next in line? No wonder the regulators are looking for a new approach!
The tick‑box system doesn't increase safety; so much as encourage risk‑averse investment. Nor does it deliver better or faster drug development – which ought to be a required output. It's a one‑size‑fits‑all, punitive approach that says I can't tell you what to decide, but get it wrong and I'll zap you. That's a regime that saps initiative and makes its victims sneaky, too, as any psychologist will tell you! Hence all those play‑it‑safe 'me‑toos', added‑values and market segmenting. Yet the opportunities are there. Cancer attracts investment aplenty: the pay‑back is clear and as short as it gets. But that leaves a universe of unmet needs that aren't addressed because the one‑size‑fits‑all regime makes them too risky to be prudent business. For most of them, you wouldn't reach payback before the patent ran out. Business decisions are contingent. Must we wait for the pandemic? No wonder pharmacos are desperate to find a way forward.
Shareholders are likely to agree. They don't want to see their shares crashing when somebody dies and the perpetrators get off. No wonder investors are finding pharma less attractive than they used to.
As a patient, I want remedies that are effective, free of side effects, cheap, and simple to use. In that order. The more serious my illness, the more important effectiveness becomes. My decision on treatment is contingent. So if business and therapy decisions are contingent, why not regulatory decisions, too? No wonder I'm looking for a bit more initiative and imagination from pharmacos and regulators alike.
The stakeholders seem to have a shared interest in a more flexible, contingent and sophisticated regulatory process.
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