Wrong opinion: Flexibility on cancer drugs approval will foster innovation

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I don’t remember how I stumbled on an old article but it was enough to set me thinking about the “new drug approvals” process. I haven’t changed the premise of the title ut prepended it with “the wrong opinion”. The author exhorts to “shorten the approval process” and indirectly blaming the regulator for “delaying” the approvals process.

I have been thinking about how the viral pandemic will radically alter the landscape for “cancer research”. It sucks up millions of dollars and the promised la-la land of “personalised medicine” is relegated to puff PowerPoint presentations in conferences because in the real world it counts to zilch.

Cancer is a moving target. Its ability to adapt to treatment and develop resistance is the single biggest challenge in the field and the reason why the disease claims so many lives. We need a diverse toolbox of innovative drugs that attack cancer in new ways and get ahead of its evolution.

Dramatic advances in our understanding of cancer biology and genetics are helping to deliver an era of precision cancer treatment. The number of cancer drugs being licensed by the European Medicines Agency has doubled in less than a decade — and many of these are new personalised treatments.

Optimism is mandated, yes but it shouldn’t be misplaced. The tradition pharma world marketing has been overpromising with under deliverance- what starts with a bang vanishes nowhere. Regulatory oversight should shift towards a strict phase IV monitoring and compliance rather than the earlier “soft points” of the Phase I trial results. As always, I remain firmly committed to the idea of pushing for radiobiology as the fundamental research (and not the target-oriented cancer research because it is a stupid analogy) Drugs can, at the most, cause a single log kill. I am not discounting the incremental gains gathered otherwise but sharpening the focus on what should constitute the “standard of care”. Biologicals, for heaven’s sake, are NOT the standard of care!

via Flexibility on cancer drugs approval will foster innovation | Financial Times

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