-miracle-drug-to-market

Links: https://www.wsj.com/articles/the-startup-that-manipulated-data-to-get-a-miracle-drug-to-market-11568433625

Your question: The article describes the field of gene therapy as one with “plenty of incentive to move fast; one of the hottest areas of pharmaceutical research, sucking in billions of dollars of investment. Early pioneers, under pressure from would-be patients and investors alike, are driven to move quickly from promising research results to the manufacturing of a safe, marketable version of their breakthroughs. What type of strategy did the company implement in placing this product in the market? Why did it backfire?

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AveXis, in an attempt to place its new groundbreaking product on the market, the company used concentration strategy, which according to the textbook, involves trying to compete successfully only within a single industry, in this case, pharmaceutical. It applies product development of a new drug – Zolgensma that cures spinal muscular atrophy (SMA), which is a genetic disorder that limits a person’s movement due to loss of nerve cells in the spinal cord and brain stem (Kraft, 2019). This is the best strategy the company can adopt since there was no cure for the diseases, and most pharmaceutical companies were also conducting research. AveXis, in its desire to outrun competitors, the company used an uncertified facility and manipulated laboratory results during the clinical trials (Roland, 2019) to get Food and Drug Administration (FDA) approval. However, it backfired as employees alerted AveXis executives about the inaccuracies in the data submitted to the FDA for approval. After AveXis acquired by Novartis, a major pharmaceutical company, which notified FDA about the data misinformation after Zolgensma’s approval for sale on the market.  FDA inspectors conducted tests on the company facility found discrepancies in the records but decided to keep the drug on the market as it considered the drug is safe for treatment.