3 Ways To Mitigate Data Manipulation Risk In Drug Development

By Alok Tayi, Ph.D.

Developing new drugs is an expensive, time-consuming endeavor. A critical output of the drug development process, besides the compound itself, is data. As you may have read recently, Zolgensma™ re-surfaced in the press because of supposed data manipulation in a specific animal testing procedure.

Needless to say, this is a big deal.

As anyone in the life sciences industry knows, scientists rigorously test and retest drugs to earn the right to bring their products to market. The data produced is the focal point of any regulatory package. In this case, the prominence of this circumstance is substantial in three ways:

1. Zolgensma treats Spinal Muscular Atrophy (SMA), a rare disease with few alternatives.
2. Novartis acquired this asset by purchasing AveXis for $8.7B, and 
3. Zolgensma is among the first gene therapies approved by regulators and at $2M+ per patient, the worlds’ most expensive drug.

Novartis stands by the clinical impact of this therapy, but this event raises the spectre of an unspoken thought circulating through boards and executive leadership at other companies:

Could this happen to us?