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The SMS-oncology 3D Biotech Guideline: Drug Data Dossier

Biotech Investigator Sponsored Oncology Studies? A double-edged-sword!

Investigator Sponsored Studies (ISS) are an attractive mean for start-up biotechs to power their clinical development with their new cancer drug: a cheap way with access to academic expertise and patient data. The deal speaks for itself: investigators get an opportunity to get hold on experimental drugs, patients for whom standard treatment is no longer available may get another chance in life, and biotechs generate patient data vital to their business.

However, biotechs must be careful not to cut themselves. All parties have high stakes and interests to find signs of efficacy. Who does not want a new cancer drug that works? Regulators! They want a safe cancer drug that works. And in that order. Safety first!

Do you want to strike a life-time deal with big pharma? Get reliable safety data in your dossier. Probably the biggest risk factor in conducting an ISS is the validity of the safety data. Without such data big pharma must repeat clinical studies to build an important part of their dossier to be submitted to regulators and may loose few years. At what costs? If big pharma looses one year of peak sales of a marketed drug opportunity costs could add up to 0,5 – 1,0 B$. Lack of reliable safety data will substantially harm a deal with a biotech. So, be smart, do not get blind-sided on efficacy, play it safe and you may earn double-digit M$ for your company.