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Tanja Obradovic: How Biotech companies approach oncology drug development and pipeline building/management

Tanja Obradovic/LinkedIn

Feb 5, 2025, 00:03

Tanja Obradovic: How Biotech companies approach oncology drug development and pipeline building/management

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared on LinkedIn:

“Possible tectonic shifts coming to how Biotech companies approach oncology drug development and pipeline building/management? Recent news in several areas indicate high likelihood that increased business acumen will be critical at every decision point and especially during clinical phases, medical affairs and post-marketing life cycle.

Biotech M&A in oncology plateaued with oncology falling behind immunology in 2024. This is coupled with trends of more mature product acquisitions (PhII or PhII/III ready) and focus on more strongly validated clinical targets. In the most important market of US, two major changes are underway -inflation reduction act (IRA) and beginning of insurers limiting coverage for drugs reaching market under accelerated FDA approval.

Taken together information indicates criticality of business evaluation beyond only medical need to account for level of regulatory barrier, competitive positioning, patient access and commercial viability starting from pre-IND to launch and post-launch.

Not clear if Biotechs started reacting to these trends in the US and also globally increasing bar for demonstration of drug treatment value. Mechanics of decision on how and in which indication to develop with limited budget remains critical pain point for success of Biotech. Model used by Big Pharma with much larger resources is not fitting as we see from many monthly negative pipeline updates. ”

Additional information.