Tag: faster approval
Last month, The Wharton School of the University of Pennsilvania dedicated a special edition of their prestigious Knowledge@Wharton newsletter to the biopharmaceutical industry. Most importantly, the authors dealt with the pressing question how the industry may continue to develop innovative drugs – and get them approved faster.
Summarizing the current challenges, the report states that “no one doubts that the drug industry’s traditional model for developing new cures is badly broken. Fewer exciting new medicines are reaching patients these days, even as spending on research and development has risen and blockbuster drugs that have long been the backbone of pharmaceutical profits have lost their patent protection. A widening gap divides the discovery of promising new laboratory compounds from the ability to turn them into innovative therapies. A similar gap separates recent scientific gains in understanding genes from the creation of new drugs that use this knowledge to fight disease.”
The report tackles key elements of the ongoing transformation of the biopharmaceutical industry, ranging from novel drug development approaches such as personalized medicine, open-source research, pricing policies, and the latest efforts at the U.S. Food and Drug Administration (FDA) to speed up regulatory processes. One of the most conclusive observations is that partnering and strategic alliances are becoming more important than ever to meet the requirements of the changing pharma industry. However, despite identifying the crucial pieces of the puzzle, it remains to be seen how both established and new biopharmaceutical companies can cope with the challenges of a transforming industry.