An outsider's perspective, free from industry dogma, can be a powerful asset in life sciences. This viewpoint enables questioning of established norms and identifying unconventional solutions, such as applying a non-profit fundraising model to drug manufacturing.
To leverage modern, faster FDA pathways for biosimilars, robust analytical data demonstrating biosimilarity is critical. Therefore, a startup's choice of a Contract Development and Manufacturing Organization (CDMO) should hinge on their analytical expertise, which can reduce or eliminate the need for lengthy clinical trials.
The scientific knowledge to produce insulin is widespread. The primary barrier to creating an affordable biosimilar is not a scientific challenge but raising sufficient capital to navigate manufacturing and distribution, a problem addressed by Project Insulin's non-profit, fundraising-first model.
High drug costs are systemic, rooted in the for-profit model's legal obligation to prioritize shareholder returns over patient affordability. This is compounded by a complex distribution chain where multiple middlemen—wholesalers, insurers, and pharmacies—each add a profit layer, inflating the final price.