As pharmaceutical and biotech companies look to speed development, lower cost, and reduce technical risks associated with new drug development, they are increasing the number and types of collaborative relationships they are forming with other developers, as well as with service providers and other stakeholders, according to the Tufts Center for the Study of Drug Development.
R&D leaders from the pharmaceutical and biotech industry, who recently participated in a roundtable discussion hosted by Tufts CSDD, said that well-structured collaborative agreements, in which the parties agree to share risks and rewards, can increase the possibility that a new medicine, which otherwise might not get to market, wins regulatory approval – and at lower cost.
Other points discussed at the roundtable, summarized in the August Tufts CSDD R&D Management Report include the following:
- Risk-sharing partnerships are most likely to succeed when governed by a charter that ensures executive engagement, clearly delineates roles and tasks for each organization and key individuals, and defines success metrics and quality measures.
- Large pharmaceutical companies are increasingly creating stand-alone entities that can access corporate resources while retaining the flexibility to partner with external early-stage development companies.
- Pre-competitive alliances, outside of relationships between a single drug sponsor and a contract research organization, which have increased nine-fold during the last decade, will likely continue to increase in number because they help set and proliferate standards and reduce redundancy.
However, the report from a previous CSDD event concluded that drug development programs that involve several partners sharing clinical development risks accounted experienced longer clinical phase times, as well as longer overall time to approval.