Tufts CSDD
Facing high innovation risk, costs, and inefficiencies, sponsor companies have increasingly engaged in establishing risk-sharing partnerships, including joint ventures, mergers and acquisitions, in-licensing, and co-development arrangements.
To understand collaboration practices and preferences, the Tufts Center for the Study of Drug Development (Tufts CSDD) examined the development and approval histories of 289 drugs approved by the FDA between 2000 through 2011. Of these drugs, half involved a collaborative development arrangement, with licensing deals being the most common risk-sharing approach.
A quarter of these collaborations were part of a merger, acquisition, or co-development arrangement. Tufts CSDD also found that the prevalence for risk-sharing collaborations varied by therapeutic area, with approved central nervous system drugs having the highest prevalence.
The growth of collaborative risk-sharing innovation models will likely accelerate in a drug-development operating environment characterized by scientifically and logistically complex and demanding protocols, low success rates, and high R&D investments that are targeting smaller market opportunities.
— Tufts Center for the Study of Drug Development, http://csdd.tufts.edu/.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.