Accumulus Synergy: modernizing interactions with and among regulators

Biopharmaceutical companies push the boundaries of science to develop medicines, employ the most sophisticated techniques to visualize and analyze data, and then painstakingly transfer the results onto paper or PDFs to communicate data to regulators. It is like flying precious cargo halfway around the world on a jet plane and then piling it onto a donkey cart. The results are predictable: data are reviewed slowly and analyses are not as sophisticated as they could be, so patients get drugs later and at higher costs than they should.

Accumulus Synergy Inc., a non-profit organization backed by a dozen multinational pharmas, was created to bring interactions between drug sponsors and regulators, and among regulators, into the 21st century. If it is successful, drug development will become less expensive and faster. It will also be more democratized, as small biotechs and under-funded regulatory agencies will have access to capabilities that today are available only to large companies and a handful of leading regulators. ...