“There could be around 10 total regulatory decisions this year on cell and gene therapies, including up to five decisions on gene therapies for rare genetic diseases alone,” said Stephen Majors, director of public affairs at the Alliance for Regenerative Medicine.

It is vital that, from the beginning of a medicine’s development, a regulatory strategy is built into all activities so companies may optimize value, control costs and reduce risks – all while ensuring proper compliance. If any step is missed along the way, lifescience companies will encounter roadblocks in the form of delays on approval cycles and lack of proper data control, which can impact the long-term revenue for the medicine.