Development of an inhaler (combination product) for the treatment of asthma and COPD

Challenge: A multi-national company with expertise in generic products had identified an opportunity for developing a branded inhaled drug delivery system for the treatment of asthma and COPD.  PharmaCRO was brought in to help develop the regulatory strategy and to provide leadership on formulation development, device development and manufacturing process development.

Solution: PharmaCRO identified regulatory experts with ANDA, 505(b)(2) and NDA experience related to inhalers and worked with the client team on two continents to fashion a regulatory, CMC and clinical strategy that involved multiple possible paths.  PharmaCRO also worked with the client’s partner, a company based in Europe, to develop and optimize the drug formulation and the delivery device.

Result: Multiple interactions with the FDA helped to clarify the regulatory path that would be acceptable to the FDA, and the scope of details in the CMC and clinical areas that would be required.  Following the pre-IND meeting, which was requested at the insistence of PharmaCRO, the client assessed the cost / benefit of the project based on the detailed input received, and determined that for cost and competitive reasons the project would not fit in their strategic framework.  PharmaCRO thus helped the client make an early decision to terminate the project, resulting in significant savings in opportunity cost.