One of RRD’s specialties lies in clinical and regulatory program design and management. Our adaptable program management team can help move a development candidate from pre-IND forward and put it on a trajectory toward successful proof-of-concept.

The Challenge

As a start up, our client had no internal capability to plan or execute the development program for its lead product. Hiring a team would be expensive and time consuming.

The Solution

RRD provided a team of development experts with strategic and operational expertise to construct a regulatory and clinical development plan for our client’s lead product candidate as well as conduct the pre-IND meeting, file the IND, maintain the IND, and conduct the initial clinical trial.

The Result

The company was able to move from product concept to clinical testing in less than two years and demonstrate compelling clinical activity in the first clinical study. Based on the progress made in this program, our client was able to raise more than $85MM in investor funding and establish a partnership with a >$20B BioPharma company that included a $50MM upfront payment.