Working Toward a Successful IND Filing

This venture-backed, clinical stage company is developing novel delivery approaches to cell therapy. Their lead product is being developed to treat Acute Kidney Injury (AKI), the sudden loss of kidney function that can occur following cardiac surgery.

Clora has worked on 3 projects with this company relating to the filing of their IND and the execution of their early stage clinical programs.

COMPANY PROFILE	• $10+ MM in VC and NIH Funding • 10+ Employees • Greater Boston
THERAPEUTIC AREA	Nephrology
INDICATION	Acute Kidney Injury
TECHNOLOGY/ PRODUCT	Biologic/ Device combination product
INVESTORS

The company began working with Clora during their Preclinical development. The company was ready to pursue an IND filing in order to initiate clinical trials, but the internal team had no previous experience in regulatory affairs or clinical development.

Their leadership team knew that it needed seasoned experts to help them take the next step, but they also knew they had to be capital-efficient. The estimates that they had received from full-service service providers proved to be cost-prohibitive, with little assurance that their team had deep experience within the company’s specific therapeutic area.

Clora brought the client two accomplished Ph.D. Medical Writers to help compose both the clinical and non-clinical sections of their IND. Additionally, a seasoned Senior Clinical Project Manager was matched to the client to help manage their IND submission timelines. Together, these experts had previously filed over 25 IND packages with the FDA, and had years of experience in the company’s treatment modalities and therapeutic areas.

Soon afterward, the client received the go-ahead from FDA on their IND. The Senior Clinical Project Manager that Clora had previously matched them to continued to lead all clinical operations activities for their Phase I/II program. This industry expert helped the client prepare for its upcoming clinical trials by aiding with vendor oversight, study start-up, and overall timeline and budget management of their Phase I/II program.