Teaming Up for Success
A Clora Case Study
This privately held biopharmaceutical company is developing new therapies for orphan diseases in ophthalmology.
Clora has worked on 9 projects with this company across 4 of its innovative ophthalmic products.
|COMPANY PROFILE||• $200+ MM in Funding
• 100+ Employees
• Greater Boston
|TECHNOLOGY/ PRODUCT||Drug-device combination product|
Part 1: Clinical Trial Execution and Regulatory Strategy
As its late-stage clinical development plans continued, the company wanted to do everything it possibly could to de-risk the execution of their Phase III studies and overall regulatory strategy. The company had previously used full-service CROs and had decided to run their clinical trials by utilizing a hybrid outsourcing model due to quality and budget issues they had encountered.
Clora furnished the company with a small group of experienced operators in ophthalmology who had previously executed similar Phase III programs with precision.
The company was able to deploy a team of proven consultants to assist with project management, site management, and clinical monitoring activities. Additionally, an experienced regulatory expert assisted with their preparation for regulatory interactions with FDA and identified potential issues within their NDA application package.
The company was concerned about outsourcing its clinical studies to a service provider that offered only an “off-the-shelf” solution. They knew they needed top experts with deep experience in their unique therapeutic area.
For this reason, they decided to work with Clora to handpick a team that had the precise therapeutic area expertise and regulatory expertise that was needed. By doing so, the company was able to decrease ramp time, ensure ongoing compliance, and eliminate the need for any expensive remediation activities at the end of their pivotal trials.
Most recently, the company has completed a successful database lock of its Phase III clinical trials, and is now interacting with FDA on their pending NDA submission.
Part 2: Peri-Approval Activities
The company was preparing to initiate commercial activities following the approval of their NDA. However, it was soon facing CMC challenges with their CDMO while in the midst of relocating their medical device manufacturing facility to support commercialization. In addition to requiring a mock inspection at their new manufacturing facility, they were also in need of software validation audit.
Within days, Clora was able to match the company to seasoned, top-tier consultants with deep experience in ophthalmic drug and device development.
The client was able to handpick a small group of consultants that had previously navigated similar challenges for other companies during the Peri-Approval stage, and deeply understood what needed to be accomplished in order to gain FDA approval.
Within just one month, these consultants were able to identify and solve their nagging QA and CMC issues, enabling the company to comply with all FDA regulations and thereby initiate commercial activities without delay following years of development.
Rahul Chaturvedi, CEO
Prior to Clora, I was the head of clinical development at several biopharma companies. I’ve led development activities for 20+ Phase II/III programs that have resulted in 6 product approvals to date. Additionally, I’ve managed business development initiatives in Europe, Asia, and Latin America.