Case Study

Ophthalmology Team Helps Small Biotech Gain Product Market Approval

Source: Chiltern

Chiltern applies its expert ophthalmology team to lead a small biotech company to gain marketing approval for their product.

Project Overview

  • A small biotech company partnered with Chiltern to perform their entire clinical program in retinal indications starting at Phase II.
  • Chiltern has provided clinical monitoring, study management, regulatory, safety, medical, data management and statistics services on ten protocols beginning in 2006.
  • Over 2,000 subjects were enrolled at 280 sites across Austria, Belarus, Belgium, Czech Republic, France, Germany, Greece, India, Italy, Netherlands, Poland, Portugal, Spain, Sweden, UK, Ukraine and US.
  • The Chiltern biostatistics group provided regulatory submission support including integrated analyses, advisory committee preparation and attendance, and responses to Food and Drug Administration (FDA) and other regulatory agency questions, leading to marketing approval.

Project Challenges

  • There were subject recruitment and retention challenges on several protocols due to study design issues, competing trials and long clinic visits with lengthy follow-up periods.
  • The Sponsor received numerous questions and requests for additional analyses from regulatory agencies, many of which required rapid turnaround
  • To be prepared for any question from the FDA advisory committee, a large number of extra analyses were required involving new subgroups, new analytical approaches and missing data handling conventions.