Client Overview

A small biotech company with a focus on rare diseases.

Timeframe: One-year

Project Objective

Develop a comprehensive pre-approval access policy and SOP that are applicable to the entire drug development portfolio.


A passionate leadership team with different ideas of how to best balance their responsibilities to patients enrolled in clinical trials and those unable to participate in a clinical trial.


  • Develop and launch best-in-class pre-approval access policy and SOP to manage requests in fair and timely manner.
  • Gain alignment within the company leadership team on sensitive issues around pre-approval access.

Key Strategies Implemented


Conducted interviews with the management team to understand their views and the beliefs driving their perspective on pre-approval access.


Developed a draft policy and SOP based on the company needs.


Organized a cross-functional workshop with senior leadership to review and discuss key pending issues; aligned on shared view of how to approach the issue of pre-approval drug access.


Provided strategic counseling and participated in follow-up calls to assist with the launch and implementation.


Tested the strength of the policy and SOP with case studies.


Developed internal communication and training materials to educate the employees about the policy and SOP.

The Outcome


Short Term

Successfully launched pre-approval access request management program with alignment from the passionate senior leaders.


Long Term

Company prepared for successful engagement with treating physicians and the advocacy community.


Key Highlights

Final pre-approval policy and SOP reflect the company’s full commitment to the patient community while balancing a multitude of internal and external considerations such as clinical trial enrollment and manufacturing capabilities.