Rare diseases often need extra support when it comes to research and drug development. Luckily, MMS Holdings Inc. (MMS) plans to provide some with their new support program. The program, which is pro-bono, grants regulatory help to patient advocacy organizations in need. 

Aid for Rare Disease Research

One of the major issues standing in the way of rare disease research is the uniqueness of each condition. Each disease requires its own approach to clinical trials and research; however, it must also remain under the requirements of any regulatory agency. 

This is where MMS comes in to help. Through their program, they will provide assistance to patient organizations regarding standards, guidelines, and laws. Through this advice, rare disease research has a better chance of success. Experienced professionals will aid with the framework, along with the selection, reviews, and strategy. 

Specific support includes:

• Regulatory strategy
• Support with medical writing, including the creation of investigational new drug applications (INDs), grants, and other materials
• Additional services depending on a group’s specific needs

The assistance will be provided to the groups based on need and feasibility. They have not yet defined “ultra-rare,” so there is no concrete cut-off for what qualifies. However, the senior global regulatory affairs manager at MMS, Amanda Beaster, stated,

“We will most likely consider applicants for diseases with fewer than 30 affected patients worldwide.”

To read more about MMS’ new program, click here.