CANTON TWP.—Officials at MMS Holdings Inc., a contract research organization for the pharmaceutical industry, announced a pro-bono support program to advance research for ultra-rare diseases.
Within this program, MMS will select from patient advocacy groups with demonstrable need and will provide complimentary regulatory assistance.
Over the past decade, MMS has supported rare disease programs, including early phase research through approval for use in more than 12 therapeutic areas and welcomes the opportunity to advance additional rare disease programs.
For those advocacy groups that MMS selects, team members’ support could include:
- Regulatory Strategy, including training on Investigational New Drug Applications (IND) requirements and consulting on nonclinical and formulation development
- Medical Writing support, including the drafting of Investigator INDs, nonclinical study reports, Office or Orphan Products (OOPD) grant writing, or others suited to the program
- Other services dependent upon assessed need
“We are proud to have built a program that affords patients and families with ultra-rare diseases the opportunity to move closer to effective therapies,” said Uma Sharma, chief scientific officer and founder of MMS. “Many of our colleagues come into this field with an altruistic focus—to help others. This program will provide a new perspective on radically new technologies and therapies that may never have made it to the licensing stage, and is set to help improve the lives of many.”
MMS will create an advisory board, with experts in regulatory strategy and writing, other industry thought leaders, and pharma or biotech Sponsor contributors who will be engaged with support of project selection, participation in reviews, and share strategic input.
Qualifications to apply for MMS support include the following:
- Verified need for effective/alternate treatments for the ultra-rare disease
- Scientific justification/rationale for efficacy in the ultra-rare disease population
- Must be a pre-established patient advocacy or parent group
- Focus on products with a limited commercial viability to continue development or pursue licensing
To apply for support, send an email to the attention of the ‘Ultra-rare disease Assistance Program’ to firstname.lastname@example.org, and visit https://www.mmsholdings.com/rare-disease/ for details on MMS rare disease expertise. The first review of applications will occur in mid-October 2021.