MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
How to Get an FDA Orphan Drug Designation
The Orphan Drug Act provides incentives to sponsors to promote the development of drugs for the prevention, diagnoses, and treatment of rare diseases or conditions that affect fewer than 200,000 individuals in the United States, and for which the sponsor is not...
Senior Biopharma Executive Joins MMS Holdings as Principal Medical Director
CANTON, Mich. (3/10/2022) – MMS Holdings, a data-focused contract research organization (CRO), announced the addition of Robert Allen, MD, as Principal Medical Director of Global Drug Safety and Pharmacovigilance to its team. Bringing more than 20 years of...
MMS Holdings Only Michigan Pharma Organization Awarded a 2022 Top Workplace USA Recognition
CANTON, Mich. (2/2/2022) - MMS Holdings, a data-focused clinical research organization, was recognized in the 2022 Top Workplace USA awards, a national list of organizations with strong company cultures and high employee satisfaction rates. MMS, a minority and...
FDA’s Recent Benefit Risk Assessment Guidance Explained: What It Means for Sponsors
In September 2021, the Food and Drug Administration (FDA) released its Benefit-Risk Assessment Guidance as part of the Prescription Drug User Fee Amendments (PDUFA) VI Implementation Plan which covers 2018 through 2022. PDUFA VI focuses on integrating patient...
New FDA Guidance to Support Ultra-Rare Disease Drug Development
Antisense oligonucleotide (ASO) drug products target a specific sense mRNA to modulate gene expression in living cells and have been used successfully to treat diseases where the pathogenic mutation has been identified. For patients with an...
Looking back at 2021 – MMS Holdings year in review
2021 brought more challenges and opportunities than ever before. From the starts and stops of opening workplaces, schools and economies to managing an overflowing email inbox, it can be challenging to keep up with all the information you need. So, we rounded up...
MMS Strengthens Leadership in the Area of Project Advisory Services
CANTON, Mich. (12/15/2021) – MMS Holdings Inc., an award-winning, data-focused CRO, announced a restructuring of their consulting services with the launch of a Project Advisory Services Unit to meet the needs of many small to mid-sized organizations in immediate,...
MMS Holdings Wins 2021 Scrip Award for Best Contract Research Organization
CANTON, Mich. (12/8/2021) - MMS Holdings, a data-focused CRO, is pleased to announce its selection as Best Contract Research Organization – Specialist Providers in the 2021 Scrip Awards. The Scrip Awards, held annually by London-based Informa Pharma...
FDA Expedited Program Designations to Support Rare Disease Drug Development
One in 10 Americans is affected by rare diseases—more than half of which are children—and approximately 95% of the more than 7,000 rare diseases have no available treatments. To advance the development of rare disease treatments, the Food and Drug Administration...