MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Forever Chasing the Shiny New Thing: Thoughts from a Long-time Biostatistician
There are new and exciting advancements in drug development all the time. In my 20+ year career, I’ve certainly seen and experienced many. However, despite these advancements, the overall efficiency of drug development really hasn’t seemed to improve much. Often, we...
How to Solve Challenges in Plain Language Summary Writing
Plain language summary (PLS) writers take highly technical and scientific language and translate it into common language so that it can be understood by patients and caregivers with no formal training in science or medicine. Because a PLS needs to be comprehended by...
How to Succeed in the Pharma Industry: Conversations with Instructors at MMS Academy Part 2
Part 2: Statistical Programming & Compliance We sat down with the instructors for MMS Academy, MMS’ learning arm, for some advice on how to be successful to help those looking to work in the pharma industry. In our first article, we talked with our instructors for...
How to Succeed in the Pharma Industry: Conversations with Instructors at MMS Academy Part 1
Part 1: Medical Writing and Pharmacovigilance We sat down with the instructors for MMS Academy, MMS’ learning arm, for some advice on how to be successful to help those looking to work in the pharma industry. In this first article, we talked with our instructors for...
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...