MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Regulatory Strategy, 505(b)(2) Applications, and Chess: A Conversation with Ben Kaspar
In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss regulatory strategy, 505(b)(2) applications, and general submission advice for any global companies outside of the US that plan to submit to the FDA. In...
Safety Writing, REMS, and Regulatory Requirements: A Conversation with Jeffrey Wiese
In this Expert Insights interview, we sit down with Jeffrey Wiese, Senior Safety Writer at MMS – to discuss safety writing in the pharmaceutical industry, pharmacovigilance, Risk Evaluation and Mitigation Strategies (REMS), and his future vision. In January 2019, Jeff...
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
BREAKING NEWS: MMS partners with MIT Julia Lab and University of Maryland to create the Health Analytics Collective
Members of the Health Analytics Collective: (left to right) Mohamad Zahreddine, Michelle Gayari, Duane Robinson, Uma Sharma, Vijay Ivaturi, Kelly Hill, Joga Gobburu, Alan Edelman, and Prasad Koppolu, gather at MMS Holdings in Canton, Michigan. Originally...
Writing for Regulatory Agencies vs. Medical Journals: The Differences
When a clinical trial is completed, regardless of the outcome, the results need to be shared. From a regulatory perspective, they have to be shared. On the other hand, from the perspective of disseminating information throughout the scientific community, researchers...
How Real World Data is Changing the Pharmaceutical Industry
Approximately 90 percent of global pharmaceutical companies are using, or have plans to use real world data in the near future, according to a 2018 benchmarking survey from Deloitte. This coincides with an increased focus on the use of real world evidence from the...
One Manager’s Career Path: Reflections of a Laboratory Scientist in Drug Development
In the early 2000s, I sat in an undergraduate microbiology lab and caught the bug. It was not a laboratory-acquired infection, but inspiration from a world only seen under the microscope. The order and the vast unknown was intriguing, leading me to expand my...
How to overcome project resourcing issues in the pharmaceutical industry
The pharmaceutical industry has eclipsed 4.4 million employees globally. With worldwide sales planned to increase from $860 billion in 2019 to more than $1.06 trillion by 2022, project resourcing will be even more critical than it is today. The continued expansion of...
Michigan SAS Users Group Chooses MMS Global Headquarters for its Q1 Statistical Programming Event
CANTON, Mich. (December 19, 2018) – MMS Holdings Inc. (MMS) – an award-winning, data-focused CRO – announced that the company will host the Michigan SAS Users Group (MSUG) for their first quarter meeting on Wednesday, March 13, 2019. At the event, members will share...