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...
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...
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...
MMS has just concluded its second annual Global Champions of Change Competition (G3C), where colleagues from all MMS regions submitted innovative ideas based on our tradition of providing high-quality, efficient services to our clients to help discover and market...
The clinical development industry is an ever-changing field. It’s crucial to stay ahead of industry changes and ensure compliance with the needs of health authorities. Experienced medical writers understand the purpose of a trial and work closely with the study team...
Why is drug development and research in the context of rare disease frequently more difficult to address? In this blog, we will outline some of the challenges with rare disease programs. What is a rare disease? Simply put, a rare disease or condition is one that...
For Sponsors planning to manufacture or distribute a medical device in the US, understanding regulatory requirements is of the utmost importance. Medical device development and approval are regulated by the FDA, under the jurisdiction of the Center for Devices and...
On 31 July 2021, the European Commission published a notice in the Official Journal of the European Union announcing that the EU Portal and Database, a key component of the Clinical Trial Information System (CTIS), is fully functional. This announcement starts...
For its leadership and culture as a clinical research organization (CRO) in the pharmaceutical industry, MMS has received much recognition and praise recently. To uncover some of the reasons behind this success, we recently sat down with Prasad M. Koppolu, Chief...