The idea and practice of using real world data in the pharmaceutical industry has driven much conversation as of late. As groups like the Health Analytics Collective begin to bring game-changing methodologies to the marketplace, we sat down with Vijay Ivaturi,...
Summer reading isn’t reserved for school-aged children, as adults and professionals alike can gain knowledge and insights from consistently reading material during the hottest months of the year. With Book Lover’s Day last week, we asked eight colleagues from varying...
The idea and practice of using real world data in the pharmaceutical industry has driven much conversation as of late. As groups like the Health Analytics Collective begin to bring game-changing methodologies to the marketplace, we sat down with Chris Hurley,...
As an integral member of the Health Analytics Collective, Julia Computing is seen as the programming language of the future. We sat down with Andrew Claster, Director of Marketing & Communication at Julia Computing to get a sense of what Julia is and where they...
New and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are continually being release. These guidances are...
SOUL stands for bringing a Sense Of Urgency and Leadership to work each day. The SOUL of MMS comes to life as project work is completed on time and as risks and solutions are identified proactively. At MMS, each colleague takes responsibility for the success of every...
The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is generally focused on the determination of a safe starting dose in humans, the...
The 505(b)(2) is a New Drug Application (NDA) containing full reports of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a...
This complimentary lay summary whitepaper will explain: the ins and outs of lay summary writing, the importance of starting a pilot program, a checklist for lay reviewers, and strategic advice for becoming more transparent. Click on the image for the full...