MMS Holdings Blog
Posted on 4/22/2016 9:51 AM
MMS Case Study: Data Transparency & Anonymization Programming – Innovation at Work. Read about the challenge, solution, and outcome to see how MMS could help your team!
Posted on 4/5/2016 10:00 AM
In an effort to give back to our community, MMS colleagues worked with the American Red Cross to deliver water to our neighbors in Flint, Michigan. On Wednesday, March 9, the MMS team was able to deliver 190 cases of water and numerous water filters to over 140 homes. Many people may have heard of the situation in the Flint through media coverage, but it was a truly different experience being in the city and talking to the residents. The lead contamination has left residents without easy access to clean water. The residents need to use bottled water to not only consume and cook, but also to wash their faces and brush their teeth.
Posted on 3/1/2016 10:00 AM
Challenge: Small Pharma Requests Regulatory Writing Support for Anti-Infective Agent A small pharma company was seeking a Fast Track designation for their anti-infective agent to provide more frequent FDA interaction and a rolling review of program submissions. Also, as part of the Pediatric Research Equity Act, the anti-infective program was required to have a plan for pediatric studies prior to the NDA submission. They were in need of regulatory writing support for the submission documents,
Posted on 12/14/2015 10:00 AM
Both the Food and Drug Administration (FDA) and independent research groups have highlighted the lack of compliance with laws (2007 FDA Amendments Act) mandating that clinical trial data for approved products be disclosed to publicly accessed websites. Furthermore, findings of a study published in BMJ Open indicate that the clinical trial data disclosed by leading pharmaceutical companies is inconsistent both across trials and across companies. Contributing factors to the noted lack of complia
Posted on 12/8/2015 11:37 AM
Or rather “cures.” Cancer is a not a single disease, but rather a complex set of diseases that consists of various genetic mutations, protein overexpression or loss of protein expression/activity. Therefore, a number of different treatment options need to be available to address not only the type of cancer (breast, prostate, etc.), but also the biochemical characteristics of that particular cancer (eg, loss of PTEN expression, overexpression of HER2). Such commonalities in disease among patient
Posted on 8/19/2015 9:50 AM
MMS Holdings, Inc. is pleased to announce the recent addition of Bob Rappaport, M.D. to their Board of Scientific Advisors. Dr. Rappaport will serve as a member of the Senior Leadership within the company. Dr. Rappaport will support and advise clients on scientific and policy issues. He will also guide and review work from internal MMS scientists as they draft regulatory submissions and other documents including briefing documents.
Posted on 7/24/2015 10:06 AM
Implementing a validated safety database can cost a pharmaceutical or biotechnology company tens of thousands of dollars. It is a significant monetary investment along with a significant investment in resources. For this reason, many smaller companies have continued to stay with “old fashioned” Excel spreadsheets to record and track serious adverse events (SAEs) reported during clinical studies. Noteworthy potential issues with this method are as follows: Excel spreadsheets are not 21 CFR Part 1
Posted on 6/12/2015 10:48 AM
MMS will be in attendance at the DIA (Drug Information Association) 51st Annual Meeting June 14th – 18th in Washington DC to deliver an educational presentation and attend the sessions, workshops, poster presentations, town hall meetings, and networking events. DIA is the largest multidisciplinary event targeted to individuals in the discovery, development, and life cycle management of pharmaceuticals, biotech, and medicinal products. DIA’s goal is to foster innovation that will lead to the deve