MMS Blog

  • MMS at PhUSE Conference March 15 – 17th in Silver Spring, MD!

    Posted on 3/10/2015 12:26 PM

    MMS will be attending the PhUSE Computational Science Symposium (CSS) conference in Silver Spring, Maryland on March 15-17th to present several posters, host a promotional booth, and attend the educational sessions. PhUSE brings together Regulators, Industry, Technology, and Service Providers to address computational science needs in support of regulatorPhUSE Logoy review. Representatives from several MMS functional departments will be in attendance, including Biostatistics, Programming, Clinica

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  • Race & Ethnicity in Clinical Research

    Posted on 3/4/2015 12:40 PM

    Defining the Problem The role of race and ethnicity in biomedical research is constantly under debate. After sequencing the human genome and mapping human genetic variations, there are contradictory beliefs and practices about the use of race and ethnicity in clinical research. These beliefs and practices endorse the concept of a socially constructed race and ethnicity, yet at the same time they are often treated as genetic variables. Is it scientifically correct to treat race and ethnicity as

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  • Risky Business: Pharmacovigilance and the Role of the NEW PSUR aka PBRER

    Posted on 1/28/2015 2:43 PM

    Pharamacovigilance (PV) is the multi-disciplined science of evaluating the risk benefit analysis of a pharmaceutical compound, which involves monitoring, detecting, assessing and preventing adverse effects of pharmaceutical products or medical devices. The ADR, or adverse drug reaction, is defined as any response to a drug which is noxious and unintended. Data gathered from patients and healthcare providers, as well as the medical literature, play a pivotal role in PV. Ultimately, PV is concerne

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  • The Year in Review: The Most Exciting Advances in Neuroscience in 2014

    Posted on 1/13/2015 2:50 PM

    Neuroscience continues to advance rapidly, with tens of thousands of new peer-reviewed articles each year. Several findings stood out to me in 2014 as being relevant for neurology and psychiatry drug discovery and development. This summary scratches the surface… Clinical Neuroscience Studies: Cognitive deficits in schizophrenia are a huge unmet challenge because existing antipsychotic drugs do little to help impaired memory, planning for the future and “emotional IQ.” Santarelli and colleagues

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  • One Small Secret to a More Successful Briefing Document

    Posted on 9/23/2014 3:27 PM

    Many of us who work in the pharmaceutical industry can recall excitedly explaining aspects of our science to friends and family. Perhaps the discussion took the form of a conversation of food effect around the thanksgiving table, or a detailed breakdown of a mechanism of action to a curious high school biology student. The questions that arise from discussions are often illuminating—allowing us to see science in a different way and helping us explain it more convincingly in the future. While dis

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  • Probiotics – Food for Thought?

    Posted on 9/9/2014 3:31 PM

    In your food, at your doctor’s office, in your body… these microorganisms seem to be supplementing our diets, supplementing our medications, and inhabiting our daily lives. But does anyone really know what they are or who’s monitoring their use? Google advertises brand name probiotics with claims to be gastroenterologist recommended and clinically tested. Further down the page, search results produce definitions of probiotics from sites such as WebMD and Wikipedia declaring the health benefits

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  • Case Study: MMS Support for Small Pharma

    Posted on 9/2/2014 3:35 PM

    Challenge: Sponsor needed Regulatory Project Management for Phase 2/3 Program A small pharmaceutical company had the need for regulatory project management and regulatory document management to support their Phase 2/3 program. The sponsor selected MMS because of the strength of our teams, infrastructure, and regulatory experience. MMS Solution: Provide Regulatory Team to Manage the Phase 2/3 Project MMS provided a regulatory team, including regulatory project manager, regulatory operations sp

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  • The COMPETE Act of 2014 – Extending the R&D Tax Credit

    Posted on 8/26/2014 3:38 PM

    Senator Tom Carper (D-Del) recently introduced the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2014, otherwise known as the COMPETE Act of 2014, in Congress. This bill seeks to amend the Internal Revenue Code of 1986 to increase and make permanent the alternative simplified research credit. Supported by the Association of Clinical Research Organizations (ACRO) and Biotechnology Industry Organization (BIO), the COMPETE Act of

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