MMS Blog

  • 5 Questions with Chief Scientific Officer Uma Sharma, Ph.D.

    Posted on 8/8/2013 11:13 AM

    The difficult and demanding role of a Chief Scientific Officer (CSO) is defined as being the “head of scientific research operations at companies performing significant scientific research projects.”¹ Yet anyone in the pharmaceutical industry who has worked with a CSO can tell you that it is much more than that. This role is a mixture of business, science, project leadership and better yet, like the industry, is dynamic on a daily basis and ever evolving. I recently sat down with Dr. Uma Sharm

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  • State vs. Federal Regulations – The Sunshine Act Changes Everything

    Posted on 8/1/2013 11:25 AM

    Case Study: Provision of Meals to a Healthcare Professional in His Office. The following case study illustrates the application of the Physician Payments Sunshine Act in practice. A pharmaceutical manufacturer sends a sales and marketing agent to provide an informational presentation regarding one of its drug products to two licensed physicians in their individual offices, one based in Michigan and the other in Vermont. The presentation is accompanied by a meal worth $15 for each physician. Can

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  • Clinical Trial Disclosures: More Transparency In The Future?

    Posted on 7/17/2013 11:31 AM

    Ed Miseta, Editor of Clinical Leader, interviews Joe Archer, Associate Director of Trial Disclosure Services at MMS Holdings Inc. at DIA 2013.  Archer discusses clinical trial disclosures, why they are important to the industry, the compliance level of companies, compliance by the international community, and whether we can expect more transparency in the future. View the original video at: http://www.clinicalleader.com/Doc/clinical-trial-disclosures-more-transparency-in-the-future-0001

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  • Traveling The Road To Clinical Trial Transparency

    Posted on 6/17/2013 11:45 AM

    First published in the June 2013 Issue of Life Science Leader Magazine. For those of us in the business of managing clinical trials, it has been quite a journey keeping up with the requirements for clinical trial disclosures. Although the road to transparency was paved with good intentions, for many it has been a bumpy one, and we are not there yet. From the very beginning, there have been proponents of and opponents to transparency, each representing its own interests. There is reason for t

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  • Pharmaceutical Regulatory Writing and Submissions 2013: Conference Recap and Highlights

    Posted on 3/31/2013 11:49 AM

    The 2nd annual Pharmaceutical Regulatory Writing and Submissions conference was held in Alexandria, VA on May 6th and 7th, and provided an exciting opportunity to exchange information and experiences with other industry leaders in medical writing and regulatory submissions. The conference covered a broad range of topics from content authoring, writing and submissions technologies, and complexities and strategies for global submissions. With presentations varying from case studies to panel discus

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  • 4 Essentials to Colleague Recruitment and Retention in Pharma

    Posted on 2/15/2013 12:01 PM

    Employee turnover is costly. There is no industry in which that assertion holds more truth than the biotech industry. In this industry, the average cost of replacing an employee is roughly 50% more than the runner-up aerospace/defense industry.1 The obvious implication here is that turnover, particularly at a biotech company or a clinical research organization (CRO), should be kept to a minimum. Retaining quality employees should be a priority for any company (for many reasons, financial and oth

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  • Pharmacovigilance: Recent Developments & Future Perspectives

    Posted on 1/17/2013 12:06 PM

    The development of new and effective medicinal products makes a positive contribution to the health and well-being of individuals. However, there is a need to improve pharmacovigilance (PV) systems to more effectively monitor and take action on safety issues associated with medicines to enhance their contribution to public health. This article looks at the current trends driving the development of PV strategies in order to achieve this aim. Factors behind the development of current trends Glob

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  • Accelerated Approval of Oncology Drugs: Overnight Successes

    Posted on 12/20/2012 9:33 AM

    The Newsweek headline on May 27, 2001 announced “A Cure for Cancer?” Just weeks before this headline, the United States Food and Drug Administration (FDA) announced the accelerated approval of a new powerful anti-cancer drug after a review period of only two and a half months, making it the fastest FDA-approved cancer drug in history. Scientists and physicians were thrilled that one of the first targeted tyrosine kinase inhibitors, Gleevec, demonstrated efficacy in patients with chronic myeloge

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