PharmExec Blog

USP Analytical Research Award Winners 2014

An international group of three scientists are the recipients of United States Pharmacopeial Convention’s 2014–2015 Global Fellowship Awards, aimed at advancing research involving quality standards for medicines. The recipients’ research will involve analytical tools useful in researching the safety of biopharmaceutical drugs, the detection of substandard drugs in the developing world, and the quality of dry powder inhaler products.

Each of the following students has received a $30,000 USP Global Fellowship Award for the 2014–2015 academic year: Read More »

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Implementing the Generic Drug User Fee Act: Struggles and Successes

Two years into the Generic Drug User Fee Act (GDUFA) program, enacted in July 2012, FDA officials are striving to meet goals and timelines for speeding new generic drugs to market. Agency reviewers have made some progress in eliminating the huge backlog in abbreviated new drug applications (ANDAs) pending in the Office of Generic Drugs (OGD), but not as quickly as manufacturers had anticipated. New guidance from FDA aims to help manufacturers meet standards and to streamline oversight. But a continual rise in submissions to the agency makes it hard for reviewers to get ahead, especially in the wake of a surge of 600 ANDAs filed in June to beat new stability testing requirements. Read More »

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mHealth Set to Transform Clinical Trials

The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June—an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.

The FDA issued new draft guidance that stated its intent to not actively regulate certain health IT devices. It also signaled that IT products that straddle the line between IT and devices would also be exempt. This is good news for mHealth solution developers and health sciences organizations engaged in clinical development, clearing the way for faster development and more confident adoption.

In this Applied Clinical Trials article, Oracle Health Science’s Mukhtar Ahmed outlines mHealth technologies’ potential to transform clinical development programs, including clinical trials.

Read more.

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Mind the (Generation) Gap: The Hunt for Talent in Asia

As more global life sciences firms see their Asian businesses skyrocket, the search for strong, internationally savvy talent in Asia-Pacific has never been more competitive, writes Susan Macdonald of RSA.

The need to build manufacturing and commercial infrastructure in Asia-Pacific with the associated regulatory, quality and compliance processes to satisfy Western authorities is reaching new heights for life sciences companies of all shapes and sizes. As the market’s eastward shift appears more permanent, the incentive for medical device, pharma, biotech, nutrition, generic and consumer health-care companies to establish and grow their businesses in Asia-Pacific has never been more urgent.

This sense of urgency translates into a highly competitive environment to recruit suitably qualified individuals. The ability of companies to attract, develop and retain highly knowledgeable and skilled business leaders in Asia is critical to many companies’ ability to gain, build and maintain a strong foothold in this rapidly growing region.

Like many growing markets, the skills gap is a major hurdle to overcome when identifying, attracting, retaining and developing the senior talent that will grow a life sciences business. Traditional MBA programs teach local and foreign talent the basics of running a commercial operation, but in specialist life sciences and medical device companies, industry knowledge and experience is critical.

For the full version of this article, click here.

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Ebola Outbreak Raises Ethical Issues

The development of new treatments and preventives to combat the lethal Ebola virus has been slow, marked by caution at public health agencies to approve testing of high-risk compounds, and reluctance of biopharmaceutical companies to invest in a field with limited market potential. All that has changed now, as thousands of people have been sickened by the virus, and the death rate has escalated. The risk of harm from an untested treatment now is much less alarming than the prospect of infection, and the potential benefit of any effective treatment outweighs the need for regulatory caution. Read More »

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