Tag: online learning

Elliott Masie’s LearningTalks

Posted on by Valentina Rosa

Elliott Masie is one of the most respected learning and development people around. I, like many training professionals, know of Elliott from his work at The MASIE Center, a “think tank focused on how organizations can support learning and knowledge within the workforce” (1).

More recently, I’ve become interested in the work Elliott’s company has been doing with LearningTalks. Modeled after the popular TED Talks, LearningTalks is a series of short, free, video interviews on all aspects of learning. There are many people and companies to choose from, including Apolo Anton Ohno, Marshall Goldsmith, and Diane Hessan, and Learning Leaders such as JC Penney, Peace Corps, and MTV.

As a serious amateur bike rider and soccer player, I was drawn to Apolo Anton Ohno’s interview right away. Entitled “Extreme Learning & Training: Mastering the Olympics and Dancing with the Stars,” Apolo talks about his father’s seminal influence on his life, the lessons he learned in his sport, and how he applied them to his business. Though I’ve never raced on a short track and can’t dance a step, I can see how Apolo’s experiences can be of direct value in business. Passion for work, commitment to excellence, and the importance of teamwork are critical for success for TRA360 and for me too.

I’ve bookmarked the site and intend to view the other learning videos when I can. It’s worth taking a few minutes out of my busy day to do so. Give the videos a try and let me know what you think. And, if your company is facing learning and development challenges, contact Valentina Rosa if you need some help.

1 http://www.masie.com/Center-Information/who-is-elliott-masie.htm

FierceBiotech: The Biotech Industry’s Daily Monitor

Posted on by Valentina Rosa

The tagline of FierceBiotech is “The Biotech Industry’s Daily Monitor” and they deserve it! It is a gold mine of information for anyone who works in the biotech, pharmaceutical, and medical device industries. And, for medical writers, medical communicators, and regulatory writers, the resources are amazing. There are 8 microsites within FierceBiotech, each with a specific focus in the biopharma universe. With news, features, events, eBooks, white papers, and webinars, they’re got pretty much all your content needs covered. (As an aside, FierceMarkets Network has more than 30 websites.)

What’s the best way to absorb all this information and use it on your job? I think the best approach is to go to FierceBiotech and take a look around. Once you’ve spent some time there, pick the kinds of media that are most useful to you and how you want to get it. Would you rather use an RSS feed to get links to articles of potential interest in your newsreader? Do you prefer to receive an e-newsletter or daily post? How about just bookmarking the website and using it as a resource like Wikipedia? All of these methods are possible and many more. You decide.

Do you know of other valuable resources for biotech and pharma professionals that you’d like to share?

FDA and Life Sciences Relationship: PwC’s Improving America’s Health V

Posted on by Valentina Rosa

Starting in 1995, PricewaterhouseCoopers (PwC) has surveyed the life sciences industry on its working relationship with the US Food and Drug Administration (FDA), its chief regulatory agency. This year’s fifth survey produced mixed results for industry and the FDA. See the PwC press release for more information.

Among the six key findings described in the Executive Summary, four seem especially important for regulatory writers (1):

  1. Despite complex scientific, economic and political changes, the relationship has improved; but problems remain. 78% of respondents said that the agency’s guidance documents have increased industry’s understanding of FDA’s expectations. I know from first-hand experience that this has been a major initiative by the FDA over the past 3-4 years. FDA personnel regularly speak at events sponsored by the Drug Industry Association (DIA) and Regulatory Affairs Professionals Society (RAPS), two of the largest professional organizations for regulatory writers and regulatory personnel. However, problems persist as 30% of respondents saw no change in the agency’s approval process over the last two years, and more than 60% said that the FDA changed its position during their review. Working with a number of biopharma customers at TRA360, this is a consistent issue and one the agency needs to address. Better training, oversight, and assessment seem like valuable areas for improvement.
  2. FDA approval process lags in both scientific and technological advances. Industry feels that the agency is not keeping up with technology, something we hear from our customers, vendors, and regulatory consultants all the time. Part of this is the usual industry-government divide, but in my opinion, both parties need to work harder to bridge the gap. Joint initiatives have been underway for years, but more creative solutions are needed.
  3. More frequent, open and clear communications could benefit both sides. After 10+ years as a regulatory professional, this is no real surprise. Industry needs to do a better job at scheduling meetings with FDA—pre-submission and end-of-phase—and FDA needs to be more proactive in requesting them. And FDA needs to work hard to standardize submission requirements throughout the development process, especially in the endgame when delays or failures are more expensive.
  4. Opportunities abound to improve America’s health. Increased collaboration between industry and the FDA are essential here, especially with regard to the agency’s high stakes, all-or-nothing approach to drug approval. Based on my experience, regulatory professionals can be key players in successful outcomes here.

Overall, I found PwC’s Improving America’s Health V an insightful survey, rich with important data for biotech, pharma, and medical device companies, regulatory professionals, regulatory writers, medical writers, and medical communicators. The complete findings of the study and a podcast on the report are available for download at: http://www.pwc.com/us/fdasurvey.

(1) Improving America’s Health V, http://bit.ly/ekbSxf, page 3.