October 18, 2019

Pharmacovigilance Best Practices: Establishing a Foundation of Drug Safety Success

Thanks to everyone on the great feedback we have received on this blog series focused on pharmacovigilance best practices for clinical and early post-approval biopharma companies. We've discussed discussed the importance of understanding reporting and submission to FDA, taking control of your pharmacovigilance software and creating a shared services model with your CRO.

Read More
October 11, 2019

Pharmacovigilance Best Practice #3: Use Software to Create a Shared Services Model with Your CRO

Last week's blog post discussed the importance of taking control of your pharmacovigilance software. This week we discuss Best Practice #3: Using software to create a shared services model with your CRO.

Read More
October 4, 2019

Pharmacovigilance Best Practice #2: Take Control of Your Software

Last week's blog post discussed the importance of understanding what adverse events are reportable to FDA and how they are submitted. This week we discuss Best Practice #2: Take control of your software. 

Read More
September 27, 2019

Pharmacovigilance Best Practice #1: Understand FDA adverse event reporting requirements

Last week's blog post introduced our new pharmacovigilance "best practices" series that we have put forward for clinical and early stage biopharma companies. This week we discuss Best Practice #1: Understand what is reportable and know how reports are submitted to FDA. 

Read More
January 19, 2018

2018- The Year of Next Gen Drug Safety and Pharmacovigilance 2.0

We have a tradition in the RxView blog of starting each new year by asking if the year ahead will be “The Year of Drug Safety” or “The Year of Healthcare Technology”. We typically lay out a few thoughts on why the year ahead has the potential to be a big year.

This year feels different. Maybe it’s the incredible bull market that has inflated our confidence or the fact that my colleague Jim Davis feels that it is a foregone conclusion that the Philadelphia Eagles will finally win the Super Bowl (sorry Jim, that’s ridiculous!). Or perhaps it’s the fact that our client roster keeps growing, Evidex keeps getting more valuable to our users every day, and key industry opinion leaders are confirming that our vision is THE path forward. Whatever the reason, I’m willing to be a bit bolder this year.

2018 WILL BE the year that the pharmacovigilance industry embraces the next generation of drug safety data, analytics, and software; What we call Pharmacovigilance 2.0.

Read More
June 9, 2017

Failure to Warn: The Week in Drug Safety News

It’s been a very busy week for many of us.  School’s finishing up for the kids here in California (no snow days here!), the annual ACSO conference was in full swing, the Warriors are up 3-0 in the NBA finals, and the media coverage of the Comey hearing has been non-stop.

With everything else going on, we wanted to make sure to draw your attention to some significant drug safety reporting over the past week, as we wouldn’t want to be accused of “failing to warn”!  

Read More
May 12, 2017

Post-Marketing Drug Safety and Pharmacovigilance Is Now More Important Than Ever

If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA.  Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval. 

Read More
February 24, 2017

A Big Data Stumble in Healthcare

This week marked the annual HIMSS Conference.  HIMSS, Healthcare Information and Management Systems Society, is the big annual gathering of IT firms trying to market their wares into healthcare systems, pharmaceutical companies, and health insurers.

While usually a time for big partnerships, acquisitions, deployments, and new client wins, this year’s HIMSS kicked off in a rather inglorious manner.  On Sunday news broke that world-renowned cancer center MD Anderson had discontinued their partnership with IBM Watson.  After a string of big wins by the Watson team, this appeared to be the first – and certainly the largest – setback.

Read More
February 2, 2017

Drug Safety Progressives – The Rise of the Pharmacovigilante

The United States is a polarized place right now. Democrats vs. Republicans. Liberals vs. Conservatives. President Trump vs. the world. The divide runs deep and battle lines have been drawn. And while there is no escaping this highly publicized political chasm, there is another fight being played out in the shadows… The Drug Safety Progressives vs. the Drug Safety Conservatives.

I was at the DIA Pharmacovigilance and Risk Management conference last week, fittingly taking place in Washington D.C right after the inauguration and the women’s march.  The division was obvious.

Read More
January 5, 2017

Working Toward a Cure: The Foundation for Sarcoidosis Research

In November 2016, I was honored to be asked to join the Board of Directors of the Foundation for Sarcoidosis Research (FSR). The foundation began in 1999 as a grassroots organization, and now has expanded their efforts and impact to become the leader in supporting sarcoidosis research. I'm looking forward to using my experiences both as a sarcoidosis patient and in drug safety to contribute to the mission. Please visit www.stopsarcoidosis.org for more information. 

I originally wrote the post below for the FSR blog. The original can be seen here

Read More