by Kevin Fetterman
April 26th, 2010
The REMS Coordination Office (RCO) is the organizing hub among a Sponsor’s cross-functional team. The RCO is responsible for coordinating and tracking various aspects of REMS and the activities of outside service providers. The RCO features a core team of individuals tasked with managing REMS activities and processes.
This was the topic of a recent webinar hosted by ParagonRx. Jeff Fetterman, ParagonRx President, opened the webinar by borrowing two examples from the nuclear industry to illustrate how two different principles for organizing operational processes and systems have the potential for two different outcomes – flawless or disastrous. Read the rest of this entry »
Posted in REMS, Tweets | No Comments »
by Marc DeLuca
April 7th, 2010
In 2001, ParagonRx first employed the science-based risk assessment methodology Failure Mode and Effect Analysis (FMEA) to proactively assess patient safety in the emerging field of Pharmaceutical Risk Management. While a novel approach for assessing drug safety issues, FMEA has a long history in other risk intensive industries used to mitigate process and design failures, including the aerospace, military, nuclear, and even pharmaceutical manufacturing. Research into how FMEA was used to mitigate risks across other industries and references made in FDA Draft RiskMAP Guidance, provided the rational for applying FMEA to pharmaceutical product and patient safety. RxFMEA®, ParagonRx’s proprietary adaption of the FMEA process, applies the principles of process mapping complex systems and systematically evaluating a process for potential failures. RxFMEA® is a proactive, bottom-up assessment that identifies the behavioral causes of medication use failures and prioritizes interventional opportunities to mitigate adverse events. RxFMEA® was specifically designed as a Pharmaceutical Risk Management tool and is now utilized in REMS development for the pharmaceutical and biotech industries. Read the rest of this entry »
Posted in Appropriate Use, General, REMS | No Comments »
by ParagonRx
March 30th, 2010
- Guest blog by Andrea J. Simon, PhD -
This blog by Andrea Simon, PhD, a corporate anthropologist, is one in a series that ParagonRx has initiated to help our readers better understand some of the trends taking place in the field of Risk Evaluation and Mitigation Strategies (REMS) and risk management under the FDA draft guidance. We know you will find them of value and encourage you to comment on them.
In April, ParagonRx is hosting its Wednesday FoREMS webinar on the topic of organizing to effectively manage Risk Evaluation and Mitigation Strategies (REMS). And, in May, the Wednesday FoREMS will host a panel of industry leaders discussing how their organizations are building REMS capabilities and resourcing them in their product development and commercialization functions. In preparation for these upcoming webinars, I thought I would share with you some of my observations from the field and encourage you to share your own company’s perspectives on how you are reorganizing to create and effectively manage REMS. Read the rest of this entry »
Posted in General, REMS | No Comments »
by Kevin Fetterman
March 26th, 2010
Jennifer Restivo, VP and Managing Director, Managed Markets at inVentiv Advance Insights, and Kevin Cast, VP, Pharmaceutical Sales at ESI-Curascript, will discuss Risk Evaluation and Mitigation Strategies (REMS). The podium presentation is scheduled on Friday, April 9, 2:45 PM – 3:45 PM. Please check your program schedule for location.
The session will assess the current and future impact of emerging REMS trends. Jennifer and Kevin will present learnings, based on original research, from manufacturers and payers, as well as provide an overview of key considerations for optimal REMS implementation. Read the rest of this entry »
Posted in General, Pharmaceuticals, REMS | No Comments »
by Kevin Fetterman
March 23rd, 2010
Below is a qualitative index of the likelihood that FDA may require a REMS for a specific development compound as part of the NDA submission.
The presence of any attribute increases the probability of a REMS requirement; some items may be more highly weighted than others: Read the rest of this entry »
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by ParagonRx
February 24th, 2010
- Guest blog by Roger Morris, The LondonBritian Company -
You’ve heard all the analogies: Is the glass half empty or half full? Does the dark storm cloud have a silver lining?
I was constantly reminded of this during the Food & Drug Law Institute’s latest conference on REMS held February 16 in Washington, D.C., as the residents and transportation system was trying to dig out of one-two snowstorms. It was an interesting conference, one that built substantially on the groundwork done at last year’s REMS conference which the FDLI co-hosted with ParagonRx. Read the rest of this entry »
Posted in Pharmaceuticals, REMS | No Comments »
by ParagonRx
February 15th, 2010
- Guest blog by Wendy Kaplan Nickel -
Perhaps one of the greatest downfalls in drug history was the steep tumble of VIOXX after it was voluntarily pulled from the market in 2004. VIOXX was approved by the FDA in 1999 and quickly became “the” drug for arthritis. It gained widespread acceptance among physicians and over 20 million people were prescribed VIOXX at some point in its 5-year tenure. In fact, in the year prior to VIOXX’s withdrawal from the market, its manufacturer, Merck, experienced sales revenue of $2.5 billion from VIOXX alone. It is assumed Merck certainly had no intention of harming patients with its product, and in fact, celebrated in the fact that so many patients benefitted from the medication. However, it is worth exploring what might have happened if VIOXX’s safety issues had been discovered during the post-FDAAA era.
Read the rest of this entry »
Posted in REMS | 2 Comments »
by ParagonRx
February 5th, 2010
- Guest blog by Roger Morris, The LondonBritain Company -
Having worked in communications in the pharmaceutical industry for more than 25 years, I continue to be amazed at how even strong competitors remain so open to sharing information and experiences. Perhaps it’s the academic nature of pharmaceutical research that filters out to everyone else in the business, but the industry is constantly talking within itself – from scientific publications about new compounds to physician disease-state annual meetings to specialty conferences.
Read the rest of this entry »
Posted in Pharmaceuticals, REMS | No Comments »
by Jeff Fetterman
January 8th, 2010
Since 2003, ParagonRx has helped design, document, or negotiate dozens of risk management programs and REMS for pharmaceutical products. Clients who choose to work with us have done so because of three operating principles:
- We believe in a balanced approach to REMS design in which safety objectives are achieved while preserving commercial viability.
- We employ science-based methods to reliably design and measure rational, defendable programs.
- We strive to inspire confidence in clients facing uncertain situations by providing specialized thinking, expert analysis and remarkable responsiveness by our experienced staff.
Those potential clients who did not choose to work with us often cited the need for a firm with broader capabilities to implement communication plans and elements to assure safe use.
At the start of this year, ParagonRx fulfilled its vision of being able to provide end-to-end REMS and risk management services by joining inVentiv Health. Read the rest of this entry »
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by Kevin Fetterman
December 22nd, 2009
As we advise clients about REMS design and implementation, the most frequent concern we encounter is related to REMS assessment. A look at the math reveals why this is so. Over 63 REMS have been approved since FDAAA statutes for REMS became effective in March 2008. Of those, more than 90% are comprised of Medication Guides and/or Communication Plans, plus an assessment. Read the rest of this entry »
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