Comments for Maxiom Group Blog http://blog.maxiomgroup.com Tue, 03 Aug 2010 18:40:41 -0700 http://wordpress.org/?v=2.8.2 hourly 1 Comment on CFO’s On-point for Managing Risk in Life Sciences by Stephen Reich http://blog.maxiomgroup.com/?p=366&cpage=1#comment-1673 Stephen Reich Tue, 03 Aug 2010 18:40:41 +0000 http://blog.maxiomgroup.com/?p=366#comment-1673 I have noticed that many companies seem to face ERM shortcomings because their viewpoints are too insular. All too often, they rely on internal signal detection as an indicator of increasing risk. Unfortunately, internal signals (even weak ones) are indicative of existing underlying problems. The best risk signals are the ones that trigger a response before you have a problem. This means examining your competitors and learning from their challenges. This also means that prospective risk identification should be performed to identify potential black swan scenarios before they occur. While this may sound simple and obvious, it requires management to take a step outside of their comfort zone. They must shed the assumption that while catastrophic risk scenarios may have impacted their competitors, it will never happen to them. After all, how many times have we heard management declare that "this won't happen to us because we have systems in place to protect us". That's an assumption that needs to be objectively challenged, better prospectively than retrospectively. I have noticed that many companies seem to face ERM shortcomings because their viewpoints are too insular. All too often, they rely on internal signal detection as an indicator of increasing risk. Unfortunately, internal signals (even weak ones) are indicative of existing underlying problems.
The best risk signals are the ones that trigger a response before you have a problem. This means examining your competitors and learning from their challenges. This also means that prospective risk identification should be performed to identify potential black swan scenarios before they occur. While this may sound simple and obvious, it requires management to take a step outside of their comfort zone. They must shed the assumption that while catastrophic risk scenarios may have impacted their competitors, it will never happen to them. After all, how many times have we heard management declare that “this won’t happen to us because we have systems in place to protect us”. That’s an assumption that needs to be objectively challenged, better prospectively than retrospectively.

]]> Comment on Just for Kicks – Will the 2010 World Cup Impact the Life Sciences Industry? by Football world http://blog.maxiomgroup.com/?p=345&cpage=1#comment-1591 Football world Tue, 27 Jul 2010 17:15:53 +0000 http://blog.maxiomgroup.com/?p=345#comment-1591 <strong>Football world...</strong> Well, great post, thanks. I love to read Soccer world cup posts and articles, thanks for sharing.... Football world…

Well, great post, thanks. I love to read Soccer world cup posts and articles, thanks for sharing….

]]> Comment on Leveraging PVBS and Dynamics NAV for Life Science Project Accounting by Leveraging PVBS and Dynamics NAV for Life Science Project … — Accounting Blog http://blog.maxiomgroup.com/?p=284&cpage=1#comment-1086 Leveraging PVBS and Dynamics NAV for Life Science Project … — Accounting Blog Mon, 17 May 2010 20:18:37 +0000 http://blog.maxiomgroup.com/?p=284#comment-1086 [...] admin wrote an interesting post today. Here’s a quick excerptThrough our work with a client, we’ve discovered a very powerful ERP package designed for extreme project baccounting/b requirements. It’s from Pleasant Valley Business Systems (PVBS) and it has been built on top of Microsoft Dynamics NAV. … [...] [...] admin wrote an interesting post today. Here’s a quick excerptThrough our work with a client, we’ve discovered a very powerful ERP package designed for extreme project baccounting/b requirements. It’s from Pleasant Valley Business Systems (PVBS) and it has been built on top of Microsoft Dynamics NAV. … [...]

]]> Comment on Life Sciences Takes Risk Management Much More Seriously, Right? by Tweets that mention Life Sciences Takes Risk Management Much More Seriously, Right? « Maxiom Group Blog -- Topsy.com http://blog.maxiomgroup.com/?p=256&cpage=1#comment-1008 Tweets that mention Life Sciences Takes Risk Management Much More Seriously, Right? « Maxiom Group Blog -- Topsy.com Wed, 05 May 2010 15:31:18 +0000 http://blog.maxiomgroup.com/?p=256#comment-1008 [...] This post was mentioned on Twitter by Dyadem International. Dyadem International said: Interesting blog post from Maxiom Group on Risk Management in Life Sciences: http://blog.maxiomgroup.com/?p=256 [...] [...] This post was mentioned on Twitter by Dyadem International. Dyadem International said: Interesting blog post from Maxiom Group on Risk Management in Life Sciences: http://blog.maxiomgroup.com/?p=256 [...]

]]> Comment on Can ERP be Used to Manage a Clinical Supply Chain? by Tweets that mention Can ERP be Used to Manage a Clinical Supply Chain? « Maxiom Group Blog -- Topsy.com http://blog.maxiomgroup.com/?p=210&cpage=1#comment-803 Tweets that mention Can ERP be Used to Manage a Clinical Supply Chain? « Maxiom Group Blog -- Topsy.com Sat, 27 Mar 2010 23:49:10 +0000 http://blog.maxiomgroup.com/?p=210#comment-803 [...] This post was mentioned on Twitter by Scott Chizzo. Scott Chizzo said: Come view our latest blog post on ERP/Clinical Supply Chain http://blog.maxiomgroup.com/?p=210 http://bit.ly/dzuvlb [...] [...] This post was mentioned on Twitter by Scott Chizzo. Scott Chizzo said: Come view our latest blog post on ERP/Clinical Supply Chain http://blog.maxiomgroup.com/?p=210 http://bit.ly/dzuvlb [...]

]]> Comment on Can ERP be Used to Manage a Clinical Supply Chain? by John Danese http://blog.maxiomgroup.com/?p=210&cpage=1#comment-797 John Danese Mon, 22 Mar 2010 18:38:54 +0000 http://blog.maxiomgroup.com/?p=210#comment-797 Bill, Excellent discussion point that you raise and one that's being raised more and more by our customers these days. Managing the clinical supply chain in the ERP also provides a significant advantage in material and resource planning, since very often clinical supplies are manufactured and packaged on equipment and lines shared with commercial product and they also share ingredients. The ERP system of choice should support, among other things, rapid planning, so it can react to the frequent changes that occur in clinical planning. Bill,
Excellent discussion point that you raise and one that’s being raised more and more by our customers these days. Managing the clinical supply chain in the ERP also provides a significant advantage in material and resource planning, since very often clinical supplies are manufactured and packaged on equipment and lines shared with commercial product and they also share ingredients.
The ERP system of choice should support, among other things, rapid planning, so it can react to the frequent changes that occur in clinical planning.

]]> Comment on QMS Panel Raises Compelling Themes by Taylor Burtis http://blog.maxiomgroup.com/?p=201&cpage=1#comment-784 Taylor Burtis Wed, 17 Mar 2010 20:04:10 +0000 http://blog.maxiomgroup.com/?p=201#comment-784 It is important for companies to always be aware that by law and regulations they are held accountable by regulatory authorities for quality oversight. When GXP activities are outsourced, companies sometime think that the CRO/CMO QMS is “good enough”. Based on the violations listed in current FDA Warning Letters, this is not the position held by the FDA. Whether the company is virtual or big Pharma they expect a QMS to be in place. It is important for companies to always be aware that by law and regulations they are held accountable by regulatory authorities for quality oversight. When GXP activities are outsourced, companies sometime think that the CRO/CMO QMS is “good enough”. Based on the violations listed in current FDA Warning Letters, this is not the position held by the FDA. Whether the company is virtual or big Pharma they expect a QMS to be in place.

]]> Comment on The MacGyver Project: Lessons Learned in Minimizing Cost and Time to Reach the Clinic by Laura Bush, Editor in Chief, BioPharm International http://blog.maxiomgroup.com/?p=142&cpage=1#comment-616 Laura Bush, Editor in Chief, BioPharm International Wed, 10 Feb 2010 17:56:24 +0000 http://blog.maxiomgroup.com/?p=142#comment-616 Very interesting case study and lessons. Thank you for sharing it. Very interesting case study and lessons. Thank you for sharing it.

]]> Comment on Novartis’ Licensing and Alliance Deal With Proteus Biomedical: A Solution To Translating Downstream Patient Demand Within The Healthcare Value Chain? by David J. Friedler, MPH, LNHA http://blog.maxiomgroup.com/?p=123&cpage=1#comment-565 David J. Friedler, MPH, LNHA Thu, 28 Jan 2010 17:18:42 +0000 http://blog.maxiomgroup.com/?p=123#comment-565 There are intriguiging ramifications to the ingestible microchip in managing geriatric patients. From the standpoint of long term care industry, many of us are just entering into the implementation of the electonic record. The notion that we would have accurate reporting as to timliness and efficacy of medication is revolutionary. Over 50% of nursing home residents have some form of dementia. Those at home can not be relied upon to convey symptomatology or organize dosage in a reliable fashion. Prevention of negative outcomes from that standpoint is one key factor to pursue this option. When accurate patient data can be integrated into electonic systems for monitoring medical, nursing and rehabilitaion practice, we will approach a new era of qualitiy control, and cost effectiveness. There are intriguiging ramifications to the ingestible microchip in managing geriatric patients. From the standpoint of long term care industry, many of us are just entering into the implementation of the electonic record. The notion that we would have accurate reporting as to timliness and efficacy of medication is revolutionary. Over 50% of nursing home residents have some form of dementia. Those at home can not be relied upon to convey symptomatology or organize dosage in a reliable fashion. Prevention of negative outcomes from that standpoint is one key factor to pursue this option. When accurate patient data can be integrated into electonic systems for monitoring medical, nursing and rehabilitaion practice, we will approach a new era of qualitiy control, and cost effectiveness.

]]> Comment on How can “Supply Chain Thinking” impact Life Science Marketing? by David J. Friedler, MPH http://blog.maxiomgroup.com/?p=62&cpage=1#comment-563 David J. Friedler, MPH Thu, 28 Jan 2010 03:00:28 +0000 http://blog.maxiomgroup.com/?p=62#comment-563 The implications of the ingestible microchip on geriatric care are fascinating and numerous. In treating a population often unable to respond verbally there are obvious benefits in judging efficacy and in tracking administrative compliance. From the standpoint of long term care where we find ourselves just emerging into the electronic medical record, the integration of actual patient response would indeed be revolutionary. Regulators anticipate the monitoring of doctor's orders, lab results, administration of medication, medication errors, dietary modifications and effectively rehabilitation outcome. Such an integration could add a new quality standard to the most regulated industry in the country. The implications of the ingestible microchip on geriatric care are fascinating and numerous. In treating a population often unable to respond verbally there are obvious benefits in judging efficacy and in tracking administrative compliance. From the standpoint of long term care where we find ourselves just emerging into the electronic medical record, the integration of actual patient response would indeed be revolutionary. Regulators anticipate the monitoring of doctor’s orders, lab results, administration of medication, medication errors, dietary modifications and effectively rehabilitation outcome. Such an integration could add a new quality standard to the most regulated industry in the country.

]]>