Whether you’re using a clinical supplies application, an ERP system, or lots of spreadsheets to track inventory (or all of the above!), you know there’s got to be a better way. We hear requirements like “I want to go to ONE place to see where ALL of my inventory is” and “I need a better method for tracing lots back to their source – too much paper involved”. But with a complex supply chain and many partners doing the manufacturing, packaging and distribution for you, visibility is not easily achieved.
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Maxiom Group's Life Sciences blog about the innovative business and IT practices that are redefining biotech, pharmaceutical and medical device companies.
June 14, 2010
Clinical Inventory Visibility: Seeing What it Takes
Posted by: Bill Stearns
Tags: Clinical Supply Chain, IT Solutions | No Comments |
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June 7, 2010
The Balance of Extremes in the Decision Making Process May Be the Optimal Way
“In any moment of decision the best thing you can do is the right thing, the next best thing is the wrong thing, and the worst thing you can do is nothing.” Theodore Roosevelt
An action is usually preceded by a decision to execute that action. These can be simple decisions, such as the choice to act to prevent a thrown ball from hitting you in the face. Or these can be much more complex decisions, such as the choice to initiate a series of actions, for example the decision to bring a therapeutic to market. While each activity is fraught with differing levels of uncertainty, the point of choosing how to deal with that uncertainty occurs prior to the action, and consequently this point can become the source of much angst. President Roosevelt’s observation offers a convenient framework for exploring the decision point.
Posted by: Andrew Putney
Tags: Business Strategy | No Comments |
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June 1, 2010
What is your organization’s level of risk management maturity (and what should it be)?
When working with companies in designing and implementing a programmatic approach to risk management, a key strategic question always emerges – what kind of company do you want to be regarding risk management?
Most organizations we observe start their Risk Management Program implementation from a current state situation where:
- There is wide variation in the risk assessment and management approaches being applied
- Risk is being addressed as a series of independent initiatives
- Processes for assessing and prioritizing risk are typically subjective
- Risk management is reactive – “after the fact” and “detection-oriented”
Posted by: Fred Greulich
Tags: Risk Management | No Comments |
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May 24, 2010
“You can’t get there from here” – A case for creating a Targeted Product Profile (TPP)
In today’s drug development world it still amazes me to find companies that don’t have an overall drug develop life cycle plan in place, especially when there is a baseline tool endorsed by FDA that could be used. In March 2007, the FDA released a draft guidance entitled, “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool”. The Target Product Profile (TPP) template format described in the guidance is a summary of a drug development program presented in terms of labeling concepts. The guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate its usefulness.
Posted by: Taylor Burtis
Tags: Business Strategy, Drug Development, FDA | No Comments |
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May 17, 2010
Leveraging PVBS and Dynamics NAV for Life Science Project Accounting
Through our work with a client, we’ve discovered a very powerful ERP package designed for extreme project accounting requirements. It’s from Pleasant Valley Business Systems (PVBS) and it has been built on top of Microsoft Dynamics NAV. Many of our clients require extreme project accounting capabilities in order to track clinical and other project spending, to enable re-imbursement from investment partners. This capability supports a key source of very significant funding.
Posted by: John Lyons
Tags: IT Solutions | 1 Comment |
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May 10, 2010
Can Operational Excellence and Compliance coexist? History shows they must and experience proves they can.
I recently read an excellent article (http://immelresources.com/HistoryofGMPs.pdf) recounting events that led up to the formation of the FDA and subsequent key laws. As an Operational Excellence (OE) person, it’s tempting to view compliance as a pain, but this reminded me of the real importance of regulatory oversight.
One of the things that can drive Operational Excellence (OE) folks crazy is the extent of inefficiency and seemingly non-value added work that occurs around maintaining compliance in a life sciences company. Tracking deviations, conducting bio-burden tests, documenting process changes and rigorously controlling documents doesn’t fundamentally change the product coming out of the bioreactors and going into patients. Instead, it is all part of the safety net and oversight that makes it harder for faulty drugs or devices to get out the door. For an OE practitioner dedicated to streamlining operations, eliminating waste, and maximizing customer value, it can be frustrating to slog through layers of red tape and quality systems to drive valuable improvements in the business. Wouldn’t our jobs be so much easier without compliance requirements? Wouldn’t drugs be cheaper? Continued
Posted by: Jason Dunklee
Tags: Operational Excellence | No Comments |
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May 3, 2010
Life Sciences Takes Risk Management Much More Seriously, Right?
Life Sciences companies undoubtedly put more effort into supply chain risk management than any other sector. We’re different. After all, patients’ lives are at stake. It’s more important to us. Isn’t it?
Over the last 6 months the MIT Center for Transportation and Logistics (CTL) conducted a worldwide survey of supply chain risk attitudes, opinions, and management practices. With 12 teams of researchers around the globe we collected 1500 valid survey responses from over 50 countries and 20 industries. Enough Life Sciences responses were obtained (103) to enable meaningful comparison between this industry and others especially industries who act as suppliers to Life Science companies.
Posted by: Bruce Arntzen
Tags: Risk Management, Supply Chain | 1 Comment |
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April 26, 2010
RFID is Dead…at the Unit Level in Pharma
Dirk Rodgers, formerly of SupplyScape and one of the foremost experts on track and trace/brand integrity, published what we’ve all been waiting for…realization that RFID is Dead (at the unit level for pharmaceuticals) on his RxTrace blog. I say “that we’ve all been waiting for” as, since the initial discussions of Florida’s pedigree law and certainly during the California pedigree debates, RFID has been mentioned as a “preferred method” by both governments and wholesalers. While debate has raged, my guidance to clients has been clear…RFID should be considered at the case and/or pallet level but not at the unit level unless there is a significant business case.
Posted by: Scott Dicks
Tags: ePedigree, RFID | No Comments |
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April 20, 2010
Zen and the Art of Innovation: Big Pharma Shifts Its R&D Focus
Here in Massachusetts, we hold a firm belief that springtime is a time of renewal. The days grow longer and brighter as the resident’s moods begin to elevate for the season to come. This “renewal” is certainly analogus to a seismic shift over the past few months within the pharmaceutical industry, for which Big Pharma is beginning to evaluate their future R&D strategies. Major industry headlines are broadcasting drastic billion dollar cuts in internal R&D spending due to the lack of substantial drug development productivity over the past decade. In response, multinational pharmaceutical companies are beginning to search for external opportunities to nurture the innovation process, namely through collaboration and alliances with external research organizations, academia, and emerging biotechnology companies. The overarching concept is it that these distinct groups posses the necessary resources and IP to develop disruptive biopharmaceutical technologies that have the potential to treat major unmet medical needs that will revolutionize the industry.
Posted by: Jeremy Friedler
Tags: Business Strategy, R&D | No Comments |
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April 12, 2010
3PL Strategies in Life Sciences – Important Points from Supply Chain Working Group Meeting
Almost all (if not all) life sciences companies outsource some portion of their Supply Chain. Among those capabilities most commonly outsourced are those associated with the downstream activities of shipping and distribution. Many companies come to the understanding very early on that to have these activities in-house is not something they want to invest in and, in doing so, turn to 3PL providers to be their partners Continued
Posted by: Mark Stesney
Tags: Alliance Management, Business Strategy, Supply Chain | No Comments |
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