The recent news of risky investment portfolios, oil spills and contaminated drug products highlight the magnitude of risks that businesses face and the devastating consequences if they are not visible or well managed. But, whose job is it to manage risk and how well is this effort being performed?
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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.
July 27, 2010
CFO’s On-point for Managing Risk in Life Sciences
Posted by: Scott Chizzo
Tags: Finance, Risk Management | No Comments |
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July 20, 2010
Ensuring Launch Success through Supply Chain Readiness
Organizations and their supply chains that are preparing to launch a new compound (chemical or biologic) are often physically prepared to support the launch but are often relying on many non-supply related functional groups to provide key information and support. This puts both the plans and launch success at risk.
Posted by: Mark Stesney
Tags: Risk Management, Supply Chain | No Comments |
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July 12, 2010
Buying into a new model – Lilly’s Alnara Acquisition
One hallmark of our industry is the incredible risks faced in bringing a new product to market. New technologies bring risks of not performing the way we’d like. Clinical and regulatory risks can delay or prevent approval. Commercial and market risks may limit success with physicians, patients and customers. All of this leads to huge financial risks for investors along the way, and we have seen this scenario play out repeatedly here in the local area in disappointing results for companies like Therion, Vion, and Acusphere.
Continued
Posted by: Todd Applebaum
Tags: Business Strategy, News Analysis | No Comments |
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June 21, 2010
Just for Kicks – Will the 2010 World Cup Impact the Life Sciences Industry?
The 2010 World Cup for Soccer runs from June 11 through July 11, 2010 and almost all of the 32 teams that are participating have a significant life sciences presence in their country. People all over the world will be glued to their TV sets, even counties that did not make it to the finals will be watching.
Posted by: Jim Baxter
Tags: General Interest | 1 Comment |
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June 14, 2010
Clinical Inventory Visibility: Seeing What it Takes
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.
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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