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?
Posts Tagged ‘Risk Management’
CFO’s On-point for Managing Risk in Life Sciences
Tuesday, July 27th, 2010Ensuring Launch Success through Supply Chain Readiness
Tuesday, July 20th, 2010Organizations 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.
What is your organization’s level of risk management maturity (and what should it be)?
Tuesday, June 1st, 2010When 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”
Life Sciences Takes Risk Management Much More Seriously, Right?
Monday, May 3rd, 2010Life 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.
Pharmaceutical Track-and-Trace Makes it Big
Monday, April 5th, 2010On April 1, pharmaceutical Track-and-trace made it to the Op Ed page of the New York Times…and it wasn’t an April Fools’ joke!
Katherine Eban, of Dangerous Doses fame, and J. Aaron Graham, former chief security officer of Purdue Pharma, who launched one of the first RFID-enabled Track-and-trace pilots for OxyContin in 2004, teamed up to write a piece on the risks of illegal (counterfeit, diverted) pharmaceutical product and the benefits and costs of track and trace technologies designed to protect against such illicit activity. The Op-Ed was written in response to a $75 million theft of psychiatric drugs (Prozac, Cymbalta, Zyprexa) from Eli Lilly’s Enfield, CT warehouse.
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News Analysis-Manufacturing Problems Prevent Drug Approval
Monday, March 29th, 2010In February, Cadence Pharmaceuticals’ pain and fever drug Ofirmev was not approved by federal regulators because of manufacturing problems at a contract manufacturing facility where the drug is made. Many of our clients outsource manufacturing and run the risk of becoming another Cadence – held up at the approval stage for reasons that have nothing to do with the safety and efficacy of the product. (more…)
Identifying High Priority Risks from Risk Studies – Examine the Two-Slope Curve
Monday, March 8th, 2010Many of our clients have undertaken programmatic risk management efforts and many more are on the verge of doing so.
In nearly all cases these organizations apply basic risk management tools to assess risk level, which provide some quantification of the level of risk. For example, frequently used FMEA assessments typically result in a Risk Priority Number (RPN) to quantify risk level for a particular process or process step. These RPN’s can be sorted in ascending or descending order to establish a relative risk priority. Similarly, other risk assessment tools result in a quantification of risk level, which can be sorted in the same way.
Utilizing a REMS Program as a Competitive Advantage?
Monday, March 1st, 2010Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), the FDA has the authority to require manufacturers submitting drug approval applications to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) program as part of the application.
There are varying degrees of a REMS program; it can be as simple as a medication guide included in each product package for patients and physicians, which outlines the risks and side effects of the medicine. Since going into effect in 2007, a majority of all approved REMS programs fall into this category.
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The Role of Talent Management in Managing Life Sciences Risk
Monday, January 18th, 2010Life science companies have been facing unprecedented pressures requiring them to become more in tune with the realities of their marketplaces and to take a more thoughtful approach to understanding and managing business risks. We know many of the issues driving risk – patent expiry, pricing competition from generics, increased regulatory scrutiny, rising costs, poor efficiency of internal business processes. The question becomes what to do about them.
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Addressing Challenges and Methods to Managing Risk Attracts Many Life Sciences Companies
Monday, December 21st, 2009On Wednesday, December 16, 2009, I presented at a Maxiom Group breakfast workshop held at the Le Meridien Hotel in Cambridge. The workshop addressed the issue of managing quality and operations related risk in life sciences companies. Attendance at the workshop was outstanding and I think this can be attributed to the urgency with which companies are attempting to come to terms with the topic. (more…)
