In 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…)
Archive for March, 2010
News Analysis-Manufacturing Problems Prevent Drug Approval
Monday, March 29th, 2010Can ERP be Used to Manage a Clinical Supply Chain?
Monday, March 22nd, 2010Some in the industry are of the opinion that ERP is not suited to manage a clinical supply chain; that there are enough unique differences between the commercial and clinical supply chain that a specialized application is required. Naturally the ERP evangelists of the world are going to say “Yes” while those with a background strictly in clinical will say “No” – but is there an absolute truth? Or even a middle ground?
QMS Panel Raises Compelling Themes
Tuesday, March 16th, 2010Maxiom Group and Sparta Systems jointly hosted a Quality Management Systems Workshop on Thursday, March 4th, 2010 in Waltham, MA. The workshop was titled “Improve Quality, Reduce Risk- Exploring QMS Earlier in the Development Lifecycle” and was attended by both life science companies that have very little QMS experience and those that have extensive knowledge about these systems. The panelists were experienced life sciences professionals from Alkermes, Mannkind and Shire HGT that have an in-depth knowledge of QMS implementations.
(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.
(more…)
