March 8, 2010
Many 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.
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Posted by: Fred Greulich
Tags: Risk Management | No Comments |
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March 1, 2010
Under 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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Posted by: Frank Gaibor
Tags: Business Strategy, Risk Management | No Comments |
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February 22, 2010
Clients used to ask, “What’s on-demand, and why would I do it?”. Now they ask, “I’m hearing on-demand is a great alternative, why wouldn’t I do it?” We’re starting to reach a tipping point, and CIOs are now asked, “what is our on-demand strategy?”
The issues clients initially become concerned about are security and data, dependence on a third party, and integration with other systems. For most emerging biotechs, the security concerns melt away when they look at their own current security versus that of any of the likely on-demand solutions and see that the provider’s security is far superior to their own. Most on-demand providers today acknowledge that the client owns the data, and will even provide a “data escrow” facility, if the client wants to go that far.
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Posted by: John Lyons
Tags: IT Solutions, Software as a Service | No Comments |
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February 16, 2010
I recently asked this question in the Linked In Pharmaceuticals Operational Excellence Group online forum which resulted in an enthusiastic and insightful dialogue.
Lean, Six Sigma and all of the other buzz words under the umbrella of Operational Excellence are traditionally applied to activities linked directly to commercial production. More recently, administrative and service functions have also been targeted. So, why not R&D?
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Posted by: Jason Dunklee
Tags: Operational Excellence, R&D | No Comments |
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February 8, 2010
Working for a large biotech company I was assigned to a product development team that was given the challenge of getting a first-in-man drug into a Phase-1 trial using the minimalist amount of resources and shortest amount of time. The project was named after the 1980s TV series hero MacGyver who applied his scientific knowledge to ordinary items (e.g. Swiss Army knife) to create for him and others a means of escape from impending doom and in the process save the world. Continued
Posted by: Taylor Burtis
Tags: Product Development, Project Management | 1 Comment |
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February 2, 2010
There is a growing trend at emerging life science companies to adopt a ‘Virtual Workforce’ model in order to keep head count and capital burn rate down, and flexibility up. Instead of hiring full time employees to fill department roles, companies are bringing on the appropriate level of talent via consulting firms, resource companies, or hiring contractors directly. Even some manager level roles are being filled this way. Some companies run virtually by design, while others do so because experienced FTE resources were simply impossible to find when they needed them.
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Posted by: Todd Martin
Tags: Business Strategy, Human Resources | No Comments |
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January 25, 2010
Swiss biopharma giant Novartis has been on a tear lately on the M&A front. It’s recent bid to acquire Alcon for $50 billion to boost its eye care franchise (encompassing everything from pharmaceuticals to contact lenses to OTC products) certainly seems in line with the wave of large deal activity within the pharmaceutical sector. However, it was not until I picked up The Economist (January 16th-22nd 2010) this week and reviewed an article entitled “Pills Get Smart: Potential Encapsulated” that I noticed another recent Novartis deal that completely flew under the radar. Despite the lack of attention this deal received, the technology associated with the deal appears to have extraordinarily broad potential through a nascent yet disruptive technology. Continued
Posted by: Jeremy Friedler
Tags: Supply Chain | 1 Comment |
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January 18, 2010
Life 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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Posted by: Fred Greulich
Tags: Human Resources, Risk Management | No Comments |
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January 11, 2010
Google Sidewiki is a new technology, released by Google in September 2009 that allows users to read and post comments on virtually any website. This offers a direct line of communication between company and customer that has historically happened behind closed doors, if at all. In a regulated industry, such as the biotechnology, pharmaceutical or medical device industry, this poses financial and business risks…and potentially some rewards.
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Posted by: Scott Dicks
Tags: IT Solutions | 1 Comment |
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January 4, 2010
External collaboration models at biopharmaceutical companies run the gamut, ranging from maintaining all operations within a nearly complete vertical structure, to being just about completely virtual. Outsourcing yields a range of perceived outcomes; in many instances the vendor’s performance does not completely satisfy their client’s expectations.
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Posted by: Andrew Putney
Tags: Alliance Management | 1 Comment |
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