Business
March 27, 2017

Are Mergers and Acquisitions Defining Pharma?

Certain industries undergo mergers and acquisitions more often than others.  Industries with a significant global market share are attractive for other companies, investors or venture capitalists that see a huge upside and immediate return on investment.  Although merger and acquisition activity is common in many industries, in the pharmaceutical industry it has noticeably reduced the number of major companies over the past 15 years. The short-term business rationale for this extensive consolidation might have been reasonable, but at what cost to research and development productivity?  (more…)
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Pharma and Politics
March 23, 2017

New Genes Associated with Autism: How Can Pharma Help?

I have a 4-year son.  When my wife and I found out our child was a boy we were over the moon with excitement.  We already have a girl, and we wanted a boy.  Feelings of luck, fortune, gratitude and love filled our home with anticipation. During her pregnancy, my wife and I were approached by the doctor with a suggestion of genetic testing.  As the doctor stated, statistically there is a rise in genetic disorders with our “advanced” age in conjunction with an increase of autism in boys. (more…)
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Custom Manufacturing
March 21, 2017

Choosing the Right CDMO Partner

Choosing the right CDMO partner for your project can make your manufacturing venture an absolute dream, or your worst nightmare.  Once you are at the height of manufacturing, it is not the time to juggle misunderstandings over timelines, critical milestones and project goals. At this point it is assumed that you have evaluated your project and decided on your internal requirements.  You have carefully crafted your RFP and are now ready to start down the path to vendor selection--which companies will get the chance to bid on your business? Companies have taken a variety of approaches in choosing companies to contact.  Everything from calling a friend in the industry for a reference to the "shotgun" approach of cold calling everyone they can find.  Which is the best choice?  Neither.  What is the best option?  It depends.  There is no one size fits all recipe for selecting a partner. (more…)
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Data Management
March 20, 2017

Maximizing Data Efficiency

I have been reading countless articles and blog posts about the pharma industry’s inability to utilize the data we produce on a daily basis in our development life cycle.  Article after article details how we are not utilizing, optimizing or constructively taking advantage of the benefits the data produces, BUT...... ....not one article tells us how. Let’s look at some solutions to accomplish the task of making your data as effective as possible; in other words, making your data work for you. ORGANIZATION “Knowledge workers spend over 50% of their time searching for data that already exist.” - Allotrope Foundation (more…)
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March 16, 2017

Trust in the Pharmaceutical Industry—Can We Change the Perception?

Stop me if you’ve heard this one.  Three guys walk into a bar—a lawyer, an oil executive and a pharmaceutical CEO. Well, never mind.  If you’re an American, chances are the pharmaceutical CEO is the bad guy in this joke.     Grim Statistics According to a recent Gallup poll on the public perception of 25 different industries, only the federal government is ranked lower by Americans than the pharmaceutical industry.  In addition, in 2016 drug companies registered their worst showing in the 16 years that Gallup has been tracking public perception of different sectors.  In fact, the overall rating of the pharmaceutical industry has suffered, with 28 percent of Americans having a positive view of drug makers and 51 percent holding a negative view.  Overall, Gallup calculated that the pharmaceutical industry has a rating of negative 23. (more…)
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Custom Manufacturing
March 14, 2017

How to Craft the Perfect Request for Proposal

Last week, we detailed some of the inward questions that should be covered as you begin outsourcing your project to a CDMO. Now we will focus on some of the best practices for crafting your Request for Proposal (RFP). Miscommunication and problems that could be avoided are often directly attributable to a poorly crafted RFP.  An effective RFP will convey clearly the scope of the project, deliverables and the timeline. (more…)
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Data Management
March 13, 2017

Efficiency and Cost Management

In efforts to improve efficiency, we often turn to the basics:  cut the time it takes to accomplish the task, cut the cost incurred to complete the project and cut the amount of waste associated with the process.  Unfortunately, as any project manager can attest to, increasing efficiency is easier said than done.  When you have cut your time, costs and waste as much as possible, what is left to cut? One simple often overlooked approach in improving efficiency is to MANAGE cost more effectively. (more…)
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Pharma and Politics
March 9, 2017

President Gutting the FDA? Impact on Drug Development and Approval

President Trump has made clear his desire to lower or even eliminate regulatory barriers for businesses; now he has brought this mandate to the door of the FDA as well.  In a recent meeting at the White House, President Trump notified pharmaceutical leaders that his administration would reduce taxes, regulations, and streamline the product approval process.  In turn, the pharmaceutical industry is expected to lower drug prices and bring manufacturing jobs to the United States. (more…)
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Custom Manufacturing
March 7, 2017

Questions to Ask Before Approaching a CDMO

The story is a common one.  Your organization has just acquired a new asset and you are responsible for finding the custom development and manufacturing organization (CDMO) that is going to take you all the way to commercialization.  If only it were that simple.  Here are some questions that you should ask yourself before you even approach a CDMO, let alone begin a draft of that all important request for proposal (RFP). (more…)
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Cost Analysis
March 6, 2017

Determination and Management of Should Cost

“As global competition becomes a hot priority for top management in many companies, there is going to be a scramble to lower prices at any cost.” - Supply Chain Quarterly Global competition is a powerful driving force in the biotech and pharmaceutical industries, as complexities continue to rise and adjustments to the way we do business need to be met.  Remaining competitive in the rapidly changing global landscape requires companies to reconsider inflexible, outdated and inefficient models of pricing. Prescription drugs often provide effective alternatives to expensive medical procedures and hospital stays. Consequently, spending on prescription drugs as a percentage of the total national health care spending is increasing and is one of the fastest growing components of health care spending.  The cost of bringing a new drug to the marketplace has also been steadily increasing, with manufacturing costs comprising a substantial part of the total cost structure. (more…)
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