All Posts By

teladm

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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Data Management
March 3, 2017

The Biggest Decisions Your Company Makes are Based Off Spreadsheets?!?

Decision-making is a core function of any drug development firm.  Developing drugs demands a firm to be highly innovative, while at the same time the activity is strictly regulated. - Antti Jekunen, NCBI                                                                                              When moving through the drug development process the high stakes decisions made will save or cost tens to hundreds of millions of dollars.  Making a decision in a timely manner with precision and accuracy is essential to bringing a drug to market.  Pressure from investors, stakeholders, stockholders, and regulators have critically changed the dynamic and pressure involved and still, the pharma industry does not adapt to innovation and maximize available technology.  How many hours are wasted searching through scribbles in random lab…
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Pharma and Politics
March 2, 2017

Drug Costs and Accountability in Our Changing Climate

“I’m going to bring down drug prices,” Trump told Time magazine, “I don’t like what has happened with drug prices.” Although biotech and pharmaceutical stocks initially rose after the election, the budding optimism drug makers enjoyed rapidly faded with Trump's comments regarding drug prices.  President Trump is not the only one concerned about drug pricing in the United States.  The increasing cost of prescription drugs has become a source of concern for patients, prescribers, payers, and policy makers.  Public outrage has intensified over recent decisions by companies to levy significant cost increases, such as the EpiPen pricing scandal.  Even pharmaceutical executives are feeling the sting over drug pricing.  Recently, Chief Executive Officer Leonard Schleifer of Regeneron Pharmaceuticals Inc. and Ian Read of Pfizer Inc. have argued over the role of drug pricing in the pharmaceutical industry.  Schleifer’s comment to Read over the cost of drugs: “You’re not entitled to a fraction of the GDP.” (more…)
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