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Data Management
April 19, 2017

Five Tips To Make Your Data Work For You

  "Scientists spend greater than 50 percent of their time searching for data that already exists." -Allotrope Foundation Does your data have a purpose? If not, you may be missing an opportunity--or worse, wasting your time collecting random bits of information. Here are the top five tips to ensure that your data is working for you. Integrity Integrity is a key component of putting your data to good use.  Technology has improved exponentially over the years to allow for document organization, data management and overall informatics control.  Control is the key when it comes to data integrity.  The ability to control your data is fundamental in guaranteeing the integrity of your data; a critical component of regulatory submissions and documentation.  Choosing the right tools to control data is imperative.  Not all tools require validation, but a solution should have the ability to trace data for consistent recall for submission and filing purposes.  Control your data and it's integrity, and you will…
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April 13, 2017

Is the Patient the Most Difficult Aspect of Healthcare?

  The pharmaceutical and medical industries are in the business of saving lives.  As a scientist, there is little to compare to the satisfaction of knowing that you have contributed to advancement in the treatment of an illness affecting millions of people.  I imagine that physicians feel much the same way, and take great pride in their work when they have a positive impact on their patients.  There is no doubt that the correct diagnosis and effective treatment are essential to a patient's survival and quality of life, and pharmaceutical companies and doctors work hand in hand in this regard.   A large percentage of illness is directly caused by the choices of the patients themselves.  Statistics from the Center for Disease Control (CDC) support the idea that patient behavior is the single largest contributor to health.  According to the CDC, up to 40% of annual deaths from each of five leading U.S. causes are due to “modifiable risk factors.”…
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Data Management
April 11, 2017

Data Integrity and the Increasing Complexity of Your Data

In this day and age there are multiple organizations whose sole purposed is to collect, organize and interpret your data.  Data has never been more critical, and the use and interpretation of it become even more important every day.  But how can we capitalize on using every bit of our data to increase our output effectively? To ensure safety and efficacy, any data associated with a pharmaceutical product must be “attributable, legitimate, contemporaneous, original, and accurate.” -Darren Barrington-Light, Biopharm International (more…)
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medicine and law
April 6, 2017

Recent Opioid Deaths Not Driven By Legal Narcotics

Problems with Prescriptions Recent restrictions on opioid prescriptions have attempted to stem the national tide of abuse and overdoses; two-thirds of the overdose deaths in the United States are related to opioids.  New Jersey just passed one of the nation’s strictest laws in efforts to address the crisis.  Multiple states have passed laws limiting opioid prescriptions and more states seem poised to follow suit.  Recently, President Trump created a commission headed by New Jersey's Governor Christie to study the epidemic and suggest policy changes. (more…)
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Pharma Pricing, Cost Analysis
April 4, 2017

Five Tips To Effectively Manage Drug Manufacturing Costs

“OUR INDUSTRY IS POISED TO TRANSLATE OUR MOST PROMISING SCIENTIFIC BREAKTHROUGHS INTO MEANINGFUL TREATMENTS CAPABLE OF TACKLING THE MOST URGENT AND VEXING MEDICAL CHALLENGES OF OUR TIMES.  WE STAND COMMITTED TO DRIVING PROGRESS FOR PATIENTS TODAY – AND HOPE FOR TOMORROW.” - KENNETH C. FRAZIER, CHAIRMAN & CEO, MERCK Inspirational words, and worthwhile goals to aspire to in manufacturing drugs to improve the lives of countless people.Somewhere in between the idea and the bottle of pills on the shelf, there is the process of manufacturing drugs and the costs associated with that endeavor.  With the increased scrutiny of the public in regards to the cost of drugs, keeping the cost of manufacturing controlled is more important than ever before. (more…)
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Pharma and Politics
April 3, 2017

Want to Practice Medicine? Become a Lawyer

Before you think I'm jaded, let me share a little perspective.  Some years ago I was an undergraduate, working as an Emergency Medical Technician in a rural emergency room, a bright-eyed aspiring doctor to be.  During a break in the action of a long night shift I was chatting with the MD and he asked me point blank “why do you want to be a doctor?”  I was caught by surprise, and I mumbled something about helping people in need--isn't that the only real reason to go to medical school? The MD looked me straight in the eye and told me, “if you want to practice medicine, go to law school.” Life changes, as life has a way of doing, and I never attended medical school after all--I earned a graduate degree in chemistry and I am very happy with my choices.  But thinking back on that conversation, I think the doctor was right. (more…)
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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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