Monthly Archives

April 2017

Patients: Pharma’s New Partners?

By | Data Management, Pharma Pricing

Value-based healthcare models have upended traditional patient care, becoming the wave of the future. How can pharma effectively ride this wave?

The pharmaceutical industry is facing rapid and comprehensive change, spearheaded by a new trend in consumerism, a move towards a value-based economy. This move puts the patients firmly in the driver’s seat and presents increased opportunities and challenges, requiring drug companies to work more closely with patients than ever before.image demonstrating relationship between patients and pharma  According to a recent report by PwC Health Research Institute, pharma’s new strategic partner may very well be patients.

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Standardizing Laboratory Data: Next Great Idea or Necessary Evil?

By | Data Management

A very close and trustworthy colleague in the industry has stated that the magic of the lab is the absolute random, disarray of work that leads to producing the best drugs.  The way that different pharma companies operate during the drug development process and the way they collect, analyze and distribute the data is unique to that company.image illustrating the effect of standardizing pharma and healthcare data

Result: The successful drugs we have today.

On the other hand, industry pressure, government regulations and financial responsibilities have pharma looking inward to see how changes in the drug development and manufacturing process can be streamlined and efficient.  A common answer to the problem of efficiency is standardization.  There are multiple benefits of standardized data:  better communication, savings of time and resources, ease of comparison and enhances collaboration between scientists and outside partners.  According to Nicola Tambascia of Clinipace, more regulatory agencies worldwide are beginning to require standardized data as part of the submission process. Read More

Direct to Consumer Pharma Marketing – Good or Bad?

By | Pharma and Politics

There are only two countries in the world that allow for the marketing of pharmaceutical products directly to potential patients, the United States and New Zealand.  One must wonder why, if it such a great idea, that it isn’t more commonly allowed.  Well maybe it isn’t such a good idea, or maybe there is a compromise.image showing the amount of information available through marketing

In 2015 US pharmaceutical companies spent 5.2 billion dollars on direct to consumer (DTC) marketing.  Proponents of DTC contend that the ads inform patients about diseases and possible treatments and encourage people to seek medical advice. Opponents contend that ads misinform patients, promote drugs before long-term safety profiles can be known and stigmatize normal conditions like wrinkles and low testosterone. Read More

Five Tips To Make Your Data Work For You

By | Data Management

 

“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.image illustrating the importance of data management in pharma submissions

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 save yourself untold amounts of time and headache when it’s time to submit your documents.

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Is the Patient the Most Difficult Aspect of Healthcare?

By | Uncategorized

 

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.EKG trace with a heart

 

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.”  In addition, patients often do not understand or follow their doctor’s recommendations:  after leaving an appointment, 50% of patients do not know how to follow the instructions of their healthcare provider.  In case this seems like a problem with a new diagnosis, people with chronic conditions only take 50% of prescribed doses of medication.

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Data Integrity and the Increasing Complexity of Your Data

By | Data Management

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?image emphasizing the importance of data integrity

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

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Recent Opioid Deaths Not Driven By Legal Narcotics

By | medicine and law

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. Read More

Five Tips To Effectively Manage Drug Manufacturing Costs

By | Pharma Pricing, Cost Analysis

“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. Read More

Want to Practice Medicine? Become a Lawyer

By | Pharma and Politics

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?image illustrating the relationship betwen medicine and legislation

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.

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