Anti-Vaxxers a Top Health Threat

By | Blog

A new threat to the health and safety of children has recently begun to take center stage: diseases that were once thought eradicated have reemerged into public consciousness.  These diseases have been aided and abetted by the irresponsible and dangerous behavior of people opposed to vaccines, otherwise known as anti-vaxxers. Read More

Anti-Cancer Gut Bacteria

By | Uncategorised

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The human microbiome is the subject of a burgeoning field of research.  The effect of gut microflora, and especially bacteria, has in the last few years been linked to anxiety, depression, gastrointestinal and autoimmune diseases, and numerous other disorders. Read More

New Genetic Test for Antimicrobial Resistance

By | disease, research, antibiotic

how-bacteria-work-360x240You’ve most likely taken an antibiotic at least once in your lifetime. From treatments for painful strep throat or ear infections as a child, to burning urinary tract infections or itchy skin infections, antibiotics are one of the most highly utilized and important medication classes we have.  Soon, your doctor may have a new weapon in their arsenal to diagnose and target treatment:  scientists at American University have developed a rapid, highly sensitive genetic test to determine whether bacteria carry a gene that causes resistance to two common antibiotics. Their research, published in BMC Infectious Diseases, demonstrated that the new test works as accurately as culture-based methods but gives results in minutes, not hours or days.

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Merck Backs Out of Vaccine Commitment to Africa

By | Uncategorised

 

Merck’s decision may leave more than 2 million children in West Africa unvaccinated and vulnerable to rotavirus in 2020.

At the same time Merck cut the vaccine supplies to West African countries, they began delivering RotaTeq to China.  Each vaccine will likely cost more than $40 per dose.  When asked if there was a connection between the launch in China and Merck not fulfilling their West African commitment, a Merck spokesperson wrote:

When faced with supply constraints, such as this, we evaluate all options to determine how we can fulfill the agreement we made with UNICEF and GAVI-eligible countries to the best of our ability, while at the same time meet the binding contract demands we have with other countries. The product we have allocated to China is what has been approved for use in that country to fulfill the terms of a binding agreement we signed with a local vaccine company in 2012. As I’m sure you can appreciate, the details of that contract is proprietary to Merck; as such, we cannot confirm the number of doses nor discuss price.

“Kids should not be denied vaccines just because they belong to a poor country.”-Dr. Mathuram Santosham at Johns Hopkins University

Where does that leave the kids in West Africa? UNICEF, which delivers vaccines to poor countries worldwide, says it’s trying to help the West African countries switch to another vaccine.  The World Health Organization prequalified two new rotavirus vaccines manufactured in India earlier this year:  Rotasil and Rotavac.  Both vaccines are available to Gavi at a cost of less than $2 per dose.

Unfortunately, the switch will not be quick-or easy.  Prequalification of a vaccine is the beginning of a long process, including a regulatory actions that must occur.   The process is daunting, with more than a few moving parts that require time and money.  New vaccines may be tested in small pilot programs, health care workers have to be retrained on vaccine administration, clinics need the ability to store and transport the new vaccine.  That will require possibly up to five years for the vaccine to be widely available in West Africa, says Frederick Cassels, at the nonprofit PATH, which helped develop Rotasil and Rotavac.  Even just a delay of a few years would put millions of babies at risk for rotavirus, says Johns Hopkins University’s Santosham. “We all as a community should come together and make sure these kids get this vaccine.”

According to Merck, their third quarter 2018 worldwide sales were $10.8 billion.  Good for Merck-really.  More profits mean more research, and more lives saved overall.  Most reasonable people realize that companies need to make a profit to stay in business, and that includes pharmaceutical companies.  But the pharmaceutical industry is not like other industries that sell tires or pizza.  Due to the nature of the business, pharmaceutical industry profits are made off of illness and disease–this requires a level of sensitivity and responsibility to the community that the local pizza joint does not need to make.

What level of responsibility do pharmaceutical companies owe to the people?  Has Merck denied their responsibility to the community and turned their back on the poor children of Africa?  Can a company be both profitable and ethical, or are those incompatible values?  These are questions that need consideration, since we live in a world with expanding need, and shrinking resources. 

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HIV Controlled by Antibody Therapy

By | Uncategorised
Today, an estimated 1.1 million people are living with HIV in the United States, and improvements in antiretroviral therapy have turned HIV into a manageable condition.  Thanks to better treatments, people with HIV are now living longer—and with a better quality of life—than ever before.  Yet even the most effective drugs only suppress the virus, which hides in the body, ready to rise to dangerous levels should a patient stop their medication regime. To continue suppression of HIV, patients must adhere to strict daily medication schedules, which can be burdensome and expensive.   Read More

Latest Research Offers Alternative to Addictive Opioids

By | Uncategorised

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The misuse of and addiction to opioids—including prescription pain relieversheroin, and synthetic opioids such as fentanyl—is a growing national crisis affecting public health and creating an enormous burden on the healthcare system.  The Centers for Disease Control and Prevention estimates that the total economic impact of prescription opioid misuse in the United States is $78.5 billion a year, including healthcare, lost productivity, addiction treatment, and criminal justice involvement.

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How Does Talking to Babies Make Them Smarter?

By | social issues, children, education, parenting
Young children who are regularly engaged in conversation by adults may have stronger connections between two developing brain regions critical for language, according to a study of healthy young children that confirms a hypothesis registered with the Open Science Framework. This finding, published in JNeurosci, suggests that talking with children from an early age could promote their language skills. Read More

New TB Study Has Hopeful Results

By | disease, research
Tuberculosis (TB), an infectious disease targeting the lungs, is the second biggest killer, globally.  In 2015, 1.8 million people died from the disease, with 10.4 million falling ill, despite the development of vaccines and effective drug treatment.  At one point, the United Nations predicted that TB would be eliminated worldwide by 2025, but treatment options remain surprisingly sparse.  The only vaccine for TB was developed nearly a century ago, and offers limited protection.  Even worse,  patients are becoming increasingly resistant to available drugs. Read More

Can an Asthma Drug Reverse Dementia?

By | Uncategorised

dementia_istock_000029744938_largeDementia is a term describing a variety of diseases that develop when nerve cells in the brain die or become impaired. The death of neurons causes changes in memory, behavior, physical capabilities and personality. In many of these diseases, such as Alzheimers, the associated changes often prove to be fatal. Read More

Louisiana Hepatitis C Cost Proposal

By | legal, legislation

Biosimilars: Growing Pains in a New Arena

By | Uncategorised

dna_3One of the key strategies for enhancing access to affordable medicines posed by the Trump administration involved establishing the pathway for the development and approval of high-quality biosimilar therapies.  Yet, out of 11 approved products, only three biosimilars are on the market eight years after the enactment of legislation streamlining the process.  If current trends continue, it may be months or years before Americans gain access to these medications.

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New Research on Spinal Cord Injury

By | Uncategorised
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The spinal cord is very sensitive to injury, and unlike other parts of your body, lacks the ability to self repair when damaged, making spinal injuries potentially devastating. A spinal cord injury — damage to any part of the spinal cord or nerves at the end of the spinal canal (cauda equina) — often causes permanent changes in strength, sensation and other body functions below the site of the injury.  An injury can occur when there is damage to the spinal cord from trauma, restriction of blood supply, or compression from a tumor or infection. There are approximately 12,000 new cases of spinal cord injury each year in the United States, most frequently in males. Read More

Preventing CTE & Head Trauma

By | ethics, social issues, legal, sports

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Football is an iconic American sport, but despite the national interest in watching football, professional athletes experience a lack of protection when it comes to brain injuries. It is not uncommon for football players at any level to experience a traumatic head injury at some point during their career. For some, the injuries come in the form of a concussion, which makes up 7.4% of all head injuries sustained from playing football.

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Long Acting Treatment for Schizophrenia May Offer New Hope

By | Uncategorised

image showing the confusion of schizophrenia

Schizophrenia, Latin for “split mind,” is a chronic, severe and disabling brain disorder, affecting an estimated 2.4 million American adults and their families.  The hallmark of schizophrenia is disorganized thinking, which can manifest as positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal).  Although schizophrenia is not as common as other mental disorders, the symptoms can be very disabling. In the past, there were different classes of schizophrenia, also known as ‘subtypes’. Disorganized schizophrenia, catatonic schizophrenia and schizoaffective disorder have since been absorbed into the larger diagnosis of schizophrenia, but are still used to describe the widely varied ways schizophrenia can manifest from person to person.  Read More

Right To Die

By | ethics

candle-2038736_1920The right to die issue – or death with dignity – as it has been named in the press and by advocacy groups, is a controversial topic. On one side of the argument some people are concerned that passing ‘death with dignity’ statutes and legalizing suicide might expose the most vulnerable groups of people in society. On the other side, some people suffering terminal illness are concerned with exercising their right to bodily autonomy, and deciding when and where that ends.

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Psychopathy as a Disability?

By | mental health

eery-1648250_1920.jpgPsychopathy is a hotly debated topic in the psychiatric community and in society at large. The nature of psychopathy is a frightening one and the root causes of the personality disorder are largely unknown. A person who is diagnosed as being a psychopath may exhibit symptoms such as reckless spending, violence towards animals and arson, ordinarily starting from a very young age. Psychopathy is generally understood by most people to be characterized by diminished capacity for empathy towards other people and living beings.

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Joyce Brown & 5150s

By | ethics, mental health

schizophrenic-2934770_1920Psychiatric care is a difficult field for many patients and providers to navigate. The ethics of psychiatry are constantly changing and are held under great scrutiny. In the eyes of the public, treating mental illness is not as straightforward as treating physical illness.

People with severe mental illness are more likely to be subject to homelessness, violence and unemployment. For many people with psychotic disorders, they’re likely to experience an involuntary psychiatric hold – known as a 5150, which enables them to be held in a psychiatric hospital for evaluation and potentially to be held longer if they’re deemed incapable of checking themselves out or caring for themselves.

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Insomnia: The Hidden Costs of Poor Sleep

By | Uncategorised
Insomnia is a common problem for people of all ages, with a number of people suffering from an inability to sleep.  Based on estimates derived from population-based studies, approximately 30% of adults worldwide report symptoms of insomnia: difficulty initiating or maintaining sleep, waking up too early or poor quality of sleep.  Common comorbidities associated with insomnia are psychiatric disorders, with an estimated 40% of all insomnia patients experiencing a coexisting psychiatric condition.  Among these psychiatric disorders, depression is the most common, and insomnia is a diagnostic symptom for depressive and anxiety disorders.

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Ketamine and Depression

By | Uncategorised

Depression is one of the most life-threatening mental illnesses in the United States today. Treatment resistant depression, which does not respond readily to talk therapy or medication — the most frequently prescribed treatments for major depression — can lead to self loathing, isolation and thoughts of suicide. Suicide is currently among the leading causes of death in America.  Even medication can have drawbacks, with first line therapies often taking as long as 6 to 8 weeks before being effective.

Faced with the long timeline of drug therapy and unwanted side effects, patients with severe depression sometimes turn to nontraditional treatments such as electroconvulsive therapy and perhaps surprisingly, ketamine therapy — a drug known as ‘Special K’ by recreational drug users. A staggering 70% of patients responded to ketamine therapy for treatment of depression in one study performed.  The study examined the use of intravenous ketamine  for depressed patients at imminent risk of suicide, and with the rapid response shown by patients, makes ketamine a potentially attractive “rescue medication” for depressed patients in need of immediate relief. Read More

Ebola Virus: Finally a Vaccine?

By | medicine, vaccination

 

The Ebola virus, discovered in 1976 near the Ebola River that can cause a severe and often fatal disease called Ebola virus disease (EVD).  Since the first discovery in 1976, there have been sporadic outbreaks of EVD, with the most recent one in 2013-2016 affecting West African countries, mainly Guinea, Sierra Leone and Liberia.  Fruit bats are the most likely reservoir of the Ebola virus.  Ebola is deadly in about 70% of those infected with Ebola; the 2013-2016 Ebola outbreak in West Africa claimed more than 11,000 lives. Read More

High Potency Compounds-Taking on the Challenge

By | Uncategorised

 

As a pharmaceutical or biotech company, if you haven’t had to deal with high potency API (HPAPI) compounds yet, chances are you will eventually.  Approximately 25 percent of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years; the global HPAPI market is expected to reach nearly $26 billion by 2022.

HPAPIs are a rapidly growing segment of the pharmaceutical industry, primarily due to an increased focus on targeted therapeutics, especially in oncology.  A compound is classified as highly potent if it has an occupational exposure limit (OEL) of ≤10μg/m3, a daily therapeutic dose of ≤10mg/day or if a 1 mg/kg/day dose produces serious toxicity in laboratory animals.

25% of drugs currently in development worldwide are highly potent.

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The Days of Clean Sheeting for Cost of Goods are Over.

By | Uncategorized

image showing person buried under paperwork

We have all been there when we need to determine various costs and where they come from.  We stare at spreadsheets, trying to gather the necessary data, critical and nonessential, and using our calculations to determine how we can lower costs.  This approach is not only time consuming, but inaccurate and inefficient, but what are the alternatives?

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DASH Diet: A Potential Treatment for Depression?

By | mental health, health

Physical health and mental health are definitively linked, and have been for some time. However, the extent that diet and exercise has on mental health remains unknown. There are anecdotes of certain diets lowering blood pressure by seemingly impossible amounts, diabetics claiming to be cured by their lifestyle and even claims of going into cancer remission as a result of a person’s diet.  None of these claims have been seriously substantiated, but recently a diet known as the DASH diet has been linked to lower blood pressure and decreased risk of depression.  Is it possible that something as simple and straightforward as your diet can affect your mental health? Read More

Flu Outbreak Worse This Year

By | healthcare, flu, vaccination

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This year’s flu season has been unprecedentedly aggressive in comparison to recent years, causing levels of panic in the United States on the level of the H1N1 outbreak that occurred in 2009. Also known as swine flu, H1N1 caused rising levels of fear on a global level, with magazine covers publishing headlines about the epidemic and leading the World Health Organization to address the matter publicly, declaring it a pandemic.

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Is Excel Holding You Back?

By | Data Management, Cost Analysis, healthcare

image demonstrating the problem with Excel spreadsheetsIs Excel a dated method of data crunching that is holding back rather than advancing your company? CFOs from Fortune 500 companies are insisting that staff stop using Excel. What does that mean for the pharmaceutical industry, and why is there push back against the popular spreadsheet software? Finance chiefs say the ubiquitous spreadsheet software that revolutionized accounting in the 1980s cannot kept up with the demands of contemporary corporate finance units. After all, just like hair metal bands, the 80s are long gone and pharmaceutical companies need to advance with the times.

Spreadsheets have been a necessary and advantageous tool in a huge number of industries. Excel has revolutionized accounting and driven decision making, but as business becomes more complex and global, Excel cannot bear the expectations and demands of many companies.

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Left Behind: Native American Healthcare

By | healthcare

image depicting native american dreamcatchersFor many Native Americans, receiving healthcare can be a difficult ordeal. Poverty runs rampant on reservations throughout the United States, with one charity named One Spirit putting the number of Lakota families living under the poverty line in South Dakota at a staggering 90%. Even acquiring heating and basic living necessities is difficult for many of these families, reducing healthcare to a secondary concern. Native American people are at high risk for unnecessary death due to an intersection of unique situations such as isolation and poverty levels.

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Autoimmune Disorder Treatment on the Horizon

By | autoimmune disorders, development

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Over 23.5 million Americans are afflicted with autoimmune diseases, including rheumatoid arthritis (RA)an autoimmune disease affecting approximately 1.3 million Americans.  In a case of mistaken identity, the body’s immune system mistakes its own tissues for foreign invaders, such as bacteria or viruses and develops antibodies to destroy the “invaders” in the synovium.  Currently, there is no cure for rheumatoid arthritis and the treatments are often saddled with a variety of side effects, some as severe as the disease.

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Technology & Pharma: An Unexpected Intersection

By | technology

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The pharmaceutical industry is currently in an era of change and in some senses is being upended by these changes, thanks to the development of new technology. Patients are rapidly becoming more empowered to do their own research and make decisions about their healthcare. One of the recent technological developments in the healthcare industry enabling this is the rise of the ‘health app’. Apple products have their own integrated health app that tracks statistics such as weight, heart rate, significant medical dates and other information. 

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Online Drug Shopping Made Easy?

By | ethics

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The names of the top pharmacies in the world will come as no surprise to most:  CVS, Walgreens, Amazon.

Wait, what?  Amazon?

CNBC recently reported that Amazon may be considering the sale of prescription drugs online, a lucrative market of approximately $560 billion annually. Breaking into the U.S. prescription drug market could be the start of huge financial gains for Amazon, but many people are wondering how they would manage the transition from sales of primarily unregulated items, into selling products from one of the most highly regulated industries.

Analysts at Leerink Partners, an investment bank specializing in healthcare, predict Amazon will be involved in prescription drug sales by the year 2019. This idea is not new for Amazon, with a previous attempt at an online site named drugstore.com, which is no longer open. Read More

States in Crisis Sue Opioid Manufacturers

By | lawsuit, opioid crisis, legal, opioids

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Mississippi and Ohio are two states that have been hit hard by the recent opioid crisis affecting the nation, with over 200,000 Ohioans addicted to opioids.  Mike DeWine, the Attorney General, filed a lawsuit in May of 2017 against 5 separate pharmaceutical companies alleging that the companies “helped unleash a health crisis that has had far-reaching financial, social, and deadly consequences in the state of Ohio”.  This makes Ohio the second state to file suit against pharma companies, with Mississippi the first state.  They allege that the manufacturers knowingly marketed opioids while minimizing the risks of addiction, while simultaneously overstating the benefits.

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Do Benzos Cause More Harm Than Good?

By | benzodiazepines, addiction, benzos, harm

worried-girl-413690_1920.jpgBenzodiazepines are a commonly prescribed medication for anxiety, seizures, and a myriad of other medical conditions. However, this medication doesn’t come without its faults, of which there are many serious ones. Benzodiazepines such as Ativan and Xanax are potentially addictive after only a short period of time, and are highly sought after by drug addicts and even patients who aren’t psychologically addicted but are physically dependent on the medication.

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Snake Oil and Social Media

By | social media, regulation, drug promotion

In 2017, advertising and promoting products is a minefield.  The availability of detailed and extensive information on consumer spending habits provides countless ethical pitfalls that are only magnified when the product in question is a drug.  In the past only magazine ads and TV commercials were utilized for drug advertising, now we have an array of choices that don’t always feel like marketing, but more like a conversation with a good friend.

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Not So Nobel Awards

By | humor

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Why do old men have big ears? Can smiling at a crocodile affect your desire to gamble?  And most importantly, can cats act as both a liquid and a solid?

These are the questions that keep us awake at night.  Fortunately, there are scientists working diligently on these puzzles, as well as many other weird and curious questions.  Their efforts have not gone unnoticed, and most recently were celebrated at the 2017 Ig Nobel Awards, a scientific recognition of the strangest and most obscure scientific experiments or studies done in that year.

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Personalized Medicine: The Future of Genetic Testing?

By | genetic sequencing,, drug development

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You’re feeling under the weather, with a cough that just won’t go away, so you decide to visit your doctor.  After a few minutes of one-on-one time, with some poking and prodding, you may be walking out of the office with a prescription in hand and on the way to feeling better.  How much more personal does it get? Perhaps not surprisingly, it can get a lot more personal, and it has nothing to do with your doctor, and everything to do with science.

In our current system of medicine, your treatment plan has very little to do with you specifically; most likely it is the exact same treatment your doctor would give to anyone with the same condition.  Medicine today is based on “standards of care,” the most prudent course of prevention or treatment for the general population.  With medication treatment for depression, for example, those standards may mean treatment with an SSRI (selective serotonin reuptake inhibitor), followed by a second trial if the first one fails. If the second treatment fails, doctors and patients move on to the next one and the next in a trial and error approach.

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AI Innovation in Pharma

By | Uncategorized

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Artificial intelligence is more than just a concept for the newest blockbuster movie, it is moving into mainstream science and the pharmaceutical industry as well.  The Korea Pharmaceutical and Bio-pharma Manufacturers Association has recently announced the launch of a team focused on purchasing artificial technology for drug development.  Artificial intelligence computing systems can be used to analyze molecular interactions, and predict drug efficacy and side effects.  The technology can be utilized to guide and optimize clinical trial planning, greatly reducing the timeline for new drug development.

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Exercise Can Prevent Dementia; Why Pharma Companies Should Care

By | Pharma and Politics

 

Alzheimer’s is a progressive, neurodegenerative disease characterized by memory loss and impaired cognition, with as many as 5.4 million Americans living with the disease.  Today Alzheimer’s disease is the sixth leading cause of death in the United States and the 5th leading cause for those 65 and older.  The symptoms of Alzheimer’s slowly creep into our lives and affect loved ones in profound ways.  Throughout the years, research and medications have helped, hindered and or even prevented some of the serious symptoms, but currently, there is no cure.

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Cost versus Quality: Is Manufacturing in India Worth It?

By | Business

image detailing the importance of maintaining high quality in drug manufacturingSix months into an administration’s promise to curb drug prices, the cost of drug development remains high.  As companies scramble to reduce costs, they are moving manufacturing overseas, enticed by lucrative savings.  The question remains: are drug companies really saving money or are reduced costs in production aligned with quality, timeline and regulation issues?

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Social Media and Pharma: The Good, the Bad and the Ugly

By | Business

Over the past decade, there has been a huge shift in the way that businesses and consumers use social media.  Society is undergoing rapid and dramatic change, fueled by an exponential rate of technological innovation.  This has an enormous impact on the pharmaceutical industry which is in a unique position to reap the benefits of increased sales, revenue and power by augmenting their technological capital.  One of the most effective methods to leverage this change is using social media, which leads us to the question:

Can social media be a game changer for pharma? Read More

5 Reasons Why Your Data Management System is Failing You

By | Data Management

 

Pharmaceutical companies are one of the major beneficiaries of emerging technologies.  From innovative ideas for developing new drugs to customer engagement, drug manufacturers are increasingly resorting to cutting edge digital technology to streamline business and improve efficiency.  Nowhere in pharma is the boom in technology more beneficial than in data management, an area where many drug companies struggle to organize and manage massive quantities of information.image illustrting the relationship between pharma and poor data management systems

As the regulatory landscape increases in complexity, the demand for improved 

data management and analytics will increase as well.  With all the new challenges that these trends create, digital data management is an innovation that pharma companies should have in their toolbox.

Below are the top five reasons that your current data management system is failing your company: Read More

Can Higher Drug Prices Lower Healthcare Costs?

By | Pharma Pricing, Pharma and Politics

Of course, if you can get the same medication for less, that is better, but what if switching to a newer more expensive drug actually saved money?  Recently I had the pleasure of moderating a panel at the Outsourced Pharma conference in Boston that was focused on cost and price pressures in the pharma industry. Based on the nodding heads in the audience, I think it is fair to say that our industry has an image problem.  While I cannot and will not try to defend some of the more recent high-profile cases that have garnered media attention, there is certainly a case to be made that not all pricing is gouging patients.Image showing the relationship between healthcare costs and pharma

Last week the Chicago Tribune highlighted a Blue Cross Report that squarely blames pharma companies for high drug prices.  According to the report, member plans spent 73 percent more on prescription drugs in 2016 than in 2010, attributed to “large year-over-year price increases” for new drugs that are protected from competition by patents.  in addition, the report highlighted the increase in consumer spending on drugs noting that consumers have been paying 3 percent more a year, out-of-pocket, for all prescription drugs but 18 percent more a year for patented drugs.”

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Cost vs Price: How Can You Maximize Value?

By | Data Management

Recently, in a forum setting, a panel discussion touched upon cost versus price and how best to address the potentially touchy issues of cost versus pricing. With recent consumer outrage over drug pricing and demands for cost controls, this is a hot button issue for both drug companies and the people they serve.
image showing the realtionship between cost and pricing in drug pricing 

A great deal of attention has been placed on the price of drugs; some have even called price increases gouging, but to paraphrase a panel commentator – ‘Beats’ headphones have margins on their products much hihger than pharma and nobody seems to care about that.”  Although this is a true statement, to be fair, nobody’s grandma has ever died without their “Beats.”  Perhaps there is a way to let grandma have her Beats AND her heart medication.  With that statement in mind let’s explore the top three ways to optimize both cost and pricing:  choosing the right CMO, maximizing communication, reducing errors and celebrating innovation.

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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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Are Mergers and Acquisitions Defining Pharma?

By | Business

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? 

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New Genes Associated with Autism: How Can Pharma Help?

By | Pharma and Politics

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.picture of blocks used to illustrate autism in children

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.

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Choosing the Right CDMO Partner

By | Custom Manufacturing

Choosing the right CDMO partner for your project can make your manufacturing venture an absolute dream, or your worst nightmare.  Once you are at theCMO man superhero 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.

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Maximizing Data Efficiency

By | Data Management

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……

image showing the importance of a plan in drug development….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 Read More

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

By | Uncategorized

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 Statisticsimage showing the broken trust between the public and drug companies

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. Read More

How to Craft the Perfect Request for Proposal

By | Custom Manufacturing

checklist for RFP creationLast 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.

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Efficiency and Cost Management

By | Data 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. Read More

President Gutting the FDA? Impact on Drug Development and Approval

By | Pharma and Politics

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.

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Questions to Ask Before Approaching a CDMO

By | Custom Manufacturing

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).

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Determination and Management of Should Cost

By | Cost Analysis

“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. Read More

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

By | Data Management

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 notebooks, searching for analytical results scattered across a desk, or hunting for stability results that you know you had in this email somewhere…..

image showing the decision making process Read More

Drug Costs and Accountability in Our Changing Climate

By | Pharma and Politics

“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.” Read More