Mike Wokasch
Articles by Mike Wokasch
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Is $2.6 billion the real cost of drug development?
Thursday, January 01, 2015You might see an article or news headline claiming that it now costs $2.6 billion to discover, develop and get a new drug to market. The pharmaceutical industry will make sure everyone becomes aware of this staggering cost number. After all, the high risk and high cost of research are the foundation for justifying high drug prices.
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What’s behind high generic drug prices?
Monday, December 08, 2014Skyrocketing generic drug prices have gotten the attention of patients, insurance companies, healthcare providers and the media. So much so that it prompted a congressional hearing during which Sen. Bernie Sanders (I-Vt.) cited federal records that suggest prices for more than 1,200 generic medications increased an average of 448 percent between July 2013 and July 2014.
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Where has all the money gone in healthcare?
Wednesday, November 19, 2014Healthcare costs keep going up with fingers often pointed at drug companies. At the same time, the pharmaceutical industry has decades of success delivering safer and more effective drugs to prevent and treat diseases that previously accounted for debilitating sickness and often death.
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Should we feel sorry for Big Pharma’s struggles?
Monday, November 03, 2014Are we feeling sorry for the struggling pharmaceutical industry yet? Generic drugs continue to replace many of the multibillion-dollar blockbuster products of the past. Biosimilars threaten extraordinary revenues and profits of the once-seemingly-irreplaceable specialty biologics. Research pipelines are depleted, and the cost of discovering and developing new products is reported to be more than a billion dollars.
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How high can I price my drug?
Monday, October 20, 2014High drug prices — especially for life-saving or life-enhancing specialty drugs — continue to attract media attention in the U.S. prescription drug market. News outlets often highlight patients lacking adequate prescription drug coverage who have been financially crippled by the cost of their prescriptions. In an attempt to justify these high prices, PhRMA continues its mantra of "high cost and high risk of research" rationale.
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5 reasons mediocre drugs still get used
Monday, October 06, 2014Ever wonder how some drugs get on the market and get prescribed extensively only to find out they are either ineffective or potentially harmful? Despite the dearth of comparative effectiveness studies, the available published literature would suggest that all drugs to treat a particular indication are not created equal. From apparent, if not proven, efficacy differences to disparate adverse reactions and dosing regimens, patients may not be getting the best product available for their particular situation.
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5 simple fixes for Big Pharma
Monday, September 08, 2014While Big Pharma companies continue to have their sporadic good news and occasional success stories, collectively the industry is still struggling to reshape its business models in the evolving healthcare market. In this article, we'll explore five "fixes" pharmaceutical companies can make to increase their probability of success in the future.
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New thinking needed for superbug treatments
Tuesday, August 19, 2014Big Pharma essentially bailed out of antibiotic research several decades ago when chronic disease treatments began to produce significantly better financial returns. While some smaller companies have continued the pursuit of new antibiotics, much of the work continues to be done on known mechanisms or modifications of known chemical structures.
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False hope for new superbug treatments
Monday, August 04, 2014The lack of effective treatments for antibiotic-resistant "superbugs" (multidrug-resistant bacteria) represents a serious global healthcare issue with potentially disastrous consequences. In the hopes of finding new treatments, a number of organizations and governments are struggling to secure and provide sufficient financial and nonfinancial incentives to encourage more research.
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The frustrating lack of comparative effectiveness — Part II
Monday, July 14, 2014Let's assume that a credible, third-party source with therapeutic, statistical and analytic expertise has established definitive evidence that one drug is better than others in treating a particular disease in certain types of patients. They publish the treatment guidelines in a peer-reviewed reputable medical journal, issue press releases and present their findings at relevant medical meetings. Would the guidelines be followed?
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The frustrating lack of comparative effectiveness — Part I
Monday, July 07, 2014When you go to the doctor's office, you expect your healthcare providers will prescribe drugs that will be effective and safe in treating your diagnosis. But which drug is best for treating your disease or medical condition? You rely on your physician or PA to make this determination.
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What is Big Pharma’s core competency?
Tuesday, June 17, 2014In a mature industry like pharmaceuticals, you might think that determining a drug company's core competency would be pretty obvious. You also might think that most Big Pharma companies have this well sorted out. Well, I'm not so sure.
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Perceptions of prescription drug prices
Tuesday, June 03, 2014Remember a couple years ago when buses of elderly patients were going to Canada to get their prescriptions filled for lower prices than at their U.S. pharmacies? While an influx of inexpensive common generic drugs and support from Medicare Part D have quieted the masses — especially among the elderly — prescription drug prices remain a hot topic of debate thanks to expensive specialty medicines, some of which have prices approaching or even exceeding $100,000.
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What really drives drug development inefficiencies — Part II
Monday, May 12, 2014In Part I of this article, we discussed the magnitude of drug development inefficiency. With the cumulative, mind-boggling amount of money and resources dedicated to drug development, it is hard to believe that fewer than 50 new drugs get approved every year. So why is drug development so inefficient?
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What really drives drug development inefficiencies — Part I
Monday, May 05, 2014According to the Pharmaceutical Research and Manufacturers of America, there are currently more than 5,000 potential new drug treatments in clinical trials. Yet every year the U.S. Food and Drug Administration (FDA) approves fewer than 50 new drugs, and many of these approvals include new indications for previously-approved drugs.
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Excluding drug companies from drug information dissemination
Monday, April 14, 2014For the past couple of decades, the healthcare market has gradually made it more difficult for drug companies to market their products. As a result, drug company marketing has tried to reach prescribers, formulary decision-makers and even patients with a variety of nonsales rep tactics, including Internet advertising, social media and television ads.
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Can pharma R&D satisfy the new healthcare market?
Tuesday, April 01, 2014A more attentive FDA and a more demanding healthcare market are forcing pharmaceutical companies to change the way they have done business for decades. Research and development is perhaps the most impacted by both of these market dynamics. After all, without new products you don't have to worry about marketing and sales or manufacturing.
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The challenging market environment for drug companies
Monday, March 17, 2014The traditional pharmaceutical industry is going through perhaps its biggest transformation since The Pure Food and Drug Act of 1906. Unfortunately, the entrenched "we have always done it this way" leadership mentality has been slow to react to the magnitude of changes taking place over the past two decades.
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Is pharmaceutical biotech investment at risk?
Tuesday, March 04, 2014High profitability, strong cash positions, large global healthcare market opportunities, reliable dividends, and perceived security and stability have provided Big Pharma Biotech investors a solid basis for investment rationale. On the other hand, increasing cost of R & D, prolonged time to market, pricing pressures, marketing constraints, and regulatory uncertainty and challenges are now eroding investor confidence and interest.
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The crucial career choices we make every day
Wednesday, February 05, 2014Many of us are in a work routine where we get up, go to work, do our job and go home. We do this without realizing that every day we make two choices that affect our job performance, career opportunities and compensation. These choices also have deeper rooted personal and job satisfaction implications that will become obvious from this discussion.
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Drug information education for practicing physicians: Part II
Tuesday, January 21, 2014As mentioned in my previous post, the recent announcement that GlaxoSmithKline would no longer pay physicians to do educational or promotional speaking about disease and prescription drugs got me thinking about the state of physician education, especially as it pertains to drug information. We talked about eliminating the potential for drug company bias and influence on physician prescribing practice by essentially "cleansing" the drug information development process of any financial support from drug companies.
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Drug information education for practicing physicians: Part I
Monday, January 13, 2014The recent announcement that GlaxoSmithKline would no longer pay physicians to do educational or promotional speaking about disease and prescription drugs got me thinking about the state of physician education, especially as it pertains to drug information for physicians.
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5 threats to effective organizational communication
Thursday, December 12, 2013Effective communication is a critical success factor in any effort involving two or more people. From small businesses to large corporations and even government, effective communication can inspire, align interests, mitigate differences and build trust. Most importantly, effective communication can get things done. When two or more people want to or need to get something done, success or failure is often attributable to how well the parties communicate with each other.
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Articulate leadership no guarantee for effective organizational communication
Thursday, December 05, 2013As a society, we admire, applaud and follow articulate people who help us understand, who inspire us and who project a future of possibilities that sound better than what we have today. This skill is essential for helping a group or organization identify "what could be" while aligning people and their beliefs to work toward a common goal. Articulate leaders can also verbally resolve differences, dispel untruths and keep the naysayer at bay. So why do they sometimes struggle to get anything done?
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Management lessons learned from HealthCare.gov launch
Tuesday, October 29, 2013The embarrassing and problematic launch of HealthCare.gov is nothing short of incomprehensible in our well-established technology driven world of commerce. How could the U.S. government not put up a functioning website to support applications and enrollment for health insurance? If you are managing a small or large project, here are a few axioms that don’t appear to have been taken into consideration when HealthCare.gov was constructed and launched.
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Informed decisions when choosing a healthcare provider
Wednesday, October 16, 2013Most would agree that healthcare is a major purchase. Whether it is for insurance or for out-of-pocket expenses, you are usually talking about hundreds, if not several thousand dollars per year. So how do healthcare customers make good, informed decisions about how to get the most out of their healthcare purchases?
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Is startup biotech funding at risk?
Monday, September 30, 2013Over the past couple of decades, small biotech companies have been an invaluable source of exciting new drug treatments. As a result, investors have been handsomely rewarded for funding these high-risk, speculative technologies that helped fill depleted Big Pharma pipelines. Companies with any hope for delivering a return on investor money have two possibilities; have one of their technologies acquired or have the entire company acquired by a cash rich Big Pharma or Big Biotech.
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Big Pharma replaces innovation with acquisition
Monday, September 16, 2013Big Pharma (including Big Biotech) has executed about 130 mergers or acquisitions in each of the past couple of years. The overwhelming majority of deals designed to fill depleted Big Pharma pipelines with more novel and innovative technologies in later stages (closer to market) than their own R&D had been able to produce.