Some Companies Leverage Medical Device Clinical Trials to Supplement FDA Submissions and Enhance Marketing Messages Despite Avoiding Necessity to Complete Them

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

The US Food and Drug Administration (FDA) does not require that all device manufacturers conduct medical device clinical trials, nor does it require that they file study findings along with regulatory submissions.  Companies developing medical devices that are similar to other products in the US market can use the pre-market notification 510(k) submission which requires bench and laboratory data, but not full-blown clinical trials. Continue reading

Next-Gen Drugs Offer Companies High Yield Pharma LCM Solutions

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Pharmaceutical companies have no shortage of options when looking for line extension strategies. Many turn to new formulations, new indications or combination drugs to boost their brand’s lifespan. However, for those companies that have the capital to invest in pharma LCM solutions, next generation drugs may be their best bet.  This particular strategy yields the highest returns, but also takes the largest investment. Continue reading

Mitigating the Risks of CER Clinical Trials

Natalie DeMasi, clinical trial and comparative effectiveness researcher
By Natalie DeMasi,
Research Analyst

One of the best ways to prove a product’s worth is to quash a competing product in comparative effectiveness research (CER) clinical trials.  Conversely, one of the best ways to harm a product’s market success is to be crushed in a comparator trial.  Of course, most CER clinical trials are not this definitive, but there are always risks of unexpected negative revelations.  Despite this, many life sciences companies look to comparative effectiveness findings to aid market access and commercialization efforts. Continue reading

Brand Marketing and Commercialization: Giving Personality to Your Product

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Most patients will never know the science behind the pills they take.  What they often do know, however, is the products marketing and public image.  But brand marketing – and brand commercialization – is more than making the products name widely known.  It is also more than doodling a fancy cartoon or song to promote a product.  According to a recent study from Concordia University, brand marketing is about creating a personality for the brand. Continue reading

Facilitate Brand-Specific Early Commercialization Activities

The window between Phase 3 and six months after drug product launch marks a pivotal time for pharmaceutical and biotechnology companies’ commercial efforts.  As products move through the pipeline, companies shift from market preparatory activities — such as medical and scientific communications — to heavy commercial activities — such as advertising and promotional campaigns.  Drug and device companies are now getting an earlier jump on initial commercialization activities — targeting strategic communications with key audiences, such as healthcare providers, payers and consumers, well before product launch.  Continue reading

Intended Usage Often Guides Brands’ Commercialization Strategies

Today pharmaceutical brand commercialization efforts begin earlier and earlier. Some companies even begin certain activities as early as pre-clinical work in support of particularly promising products. The key time period for pharmaceutical brands’ marketing success begins at Phase 3 and runs through brands’ early launch windows, however. Here companies lay the foundations for marketing strategies and prepare markets for the arrival of their newest innovations. Continue reading

Dedicated Patient Adherence Fuels Bigger Budgets

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Saying that patient adherence is straightforward is like saying the only thing required to compete at the Olympics is a plane ticket. It’s simply not true. Fostering long-term patient adherence goes beyond the scope of simply getting patients to take their prescribed medications. Successful patient adherence efforts require the implementation of various channels, from traditional print sources to increasingly popular mobile and digital technologies. It also requires a certain amount of ingenuity and creativity. Having a team run patient adherence as a part of their overall duties simply does not allow companies to do the task justice. Continue reading

Shape Pharmaceutical Commercialization Strategies with Market Research and Competitive Intelligence

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

Commercialization teams face tremendous challenges as they bring new pharmaceutical brands to market. Many of the decisions these individuals make ultimately determine a brand’s success or failure. With this great weight on their shoulders, pharmaceutical commercialization strategies teams invest a great deal on market research and competitive intelligence prior to brands’ launches. Continue reading

There Are Many Reasons for Non-Adherent Patients

In an earlier blog post, I discussed the cost of non-adherent patients — poorer health outcomes for patients and billions of dollars in lost product revenue. Low adherence rates have been a problem for a long time, plaguing not only the industry that develops products but also patients themselves, who do not realize the dangers of partial treatment. As companies seek to realize their products’ full potential usage and revenue, they are increasingly forming dedicated Adherence Teams to better understand why patients are non-compliant.

Reasons for non-adherent patients vary from simple forgetfulness to more complex social and financial issues. Continue reading