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Shelly James

Shelly James joined Rondaxe in 2015 as Director of Technical Services. Shelly is involved in multiple projects and handles a diverse array of client needs, including project management, generating technical documents,supplier identification, sourcing and the analysis of cost of goods. Prior to joining Rondaxe, she performed her post-doctoral work at the University of California, San Francisco, where she honed her skills and expertise in non-invasive molecular imaging techniques and synthetic strategies. Shelly received her Ph.D. in Chemistry from Syracuse University, and her B.S. in Chemistry from the University of California, Santa Barbara.

Recent Posts

High Potency Compounds-Taking on the Challenge

Posted by Shelly James on Mar 13, 2018 2:00:00 PM

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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Microfighters: Nanotechnology Takes on Cancer

Posted by Shelly James on Dec 13, 2017 11:37:00 AM

Cancer is a devastating disease, with approximately 40% of men and women facing a diagnosis of cancer at some point during their lifetimes (based on 2010-2012 data).  In addition, cancer is a costly disease, with national expenditures in the United States reaching nearly $125 billion in 2010 and a projected $156 billion in 2020.

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Topics: cancer, technology, chemotherapy

Technology & Pharma: An Unexpected Intersection

Posted by Shelly James on Nov 10, 2017 11:00:00 AM

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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Topics: technology

Snake Oil and Social Media

Posted by Shelly James on Sep 25, 2017 11:30:00 AM

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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Topics: social media, regulation, drug promotion

Not So Nobel Awards

Posted by Shelly James on Sep 20, 2017 11:30:00 AM

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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Topics: humor

Personalized Medicine:  The Future of Genetic Testing?

Posted by Shelly James on Sep 18, 2017 1:00:00 PM

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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Topics: genetic sequencing,, drug development

AI Innovation in Pharma

Posted by Shelly James on Sep 14, 2017 10:00:00 AM

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

Posted by Shelly James on May 25, 2017 12:46:47 PM

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?

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Topics: Business

5 Reasons Why Your Data Management System is Failing You

Posted by Shelly James on May 18, 2017 11:28:46 AM

 

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.

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:

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Topics: Data Management

Patients: Pharma's New Partners?

Posted by Shelly James on Apr 27, 2017 1:23:42 PM

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.  According to a recent report by PwC Health Research Institute, pharma’s new strategic partner may very well be patients.

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Topics: Data Management, Pharma Pricing