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Brian James

Dr. James is a Vice President of Operations and has been with Rondaxe since 2006. Brian oversees project management, API synthesis design and API/Formulation sourcing support to our clients. He manages and oversees projects ranging from pre-IND chemistry development to pre-launch validation and material sourcing for late-stage clinical trials. Prior to joining Rondaxe, he was with Bristol-Myers Squibb for 7 years, where he honed his skills and expertise in API synthesis and sourcing strategies. Brian received both his Ph.D. in Chemistry from University of California, his M.B.A. from Le Moyne College, and performed his post-doctoral fellowship at Colorado State University.
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Recent Posts

Can Higher Drug Prices Lower Healthcare Costs?

Posted by Brian James on May 11, 2017 9:33:00 AM

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.

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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Topics: Pharma Pricing, Pharma and Politics

Direct to Consumer Pharma Marketing - Good or Bad?

Posted by Brian James on Apr 20, 2017 11:21:17 AM

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.

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.

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Topics: Pharma and Politics

Want to Practice Medicine?  Become a Lawyer

Posted by Brian James on Apr 3, 2017 11:25:00 AM

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?

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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Topics: Pharma and Politics

Choosing the Right CDMO Partner

Posted by Brian James on Mar 21, 2017 11:15:00 AM

Choosing the right CDMO partner for your project can make your manufacturing venture an absolute dream, or your worst nightmare.  Once you are at the 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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Topics: Custom Manufacturing

How to Craft the Perfect Request for Proposal

Posted by Brian James on Mar 14, 2017 11:30:00 AM

Last 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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Topics: Custom Manufacturing

Questions to Ask Before Approaching a CDMO

Posted by Brian James on Mar 7, 2017 1:20:00 PM

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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Topics: Custom Manufacturing