Monthly Archives: July 2018

Personalized Medicines, serialization

Personalized Medicines In A Serialized World

3d render of T cells attacking cancer cells

The era of personalized medicines has begun.  These are medicines that are tailored specifically for a single patient, using that patient’s specific DNA or other blood characteristic as a guide or actual source component.  The new chimeric antigen receptor T-cells (CAR-T) is an exciting example.  It results in the conversion of a patient’s own T-cells into cells that are able to recognize the specific type of cancer cells that the patient has, and thus able to attack them in the same way that normal T-cells attack normal infectious cells.  In short, it’s a way of manipulating a person’s own immune system to attack cancer cells that it would normally be blind to.  When it works, the results can be breathtaking.  The question is, how are these drugs treated under today’s serialization and tracing regulations?  Let’s take a look. Continue reading Personalized Medicines In A Serialized World →

Russia

New Direction For Pharma Serialization In The Russian Federation

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Click image to enlarge. Image from www.GreenwichMeanTime.com

Over the last 18 months or so, the Ministry of Health in the Russian Federation has been conducting a pilot to learn what works and what doesn’t work for pharma serialization and tracing (see “Russia Begins Its Pharma Supply Chain Pilot” and “The Russia Serialization Pilot Guideline”).  They were due to publish a report on their findings in February of this year, but we are still watching for that.  As we’ve learned over the years, it’s not uncommon for governments to miss their deadlines, at the same time, making tough statements about the industry needing to meet theirs, followed by caving on those deadlines too (See US, China, Brazil, US, India, Pakistan…).  That pattern is repeating in Russia. Continue reading New Direction For Pharma Serialization In The Russian Federation →

DSCSA

HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance

Unlike the implication of this drawing, FDA does hear and care about submitted comments.

The Healthcare Distribution Alliance (HDA) recently posted their response to the latest draft Drug Supply Chain Security Act (DSCSA) guidance published by the FDA.  That draft guidance explains how, when and why companies in the US pharma supply chain can apply for waivers, exemptions and exceptions to provisions in the DSCSA (see “FDA Draft Guidance: How To Apply For A Waiver, Exception or Exemption”).  As usual, the HDA took close to the full sixty day comment period to respond.  The comment period closed last Monday. Continue reading HDA Responds To FDA Waivers, Exceptions, Exemptions Draft Guidance →

DSCSA

Newly Published Material From HDA and C4SCS

I was on vacation last week and only arrived home Sunday evening so I didn’t have time to write an essay for Monday, but this is Tuesday!  Near the end of last month there was a spike in the number of things that need to be covered in RxTrace.  Two of them are important things from HDA and the Center For Supply Chain Studies.  I’ve been waiting for both for months, and here they are. Continue reading Newly Published Material From HDA and C4SCS →