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Therapeutic Drug Monitoring and Clinical Toxicology
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September Compass

Many thanks to the Compass Editorial Team:

Paula Schaiquevich
Edgar Spencer
Franck Saint-Marcoux.

As we have come to expect, the Compass this month was full of great reports. In this issue we hear about scientific meetings in several very diverse locations, while the Anti-Infective Committee report on emerging developments in the Therapeutic Drug Monitoring of antiretrovirals and echonocandin class of antifungals.


Finally, there is a forum piece about the future of Precision Medicine (that sent me thinking down a rabbit hole into the past) and a report about the upcoming book, Individualized Drug Therapy, from two of our members, leaders in their field. Precision medicine, individualized therapy: is it precise to say they are the same?

Our members are very lucky folk, privileged to visit such exotic places as Utsonomiya, Kuşadası and Munich, as diverse as our members.

President Loralie Langman represented the Association at the 33rd Annual Meeting of the Japanese Society of Therapeutic Drug Monitoring in Utsonomiya, Japan. While there she visited Kyoto, the site of next year’s congress, received by Yusuke Tanigawara and Satohiro Masuda, chair and secretary of the congress respectively. She leaves us with confidence that the hosts have an excellent program planned, and that the 2017 congress will be very special indeed.

Saeed Jortani, Marilyn Huestis and Alain Verstraete represented the Association as members of the Clinical Toxicology/Drug of Abuse Scientific Committee at this year’s Regional Meeting in Kuşadası, Turkey; covering challenges particularly related to drugs of abuse, and the most recent technological advances and national programs in this challenging area.

Not so far off, the Young Scientist report from Markus Mayer was about the Toxicological and Forensic Chemistry Symposium at the Analytica fair (Munich, Germany) where several members presented. Many of these might be Young Scientists but all are recognised and established experts. Markus details the presentations very well, capturing individual members’ experiences with the incorporation of the latest technologies in their areas of work.

The Anti-Infective Drugs Committee was busy this month with two reports on emerging developments in the Therapeutic Drug Monitoring of antiretrovirals and echonocandins. In both instances, it is really useful to see local perspectives and local data presented alongside published data, especially as it seems that there is a continued fight in the space where clinical evidence is lacking, and TDM interventions are purported not to be cost-effective prior to clinical trials of an intervention, where efficacy and cost-effectiveness might be evaluated.

David Burger covers antiretrovirals where there was no doubt that TDM was useful for the protease inhibitors, nelfinavir and indinavir (David being lead author of the ATHEN trial). For newer drugs, such as the NNRTIs efavirenz and ripilvirine, and the integrase inhibitors raltegravir, elvitegravir (boosted by cobicistat) and dolutegravir, the case for TDM is emerging (some more than others), but none count on assays with FDA or CE approval. This is a really nice and informal overview of the topic.

I learned from Mariadelfino Molinaro that echonocandin antifungals have a favourable safety and efficacy profile compared to other antifungals used in treatment, exhibit concentration dependent efficacy and exhibit a post-antifungal effect. Evidence is lacking for a therapeutic range in prophylaxis. Mariadelfino presents three paediatric cases for micafungin, caspofungin and andulafungin used for treatment. Once again, a great, easy to read overview, with useful reference to local cases.

My close friend and colleague, Ofelia Noceti, writes a forum piece about the growth of Precision Medicine as a concept, and recent boom in the area. I was surprised to see the origin of Precision Medicine attributed to the Harvard Business School, 2008. After some google-ing I came to the purported source of this widely quoted claim. 

Members that participated at the Stuttgart congress will no doubt remember the Plenary talk "Transitioning TDM to Personalize Healthcare" by Roland Valdes Jr. from Louisville, Kentucky. Indeed, I have seen members directly quote aspects from this plenary in subsequent congresses (for example, Prof Michael Oellerich in the context of the emergence of cfDNA as a marker for graft patency post-transplant in Rotterdam last year). The cornerstone of Dr. Valdes’ talk was a book called “The Innovator’s Prescription” by Clayton Christensen of HBS, released in 2008.

I was strongly impacted by Dr Valdes’ talk, and the book (hat tip to Prof Pierre Marquet for obtaining it for our lab following the congress). Christensen and co-authors claim the term "precision medicine" to distinguish from "personalized medicine", and separate the two concepts, the former referring to precision diagnostics:

Another term, “personalized medicine”, is often used for this phenomenon that we’re calling “precision medicine”. The reason we decided to coin a new term is that most precisely diagnosed diseases are in fact not uniquely personal. The same causal mechanism that predictably yields to the same therapy can be at work in many different people. As we shall soon discuss, the precise biological definition of a disease also does not incorporate “personalization”, that is, how an individual patient might respond to a particular treatment. Thus we concluded that the term “precision medicine” more accurately connotes the nature and enabling potential of scientific and technological progress in health care, while “personalized medicine” should refer to the additional aspect of incorporating biological and nonphysiological issues that deal with an individual’s response to precise care. – p67

The authors elaborate “personalization” as adapting therapy based on an individual’s unique characteristics for an optimal response, or “tailoring treatment”. Warfarin pharmacogenetics gets the centre stage position to illustrate their point. Indeed, Dr Valdes positions TDM in ‘personalizing’ health care. It sounds to me what we do as a community fits better into this space, although the technologies we employ and the knowledge that influences us certainly pass between the two. Further googling reveals much confusion in the subsequent discourse, and imprecise use of two terms.

Between personalization and individualization, I’m happy for Roger Jelliffe and Michael Neely to decide on the verb they feel most adequately describes their efforts. I have been anticipating their book ‘Individualized Drug Therapy’ since the recent interview with Roger, and in this Compass we hear about what to expect. The book sounds wonderful, and I’m really looking forward to getting my hands on a copy.

Read the Full reports in the September 2016 Compass.

The content of the IATDMCT Blog does not necessarily have the endorsement of the Association.