post-ACoP: How to train future pharmacometricians

Hello: I attended the ACoP last week, where we talked about how to train future pharmacometricians - http://www.go-acop.org/acop2009/program Here is my thought I could not share due to lack of time during the meeting. Local scientists in NJ area teach PK, PD and some basic M&S at a Pharmacy school for undergraduate and graduate students. Last year when I taught population analysis for 4 hours straight (with 10 minutes of bio-break) to the graduate students, they clearly showed their interest to learn, and we ended up going over the teaching material 1 more hour without any complaint from about 15 students. Of course, I emphasized the usefulness of the knowledge in getting an industry job at the beginning of the lecture. We also have tried to form a full M&S graduate course at the school, but it has been difficult because of the fact that most of the faculties at the school have more pharmacology / pharmacogenomics oriented research interests, hence less interest in pharmacometrics: students need professors who can guide M&S exercises at school, not just adjunct professors who visits now and then…. So... I wonder if we can extend this NJ example to a Global University where Pharmacometrics - at least, concept - can be taught free of charge to students all over the world by pharmacometricians in industry, academia and regulatory agencies. Later, we may further consider to have a one-to-one mentoring program. AAPS supports webinars on many interesting topics. Maybe ACoP can support pharmacometrics webinar? Maybe National Science Foundation? Or, Bill Gates? :-) Best wishes, Holly Huicy Kimko P.S.: Let's dream first... a good one... http://www.youtube.com/watch?v=_km0u64OLng

Hi Holly Education in pharmacometrics is obviously an important role to maintain the health of M&S in the future of both industry and academia. Many academic centres offer pharmacometric research training to graduate students during the course of their PhD. This in many cases takes the form of a 1:1 mentoring programme. > I wonder if we can extend this NJ example to a Global University where > Pharmacometrics - at least, concept - can be taught free of charge to > students all over the world by pharmacometricians in industry, academia > and regulatory agencies. Later, we may further consider to have a one- > to-one mentoring program. AAPS supports webinars on many interesting > topics. Maybe ACoP can support pharmacometrics webinar? Maybe National > Science Foundation? Or, Bill Gates? :-) Perhaps, rather than starting something new, what we need is better financial support for those academic centres that are currently offering research opportunities (and hence training) in pharmacometrics. Does anyone know: 1) how many pharmacometric positions exist in industry + academia? 2) what the attrition rate is from these positions? Armed with this knowledge, and factoring in some growth and applying an equilibrium model, we can predict the required training rate... Regards Steve -- Professor Stephen Duffull Chair of Clinical Pharmacy School of Pharmacy University of Otago PO Box 913 Dunedin New Zealand E: [email protected] P: +64 3 479 5044 F: +64 3 479 7034 Design software: www.winpopt.com

Hi Holly and Steve, I think we might want to revisit the paper by Marc Gastonguay, Jeff Barrett et al regarding this. They enumerated programs that were available worldwide (although it is always changing). Their suggestion for a shared program to take advantage of different areas of expertise (and to really expose trainees to the key experts in each of the various aspects related to pharmacometrics and quantitative pharmacology) is very much along the lines of what is being proposed here. However, you have touched on some of the key issues - and these issues extend to how well aligned the various institutions are at sharing (i.e., how does one distribute resources in a shared curriculum across institutions - how is this vetted if one wants to provide an "accredited" Ph.D. degree in this area - so how are the various contributions recognized across institutions as being appropriate and sufficient to contribute to the Ph.D. from any given institution that is participating). There are already curricula established that could be used to show the core need for training across multiple sites (see the Metrum Institute curriculum - perhaps Marc can comment on this further). In addition, Jeff Barrett has incorporated into the UPENN CTSI a training program (Ph.D.) in pharmacometrics - although I believe there are additional funded needs to get this fully established and the CTSI at Indiana has created a disease modeling program that is focused on quantitative pharmacology approaches (encompassing pharmacometrics) as a key for training at least at the post-doctoral fellowship level. As for the attrition rate in academia - it is substantial - it is also viewed as quite unfriendly to this area at least in the U.S. - there are several institutions in the U.S. that I am aware of that have open faculty slots that they are unable to find qualified and willing individuals to fill. This is a significant problem that poses a challenge at least from the standpoint of U.S. institutions. The typical attrition rate in academia is about 75% (i.e., 1 in four who start as a tenure track assistant professor will succeed - it was actually lower in the school of medicine at the University of Pittsburgh). As for the suggestion regarding Bill Gates - typically the grants from the Bill and Melinda Gates Foundation focus on public health issues that affect populations in terribly underserved populations (malaria in Africa for example, HIV in the third world) so I'm not sure our current focus fits into this exactly. An issue with NSF funding is that typically (although not always - sometimes you can persuade them to produce an RFA that will allow this) any indication of applicability to biomedical sciences is not viewed positively (it usually kills the grant) - they are really focused on the very basic theoretical/fundamental types of problems where there is not an obvious application in this area. Perhaps a useful strategy would be to see if the NIH would see this shared program as something that a modified multi-institution (and international) T32 mechanism could suit. The current T32 mechanism is really focused on single institutions/departments - so this would have to be addressed with perhaps a modification of the funding mechanism that comes from the level of program/council to address this? At any rate - I welcome your comments on this. Best Regards, Rob

Rob I think what you indicate is perhaps more formal than what I am thinking. > across institutions - how is this vetted if one wants to provide an > "accredited" Ph.D. degree in this area - so how are the various > contributions recognized across institutions as being appropriate and > sufficient to contribute to the Ph.D. from any given institution that > is participating). There are already curricula established that could > be used to show the core need for training across multiple sites (see > the Metrum Institute curriculum - perhaps Marc can comment on this > further). The above sounds like a training programme. A PhD is about a student learning about research and problem solving in an environment that maximises their ability to discover answers/solutions. It is not about training someone up for a job somewhere. It happens that PhD students who are trained in pharmacometrics will generally get quite a broad range of experiences and knowledge of current tools. However, we are training thinking players for the future who are quite capable of learning new methods on the fly and not technicians for the present. What I hear in this discussion is more of a course taught, perhaps a Masters type, programme whereby a student could tick off the necessary components to attain the title of pharmacometrician. I don't know the attrition rates in academia in Australasia, but I imagine that we have as much difficulty either in setting up a position which is principally pharmacometrics (due to available funding) or attracting staff of the right background. Without faculty we get no PhD students and no thinking players for the future... So, for me there are essentially three different types of solutions: 1) Industry & academia grow their own pharmacometricians by taking on someone in an allied field and training them up in house (or via external courses) and then run the risk of losing them after a substantial investment. 2) A teaching programme is set up specifically to train pharmacometrics (e.g. a Masters programme of some sort). 3) More faculty become available at Universities who will take on PhD students and then train the next generation of players. I believe (1) happens now and for me (3) is the solution for the future. I believe the criterion to determine the health of the discipline is the total number of young faculty in pharmacometrics across the world. They say (at least Stephen Pinker does) that a language is officially dead when less than 6000 children speak it... Steve -- Professor Stephen Duffull Chair of Clinical Pharmacy School of Pharmacy University of Otago PO Box 913 Dunedin New Zealand E: [email protected] P: +64 3 479 5044 F: +64 3 479 7034 Design software: www.winpopt.com

Steve, Thank you for your thoughtful comments here. I guess I didn't express myself clearly with respect to the Ph.D. elements - I wasn't thinking about a formal or rigid training program - but rather some of the mechanics of departments recognizing that these approaches and the elements that we think are necessary in terms of developing thinkers in this area are recognized within and/or across departments (i.e., that a student could do a thesis primarily based in questions addressed with a Modeling and Simulation approach for example). I agree that it is critical that we developing those "who are quite capable of learning new methods on the fly and not technicians for the present". The not producing technicians is a key challenge but a critical element to success in this area. We are hoping to developing some of those folks (i.e., the faculty of the future) with the program here. Some of the sharing/vetting was more in the vein of being able to expose the students to the leaders in each of the areas of the field for perspective (perhaps additional cultivation in the context of growing). I suppose Stephen Pinker's assessment is some cause for concern - but at the same time a stimulus to begin thinking about how to "grow" the field. The hope at Indiana is that the initial program will evolve into one that has a Ph.D. training element (and already there is significant interest from Ph.D. students in the inter-disciplinary programs here in medical genetics and pharmacology). Best Regards, Rob Robert R. Bies Pharm.D.Ph.D. Associate Professor of Clinical Pharmacology Member Center for Computational Biology and Bioinformatics Indiana University School of Medicine 1001 W 10th Street W7138 Indianapolis, IN 46202

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Dear all, I appreciate the calls, private emails and postings on this topic. I am surely not a lonely dreamer - specially with internet. :-) Thank you. I see the points discussed by Rob, Steve and three others (private communications) as academicians. Some relevant topics are also discussed very nicely in the paper titled: Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research Settings - Barrett et al. (Clin Pharmacol 2008;48:632-649). While reading those messages, I had to think about the definition of "pharmacometrician" again. To me, it means a person who analyzes drug-related data ("pharma") in a quantitative way ("metric") - especially those who uses subjects of quantitative pharmacology, pharmacokinetics, pharmacodynamics, disease progress model and protocol adherence model with a focus on populations and variability via stochastic simulations, applicable in drug development. In my previous posting, my "pharmacometrician" was partially those who are in specific fields of pharmacology (=drug exposure effect), because I was thinking of the students from the local Pharmacy school whose thesis projects are cell biology, transporters, etc. Some of them will find jobs in pharmaceutical industry. The target is anybody who wants to know more about Pharmacometrics at his/her position without quitting the current job as a student or an employee to spend a certain period of time to get a certificate or a diploma. I am not sure how many students or employees in small pharma companies can afford such a nice training opportunity in terms of money and time. They have to start small. Later when they see a strong necessity, they may go for the opportunity. Fortunately, I was contacted by a person who had similar experiences as mine in a local university. We need some good ideas on how to fill up this niche. It may take a long time, but as he said, "I am stubborn and I want to do something <about quantitative pharmacology/pharmacometrics training>." Thanks, Holly

Dear all, I appreciate the calls, private emails and postings on this topic. I am surely not a lonely dreamer - specially with internet. :-) Thank you. I see the points discussed by Rob, Steve and three others (private communications) as academicians. Some relevant topics are also discussed very nicely in the paper titled: Pharmacometrics: A Multidisciplinary Field to Facilitate Critical Thinking in Drug Development and Translational Research Settings - Barrett et al. (Clin Pharmacol 2008;48:632-649). While reading those messages, I had to think about the definition of "pharmacometrician" again. To me, it means a person who analyzes drug-related data ("pharma") in a quantitative way ("metric") - especially those who uses subjects of quantitative pharmacology, pharmacokinetics, pharmacodynamics, disease progress model and protocol adherence model with a focus on populations and variability via stochastic simulations, applicable in drug development. In my previous posting, my "pharmacometrician" was partially those who are in specific fields of pharmacology (=drug exposure effect), because I was thinking of the students from the local Pharmacy school whose thesis projects are cell biology, transporters, etc. Some of them will find jobs in pharmaceutical industry. The target is anybody who wants to know more about Pharmacometrics at his/her position without quitting the current job as a student or an employee to spend a certain period of time to get a certificate or a diploma. I am not sure how many students or employees in small pharma companies can afford such a nice training opportunity in terms of money and time. They have to start small. Later when they see a strong necessity, they may go for the opportunity. Fortunately, I was contacted by a person who had similar experiences as mine in a local university. We need some good ideas on how to fill up this niche. It may take a long time, but as he said, "I am stubborn and I want to do something <about quantitative pharmacology/pharmacometrics training>." Thanks, Holly