RE: [NMusers] ASCO and pharmacometrics

From: Naoto Hayashi <neohayashi_at_gmail.com>
Date: Wed, 6 Apr 2016 19:28:11 +0900

Dear Rene,

I now understand as ASCO is interested in new drugs/regimens and others
only.

Pascal introduced your success but probably mainly their interesting is
just robust observation and not sophisticated analysis method.

I have learnt it today but it was too late.

BR,
Naoto
2016/04/06 18:30 "Rene Bruno" <Rene.Bruno_at_certara.com>:

>
>
> Hum, thanks Pascal… but I got several abstracts as publications o=
nly too
> including one that ended-up as a full paper in CPT (Phase II clinical tri=
al
> simulation based on Phase II data)… so ASCO is very frustrating. =
Problem is
> that they are getting too many abstracts and they only are selecting to
> most ‘sexy’ ones and by ‘sexy’ I don=
t mean in term of data analysis but in
> term of the drug. So an analysis relating tumor growth inhibition to
> survival for a PD-1 inhibitor with a simple Kaplan-Meier plot will make i=
t
> when a state-of-the-art model with simulation-based assessments and
> clinical trial simulations with the nth tyrosine kinase inhibitor may
> end-up in the abstract book only.
>
>
>
> The same applies with the clinical journals (e.g. JCO)… So it=
s
> frustrating but we have to keep trying and message the work in a
> ‘marketing’ and simple way even if the analysis behind is=
 sophisticated to
> capture interest of the clinical community.
>
>
>
> Best,
>
> Rene
>
>
>
> *From:* owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com=
]
> *On Behalf Of *Pascal Girard
> *Sent:* 06 April 2016 10:39
> *To:* Naoto Hayashi <neohayashi_at_gmail.com>; jgrevel_at_btconnect.com
> *Cc:* nmusers <nmusers_at_globomaxnm.com>
> *Subject:* RE: [NMusers] ASCO and pharmacometrics
>
>
>
> Dear Naoto,
>
>
>
> In the past, Rene Bruno got one poster accepted with discussion at ASCO.
> He is our ”champion” !
>
>
>
> I got one accepted on model for Exp-Tumor Size – OS at European C=
ancer
> Congress 2013 . But I can tell you that a medical writer rewrote it
> entirely and it took 1 month to get it reviewed and corrected by clinicia=
ns
> challenging every comma and p-value.
>
>
>
> To give you an idea of the respective size of the meetings: ACOP N=500,
> PAGE N>600, ECC N> 10,000, ASCO N>20,000.
>
>
>
> So the advice I would give, is just improve the quality and readability o=
f
> our abstract and it will meke it. By readability, I mean show it to an
> oncologist clinician. If he does not understand, rewrite it with the help
> of a medical writer …
>
>
>
> *With best regards / Mit freundlichen Grüßen / Cordialement*
>
>
>
> Pascal
>
>
>
> *Vacation*
>
> 7 April
>
>
>
>
>
> *From:* owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com
> <owner-nmusers_at_globomaxnm.com>] *On Behalf Of *Naoto Hayashi
> *Sent:* 06 April 2016 09:46
> *To:* jgrevel_at_btconnect.com
> *Cc:* nmusers <nmusers_at_globomaxnm.com>
> *Subject:* Re: [NMusers] ASCO and pharmacometrics
>
>
>
> Dear Joachim,
>
>
>
> Thank you so much for your reply.
>
>
>
> Their abstract instruction allows very small number of characters, and no
> enough room to express what we had established in this work.
>
>
>
> Although we described the unique results in the table, they probably coul=
d
> not understand its meaning, or the model's outcome that I was so excited
> has no meaning to oncologist.
>
>
>
> It seemed so nice work for me and I hope that US pharmacometrician societ=
y
> would communicate with ASCO people for our future.
>
>
>
> Thanks!
>
>
>
> Best regards,
>
> Naoto Hayashi, PhD
>
>
>
>
>
> 2016-04-06 15:58 GMT+09:00 Joachim Grevel <jgrevel_at_btconnect.com>:
>
> Dear Naoto,
>
> Your experience is also mine. For a combined TTE safety and efficacy
> analysis I earned the online publication. The organisers do not believe i=
n
> modelling, unless it describes what is already visible in graphs and tabl=
es
> of raw data.
>
> This is just my personal impression. I have not been to ASCO either.
>
>
>
> Good luck,
>
> Joachim
>
>
>
>
>
> *Joachim Grevel, PhD*
>
> Scientific Director
>
> BAST Inc Limited
>
> Science & Enterprise Park
>
> Loughborough University
>
> Loughborough, LE11 3AQ
>
> United Kingdom
>
>
>
> Tel: +44 (0)1509 222908
>
> www.bastinc.eu
>
>
>
>
>
>
>
> *From:* owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com=
]
> *On Behalf Of *Naoto Hayashi
> *Sent:* 06 April 2016 02:38
> *To:* nmusers_at_globomaxnm.com
> *Subject:* [NMusers] ASCO and pharmacometrics
>
>
>
>
>
> Dear all,
>
>
>
> I have a question and appreciate it if somebody can answer to me.
>
>
>
> We had submitted an abstract to ASCO annual meeting presentation 2016, an=
d
> its contents included a pharmacometrics work of quantitative safety profi=
le
> analysis of an anticancer drug. The behave of the safety index time
> courses is very unique and its results showed a very high usefulness of
> this drug. The abstract also included the table of population PK/PD
> parameters that expressed its nature, and it was compared with the simila=
r
> older drug safety profile and demonstrated very high safer profile
> quantitatively.
>
>
>
> I have some experiences to publish some articles of population PK/PD work
> in several clinical pharmacology journals in the past, and I was so
> confident for just a poster presentation in ASCO. However, the judgment
> was “publication only”, i.e. just presentation in online =
but no poster
> presentation and no official record of publication officially.
>
>
>
> So, my question is whether pharmacometrics work is difficult to be picked
> up in ASCO presentation. Or, was my work evaluated to have no worth to b=
e
> presented even in poster session because the pharmacometrics works
> presented in ASCO are having very high level?
>
>
>
> I have never visited ASCO before, and I just want to hear opinions about
> how much of importance is considered for pharmacometrics work in ASCO.
>
>
>
> Thanks a lot in advance for your comments/thoughts.
>
>
>
> Best regards,
>
> Naoto Hayashi
>
>
>
>
>
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Received on Wed Apr 06 2016 - 06:28:11 EDT

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