RE: [NMusers] ASCO and pharmacometrics

From: Naoto Hayashi <neohayashi_at_gmail.com>
Date: Fri, 8 Apr 2016 11:35:07 +0900

Dear Joga-san,



Thank you so much for your reply. I cannot disclose the abstract and you
of course cannot decide whether it has worth to discuss or not.



You and other FDA pharmacometrics specialist have done greatest works so
far and the many clinicians nowadays have recognized that pharmacometrics
is useful and needed technology for clinical development and therapeutics.



Unfortunately, pharmacometrics would be still not yet so matured for
prediction/explanation of the true efficacy, OS, in oncology field.
Therefore, ASCO would not be fully welcome for pharmacometrics presentation=
.



Even though, many pharmacometrics works demonstrated usefulness for safety
profile of anti-cancer drugs and dosage rationale etc., and they would need
to consider that pharmacometrics would be also important for world biggest
oncologist congress.



I want to ask such influencing people as you for pharmacometrics to
convince ASCO as our field is important even in oncology field.



Sorry, in the case that our abstract became just “publication only=
” with
appropriate evaluation by pharmaceutics specialist as no worth for poster.



Best regards,

Naoto



*From:* owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com
<owner-nmusers_at_globomaxnm.com>] *On Behalf Of *Gobburu, Joga
*Sent:* Friday, April 08, 2016 3:00 AM
*To:* Dennis Fisher; nmusers
*Subject:* RE: [NMusers] ASCO and pharmacometrics



Dear Naoto-san et al,



Has it ever occurred to us that we might have to change first, not others!


Not having reviewed the abstract, I cannot comment on the potential reasons
why the abstract was not accepted at ASCO. Somehow – that event is
translated in to ‘Oh! ASCO doesn’t like pharmacometrics=
– it is a stretch.
On the same token, are we inviting with open arms ASCO scientists to our
clinical pharmacology meetings? This is a two-way street.

I don’t deny that there is room for change on both sides – =
but it has to be
both sides. Most pharmacometricians talk in PREDPP, and not in drug
development terms. We need to take a long term view – 10 or 20 year=
s ago we
might not have considered submitting our work to clinical meetings. Today
we are – which is progress. I see more and more clinical pharmacol=
ogy
topics discussed at clinical meetings. So picture is not so gloomy.



How do we catalyze our presence at clinical meetings?

a. We first need to understand the agenda of those meetings and find
mutually interesting topics.

b. We need to build relationships with key leadership of these
clinical organizations. These clinical meetings are sponsored to a great
extent by companies. Well our folks in the companies can lobby to create
sessions of interest to both groups.

c. We should be the change we want to see. Invite key leaders from the
clinical conference to ours.

d. We need to train ourselves better in drug development and
communicating with inter-disciplinary scientists; and not stuck on the
methodology.



Joga Gobburu

Professor, University of Maryland

Center for Translational Medicine



*From:* owner-nmusers_at_globomaxnm.com [mailto:owner-nmusers_at_globomaxnm.com
<owner-nmusers_at_globomaxnm.com>] *On Behalf Of *Dennis Fisher
*Sent:* Thursday, April 7, 2016 11:36 AM
*To:* nmusers <nmusers_at_globomaxnm.com>
*Subject:* Re: [NMusers] ASCO and pharmacometrics



I agree with Phil. I have presented recently at two large endocrine
meetings, one in the US, one in Europe. In both cases, I took complicated
PK/PD models and kept it simple, emphasizing how the models could / would
be used in clinical development and clinical practice. The response at
both meetings was excellent — lots of people expressing interest in=
 the
models (and, interestingly, two of the competitors to the company for which
I was consulting tried to enlist my consulting help).



And, I disagree with Nick’s comment yesterday. Perhaps oncology cl=
inicians
are concerned about commas (I cannot speak to that issue) but I truly doubt
Nick’s claim that they don’t care about science — t=
he advances in oncology
in recent years have been remarkable.





Dennis Fisher MD
P < (The "P Less Than" Company)
Phone: 1-866-PLessThan (1-866-753-7784)
Fax: 1-866-PLessThan (1-866-753-7784)
www.PLessThan.com <http://www.plessthan.com/>

Received on Thu Apr 07 2016 - 22:35:07 EDT

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