ASCO and pharmacometrics

On Apr 5, 2016, at 8:44 PM, Naoto Hayashi <[email protected]<mailto:[email protected]>> wrote: 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, and its contents included a pharmacometrics work of quantitative safety profile 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 similar 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 be 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 ******************************************************************************** This e-mail is intended only for the use of the individual or entity to which it is addressed and may contain information that is privileged and confidential. If the reader of this e-mail message is not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this communication is prohibited. If you have received this e-mail in error, please notify the sender and destroy all copies of the transmittal. Thank you University of Chicago Medicine and Biological Sciences ********************************************************************************

From: [email protected] [mailto:[email protected]] On Behalf Of Naoto Hayashi Sent: 06 April 2016 02:38 To: [email protected] 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, and its contents included a pharmacometrics work of quantitative safety profile 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 similar 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 be 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

From: [email protected] [mailto:[email protected]] On Behalf Of Naoto Hayashi Sent: 06 April 2016 09:46 To: [email protected] Cc: nmusers <[email protected]> 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 could 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 society would communicate with ASCO people for our future. Thanks! Best regards, Naoto Hayashi, PhD 2016-04-06 15:58 GMT+09:00 Joachim Grevel <[email protected]<mailto:[email protected]>>: 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 in modelling, unless it describes what is already visible in graphs and tables 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<tel:%2B44%20%280%291509%20222908> http://www.bastinc.eu/ From: [email protected]<mailto:[email protected]> [mailto:[email protected]<mailto:[email protected]>] On Behalf Of Naoto Hayashi Sent: 06 April 2016 02:38 To: [email protected]<mailto:[email protected]> 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, and its contents included a pharmacometrics work of quantitative safety profile 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 similar 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 be 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 This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith. Click http://www.merckgroup.com/disclaimer to access the German, French, Spanish and Portuguese versions of this disclaimer.

On 06-Apr-16 10:39, Pascal Girard wrote: > 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 Cancer 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 clinicians 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 of 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:* [email protected] [ mailto: [email protected] ] *On Behalf Of *Naoto Hayashi > > *Sent:* 06 April 2016 09:46 > *To:* [email protected] > *Cc:* nmusers <[email protected]> > *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 could 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 society would communicate with ASCO people for our future. > > Thanks! > > Best regards, > > Naoto Hayashi, PhD > > 2016-04-06 15:58 GMT+09:00 Joachim Grevel < [email protected] < mailto: [email protected] >>: > > 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 in modelling, unless it describes what is already > visible in graphs and tables 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 <tel:%2B44%20%280%291509%20222908> > > www.bastinc.eu http://www.bastinc.eu/ > > *From:*[email protected] > <mailto:[email protected]> > [mailto:[email protected] > <mailto:[email protected]>] *On Behalf Of *Naoto Hayashi > *Sent:* 06 April 2016 02:38 > *To:* [email protected] <mailto:[email protected]> > *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, and its contents included a pharmacometrics work of > quantitative safety profile 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 similar 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 be 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 > > This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith. > > Click http://www.merckgroup.com/disclaimerto access the German, French, Spanish and Portuguese versions of this disclaimer. -- Nick Holford, Professor Clinical Pharmacology Dept Pharmacology & Clinical Pharmacology, Bldg 503 Room 302A University of Auckland,85 Park Rd,Private Bag 92019,Auckland,New Zealand office:+64(9)923-6730 mobile:NZ+64(21)46 23 53 FR+33(6)62 32 46 72 email: [email protected] http://holford.fmhs.auckland.ac.nz/ "Declarative languages are a form of dementia -- they have no memory of events" Holford SD, Allegaert K, Anderson BJ, Kukanich B, Sousa AB, Steinman A, Pypendop, B., Mehvar, R., Giorgi, M., Holford,N.H.G. Parent-metabolite pharmacokinetic models - tests of assumptions and predictions. Journal of Pharmacology & Clinical Toxicology. 2014;2(2):1023-34. Holford N. Clinical pharmacology = disease progression + drug action. Br J Clin Pharmacol. 2015;79(1):18-27.

From: [email protected] [mailto:[email protected]] On Behalf Of Pascal Girard Sent: 06 April 2016 10:39 To: Naoto Hayashi; [email protected] Cc: nmusers 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 Cancer 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 clinicians 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 of our abstract and it will make 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

> On Apr 7, 2016, at 7:49 AM, Lowe, Phil <[email protected]> wrote: > > I would echo Pascal’s point. Getting pharmacometric work into large clinical > conferences is not straightforward. It can be done (see > link) http://erj.ersjournals.com/content/46/suppl_59/PA5091.abstract > http://erj.ersjournals.com/content/46/suppl_59/PA5091.abstract but note > where I was in the author list as the sole modeller. It helps to work closely > with the clinicians on the messaging. That said, it was fun at the meeting, > explaining the data and model curves to clinicians with them asking how such > knowledge could impact their patients. An eye-opener. Keep trying Naoto! > > All the best, Phil > > Philip J Lowe PhD > Executive Director Pharmacometrics Scientist > Novartis Pharma AG, WSJ-027.6.25 or WSJ-386.12.48.46 > 4056 Basel, Switzerland > Phone: +41 61 324 4676 > [email protected] <mailto:[email protected]> > > From: [email protected] <mailto:[email protected]> > [mailto:[email protected] <mailto:[email protected]>] > On Behalf Of Pascal Girard > Sent: 06 April 2016 10:39 > To: Naoto Hayashi; [email protected] <mailto:[email protected]> > Cc: nmusers > 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 Cancer > 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 clinicians > 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 of > our abstract and it will make 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

2016-04-06 3:38 GMT+02:00 Naoto Hayashi <[email protected]>: > > 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, and > its contents included a pharmacometrics work of quantitative safety profile > 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 similar > 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 be > 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 >

From: [email protected] [mailto:[email protected]] On Behalf Of Dennis Fisher Sent: Thursday, April 7, 2016 11:36 AM To: nmusers <[email protected]> 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 clinicians are concerned about commas (I cannot speak to that issue) but I truly doubt Nick’s claim that they don’t care about science — the 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) http://www.plessthan.com/ On Apr 7, 2016, at 7:49 AM, Lowe, Phil <[email protected]<mailto:[email protected]>> wrote: I would echo Pascal’s point. Getting pharmacometric work into large clinical conferences is not straightforward. It can be done (see link) http://erj.ersjournals.com/content/46/suppl_59/PA5091.abstract but note where I was in the author list as the sole modeller. It helps to work closely with the clinicians on the messaging. That said, it was fun at the meeting, explaining the data and model curves to clinicians with them asking how such knowledge could impact their patients. An eye-opener. Keep trying Naoto! All the best, Phil Philip J Lowe PhD Executive Director Pharmacometrics Scientist Novartis Pharma AG, WSJ-027.6.25 or WSJ-386.12.48.46 4056 Basel, Switzerland Phone: +41 61 324 4676 [email protected]<mailto:[email protected]> From: [email protected]<mailto:[email protected]> [mailto:[email protected]] On Behalf Of Pascal Girard Sent: 06 April 2016 10:39 To: Naoto Hayashi; [email protected]<mailto:[email protected]> Cc: nmusers 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 Cancer 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 clinicians 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 of our abstract and it will make 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

On Apr 7, 2016, at 7:49 AM, Lowe, Phil <[email protected]<mailto:[email protected]>> wrote: I would echo Pascal's point. Getting pharmacometric work into large clinical conferences is not straightforward. It can be done (see link) http://erj.ersjournals.com/content/46/suppl_59/PA5091.abstract but note where I was in the author list as the sole modeller. It helps to work closely with the clinicians on the messaging. That said, it was fun at the meeting, explaining the data and model curves to clinicians with them asking how such knowledge could impact their patients. An eye-opener. Keep trying Naoto! All the best, Phil Philip J Lowe PhD Executive Director Pharmacometrics Scientist Novartis Pharma AG, WSJ-027.6.25 or WSJ-386.12.48.46 4056 Basel, Switzerland Phone: +41 61 324 4676 [email protected]<mailto:[email protected]> From: [email protected]<mailto:[email protected]> [mailto:[email protected]] On Behalf Of Pascal Girard Sent: 06 April 2016 10:39 To: Naoto Hayashi; [email protected]<mailto:[email protected]> Cc: nmusers 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 Cancer 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 clinicians 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 of our abstract and it will make 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 Gr??en / Cordialement Pascal This message and any attachment are confidential and may be privileged or otherwise protected from disclosure. If you are not the intended recipient, you must not copy this message or attachment or disclose the contents to any other person. If you have received this transmission in error, please notify the sender immediately and delete the message and any attachment from your system. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not accept liability for any omissions or errors in this message which may arise as a result of E-Mail-transmission or for damages resulting from any unauthorized changes of the content of this message and any attachment thereto. Merck KGaA, Darmstadt, Germany and any of its subsidiaries do not guarantee that this message is free of viruses and does not accept liability for any damages caused by any virus transmitted therewith. Click http://www.merckgroup.com/disclaimer to access the German, French, Spanish and Portuguese versions of this disclaimer.