[NMusers] Simulo: a new service for drug trial simulation

[Faelens, Ruben (Belgium)]

Dear NONMEM users,

We all know how difficult it is to simulate full drug trials using NONMEM. It 
is often necessary to generate the full dosing scheme(s) beforehand, and 
response-based dose adaptation requires iteratively rerunning your model until 
you have the results you are happy with.

At SGS Exprimo, we have been working for 4 years to develop a new software that 
makes drug trial simulation much more straight-forward. The software has been 
developed in collaboration with Roche and has been used internally within SGS 
Exprimo for the last 2 years. We are now presenting it to the public as a new 
consultancy service. You may have seen us in Crete at PAGE 2015.

We invite you to visit our website www.simulo.eu or 
contact us directly to request an on-site demo or web conference, or to ask any 
questions you may have.

We look forward to hearing from you.

Kind regards,
Ruben Faelens for SGS Exprimo
Ruben Faelens, MSc
Life Science Services - Exprimo
IT Scientist
Phone:

+32 494 06 72 59



















E-mail:

ruben.fael...@sgs.com



















Web:

www.exprimo.com






















Information in this email and any attachments is confidential and
intended solely for the use of the individual(s) to whom it is addressed
or otherwise directed. Please note that any views or opinions presented
in this email are solely those of the author and do not necessarily
represent those of the Company.
Finally, the recipient should check this email and any attachments for
the presence of viruses. The Company accepts no liability for any damage
caused by any virus transmitted by this email.
All SGS services are rendered in accordance with the applicable SGS
conditions of service available on request and accessible at
http://www.sgs.com/en/Terms-and-Conditions.aspx

[NMusers] Excellent Opportunity for Associate Director, Pharmacometric Scientist - EU

[Ian Kulka]

Dear NONMEM Users Group,

My name is Ian Kulka and I am a specialist recruiter within the field of 
Pharmacokinetics and Pharmacometrics, within Drug Discovery and Translational 
Medicine. I am currently working with a successful company who have an 
opportunity for an Associate Director to join their leading Modelling and 
Simulation team in the Netherlands. This is an exciting opportunity to work on 
projects with very high levels of innovative science, and be accountable for 
success within their research process. With continued growth and accomplishment 
across their product areas and ongoing projects, now is an exciting time to 
take on an exciting role with high levels of responsibility.

As Associate Director, Pharmacometric Scientist you will;


*Take responsibility for leading projects handling advanced PK/PD 
modelling research within both clinical and translational areas.

*Have full responsibility for the technical aspects of interpreting, 
organizing, executing, and coordinating the ongoing projects within the group.

*Take responsibility for the technical expertise within the 
organization alongside the application of advanced PK/PD and disease modelling 
principles, as well as within mechanism-based concepts and processes.

*Consider the analysis of data to support the ongoing product 
development throughout various stages in research and development.

*Lead the development of, and maintain, worldwide collaborations with 
external Academic groups within the specific areas of specialism.

The ideal candidate for this position will be educated to a PhD level within a 
relevant field and possess a strong knowledge of the drug discovery, and the 
role of modelling and simulation in the development process. They should have 
significant experience with Pharmacometrics, PK/PD modelling, or other relative 
areas. Strong experiences within NonMem and R, along with other modelling and 
simulation software is essential. Experiences within Oncology or Infectious 
Diseases would also be highly beneficial. You also must have proven success 
overseeing PK/PD studies within an R&D environment. The successful candidate 
will also require excellent spoken and written English.

If you feel like this could be a great opportunity for your career, then please 
do get in touch. I am reachable on +44 (0)1293 584 300, or email a copy of your 
CV to ian.ku...@rbwconsulting.com. If this 
position does not quite hit the mark, then please get in touch to discuss your 
industry options.
I look forward to speaking with anybody interested in this opportunity, to 
discuss the further details. Likewise, I am more than happy to discuss your 
current experiences to ensure I can keep you informed of exciting 
opportunities, of all levels of seniority, within the industry.

Kind regards,

Ian

Ian Kulka
Translational Medicine & Pharmacology Specialist Recruiter

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cid:image001.jpg@01CAEC3A.0056D770]

Permanent and Contract
Specialist Recruitment

T: +44 (0)1293 584 300
E: ian.ku...@rbwconsulting.com
W: www.rbwconsulting.com

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Re: [NMusers] Simulo: a new service for drug trial simulation

[Leonid Gibiansky]

Actually, nonmem can be used to simulate the response-based dose 
adaptation without iteratively rerunning your model, with single 
simulation (using $ABB COMRES functionality to pass simulated response 
to the dose-adjustment algorithm code), although it is indeed cumbersome


Leonid

--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web:www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
tel:(301) 767 5566



On 6/23/2015 4:48 AM, Faelens, Ruben (Belgium) wrote:

Dear NONMEM users,

We all know how difficult it is to simulate full drug trials using
NONMEM. It is often necessary to generate the full dosing scheme(s)
beforehand, and response-based dose adaptation requires iteratively
rerunning your model until you have the results you are happy with.

At SGS Exprimo, we have been working for 4 years to develop a new
software that makes drug trial simulation much more straight-forward.
The software has been developed in collaboration with Roche and has been
used internally within SGS Exprimo for the last 2 years. We are now
presenting it to the public as a new consultancy service. You may have
seen us in Crete at PAGE 2015.

We invite you to visit our website www.simulo.eu 
or contact us directly to request an on-site demo or web conference, or
to ask any questions you may have.

We look forward to hearing from you.

Kind regards,

Ruben Faelens for SGS Exprimo

*Ruben Faelens, MSc*
*Life Science Services - Exprimo*
IT Scientist

Phone:



+32 494 06 72 59



















E-mail:



_ruben.fael...@sgs.com _



















Web:



www.exprimo.com 



















Information in this email and any attachments is confidential and
intended solely for the use of the individual(s) to whom it is addressed
or otherwise directed. Please note that any views or opinions presented
in this email are solely those of the author and do not necessarily
represent those of the Company. Finally, the recipient should check this
email and any attachments for the presence of viruses. The Company
accepts no liability for any damage caused by any virus transmitted by
this email. All SGS services are rendered in accordance with the
applicable SGS conditions of service available on request and accessible
at http://www.sgs.com/en/Terms-and-Conditions.aspx

[NMusers] PK/PD & Population Modeling Training in Seattle, WA

[Andre Keller]

Dear Members,



Certara will be holding two training courses in Seattle, WA for new or current 
users of Phoenix NLME and Phoenix WinNonlin. Register for both classes and 
receive a 30% discount! Simply enter the promo code "2ormore".



Introduction to Population Modeling Methodology using Phoenix NLME

August 19 - 20, 2015 (1.5 days)

Seattle, Washington



Registration link: https://www.certara.com/training/classes/100



The objective of this course is to train Phoenix WinNonlin users how to perform 
population PK/PD using Phoenix NLME. This will be a 1.5-day hands-on workshop 
with introductory theory of Population PK/PD.



Introduction to Phoenix WinNonlin

August 17 - 19, 2015 (2.5 days)

Seattle, Washington



Registration link: https://www.certara.com/training/classes/98



The focus of this course is to train new and current WinNonlin users how to use 
Phoenix WinNonlin, and includes hands-on exercises with some discussion of 
theory behind the exercises.



Hope to see you there!

Andre Keller
Certara(tm)
5520 Dillard Dr., Suite 260
Cary, NC 27518
Tel  +1-919-852-4611
andre.kel...@certara.com


NOTICE: The information contained in this electronic mail message is intended 
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RE: [NMusers] Simulo: a new service for drug trial simulation

[Mats Karlsson]

Hi,

In many cases you don't even need to use $ABB COMRES to do response-adaptive 
designs, simulated response could just impact a bioavailability term (Fx) of 
the next dose(s) to indicate dose change. I'm sure that more complex 
response-adaptive designs could benefit from a dedicated software though.

Best regards,
Mats


Mats Karlsson, PhD
Professor of Pharmacometrics
 
Dept of Pharmaceutical Biosciences
Faculty of Pharmacy
Uppsala University
Box 591
75124 Uppsala
 
Phone: +46 18 4714105
Fax + 46 18 4714003
www.farmbio.uu.se/research/researchgroups/pharmacometrics/

-Original Message-
From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On 
Behalf Of Leonid Gibiansky
Sent: Tuesday, June 23, 2015 4:14 PM
To: Faelens, Ruben (Belgium); nmusers@globomaxnm.com
Subject: Re: [NMusers] Simulo: a new service for drug trial simulation

Actually, nonmem can be used to simulate the response-based dose adaptation 
without iteratively rerunning your model, with single simulation (using $ABB 
COMRES functionality to pass simulated response to the dose-adjustment 
algorithm code), although it is indeed cumbersome

Leonid

--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web:www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
tel:(301) 767 5566



On 6/23/2015 4:48 AM, Faelens, Ruben (Belgium) wrote:
> Dear NONMEM users,
>
> We all know how difficult it is to simulate full drug trials using 
> NONMEM. It is often necessary to generate the full dosing scheme(s) 
> beforehand, and response-based dose adaptation requires iteratively 
> rerunning your model until you have the results you are happy with.
>
> At SGS Exprimo, we have been working for 4 years to develop a new 
> software that makes drug trial simulation much more straight-forward.
> The software has been developed in collaboration with Roche and has 
> been used internally within SGS Exprimo for the last 2 years. We are 
> now presenting it to the public as a new consultancy service. You may 
> have seen us in Crete at PAGE 2015.
>
> We invite you to visit our website www.simulo.eu 
>  or contact us directly to request an on-site 
> demo or web conference, or to ask any questions you may have.
>
> We look forward to hearing from you.
>
> Kind regards,
>
> Ruben Faelens for SGS Exprimo
>
> *Ruben Faelens, MSc*
> *Life Science Services - Exprimo*
> IT Scientist
>
> Phone:
>
>   
>
> +32 494 06 72 59
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
> E-mail:
>
>   
>
> _ruben.fael...@sgs.com _
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
> Web:
>
>   
>
> www.exprimo.com 
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
>   
>
> Information in this email and any attachments is confidential and 
> intended solely for the use of the individual(s) to whom it is 
> addressed or otherwise directed. Please note that any views or 
> opinions presented in this email are solely those of the author and do 
> not necessarily represent those of the Company. Finally, the recipient 
> should check this email and any attachments for the presence of 
> viruses. The Company accepts no liability for any damage caused by any 
> virus transmitted by this email. All SGS services are rendered in 
> accordance with the applicable SGS conditions of service available on 
> request and accessible at 
> http://www.sgs.com/en/Terms-and-Conditions.aspx

RE: [NMusers] Simulo: a new service for drug trial simulation

[Michael Fossler]

Does anyone have an example of using Fn (bioavailability of compartment n) to 
do adaptive dosing simulations? I am not having much luck getting it to work.


Mike
Michael J. Fossler, Pharm. D., Ph. D., F.C.P.
VP, Quantitative Sciences
Trevena, Inc
mfoss...@trevenainc.com
Office: 610-354-8840, ext. 249
Cell: 610-329-6636


-Original Message-
From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On 
Behalf Of Mats Karlsson
Sent: Tuesday, June 23, 2015 12:06 PM
To: Leonid Gibiansky; Faelens, Ruben (Belgium); nmusers@globomaxnm.com
Subject: RE: [NMusers] Simulo: a new service for drug trial simulation

Hi,

In many cases you don't even need to use $ABB COMRES to do response-adaptive 
designs, simulated response could just impact a bioavailability term (Fx) of 
the next dose(s) to indicate dose change. I'm sure that more complex 
response-adaptive designs could benefit from a dedicated software though.

Best regards,
Mats


Mats Karlsson, PhD
Professor of Pharmacometrics

Dept of Pharmaceutical Biosciences
Faculty of Pharmacy
Uppsala University
Box 591
75124 Uppsala

Phone: +46 18 4714105
Fax + 46 18 4714003
www.farmbio.uu.se/research/researchgroups/pharmacometrics/

-Original Message-
From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On 
Behalf Of Leonid Gibiansky
Sent: Tuesday, June 23, 2015 4:14 PM
To: Faelens, Ruben (Belgium); nmusers@globomaxnm.com
Subject: Re: [NMusers] Simulo: a new service for drug trial simulation

Actually, nonmem can be used to simulate the response-based dose adaptation 
without iteratively rerunning your model, with single simulation (using $ABB 
COMRES functionality to pass simulated response to the dose-adjustment 
algorithm code), although it is indeed cumbersome

Leonid

--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web:www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
tel:(301) 767 5566



On 6/23/2015 4:48 AM, Faelens, Ruben (Belgium) wrote:
> Dear NONMEM users,
>
> We all know how difficult it is to simulate full drug trials using
> NONMEM. It is often necessary to generate the full dosing scheme(s)
> beforehand, and response-based dose adaptation requires iteratively
> rerunning your model until you have the results you are happy with.
>
> At SGS Exprimo, we have been working for 4 years to develop a new
> software that makes drug trial simulation much more straight-forward.
> The software has been developed in collaboration with Roche and has
> been used internally within SGS Exprimo for the last 2 years. We are
> now presenting it to the public as a new consultancy service. You may
> have seen us in Crete at PAGE 2015.
>
> We invite you to visit our website www.simulo.eu
>  or contact us directly to request an on-site
> demo or web conference, or to ask any questions you may have.
>
> We look forward to hearing from you.
>
> Kind regards,
>
> Ruben Faelens for SGS Exprimo
>
> *Ruben Faelens, MSc*
> *Life Science Services - Exprimo*
> IT Scientist
>
> Phone:
>
>
>
> +32 494 06 72 59
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
> E-mail:
>
>
>
> _ruben.fael...@sgs.com _
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
> Web:
>
>
>
> www.exprimo.com 
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
>
> Information in this email and any attachments is confidential and
> intended solely for the use of the individual(s) to whom it is
> addressed or otherwise directed. Please note that any views or
> opinions presented in this email are solely those of the author and do
> not necessarily represent those of the Company. Finally, the recipient
> should check this email and any attachments for the presence of
> viruses. The Company accepts no liability for any damage caused by any
> virus transmitted by this email. All SGS services are rendered in
> accordance with the applicable SGS conditions of service available on
> request and accessible at
> http://www.sgs.com/en/Terms-and-Conditions.aspx



Notice: This e-mail message, together with any attachments, contains 
information of Trevena, Inc., 1018 West 8th Avenue, King of Prussia, PA 19406, 
USA. This information may be confidential, proprietary, copyrighted and/or 
legally privileged.
It is intended solely for use by the individual or entity named on this 
message. If you are not the intended recipient, and have received this message 
in error, please notify us immediately and delete it and any attachments from 
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Re: [NMusers] Simulo: a new service for drug trial simulation

[Leonid Gibiansky]

This is a very basic code that will reduce bioavailability in half if 
some PD effect (the output of the model) drops below 100


$ABB COMRES=1   ; space to save simulated PD

$PK
  IF(NEWIND.LT.2)  COM(1)=0  ; for each subject, COM(1) starts from zero
  F1 = 1
  IF(COM(1).EQ.1) F1=0.5   ; if COM(1) = 1, this will set F1 to 1/2
$ERROR
  IPRED=Y  ; this is PD measure that need to be above 100
  IF(IPRED.LT.100) COM(1)=1 ; if PD drops below 100 at any time, halve 
future doses


Leonid


--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web:www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
tel:(301) 767 5566



On 6/23/2015 2:30 PM, Michael Fossler wrote:

Does anyone have an example of using Fn (bioavailability of compartment n) to 
do adaptive dosing simulations? I am not having much luck getting it to work.


Mike
Michael J. Fossler, Pharm. D., Ph. D., F.C.P.
VP, Quantitative Sciences
Trevena, Inc
mfoss...@trevenainc.com
Office: 610-354-8840, ext. 249
Cell: 610-329-6636


-Original Message-
From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On 
Behalf Of Mats Karlsson
Sent: Tuesday, June 23, 2015 12:06 PM
To: Leonid Gibiansky; Faelens, Ruben (Belgium); nmusers@globomaxnm.com
Subject: RE: [NMusers] Simulo: a new service for drug trial simulation

Hi,

In many cases you don't even need to use $ABB COMRES to do response-adaptive 
designs, simulated response could just impact a bioavailability term (Fx) of 
the next dose(s) to indicate dose change. I'm sure that more complex 
response-adaptive designs could benefit from a dedicated software though.

Best regards,
Mats


Mats Karlsson, PhD
Professor of Pharmacometrics

Dept of Pharmaceutical Biosciences
Faculty of Pharmacy
Uppsala University
Box 591
75124 Uppsala

Phone: +46 18 4714105
Fax + 46 18 4714003
www.farmbio.uu.se/research/researchgroups/pharmacometrics/

-Original Message-
From: owner-nmus...@globomaxnm.com [mailto:owner-nmus...@globomaxnm.com] On 
Behalf Of Leonid Gibiansky
Sent: Tuesday, June 23, 2015 4:14 PM
To: Faelens, Ruben (Belgium); nmusers@globomaxnm.com
Subject: Re: [NMusers] Simulo: a new service for drug trial simulation

Actually, nonmem can be used to simulate the response-based dose adaptation 
without iteratively rerunning your model, with single simulation (using $ABB 
COMRES functionality to pass simulated response to the dose-adjustment 
algorithm code), although it is indeed cumbersome

Leonid

--
Leonid Gibiansky, Ph.D.
President, QuantPharm LLC
web:www.quantpharm.com
e-mail: LGibiansky at quantpharm.com
tel:(301) 767 5566



On 6/23/2015 4:48 AM, Faelens, Ruben (Belgium) wrote:

Dear NONMEM users,

We all know how difficult it is to simulate full drug trials using
NONMEM. It is often necessary to generate the full dosing scheme(s)
beforehand, and response-based dose adaptation requires iteratively
rerunning your model until you have the results you are happy with.

At SGS Exprimo, we have been working for 4 years to develop a new
software that makes drug trial simulation much more straight-forward.
The software has been developed in collaboration with Roche and has
been used internally within SGS Exprimo for the last 2 years. We are
now presenting it to the public as a new consultancy service. You may
have seen us in Crete at PAGE 2015.

We invite you to visit our website www.simulo.eu
 or contact us directly to request an on-site
demo or web conference, or to ask any questions you may have.

We look forward to hearing from you.

Kind regards,

Ruben Faelens for SGS Exprimo

*Ruben Faelens, MSc*
*Life Science Services - Exprimo*
IT Scientist

Phone:



+32 494 06 72 59



















E-mail:



_ruben.fael...@sgs.com _



















Web:



www.exprimo.com 



















Information in this email and any attachments is confidential and
intended solely for the use of the individual(s) to whom it is
addressed or otherwise directed. Please note that any views or
opinions presented in this email are solely those of the author and do
not necessarily represent those of the Company. Finally, the recipient
should check this email and any attachments for the presence of
viruses. The Company accepts no liability for any damage caused by any
virus transmitted by this email. All SGS services are rendered in
accordance with the applicable SGS conditions of service available on
request and accessible at
http://www.sgs.com/en/Terms-and-Conditions.aspx




Notice: This e-mail message, together with any attachments, contains 
information of Trevena, Inc., 1018 West 8th Avenue, King of Prussia, PA 19406, 
USA. This information may be confidential, proprietary, copyrighted and/or 
legally privileged.
It is intended solely for use by the individual or entity named on this 
message. If you are no

[NMusers] Senior Pharmacometrician (Director/Associate Director) opportunity at Vertex, Boston

[Ulf Bredberg]

Senior Pharmacometrician- Associate Director/Director at Vertex, Boston

Modeling & Simulation methodologies plays an increasingly important role in the 
development of new drugs within Vertex Pharmaceuticals and our goal is to fully 
implement Model based principles to support drug development program in terms 
of translational modeling, clinical trial design, dose selection and to improve 
critical decision making.
We are now seeking an experienced Pharmacometrician to our Modeling & 
Simulations (M&S) group to help us achieve this vision.
The successful candidate will be responsible for developing and executing M&S 
strategies in cross functional drug development project teams in close 
collaboration with colleagues in Clinical Pharmacology, Biostatistics, Research 
and other colleagues within the clinical and preclinical organization. The 
successful candidate will play a key role in building the Pharmacometrics and 
Modeling capability within Vertex by strongly contributing to the continuous 
improvement of our technical skill, computational infrastructure and the 
strategic use of M&S methodologies across our projects and disease areas.

Key responsibilities


* As M&S lead in one or more cross functional drug development teams, 
develop and execute Modeling & Simulation plans fully integrated with the 
overall clinical plans

* By using state of the art Modeling&Simulation methodologies strongly 
contribute to decision making at critical milestones based on quantitative 
principles in close collaboration with Biostats, Clin Pharm and other 
quantitative disciplines

* Perform population  PK, PKPD-analyses, Clinical trial simulations and 
other model based analyses on a regular basis

* Initiate and coordinate outsourced Modeling&Simulation activities 
when appropriate

* Provide technical and tactical support to other Modeling colleagues

* Strengthen our internal Modeling&Simulation  capability  on a 
continuous basis by initiating training activities,  evaluating and 
incorporating new M&S  tools as appropriate

Required Qualifications

* PhD  in PKPD, Clinical pharmacology, or other quantitative discipline 
with an emphasis Pharmacometric methodologies

* 10 yrs hands-on experience in the application of Pharmacometrics 
within the context of drug development.

* Expert hands-on skills from population-based PKPD modeling, Clinical 
trial simulation and optimal design, probability of success calculations, 
Disease progression modeling, Meta analyses etc.

* A solid understanding of fundamental pharmacokinetic and quantitative 
pharmacology (PKPD) principles.

* Excellent programming skills (NonMem, R, Phoenix, SAS and other 
similar tools)

* Demonstrated strong leadership- and influencing skills

* Excellent  collaborative, verbal and written communication skills

* Experience from Regulatory interactions and guidelines relevant for 
M&S


Desirable qualifications


* Experience from Pharmacometric approaches in Pulmonary diseases, 
Oncology and Neurological disorders.



* Experience from the application of System pharmacology methodologies  
in a drug development context


If you are interested in the above position, please send your resume to:  
Stephen Krenitsky, Director Talent Acquisition, Vertex Pharmaceuticals, Boston, 
MA, USA.  Email:  stephen_krenit...@vrtx.com 
  Vertex is an Equal Opportunity Employer.



Ulf Bredberg, Ph.D.
Sr Director, Head of Modeling&Simulations
Vertex Pharmaceuticals
50 Northern Avenue
Boston, MA 02210
Office: 1-617-961-0622
Mobile: 1-857-523-1077
Email: ulf_bredb...@vrtx.com

This email message and any attachments are confidential and intended for use by 
the addressee(s) only. If you are not the intended recipient, please notify me 
immediately by replying to this message, and destroy all copies of this message 
and any attachments. Thank you.