BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:GMT Standard Time BEGIN:STANDARD DTSTART:20251002T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=10 TZNAME:GMT Standard Time TZOFFSETFROM:+0100 TZOFFSETTO:+0000 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T010000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=1;BYMINUTE=0;BYMONTH=3 TZNAME:GMT Daylight Time TZOFFSETFROM:+0000 TZOFFSETTO:+0100 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION: Time Session\n  \;  \;Speaker  \;A bstract Slides \;  \;8:50  \;Registration &\; Coffee  \;  \;  \;  \;  \;9:10  \;Welcome &\; Introducti on \;  \;  \;  \;  \;9:15  \;What&rsquo\;s new in simulation Benoit Beck (Axiosis) \;\n  \; TBC\n  \;  \;10:00  \;Best practice in modelling and sim ulation: initiatives from PSI and EFPIA  \;Michael O&rsquo\;Kelly (Qu intiles)  \;At \;an EMA-IFPIA workshop on modelling and simulatio n in 2011\, regulators called for a Best Practice document for projects in volving modelling and simulation. Finally\, in the last few months\, two d ifferent working groups have come up with two tools aimed at helping stati sticians and their colleagues to promote and use best practice. The Europe an Federation of Pharmaceutical Industries &\; Associations (EFPIA) wor king group on Model Informed Drug Discovery and Development (MID3) has jus t published a wide-ranging 90-page paper on the whys and hows of Best Prac tice. The paper includes as a supplement a table of 103 examples of the us e of modelling and simulation in pharmaceutical science. At the same time\ , the Board of PSI in December adopted a Best Practice document proposed b y the PSI Modelling and Simulation Special Interest Group (SIG). The two i nitiatives are consistent in their recommendations\, with the SIG providin g a template that could be used to put the recommendations for best practi ce into action. This presentation will identify the elements necessary for best practice in simulation of clinical trials\, and survey current pract ice in this area.  \;10:45  \;Tea &\; Coffee \; &nbs p\;  \;  \;  \;11:15  \;Writing Clinical Trial \;Sim ulators: there&rsquo\;s more to it than the stats analysis.  \;Tom Pa rke (Berry Consultants) When writing ones first trial simulator it&rsquo\ ;s inevitable that one&rsquo\;s focus (as a \;stats programmer) is on the novel aspect of the trial design that has required writing a simulator in the first place. However there are other aspects of trial simulation t hat will end up as being every bit as important. By understanding these ot her aspects in advance you&rsquo\;ll be able to better plan to accommodate them and do a better job of writing and using a trial simulator.  \ ;  \;12:00  \;Assessment of various continual reassessment meth od models for dose-escalation phase 1 oncology clinical trials: Clinical t rial data and simulation studies  \;Gareth James (Phastar)  \;\n Background: The continual reassessment method (CRM) is conside red more efficient and ethical than standard methods for dose-escalation t rials in oncology\, but requires an underlying estimate of the dose-toxici ty relationship (&ldquo\;prior skeleton&rdquo\;) and there is limited guid ance of what this should be when little is known about this association. A im: \; To compare the CRM with different prior skeleton approaches and the 3+3 method in their ability to determine the true maximum tolerated d ose (MTD) of various &ldquo\;true&rdquo\; dose-toxicity relationships. &n bsp\;  \;12:45  \;Lunch  \;  \;  \;  \;13:45 Simulating Dose Finding Designs using Bayesian Decisions\, with examples f or Severe Asthma\, Ulcerative Colitis and Alzheimer&rsquo\;s Disease. &n bsp\;Alun Bedding (AZ)  \;Choosing the correct dose for Phase III is a pivotal part of drug development. \; Model based approaches are the most appropriate way of doing this and Bayesian decisions are more informa tive. Simulation is needed in order to understand the operating characteri stics of designs given different assumptions. \; Examples\, including those for severe asthma\, ulcerative colitis and Alzheimer&rsquo\;s diseas e will be used for illustration.  \;  \;14:30  \;Use of si mulations to aid decision making  \;Jane Temple (GSK)  \; \ ;In clinical trial design we often use simulations to illustrate operation al characteristics where analytical solutions are intractable. \; In t his talk we will look at some case studies where these simulations have ai ded decision making and so increased understanding within the project team . \; We will look at an example of complex go/no go criteria and how t hese criteria were refined based on the results of the simulation. \; We will look at an example of how simulations were used to explore the imp act of partial data on the operational characteristics of a futility analy sis.  \;  \;15:15  \;Tea &\; Coffee  \;  \ ;  \;15:45  \;Simulating a sequences of clinical trials - a whol e drug development program\, in order to optimize the design\, planning an d resource allocation  \;Tom Parke (Berry Consultants)  \;It&rsq uo\;s hard to judge how big a phase 2 should be\, what the trade off in po wer and type error should be\, and what the significance of other post pha se 2 errors (such dose selection\, population selection\, estimate of effe ct size) might be\, without considering the whole picture of time to regis tration\, overall probability of technical success and overall value / cli nical usefulness should the treatment be successfully registered.  \;  \;14:30  \;Close  \;  \;  \; Registration Costs  \;  \;Registration on or before 4th April  \; &nb sp\;PSI Member £\;120 (plus VAT) \;  \;Non-Member £\ ;160 (plus VAT)  \;Academic £\;60  \; (plus VAT)  \; Registration after 4th April  \;  \;PSI Member £\;160 (pl us VAT)  \;Non-Member £\;220 (plus VAT) \;  \;Academ ic £\;90  \; (plus VAT)  \;Fee includes lunch &\; refre shments  \; \nPlease contact the PSI Secretariat if you require par king on the day of the event. Please contact us if you have any dietary re quirements. \nFor information regarding the scientific content\, contact : Nick Manamley\nTel: +44 (0)1223 436196 Nick.manamley@amgen.com David L awrence \;\nTel: +44 (0)788 473 5459 David.Lawrence@astrazeneca.com C arly Barnett \;\nTel: +44 208 990 3781 Carly.m.barnett@gsk.com  \; DTEND:20160427T160000Z DTSTAMP:20260913T050125Z DTSTART:20160427T075000Z LOCATION: SEQUENCE:0 SUMMARY:Use of Simulation in Clinical Trial Design UID:RFCALITEM639248724854171888 X-ALT-DESC;FMTTYPE=text/html:

Time < td class="PSI-default-tableTableFirstCol"> \;9:15 < td class="PSI-default-tableTableOddCol"> \;Writing Clinical Tr ial \;Si mulators: there&rsquo\;s more to it than the stats analysis.
 \;  \;Alun Bedding (AZ)
Session
\n  \;		 &n bsp\;Speaker
  \;Abstract Slides \;
 \;8:50 &nbs p\;Registration &\; Coffee \;
  \;  \; &nbs p\;
 \;9:10  \;Welcome &\; Introduction \;
  \;  \;  \;
 \;What&rsquo\;s new in simulation
 Beno it Beck (Axiosis) \;
\n  \;		 TBC
\n  \;
  \;10:00  \;Best practice in modelling and simulation: initiatives from PSI and EFPIA
  \;M ichael O&rsquo\;Kelly (Quintiles)
  \;At \;an EMA-IFPIA workshop on modelling and simulation in 2011\, regulators called for a Best Practice document fo r projects involving modelling and simulation. Finally\, in the last few m onths\, two different working groups have come up with two tools aimed at helping statisticians and their colleagues to promote and use best practic e. The European Federation of Pharmaceutical Industries &\; Association s (EFPIA) working group on Model Informed Drug Discovery and Development ( MID3) has just published a wide-ranging 90-page paper on the whys and hows of Best Practice. The paper includes as a supplement a table of 103 examp les of the use of modelling and simulation in pharmaceutical science. At t he same time\, the Board of PSI in December adopted a Best Practice docume nt proposed by the PSI Modelling and Simulation Special Interest Group (SI G). The two initiatives are consistent in their recommendations\, with the SIG providing a template that could be used to put the recommendations fo r best practice into action. This presentation will identify the elements necessary for best practice in simulation of clinical trials\, and survey current practice in this area.
 \;10:45  \;Tea &\; Coffee \;
  \;  \;  \;
 \;11:15  \;Tom Parke (Berry Consultants)
 When writing ones first trial simulator it&rsquo\;s inevitable t hat one&rsquo\;s focus (as a \;stats programmer) is on the novel aspec t of the trial design that has required writing a simulator in the first p lace. However there are other aspects of trial simulation that will end up as being every bit as important. By understanding these other aspects in advance you&rsquo\;ll be able to better plan to accommodate them and do a better job of writing and using a trial simulator.

  \;
 \;12:00  \;Assessment of various continual reassessment method models for dose-escal ation phase 1 oncology clinical trials: Clinical trial data and simulation studies
 &n bsp\;Gareth James (Phastar)
  \;\n

Background: The continual reassessment method (CRM) is considered more efficient a nd ethical than standard methods for dose-escalation trials in oncology\, but requires an underlying estimate of the dose-toxicity relationship (&ld quo\;prior skeleton&rdquo\;) and there is limited guidance of what this sh ould be when little is known about this association.

Aim: \; To compare the CRM with different prior skeleton approaches an d the 3+3 method in their ability to determine the true maximum tolerated dose (MTD) of various &ldquo\;true&rdquo\; dose-toxicity relationships.
  \;
 \;12:45  \ ;Lunch
  \;  \;
&nb sp\;13:45 Simulating Dose Finding Designs u sing Bayesian Decisions\, with examples for Severe Asthma\, Ulcerative Col itis and Alzheimer&rsquo\;s Disease.

  \;Choos ing the correct dose for Phase III is a pivotal part of drug development.& nbsp\; Model based approaches are the most appropriate way of doing this a nd Bayesian decisions are more informative. Simulation is needed in order to understand the operating characteristics of designs given different ass umptions. \; Examples\, including those for severe asthma\, ulcerative colitis and Alzheimer&rsquo\;s disease will be used for illustration.
  \;
 \;14:30 & nbsp\;Use of simulations to aid decision making

  \;Jane Te mple (GSK)
  \; \;In clinical trial design we often use simulations to illustr ate operational characteristics where analytical solutions are intractable . \; In this talk we will look at some case studies where these simula tions have aided decision making and so increased understanding within the project team. \; We will look at an example of complex go/no go crite ria and how these criteria were refined based on the results of the simula tion. \; We will look at an example of how simulations were used to ex plore the impact of partial data on the operational characteristics of a f utility analysis.
 &n bsp\;
 \;15:15  \;Tea &\; Coffee

  \;
 \;
 \;15:45  \;Simulating a sequences of clinical trials - a whole drug development program\, in order to optimize the design\, planning and resource allocation
  \;Tom Parke (Berry Consul tants)
 &nbs p\;It&rsquo\;s hard to judge how big a phase 2 should be\, what the trade off in power and type error should be\, and what the significance of other post phase 2 errors (such dose selection\, population selection\, estimat e of effect size) might be\, without considering the whole picture of time to registration\, overall probability of technical success and overall va lue / clinical usefulness should the treatment be successfully registered.
 \;
 \;14:30  \;Close
  \;   \;  \;

Registration Costs  \;
 \;Regist ration on or before 4th April
  \;
 \;PSI Me mber
 £\;120 (pl us VAT) \;
 \;Non-Member
 £\;160 (plus VAT)
 \;Academic
 £\;60  \; (plus VAT)
 \;Regi stration after 4th April
  \;
 \;PSI Member< br /> £\;160 (plus VA T)
 \;Non-Member
 £\;220 (plus VAT) \;
 \;Academic
 &p ound\;90  \; (plus VAT)
 \;Fee includes lunch &\; refre shments  \ ;

\nPlease contact the PSI Secretariat if you require parking on the day of the event. Please contact us if you h ave any dietary requirements.


\nFor information reg arding the scientific content\, contact:

Nick Manamle y
\nTel: +44 (0)1223 436196
Nick.manamley@amgen.com

David Lawr ence \;
\nTel: +44 (0)788 473 5459
David.Lawrence@astrazeneca.com

Carly Barnett \;
\nTel: +44 208 990 3781< br /> Carly.m.barnett@gsk.com

 \;
END:VEVENT END:VCALENDAR