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:presented by Frank Bretz &\; Bjö\;rn Bornkamp\nStatisti cal Methodology and Consulting\, Novartis Pharma \nincluding regulatory pe rspectives from Rob Hemmings \;\nStatistics and Pharmacokinetics Unit Manager\, MHRA\, UK \; This course will introduce and discuss method s for Phase II dose finding studies\, including a review of basic multiple comparisons and modelling methods\, as traditionally used in these studie s. A unified strategy for designing and analysing dose finding trials deno ted MCP-Mod\, combining multiple comparisons and modelling\, will be the f ocus of the course. Click here to see the full event flyer CLICK HERE TO REGISTER! \nDay 1 The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MC P) and modelling approaches (Mod) will then be covered\, including a revie w of contrast tests as well as nonlinear regression methods for dose respo nse and target dose estimation. Then a step-by-step description of MCP-Mod will be provided\, including a detailed discussion of its five main steps across the design and analysis stages: Identification of candidate param etric models\, which are likely to represent the underlying dose response shape. Derivation of optimum contrast coefficients\, such that the margina l power to detect a specific dose response shape associated with the respe ctive candidate model is maximized. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previo usly derived optimal contrast coefficients. Model selection or model avera ging\, provided statistical significance has been shown in the previous st ep. Use the selected model(s) to produce inferences on adequate doses\, em ploying a model-based approach. MCP-Mod will first be introduced in its o riginally published version for a single\, normally distributed efficacy e ndpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized no n-linear models\, linear and non-linear mixed effects models\, and Cox pro portional hazards models. \; Day 2 On day two\, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its desig n aspects\, in particular sample size derivations. As MCP-Mod is a hybrid procedure\, focusing on hypothesis testing and estimation\, sample size ca lculation procedures for both objectives will be presented and their appli cation on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail\, including a description of functions for the des ign and analysis of dose finding trials using MCP\, Mod or MCP-Mod. Hands- on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement th e MCP-Mod methodology. The course ends with a review of regulatory conside rations. \;  \;Speaker About the Speaker \; Frank Bretz\n  \; Frank Bretz joined Novartis in 2004\, where he is cur rently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug dev elopment\, including dose-finding\, multiple comparisons\, and adaptive de signs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Res earch. He has authored or co-authored more than 120 articles in peer-revie wed journals and four books. Bjö\;rn Bornkamp Bjö\;rn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Met hodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the inte rface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology i n Germany. Rob Hemmings Rob Hemmings has been with the Medicines and Hea lthcare products Regulatory Agency for 16 years and heads the group of med ical statisticians and pharmacokineticists. \; Much of Rob&rsquo\;s ti me is spent educating medical colleagues in the importance and artistry of clinical trial statistics\; their use in proof and in obfuscation. \; Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP&rsquo\;s Scientifi c Advice Working Party. \; These positions\, and involvement at the Bi ostatistics Working Party of CHMP and the EMA&rsquo\;s extrapolation and m odelling and simulation groups\, have presented the opportunity for pursue a particular interest in understanding &lsquo\;dose&rsquo\; and he has be en actively involved in recent EMA initiatives in this area.  \; Agenda  \;9.30 - 10.00 Registration  \;10.00 - 17.00  \;D ay 1  \;9.00 - 16.30  \;Day 2  \; Registration   \;PSI Members £\;495 + VAT \;  \;Non - Members  \;&poun d\;570 + VAT (includes PSI membership for 1 year) Registration costs in cludes lunch and refreshments PSI are holding a limited number of hotel ro oms until the 31st January which will be allocated on a first come first s erved basis. Rob Hemmings Rob Hemmings CLICK HERE TO REGIS TER! Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI @mci-group.com for further information. DTEND:20170302T163000Z DTSTAMP:20260812T023718Z DTSTART:20170301T093000Z LOCATION: SEQUENCE:0 SUMMARY:Dose Finding in Drug Development using MCP-Mod UID:RFCALITEM639220990389947705 X-ALT-DESC;FMTTYPE=text/html:

presented by

Frank Bretz &\; Bjö\;rn Bornkamp
\nStatistical Methodology and Consulting\, Novartis Pharma

\ nincluding regulatory perspectives from
Rob Hemmings \;< /strong>
\nStatistics and Pharmacokinetics Unit Manager\, MHRA\, UK&n bsp\;

This course will int roduce and discuss methods for Phase II dose finding studies\, including a review of basic multiple comparisons and modelling methods\, as tradition ally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod\, combining multiple comparisons and modelling\, will be the focus of the course.
Cl ick here to see the full event flyer

CLICK HERE TO REGISTER!


\nDay 1

The first day will pro vide an overview of dose finding in drug development. The application of m ultiple comparison procedures (MCP) and modelling approaches (Mod) will th en be covered\, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a st ep-by-step description of MCP-Mod will be provided\, including a detailed discussion of its five main steps across the design and analysis stages:

  1. Identification of candidate parametric models\, which are like ly to represent the underlying dose response shape.
  2. Derivation of optimum contrast coefficients\, such that the marginal power to detect a specific dose response shape associated with the respective candidate mode l is maximized.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derive d optimal contrast coefficients.
  4. Model selection or model averagi ng\, provided statistical significance has been shown in the previous step .
  5. Use the selected model(s) to produce inferences on adequate dos es\, employing a model-based approach.

MCP-Mod will first be introduced in its originally published version for a single\, normally di stributed efficacy endpoint. The extension of this framework will be descr ibed for count data and time-to-event endpoints as well as situations invo lving generalized non-linear models\, linear and non-linear mixed effects models\, and Cox proportional hazards models. \;

Day 2

On day t wo\, considerations will be given to practical aspects around the design a nd analysis of dose finding trials using MCP-Mod. This includes importantl y a discussion of its design aspects\, in particular sample size derivatio ns. As MCP-Mod is a hybrid procedure\, focusing on hypothesis testing and estimation\, sample size calculation procedures for both objectives will b e presented and their application on the design illustrated with a real do se finding study. A variety of further practical considerations will be di scussed that summarizes the collective experience over the past 10 years i n using MCP-Mod in Phase II dose finding trials. The application of the Do seFinding R package will be demonstrated in detail\, including a descripti on of functions for the design and analysis of dose finding trials using M CP\, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use it s functions to implement the MCP-Mod methodology. The course ends with a r eview of regulatory considerations. \;

 \;Speaker About the Speaker \;
Frank Bretz
\n  \;

Frank Bretz joined Novartis in 2004\, w here he is currently Global Head of the Statistical Methodology and Consul ting group. He has supported the methodological development in various are as of drug development\, including dose-finding\, multiple comparisons\, a nd adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biophar maceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Bjö\;rn Bornkamp
 Bjö\ ;rn Bornkamp works as a Senior Expert Statistical Methodologist in the Sta tistical Methodology group at Novartis Pharmaceuticals. He has research an d practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings Rob Hemmings has been with the Medicines a nd Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. \; Much of Rob&rsquo \;s time is spent educating medical colleagues in the importance and artis try of clinical trial statistics\; their use in proof and in obfuscation.& nbsp\; Rob is a member of the European Medicines Agency Committee for Medi cinal Products for Human Use (CHMP) and the chair of the CHMP&rsquo\;s Sci entific Advice Working Party. \; These positions\, and involvement at the Biostatistics Working Party of CHMP and the EMA&rsquo\;s extrapolation and modelling and simulation groups\, have presented the opportunity for pursue a particular interest in understanding &lsquo\;dose&rsquo\; and he has been actively involved in recent EMA initiatives in this area.< /td>

 \;

Age nda  \;9.30 - 10.00 Registration  \;10.00 - 17.0 0  \;Day 1 < tr class="PSI-default-tableTableOddRow">  \;9.00 - 16.30  \;Day 2

 \;

£\;495 + VAT \;
Registration
 \;PSI Members
 \;Non - Members  \;£\;570 + VAT (includes PSI membership for 1 year)

Registration co sts includes lunch and refreshments
PSI are holding a l imited number of hotel rooms until the 31st January which will be allocate d on a first come first served basis.

Rob Hemmings
Rob Hemmings
CLICK HER E TO REGISTER!

Please contact the PSI Secretariat on + 44 (0) 1730 715 235 or at PSI@mci-g roup.com for further information. END:VEVENT END:VCALENDAR