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:PSI One Day Meeting: The Innovative\, Challenging and Diversifi ed World of Respiratory Disease During this one day meeting\, PSI aims to cover a wide range of respiratory diseases and design considerations when working in this therapeutic area. We hope that sharing between different a reas\; will stimulate interesting discussion and an opportunity to knowled ge share. 8.45 -9.10 Registration and Coffee 9.10 &ndash\; 9.15 Welcome and Introduction 9.15 &ndash\; 10.00 Respiratory diseases\ , where we are and where we want to be in clinical science and medicines d evelopment: unmet needs\, challenges and opportunities  \; Ja nusz Kaminski (Roche) 10.00 &ndash\; 10.45 Statistical input into im proving data quality: the impact on respiratory endpoints in a COPD trial  \; Abigail Fuller &\; Nick Cowans (Veramed) 10.45 &nd ash\; 11.00 Coffee 11.00 &ndash\; 11.45 CDISC Asthma Therapeutic A rea Data Standards User Guide - Yes\, it is interesting!  \; Paul Terrill (CROSNT) 11.45 &ndash\; 12.30 Reflections on the method ological issues associated with the CHMP guideline on the evaluation of me dicinal products for treatment of bacterial infections (CPMP/EWP/558/95 re v 2)  \; Dr David Wright (MHRA) 12.30 &ndash\; 1.30 Lun ch 1.30- 2.15 Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patie nts with advanced NSCLC  \; Rachael Lawrance (AZ) 2.15 &n dash\; 3.00 Respiratory Device Development and the PBE method  \ ; Misbah Ahmed (GSK) 3.00 &ndash\; 3.20 Coffee 3.20 &ndash\; 4 .05 Clinical Development Challenges in Idiopathic Pulmonary Fibrosis  \; Andy Kenwright (Roche) 4.05 &ndash\; 4.50 Statistical Analysis in the UBIOPRED Consortium  \; Aruna Bansal (U-BIOPRED) 4.50 &ndash\; 5.00 Discussion and Close Respiratory diseases\, where we are and where we want to be in clinical science and medicines dev elopment: unmet needs\, challenges and opportunities Abstract: \;A bri ef overview of respiratory diseases\, with a more detailed characteristics of selected indications (focusing on asthma\, COPD and IPF) will be given at the start of the presentation. An overview of unmet needs and challeng es in overcoming them\, both from the clinical and the medicines developme nt points of view\, will follow. Some of the challenges are disease specif ic while some of them are relevant across indications\, if not beyond the area of respiratory\, which will be reflected in the talk. An overview of "where we are and where we want to be" for the discussed indications\, and respiratory medicine\, will follow. \; \; \; Janusz Kaminski (Roche) Associate Group Clinical Director\, Product Development Immunolog y\, Infectious Diseases and Ophthalmology (PD I2O)\, Welwyn Garden City. J anusz is a physician with approximately 20 years of professional experienc e spanning careers in academia\, clinical medicine and pharmaceutical indu stry. Statistical input into improving data quality: the impact on respir atory endpoints in a COPD trial Abstract: \;Large\, global late phase studies often involve huge amounts of data of varying quality. Data freque ntly needs cleaning up prior to locking the database\, a responsibility ty pically lying with data management. The ability to look at multiple extrac ts of data while the study is ongoing and blinded has enabled us to develo p novel methods for increasing the confidence in data quality. In COPD tri als\, outcomes such as rate of decline of FEV1 can be heavily influenced b y outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly\, when rat es of respiratory tract exacerbations are an endpoint\, recording duplicat e or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will pres ent a variety of Patient Profile review tools that has made clinical revie w a quick and easy process stressing the importance of these data on our e ndpoints. We attempt to assess the value of statistical input on the data management processes. Nick Cowans (Veramed) Nick has been working as a Statistician at Veramed since September 2013\, where he has been primarily involved in a large Phase IIIb clinical trial. During this time he has de veloped his skills in R and SAS programming as well as his knowledge in th e respiratory therapeutic area. Nick has 9 years&rsquo\; experience as a r esearch assistant within a group focused on developments in prenatal scree ning. \; During this time he developed strong statistical skills to bu ild upon his biochemistry and pharmacology background. \; He was able to acquire experience and expertise in statistical analysis\, report writi ng and communication of data through published papers and presentations at conferences and meetings. Nick holds an MSc in Statistics (University of Sheffield)\, an MSc in Pharmacology (Kings College London) and a BSc in Bi ochemistry (Imperial College London). Abigail Fuller (Veramed) Since Nov ember 2012\, Abby has been working as a Statistician at Veramed\, where sh e has been primarily involved in a large\, global Phase IIIb clinical stud y. During this time she has developed her skills in SAS programming\, appl ying statistical methods\, RAP writing and study management\, as well as h er knowledge in the respiratory therapeutic area. She gained an interest i n the industry after completing a placement year working at Amgen in Oncol ogy and went on to study an MSc in Statistics with Applications in Medicin e (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Program mer (SAS Institute) CDISC Asthma Therapeutic Area Data Standards User Gui de - Yes\, it is interesting! Abstract: \;CDISC has developed industry -wide data standards enabling the harmonization of clinical data and strea mlining research processes from protocol (study plan) through analysis and reporting. In December 2013\, the Therapeutic Area Data Standards User Gu ide (TAUG) for Asthma was released in order to improve standardization of Asthma studies. \;The TAUG \;describes the most common data needed for asthma studies\, so that those handling the data (e.g.\, data manager s\, statisticians\, programmers) understand the data and can apply standar ds appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAU G also strives to define research concepts unambiguously\, so that consist ent terminology can be used in asthma studies to enable aggregation and co mparison of data across studies and drug programs. This presentation provi des an overview of the information that exists within the standard along w ith a couple of specific examples\, with the objective being to show that the data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area. Paul T errill Paul Terrill is a Consultant Statistician working for CROS NT\,&nb sp\;an international Contract Research Organization specialized in clinica l data services. Paul started his career \;working as a statistician i n the agrochemical industry at Jealott&rsquo\;s Hill\, Berkshire before be coming a statistical trainer for SAS. He moved into the pharmaceutical ind ustry in 2005 and primarily provides support to biotech and small pharmace utical companies who lack in-house statistical expertise. In addition to p roviding advice on study design\,  \;analysis and interpretation he is involved in a team responsible for developing and governing standards tha t apply to clinical trial datasets. \; Paul holds a BSc in Applied Mat hematics and Statistics from the University of Wales\, Aberystwyth and a P hD in Statistics from the University of Kent\, Canterbury Reflections on the methodological issues associated with the CHMP guideline on the evalua tion of medicinal products for treatment of bacterial infections (CPMP/EWP /558/95 rev 2) \nAbstract: \;This talk will focus on the methodologic al issues associated with the bacterial infections guideline. In particula r the design of non-inferiority studies including defining an appropriate non-inferiority margin. Also alternative study designs that might be used when it is not feasible to conduct at least one adequately powered randomi sed controlled clinical trial will be discussed Dr David Wright (MHRA) Dr David Wright \;has worked at the MHRA for 15 years and is an Expert St atistical Assessor and Deputy Manager of the Statistics and Pharmacokineti cs Unit. He coordinated MHRA scientific advice for over 5 years and is now the Chair of the review committee that approves advice letters. He is the chair of the CHMP \; Biostatistics Working Party . David writes asses sment reports on methodological aspects of licensing applications for CHM and CHMP\, advises companies on methodological aspects of their clinical d evelopment programme via national and CHMP scientific advice\, and is invo lved in writing methodological guidelines for CHMP. Before joining the MHR A David was a Lecturer in Medical Statistics at University College London. Clinical trial design and analyses considerations for the clinical devel opment of a molecularly target agent (AZD9291) for patients with advanced NSCLC Abstract: \;Non-Small Cell Lung Cancer is estimated to be the mo st common cause of death from cancer worldwide. Molecularly targeted agent s are an important area of clinical research for the development of therap ies appropriate to treat these patients. AZD9291 is a highly selected mole cularly targeted therapy which is currently in clinical development. The t alk will cover the design of the clinical programme for AZD9291 to meet th e specific area of unmet medical in this field\, focusing on phase II stud ies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting Rachael Lawrance (AZ) \nI am currently a Principal Statistician at AstraZeneca leading sta AZD9 291 which is in late-stage clinical development in advanced NSCLC. I have worked on the design and the analyses of studies with registration intent for a molecularly targeted indication (EGFR T790M resistance mutation). I have worked various oncology and respiratory projects in different stages of clinical development (including IRESSA for treatment of NSCLC\, and a p hase II programme in rheumatoid arthritis). Prior to working in clinical d evelopment I worked as a statistical geneticist on various projects\, incl uding Symbicort (COPD) Respiratory Device Development and the PBE method Abstract: \;The development of a respiratory device is a challenging a nd dynamic process. \; In-vitro assessments are typically performed wi thin the Pharmaceutical arena to evaluate the impact of device changes dur ing development. \; \; Regulatory bodies recommend a number of sta tistical tests to assess such changes\, including the population bioequiva lence (PBE) method. \; The purpose of this talk is to give a brief ove rview of the development of a respiratory device\, and to share some of th e recent statistical debates ongoing about the PBE method. Misbah Ahmed (G SK) Misbah Ahmed is a statistician at GlaxoSmithKline\, currently based in Stevenage. \; She joined GSK in 2009 after completing her MSc in St atistics at UCL. \; She has spent the majority of her career at GSK su pporting the CMC (Chemistry\, Manufacturing and Control) aspects of regula tory dossiers within the Respiratory therapeutic area\, including inhaled products recently launched by GSK. \; She now supports early phase cli nical trials\, currently working on proof of concept studies in COPD\, foc using on the statistical modelling of novel correlated endpoints measured through imaging techniques. Clinical Development Challenges in Idiopathic Pulmonary Fibrosis Abstract: \;Idiopathic Pulmonary Fibrosis (IPF) is a severe\, debilitating disease with a prognosis worse than most forms of cancer. Despite recently approved therapies an unmet need still exists. D evelopment of clinical study designs in the rapidly changing landscape of IPF has been dynamic in the extreme. \; Switching between monotherapy and combination treatments\, from very early readouts on PD markers to fut ility interims on "halfway" endpoints\, from positive risk taking via borr owing data to old school conservatism\, an IPF statistician's life is...in teresting. \; By discussing the disease related considerations and des ign challenges\, we aim to give a picture of the evolving treatment paradi gm for IPF Andy Kenwright (Roche) Andy has been a statistician in the ind ustry for 22 years\, starting in pre-clinical and moving through the CRO w orld to become head of stats at two small CROs in Norfolk &\; Newcastle where he dabbled in medical writing and PK analysis also. He joined Roche in 2008. Since then he has helped bring treatment to children with unmet need in severe forms of rheumatoid arthritis and become a specialist in pe diatric clinical development. He has taken the lead on clinical developmen t programs in osteo and rheumatoid arthritidies\, pulmonary fibrosis and i nfluenza at Roche and is too busy with work and children to have interesti ng hobbies anymore  \;  \; Statistical Analysis in the UBIOPRED C onsortium Abstract: \;U-BIOPRED (Ubiased BIOmarkers in PREDiction of r espiratory disease outcomes) is a research project using information and s amples from adults and children\, to learn about different types of asthma and to ensure better diagnosis and treatment for each person. \; A co nsortium of pharmaceutical companies\, biotechnology companies\, hospitals and universities\, drawn from Europe and North America\, joined forces in this Innovative Medicines Initiative. \; There were a total of 1025 s tudy participants\, representing the spectrum of health to severe asthma\, across all ages. \; Detailed health-assessment and questionnaire data were gathered\, together with blood\, sputum\, urine and lung-biopsy samp les\, with the aim of stratifying the disease and obtaining predictive bio markers. \; Aruna will discuss some of the key statistical issues enco untered in this endeavour\, and describe how they were addressed. Aruna Aruna has an MSc in statistics and a PhD in biostatistics. \; She star ted her career working as a lecturer in the USA\, before returning to the UK to work in biotech\, then the pharmaceutical industry. \; She now w orks as a consultant biostatistician\, and her many roles include that of Chief Statistician for the UBIOPRED Consortium. DTEND:20151113T103000Z DTSTAMP:20261013T163849Z DTSTART:20151113T093000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Respiratory One Day Meeting UID:RFCALITEM639275063299763878 X-ALT-DESC;FMTTYPE=text/html:

PSI One Day Meeting: The Innovative\, Chal lenging and Diversified World of Respiratory Disease

During this o ne day meeting\, PSI aims to cover a wide range of respiratory diseases an d design considerations when working in this therapeutic area. We hope tha t sharing between different areas\; will stimulate interesting discussion and an opportunity to knowledge share.

< /tr> < td class="PSI-default-tableTableLastCol">

Respiratory Device De velopment and the PBE method

< td style="width: 100px\;" class="PSI-default-tableTableFirstCol">

4.50 &ndash\; 5.00

8.45 -9.10

Registration and Coffee

9.10 &ndash\; 9.15

Welcome and Introduction

9.15 &ndash\; 10.00

Respiratory diseases\, where we are and w here we want to be in clinical science and medicines development: unmet ne eds\, challenges and opportunities

 \;

Janusz Kaminski (Roche)

10.00 &ndash\; 10.45

Statistical in put into improving data quality: the impact on respiratory endpoints in a COPD trial

 \;

Abigail Fuller &\; Nick Cowans (Veramed)

10.45 &ndash\; 11.00

Coffee

11.00 &ndash\; 11.45

CDISC Asthma Therapeutic Area Data St andards User Guide - Yes\, it is interesting!

 \;

Paul Terrill (CROSNT)

11.45 &ndash\; 1 2.30

Refle ctions on the methodological issues associated with the CHMP guideline on the evaluation of medicinal products for treatment of bacterial infections (CPMP/EWP/558/95 rev 2)

 \;

Dr David Wright (MHRA)

12.30 &ndash\; 1.30

Lunch

1.30- 2.15

Clinical trial design and analyses considerati ons for the clinical development of a molecularly target agent (AZD9291) f or patients with advanced NSCLC

 \;

Rachael Lawrance (AZ)

2.15 &ndash\; 3.00

 \;

Misbah Ahmed (GSK)

3.00 &ndash\; 3.20

Coffee

3.20 &ndash\; 4.05

Clinical Development Challenges in Idiopathic Pulmonary Fibr osis

 \;

Andy Kenwright (Roche)

4.05 &ndash\; 4.50

Statistical Analysis in the UBIOPRED Consortium

 \;

Aruna Bansal (U -BIOPRED)

Disc ussion and Close

Respiratory diseases\, where we are and where we want to be in clinical science and me dicines development: unmet needs\, challenges and opportunities

Abstract: \;A brief overview o f respiratory diseases\, with a more detailed characteristics of selected indications (focusing on asthma\, COPD and IPF) will be given at the start of the presentation. An overview of unmet needs and challenges in overcom ing them\, both from the clinical and the medicines development points of view\, will follow. Some of the challenges are disease specific while some of them are relevant across indications\, if not beyond the area of respi ratory\, which will be reflected in the talk. An overview of "where we are and where we want to be" for the discussed indications\, and respiratory medicine\, will follow. \; \; \;

Janusz Kaminsk i (Roche)

Associate Group Clinical Director\, Prod uct Development Immunology\, Infectious Diseases and Ophthalmology (PD I2O )\, Welwyn Garden City. Janusz is a physician with approximately 20 years of professional experience spanning careers in academia\, clinical medicin e and pharmaceutical industry.

Statistical input into improving data quality: the impact on respira tory endpoints in a COPD trial

Abstract: \;Large\, global late phase studies often involve hug e amounts of data of varying quality. Data frequently needs cleaning up pr ior to locking the database\, a responsibility typically lying with data m anagement. The ability to look at multiple extracts of data while the stud y is ongoing and blinded has enabled us to develop novel methods for incre asing the confidence in data quality.

In COPD trials\, outcomes suc h as rate of decline of FEV1 can be heavily influenced by outliers. Lookin g at these in a visual way emphasises the importance of ensuring that thes e outliers are genuine data points. Similarly\, when rates of respiratory tract exacerbations are an endpoint\, recording duplicate or overlapping e vents will alter results. Prior to this work clinicians would spend time l ooking through vast amounts of data. This talk will present a variety of P atient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. We attem pt to assess the value of statistical input on the data management process es.

Nick Cowans (Veramed)< em>

< /p>

Nick has been working as a Statistician at Veramed since September 2013\, where he has been primarily involved in a large Phase IIIb clinical trial. During this time he has developed his skills in R and SAS programm ing as well as his knowledge in the respiratory therapeutic area. Nick has 9 years&rsquo\; experience as a research assistant within a group focused on developments in prenatal screening. \; During this time he develop ed strong statistical skills to build upon his biochemistry and pharmacolo gy background. \; He was able to acquire experience and expertise in s tatistical analysis\, report writing and communication of data through pub lished papers and presentations at conferences and meetings. Nick holds an MSc in Statistics (University of Sheffield)\, an MSc in Pharmacology (Kin gs College London) and a BSc in Biochemistry (Imperial College London).

Abigail Fuller (Veramed)

Since November 2012\, Abby ha s been working as a Statistician at Veramed\, where she has been primarily involved in a large\, global Phase IIIb clinical study. During this time she has developed her skills in SAS programming\, applying statistical met hods\, RAP writing and study management\, as well as her knowledge in the respiratory therapeutic area. She gained an interest in the industry after completing a placement year working at Amgen in Oncology and went on to s tudy an MSc in Statistics with Applications in Medicine (University of Sou thampton) after completing her BSc in Mathematics and its Applications (Ca rdiff University). She is a SAS Certified Base Programmer (SAS Institute)< /p>

CDISC Asthma Therapeutic Area Data Standards User Guide - Yes\, it is interesting!

Abstract: \;CDISC has developed industry-wide data st andards enabling the harmonization of clinical data and streamlining resea rch processes from protocol (study plan) through analysis and reporting. I n December 2013\, the Therapeutic Area Data Standards User Guide (TAUG) fo r Asthma was released in order to improve standardization of Asthma studie s. \;The TAUG \;describes the most common data needed for asthma s tudies\, so that those handling the data (e.g.\, data managers\, statistic ians\, programmers) understand the data and can apply standards appropriat ely. Descriptions include the clinical situations from which the data aris e and the reasons these data are relevant for asthma. The TAUG also strive s to define research concepts unambiguously\, so that consistent terminolo gy can be used in asthma studies to enable aggregation and comparison of d ata across studies and drug programs.

This presentation provides an overview of the information that exists within the standard along with a couple of specific examples\, with the objective being to show that the da ta standards work produced by CDISC should be of interest and of use to st udy statisticians working within the asthma therapeutic area.

Paul Terrill

Paul Terrill is a Consultant Statisticia n working for CROS NT\, \;an international Contract Research Organizat ion specialized in clinical data services. Paul started his career \;w orking as a statistician in the agrochemical industry at Jealott&rsquo\;s Hill\, Berkshire before becoming a statistical trainer for SAS. He moved i nto the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical e xpertise. In addition to providing advice on study design\,  \;analysi s and interpretation he is involved in a team responsible for developing a nd governing standards that apply to clinical trial datasets. \;

< p>Paul holds a BSc in Applied Mathematics and Statistics from the Universi ty of Wales\, Aberystwyth and a PhD in Statistics from the University of K ent\, Canterbury

Reflecti ons on the methodological issues associated with the CHMP guideline on the evaluation of medicinal products for treatment of bacterial infections (C PMP/EWP/558/95 rev 2)


\nAbstract: \;This talk will focus on the methodological issues a ssociated with the bacterial infections guideline. In particular the desig n of non-inferiority studies including defining an appropriate non-inferio rity margin. Also alternative study designs that might be used when it is not feasible to conduct at least one adequately powered randomised control led clinical trial will be discussed

Dr David Wright (MHRA)

Dr David Wright \;has worked at the MHRA for 15 years and is an Expert Statistical Assessor and Deputy Manager of the Statistic s and Pharmacokinetics Unit. He coordinated MHRA scientific advice for ove r 5 years and is now the Chair of the review committee that approves advic e letters. He is the chair of the CHMP \; Biostatistics Working Party . David writes assessment reports on methodological aspects of licensing a pplications for CHM and CHMP\, advises companies on methodological aspects of their clinical development programme via national and CHMP scientific advice\, and is involved in writing methodological guidelines for CHMP. Be fore joining the MHRA David was a Lecturer in Medical Statistics at Univer sity College London.

Clin ical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC< /strong>

Abstract: \;Non-Smal l Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of cli nical research for the development of therapies appropriate to treat these patients. AZD9291 is a highly selected molecularly targeted therapy which is currently in clinical development. The talk will cover the design of t he clinical programme for AZD9291 to meet the specific area of unmet medic al in this field\, focusing on phase II studies with registration intent a nd including the analyses considerations for the evaluation of clinical be nefit in this setting

Rachael Lawrance (AZ)



\nI am currently a Principal Stat istician at AstraZeneca leading sta AZD9291 which is in late-stage clinica l development in advanced NSCLC. I have worked on the design and the analy ses of studies with registration intent for a molecularly targeted indicat ion (EGFR T790M resistance mutation). I have worked various oncology and r espiratory projects in different stages of clinical development (including IRESSA for treatment of NSCLC\, and a phase II programme in rheumatoid ar thritis). Prior to working in clinical development I worked as a statistic al geneticist on various projects\, including Symbicort (COPD)

Respiratory Device Development and t he PBE method

Abstract:& nbsp\;The development of a respiratory device is a challenging and dynamic process. \; In-vitro assessments are typically performed within the P harmaceutical arena to evaluate the impact of device changes during develo pment. \; \; Regulatory bodies recommend a number of statistical t ests to assess such changes\, including the population bioequivalence (PBE ) method. \; The purpose of this talk is to give a brief overview of t he development of a respiratory device\, and to share some of the recent s tatistical debates ongoing about the PBE method.

Misbah Ahm ed (GSK)

Misbah A hmed is a statistician at GlaxoSmithKline\, currently based in Stevenage.& nbsp\; She joined GSK in 2009 after completing her MSc in Statistics at UC L. \; She has spent the majority of her career at GSK supporting the C MC (Chemistry\, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area\, including inhaled products recen tly launched by GSK. \; She now supports early phase clinical trials\, currently working on proof of concept studies in COPD\, focusing on the s tatistical modelling of novel correlated endpoints measured through imagin g techniques.

Clinical De velopment Challenges in Idiopathic Pulmonary Fibrosis

Abstract: \;Idiopathic Pulmonary Fibrosi s (IPF) is a severe\, debilitating disease with a prognosis worse than mos t forms of cancer. Despite recently approved therapies an unmet need still exists. Development of clinical study designs in the rapidly changing lan dscape of IPF has been dynamic in the extreme. \; Switching between mo notherapy and combination treatments\, from very early readouts on PD mark ers to futility interims on "halfway" endpoints\, from positive risk takin g via borrowing data to old school conservatism\, an IPF statistician's li fe is...interesting. \; By discussing the disease related consideratio ns and design challenges\, we aim to give a picture of the evolving treatm ent paradigm for IPF

Andy Kenwright (Roche)

Andy has bee n a statistician in the industry for 22 years\, starting in pre-clinical a nd moving through the CRO world to become head of stats at two small CROs in Norfolk &\; Newcastle where he dabbled in medical writing and PK ana lysis also. He joined Roche in 2008. Since then he has helped bring treatm ent to children with unmet need in severe forms of rheumatoid arthritis an d become a specialist in pediatric clinical development. He has taken the lead on clinical development programs in osteo and rheumatoid arthritidies \, pulmonary fibrosis and influenza at Roche and is too busy with work and children to have interesting hobbies anymore

 \;

 \;

Statistical Analysis in the UBIOPRED Consortium

Abstract: \;U-BIOPRED (Ubiased BIOmarkers in PREDiction of respiratory disease outcomes) is a re search project using information and samples from adults and children\, to learn about different types of asthma and to ensure better diagnosis and treatment for each person. \;

A consortium of pharmaceutical co mpanies\, biotechnology companies\, hospitals and universities\, drawn fro m Europe and North America\, joined forces in this Innovative Medicines In itiative. \; There were a total of 1025 study participants\, represent ing the spectrum of health to severe asthma\, across all ages. \; Deta iled health-assessment and questionnaire data were gathered\, together wit h blood\, sputum\, urine and lung-biopsy samples\, with the aim of stratif ying the disease and obtaining predictive biomarkers. \; Aruna will di scuss some of the key statistical issues encountered in this endeavour\, a nd describe how they were addressed.

Aruna

Aruna has an MSc in statisti cs and a PhD in biostatistics. \; She started her career working as a lecturer in the USA\, before returning to the UK to work in biotech\, then the pharmaceutical industry. \; She now works as a consultant biostat istician\, and her many roles include that of Chief Statistician for the U BIOPRED Consortium.

END:VEVENT END:VCALENDAR