VENUE Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City Al7 1TW
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 areas; will stimulate interesting discussion and an opportunity to knowledge share.
| 8.45 -9.10 | Registration and Coffee |
| 9.10 – 9.15 | Welcome and Introduction |
| 9.15 – 10.00 | Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities |
|
| Janusz Kaminski (Roche) |
| 10.00 – 10.45 | Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial |
|
| Abigail Fuller & Nick Cowans (Veramed) |
| 10.45 – 11.00 | Coffee |
| 11.00 – 11.45 | CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting! |
|
| Paul Terrill (CROSNT) |
| 11.45 – 12.30 | Reflections 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 – 1.30 | Lunch |
| 1.30- 2.15 | Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC |
|
| Rachael Lawrance (AZ) |
| 2.15 – 3.00 | Respiratory Device Development and the PBE method |
|
| Misbah Ahmed (GSK) |
| 3.00 – 3.20 | Coffee |
| 3.20 – 4.05 | Clinical Development Challenges in Idiopathic Pulmonary Fibrosis |
|
| Andy Kenwright (Roche) |
| 4.05 – 4.50 | Statistical Analysis in the UBIOPRED Consortium |
|
| Aruna Bansal (U-BIOPRED) |
| 4.50 – 5.00 | Discussion and Close |
Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities
Abstract: A brief 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 challenges in overcoming 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 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)
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Associate Group Clinical Director, Product 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 medicine and pharmaceutical industry.
Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial
Abstract: Large, global late phase studies often involve huge amounts of data of varying quality. Data frequently needs cleaning up prior to locking the database, a responsibility typically lying with data management. The ability to look at multiple extracts of data while the study is ongoing and blinded has enabled us to develop novel methods for increasing the confidence in data quality.
In COPD trials, outcomes such as rate of decline of FEV1 can be heavily influenced by outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly, when rates of respiratory tract exacerbations are an endpoint, recording duplicate or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will present a variety of Patient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. 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 developed his skills in R and SAS programming as well as his knowledge in the respiratory therapeutic area. Nick has 9 years’ experience as a research assistant within a group focused on developments in prenatal screening. During this time he developed strong statistical skills to build upon his biochemistry and pharmacology background. He was able to acquire experience and expertise in statistical analysis, report writing 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 Biochemistry (Imperial College London).
Abigail Fuller (Veramed)
Since November 2012, Abby has 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 methods, 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 study an MSc in Statistics with Applications in Medicine (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Programmer (SAS Institute)
CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting!
Abstract: CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting. In December 2013, the Therapeutic Area Data Standards User Guide (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 managers, statisticians, programmers) understand the data and can apply standards appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAUG also strives to define research concepts unambiguously, so that consistent terminology can be used in asthma studies to enable aggregation and comparison of data 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 data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area.
Paul Terrill
Paul Terrill is a Consultant Statistician working for CROS NT, an international Contract Research Organization specialized in clinical data services. Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. In addition to providing advice on study design, analysis and interpretation he is involved in a team responsible for developing and governing standards that apply to clinical trial datasets.
Paul holds a BSc in Applied Mathematics and Statistics from the University of Wales, Aberystwyth and a PhD in Statistics from the University of Kent, Canterbury
Reflections 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)
Abstract: This talk will focus on the methodological issues associated with the bacterial infections guideline. In particular 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 randomised 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 Statistical Assessor and Deputy Manager of the Statistics and Pharmacokinetics 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 assessment reports on methodological aspects of licensing applications 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. Before joining the MHRA David was a Lecturer in Medical Statistics at University College London.
Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC
Abstract: Non-Small Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of clinical 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 the clinical programme for AZD9291 to meet the specific area of unmet medical in this field, focusing on phase II studies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting
Rachael Lawrance (AZ)
I am currently a Principal Statistician at AstraZeneca leading sta AZD9291 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 phase II programme in rheumatoid arthritis). Prior to working in clinical development I worked as a statistical geneticist on various projects, including Symbicort (COPD)
Respiratory Device Development and the PBE method
Abstract: The development of a respiratory device is a challenging and dynamic process. In-vitro assessments are typically performed within the Pharmaceutical arena to evaluate the impact of device changes during development. Regulatory bodies recommend a number of statistical tests to assess such changes, including the population bioequivalence (PBE) method. The purpose of this talk is to give a brief overview of the development of a respiratory device, and to share some of the recent statistical debates ongoing about the PBE method.
Misbah Ahmed (GSK)
Misbah Ahmed is a statistician at GlaxoSmithKline, currently based in Stevenage. She joined GSK in 2009 after completing her MSc in Statistics at UCL. She has spent the majority of her career at GSK supporting the CMC (Chemistry, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area, including inhaled products recently launched by GSK. She now supports early phase clinical trials, currently working on proof of concept studies in COPD, focusing 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. Development 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 futility interims on "halfway" endpoints, from positive risk taking via borrowing data to old school conservatism, an IPF statistician's life is...interesting. By discussing the disease related considerations and design challenges, we aim to give a picture of the evolving treatment paradigm for IPF
Andy Kenwright (Roche)
Andy has been a statistician in the industry for 22 years, starting in pre-clinical and 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 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 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 research 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 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 study 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 samples, with the aim of stratifying the disease and obtaining predictive biomarkers. Aruna will discuss some of the key statistical issues encountered in this endeavour, and describe how they were addressed.
Aruna has an MSc in statistics 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 biostatistician, and her many roles include that of Chief Statistician for the UBIOPRED Consortium.
VENUE Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City Al7 1TW
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 areas; will stimulate interesting discussion and an opportunity to knowledge share.
| 8.45 -9.10 | Registration and Coffee |
| 9.10 – 9.15 | Welcome and Introduction |
| 9.15 – 10.00 | Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities |
|
| Janusz Kaminski (Roche) |
| 10.00 – 10.45 | Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial |
|
| Abigail Fuller & Nick Cowans (Veramed) |
| 10.45 – 11.00 | Coffee |
| 11.00 – 11.45 | CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting! |
|
| Paul Terrill (CROSNT) |
| 11.45 – 12.30 | Reflections 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 – 1.30 | Lunch |
| 1.30- 2.15 | Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC |
|
| Rachael Lawrance (AZ) |
| 2.15 – 3.00 | Respiratory Device Development and the PBE method |
|
| Misbah Ahmed (GSK) |
| 3.00 – 3.20 | Coffee |
| 3.20 – 4.05 | Clinical Development Challenges in Idiopathic Pulmonary Fibrosis |
|
| Andy Kenwright (Roche) |
| 4.05 – 4.50 | Statistical Analysis in the UBIOPRED Consortium |
|
| Aruna Bansal (U-BIOPRED) |
| 4.50 – 5.00 | Discussion and Close |
Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities
Abstract: A brief 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 challenges in overcoming 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 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 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 medicine and pharmaceutical industry.
Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial
Abstract: Large, global late phase studies often involve huge amounts of data of varying quality. Data frequently needs cleaning up prior to locking the database, a responsibility typically lying with data management. The ability to look at multiple extracts of data while the study is ongoing and blinded has enabled us to develop novel methods for increasing the confidence in data quality.
In COPD trials, outcomes such as rate of decline of FEV1 can be heavily influenced by outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly, when rates of respiratory tract exacerbations are an endpoint, recording duplicate or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will present a variety of Patient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. 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 developed his skills in R and SAS programming as well as his knowledge in the respiratory therapeutic area. Nick has 9 years’ experience as a research assistant within a group focused on developments in prenatal screening. During this time he developed strong statistical skills to build upon his biochemistry and pharmacology background. He was able to acquire experience and expertise in statistical analysis, report writing 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 Biochemistry (Imperial College London).
Abigail Fuller (Veramed)
Since November 2012, Abby has 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 methods, 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 study an MSc in Statistics with Applications in Medicine (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Programmer (SAS Institute)
CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting!
Abstract: CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting. In December 2013, the Therapeutic Area Data Standards User Guide (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 managers, statisticians, programmers) understand the data and can apply standards appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAUG also strives to define research concepts unambiguously, so that consistent terminology can be used in asthma studies to enable aggregation and comparison of data 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 data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area.
Paul Terrill
Paul Terrill is a Consultant Statistician working for CROS NT, an international Contract Research Organization specialized in clinical data services. Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. In addition to providing advice on study design, analysis and interpretation he is involved in a team responsible for developing and governing standards that apply to clinical trial datasets.
Paul holds a BSc in Applied Mathematics and Statistics from the University of Wales, Aberystwyth and a PhD in Statistics from the University of Kent, Canterbury
Reflections 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)
Abstract: This talk will focus on the methodological issues associated with the bacterial infections guideline. In particular 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 randomised 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 Statistical Assessor and Deputy Manager of the Statistics and Pharmacokinetics 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 assessment reports on methodological aspects of licensing applications 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. Before joining the MHRA David was a Lecturer in Medical Statistics at University College London.
Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC
Abstract: Non-Small Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of clinical 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 the clinical programme for AZD9291 to meet the specific area of unmet medical in this field, focusing on phase II studies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting
Rachael Lawrance (AZ)
I am currently a Principal Statistician at AstraZeneca leading sta AZD9291 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 phase II programme in rheumatoid arthritis). Prior to working in clinical development I worked as a statistical geneticist on various projects, including Symbicort (COPD)
Respiratory Device Development and the PBE method
Abstract: The development of a respiratory device is a challenging and dynamic process. In-vitro assessments are typically performed within the Pharmaceutical arena to evaluate the impact of device changes during development. Regulatory bodies recommend a number of statistical tests to assess such changes, including the population bioequivalence (PBE) method. The purpose of this talk is to give a brief overview of the development of a respiratory device, and to share some of the recent statistical debates ongoing about the PBE method.
Misbah Ahmed (GSK)
Misbah Ahmed is a statistician at GlaxoSmithKline, currently based in Stevenage. She joined GSK in 2009 after completing her MSc in Statistics at UCL. She has spent the majority of her career at GSK supporting the CMC (Chemistry, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area, including inhaled products recently launched by GSK. She now supports early phase clinical trials, currently working on proof of concept studies in COPD, focusing 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. Development 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 futility interims on "halfway" endpoints, from positive risk taking via borrowing data to old school conservatism, an IPF statistician's life is...interesting. By discussing the disease related considerations and design challenges, we aim to give a picture of the evolving treatment paradigm for IPF
Andy Kenwright (Roche)
Andy has been a statistician in the industry for 22 years, starting in pre-clinical and 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 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 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 research 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 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 study 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 samples, with the aim of stratifying the disease and obtaining predictive biomarkers. Aruna will discuss some of the key statistical issues encountered in this endeavour, and describe how they were addressed.
Aruna has an MSc in statistics 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 biostatistician, and her many roles include that of Chief Statistician for the UBIOPRED Consortium.
VENUE Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City Al7 1TW
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 areas; will stimulate interesting discussion and an opportunity to knowledge share.
| 8.45 -9.10 | Registration and Coffee |
| 9.10 – 9.15 | Welcome and Introduction |
| 9.15 – 10.00 | Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities |
|
| Janusz Kaminski (Roche) |
| 10.00 – 10.45 | Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial |
|
| Abigail Fuller & Nick Cowans (Veramed) |
| 10.45 – 11.00 | Coffee |
| 11.00 – 11.45 | CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting! |
|
| Paul Terrill (CROSNT) |
| 11.45 – 12.30 | Reflections 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 – 1.30 | Lunch |
| 1.30- 2.15 | Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC |
|
| Rachael Lawrance (AZ) |
| 2.15 – 3.00 | Respiratory Device Development and the PBE method |
|
| Misbah Ahmed (GSK) |
| 3.00 – 3.20 | Coffee |
| 3.20 – 4.05 | Clinical Development Challenges in Idiopathic Pulmonary Fibrosis |
|
| Andy Kenwright (Roche) |
| 4.05 – 4.50 | Statistical Analysis in the UBIOPRED Consortium |
|
| Aruna Bansal (U-BIOPRED) |
| 4.50 – 5.00 | Discussion and Close |
Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities
Abstract: A brief 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 challenges in overcoming 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 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 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 medicine and pharmaceutical industry.
Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial
Abstract: Large, global late phase studies often involve huge amounts of data of varying quality. Data frequently needs cleaning up prior to locking the database, a responsibility typically lying with data management. The ability to look at multiple extracts of data while the study is ongoing and blinded has enabled us to develop novel methods for increasing the confidence in data quality.
In COPD trials, outcomes such as rate of decline of FEV1 can be heavily influenced by outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly, when rates of respiratory tract exacerbations are an endpoint, recording duplicate or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will present a variety of Patient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. 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 developed his skills in R and SAS programming as well as his knowledge in the respiratory therapeutic area. Nick has 9 years’ experience as a research assistant within a group focused on developments in prenatal screening. During this time he developed strong statistical skills to build upon his biochemistry and pharmacology background. He was able to acquire experience and expertise in statistical analysis, report writing 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 Biochemistry (Imperial College London).
Abigail Fuller (Veramed)
Since November 2012, Abby has 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 methods, 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 study an MSc in Statistics with Applications in Medicine (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Programmer (SAS Institute)
CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting!
Abstract: CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting. In December 2013, the Therapeutic Area Data Standards User Guide (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 managers, statisticians, programmers) understand the data and can apply standards appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAUG also strives to define research concepts unambiguously, so that consistent terminology can be used in asthma studies to enable aggregation and comparison of data 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 data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area.
Paul Terrill
Paul Terrill is a Consultant Statistician working for CROS NT, an international Contract Research Organization specialized in clinical data services. Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. In addition to providing advice on study design, analysis and interpretation he is involved in a team responsible for developing and governing standards that apply to clinical trial datasets.
Paul holds a BSc in Applied Mathematics and Statistics from the University of Wales, Aberystwyth and a PhD in Statistics from the University of Kent, Canterbury
Reflections 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)
Abstract: This talk will focus on the methodological issues associated with the bacterial infections guideline. In particular 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 randomised 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 Statistical Assessor and Deputy Manager of the Statistics and Pharmacokinetics 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 assessment reports on methodological aspects of licensing applications 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. Before joining the MHRA David was a Lecturer in Medical Statistics at University College London.
Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC
Abstract: Non-Small Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of clinical 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 the clinical programme for AZD9291 to meet the specific area of unmet medical in this field, focusing on phase II studies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting
Rachael Lawrance (AZ)
I am currently a Principal Statistician at AstraZeneca leading sta AZD9291 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 phase II programme in rheumatoid arthritis). Prior to working in clinical development I worked as a statistical geneticist on various projects, including Symbicort (COPD)
Respiratory Device Development and the PBE method
Abstract: The development of a respiratory device is a challenging and dynamic process. In-vitro assessments are typically performed within the Pharmaceutical arena to evaluate the impact of device changes during development. Regulatory bodies recommend a number of statistical tests to assess such changes, including the population bioequivalence (PBE) method. The purpose of this talk is to give a brief overview of the development of a respiratory device, and to share some of the recent statistical debates ongoing about the PBE method.
Misbah Ahmed (GSK)
Misbah Ahmed is a statistician at GlaxoSmithKline, currently based in Stevenage. She joined GSK in 2009 after completing her MSc in Statistics at UCL. She has spent the majority of her career at GSK supporting the CMC (Chemistry, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area, including inhaled products recently launched by GSK. She now supports early phase clinical trials, currently working on proof of concept studies in COPD, focusing 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. Development 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 futility interims on "halfway" endpoints, from positive risk taking via borrowing data to old school conservatism, an IPF statistician's life is...interesting. By discussing the disease related considerations and design challenges, we aim to give a picture of the evolving treatment paradigm for IPF
Andy Kenwright (Roche)
Andy has been a statistician in the industry for 22 years, starting in pre-clinical and 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 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 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 research 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 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 study 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 samples, with the aim of stratifying the disease and obtaining predictive biomarkers. Aruna will discuss some of the key statistical issues encountered in this endeavour, and describe how they were addressed.
Aruna has an MSc in statistics 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 biostatistician, and her many roles include that of Chief Statistician for the UBIOPRED Consortium.
VENUE Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City Al7 1TW
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 areas; will stimulate interesting discussion and an opportunity to knowledge share.
| 8.45 -9.10 | Registration and Coffee |
| 9.10 – 9.15 | Welcome and Introduction |
| 9.15 – 10.00 | Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities |
|
| Janusz Kaminski (Roche) |
| 10.00 – 10.45 | Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial |
|
| Abigail Fuller & Nick Cowans (Veramed) |
| 10.45 – 11.00 | Coffee |
| 11.00 – 11.45 | CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting! |
|
| Paul Terrill (CROSNT) |
| 11.45 – 12.30 | Reflections 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 – 1.30 | Lunch |
| 1.30- 2.15 | Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC |
|
| Rachael Lawrance (AZ) |
| 2.15 – 3.00 | Respiratory Device Development and the PBE method |
|
| Misbah Ahmed (GSK) |
| 3.00 – 3.20 | Coffee |
| 3.20 – 4.05 | Clinical Development Challenges in Idiopathic Pulmonary Fibrosis |
|
| Andy Kenwright (Roche) |
| 4.05 – 4.50 | Statistical Analysis in the UBIOPRED Consortium |
|
| Aruna Bansal (U-BIOPRED) |
| 4.50 – 5.00 | Discussion and Close |
Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities
Abstract: A brief 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 challenges in overcoming 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 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 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 medicine and pharmaceutical industry.
Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial
Abstract: Large, global late phase studies often involve huge amounts of data of varying quality. Data frequently needs cleaning up prior to locking the database, a responsibility typically lying with data management. The ability to look at multiple extracts of data while the study is ongoing and blinded has enabled us to develop novel methods for increasing the confidence in data quality.
In COPD trials, outcomes such as rate of decline of FEV1 can be heavily influenced by outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly, when rates of respiratory tract exacerbations are an endpoint, recording duplicate or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will present a variety of Patient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. 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 developed his skills in R and SAS programming as well as his knowledge in the respiratory therapeutic area. Nick has 9 years’ experience as a research assistant within a group focused on developments in prenatal screening. During this time he developed strong statistical skills to build upon his biochemistry and pharmacology background. He was able to acquire experience and expertise in statistical analysis, report writing 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 Biochemistry (Imperial College London).
Abigail Fuller (Veramed)
Since November 2012, Abby has 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 methods, 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 study an MSc in Statistics with Applications in Medicine (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Programmer (SAS Institute)
CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting!
Abstract: CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting. In December 2013, the Therapeutic Area Data Standards User Guide (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 managers, statisticians, programmers) understand the data and can apply standards appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAUG also strives to define research concepts unambiguously, so that consistent terminology can be used in asthma studies to enable aggregation and comparison of data 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 data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area.
Paul Terrill
Paul Terrill is a Consultant Statistician working for CROS NT, an international Contract Research Organization specialized in clinical data services. Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. In addition to providing advice on study design, analysis and interpretation he is involved in a team responsible for developing and governing standards that apply to clinical trial datasets.
Paul holds a BSc in Applied Mathematics and Statistics from the University of Wales, Aberystwyth and a PhD in Statistics from the University of Kent, Canterbury
Reflections 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)
Abstract: This talk will focus on the methodological issues associated with the bacterial infections guideline. In particular 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 randomised 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 Statistical Assessor and Deputy Manager of the Statistics and Pharmacokinetics 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 assessment reports on methodological aspects of licensing applications 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. Before joining the MHRA David was a Lecturer in Medical Statistics at University College London.
Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC
Abstract: Non-Small Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of clinical 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 the clinical programme for AZD9291 to meet the specific area of unmet medical in this field, focusing on phase II studies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting
Rachael Lawrance (AZ)
I am currently a Principal Statistician at AstraZeneca leading sta AZD9291 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 phase II programme in rheumatoid arthritis). Prior to working in clinical development I worked as a statistical geneticist on various projects, including Symbicort (COPD)
Respiratory Device Development and the PBE method
Abstract: The development of a respiratory device is a challenging and dynamic process. In-vitro assessments are typically performed within the Pharmaceutical arena to evaluate the impact of device changes during development. Regulatory bodies recommend a number of statistical tests to assess such changes, including the population bioequivalence (PBE) method. The purpose of this talk is to give a brief overview of the development of a respiratory device, and to share some of the recent statistical debates ongoing about the PBE method.
Misbah Ahmed (GSK)
Misbah Ahmed is a statistician at GlaxoSmithKline, currently based in Stevenage. She joined GSK in 2009 after completing her MSc in Statistics at UCL. She has spent the majority of her career at GSK supporting the CMC (Chemistry, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area, including inhaled products recently launched by GSK. She now supports early phase clinical trials, currently working on proof of concept studies in COPD, focusing 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. Development 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 futility interims on "halfway" endpoints, from positive risk taking via borrowing data to old school conservatism, an IPF statistician's life is...interesting. By discussing the disease related considerations and design challenges, we aim to give a picture of the evolving treatment paradigm for IPF
Andy Kenwright (Roche)
Andy has been a statistician in the industry for 22 years, starting in pre-clinical and 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 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 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 research 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 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 study 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 samples, with the aim of stratifying the disease and obtaining predictive biomarkers. Aruna will discuss some of the key statistical issues encountered in this endeavour, and describe how they were addressed.
Aruna has an MSc in statistics 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 biostatistician, and her many roles include that of Chief Statistician for the UBIOPRED Consortium.
VENUE Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City Al7 1TW
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 areas; will stimulate interesting discussion and an opportunity to knowledge share.
| 8.45 -9.10 | Registration and Coffee |
| 9.10 – 9.15 | Welcome and Introduction |
| 9.15 – 10.00 | Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities |
|
| Janusz Kaminski (Roche) |
| 10.00 – 10.45 | Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial |
|
| Abigail Fuller & Nick Cowans (Veramed) |
| 10.45 – 11.00 | Coffee |
| 11.00 – 11.45 | CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting! |
|
| Paul Terrill (CROSNT) |
| 11.45 – 12.30 | Reflections 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 – 1.30 | Lunch |
| 1.30- 2.15 | Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC |
|
| Rachael Lawrance (AZ) |
| 2.15 – 3.00 | Respiratory Device Development and the PBE method |
|
| Misbah Ahmed (GSK) |
| 3.00 – 3.20 | Coffee |
| 3.20 – 4.05 | Clinical Development Challenges in Idiopathic Pulmonary Fibrosis |
|
| Andy Kenwright (Roche) |
| 4.05 – 4.50 | Statistical Analysis in the UBIOPRED Consortium |
|
| Aruna Bansal (U-BIOPRED) |
| 4.50 – 5.00 | Discussion and Close |
Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities
Abstract: A brief 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 challenges in overcoming 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 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 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 medicine and pharmaceutical industry.
Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial
Abstract: Large, global late phase studies often involve huge amounts of data of varying quality. Data frequently needs cleaning up prior to locking the database, a responsibility typically lying with data management. The ability to look at multiple extracts of data while the study is ongoing and blinded has enabled us to develop novel methods for increasing the confidence in data quality.
In COPD trials, outcomes such as rate of decline of FEV1 can be heavily influenced by outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly, when rates of respiratory tract exacerbations are an endpoint, recording duplicate or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will present a variety of Patient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. 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 developed his skills in R and SAS programming as well as his knowledge in the respiratory therapeutic area. Nick has 9 years’ experience as a research assistant within a group focused on developments in prenatal screening. During this time he developed strong statistical skills to build upon his biochemistry and pharmacology background. He was able to acquire experience and expertise in statistical analysis, report writing 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 Biochemistry (Imperial College London).
Abigail Fuller (Veramed)
Since November 2012, Abby has 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 methods, 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 study an MSc in Statistics with Applications in Medicine (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Programmer (SAS Institute)
CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting!
Abstract: CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting. In December 2013, the Therapeutic Area Data Standards User Guide (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 managers, statisticians, programmers) understand the data and can apply standards appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAUG also strives to define research concepts unambiguously, so that consistent terminology can be used in asthma studies to enable aggregation and comparison of data 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 data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area.
Paul Terrill
Paul Terrill is a Consultant Statistician working for CROS NT, an international Contract Research Organization specialized in clinical data services. Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. In addition to providing advice on study design, analysis and interpretation he is involved in a team responsible for developing and governing standards that apply to clinical trial datasets.
Paul holds a BSc in Applied Mathematics and Statistics from the University of Wales, Aberystwyth and a PhD in Statistics from the University of Kent, Canterbury
Reflections 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)
Abstract: This talk will focus on the methodological issues associated with the bacterial infections guideline. In particular 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 randomised 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 Statistical Assessor and Deputy Manager of the Statistics and Pharmacokinetics 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 assessment reports on methodological aspects of licensing applications 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. Before joining the MHRA David was a Lecturer in Medical Statistics at University College London.
Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC
Abstract: Non-Small Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of clinical 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 the clinical programme for AZD9291 to meet the specific area of unmet medical in this field, focusing on phase II studies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting
Rachael Lawrance (AZ)
I am currently a Principal Statistician at AstraZeneca leading sta AZD9291 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 phase II programme in rheumatoid arthritis). Prior to working in clinical development I worked as a statistical geneticist on various projects, including Symbicort (COPD)
Respiratory Device Development and the PBE method
Abstract: The development of a respiratory device is a challenging and dynamic process. In-vitro assessments are typically performed within the Pharmaceutical arena to evaluate the impact of device changes during development. Regulatory bodies recommend a number of statistical tests to assess such changes, including the population bioequivalence (PBE) method. The purpose of this talk is to give a brief overview of the development of a respiratory device, and to share some of the recent statistical debates ongoing about the PBE method.
Misbah Ahmed (GSK)
Misbah Ahmed is a statistician at GlaxoSmithKline, currently based in Stevenage. She joined GSK in 2009 after completing her MSc in Statistics at UCL. She has spent the majority of her career at GSK supporting the CMC (Chemistry, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area, including inhaled products recently launched by GSK. She now supports early phase clinical trials, currently working on proof of concept studies in COPD, focusing 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. Development 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 futility interims on "halfway" endpoints, from positive risk taking via borrowing data to old school conservatism, an IPF statistician's life is...interesting. By discussing the disease related considerations and design challenges, we aim to give a picture of the evolving treatment paradigm for IPF
Andy Kenwright (Roche)
Andy has been a statistician in the industry for 22 years, starting in pre-clinical and 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 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 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 research 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 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 study 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 samples, with the aim of stratifying the disease and obtaining predictive biomarkers. Aruna will discuss some of the key statistical issues encountered in this endeavour, and describe how they were addressed.
Aruna has an MSc in statistics 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 biostatistician, and her many roles include that of Chief Statistician for the UBIOPRED Consortium.
VENUE Roche Products Limited 6 Falcon Way Shire Park Welwyn Garden City Al7 1TW
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 areas; will stimulate interesting discussion and an opportunity to knowledge share.
| 8.45 -9.10 | Registration and Coffee |
| 9.10 – 9.15 | Welcome and Introduction |
| 9.15 – 10.00 | Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities |
|
| Janusz Kaminski (Roche) |
| 10.00 – 10.45 | Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial |
|
| Abigail Fuller & Nick Cowans (Veramed) |
| 10.45 – 11.00 | Coffee |
| 11.00 – 11.45 | CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting! |
|
| Paul Terrill (CROSNT) |
| 11.45 – 12.30 | Reflections 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 – 1.30 | Lunch |
| 1.30- 2.15 | Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC |
|
| Rachael Lawrance (AZ) |
| 2.15 – 3.00 | Respiratory Device Development and the PBE method |
|
| Misbah Ahmed (GSK) |
| 3.00 – 3.20 | Coffee |
| 3.20 – 4.05 | Clinical Development Challenges in Idiopathic Pulmonary Fibrosis |
|
| Andy Kenwright (Roche) |
| 4.05 – 4.50 | Statistical Analysis in the UBIOPRED Consortium |
|
| Aruna Bansal (U-BIOPRED) |
| 4.50 – 5.00 | Discussion and Close |
Respiratory diseases, where we are and where we want to be in clinical science and medicines development: unmet needs, challenges and opportunities
Abstract: A brief 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 challenges in overcoming 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 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 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 medicine and pharmaceutical industry.
Statistical input into improving data quality: the impact on respiratory endpoints in a COPD trial
Abstract: Large, global late phase studies often involve huge amounts of data of varying quality. Data frequently needs cleaning up prior to locking the database, a responsibility typically lying with data management. The ability to look at multiple extracts of data while the study is ongoing and blinded has enabled us to develop novel methods for increasing the confidence in data quality.
In COPD trials, outcomes such as rate of decline of FEV1 can be heavily influenced by outliers. Looking at these in a visual way emphasises the importance of ensuring that these outliers are genuine data points. Similarly, when rates of respiratory tract exacerbations are an endpoint, recording duplicate or overlapping events will alter results. Prior to this work clinicians would spend time looking through vast amounts of data. This talk will present a variety of Patient Profile review tools that has made clinical review a quick and easy process stressing the importance of these data on our endpoints. 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 developed his skills in R and SAS programming as well as his knowledge in the respiratory therapeutic area. Nick has 9 years’ experience as a research assistant within a group focused on developments in prenatal screening. During this time he developed strong statistical skills to build upon his biochemistry and pharmacology background. He was able to acquire experience and expertise in statistical analysis, report writing 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 Biochemistry (Imperial College London).
Abigail Fuller (Veramed)
Since November 2012, Abby has 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 methods, 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 study an MSc in Statistics with Applications in Medicine (University of Southampton) after completing her BSc in Mathematics and its Applications (Cardiff University). She is a SAS Certified Base Programmer (SAS Institute)
CDISC Asthma Therapeutic Area Data Standards User Guide - Yes, it is interesting!
Abstract: CDISC has developed industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol (study plan) through analysis and reporting. In December 2013, the Therapeutic Area Data Standards User Guide (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 managers, statisticians, programmers) understand the data and can apply standards appropriately. Descriptions include the clinical situations from which the data arise and the reasons these data are relevant for asthma. The TAUG also strives to define research concepts unambiguously, so that consistent terminology can be used in asthma studies to enable aggregation and comparison of data 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 data standards work produced by CDISC should be of interest and of use to study statisticians working within the asthma therapeutic area.
Paul Terrill
Paul Terrill is a Consultant Statistician working for CROS NT, an international Contract Research Organization specialized in clinical data services. Paul started his career working as a statistician in the agrochemical industry at Jealott’s Hill, Berkshire before becoming a statistical trainer for SAS. He moved into the pharmaceutical industry in 2005 and primarily provides support to biotech and small pharmaceutical companies who lack in-house statistical expertise. In addition to providing advice on study design, analysis and interpretation he is involved in a team responsible for developing and governing standards that apply to clinical trial datasets.
Paul holds a BSc in Applied Mathematics and Statistics from the University of Wales, Aberystwyth and a PhD in Statistics from the University of Kent, Canterbury
Reflections 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)
Abstract: This talk will focus on the methodological issues associated with the bacterial infections guideline. In particular 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 randomised 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 Statistical Assessor and Deputy Manager of the Statistics and Pharmacokinetics 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 assessment reports on methodological aspects of licensing applications 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. Before joining the MHRA David was a Lecturer in Medical Statistics at University College London.
Clinical trial design and analyses considerations for the clinical development of a molecularly target agent (AZD9291) for patients with advanced NSCLC
Abstract: Non-Small Cell Lung Cancer is estimated to be the most common cause of death from cancer worldwide. Molecularly targeted agents are an important area of clinical 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 the clinical programme for AZD9291 to meet the specific area of unmet medical in this field, focusing on phase II studies with registration intent and including the analyses considerations for the evaluation of clinical benefit in this setting
Rachael Lawrance (AZ)
I am currently a Principal Statistician at AstraZeneca leading sta AZD9291 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 phase II programme in rheumatoid arthritis). Prior to working in clinical development I worked as a statistical geneticist on various projects, including Symbicort (COPD)
Respiratory Device Development and the PBE method
Abstract: The development of a respiratory device is a challenging and dynamic process. In-vitro assessments are typically performed within the Pharmaceutical arena to evaluate the impact of device changes during development. Regulatory bodies recommend a number of statistical tests to assess such changes, including the population bioequivalence (PBE) method. The purpose of this talk is to give a brief overview of the development of a respiratory device, and to share some of the recent statistical debates ongoing about the PBE method.
Misbah Ahmed (GSK)
Misbah Ahmed is a statistician at GlaxoSmithKline, currently based in Stevenage. She joined GSK in 2009 after completing her MSc in Statistics at UCL. She has spent the majority of her career at GSK supporting the CMC (Chemistry, Manufacturing and Control) aspects of regulatory dossiers within the Respiratory therapeutic area, including inhaled products recently launched by GSK. She now supports early phase clinical trials, currently working on proof of concept studies in COPD, focusing 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. Development 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 futility interims on "halfway" endpoints, from positive risk taking via borrowing data to old school conservatism, an IPF statistician's life is...interesting. By discussing the disease related considerations and design challenges, we aim to give a picture of the evolving treatment paradigm for IPF
Andy Kenwright (Roche)
Andy has been a statistician in the industry for 22 years, starting in pre-clinical and 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 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 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 research 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 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 study 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 samples, with the aim of stratifying the disease and obtaining predictive biomarkers. Aruna will discuss some of the key statistical issues encountered in this endeavour, and describe how they were addressed.
Aruna has an MSc in statistics 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 biostatistician, and her many roles include that of Chief Statistician for the UBIOPRED Consortium.
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
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