Date: Tuesday 8th October 2024 Time: 14:00-15:00 BST | 15:00-16:00 CEST | 09:00-10:00 ET Location: Online via Zoom Speakers: Phil Kay (JMP) and Chandramouli Ramnarayanan (JMP).
Who is this event intended for? Statisticians and data scientists working on pre-clinical experiments in the pharmaceutical industry. What is the benefit of attending? Learning about experimenting with maximum efficiency i.e. the least number of experiments.
Registration
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Overview
Advances in AI, lab automation and closed-loop optimisation promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.
Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.
We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.
Speaker details
Speaker
Biography
Phil Kay
Phil leads a global team with a mission to spread the use and impact of data analytics amongst scientists and engineers at some of the world’s largest chemical, pharmaceutical, semiconductor and consumer product companies. Earlier in his career he gained a passion for statistical design and analysis of experiments while working as a development chemist at FujiFilm. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is a chartered chemist and chair of the RSC process chemistry and technology interest group.
Chandramouli Ramnarayanan
Chandra (Chandramouli Ramnarayanan), PhD, is a member of the Global Technical Enablement team at JMP Statistical Discovery LLC, a SAS Institute subsidiary. He provides technical support to leading health and life sciences clients and contributes to product development. Previously, Chandra held senior roles in quality assurance within the pharmaceutical sector and served as a professor of pharmaceutical quality assurance. With a PhD in Pharmaceutical Sciences, over 30 publications, and certifications in SAS® Programming, PRINCE2 Agile®, and ITIL 4.
Scientific Meetings
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing
Date: Tuesday 8th October 2024 Time: 14:00-15:00 BST | 15:00-16:00 CEST | 09:00-10:00 ET Location: Online via Zoom Speakers: Phil Kay (JMP) and Chandramouli Ramnarayanan (JMP).
Who is this event intended for? Statisticians and data scientists working on pre-clinical experiments in the pharmaceutical industry. What is the benefit of attending? Learning about experimenting with maximum efficiency i.e. the least number of experiments.
Registration
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Overview
Advances in AI, lab automation and closed-loop optimisation promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.
Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.
We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.
Speaker details
Speaker
Biography
Phil Kay
Phil leads a global team with a mission to spread the use and impact of data analytics amongst scientists and engineers at some of the world’s largest chemical, pharmaceutical, semiconductor and consumer product companies. Earlier in his career he gained a passion for statistical design and analysis of experiments while working as a development chemist at FujiFilm. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is a chartered chemist and chair of the RSC process chemistry and technology interest group.
Chandramouli Ramnarayanan
Chandra (Chandramouli Ramnarayanan), PhD, is a member of the Global Technical Enablement team at JMP Statistical Discovery LLC, a SAS Institute subsidiary. He provides technical support to leading health and life sciences clients and contributes to product development. Previously, Chandra held senior roles in quality assurance within the pharmaceutical sector and served as a professor of pharmaceutical quality assurance. With a PhD in Pharmaceutical Sciences, over 30 publications, and certifications in SAS® Programming, PRINCE2 Agile®, and ITIL 4.
Training Courses
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing
Date: Tuesday 8th October 2024 Time: 14:00-15:00 BST | 15:00-16:00 CEST | 09:00-10:00 ET Location: Online via Zoom Speakers: Phil Kay (JMP) and Chandramouli Ramnarayanan (JMP).
Who is this event intended for? Statisticians and data scientists working on pre-clinical experiments in the pharmaceutical industry. What is the benefit of attending? Learning about experimenting with maximum efficiency i.e. the least number of experiments.
Registration
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Overview
Advances in AI, lab automation and closed-loop optimisation promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.
Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.
We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.
Speaker details
Speaker
Biography
Phil Kay
Phil leads a global team with a mission to spread the use and impact of data analytics amongst scientists and engineers at some of the world’s largest chemical, pharmaceutical, semiconductor and consumer product companies. Earlier in his career he gained a passion for statistical design and analysis of experiments while working as a development chemist at FujiFilm. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is a chartered chemist and chair of the RSC process chemistry and technology interest group.
Chandramouli Ramnarayanan
Chandra (Chandramouli Ramnarayanan), PhD, is a member of the Global Technical Enablement team at JMP Statistical Discovery LLC, a SAS Institute subsidiary. He provides technical support to leading health and life sciences clients and contributes to product development. Previously, Chandra held senior roles in quality assurance within the pharmaceutical sector and served as a professor of pharmaceutical quality assurance. With a PhD in Pharmaceutical Sciences, over 30 publications, and certifications in SAS® Programming, PRINCE2 Agile®, and ITIL 4.
Journal Club
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing
Date: Tuesday 8th October 2024 Time: 14:00-15:00 BST | 15:00-16:00 CEST | 09:00-10:00 ET Location: Online via Zoom Speakers: Phil Kay (JMP) and Chandramouli Ramnarayanan (JMP).
Who is this event intended for? Statisticians and data scientists working on pre-clinical experiments in the pharmaceutical industry. What is the benefit of attending? Learning about experimenting with maximum efficiency i.e. the least number of experiments.
Registration
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Overview
Advances in AI, lab automation and closed-loop optimisation promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.
Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.
We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.
Speaker details
Speaker
Biography
Phil Kay
Phil leads a global team with a mission to spread the use and impact of data analytics amongst scientists and engineers at some of the world’s largest chemical, pharmaceutical, semiconductor and consumer product companies. Earlier in his career he gained a passion for statistical design and analysis of experiments while working as a development chemist at FujiFilm. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is a chartered chemist and chair of the RSC process chemistry and technology interest group.
Chandramouli Ramnarayanan
Chandra (Chandramouli Ramnarayanan), PhD, is a member of the Global Technical Enablement team at JMP Statistical Discovery LLC, a SAS Institute subsidiary. He provides technical support to leading health and life sciences clients and contributes to product development. Previously, Chandra held senior roles in quality assurance within the pharmaceutical sector and served as a professor of pharmaceutical quality assurance. With a PhD in Pharmaceutical Sciences, over 30 publications, and certifications in SAS® Programming, PRINCE2 Agile®, and ITIL 4.
Webinars
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing
Date: Tuesday 8th October 2024 Time: 14:00-15:00 BST | 15:00-16:00 CEST | 09:00-10:00 ET Location: Online via Zoom Speakers: Phil Kay (JMP) and Chandramouli Ramnarayanan (JMP).
Who is this event intended for? Statisticians and data scientists working on pre-clinical experiments in the pharmaceutical industry. What is the benefit of attending? Learning about experimenting with maximum efficiency i.e. the least number of experiments.
Registration
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Overview
Advances in AI, lab automation and closed-loop optimisation promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.
Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.
We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.
Speaker details
Speaker
Biography
Phil Kay
Phil leads a global team with a mission to spread the use and impact of data analytics amongst scientists and engineers at some of the world’s largest chemical, pharmaceutical, semiconductor and consumer product companies. Earlier in his career he gained a passion for statistical design and analysis of experiments while working as a development chemist at FujiFilm. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is a chartered chemist and chair of the RSC process chemistry and technology interest group.
Chandramouli Ramnarayanan
Chandra (Chandramouli Ramnarayanan), PhD, is a member of the Global Technical Enablement team at JMP Statistical Discovery LLC, a SAS Institute subsidiary. He provides technical support to leading health and life sciences clients and contributes to product development. Previously, Chandra held senior roles in quality assurance within the pharmaceutical sector and served as a professor of pharmaceutical quality assurance. With a PhD in Pharmaceutical Sciences, over 30 publications, and certifications in SAS® Programming, PRINCE2 Agile®, and ITIL 4.
Careers Meetings
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Efficient R&D: SVEM and Advanced DOE in Preclinical Toxicity Testing
Date: Tuesday 8th October 2024 Time: 14:00-15:00 BST | 15:00-16:00 CEST | 09:00-10:00 ET Location: Online via Zoom Speakers: Phil Kay (JMP) and Chandramouli Ramnarayanan (JMP).
Who is this event intended for? Statisticians and data scientists working on pre-clinical experiments in the pharmaceutical industry. What is the benefit of attending? Learning about experimenting with maximum efficiency i.e. the least number of experiments.
Registration
This event is free to attend for both Members of PSI and Non-Members. To register your place, please click here.
Overview
Advances in AI, lab automation and closed-loop optimisation promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.
Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.
We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.
Speaker details
Speaker
Biography
Phil Kay
Phil leads a global team with a mission to spread the use and impact of data analytics amongst scientists and engineers at some of the world’s largest chemical, pharmaceutical, semiconductor and consumer product companies. Earlier in his career he gained a passion for statistical design and analysis of experiments while working as a development chemist at FujiFilm. Phil has a master’s degree in applied statistics and a master’s and PhD in chemistry. He is a chartered chemist and chair of the RSC process chemistry and technology interest group.
Chandramouli Ramnarayanan
Chandra (Chandramouli Ramnarayanan), PhD, is a member of the Global Technical Enablement team at JMP Statistical Discovery LLC, a SAS Institute subsidiary. He provides technical support to leading health and life sciences clients and contributes to product development. Previously, Chandra held senior roles in quality assurance within the pharmaceutical sector and served as a professor of pharmaceutical quality assurance. With a PhD in Pharmaceutical Sciences, over 30 publications, and certifications in SAS® Programming, PRINCE2 Agile®, and ITIL 4.
Upcoming Events
PSI Introduction to Industry Training (ITIT) Course - 2026/2027
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.
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 webinar brings together three bitesize complementary sessions to help PSI contributors create conference presentations and posters that communicate clearly and inclusively. Participants will explore how to refine their message, prepare materials effectively, and adopt practical habits that support confident, accessible delivery. A focused, supportive session designed to elevate every contribution.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
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.
Join our Health Technology Assessment (HTA) European Special Interest Group (ESIG) for a webinar on the strategic role of statisticians in the Joint Clinical Assessment (JCA). The introduction of the JCA marks a new era for evidence generation and market access in Europe. As HTA requirements become more harmonized and methodologically demanding, the role of statisticians has evolved far beyond data analysis. Today, statistical expertise is central to shaping clinical development strategies, designing robust comparative evidence, and ensuring that submissions withstand the scrutiny of EU-level assessors. In this webinar, we explore how statisticians contribute strategically to successful JCA outcomes.
Statisticians in the Age of AI: On Route to Strategic Partnership
A 90-minute webinar featuring two case studies from Bayer and Roche demonstrating how statisticians successfully integrated into AI programs, followed by interactive discussion on strategies for elevating statistical expertise in the AI era.
Enhancing Clinical Study Reporting with the Estimand Framework
Join us for an insightful webinar where we explore practical strategies for applying the estimand framework in clinical study reporting. Drawing on real-world experiences and case studies, we will share recommendations to help you:
• Understand the role of estimands in improving transparency and interpretation of trial results.
• Navigate common challenges in implementing the framework during reporting.
• Apply best practices to enhance regulatory submissions, webposting in public registries (clinicaltrials.gov/CTIS), and scientific publications.
Whether you are involved in clinical trial design, data analysis, or regulatory submissions, this session will provide actionable guidance to realize the full potential of the estimand framework.
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 networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
GSK - Statistics Director - Vaccines and Infectious Disease
We are seeking an experienced and visionary Statistics Director to join our Team and lead strategic statistical innovation across GSK’s Vaccines and Infectious Disease portfolio.
As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
As a Statistical Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
We have an exciting opportunity for an Associate Director, Biostatistics to join a passionate team within Advanced Quantitative Sciences – Full Development.
: We have an exciting opportunity for an Associate Director (AD), Statistical Programming, to join a passionate team within Advanced Quantitative Sciences- Development.
Novartis - Senior Principal Statistical Programmer
We have an exciting opportunity for a Senior Principal Statistical Programmer, to join a passionate team within Advanced Quantitative Sciences – Development.
Pierre Fabre - Clinical Development Safety Statistics Expert M/F
We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92).
Pierre Fabre - Lead Statistician – Real World Evidence -CDI- M/F
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.
Pierre Fabre - Lead Statistician- Clinical Trials M/F
We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department based in Toulouse (31, Oncopole) or Boulogne (92).
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.