Knowledge

How the R Consortium Is Transforming Regulatory Submissions and AI in Clinical Trials

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In this episode, I talk with Ning Leng, Ph.D., Director II, Data and AI Acceleration Group, Data & Statistical Sciences at AbbVie, about the growing role of the R Consortium in the pharmaceutical industry.

Ning brings extensive experience in statistics, computational genomics, open-source technology, and the adoption of R across the pharmaceutical industry. Before joining AbbVie, she spent 10 years at Roche Genentech, where she helped drive the adoption of R, cloud technologies, Git, and Shiny.

We discuss how the R Consortium creates a platform for statisticians, programmers, pharmaceutical companies, and regulators to collaborate on practical challenges—and how that collaboration is changing the way we approach regulatory submissions.

Why you should listen

Weiterlesen …

Dr. Alexander Schacht

All Episodes

In this episode, I talk with Ning Leng, Ph.D., Director II, Data and AI Acceleration Group, Data & Statistical Sciences at AbbVie, about the growing role of the R Consortium in the pharmaceutical industry.

Ning brings extensive experience in statistics, computational genomics, open-source technology, and the adoption of R across the pharmaceutical industry. Before joining AbbVie, she spent 10 years at Roche Genentech, where she helped drive the adoption of R, cloud technologies, Git, and Shiny.

We discuss how the R Consortium creates a platform for statisticians, programmers, pharmaceutical companies, and regulators to collaborate on practical challenges—and how that collaboration is changing the way we approach regulatory submissions.

Why you should listen

Weiterlesen …

How the R Consortium Is Transforming Regulatory Submissions and AI in Clinical Trials

Dr. Alexander Schacht

All Episodes

In this episode, I talk with Ning Leng, Ph.D., Director II, Data and AI Acceleration Group, Data & Statistical Sciences at AbbVie, about the growing role of the R Consortium in the pharmaceutical industry.

Ning brings extensive experience in statistics, computational genomics, open-source technology, and the adoption of R across the pharmaceutical industry. Before joining AbbVie, she spent 10 years at Roche Genentech, where she helped drive the adoption of R, cloud technologies, Git, and Shiny.

We discuss how the R Consortium creates a platform for statisticians, programmers, pharmaceutical companies, and regulators to collaborate on practical challenges—and how that collaboration is changing the way we approach regulatory submissions.

Why you should listen

Weiterlesen …

Project Optimus and what you need to know about it

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Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace?

In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology.

Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability.

Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

Why you should listen

Weiterlesen …

Dr. Alexander Schacht

All Episodes

Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace?

In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology.

Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability.

Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

Why you should listen

Weiterlesen …

Project Optimus and what you need to know about it

Dr. Alexander Schacht

All Episodes

Cancer treatments have changed dramatically over the past decade, but have our dose-finding strategies kept pace?

In this episode, I speak with Dr. Ayon Mukherjee, who leads statistical innovation in early oncology development at Eli Lilly. Together, we explore Project Optimus, the FDA initiative that is changing how we think about dose optimization in oncology.

Instead of simply finding the highest dose patients can tolerate, Project Optimus encourages us to identify the dose that provides the best balance between efficacy, safety, pharmacokinetics, pharmacodynamics, and long-term tolerability.

Ayon explains why the traditional maximum tolerated dose approach worked well for chemotherapy but often falls short for targeted therapies and immunotherapies. We also discuss how statisticians can help lead this transformation by designing better dose optimization studies and collaborating more effectively with clinicians, pharmacologists, and regulators.

Why you should listen

Weiterlesen …

Unlocking Growth: The Power of Coaching and Mentoring for Statisticians

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In this insightful interview, Emma May and Alun Bedding explore the nuances of coaching and mentoring, sharing personal stories, frameworks, and practical tips to enhance professional growth. Discover how these powerful tools can transform statisticians’ careers and foster leadership development.

Key Topics:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

In this insightful interview, Emma May and Alun Bedding explore the nuances of coaching and mentoring, sharing personal stories, frameworks, and practical tips to enhance professional growth. Discover how these powerful tools can transform statisticians’ careers and foster leadership development.

Key Topics:

Weiterlesen …

Unlocking Growth: The Power of Coaching and Mentoring for Statisticians

Dr. Alexander Schacht

All Episodes

In this insightful interview, Emma May and Alun Bedding explore the nuances of coaching and mentoring, sharing personal stories, frameworks, and practical tips to enhance professional growth. Discover how these powerful tools can transform statisticians’ careers and foster leadership development.

Key Topics:

Weiterlesen …

Understanding and Mitigating Endpoint Bias in External Control Arms

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External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations.

In this episode, I speak with Benjamin Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges.

If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.

Key Topics:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations.

In this episode, I speak with Benjamin Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges.

If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.

Key Topics:

Weiterlesen …

Understanding and Mitigating Endpoint Bias in External Control Arms

Dr. Alexander Schacht

All Episodes

External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations.

In this episode, I speak with Benjamin Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges.

If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.

Key Topics:

Weiterlesen …

The Future of Statistical Methodology in Drug Development

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This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI integration, and strategies to accelerate adoption of innovative methods.

Key Topics:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI integration, and strategies to accelerate adoption of innovative methods.

Key Topics:

Weiterlesen …

The Future of Statistical Methodology in Drug Development

Dr. Alexander Schacht

All Episodes

This episode features three leading statistical methodology experts discussing the role, impact, and future of methodology groups in the pharmaceutical industry. They explore organizational structures, skill sets, AI integration, and strategies to accelerate adoption of innovative methods.

Key Topics:

Weiterlesen …

Measuring Trust – A Key to Effective Leadership

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Trust is one of the most fundamental elements of effective leadership—and yet, most organizations don’t measure it properly.

In this episode, I speak again with my good friend Alun Bedding about how we can move from talking about trust to actually quantifying and improving it. We explore why trust is essential for collaboration, leadership, and performance, and what happens when it’s missing.

We also dive into practical tools like the Leadership Trust Index, how to interpret trust as a lead measure, and how organizations can systematically improve trust over time.

If you want to become a more effective leader and create real impact, this episode gives you both the mindset and the tools to do it.

Why You Should Listen:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

Trust is one of the most fundamental elements of effective leadership—and yet, most organizations don’t measure it properly.

In this episode, I speak again with my good friend Alun Bedding about how we can move from talking about trust to actually quantifying and improving it. We explore why trust is essential for collaboration, leadership, and performance, and what happens when it’s missing.

We also dive into practical tools like the Leadership Trust Index, how to interpret trust as a lead measure, and how organizations can systematically improve trust over time.

If you want to become a more effective leader and create real impact, this episode gives you both the mindset and the tools to do it.

Why You Should Listen:

Weiterlesen …

Measuring Trust – A Key to Effective Leadership

Dr. Alexander Schacht

All Episodes

Trust is one of the most fundamental elements of effective leadership—and yet, most organizations don’t measure it properly.

In this episode, I speak again with my good friend Alun Bedding about how we can move from talking about trust to actually quantifying and improving it. We explore why trust is essential for collaboration, leadership, and performance, and what happens when it’s missing.

We also dive into practical tools like the Leadership Trust Index, how to interpret trust as a lead measure, and how organizations can systematically improve trust over time.

If you want to become a more effective leader and create real impact, this episode gives you both the mindset and the tools to do it.

Why You Should Listen:

Weiterlesen …

How Statisticians Can Build Trust and Lead with Emotional Intelligence

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In this episode of The Effective Statistician, Alun Bedding speaks with Emma May about the skills that truly differentiate effective statisticians from great leaders.

While technical expertise remains essential, success in today’s environment increasingly depends on the ability to build trust, communicate effectively, and lead with emotional intelligence. Drawing from their joint leadership workshops, Alun and Emma explore how statisticians can develop these capabilities and apply them in real-world settings.

They discuss practical approaches to creating psychological safety, shifting from a “telling” to a coaching mindset, and fostering a growth mindset within teams. The conversation highlights why leadership is not about having all the answers—but about enabling others to contribute, grow, and succeed.

Why You Should Listen

Weiterlesen …

Dr. Alexander Schacht

All Episodes

In this episode of The Effective Statistician, Alun Bedding speaks with Emma May about the skills that truly differentiate effective statisticians from great leaders.

While technical expertise remains essential, success in today’s environment increasingly depends on the ability to build trust, communicate effectively, and lead with emotional intelligence. Drawing from their joint leadership workshops, Alun and Emma explore how statisticians can develop these capabilities and apply them in real-world settings.

They discuss practical approaches to creating psychological safety, shifting from a “telling” to a coaching mindset, and fostering a growth mindset within teams. The conversation highlights why leadership is not about having all the answers—but about enabling others to contribute, grow, and succeed.

Why You Should Listen

Weiterlesen …

How Statisticians Can Build Trust and Lead with Emotional Intelligence

Dr. Alexander Schacht

All Episodes

In this episode of The Effective Statistician, Alun Bedding speaks with Emma May about the skills that truly differentiate effective statisticians from great leaders.

While technical expertise remains essential, success in today’s environment increasingly depends on the ability to build trust, communicate effectively, and lead with emotional intelligence. Drawing from their joint leadership workshops, Alun and Emma explore how statisticians can develop these capabilities and apply them in real-world settings.

They discuss practical approaches to creating psychological safety, shifting from a “telling” to a coaching mindset, and fostering a growth mindset within teams. The conversation highlights why leadership is not about having all the answers—but about enabling others to contribute, grow, and succeed.

Why You Should Listen

Weiterlesen …

AI and Statistics Start-ups: Opportunities and Challenges

by

In this thought-provoking keynote recording, Manjari Narayan takes us on a journey through one of the most pressing and promising intersections in modern science: the convergence of artificial intelligence, statistics, and biotechnology. Drawing on her extensive experience in both academia and biotech startups, Manjari explores the critical role statisticians can play in AI-driven drug discovery, biomarker validation, and experimental design.

We are living in a “Cambrian explosion” of biotechnology, where high-throughput experiments, protein engineering, humanized models, and AI-powered screening open massive opportunities—but also introduce challenges in scientific validity, reproducibility, and decision-making. Through personal vignettes and cutting-edge examples, Manjari lays out how statistical thinking can (and should) drive better outcomes in early-stage drug development, biomarker discovery, and translational model evaluation.

This episode is a must-listen for statisticians, data scientists, and healthcare innovators navigating the rapidly evolving biotech and AI startup landscape.

What You’ll Learn:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

In this thought-provoking keynote recording, Manjari Narayan takes us on a journey through one of the most pressing and promising intersections in modern science: the convergence of artificial intelligence, statistics, and biotechnology. Drawing on her extensive experience in both academia and biotech startups, Manjari explores the critical role statisticians can play in AI-driven drug discovery, biomarker validation, and experimental design.

We are living in a “Cambrian explosion” of biotechnology, where high-throughput experiments, protein engineering, humanized models, and AI-powered screening open massive opportunities—but also introduce challenges in scientific validity, reproducibility, and decision-making. Through personal vignettes and cutting-edge examples, Manjari lays out how statistical thinking can (and should) drive better outcomes in early-stage drug development, biomarker discovery, and translational model evaluation.

This episode is a must-listen for statisticians, data scientists, and healthcare innovators navigating the rapidly evolving biotech and AI startup landscape.

What You’ll Learn:

Weiterlesen …

AI and Statistics Start-ups: Opportunities and Challenges

Dr. Alexander Schacht

All Episodes

In this thought-provoking keynote recording, Manjari Narayan takes us on a journey through one of the most pressing and promising intersections in modern science: the convergence of artificial intelligence, statistics, and biotechnology. Drawing on her extensive experience in both academia and biotech startups, Manjari explores the critical role statisticians can play in AI-driven drug discovery, biomarker validation, and experimental design.

We are living in a “Cambrian explosion” of biotechnology, where high-throughput experiments, protein engineering, humanized models, and AI-powered screening open massive opportunities—but also introduce challenges in scientific validity, reproducibility, and decision-making. Through personal vignettes and cutting-edge examples, Manjari lays out how statistical thinking can (and should) drive better outcomes in early-stage drug development, biomarker discovery, and translational model evaluation.

This episode is a must-listen for statisticians, data scientists, and healthcare innovators navigating the rapidly evolving biotech and AI startup landscape.

What You’ll Learn:

Weiterlesen …

Combining RCT and RWD – Applications in Rare Diseases and Practical Recommendations

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In this special keynote episode, I’m excited to share the recording of Professor Tim Friede’s thought-provoking presentation from The Effective Statistician Conference 2024. Tim, a leading expert in biostatistics and clinical trial design, dives deep into the combination of randomized controlled trials (RCTs) and real-world data (RWD)—especially in the context of rare diseases.

Drawing from his work at the University Medical Center Göttingen and numerous European research initiatives, Tim presents a compelling case for integrating RWD to support small or underpowered RCTs using advanced statistical models. He shares real-world examples (including CJD and Alport syndrome), simulation insights, and practical recommendations that can change how we approach evidence generation in low-prevalence populations.

What You’ll Learn:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

In this special keynote episode, I’m excited to share the recording of Professor Tim Friede’s thought-provoking presentation from The Effective Statistician Conference 2024. Tim, a leading expert in biostatistics and clinical trial design, dives deep into the combination of randomized controlled trials (RCTs) and real-world data (RWD)—especially in the context of rare diseases.

Drawing from his work at the University Medical Center Göttingen and numerous European research initiatives, Tim presents a compelling case for integrating RWD to support small or underpowered RCTs using advanced statistical models. He shares real-world examples (including CJD and Alport syndrome), simulation insights, and practical recommendations that can change how we approach evidence generation in low-prevalence populations.

What You’ll Learn:

Weiterlesen …

Combining RCT and RWD – Applications in Rare Diseases and Practical Recommendations

Dr. Alexander Schacht

All Episodes

In this special keynote episode, I’m excited to share the recording of Professor Tim Friede’s thought-provoking presentation from The Effective Statistician Conference 2024. Tim, a leading expert in biostatistics and clinical trial design, dives deep into the combination of randomized controlled trials (RCTs) and real-world data (RWD)—especially in the context of rare diseases.

Drawing from his work at the University Medical Center Göttingen and numerous European research initiatives, Tim presents a compelling case for integrating RWD to support small or underpowered RCTs using advanced statistical models. He shares real-world examples (including CJD and Alport syndrome), simulation insights, and practical recommendations that can change how we approach evidence generation in low-prevalence populations.

What You’ll Learn:

Weiterlesen …

Real-World Evidence vs. Randomized Trials: Can We Emulate Accuracy?

by

In this keynote episode, Professor Sebastian Schneeweiss from Harvard Medical School shares groundbreaking insights from his extensive research into emulating randomized controlled trials (RCTs) using real-world data (RWD). Recorded live at The Effective Statistician Conference 2024, this talk explores whether non-randomized studies based on electronic health records and claims data can reach conclusions as reliable as those from traditional RCTs.

Prof. Schneeweiss, also Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, walks us through the RCT DUPLICATE project, a major FDA-funded initiative that evaluated whether regulatory decisions could be replicated through high-quality real-world evidence (RWE).

From the successes to the limitations—and everything in between—this episode is packed with lessons for statisticians, regulators, and pharmaceutical leaders interested in the future of data-driven healthcare decisions.

What You’ll Learn:

Weiterlesen …

Dr. Alexander Schacht

All Episodes

In this keynote episode, Professor Sebastian Schneeweiss from Harvard Medical School shares groundbreaking insights from his extensive research into emulating randomized controlled trials (RCTs) using real-world data (RWD). Recorded live at The Effective Statistician Conference 2024, this talk explores whether non-randomized studies based on electronic health records and claims data can reach conclusions as reliable as those from traditional RCTs.

Prof. Schneeweiss, also Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, walks us through the RCT DUPLICATE project, a major FDA-funded initiative that evaluated whether regulatory decisions could be replicated through high-quality real-world evidence (RWE).

From the successes to the limitations—and everything in between—this episode is packed with lessons for statisticians, regulators, and pharmaceutical leaders interested in the future of data-driven healthcare decisions.

What You’ll Learn:

Weiterlesen …

Real-World Evidence vs. Randomized Trials: Can We Emulate Accuracy?

Dr. Alexander Schacht

All Episodes

In this keynote episode, Professor Sebastian Schneeweiss from Harvard Medical School shares groundbreaking insights from his extensive research into emulating randomized controlled trials (RCTs) using real-world data (RWD). Recorded live at The Effective Statistician Conference 2024, this talk explores whether non-randomized studies based on electronic health records and claims data can reach conclusions as reliable as those from traditional RCTs.

Prof. Schneeweiss, also Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, walks us through the RCT DUPLICATE project, a major FDA-funded initiative that evaluated whether regulatory decisions could be replicated through high-quality real-world evidence (RWE).

From the successes to the limitations—and everything in between—this episode is packed with lessons for statisticians, regulators, and pharmaceutical leaders interested in the future of data-driven healthcare decisions.

What You’ll Learn:

Weiterlesen …