Date: Wednesday 7th August 2024 Time: 14:00-15:30 BST Location: Online via Zoom Speakers: Avery McIntosh (Pfizer) and Oleksandr Sverdlov (Novartis)
Who is this event intended for? Biostatisticians and drug developers in the pharmaceutical industry, as well as students, patient advocates, and healthcare policy regulators. What is the benefit of attending? Attendees will gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into the most complex biologics ever constructed, leading to regulatory approval of several gene therapy products in oncology, hematology, neurology, and ophthalmology indications. These drugs are at the apex of biological manufacturing complexity, and have the potential to be disease modifying or even curative. Evidence-based and innovative quantitative clinical development and lifecycle management strategies will be required as fixtures in the development for these unique drugs in order to reach patients in need. In this webinar we provide an overview of the history and future of gene therapies, and discuss the crucial role of the statistician in the drug development process of these drugs, with a focus on innovative trial design and analysis techniques.
Speaker details
Speaker
Biography
Avery McIntosh
Avery McIntosh, PhD is a drug developer working in internal medicine and rare disease at Pfizer. He received his MSc and PhD in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.
Oleksandr Sverdlov
Oleksandr Sverdlov, PhD is a Neuroscience Disease Area Statistical Lead at Novartis. He earned his BSc in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, MSc in Statistics from University of Maryland, Baltimore County (UMBC), and PhD in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book “Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach” (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies.
Scientific Meetings
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
Date: Wednesday 7th August 2024 Time: 14:00-15:30 BST Location: Online via Zoom Speakers: Avery McIntosh (Pfizer) and Oleksandr Sverdlov (Novartis)
Who is this event intended for? Biostatisticians and drug developers in the pharmaceutical industry, as well as students, patient advocates, and healthcare policy regulators. What is the benefit of attending? Attendees will gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into the most complex biologics ever constructed, leading to regulatory approval of several gene therapy products in oncology, hematology, neurology, and ophthalmology indications. These drugs are at the apex of biological manufacturing complexity, and have the potential to be disease modifying or even curative. Evidence-based and innovative quantitative clinical development and lifecycle management strategies will be required as fixtures in the development for these unique drugs in order to reach patients in need. In this webinar we provide an overview of the history and future of gene therapies, and discuss the crucial role of the statistician in the drug development process of these drugs, with a focus on innovative trial design and analysis techniques.
Speaker details
Speaker
Biography
Avery McIntosh
Avery McIntosh, PhD is a drug developer working in internal medicine and rare disease at Pfizer. He received his MSc and PhD in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.
Oleksandr Sverdlov
Oleksandr Sverdlov, PhD is a Neuroscience Disease Area Statistical Lead at Novartis. He earned his BSc in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, MSc in Statistics from University of Maryland, Baltimore County (UMBC), and PhD in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book “Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach” (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies.
Training Courses
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
Date: Wednesday 7th August 2024 Time: 14:00-15:30 BST Location: Online via Zoom Speakers: Avery McIntosh (Pfizer) and Oleksandr Sverdlov (Novartis)
Who is this event intended for? Biostatisticians and drug developers in the pharmaceutical industry, as well as students, patient advocates, and healthcare policy regulators. What is the benefit of attending? Attendees will gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into the most complex biologics ever constructed, leading to regulatory approval of several gene therapy products in oncology, hematology, neurology, and ophthalmology indications. These drugs are at the apex of biological manufacturing complexity, and have the potential to be disease modifying or even curative. Evidence-based and innovative quantitative clinical development and lifecycle management strategies will be required as fixtures in the development for these unique drugs in order to reach patients in need. In this webinar we provide an overview of the history and future of gene therapies, and discuss the crucial role of the statistician in the drug development process of these drugs, with a focus on innovative trial design and analysis techniques.
Speaker details
Speaker
Biography
Avery McIntosh
Avery McIntosh, PhD is a drug developer working in internal medicine and rare disease at Pfizer. He received his MSc and PhD in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.
Oleksandr Sverdlov
Oleksandr Sverdlov, PhD is a Neuroscience Disease Area Statistical Lead at Novartis. He earned his BSc in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, MSc in Statistics from University of Maryland, Baltimore County (UMBC), and PhD in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book “Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach” (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies.
Journal Club
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
Date: Wednesday 7th August 2024 Time: 14:00-15:30 BST Location: Online via Zoom Speakers: Avery McIntosh (Pfizer) and Oleksandr Sverdlov (Novartis)
Who is this event intended for? Biostatisticians and drug developers in the pharmaceutical industry, as well as students, patient advocates, and healthcare policy regulators. What is the benefit of attending? Attendees will gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into the most complex biologics ever constructed, leading to regulatory approval of several gene therapy products in oncology, hematology, neurology, and ophthalmology indications. These drugs are at the apex of biological manufacturing complexity, and have the potential to be disease modifying or even curative. Evidence-based and innovative quantitative clinical development and lifecycle management strategies will be required as fixtures in the development for these unique drugs in order to reach patients in need. In this webinar we provide an overview of the history and future of gene therapies, and discuss the crucial role of the statistician in the drug development process of these drugs, with a focus on innovative trial design and analysis techniques.
Speaker details
Speaker
Biography
Avery McIntosh
Avery McIntosh, PhD is a drug developer working in internal medicine and rare disease at Pfizer. He received his MSc and PhD in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.
Oleksandr Sverdlov
Oleksandr Sverdlov, PhD is a Neuroscience Disease Area Statistical Lead at Novartis. He earned his BSc in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, MSc in Statistics from University of Maryland, Baltimore County (UMBC), and PhD in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book “Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach” (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies.
Webinars
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
Date: Wednesday 7th August 2024 Time: 14:00-15:30 BST Location: Online via Zoom Speakers: Avery McIntosh (Pfizer) and Oleksandr Sverdlov (Novartis)
Who is this event intended for? Biostatisticians and drug developers in the pharmaceutical industry, as well as students, patient advocates, and healthcare policy regulators. What is the benefit of attending? Attendees will gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into the most complex biologics ever constructed, leading to regulatory approval of several gene therapy products in oncology, hematology, neurology, and ophthalmology indications. These drugs are at the apex of biological manufacturing complexity, and have the potential to be disease modifying or even curative. Evidence-based and innovative quantitative clinical development and lifecycle management strategies will be required as fixtures in the development for these unique drugs in order to reach patients in need. In this webinar we provide an overview of the history and future of gene therapies, and discuss the crucial role of the statistician in the drug development process of these drugs, with a focus on innovative trial design and analysis techniques.
Speaker details
Speaker
Biography
Avery McIntosh
Avery McIntosh, PhD is a drug developer working in internal medicine and rare disease at Pfizer. He received his MSc and PhD in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.
Oleksandr Sverdlov
Oleksandr Sverdlov, PhD is a Neuroscience Disease Area Statistical Lead at Novartis. He earned his BSc in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, MSc in Statistics from University of Maryland, Baltimore County (UMBC), and PhD in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book “Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach” (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies.
Careers Meetings
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
Date: Wednesday 7th August 2024 Time: 14:00-15:30 BST Location: Online via Zoom Speakers: Avery McIntosh (Pfizer) and Oleksandr Sverdlov (Novartis)
Who is this event intended for? Biostatisticians and drug developers in the pharmaceutical industry, as well as students, patient advocates, and healthcare policy regulators. What is the benefit of attending? Attendees will gain a broader understanding of a recent and rapidly advancing core area of pharmaceutical drug development. The content will be broad, but will focus on clinical design and analysis strategies for advanced therapeutics such as cell/gene therapies, and strategic options to advance candidate drugs in this space.
Registration
This event is free to both Members of PSI and Non-Members. To register your place for this event, please click here.
Overview
One of the recent advances in 21st century medicine is the emergence of gene therapies, drugs that affect the basic biology of genetic disease. The field has seen some notable setbacks in the past, but in recent years has exploded as decades of basic science have been successfully translated into the most complex biologics ever constructed, leading to regulatory approval of several gene therapy products in oncology, hematology, neurology, and ophthalmology indications. These drugs are at the apex of biological manufacturing complexity, and have the potential to be disease modifying or even curative. Evidence-based and innovative quantitative clinical development and lifecycle management strategies will be required as fixtures in the development for these unique drugs in order to reach patients in need. In this webinar we provide an overview of the history and future of gene therapies, and discuss the crucial role of the statistician in the drug development process of these drugs, with a focus on innovative trial design and analysis techniques.
Speaker details
Speaker
Biography
Avery McIntosh
Avery McIntosh, PhD is a drug developer working in internal medicine and rare disease at Pfizer. He received his MSc and PhD in biostatistics from Boston University with a dissertation on Bayesian methods to model household tuberculosis transmission. He has managed teams of statisticians across study phases and in a variety of drug types and disease areas, including neurology, ophthalmology, infectious disease/global health, hematology, and oncology. He has published peer-reviewed articles on various topics in drug development and biostatistics, including development of cell and gene therapies and qualification of digital endpoints in neurological diseases.
Oleksandr Sverdlov
Oleksandr Sverdlov, PhD is a Neuroscience Disease Area Statistical Lead at Novartis. He earned his BSc in Applied Mathematics from V.N. Karazin Kharkiv National University, Ukraine, MSc in Statistics from University of Maryland, Baltimore County (UMBC), and PhD in Information Technology with Concentration in Statistical Science from George Mason University. He has been actively involved in methodological research and applications of innovative statistical approaches in drug development. He has co-authored over forty refereed articles, edited two monographs, and co-authored a book “Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach” (CRC Press/Chapman & Hall, 2019). His most recent work involves design and analysis of clinical trials evaluating novel digital technologies.
Upcoming Events
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.
Topic: R Package Basics.
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, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.