What are gene therapies? What are some recent advancement in gene therapy? How does development in gene therapy differ from common drugs?

Today's episode is slightly different from the previous ones. It is the first time that TWO brilliant biostatisticians share their insight in the same episode! Avery McIntosh and Alex Sverdlov will answer all the questions about gene therapy for you!

Dr. McIntosh is currently engaged in drug development for rare diseases at Pfizer, where he leads a team of statisticians working across different study phases and a range of drug types and disease areas. Meanwhile, Dr. Sverdlov serves as the Neuroscience Disease Area statistical lead at Novartis, where he focuses on methodological research and the application of innovative statistical methods in drug development.

Other than an interesting gene therapy 101 that Avery and Alex gave in this episode, they also recently co-published a book called "Development of gene therapies: strategic, scientific, regulatory, and Access considerations", which is now available. I will put the link of the book in the show notes and please check it out if you are either a long term enthusiast of gene therapy or if you start to think gene therapy is interesting after listening to this episode. Let dive into this episode and see what Avery and Alex have shared with us.

You can find Avery and Alex's new book here.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback, or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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What is it like to work as a statistical methodologist in the industry? What is the importance of being collaborative and building leadership skills in the industry? How does "over-preparing" get you far in your career?

Godwin Yung will answer all these questions for you. Dr. Yung obtained his PhD in Biostatistics at Harvard University and currently works as a principal statistical methodologist at Genentech. He works on enabling the use of the most appropriate quantitative methodology in pharmaceutical development, including adaptive designs, estimands framework, borrowing external information, and surrogate endpoints etc. He also collaborates with external stakeholders outside of Genentech to advance the field of statistics. Let's dive into this episode and see what Godwin has shared with us.

You can find the FDA Overall Survival workshop here.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback, or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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What is it like to work as a statistician in the UCLA department of medicine statistics core? How do biostatisticians contribute to public policy making? What are some typical methods that are used in longitudinal studies?

Nicholas Jackson will answer all these questions for you. Dr. Jackson earned his PhD in Quantitative Psychology from University of Southern California, and now serves as an associated professor in the Division of general internal medicine and health services research in UCLA. His research interests span a broad spectrum, from sophisticated longitudinal methods to the cutting-edge machine learning methods of big data analysis. His practical work focuses on child and adolescent behavioural development, diabetes prevention. and health service research. Let's dive into this episode and see what Nick has shared with us.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback, or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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How can AI and machine learning be applied to clinical trial designs? What are some interesting applications of AI in health? With AI and machine learning being the hot topic, what are some skills or background you need to succeed in the field?

James Zou will answer all these questions for you. Dr. Zou obtained his PhD in Harvard University and is currently an associate professor of Biomedical data Science at Stanford University. He also acts as the faculty director of Stanford AI4Health. He collaborates extensively with experts across disciplines to advance both the foundations of machine learning and its practical implementation in clinical settings. His innovative work aims to enhance the accuracy, efficiency, and fairness of AI systems in medicine, driving forward the integration of cutting-edge technology in healthcare. Let's dive into this episode and see what James has shared with us.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback, or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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What is it like to work for a statistical consulting company? What are some common paths for statisticians to take in a consulting company? What are some skills needed in a statistical consultancy?

Grace Hsu will answer all these questions for you! Grace got her master's degree in statistics from Simon Fraser University and currently is working in Cytel as an associate Director & Research principal. She has a lot of experience in developing and presenting advanced statistical methods to both statistical and non-statistical audiences and has supported submissions to HTAs and other regulatory bodies. Let's dive into this episode and see what Grace has shared with us!

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback, or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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How to use latent variable models to address differential measurement problems? What are some interesting aging problems that can be addressed by biostatistics? What's the difference between epidemiology and biostatistics?

Karen Bandeen Roche will answer all these questions for you. Dr. Bandeen Roche obtained her Ph.D. degree in operations research and industrial engineering from Cornell University. And she is particularly interested in the development, implementation, and application of models for problems that include underlying or unobservable processes of interest. She focuses on creating statistical reasoning needed to learn how we can lengthen healthy lives and increase independence for older adults. Let's dive into this episode and see what Karen has shared with us.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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What are some important skills that are helpful while doing post-graduate training? What is the trend in academia as Biostatistics gets more and more competitive? How to navigate career choice between industry and academia?

Dr. Jin Jin will answer all these questions for you. Jin Jin received her phd in Biostatistics from the University of Minnesota and now works as an Assistant Professor of Biostatistics at the University of Pennsylvania, Department of Biostatistics, Epidemiology and Informatics. With a research focus on integrating large-scale datasets to address cutting-edge problems in public health and medicine, she deals with complex issues such as health equity in disease risk prediction, statistical genetics, and Bayesian hierarchical models for high-dimensional data. Let's dive into this episode and see what Jin Jin has shared with us.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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What's the difference between epidemiology and biostatistics? What do epidemiologists support in a consulting company? How to build a start-up with your statistical knowledge?

Dr. Paul Arora will answer all these questions for you! Paul holds the position of Vice President, Advanced Epidemiology at Cytel, where his primary areas of focus encompass real-world evidence, epidemiological methods, and the application of machine learning to health outcome issues. Additionally, he played a significant role in establishing Lighthouse Outcomes, a specialized consulting firm dedicated to advanced analytics in clinical epidemiology research. Moreover, Paul is an Assistant Professor within the Division of Epidemiology at the Dalla Lana School of Public Health, University of Toronto. His professional background is rooted in epidemiology, with over fifteen years of experience leading assessments in both public health and clinical epidemiology. He possesses extensive expertise in evidence synthesis methodologies and has held influential consulting positions, collaborating with domestic and international public and private institutions. Let's dive into this episode and see what Paul shared with us!

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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What are the differences between early phase trial design and late phase trial design? What are some common assumptions for early trial designs? What are some challenges for statistics nowadays?

Dr. Brian Smith will answer all these questions for you. Brian got his Phd in statistics from the University of Kentucky and has been actively involved in promoting quantitative sciences in drug development. He has a diverse background in biostatistics and has held numerous positions in the pharmaceutical industry and academia. He currently holds the position of executive director of Biostatistics at Novartis.

Throughout his career, Brian has focused on early clinical development in the pharmaceutical industry. He has played an active role in the development and implementation of statistical methods to improve the efficiency and quality of drug development. With his vast experience and expertise in biostatistics, Brian has become a respected leader in the field and continues to contribute to the advancement of quantitative sciences in drug development. Let’s dive into this episode and see what Brian shared with us.

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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How will the biostatistics industry evolve in the coming years? Is SAS still an important skill recruiters look at when hiring for a biostatistics related job?

In this episode, you will hear Doctor Xiaoling Wu answering these questions after being in the field for over 15 years. Xiaoling holds a PhD degree in statistics from the Johns Hopkins University. She has contributed to over 10 successful global submission of drugs treating cancer and CNS disorder. She was the director and head of biostatistics in Legend Biotech in New Jersey. And led the successful BLA submission of a breakthrough cell therapy treating multiple myeloma during her 3 year tenure. Currently, Xiaoling is the statistics technical lead of a game changing ADC at a leading global oncology company.

Xiaoling was lead statistician of five successful IND clearance and 1 BLA/MAA/PMDA approval valued at $5B. She addressed statistics query from FDA, SEC and institution investors and co-authored over 150 abstracts published at ASCO, ASH and other international medical congress. Let's dive in this episode to see what Xiaoling shared with us

Please visit our website https://biostatisticspodcast.github.io/ for the latest updates and transcripts of the published episodes.
If you have any comments, feedback or suggestions, feel free to email us via [email protected] or DM us on Twitter @BiostatsPodcast

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