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A myriad of AI, science, and technology experts explore the real challenges and enormous opportunities facing entrepreneurs who are building the future of health. Raising Health, a podcast by a16z Bio + Health and hosted by Kris Tatiossian and Olivia Webb, dives deep into the heart of biotechnology and healthcare innovation. Join veteran company builders, operators, and investors Vijay Pande, Julie Yoo, Vineeta Agarwala, and Jorge Conde, along with distinguished guests like Mark Cuban, Greg ...
I discuss a variety of topics in both the natural and social sciences, exploring the many fascinating insights that the scientific method yields about the world around us.
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The Science Show gives Australians unique insights into the latest scientific research and debate, from the physics of cricket to prime ministerial biorhythms.
When you hear the words Alzheimer's disease, what do you think of? The truth is, the picture most of us have of the disease is incomplete. Alzheimer's disease doesn't start when someone starts to lose their memory. It actually starts years – sometimes decades – earlier. The Rethinking Alzheimer's Disease Podcast is an engaging, narrative-style podcast miniseries for those curious or motivated to learn about Alzheimer’s disease. Perhaps you have a family member with Alzheimer’s disease, or ca ...
Flash Forward is a show about possible (and not so possible) future scenarios. What would the warranty on a sex robot look like? How would diplomacy work if we couldn’t lie? Could there ever be a fecal transplant black market? (Complicated, it wouldn’t, and yes, respectively, in case you’re curious.) Hosted and produced by award winning science journalist Rose Eveleth, each episode combines audio drama and journalism to go deep on potential tomorrows, and uncovers what those futures might re ...
DNA science. Artificial intelligence. Smartphones and 3D printers. Science and technology have transformed the world we live in. But how did we get here? It wasn’t by accident. Well, sometimes it was. It was also the result of hard work, teamwork, and competition. And incredibly surprising moments. Hosted by bestselling author Steven Johnson (“How We Got To Now”), American Innovations uses immersive scenes to tell the stories of the scientists, engineers, and ordinary people behind the great ...
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Interview with Lara Wolfson and Anders Gorst-Rasmussen
Why You Should Listen:
✔ EU HTA is becoming reality: Joint Clinical Assessments begin soon with oncology/ATMPs and will expand to all medicines over the next years.
✔ Statisticians are central: Re-analyses, indirect comparisons, RWE, and quality-of-life analyses will be required—often beyond what regulatory trials were designed for.
✔ Timelines are tight: From EMA Day 120 scoping to dossier deadlines and final JCAs just 30 days post-marketing authorization.
✔ Transparency and resources matter: Joint assessments will be public, and both companies and agencies face capacity and clarity challenges.
✔ You can prepare now: Incorporate HTA needs into trial design, analysis planning, and cross-functional collaborations.
Episode Highlights:
00:00 – 02:30 | I introduce the episode and explain why EU HTA is such a critical topic
02:30 – 05:30 | Lara and Anders introduce themselves and their HTA work at MSD and Novo Nordisk
05:30 – 10:45 | Regulatory vs. HTA: safe & effective vs. how good, for whom, and at what cost
10:45 – 18:30 | Europe’s patchwork: national differences in comparators, standards of care, and access
18:30 – 23:45 | The EU regulation: joint clinical assessments, economic modeling, and what’s changing
23:45 – 32:30 | What it means for us as statisticians: re-analyses, ITCs/NMAs, RWE, QoL, and capacity issues
32:30 – 36:00 | Why “transparency” can’t just be 50,000-page PDFs—clear, reproducible evidence matters
36:00 – 45:00 | The PSI HTA SIG’s role, current activities, and how you can get involved
45:00 – end | Our final takeaways and a call for statisticians to engage now
🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.
🔗 My New Book: How to Be an Effective Statistician - Volume 1– It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.
Join the Conversation: Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion.
Subscribe & Stay Updated: Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.
Glossary:
HTA – Health Technology Assessment
EU HTA / JCA – Joint Clinical Assessment forming the evidence base for national HTA decisions
EMA / CHMP – European Medicines Agency / Committee for Medicinal Products for Human Use
Interview with Lara Wolfson and Anders Gorst-Rasmussen
Why You Should Listen:
✔ EU HTA is becoming reality: Joint Clinical Assessments begin soon with oncology/ATMPs and will expand to all medicines over the next years.
✔ Statisticians are central: Re-analyses, indirect comparisons, RWE, and quality-of-life analyses will be required—often beyond what regulatory trials were designed for.
✔ Timelines are tight: From EMA Day 120 scoping to dossier deadlines and final JCAs just 30 days post-marketing authorization.
✔ Transparency and resources matter: Joint assessments will be public, and both companies and agencies face capacity and clarity challenges.
✔ You can prepare now: Incorporate HTA needs into trial design, analysis planning, and cross-functional collaborations.
Episode Highlights:
00:00 – 02:30 | I introduce the episode and explain why EU HTA is such a critical topic
02:30 – 05:30 | Lara and Anders introduce themselves and their HTA work at MSD and Novo Nordisk
05:30 – 10:45 | Regulatory vs. HTA: safe & effective vs. how good, for whom, and at what cost
10:45 – 18:30 | Europe’s patchwork: national differences in comparators, standards of care, and access
18:30 – 23:45 | The EU regulation: joint clinical assessments, economic modeling, and what’s changing
23:45 – 32:30 | What it means for us as statisticians: re-analyses, ITCs/NMAs, RWE, QoL, and capacity issues
32:30 – 36:00 | Why “transparency” can’t just be 50,000-page PDFs—clear, reproducible evidence matters
36:00 – 45:00 | The PSI HTA SIG’s role, current activities, and how you can get involved
45:00 – end | Our final takeaways and a call for statisticians to engage now
🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.
🔗 My New Book: How to Be an Effective Statistician - Volume 1– It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.
Join the Conversation: Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion.
Subscribe & Stay Updated: Never miss an episode! Subscribe to The Effective Statistician on your favorite podcast platform and continue growing your influence as a statistician.
Glossary:
HTA – Health Technology Assessment
EU HTA / JCA – Joint Clinical Assessment forming the evidence base for national HTA decisions
EMA / CHMP – European Medicines Agency / Committee for Medicinal Products for Human Use
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How many organs could you donate and remain alive? How many planet Earths could fit inside the Sun? How high is a giraffe's blood pressure? Why is the sea blue? To find out, Ask The Naked Scientists!
A myriad of AI, science, and technology experts explore the real challenges and enormous opportunities facing entrepreneurs who are building the future of health. Raising Health, a podcast by a16z Bio + Health and hosted by Kris Tatiossian and Olivia Webb, dives deep into the heart of biotechnology and healthcare innovation. Join veteran company builders, operators, and investors Vijay Pande, Julie Yoo, Vineeta Agarwala, and Jorge Conde, along with distinguished guests like Mark Cuban, Greg ...
I discuss a variety of topics in both the natural and social sciences, exploring the many fascinating insights that the scientific method yields about the world around us.
Whether the topic is popcorn or particle physics, you can count on BrainStuff to explore -- and explain -- the everyday science in the world around us.
The Science Show gives Australians unique insights into the latest scientific research and debate, from the physics of cricket to prime ministerial biorhythms.
When you hear the words Alzheimer's disease, what do you think of? The truth is, the picture most of us have of the disease is incomplete. Alzheimer's disease doesn't start when someone starts to lose their memory. It actually starts years – sometimes decades – earlier. The Rethinking Alzheimer's Disease Podcast is an engaging, narrative-style podcast miniseries for those curious or motivated to learn about Alzheimer’s disease. Perhaps you have a family member with Alzheimer’s disease, or ca ...
Flash Forward is a show about possible (and not so possible) future scenarios. What would the warranty on a sex robot look like? How would diplomacy work if we couldn’t lie? Could there ever be a fecal transplant black market? (Complicated, it wouldn’t, and yes, respectively, in case you’re curious.) Hosted and produced by award winning science journalist Rose Eveleth, each episode combines audio drama and journalism to go deep on potential tomorrows, and uncovers what those futures might re ...
DNA science. Artificial intelligence. Smartphones and 3D printers. Science and technology have transformed the world we live in. But how did we get here? It wasn’t by accident. Well, sometimes it was. It was also the result of hard work, teamwork, and competition. And incredibly surprising moments. Hosted by bestselling author Steven Johnson (“How We Got To Now”), American Innovations uses immersive scenes to tell the stories of the scientists, engineers, and ordinary people behind the great ...
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