{"id":9686,"date":"2025-03-18T01:00:00","date_gmt":"2025-03-18T00:00:00","guid":{"rendered":"https:\/\/theeffectivestatistician.com\/?p=9686"},"modified":"2025-03-18T01:00:00","modified_gmt":"2025-03-18T00:00:00","slug":"statistics-and-market-access-from-foes-to-friends","status":"publish","type":"post","link":"https:\/\/clinicalresearchpulse.com\/?p=9686","title":{"rendered":"Statistics and Market access &#8211; from foes to friends"},"content":{"rendered":"<div class=\"gb-container gb-container-097d555a\" id=\"Header\"><div class=\"gb-inside-container\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-b864dd5d\">\n<div class=\"gb-grid-column gb-grid-column-f9dc6c8c\"><div class=\"gb-container gb-container-f9dc6c8c\"><div class=\"gb-inside-container\">\n\n<h1 class=\"gb-headline gb-headline-ec95b616 gb-headline-text\">Statistics and Market access &#8211; from foes to friends<\/h1>\n\n<\/div><\/div><\/div>\n<\/div>\n\n\n<\/div><\/div>\n\n<div class=\"gb-container gb-container-97fcd8fe\" id=\"Content\"><div class=\"gb-inside-container\">\n<div class=\"gb-container gb-container-94751406\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-c9855146\">\n<div class=\"gb-grid-column gb-grid-column-0b319b99\"><div class=\"gb-container gb-container-0b319b99\" id=\"profilpicture-dr-alexander-schacht\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-241e6869\">\n<div class=\"gb-grid-column gb-grid-column-97f71937\"><div class=\"gb-container gb-container-97f71937\">\n<div class=\"wp-block-image is-style-rounded\">\n<figure class=\"alignleft size-large is-resized\"><img decoding=\"async\" src=\"https:\/\/theeffectivestatistician.com\/wp-content\/uploads\/2023\/11\/theeffective-statistician-alexander_profil_1-1024x1024.webp\" alt=\"\" class=\"wp-image-2861\" style=\"object-fit:cover;width:140px;height:140px\"\/><\/figure>\n<\/div>\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-d3753d6b\"><div class=\"gb-container gb-container-d3753d6b\">\n\n<h3 class=\"gb-headline gb-headline-7fe121cc gb-headline-text\"><a href=\"\/about-dr-alexander-schacht\/\" title=\"\u00dcber mich\">Dr. Alexander Schacht<\/a><\/h3>\n\n<\/div><\/div>\n<\/div>\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-ce3f1670\"><div class=\"gb-container gb-container-ce3f1670\"><\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-1862fcee\"><div class=\"gb-container gb-container-1862fcee\" id=\"Podcast-player\">\n\n<script class=\"podigee-podcast-player\" src=\"https:\/\/player.podigee-cdn.net\/podcast-player\/javascripts\/podigee-podcast-player.js\" data-configuration=\"https:\/\/podcastae8fac.podigee.io\/428-new-episode\/embed?context=external\"><\/script>\n\n\n\n<a class=\"gb-button gb-button-dbb384bd smooth-scroll mobile-btn-left\" href=\"\/podcast\/\" aria-label=\"Zu den Modulen\"><span class=\"gb-icon\"><svg aria-hidden=\"true\" role=\"img\" height=\"1em\" width=\"1em\" viewBox=\"0 0 256 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path fill=\"currentColor\" d=\"M224.3 273l-136 136c-9.4 9.4-24.6 9.4-33.9 0l-22.6-22.6c-9.4-9.4-9.4-24.6 0-33.9l96.4-96.4-96.4-96.4c-9.4-9.4-9.4-24.6 0-33.9L54.3 103c9.4-9.4 24.6-9.4 33.9 0l136 136c9.5 9.4 9.5 24.6.1 34z\"><\/path><\/svg><\/span><span class=\"gb-button-text\">All Episodes<\/span><\/a>\n\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-61f59e18\">\n<div class=\"gb-grid-column gb-grid-column-5384fd4d\"><div class=\"gb-container gb-container-5384fd4d\"><div class=\"gb-inside-container\">\n\n<p>In this episode, I welcome back <a href=\"https:\/\/www.linkedin.com\/in\/necdet-gunsoy-11420b59\/\" target=\"_blank\" rel=\"noopener\" title=\"Necdet Gunsoy\"><strong>Necdet Gunsoy<\/strong><\/a>, who\u2019s now in a new role as the founder of <a href=\"https:\/\/www.evimed.co.uk\/\" target=\"_blank\" rel=\"noopener\" title=\"EviMed\"><strong>EviMed<\/strong><\/a>, a boutique consultancy specializing in health economics, outcomes research, real-world evidence, and market access. <\/p>\n\n\n\n<p>We dive into the often tense relationship between statisticians and market access professionals, exploring why these functions struggle to collaborate and, more importantly, how we can work together more effectively.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What You\u2019ll Learn in This Episode<\/strong><\/h3>\n\n\n\n<!--more-->\n\n\n\n<p>\u2714 Necdet\u2019s Journey<\/p>\n\n\n\n<p>\u2714 Breaking Down Key Market Access Concepts<\/p>\n\n\n\n<p>\u2714 The Real Cost of Poor Collaboration<\/p>\n\n\n\n<p>\u2714 How We Can Work Together More Effectively<\/p>\n\n\n\n<p>\u2714 Looking Ahead: The Impact of Joint Clinical Assessment (JCA)<\/p>\n\n<\/div><\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-182f6279\"><div class=\"gb-container gb-container-182f6279\"><div class=\"gb-inside-container\">\n\n<h3 class=\"wp-block-heading\"><strong>Why You Should Listen<\/strong><\/h3>\n\n\n\n<p>If you work in biostatistics, health economics, or market access, this episode is packed with practical insights to help you collaborate more effectively. Whether you&#8217;re a statistician looking to better support HTA submissions or a market access professional trying to understand statistical challenges, you\u2019ll walk away with actionable strategies that can make a real difference.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Resources &amp; Links<\/strong><\/h3>\n\n\n\n<p><strong>Resources &amp; Links:<\/strong> <br>\ud83d\udd17 Necdet Gunsoy on <a href=\"https:\/\/www.linkedin.com\/in\/necdet-gunsoy-11420b59\/\" target=\"_blank\" rel=\"noopener\" title=\"LinkedIn\"><em><span style=\"text-decoration: underline;\">LinkedIn<\/span><\/em><\/a><br>\ud83d\udd17 <a href=\"https:\/\/www.evimed.co.uk\/\" target=\"_blank\" rel=\"noopener\" title=\"EviMed\"><em><span style=\"text-decoration: underline;\">EviMed<\/span><\/em><\/a><br>\ud83d\udd17 <em><a href=\"https:\/\/theeffectivestatisticianleadershipprogram.teachable.com\/\" target=\"_blank\" rel=\"noopener\" title=\"The Effective Statistician Academy\"><span style=\"text-decoration: underline;\">The Effective Statistician Academy<\/span><\/a><\/em> \u2013 I offer free and premium resources to help you become a more effective statistician.<br>\ud83d\udd17 <em><a href=\"https:\/\/theeffectivestatistician.com\/leadership-program\/\" target=\"_blank\" rel=\"noopener\" title=\"Medical Data Leaders Community\"><span style=\"text-decoration: underline;\">Medical Data Leaders Community<\/span><\/a><\/em> \u2013 Join my network of statisticians and data leaders to enhance your influencing skills.<br>\ud83d\udd17 <a href=\"https:\/\/theeffectivestatistician.com\/book-launch\/\" target=\"_blank\" rel=\"noopener\" title=\"My New Book: How to Be an Effective Statistician - Volume 1 \"><span style=\"text-decoration: underline;\"><em>My New Book: How to Be an Effective Statistician &#8211; Volume 1<\/em> <\/span><\/a>\u2013 It\u2019s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.<br>\ud83d\udd17 <em><a href=\"https:\/\/www.psiweb.org\/\" target=\"_blank\" rel=\"noopener\" title=\"PSI (Statistical Community in Healthcare)\"><span style=\"text-decoration: underline;\">PSI (Statistical Community in Healthcare)<\/span><\/a><\/em> \u2013 Access webinars, training, and networking opportunities.<\/p>\n\n\n\n<p><strong>Join the Conversation:<\/strong><br>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.<\/p>\n\n\n\n<p><strong>Subscribe &amp; Stay Updated:<\/strong><br>Never miss an episode! Subscribe to <em>The Effective Statistician<\/em> on your favorite podcast platform and continue growing your influence as a statistician.<\/p>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-1837dffa\">\n<div class=\"gb-grid-column gb-grid-column-20e364f2\"><div class=\"gb-container gb-container-20e364f2\">\n\n<figure class=\"wp-block-image size-full\"><a href=\"https:\/\/podcasts.apple.com\/us\/podcast\/the-effective-statistician-in-association-with-psi\/id1360198752\" target=\"_blank\" rel=\" noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"900\" height=\"300\" src=\"https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-69-1.png\" alt=\"\" class=\"wp-image-9617\" srcset=\"https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-69-1.png 900w, https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-69-1-300x100.png 300w, https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-69-1-768x256.png 768w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><\/a><\/figure>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-f45f4a02\"><div class=\"gb-container gb-container-f45f4a02\">\n\n<figure class=\"wp-block-image size-full is-resized\"><a href=\"https:\/\/open.spotify.com\/show\/7gD9D4feE2uGozsa7O32pq?si=cda91c16e8034062\" target=\"_blank\" rel=\" noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"900\" height=\"300\" src=\"https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-70-1.png\" alt=\"\" class=\"wp-image-9618\" style=\"width:260px;height:auto\" srcset=\"https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-70-1.png 900w, https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-70-1-300x100.png 300w, https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Untitled-design-70-1-768x256.png 768w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><\/a><\/figure>\n\n<\/div><\/div>\n<\/div>\n<\/div><\/div><\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n\n\n<div class=\"gb-container gb-container-e6cde9c5\" id=\"learn-on-demand\"><div class=\"gb-inside-container\">\n\n<h3 class=\"gb-headline gb-headline-ca2cdf98 gb-headline-text\" id=\"Sales\">Learn on demand<\/h3>\n\n\n<p>[borlabs-cookie id=&#8221;teachable&#8221; type=&#8221;content-blocker&#8221;]<div class=\"courses\"><\/div><\/div>[\/borlabs-cookie]<\/p>\n\n<\/div><\/div>\n\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\"><\/div>\n\n\n\n<p><\/p>\n\n\n<div class=\"gb-container gb-container-a3062584\">\n<div class=\"gb-container gb-container-7b2ab4cd\" id=\"Transcript\"><div class=\"gb-inside-container\">\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\"><a href=\"https:\/\/www.linkedin.com\/in\/necdet-gunsoy-11420b59\/\" target=\"_blank\" rel=\"noopener\" title=\"Necdet Gunsoy, MPH PhD\">Necdet Gunsoy, MPH PhD<\/a><\/h3>\n\n\n\n<p>Founder &amp; Managing Director of <a href=\"https:\/\/www.evimed.co.uk\/\" target=\"_blank\" rel=\"noopener\" title=\"Evimed\"><strong><span style=\"text-decoration: underline;\">Evimed<\/span><\/strong><\/a><\/p>\n\n\n\n<p>Necdet Gunsoy has over a decade of technical and leadership expertise in the pharmaceutical industry, specializing in health economics and outcomes research (HEOR), health technology assessment (HTA), indirect treatment comparisons (ITC), and real world evidence (RWE). He has a proven track record of developing reimbursement evidence and economic models for global markets, including key regions such as the UK, Germany, France, and Canada. Necdet&#8217;s extensive leadership experience includes building and managing large technical teams, launch evidence strategy planning, preparation, and execution. His technical knowledge and strategic insights have made significant contributions to market access and pricing strategies in diverse therapeutic areas.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<figure class=\"wp-block-image size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"912\" height=\"774\" src=\"https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Necdet-1.avif\" alt=\"\" class=\"wp-image-9689\" style=\"width:385px;height:auto\" srcset=\"https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Necdet-1.avif 912w, https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Necdet-1-300x255.avif 300w, https:\/\/clinicalresearchpulse.com\/wp-content\/uploads\/2025\/03\/Necdet-1-768x652.avif 768w\" sizes=\"auto, (max-width: 912px) 100vw, 912px\" \/><\/figure>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"gb-headline gb-headline-abbcc7f6 gb-headline-text\"><strong>Transcript<\/strong><\/h3>\n\n\n\n<p><strong>Statistics and Market access &#8211; from foes to friends<\/strong><\/p>\n\n\n\n<p>00:00:00.640 &#8211;&gt; 00:00:16.855<br>You are listening to the Effective Statistician Podcast, the weekly podcast with Alexander Schacht and Benjamin Piske designed to help you reach your potential, lead great science, and serve patients while having a great work life balance.<\/p>\n\n\n\n<p>00:00:23.315 &#8211;&gt; 00:00:39.175<br>In addition to our premium courses on the Effective Statistician Academy, we also have lots of free resources for you across all kind of different topics within that academy.<\/p>\n\n\n\n<p>00:00:39.635 &#8211;&gt; 00:00:50.055<br>Head over to www.theeffectivestatistician.com and find the academy and much more for you to become an effective statistician.<\/p>\n\n\n\n<p>00:00:50.930 &#8211;&gt; 00:01:01.670<br>I&#8217;m producing this podcast in association with PSI, a community dedicated to leading and promoting the use of statistics within the health care industry for the benefit of patients.<\/p>\n\n\n\n<p>00:01:02.290 &#8211;&gt; 00:01:14.605<br>Join PSI today to further develop your statistical capabilities with access to the ever growing video on demand content library, free registration to all PSI webinars and much, much more.<\/p>\n\n\n\n<p>00:01:14.985 &#8211;&gt; 00:01:23.670<br>Head over to the PSI website at psiweb.org to learn more about PSI activities and become a PSI member today.<\/p>\n\n\n\n<p>00:01:31.045 &#8211;&gt; 00:01:33.865<br>Welcome to another episode of the effective statistician.<\/p>\n\n\n\n<p>00:01:34.325 &#8211;&gt; 00:01:43.445<br>Today, I&#8217;m super happy to have someone on the podcast that already has been on the show, but now in a new role.<\/p>\n\n\n\n<p>00:01:43.445 &#8211;&gt; 00:01:44.185<br>Hi, Necdet.<\/p>\n\n\n\n<p>00:01:44.245 &#8211;&gt; 00:01:45.065<br>How are you doing?<\/p>\n\n\n\n<p>00:01:45.640 &#8211;&gt; 00:01:46.380<br>Hi, Alexander.<\/p>\n\n\n\n<p>00:01:46.440 &#8211;&gt; 00:01:46.920<br>I&#8217;m good.<\/p>\n\n\n\n<p>00:01:46.920 &#8211;&gt; 00:01:47.320<br>I&#8217;m good.<\/p>\n\n\n\n<p>00:01:47.320 &#8211;&gt; 00:01:48.200<br>How are you doing?<\/p>\n\n\n\n<p>00:01:48.200 &#8211;&gt; 00:01:49.260<br>It&#8217;s been a while.<\/p>\n\n\n\n<p>00:01:49.800 &#8211;&gt; 00:01:55.500<br>It&#8217;s been a while since you&#8217;ve been on the show, and there has been some changes on your end.<\/p>\n\n\n\n<p>00:01:55.560 &#8211;&gt; 00:01:59.745<br>Let&#8217;s talk shortly about this and, introduce yourself and what you&#8217;re doing now.<\/p>\n\n\n\n<p>00:01:59.985 &#8211;&gt; 00:02:00.225<br>Yes.<\/p>\n\n\n\n<p>00:02:00.225 &#8211;&gt; 00:02:00.705<br>Of course.<\/p>\n\n\n\n<p>00:02:00.705 &#8211;&gt; 00:02:02.485<br>So I&#8217;m, Necdet Gunsoy.<\/p>\n\n\n\n<p>00:02:02.785 &#8211;&gt; 00:02:07.925<br>I think the last time that I spoke on the podcast was at PSI.<\/p>\n\n\n\n<p>00:02:08.145 &#8211;&gt; 00:02:11.265<br>I feel like saying 2018, maybe 2019.<\/p>\n\n\n\n<p>00:02:11.265 &#8211;&gt; 00:02:16.040<br>I I can&#8217;t remember, but it was about, subgroups, I think.<\/p>\n\n\n\n<p>00:02:16.040 &#8211;&gt; 00:02:17.020<br>That was the episode.<\/p>\n\n\n\n<p>00:02:17.240 &#8211;&gt; 00:02:23.660<br>So since then, I&#8217;ve actually shifted more into working in HTA and market access.<\/p>\n\n\n\n<p>00:02:23.720 &#8211;&gt; 00:02:26.620<br>I was in GSK back then, and then I moved to AbbVie.<\/p>\n\n\n\n<p>00:02:26.920 &#8211;&gt; 00:02:43.460<br>But recently, I left AbbVie, and I&#8217;ve set up my consultancy company called EviMed, and we are a kind of boutique technical consultancy which specialize in health economics and outcomes research, real world evidence, HTA and market access.<\/p>\n\n\n\n<p>00:02:43.680 &#8211;&gt; 00:02:44.180<br>Yeah.<\/p>\n\n\n\n<p>00:02:44.400 &#8211;&gt; 00:02:50.640<br>Which is quite an interesting perspective because that is the topics that we&#8217;ll talk about today.<\/p>\n\n\n\n<p>00:02:50.640 &#8211;&gt; 00:03:10.885<br>You have now worked on both sides, on the statistics side as well as on the market access side, And you support also both sides with your business, which I think is brilliant because there&#8217;s a very often a lot of struggle between market access organizations and statistics organizations.<\/p>\n\n\n\n<p>00:03:11.505 &#8211;&gt; 00:03:18.940<br>And me having worked as an HDA statistician for quite a long time, I know what I&#8217;m talking about.<\/p>\n\n\n\n<p>00:03:20.520 &#8211;&gt; 00:03:26.060<br>So why do you see these organizations very often struggle with each other?<\/p>\n\n\n\n<p>00:03:26.395 &#8211;&gt; 00:03:30.975<br>It&#8217;s complex really, but I think it really boils down to a few key things.<\/p>\n\n\n\n<p>00:03:31.195 &#8211;&gt; 00:03:49.690<br>You know, I think when you&#8217;re a statistician and if, let&#8217;s say, you&#8217;re not necessarily split in different functions within statistics, generally speaking, the request for mark access or the preparation for HTA reimbursement submissions, it starts often at the same time that, you know, the statistician is busy with regulatory submissions.<\/p>\n\n\n\n<p>00:03:49.690 &#8211;&gt; 00:03:58.335<br>So actually running all the clinical trial analysis that would go into the regulatory submissions or in the course of the regulatory submission when you&#8217;re getting questions and you have to all of these requests.<\/p>\n\n\n\n<p>00:03:58.335 &#8211;&gt; 00:04:09.235<br>Perhaps one of the big struggles is always getting these requests when you are being told from other stakeholders that, you know, regulatory is the top priority and you can&#8217;t work on anything else.<\/p>\n\n\n\n<p>00:04:09.375 &#8211;&gt; 00:04:14.390<br>Another thing that&#8217;s confusing for statisticians, right, is they&#8217;ll get a lot of requests.<\/p>\n\n\n\n<p>00:04:14.390 &#8211;&gt; 00:04:14.630<br>Right?<\/p>\n\n\n\n<p>00:04:14.630 &#8211;&gt; 00:04:30.515<br>There&#8217;ll be a lot and I do mean a lot sort of maybe like thousands of tables that the mark access team is asking for things requests for lots of different countries And often this leads to a lot of confusion from the stats end because, you know, they&#8217;re thinking why is there so much?<\/p>\n\n\n\n<p>00:04:30.515 &#8211;&gt; 00:04:35.075<br>Why is it you know, on the market access side, it&#8217;s sort of the flip you know, the other side of the coin.<\/p>\n\n\n\n<p>00:04:35.075 &#8211;&gt; 00:04:35.315<br>Right?<\/p>\n\n\n\n<p>00:04:35.315 &#8211;&gt; 00:04:41.500<br>For them, obviously obviously, like, you can&#8217;t have patients can&#8217;t have access to a medicine without regulatory approval.<\/p>\n\n\n\n<p>00:04:41.500 &#8211;&gt; 00:04:41.980<br>Right?<\/p>\n\n\n\n<p>00:04:41.980 &#8211;&gt; 00:04:44.140<br>But equally, you can have regulatory approval.<\/p>\n\n\n\n<p>00:04:44.140 &#8211;&gt; 00:04:46.720<br>If it&#8217;s not reimbursed, the patients don&#8217;t get it either.<\/p>\n\n\n\n<p>00:04:46.780 &#8211;&gt; 00:04:56.145<br>And so, you know, it&#8217;s a very important priority as well to ensure that we&#8217;re doing reimbursement submissions as quickly and as early as possible so that patients get access as soon as possible.<\/p>\n\n\n\n<p>00:04:56.145 &#8211;&gt; 00:04:56.385<br>Right?<\/p>\n\n\n\n<p>00:04:56.385 &#8211;&gt; 00:04:57.825<br>That makes sense.<\/p>\n\n\n\n<p>00:04:57.825 &#8211;&gt; 00:05:09.600<br>There&#8217;s always this kind of dynamic between kind of regulatory and reimbursement that always kind of causes a lot of anxiety between different functions, a lot of confusion, a lot of stress.<\/p>\n\n\n\n<p>00:05:10.140 &#8211;&gt; 00:05:15.660<br>And the last thing, and I think this is on both sides as well, is just the foundational knowledge.<\/p>\n\n\n\n<p>00:05:15.660 &#8211;&gt; 00:05:16.160<br>Right?<\/p>\n\n\n\n<p>00:05:16.540 &#8211;&gt; 00:05:27.515<br>Being in statistics, you know, I think I experience statisticians don&#8217;t really understand how mock access necessarily works, how reimbursement submissions work<\/p>\n\n\n\n<p>00:05:27.755 &#8211;&gt; 00:05:27.995<br>Yeah.<\/p>\n\n\n\n<p>00:05:28.315 &#8211;&gt; 00:05:31.935<br>What evidence is needed for them, what are the different steps.<\/p>\n\n\n\n<p>00:05:32.315 &#8211;&gt; 00:05:37.260<br>And that fuels the idea that they&#8217;re confused and they don&#8217;t understand why these are coming from.<\/p>\n\n\n\n<p>00:05:37.340 &#8211;&gt; 00:05:53.935<br>On the market access side, maybe what they lack is a little bit understanding around how stats work more like in terms of processes and, you know, how maybe something simple can actually take a lot of time to do because of the systems, approvals, all of these kinds of things.<\/p>\n\n\n\n<p>00:05:53.935 &#8211;&gt; 00:05:56.655<br>You know, I hear a lot of kind of folks in Mark Access.<\/p>\n\n\n\n<p>00:05:56.655 &#8211;&gt; 00:05:58.415<br>They&#8217;ll say, oh, it&#8217;s just the click of a button.<\/p>\n\n\n\n<p>00:05:58.415 &#8211;&gt; 00:05:58.655<br>Right?<\/p>\n\n\n\n<p>00:05:58.655 &#8211;&gt; 00:06:00.255<br>You know, it&#8217;s like a couple of analysis.<\/p>\n\n\n\n<p>00:06:00.255 &#8211;&gt; 00:06:01.535<br>All they have to do is click a button.<\/p>\n\n\n\n<p>00:06:01.535 &#8211;&gt; 00:06:02.915<br>Why does it take three months?<\/p>\n\n\n\n<p>00:06:03.980 &#8211;&gt; 00:06:09.200<br>And so it&#8217;s that kind of mutual lack of understanding a little bit makes it, very challenging as well.<\/p>\n\n\n\n<p>00:06:09.740 &#8211;&gt; 00:06:09.980<br>Yeah.<\/p>\n\n\n\n<p>00:06:09.980 &#8211;&gt; 00:06:17.615<br>I think one of the misunderstandings are all the acronyms and abbreviations and terms that I use.<\/p>\n\n\n\n<p>00:06:17.675 &#8211;&gt; 00:06:26.175<br>As you started to introduce yourself, I was thinking like, oh my god, maybe there&#8217;s a lot of confusion about all these terms.<\/p>\n\n\n\n<p>00:06:26.395 &#8211;&gt; 00:06:26.895<br>Yeah.<\/p>\n\n\n\n<p>00:06:27.115 &#8211;&gt; 00:06:31.455<br>So let&#8217;s shortly walk through what that actually means.<\/p>\n\n\n\n<p>00:06:31.610 &#8211;&gt; 00:06:35.310<br>The first abbreviation you mentioned is HTA.<\/p>\n\n\n\n<p>00:06:35.770 &#8211;&gt; 00:06:37.310<br>What is actually HTA?<\/p>\n\n\n\n<p>00:06:38.250 &#8211;&gt; 00:06:40.350<br>HTA is health technology assessment.<\/p>\n\n\n\n<p>00:06:40.650 &#8211;&gt; 00:06:43.470<br>Generally refers to the process of trying to get reimbursement.<\/p>\n\n\n\n<p>00:06:43.530 &#8211;&gt; 00:06:43.995<br>Right?<\/p>\n\n\n\n<p>00:06:44.075 &#8211;&gt; 00:06:45.515<br>So you&#8217;ll do an h t a dossier.<\/p>\n\n\n\n<p>00:06:45.515 &#8211;&gt; 00:06:46.895<br>People say h t a dossier.<\/p>\n\n\n\n<p>00:06:47.115 &#8211;&gt; 00:06:49.055<br>Sometimes they&#8217;ll say a reimbursement dossier.<\/p>\n\n\n\n<p>00:06:49.355 &#8211;&gt; 00:06:52.955<br>Pedanticly speaking, h t a probably refers to the t a agency.<\/p>\n\n\n\n<p>00:06:52.955 &#8211;&gt; 00:06:58.175<br>So every country will have an agency that assesses the reimbursement of products.<\/p>\n\n\n\n<p>00:06:58.400 &#8211;&gt; 00:07:00.960<br>They&#8217;re not necessarily an h t a agency.<\/p>\n\n\n\n<p>00:07:00.960 &#8211;&gt; 00:07:17.115<br>So when we say h t a agency, it&#8217;s probably like a mature, evolved agency that has a very set and defined process for evaluating the efficacy, safety, and sort of pharmacoeconomic value of a particular treatment.<\/p>\n\n\n\n<p>00:07:17.255 &#8211;&gt; 00:07:22.615<br>People would interchangeably refer to HTA or reimbursement or these kinds of terms.<\/p>\n\n\n\n<p>00:07:22.615 &#8211;&gt; 00:07:23.115<br>Yeah.<\/p>\n\n\n\n<p>00:07:23.620 &#8211;&gt; 00:07:28.500<br>And HTA agencies are, for example, in The UK, it&#8217;s NICE.<\/p>\n\n\n\n<p>00:07:28.500 &#8211;&gt; 00:07:29.960<br>In Germany, it&#8217;s ICBIC.<\/p>\n\n\n\n<p>00:07:30.340 &#8211;&gt; 00:07:32.040<br>In France, it&#8217;s HAS.<\/p>\n\n\n\n<p>00:07:32.420 &#8211;&gt; 00:07:33.080<br>That&#8217;s right.<\/p>\n\n\n\n<p>00:07:33.860 &#8211;&gt; 00:07:38.295<br>In Canada, I think is c h d t h.<\/p>\n\n\n\n<p>00:07:38.435 &#8211;&gt; 00:07:40.355<br>So it used to be CATHITH, but it&#8217;s changed now.<\/p>\n\n\n\n<p>00:07:40.355 &#8211;&gt; 00:07:41.715<br>It&#8217;s, called the CDA.<\/p>\n\n\n\n<p>00:07:41.715 &#8211;&gt; 00:07:42.755<br>So they&#8217;ve joined.<\/p>\n\n\n\n<p>00:07:42.755 &#8211;&gt; 00:07:43.575<br>They&#8217;ve reorganised.<\/p>\n\n\n\n<p>00:07:43.955 &#8211;&gt; 00:07:45.075<br>It&#8217;s a different agency.<\/p>\n\n\n\n<p>00:07:45.075 &#8211;&gt; 00:07:45.575<br>Yeah.<\/p>\n\n\n\n<p>00:07:45.715 &#8211;&gt; 00:07:46.115<br>Yeah.<\/p>\n\n\n\n<p>00:07:46.115 &#8211;&gt; 00:07:48.915<br>So you will have acronyms from all over the place.<\/p>\n\n\n\n<p>00:07:48.915 &#8211;&gt; 00:07:52.970<br>And in The US, there&#8217;s an organization called ISA.<\/p>\n\n\n\n<p>00:07:53.350 &#8211;&gt; 00:07:55.050<br>It&#8217;s also quite impactful.<\/p>\n\n\n\n<p>00:07:55.510 &#8211;&gt; 00:08:04.730<br>Since they named themselves ISA isn&#8217;t really helpful because that is also an acronym for something else, but that&#8217;s, that&#8217;s another topic.<\/p>\n\n\n\n<p>00:08:04.870 &#8211;&gt; 00:08:07.775<br>These are the HTA organizations.<\/p>\n\n\n\n<p>00:08:08.075 &#8211;&gt; 00:08:15.295<br>And these are similar to FDA or EMA, but they all exist just on a local level.<\/p>\n\n\n\n<p>00:08:15.355 &#8211;&gt; 00:08:19.215<br>So you don&#8217;t have any kind of global organizations there.<\/p>\n\n\n\n<p>00:08:19.275 &#8211;&gt; 00:08:22.870<br>I think that leads also to the next challenge.<\/p>\n\n\n\n<p>00:08:23.730 &#8211;&gt; 00:08:30.230<br>Market access, is that actually just a local function, or is that also a global function?<\/p>\n\n\n\n<p>00:08:30.930 &#8211;&gt; 00:08:31.250<br>Both.<\/p>\n\n\n\n<p>00:08:31.250 &#8211;&gt; 00:08:36.875<br>There&#8217;ll be market access generally at the global, regional, local level.<\/p>\n\n\n\n<p>00:08:37.095 &#8211;&gt; 00:08:43.655<br>And, yes, mark access is, let&#8217;s say, vision is to provide access for patients to new medicines.<\/p>\n\n\n\n<p>00:08:43.655 &#8211;&gt; 00:08:43.815<br>Right?<\/p>\n\n\n\n<p>00:08:43.815 &#8211;&gt; 00:08:44.935<br>That&#8217;s their ultimate goal.<\/p>\n\n\n\n<p>00:08:44.935 &#8211;&gt; 00:08:48.390<br>But there&#8217;s a lot more to mark access than just the HTA.<\/p>\n\n\n\n<p>00:08:48.390 &#8211;&gt; 00:08:48.630<br>HTA.<\/p>\n\n\n\n<p>00:08:48.630 &#8211;&gt; 00:08:48.870<br>Right?<\/p>\n\n\n\n<p>00:08:48.870 &#8211;&gt; 00:08:49.990<br>Maybe that&#8217;s the end of it.<\/p>\n\n\n\n<p>00:08:49.990 &#8211;&gt; 00:08:50.230<br>Right?<\/p>\n\n\n\n<p>00:08:50.230 &#8211;&gt; 00:08:52.890<br>That&#8217;s at the end you&#8217;re getting the reimbursement.<\/p>\n\n\n\n<p>00:08:53.270 &#8211;&gt; 00:09:04.090<br>Still goes on afterwards because then there&#8217;s thinking about competitive positioning, kind of all of the follow-up work to make sure that you are constantly disseminating the value of your treatment to patients.<\/p>\n\n\n\n<p>00:09:04.205 &#8211;&gt; 00:09:32.010<br>The market access concept starts very early on in the process from even when you&#8217;re deciding whether or not you&#8217;re investing in an asset or not because, you know, part of what market access would do is kind of define a strategy, a market access strategy for a product, and it starts as early as phase one, even preclinical I&#8217;ve experienced, where you try and think about the potential value for treatment for patients might be of this drug when it&#8217;s commercialized in, you know, five, ten years depending on what you&#8217;re looking at.<\/p>\n\n\n\n<p>00:09:32.010 &#8211;&gt; 00:09:41.225<br>But so there&#8217;s a strategy in terms of, you know, how we achieve access and really HTA is more like the kind of almost the end game where you executing that submission.<\/p>\n\n\n\n<p>00:09:41.525 &#8211;&gt; 00:09:51.050<br>Of course, with HTA it&#8217;s, you start early as well because clinical trial design, you need to think ahead of whether your clinical trial design is addressing the needs of agencies.<\/p>\n\n\n\n<p>00:09:51.990 &#8211;&gt; 00:10:08.605<br>Just like with regulatory bodies, you go for early scientific advice with agencies to kind of understand, you know, what would be relevant comparators, what would be endpoints that they&#8217;re interested in, what are the value drivers from a payer perspective.<\/p>\n\n\n\n<p>00:10:08.665 &#8211;&gt; 00:10:19.340<br>So again, we refer to payer as the organisations who pay for treatments and thinking about all of these things would be kind of the market access role, per se.<\/p>\n\n\n\n<p>00:10:19.340 &#8211;&gt; 00:10:22.160<br>And then when you have this, you have, like, a global strategy.<\/p>\n\n\n\n<p>00:10:22.220 &#8211;&gt; 00:10:22.700<br>Right?<\/p>\n\n\n\n<p>00:10:22.700 &#8211;&gt; 00:10:27.040<br>And obviously, you have a global strategy which has kind of maybe your value proposition.<\/p>\n\n\n\n<p>00:10:27.100 &#8211;&gt; 00:10:27.980<br>Like, what&#8217;s the value?<\/p>\n\n\n\n<p>00:10:27.980 &#8211;&gt; 00:10:29.900<br>How do you communicate the value of this treatment?<\/p>\n\n\n\n<p>00:10:29.900 &#8211;&gt; 00:10:44.875<br>And then obviously, we have then from a regional and local level, how that is actually operationalized will vary from country to country because payers are different, regulations are different, the environment is different, guidelines are different, and so that&#8217;s how the local part works.<\/p>\n\n\n\n<p>00:10:45.130 &#8211;&gt; 00:10:50.650<br>There&#8217;s another abbreviation that I hear very often, p r a Mhmm.<\/p>\n\n\n\n<p>00:10:50.730 &#8211;&gt; 00:10:52.590<br>Pricing reimbursement and access.<\/p>\n\n\n\n<p>00:10:53.130 &#8211;&gt; 00:10:56.250<br>This acronym speaks also to the other parts of it.<\/p>\n\n\n\n<p>00:10:56.250 &#8211;&gt; 00:10:56.650<br>Mhmm.<\/p>\n\n\n\n<p>00:10:56.650 &#8211;&gt; 00:10:59.035<br>It&#8217;s not just the getting access.<\/p>\n\n\n\n<p>00:10:59.035 &#8211;&gt; 00:11:01.375<br>It&#8217;s also about the reimbursement piece.<\/p>\n\n\n\n<p>00:11:01.515 &#8211;&gt; 00:11:09.855<br>And of course, setting the price is a very delicate thing because, that is not as easy as setting a price for any other products.<\/p>\n\n\n\n<p>00:11:09.995 &#8211;&gt; 00:11:19.720<br>There&#8217;s high dependencies between the different markets and prices will vary quite a lot and it can also vary over time quite a lot.<\/p>\n\n\n\n<p>00:11:20.260 &#8211;&gt; 00:11:20.500<br>Yeah.<\/p>\n\n\n\n<p>00:11:20.500 &#8211;&gt; 00:11:24.740<br>Pricing is very, very complicated and variable across countries.<\/p>\n\n\n\n<p>00:11:24.740 &#8211;&gt; 00:11:26.420<br>The rules are different in each country.<\/p>\n\n\n\n<p>00:11:26.420 &#8211;&gt; 00:11:27.800<br>The mechanisms are different.<\/p>\n\n\n\n<p>00:11:28.215 &#8211;&gt; 00:11:30.295<br>The the evidence supporting pricing is different.<\/p>\n\n\n\n<p>00:11:30.295 &#8211;&gt; 00:11:31.755<br>The methods used are different.<\/p>\n\n\n\n<p>00:11:31.815 &#8211;&gt; 00:11:35.495<br>But pricing also is this is kind of the same philosophy as market access.<\/p>\n\n\n\n<p>00:11:35.495 &#8211;&gt; 00:11:45.150<br>You would generally have a strategy on pricing, which is global, and then those would kind of be locally translated locally and how it applies locally.<\/p>\n\n\n\n<p>00:11:45.530 &#8211;&gt; 00:11:52.430<br>But, again, it starts with a global vision, and it kind of filters through to the regions and to local countries.<\/p>\n\n\n\n<p>00:11:52.570 &#8211;&gt; 00:11:53.070<br>Yeah.<\/p>\n\n\n\n<p>00:11:54.045 &#8211;&gt; 00:12:06.385<br>Then these two other acronyms that you mentioned, RWE and Health Outcomes and Research or Health Economics and Outcomes Research, HEOR.<\/p>\n\n\n\n<p>00:12:07.165 &#8211;&gt; 00:12:07.985<br>That&#8217;s right.<\/p>\n\n\n\n<p>00:12:08.120 &#8211;&gt; 00:12:11.580<br>What is that compared to PRA or market access?<\/p>\n\n\n\n<p>00:12:12.040 &#8211;&gt; 00:12:20.775<br>So h o r, maybe h o r, all the way perhaps represents more of the, let&#8217;s say, the scientific arm of what is market access in general.<\/p>\n\n\n\n<p>00:12:20.775 &#8211;&gt; 00:12:25.495<br>I mean, people may disagree or agree, but so HUI is two bits.<\/p>\n\n\n\n<p>00:12:25.495 &#8211;&gt; 00:12:25.735<br>Right?<\/p>\n\n\n\n<p>00:12:25.735 &#8211;&gt; 00:12:28.315<br>There&#8217;s the health economics and there&#8217;s the outcomes research.<\/p>\n\n\n\n<p>00:12:28.935 &#8211;&gt; 00:12:31.495<br>So the health economics side is basically what it is.<\/p>\n\n\n\n<p>00:12:31.495 &#8211;&gt; 00:12:31.735<br>Right?<\/p>\n\n\n\n<p>00:12:31.735 &#8211;&gt; 00:12:33.915<br>It&#8217;s kind of trying to merge health and economics.<\/p>\n\n\n\n<p>00:12:33.975 &#8211;&gt; 00:12:38.500<br>It&#8217;s trying to demonstrate the value of treatments more in economics terms.<\/p>\n\n\n\n<p>00:12:38.880 &#8211;&gt; 00:12:42.980<br>There are different types of tools that would be used to kind of demonstrate that.<\/p>\n\n\n\n<p>00:12:43.440 &#8211;&gt; 00:12:52.175<br>You may have heard of cost effectiveness models, which is trying to calculate the incremental cost effectiveness ratio, which is the, the other thing for ISA.<\/p>\n\n\n\n<p>00:12:52.875 &#8211;&gt; 00:13:01.775<br>So that looks at, you know, how much extra does a new drug cost versus how much benefit is it providing, how much does it prolong the quality of life of patients.<\/p>\n\n\n\n<p>00:13:02.460 &#8211;&gt; 00:13:09.840<br>Some countries have thresholds in terms of how much they&#8217;re willing to pay for a certain improvement in quality of life for patients.<\/p>\n\n\n\n<p>00:13:10.300 &#8211;&gt; 00:13:14.160<br>And that would be the basis of kind of setting the price in those countries.<\/p>\n\n\n\n<p>00:13:14.565 &#8211;&gt; 00:13:18.805<br>You have other tools, kind of budget impact models or cost comparison models.<\/p>\n\n\n\n<p>00:13:18.805 &#8211;&gt; 00:13:21.065<br>But anyway, that&#8217;s kind of the health economic side.<\/p>\n\n\n\n<p>00:13:21.205 &#8211;&gt; 00:13:26.485<br>The outcomes research side is more focused on trying to quantify the impact on patients.<\/p>\n\n\n\n<p>00:13:26.485 &#8211;&gt; 00:13:26.725<br>Right?<\/p>\n\n\n\n<p>00:13:26.725 &#8211;&gt; 00:13:46.085<br>So it goes from things like burden of illness to patient reported outcomes, patient experience, all these kinds of things that are not quite kind of hard efficacy endpoints, let&#8217;s say, but more thinking about the quality of life aspects of patients and also outcomes in terms of kind of long term outcomes of disease.<\/p>\n\n\n\n<p>00:13:46.085 &#8211;&gt; 00:13:58.185<br>You know, it&#8217;s a little bit of a mix of maybe the epidemiology as well, but it&#8217;s more that that outcomes type of research can be using clinical trial data, but would use kind of other sources of data as well, you know, observational data, etcetera.<\/p>\n\n\n\n<p>00:13:58.520 &#8211;&gt; 00:14:02.620<br>And then real world evidence is sort of like, let&#8217;s say a piece of all of this as well.<\/p>\n\n\n\n<p>00:14:02.680 &#8211;&gt; 00:14:10.380<br>I think we can simplify it by saying real world evidence is any kind of research that is done on data from the real world per se.<\/p>\n\n\n\n<p>00:14:10.615 &#8211;&gt; 00:14:23.815<br>But generally, when people refer to real world evidence, it would be, you know, analysis of data maybe that was collected for not necessarily the purpose that you&#8217;re using it for, but data that is available there such as things like claims data in The UK.<\/p>\n\n\n\n<p>00:14:23.815 &#8211;&gt; 00:14:31.840<br>You have, like, hospital episodes, statistics, these kinds of things that you can and that you could leverage to do answer some research questions using that data.<\/p>\n\n\n\n<p>00:14:31.900 &#8211;&gt; 00:14:36.080<br>Initial purpose wasn&#8217;t specifically designed for this, but it can help answer those questions.<\/p>\n\n\n\n<p>00:14:36.140 &#8211;&gt; 00:14:50.635<br>And there&#8217;ll be a lot of real world evidence out there both in terms of health care data, but also different companies doing surveys with patients or registry studies set up by universities, for example, or patient organizations or, you know, these kinds of things.<\/p>\n\n\n\n<p>00:14:50.635 &#8211;&gt; 00:14:55.470<br>There are many different sources out there that you can use in that kind of reward evidence umbrella.<\/p>\n\n\n\n<p>00:14:55.610 &#8211;&gt; 00:14:55.930<br>Yep.<\/p>\n\n\n\n<p>00:14:55.930 &#8211;&gt; 00:15:01.870<br>And all these organizations, all these groups working on these set up differently in the different companies.<\/p>\n\n\n\n<p>00:15:02.250 &#8211;&gt; 00:15:05.070<br>But very often you will have two branches.<\/p>\n\n\n\n<p>00:15:05.370 &#8211;&gt; 00:15:12.785<br>One is more kind of the scientific part of it and the other part will be the more business side of it.<\/p>\n\n\n\n<p>00:15:13.885 &#8211;&gt; 00:15:24.600<br>And as statisticians you will most likely more work with the scientific part because they will create the HCA dosiers for example.<\/p>\n\n\n\n<p>00:15:25.380 &#8211;&gt; 00:15:37.075<br>Now when we don&#8217;t work well together what can ultimately happen if statistics, organizations, and these market access organizations don&#8217;t work well together?<\/p>\n\n\n\n<p>00:15:37.075 &#8211;&gt; 00:15:37.575<br>So<\/p>\n\n\n\n<p>00:15:38.115 &#8211;&gt; 00:15:39.235<br>probably three things.<\/p>\n\n\n\n<p>00:15:39.235 &#8211;&gt; 00:15:39.735<br>Right?<\/p>\n\n\n\n<p>00:15:39.955 &#8211;&gt; 00:15:46.775<br>The first really important thing would be not being able to have effective prioritization discussions.<\/p>\n\n\n\n<p>00:15:47.075 &#8211;&gt; 00:15:47.315<br>Right?<\/p>\n\n\n\n<p>00:15:47.315 &#8211;&gt; 00:15:58.210<br>Because when you don&#8217;t understand the why and the what and the how mutually, you can&#8217;t really have a prioritization discussion.<\/p>\n\n\n\n<p>00:15:58.590 &#8211;&gt; 00:16:14.745<br>If statisticians don&#8217;t necessarily understand, you know, have a foundation understanding of how reimbursement submissions work, what evidence goes in there, it will be very difficult for them to then negotiate competing priorities with if they&#8217;re working on regulatory or other work that they&#8217;re doing.<\/p>\n\n\n\n<p>00:16:14.885 &#8211;&gt; 00:16:23.100<br>Equally, I think that in market access, they might tend to kind of request everything they need or everything they might need in one go.<\/p>\n\n\n\n<p>00:16:23.560 &#8211;&gt; 00:16:32.540<br>And if they&#8217;re not pushed to have those prioritization discussions, it would be very they wouldn&#8217;t necessarily be able to communicate what are the priorities, effectively.<\/p>\n\n\n\n<p>00:16:32.725 &#8211;&gt; 00:16:40.985<br>And it&#8217;s maybe a lack of understanding of processes as well, right, in terms of how then those requests are managed and how they&#8217;re fulfilled in the stats organization.<\/p>\n\n\n\n<p>00:16:41.445 &#8211;&gt; 00:16:44.165<br>So that leads to kind of this inefficient handling of requests.<\/p>\n\n\n\n<p>00:16:44.165 &#8211;&gt; 00:16:44.665<br>Right?<\/p>\n\n\n\n<p>00:16:44.885 &#8211;&gt; 00:17:00.260<br>So let&#8217;s say you have a thousand tables to do and, maybe you need to write an analysis plan, get it approved, all of the stuff on the stats side and then you begin delivering on results and you&#8217;re doing this in a way that, let&#8217;s say, might be most efficient in your stats organization.<\/p>\n\n\n\n<p>00:17:00.480 &#8211;&gt; 00:17:06.835<br>So maybe you get safety done first and you send the safety results to mark access and say, well, why are you sending me safety?<\/p>\n\n\n\n<p>00:17:06.835 &#8211;&gt; 00:17:07.955<br>I don&#8217;t want safety now.<\/p>\n\n\n\n<p>00:17:07.955 &#8211;&gt; 00:17:08.755<br>I don&#8217;t need this.<\/p>\n\n\n\n<p>00:17:08.755 &#8211;&gt; 00:17:09.255<br>Right.<\/p>\n\n\n\n<p>00:17:09.715 &#8211;&gt; 00:17:15.655<br>And and actually they wanted something else first or maybe they possibly never even needed this stuff that you delivered.<\/p>\n\n\n\n<p>00:17:15.875 &#8211;&gt; 00:17:26.160<br>And that&#8217;s the inefficient side because, obviously, you know, everyone is trying to do things as efficiently as possible, but if they don&#8217;t understand what the priorities are, then it&#8217;s going to be inefficient in the end.<\/p>\n\n\n\n<p>00:17:26.160 &#8211;&gt; 00:17:37.625<br>And, ultimately, like, with all these in it lack of prioritization, inefficiencies, the worst thing that can happen is that you you end up delaying a reimbursement submission, which you could have easily avoided.<\/p>\n\n\n\n<p>00:17:37.625 &#8211;&gt; 00:17:37.865<br>Right?<\/p>\n\n\n\n<p>00:17:37.865 &#8211;&gt; 00:17:40.525<br>Because everyone&#8217;s working at very tight timelines.<\/p>\n\n\n\n<p>00:17:40.585 &#8211;&gt; 00:17:45.720<br>So even a couple of weeks delay or three weeks delay on something could mean a delay to a submission.<\/p>\n\n\n\n<p>00:17:46.100 &#8211;&gt; 00:17:53.960<br>And that ultimately means that patients are suffering from that, right, because they don&#8217;t get the treatment as early as they could have.<\/p>\n\n\n\n<p>00:17:54.020 &#8211;&gt; 00:17:54.520<br>Yep.<\/p>\n\n\n\n<p>00:17:54.580 &#8211;&gt; 00:17:56.440<br>And and that&#8217;s what we really want to avoid.<\/p>\n\n\n\n<p>00:17:56.500 &#8211;&gt; 00:17:58.600<br>I&#8217;ve seen that, and I&#8217;ve seen that happening.<\/p>\n\n\n\n<p>00:17:59.115 &#8211;&gt; 00:17:59.515<br>Yeah.<\/p>\n\n\n\n<p>00:17:59.515 &#8211;&gt; 00:18:05.855<br>Delaying reimbursement submission very often means delaying the launch of a new compound.<\/p>\n\n\n\n<p>00:18:05.995 &#8211;&gt; 00:18:19.140<br>So I&#8217;ve seen that a new drug couldn&#8217;t be launched in Germany because pricing very often depends on Germany, could therefore also not be launched in many other European countries just because of that.<\/p>\n\n\n\n<p>00:18:19.360 &#8211;&gt; 00:18:36.595<br>You have optimized everything to get regulatory approval, and then you have an approved drug that you can&#8217;t sell, which of course is a nightmare from a commercial point of view and can really increase then the pressure on getting everything ready.<\/p>\n\n\n\n<p>00:18:37.295 &#8211;&gt; 00:18:44.030<br>There&#8217;s also very often confusion about terms between these two functions.<\/p>\n\n\n\n<p>00:18:44.090 &#8211;&gt; 00:18:51.390<br>And I know of a company, a very big one, where they got confused about the term data.<\/p>\n\n\n\n<p>00:18:52.875 &#8211;&gt; 00:19:00.895<br>The statistician said, yeah, we&#8217;ll get the data by June.<\/p>\n\n\n\n<p>00:19:01.995 &#8211;&gt; 00:19:09.940<br>And then the market access people were planning everything and at the June they would start with stuff.<\/p>\n\n\n\n<p>00:19:10.880 &#8211;&gt; 00:19:30.305<br>However, the statistician was thinking we will get this data from an external organization, then we will have three months to clean it, then we will have three months to work on it for the regulatory submission, and then we will have three months to prepare it for market access.<\/p>\n\n\n\n<p>00:19:30.925 &#8211;&gt; 00:19:52.475<br>So the time delay was actually nine months between what the market access people perceived as data actually the results in forms of summary statistics and summary data and the statistics team thinking about the actual by patient level data getting that.<\/p>\n\n\n\n<p>00:19:52.855 &#8211;&gt; 00:20:04.290<br>And that is an example of not really communicating well, of this kind of superficial communication, not really understanding what is happening when.<\/p>\n\n\n\n<p>00:20:04.990 &#8211;&gt; 00:20:10.850<br>And that, of course, led to a huge kind of debate within that company.<\/p>\n\n\n\n<p>00:20:11.550 &#8211;&gt; 00:20:16.335<br>VPs got involved on why there is this huge delay and things like that.<\/p>\n\n\n\n<p>00:20:16.655 &#8211;&gt; 00:20:19.475<br>And you don&#8217;t wanna be in in that situation.<\/p>\n\n\n\n<p>00:20:19.775 &#8211;&gt; 00:20:31.455<br>And and that&#8217;s an interesting situation because if you have that conversation within a technical environment, maybe everyone would probably assume that means when you get the data, not when the analysis is done.<\/p>\n\n\n\n<p>00:20:31.455 &#8211;&gt; 00:20:31.860<br>Right?<\/p>\n\n\n\n<p>00:20:32.020 &#8211;&gt; 00:20:33.460<br>You know, I guess it&#8217;s the language thing.<\/p>\n\n\n\n<p>00:20:33.460 &#8211;&gt; 00:20:33.780<br>Right?<\/p>\n\n\n\n<p>00:20:33.780 &#8211;&gt; 00:20:39.220<br>And part of this mutual understanding is also knowing the language of each other.<\/p>\n\n\n\n<p>00:20:39.220 &#8211;&gt; 00:20:39.720<br>Right?<\/p>\n\n\n\n<p>00:20:39.780 &#8211;&gt; 00:20:54.825<br>Part of that is then the lack of communication is a little bit from the lack of understanding, right, from both sides because, you know, someone in mark access should know that maybe receiving data doesn&#8217;t mean completion of analysis in in terms of a technical term when when you would speak technically.<\/p>\n\n\n\n<p>00:20:55.045 &#8211;&gt; 00:20:55.205<br>Yep.<\/p>\n\n\n\n<p>00:20:55.365 &#8211;&gt; 00:21:05.820<br>But equally, I think from the statistician side, you need to know that you need to know that you have to explain these things very clearly and be very clear on the timelines associated with each step because they don&#8217;t know.<\/p>\n\n\n\n<p>00:21:05.820 &#8211;&gt; 00:21:06.140<br>Right?<\/p>\n\n\n\n<p>00:21:06.140 &#8211;&gt; 00:21:07.340<br>Mark access or yeah.<\/p>\n\n\n\n<p>00:21:07.340 &#8211;&gt; 00:21:14.000<br>They need that understanding that they know that Mark access doesn&#8217;t know about this, and they have to tell them very simply the whole communication.<\/p>\n\n\n\n<p>00:21:15.005 &#8211;&gt; 00:21:18.065<br>So how can we avoid all these kind of struggles?<\/p>\n\n\n\n<p>00:21:18.525 &#8211;&gt; 00:21:21.185<br>Because they are often there.<\/p>\n\n\n\n<p>00:21:21.245 &#8211;&gt; 00:21:25.905<br>And what can we do to smoothen this relationship?<\/p>\n\n\n\n<p>00:21:27.080 &#8211;&gt; 00:21:31.900<br>So, really, I think the first thing is the education and the mutual understanding.<\/p>\n\n\n\n<p>00:21:32.280 &#8211;&gt; 00:21:50.455<br>And I think this applies for every function, but for statisticians specifically, statisticians, they need a foundational understanding of kind of how pricing and reimbursement processes work, how HTA submissions are done, what the requirements are, and, of course, what the methodologies are.<\/p>\n\n\n\n<p>00:21:50.455 &#8211;&gt; 00:21:53.755<br>But that&#8217;s, let&#8217;s say, specific to statisticians, they need to know that anyway.<\/p>\n\n\n\n<p>00:21:53.815 &#8211;&gt; 00:22:11.855<br>But aside from the methodology, which I think a lot of statisticians kind of focus on that, obviously, because they&#8217;re the people sometimes running the analysis, they need to understand all of these processes because that really would help them then have those conversations with their mock access HUR, epi colleagues.<\/p>\n\n\n\n<p>00:22:12.315 &#8211;&gt; 00:22:36.240<br>That could then equip them equipped with that knowledge then, they could have those prioritization discussions with market access counterparts and make sure that they understand or they&#8217;re agreeing on what are the key critical evidence needs, in what order they need to be generated, and set then a plan in terms of what results will be available when.<\/p>\n\n\n\n<p>00:22:36.620 &#8211;&gt; 00:22:40.585<br>In some countries, let&#8217;s say it&#8217;s easy to determine what you need.<\/p>\n\n\n\n<p>00:22:41.285 &#8211;&gt; 00:22:44.105<br>So in Germany, for example, it&#8217;s sort of predictable.<\/p>\n\n\n\n<p>00:22:44.245 &#8211;&gt; 00:22:45.605<br>You can write a full plan.<\/p>\n\n\n\n<p>00:22:45.605 &#8211;&gt; 00:22:47.145<br>You execute the full plan.<\/p>\n\n\n\n<p>00:22:48.405 &#8211;&gt; 00:22:49.445<br>That&#8217;s probably fine.<\/p>\n\n\n\n<p>00:22:49.445 &#8211;&gt; 00:22:50.325<br>It&#8217;s a big plan.<\/p>\n\n\n\n<p>00:22:50.325 &#8211;&gt; 00:22:51.285<br>So Right.<\/p>\n\n\n\n<p>00:22:51.285 &#8211;&gt; 00:22:52.085<br>A big plan.<\/p>\n\n\n\n<p>00:22:52.085 &#8211;&gt; 00:22:54.490<br>But it&#8217;s kind of it&#8217;s deterministic.<\/p>\n\n\n\n<p>00:22:54.710 &#8211;&gt; 00:22:58.570<br>You can determine it sort of upfront and get it done.<\/p>\n\n\n\n<p>00:22:58.710 &#8211;&gt; 00:23:07.385<br>With most other countries, let&#8217;s say there&#8217;s a cool bit that, you know, you need and there&#8217;s probably 80 of it that you may need.<\/p>\n\n\n\n<p>00:23:07.765 &#8211;&gt; 00:23:12.425<br>And maybe then some of that 80% is things that you would need reactively.<\/p>\n\n\n\n<p>00:23:13.045 &#8211;&gt; 00:23:22.340<br>But I think because in market access, people have been burned so many times that it takes so long to generate evidence that they ask for everything upfront.<\/p>\n\n\n\n<p>00:23:22.480 &#8211;&gt; 00:23:22.960<br>Everything.<\/p>\n\n\n\n<p>00:23:22.960 &#8211;&gt; 00:23:24.240<br>Absolutely everything they might need.<\/p>\n\n\n\n<p>00:23:24.240 &#8211;&gt; 00:23:25.360<br>And and that&#8217;s the challenge.<\/p>\n\n\n\n<p>00:23:25.360 &#8211;&gt; 00:23:37.515<br>And that&#8217;s why the understanding of HTA process is really important because the statistician needs to know that for example, for an Australian submission, you have a few business days turnaround for a request.<\/p>\n\n\n\n<p>00:23:37.655 &#8211;&gt; 00:23:37.815<br>Yeah.<\/p>\n\n\n\n<p>00:23:37.815 &#8211;&gt; 00:23:43.975<br>So when a question comes from PBAC, the stats needs to be done in one business day.<\/p>\n\n\n\n<p>00:23:43.975 &#8211;&gt; 00:23:49.950<br>And even if if the team is based in Europe or US, you lose already a business day from the time difference.<\/p>\n\n\n\n<p>00:23:49.950 &#8211;&gt; 00:23:50.270<br>Yeah.<\/p>\n\n\n\n<p>00:23:50.270 &#8211;&gt; 00:23:52.350<br>So it really has to be done within a business day.<\/p>\n\n\n\n<p>00:23:52.350 &#8211;&gt; 00:23:54.750<br>So to know that, they need to be ready for that.<\/p>\n\n\n\n<p>00:23:54.750 &#8211;&gt; 00:23:57.230<br>And equally, Mark Access needs to communicate the timeline.<\/p>\n\n\n\n<p>00:23:57.230 &#8211;&gt; 00:24:01.730<br>But if they don&#8217;t know that this could be the case, they don&#8217;t have that conversation.<\/p>\n\n\n\n<p>00:24:02.110 &#8211;&gt; 00:24:05.395<br>Mark Access doesn&#8217;t want everything in a plan at once.<\/p>\n\n\n\n<p>00:24:05.395 &#8211;&gt; 00:24:07.255<br>They don&#8217;t wanna wait nine months for everything.<\/p>\n\n\n\n<p>00:24:07.475 &#8211;&gt; 00:24:10.995<br>But maybe you can negotiate and say, okay, I&#8217;ll do this bit in a month.<\/p>\n\n\n\n<p>00:24:10.995 &#8211;&gt; 00:24:11.315<br>Right?<\/p>\n\n\n\n<p>00:24:11.315 &#8211;&gt; 00:24:14.615<br>These 50 tables we can do in a month.<\/p>\n\n\n\n<p>00:24:14.675 &#8211;&gt; 00:24:19.760<br>And then maybe six months later, you can have this bit, and then three months after, you can have that bit.<\/p>\n\n\n\n<p>00:24:19.760 &#8211;&gt; 00:24:22.160<br>And then they can do the planning on their side.<\/p>\n\n\n\n<p>00:24:22.160 &#8211;&gt; 00:24:22.320<br>Right?<\/p>\n\n\n\n<p>00:24:22.320 &#8211;&gt; 00:24:29.280<br>Let&#8217;s say to there&#8217;s some evidence that you need to be able to finalize the strategy, let&#8217;s say.<\/p>\n\n\n\n<p>00:24:29.280 &#8211;&gt; 00:24:32.865<br>And you need that as soon as possible because you wanna finalize the strategy.<\/p>\n\n\n\n<p>00:24:33.245 &#8211;&gt; 00:24:36.305<br>A lot of the things are just things that need to be in a dossier.<\/p>\n\n\n\n<p>00:24:36.365 &#8211;&gt; 00:24:40.685<br>It&#8217;s not influencing that your decisions in terms of your strategy.<\/p>\n\n\n\n<p>00:24:40.685 &#8211;&gt; 00:24:44.045<br>It&#8217;s not influencing the outcome of the submission, but it has to be there.<\/p>\n\n\n\n<p>00:24:44.045 &#8211;&gt; 00:24:45.085<br>Safety, for example.<\/p>\n\n\n\n<p>00:24:45.085 &#8211;&gt; 00:24:45.420<br>Right?<\/p>\n\n\n\n<p>00:24:45.500 &#8211;&gt; 00:24:46.860<br>You need safety in your submission.<\/p>\n\n\n\n<p>00:24:46.860 &#8211;&gt; 00:24:52.460<br>You have to describe the safety, but it&#8217;s just tables that need to be there essentially because you already know the safety profile of the drug.<\/p>\n\n\n\n<p>00:24:52.460 &#8211;&gt; 00:24:54.800<br>That&#8217;s not changing because you&#8217;re doing additional analysis.<\/p>\n\n\n\n<p>00:24:55.100 &#8211;&gt; 00:25:00.735<br>It&#8217;s just you maybe need it in the format that is required by your agency, and therefore, it needs to be done.<\/p>\n\n\n\n<p>00:25:00.815 &#8211;&gt; 00:25:07.875<br>But if you don&#8217;t have that knowledge, then you&#8217;re just churning these tables without an understanding of why you&#8217;re doing them.<\/p>\n\n\n\n<p>00:25:08.335 &#8211;&gt; 00:25:11.375<br>And that is a very bad situation to be in.<\/p>\n\n\n\n<p>00:25:11.375 &#8211;&gt; 00:25:11.695<br>Yeah.<\/p>\n\n\n\n<p>00:25:11.695 &#8211;&gt; 00:25:11.935<br>Yes.<\/p>\n\n\n\n<p>00:25:11.935 &#8211;&gt; 00:25:19.600<br>If you don&#8217;t understand why you&#8217;re doing them and what is actually leeway of discussing about it.<\/p>\n\n\n\n<p>00:25:19.600 &#8211;&gt; 00:25:22.560<br>So typical discussions that, for example, could come up.<\/p>\n\n\n\n<p>00:25:22.560 &#8211;&gt; 00:25:24.980<br>Why do we need to do all these subgroup analysis?<\/p>\n\n\n\n<p>00:25:25.360 &#8211;&gt; 00:25:30.170<br>Well, because you have specified these subgroups and these endpoints in your protocol.<\/p>\n\n\n\n<p>00:25:30.170 &#8211;&gt; 00:25:39.275<br>And Therefore, by design and by requirement in Germany, you will need to submit these subgroup analysis.<\/p>\n\n\n\n<p>00:25:39.895 &#8211;&gt; 00:25:42.475<br>You can&#8217;t negotiate about these certain things.<\/p>\n\n\n\n<p>00:25:42.695 &#8211;&gt; 00:25:50.100<br>And you can have an opinion about how stupid or not stupid it is, but that opinion will not change the requirement.<\/p>\n\n\n\n<p>00:25:51.280 &#8211;&gt; 00:25:57.540<br>So certain things are just the way it is and the understanding that there&#8217;s no kind of discussion about certain things.<\/p>\n\n\n\n<p>00:25:57.760 &#8211;&gt; 00:26:00.495<br>However, there&#8217;s of course discussion about other things.<\/p>\n\n\n\n<p>00:26:01.055 &#8211;&gt; 00:26:06.515<br>And having an understanding about this is really important also for the design of the study.<\/p>\n\n\n\n<p>00:26:06.815 &#8211;&gt; 00:26:08.755<br>For what do you write in your protocol?<\/p>\n\n\n\n<p>00:26:09.215 &#8211;&gt; 00:26:12.835<br>When do you collect, for example, certain endpoints?<\/p>\n\n\n\n<p>00:26:13.295 &#8211;&gt; 00:26:21.320<br>I&#8217;ve seen that people miss to collect EQ5D at various other endpoints across the study.<\/p>\n\n\n\n<p>00:26:21.620 &#8211;&gt; 00:26:27.795<br>And because they thought, that&#8217;s too too much of a burden, so we cut it out.<\/p>\n\n\n\n<p>00:26:28.035 &#8211;&gt; 00:26:28.275<br>Yeah.<\/p>\n\n\n\n<p>00:26:28.275 &#8211;&gt; 00:26:32.055<br>It doesn&#8217;t seem to be relevant, given that&#8217;s just five questions.<\/p>\n\n\n\n<p>00:26:32.435 &#8211;&gt; 00:26:33.875<br>So, can&#8217;t be that relevant?<\/p>\n\n\n\n<p>00:26:33.875 &#8211;&gt; 00:26:34.915<br>Let&#8217;s kick it out.<\/p>\n\n\n\n<p>00:26:34.915 &#8211;&gt; 00:26:35.415<br>Yeah.<\/p>\n\n\n\n<p>00:26:35.715 &#8211;&gt; 00:26:36.775<br>Protocol simplification.<\/p>\n\n\n\n<p>00:26:37.555 &#8211;&gt; 00:26:41.370<br>And then, you know, people don&#8217;t see what is the impact of that.<\/p>\n\n\n\n<p>00:26:41.530 &#8211;&gt; 00:26:50.410<br>And years later, when the data readout comes and the questions from the market access people come, you&#8217;re just getting like, oh, we haven&#8217;t recorded it.<\/p>\n\n\n\n<p>00:26:50.410 &#8211;&gt; 00:26:53.630<br>And that&#8217;s a really, really difficult situation to be in.<\/p>\n\n\n\n<p>00:26:53.915 &#8211;&gt; 00:26:53.995<br>Yeah.<\/p>\n\n\n\n<p>00:26:53.995 &#8211;&gt; 00:27:00.155<br>And I&#8217;m hoping that, obviously, you know, mark access teams are involved in these designs, but actually, yeah, it would help as well.<\/p>\n\n\n\n<p>00:27:00.155 &#8211;&gt; 00:27:13.670<br>And, you know, for example, in France, if you want reimbursement in a particular subgroup, or if the plan is to get reimbursement only in a subgroup of the label population, You need the subgroup to be in your hierarchy per protocol.<\/p>\n\n\n\n<p>00:27:13.730 &#8211;&gt; 00:27:15.250<br>It has to be a formal subgroup.<\/p>\n\n\n\n<p>00:27:15.250 &#8211;&gt; 00:27:16.530<br>You have to do a test.<\/p>\n\n\n\n<p>00:27:16.530 &#8211;&gt; 00:27:18.470<br>You have to show significance in that subgroup.<\/p>\n\n\n\n<p>00:27:18.930 &#8211;&gt; 00:27:21.735<br>And and that has major protocol implications, for example.<\/p>\n\n\n\n<p>00:27:21.975 &#8211;&gt; 00:27:23.495<br>There are limited examples of that.<\/p>\n\n\n\n<p>00:27:23.495 &#8211;&gt; 00:27:26.395<br>The endpoint one is probably like a more common thing that happens.<\/p>\n\n\n\n<p>00:27:26.535 &#8211;&gt; 00:27:35.115<br>Obviously, having that understanding helps not only the HTA statisticians, right, but also the ones who are, you know, responsible for the design of the trial.<\/p>\n\n\n\n<p>00:27:35.560 &#8211;&gt; 00:27:44.120<br>And, you know, there will always be a push from different functions for different things, endpoints, or to simplify or to, you know, reduce the burden for the patient.<\/p>\n\n\n\n<p>00:27:44.120 &#8211;&gt; 00:27:48.700<br>And you need to make sure that kind of all of the right parties are involved in making those decisions.<\/p>\n\n\n\n<p>00:27:48.840 &#8211;&gt; 00:27:49.340<br>Right?<\/p>\n\n\n\n<p>00:27:49.880 &#8211;&gt; 00:27:50.380<br>Yep.<\/p>\n\n\n\n<p>00:27:51.295 &#8211;&gt; 00:28:02.415<br>Maybe maybe another thing that would help as well that having that education is I think, you know, statisticians can take kind of a much more active role in educating other functions as well.<\/p>\n\n\n\n<p>00:28:02.415 &#8211;&gt; 00:28:04.355<br>So, like, for example, Mark Access colleagues.<\/p>\n\n\n\n<p>00:28:04.710 &#8211;&gt; 00:28:13.350<br>So in in one of the previous companies I worked at, some of the work would be outsourced to a CRO and there&#8217;d be a specific cost to, like, a per table cost.<\/p>\n\n\n\n<p>00:28:13.350 &#8211;&gt; 00:28:13.850<br>Right?<\/p>\n\n\n\n<p>00:28:13.910 &#8211;&gt; 00:28:27.605<br>So the first thing I would do when I receive the request from an affiliate, for example, 700 tables, the first thing I would tell them is you realize this will cost the company 7, you know, whatever, how many hundred times that that price.<\/p>\n\n\n\n<p>00:28:27.605 &#8211;&gt; 00:28:30.260<br>And then they&#8217;ll think, oh, I didn&#8217;t know that.<\/p>\n\n\n\n<p>00:28:30.260 &#8211;&gt; 00:28:31.300<br>That&#8217;s a lot of money.<\/p>\n\n\n\n<p>00:28:31.300 &#8211;&gt; 00:28:32.740<br>Maybe we&#8217;ll take out some stuff.<\/p>\n\n\n\n<p>00:28:32.740 &#8211;&gt; 00:28:34.520<br>We don&#8217;t really need this stuff actually.<\/p>\n\n\n\n<p>00:28:34.820 &#8211;&gt; 00:28:39.940<br>And just even that something simple like that kind of is immediately people prioritize immediately after that.<\/p>\n\n\n\n<p>00:28:39.940 &#8211;&gt; 00:28:45.935<br>Because again, in many countries, you&#8217;re sure about some things, but most of the things you&#8217;re not a % sure about.<\/p>\n\n\n\n<p>00:28:46.235 &#8211;&gt; 00:29:02.080<br>And getting them to focus on what they&#8217;re sure about, but making sure you have processes in place to quickly generate the things that they might need on short notice is kind of critical to avoiding the massive workload and unnecessary work at the end of the day.<\/p>\n\n\n\n<p>00:29:02.080 &#8211;&gt; 00:29:05.700<br>Without those quick turnaround processes in place, this wouldn&#8217;t work.<\/p>\n\n\n\n<p>00:29:05.760 &#8211;&gt; 00:29:06.000<br>Right?<\/p>\n\n\n\n<p>00:29:06.000 &#8211;&gt; 00:29:08.900<br>And you&#8217;d be back in the place where they&#8217;ll say, well, you know what?<\/p>\n\n\n\n<p>00:29:08.960 &#8211;&gt; 00:29:14.015<br>We can&#8217;t wait two weeks to have the results of an urgent request, so we just want everything upfront.<\/p>\n\n\n\n<p>00:29:14.015 &#8211;&gt; 00:29:14.175<br>Right?<\/p>\n\n\n\n<p>00:29:14.175 &#8211;&gt; 00:29:16.115<br>And then it&#8217;s very difficult to then negotiate.<\/p>\n\n\n\n<p>00:29:17.375 &#8211;&gt; 00:29:24.595<br>I highly recommend that you have dedicated statisticians that work on nothing but said.<\/p>\n\n\n\n<p>00:29:25.130 &#8211;&gt; 00:29:34.190<br>To be realistic, Craig Mallebrad once said to me, if you&#8217;re working regulatory and something else, this something else will just not happen.<\/p>\n\n\n\n<p>00:29:34.730 &#8211;&gt; 00:29:37.470<br>When push comes to shove, it will not happen.<\/p>\n\n\n\n<p>00:29:37.625 &#8211;&gt; 00:29:37.945<br>Yeah.<\/p>\n\n\n\n<p>00:29:37.945 &#8211;&gt; 00:29:39.165<br>It will always lose.<\/p>\n\n\n\n<p>00:29:39.305 &#8211;&gt; 00:29:59.990<br>So having some ring fenced, both programming and statistics resources that can kind of prioritize these kind of requests will make a huge difference and can decrease the overall burden because you can ensure the local affiliates that they will get what they need if they really need it.<\/p>\n\n\n\n<p>00:30:00.050 &#8211;&gt; 00:30:00.550<br>Mhmm.<\/p>\n\n\n\n<p>00:30:00.610 &#8211;&gt; 00:30:04.070<br>It definitely helps, and that&#8217;s where the planning is important as well.<\/p>\n\n\n\n<p>00:30:04.285 &#8211;&gt; 00:30:14.765<br>Because also sometimes I do realize I mean, I have experience, for example, even if there&#8217;s a dedicated team, sometimes they&#8217;re like brought in to help with regulatory anyway, some other products.<\/p>\n\n\n\n<p>00:30:14.765 &#8211;&gt; 00:30:21.930<br>So I think, yeah, the the most important aspect is just having dedicated people, but also being very clear about when you will need help.<\/p>\n\n\n\n<p>00:30:21.930 &#8211;&gt; 00:30:22.250<br>Right?<\/p>\n\n\n\n<p>00:30:22.250 &#8211;&gt; 00:30:26.030<br>Because some countries very predictable when you&#8217;re gonna get questions.<\/p>\n\n\n\n<p>00:30:26.330 &#8211;&gt; 00:30:29.075<br>So, you know, this date is when I&#8217;m getting questions.<\/p>\n\n\n\n<p>00:30:29.075 &#8211;&gt; 00:30:33.155<br>So you need to block the five days after that to do all the analysis that are needed.<\/p>\n\n\n\n<p>00:30:33.155 &#8211;&gt; 00:30:33.635<br>Yeah.<\/p>\n\n\n\n<p>00:30:33.635 &#8211;&gt; 00:30:34.435<br>Some is like this.<\/p>\n\n\n\n<p>00:30:34.435 &#8211;&gt; 00:30:35.795<br>Some you don&#8217;t know when you get it.<\/p>\n\n\n\n<p>00:30:35.795 &#8211;&gt; 00:30:39.155<br>But there&#8217;s a lot of the work that you can preplan and kind of yes.<\/p>\n\n\n\n<p>00:30:39.155 &#8211;&gt; 00:30:39.655<br>Exactly.<\/p>\n\n\n\n<p>00:30:40.035 &#8211;&gt; 00:30:43.955<br>Ring fence the resource that you will need because you know when you&#8217;re gonna need it.<\/p>\n\n\n\n<p>00:30:43.955 &#8211;&gt; 00:30:44.310<br>Right?<\/p>\n\n\n\n<p>00:30:44.470 &#8211;&gt; 00:30:46.390<br>But, you know, a lot of it is also the processes.<\/p>\n\n\n\n<p>00:30:46.390 &#8211;&gt; 00:30:46.630<br>Right?<\/p>\n\n\n\n<p>00:30:46.630 &#8211;&gt; 00:30:54.950<br>And I think we can&#8217;t forget processes because if you need to turn something around in twenty four hours, you can&#8217;t have a three day approval period.<\/p>\n\n\n\n<p>00:30:54.950 &#8211;&gt; 00:30:55.450<br>Right?<\/p>\n\n\n\n<p>00:30:55.670 &#8211;&gt; 00:30:55.830<br>So<\/p>\n\n\n\n<p>00:30:56.070 &#8211;&gt; 00:30:56.570<br>Yes.<\/p>\n\n\n\n<p>00:30:56.710 &#8211;&gt; 00:31:06.605<br>And that&#8217;s maybe more the onus of the mark access team is to make sure when you get this request that the people who approve are there as well because you need the approval immediately.<\/p>\n\n\n\n<p>00:31:06.745 &#8211;&gt; 00:31:17.750<br>So you need to make sure that everyone is sitting at a table, a virtual table, and that we&#8217;re going through the request and that it&#8217;s immediately approved on that call and that this can begin work immediate.<\/p>\n\n\n\n<p>00:31:18.050 &#8211;&gt; 00:31:22.310<br>Again, this is where process is very important.<\/p>\n\n\n\n<p>00:31:22.370 &#8211;&gt; 00:31:23.910<br>Understanding process is important.<\/p>\n\n\n\n<p>00:31:23.970 &#8211;&gt; 00:31:29.595<br>A lot of the pieces of the education on the market access side is if they know the process, they know who to involve.<\/p>\n\n\n\n<p>00:31:30.055 &#8211;&gt; 00:31:41.400<br>They also need to explain to the people approving that you need to approve it immediately because, like, if you don&#8217;t agree, you have to conversation right now, right here because then we need to figure out a plan b, but, you know, you need to be there.<\/p>\n\n\n\n<p>00:31:41.400 &#8211;&gt; 00:31:42.920<br>So that&#8217;s kind of really important as well.<\/p>\n\n\n\n<p>00:31:42.920 &#8211;&gt; 00:31:49.240<br>And, you know, even beyond that, I&#8217;d say another like, the upcoming challenge now and, you know, some some companies are living it right now.<\/p>\n\n\n\n<p>00:31:49.240 &#8211;&gt; 00:31:50.040<br>It&#8217;s JCA.<\/p>\n\n\n\n<p>00:31:50.040 &#8211;&gt; 00:31:52.540<br>You didn&#8217;t mention JCA, but the joint clinical assessment.<\/p>\n\n\n\n<p>00:31:52.600 &#8211;&gt; 00:31:53.740<br>I won&#8217;t use an acronym.<\/p>\n\n\n\n<p>00:31:54.360 &#8211;&gt; 00:31:54.860<br>Yeah.<\/p>\n\n\n\n<p>00:31:55.605 &#8211;&gt; 00:32:00.405<br>For the joint clinical assessment is a new kind of as if it wasn&#8217;t complicated already.<\/p>\n\n\n\n<p>00:32:00.405 &#8211;&gt; 00:32:09.060<br>This is the consolidation of, let&#8217;s say, the clinical evaluation of new treatments from a health technology assessment perspective.<\/p>\n\n\n\n<p>00:32:09.060 &#8211;&gt; 00:32:09.460<br>Right.<\/p>\n\n\n\n<p>00:32:09.460 &#8211;&gt; 00:32:12.360<br>A European, consolidated assessment.<\/p>\n\n\n\n<p>00:32:12.500 &#8211;&gt; 00:32:20.920<br>So the idea is that, right, your regulatory assessment is assessing the efficacy and safety of your product and making decisions on that benefit risk profile.<\/p>\n\n\n\n<p>00:32:21.485 &#8211;&gt; 00:32:31.085<br>What is done in the joint clinical assessment is now understanding how this new treatment is changing the therapeutic context in that disease.<\/p>\n\n\n\n<p>00:32:31.085 &#8211;&gt; 00:32:31.325<br>Right?<\/p>\n\n\n\n<p>00:32:31.325 &#8211;&gt; 00:32:39.560<br>So they&#8217;re interested in looking at, yes, again, the your safety and efficacy data but maybe more like in comparison to what&#8217;s already available.<\/p>\n\n\n\n<p>00:32:39.860 &#8211;&gt; 00:32:44.280<br>So it&#8217;s things like indirect treatment comparisons, these kinds of things you will need in your dossier.<\/p>\n\n\n\n<p>00:32:44.820 &#8211;&gt; 00:32:52.360<br>But the major complication with this for statisticians is the timeline aspect and the amount of work aspect.<\/p>\n\n\n\n<p>00:32:53.035 &#8211;&gt; 00:33:09.880<br>And even with ring fenced resources with quick processes, I think it would be very difficult to get everything done on time without thinking much more broader than that in terms of how you are more efficient.<\/p>\n\n\n\n<p>00:33:10.500 &#8211;&gt; 00:33:26.415<br>Things like automation, programs already set in place, thinking a little bit outside the box of how things are done normally because I don&#8217;t wanna go too much in detail on the process, but, essentially by the time you&#8217;re locked into what you know you need to do for the dossier.<\/p>\n\n\n\n<p>00:33:26.415 &#8211;&gt; 00:33:31.635<br>So there&#8217;s something called a PICO, which is patient intervention comparator outcomes.<\/p>\n\n\n\n<p>00:33:32.095 &#8211;&gt; 00:33:38.760<br>The initial stage of the process of the JCA dossier is to define all the picos that are relevant for the European area.<\/p>\n\n\n\n<p>00:33:38.820 &#8211;&gt; 00:33:39.320<br>Right?<\/p>\n\n\n\n<p>00:33:39.380 &#8211;&gt; 00:33:42.600<br>So you may have one, five, 10, 20 picos in the end.<\/p>\n\n\n\n<p>00:33:42.900 &#8211;&gt; 00:33:49.000<br>But from that point onwards where the picos are set, you have less than a hundred days to submit a dossier.<\/p>\n\n\n\n<p>00:33:49.515 &#8211;&gt; 00:33:55.835<br>And, you know, if you&#8217;re working in a cross functional team that is preparing a dossier, they want the stats analysis Yep.<\/p>\n\n\n\n<p>00:33:56.155 &#8211;&gt; 00:33:56.635<br>Today.<\/p>\n\n\n\n<p>00:33:56.635 &#8211;&gt; 00:34:02.235<br>The day that they want it immediately because that&#8217;s delay because they need as much time as possible to write the dossier.<\/p>\n\n\n\n<p>00:34:02.235 &#8211;&gt; 00:34:02.670<br>Right?<\/p>\n\n\n\n<p>00:34:02.830 &#8211;&gt; 00:34:09.250<br>And to prepare and to finalize the dossier and for it to go through review all of this stuff, a hundred days is not a very long time at all.<\/p>\n\n\n\n<p>00:34:09.390 &#8211;&gt; 00:34:17.490<br>So with this, you need to think very, very carefully, not just resource but also all of the operational aspects surrounding the resource.<\/p>\n\n\n\n<p>00:34:17.895 &#8211;&gt; 00:34:40.110<br>And, again, think about templates, processes, programming, automation, you know, all of the identifying all the possible bottlenecks that you might have and trying to figure out how you avoid them, these kinds of things, because otherwise, you know, in an environment where you want things immediately, any delay is is too much.<\/p>\n\n\n\n<p>00:34:40.110 &#8211;&gt; 00:34:40.610<br>Right?<\/p>\n\n\n\n<p>00:34:40.830 &#8211;&gt; 00:34:43.950<br>You&#8217;re you&#8217;re gonna frustrate the the the the other members of the team.<\/p>\n\n\n\n<p>00:34:43.950 &#8211;&gt; 00:34:47.305<br>So I think it&#8217;s very important to, think about that.<\/p>\n\n\n\n<p>00:34:47.305 &#8211;&gt; 00:34:55.325<br>You you need you&#8217;ll need the dedicated people definitely, but even with dedicated people, when you think about potentially having to do thousands of tables<\/p>\n\n\n\n<p>00:34:55.785 &#8211;&gt; 00:34:57.805<br>And I can share a story about that.<\/p>\n\n\n\n<p>00:34:57.865 &#8211;&gt; 00:35:00.205<br>We submitted a dossier to Germany.<\/p>\n\n\n\n<p>00:35:00.740 &#8211;&gt; 00:35:07.240<br>And for one of the studies that we are analyzing, they pushed back on the overall population that we analyzed.<\/p>\n\n\n\n<p>00:35:07.860 &#8211;&gt; 00:35:17.735<br>And so, basically, with this pushback on the population, they said, well, for the studies, there&#8217;s no evidence because all the tables were based on that population.<\/p>\n\n\n\n<p>00:35:17.955 &#8211;&gt; 00:35:18.435<br>Yeah.<\/p>\n\n\n\n<p>00:35:18.435 &#8211;&gt; 00:35:23.095<br>And so no evidence there would have had a major impact in the price.<\/p>\n\n\n\n<p>00:35:23.635 &#8211;&gt; 00:35:34.110<br>And within the German process, you have, after you know that, three weeks, real weeks, not working weeks, you have three weeks to respond.<\/p>\n\n\n\n<p>00:35:34.730 &#8211;&gt; 00:35:56.025<br>But because we knew that this could happen, we had set up all our systems and processes so that we had more than 12,000 tables reproduced, checked against the original tables so that we can see what were the differences within three days.<\/p>\n\n\n\n<p>00:35:56.245 &#8211;&gt; 00:36:08.490<br>So we had the rest more than two weeks to actually then write the dossier, and we more or less submitted a completely new dossier, which kind of surprised the HDA body.<\/p>\n\n\n\n<p>00:36:08.490 &#8211;&gt; 00:36:13.305<br>But, because they had very, very little time to review everything.<\/p>\n\n\n\n<p>00:36:13.785 &#8211;&gt; 00:36:16.525<br>But this is how we saved that submission.<\/p>\n\n\n\n<p>00:36:17.225 &#8211;&gt; 00:36:26.205<br>And in the similar way for JCA, you also need to have systems in place so that you can react really, really fast.<\/p>\n\n\n\n<p>00:36:26.820 &#8211;&gt; 00:36:27.320<br>Yes.<\/p>\n\n\n\n<p>00:36:27.540 &#8211;&gt; 00:36:29.160<br>So preparation is key.<\/p>\n\n\n\n<p>00:36:29.300 &#8211;&gt; 00:36:31.460<br>And in this case, right, preparation was key.<\/p>\n\n\n\n<p>00:36:31.460 &#8211;&gt; 00:36:38.820<br>And you need to think about all of this upfront because exactly that in in your situation, if the preparation hadn&#8217;t been done, it would have been impossible.<\/p>\n\n\n\n<p>00:36:38.820 &#8211;&gt; 00:36:38.980<br>Right?<\/p>\n\n\n\n<p>00:36:38.980 &#8211;&gt; 00:36:39.300<br>Yep.<\/p>\n\n\n\n<p>00:36:39.620 &#8211;&gt; 00:36:40.100<br>Even with<\/p>\n\n\n\n<p>00:36:40.420 &#8211;&gt; 00:36:41.300<br>All hands on deck.<\/p>\n\n\n\n<p>00:36:41.300 &#8211;&gt; 00:36:41.800<br>Yeah.<\/p>\n\n\n\n<p>00:36:42.075 &#8211;&gt; 00:36:43.215<br>No no problem.<\/p>\n\n\n\n<p>00:36:43.355 &#8211;&gt; 00:36:43.835<br>Yeah.<\/p>\n\n\n\n<p>00:36:43.835 &#8211;&gt; 00:36:45.675<br>Well, hands on deck, you wouldn&#8217;t be able to do it.<\/p>\n\n\n\n<p>00:36:45.675 &#8211;&gt; 00:36:49.915<br>And I think that&#8217;s really important because, you know, often systems are not set up to do that.<\/p>\n\n\n\n<p>00:36:49.915 &#8211;&gt; 00:36:50.315<br>Right?<\/p>\n\n\n\n<p>00:36:50.315 &#8211;&gt; 00:36:53.915<br>You need to proactively prepare this kind of thing.<\/p>\n\n\n\n<p>00:36:53.915 &#8211;&gt; 00:36:57.030<br>And, you know, with JCA, it&#8217;s going to be by 2028.<\/p>\n\n\n\n<p>00:36:57.030 &#8211;&gt; 00:37:03.030<br>Most submissions will have the JCA be a reality for everyone for for every every asset.<\/p>\n\n\n\n<p>00:37:03.030 &#8211;&gt; 00:37:08.150<br>So Currently only affects oncology, but the other areas will come as well.<\/p>\n\n\n\n<p>00:37:08.150 &#8211;&gt; 00:37:09.370<br>Oncology and AMTPs.<\/p>\n\n\n\n<p>00:37:09.430 &#8211;&gt; 00:37:09.750<br>Yeah.<\/p>\n\n\n\n<p>00:37:09.750 &#8211;&gt; 00:37:25.620<br>One other tactic that I have seen being really helpful is my European PRI counterpart organized a meeting where she invited all the local architects as people into one place at one time.<\/p>\n\n\n\n<p>00:37:27.200 &#8211;&gt; 00:37:32.100<br>And every MarketAxess team needed to present what they wanted.<\/p>\n\n\n\n<p>00:37:32.240 &#8211;&gt; 00:37:41.165<br>And that helped to understand, you know, mutual how things were overlapping, where were actually differences.<\/p>\n\n\n\n<p>00:37:42.025 &#8211;&gt; 00:37:57.770<br>And it also forced the market access people to really think upfront what they really need, which is sometimes actually a challenge because it could be that your local market access people are staffed quite late in the process.<\/p>\n\n\n\n<p>00:37:58.230 &#8211;&gt; 00:38:03.370<br>By the time you want to talk to them, maybe they don&#8217;t have someone in the seat at the office.<\/p>\n\n\n\n<p>00:38:03.545 &#8211;&gt; 00:38:11.405<br>So that can be another kind of challenge with staff turnover or staff not, not being in, assigned yet.<\/p>\n\n\n\n<p>00:38:12.105 &#8211;&gt; 00:38:12.425<br>Yes.<\/p>\n\n\n\n<p>00:38:12.425 &#8211;&gt; 00:38:13.465<br>That&#8217;s very useful.<\/p>\n\n\n\n<p>00:38:13.465 &#8211;&gt; 00:38:41.495<br>And, you know, I think if you are a kind of medium sized company, at least you should think about things like having kind of statistical analysis plans dedicated to HTA and these kinds of things where you would formalize this this process of engaging with countries via your mark access counterparts and consolidating all of the requests into a plan and also having the prioritization of that plan as well within that.<\/p>\n\n\n\n<p>00:38:41.495 &#8211;&gt; 00:38:41.655<br>Right?<\/p>\n\n\n\n<p>00:38:41.655 &#8211;&gt; 00:38:45.435<br>So I think, again, with with this kind of thing as well, you have to be flexible.<\/p>\n\n\n\n<p>00:38:47.490 &#8211;&gt; 00:38:50.630<br>You know, I think when statisticians thinks of an SAP, they think I have to do everything in that SAP.<\/p>\n\n\n\n<p>00:38:50.690 &#8211;&gt; 00:38:51.190<br>Right?<\/p>\n\n\n\n<p>00:38:51.970 &#8211;&gt; 00:38:55.350<br>There&#8217;s a plan and everything needs to be done that&#8217;s on there that&#8217;s prespecified.<\/p>\n\n\n\n<p>00:38:56.370 &#8211;&gt; 00:39:02.165<br>But that&#8217;s why HTA is a bit different because some of the things, you know, you need, some of the things you don&#8217;t.<\/p>\n\n\n\n<p>00:39:02.165 &#8211;&gt; 00:39:05.205<br>So why should you do things that you don&#8217;t necessarily need?<\/p>\n\n\n\n<p>00:39:05.205 &#8211;&gt; 00:39:05.445<br>Right?<\/p>\n\n\n\n<p>00:39:05.445 &#8211;&gt; 00:39:21.250<br>And I think sometimes that requires a shift in the way processes are defined or shift in the way people think about things and a new SOP, for example, just for the HTA part where it&#8217;s clearly defined that certain things are only done if needed, for example.<\/p>\n\n\n\n<p>00:39:21.250 &#8211;&gt; 00:39:21.410<br>Right?<\/p>\n\n\n\n<p>00:39:21.410 &#8211;&gt; 00:39:28.070<br>These are the flexibilities that you need to introduce to avoid being inefficient and avoid doing things unnecessarily in organization.<\/p>\n\n\n\n<p>00:39:28.795 &#8211;&gt; 00:39:29.035<br>Yeah.<\/p>\n\n\n\n<p>00:39:29.035 &#8211;&gt; 00:39:35.375<br>And these kind of process changes, let&#8217;s be realistic, can take quite a time.<\/p>\n\n\n\n<p>00:39:35.515 &#8211;&gt; 00:39:36.015<br>Mhmm.<\/p>\n\n\n\n<p>00:39:36.395 &#8211;&gt; 00:39:40.175<br>So that&#8217;s why you also need to work early on it.<\/p>\n\n\n\n<p>00:39:40.795 &#8211;&gt; 00:39:44.680<br>Now, of course, there&#8217;s one other thing you can do.<\/p>\n\n\n\n<p>00:39:44.820 &#8211;&gt; 00:39:48.280<br>You could just ask Neshedd to help you with things.<\/p>\n\n\n\n<p>00:39:50.180 &#8211;&gt; 00:39:54.600<br>Neshedd, how could you help, companies improve these things?<\/p>\n\n\n\n<p>00:39:54.965 &#8211;&gt; 00:40:06.325<br>As a company, we we really try and focus on being a bridge between kind of how a strategy is defined and then how that strategy is kind of executed down the line.<\/p>\n\n\n\n<p>00:40:06.325 &#8211;&gt; 00:40:06.645<br>Right?<\/p>\n\n\n\n<p>00:40:06.645 &#8211;&gt; 00:40:21.900<br>So global vision, local strategy, or thinking about then thinking about how to take things locally and put it into some kind of global structure or global plan with specifically in terms of how we can help kind of stats organizations.<\/p>\n\n\n\n<p>00:40:22.925 &#8211;&gt; 00:40:24.765<br>We can offer things like the training.<\/p>\n\n\n\n<p>00:40:24.765 &#8211;&gt; 00:40:25.005<br>Right.<\/p>\n\n\n\n<p>00:40:25.005 &#8211;&gt; 00:40:29.585<br>So I talked a lot about, mutual understanding, kind of foundational knowledge.<\/p>\n\n\n\n<p>00:40:30.045 &#8211;&gt; 00:41:11.510<br>So that&#8217;s something that we do thinking about HTA one zero one for for statisticians and really focusing on what does a statistician need to know about, reimbursement, pricing, market access, etcetera, so that they can be more effective in how they work and so that they&#8217;re equipped with the knowledge and tools to be able to have those critical conversations with market access eye to eye and be able to ask the right questions and ensure that they&#8217;re getting the right information so that then they can work with Mark Access to really ensure that, you know, everyone is getting what they need when they need it and that people aren&#8217;t doing work unnecessarily or aren&#8217;t working on things when they&#8217;re not needed.<\/p>\n\n\n\n<p>00:41:11.510 &#8211;&gt; 00:41:28.055<br>You know, conversely, the the same way around for mock access, you know, your HR functions, etcetera, giving them the understanding a little bit of how stats works and how processes work would then help them also understand how they can communicate better with statistics.<\/p>\n\n\n\n<p>00:41:28.055 &#8211;&gt; 00:41:28.375<br>Right?<\/p>\n\n\n\n<p>00:41:28.375 &#8211;&gt; 00:41:36.395<br>But I think statisticians, if they have the understanding, they can have the active role asking the right questions, and that&#8217;s why the foundational training is very important.<\/p>\n\n\n\n<p>00:41:37.470 &#8211;&gt; 00:41:45.170<br>Another thing that we do is with the well, HTA in general, but specifically really the the JCA prep.<\/p>\n\n\n\n<p>00:41:45.310 &#8211;&gt; 00:41:49.090<br>So kind of thinking about organizational readiness for JCA.<\/p>\n\n\n\n<p>00:41:49.310 &#8211;&gt; 00:41:55.605<br>We talked a lot about processes, automation, bottlenecks, you know, all of this stuff.<\/p>\n\n\n\n<p>00:41:55.665 &#8211;&gt; 00:42:13.860<br>But really thinking kind of thinking very comprehensively about how is the organization set up and how does it need to change to be able to overcome the different challenges of having to do JCA at the same time as regulatory submissions?<\/p>\n\n\n\n<p>00:42:13.920 &#8211;&gt; 00:42:16.500<br>Do they need to rethink how the teams are structured?<\/p>\n\n\n\n<p>00:42:16.800 &#8211;&gt; 00:42:21.380<br>Do they need to address policies, standard operating procedures?<\/p>\n\n\n\n<p>00:42:21.520 &#8211;&gt; 00:42:31.485<br>Do they need to think about different ways of doing things, templates, programming code, how approval processes work, automation of things, all of these things.<\/p>\n\n\n\n<p>00:42:31.545 &#8211;&gt; 00:42:44.180<br>And, you know, every company will kind of address it in a different way, but really going through that assessment and decision making around how the organization needs to evolve, that&#8217;s something that we can support with as well.<\/p>\n\n\n\n<p>00:42:44.480 &#8211;&gt; 00:42:52.545<br>And then, of course, we can support with all of those changes, whether it&#8217;s new programs, new tools, new frameworks, these kinds of things.<\/p>\n\n\n\n<p>00:42:52.845 &#8211;&gt; 00:42:58.065<br>Being a kind of technically focused consultancy, it&#8217;s something that we can support with as well.<\/p>\n\n\n\n<p>00:42:59.245 &#8211;&gt; 00:42:59.745<br>Awesome.<\/p>\n\n\n\n<p>00:43:00.125 &#8211;&gt; 00:43:16.155<br>Thanks, Neshdette, for this amazing discussion about statistics and market access, how they can work effectively together, because I think that making that relationship effective takes out so much pain of the process.<\/p>\n\n\n\n<p>00:43:17.035 &#8211;&gt; 00:43:19.435<br>And so I&#8217;ve seen both sides.<\/p>\n\n\n\n<p>00:43:19.435 &#8211;&gt; 00:43:25.295<br>I&#8217;ve seen very painful collaborations and I&#8217;ve seen very very smooth collaborations.<\/p>\n\n\n\n<p>00:43:25.595 &#8211;&gt; 00:43:29.375<br>And you really wanna work on Zolata, on Zolata.<\/p>\n\n\n\n<p>00:43:29.595 &#8211;&gt; 00:43:31.050<br>I can&#8217;t guarantee you.<\/p>\n\n\n\n<p>00:43:31.530 &#8211;&gt; 00:43:32.670<br>Thanks so much, Nashtad.<\/p>\n\n\n\n<p>00:43:33.130 &#8211;&gt; 00:43:34.730<br>And thank you very much for inviting me.<\/p>\n\n\n\n<p>00:43:34.730 &#8211;&gt; 00:43:37.070<br>It&#8217;s been a pleasure after so many years.<\/p>\n\n\n\n<p>00:43:37.370 &#8211;&gt; 00:43:38.910<br>I look forward to the next one.<\/p>\n\n\n\n<p>00:43:39.530 &#8211;&gt; 00:43:41.470<br>Probably sooner rather than later.<\/p>\n\n\n\n<p>00:43:41.930 &#8211;&gt; 00:43:42.410<br>Alright.<\/p>\n\n\n\n<p>00:43:42.410 &#8211;&gt; 00:43:42.890<br>Thank you.<\/p>\n\n\n\n<p>00:43:42.890 &#8211;&gt; 00:43:43.870<br>Thank you, Alexander.<\/p>\n\n\n\n<p>00:50:22.570 &#8211;&gt; 00:50:26.190<br>This show was created in association with, PSI.<\/p>\n\n\n\n<p>00:50:26.570 &#8211;&gt; 00:50:32.110<br>Thanks to Reine and her team at VVS who helped with the show in the background, and thank you for listening.<\/p>\n\n\n\n<p>00:50:32.570 &#8211;&gt; 00:50:35.790<br>Reach your potential, lead great science, and serve patients.<\/p>\n\n\n\n<p>00:50:36.385 &#8211;&gt; 00:50:38.805<br>Just be an effective statistician.<\/p>\n\n\n<div class=\"gb-grid-wrapper gb-grid-wrapper-945c0196\"><\/div>\n<\/div><\/div>\n<\/div>\n\n\n\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In this episode of The Effective Statistician podcast, I dive into the art of persuasion. As statisticians and data scientists, we often rely on logic and data, but true influence requires more than just being right. <\/p>\n<p>Drawing from ancient Greek philosophy, I explore the three pillars of persuasion\u2014ethos (credibility), logos (logic), and pathos (emotion)\u2014and share practical strategies to help you effectively convince others.<\/p>\n","protected":false},"author":2,"featured_media":9687,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15,17,18,21],"tags":[26,28,31,33,36,38],"class_list":["post-9686","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovation","category-knowledge","category-leadership","category-podcast","tag-career","tag-effective","tag-innovation","tag-leadership","tag-productivity","tag-statisticians"],"aioseo_notices":[],"lang":"en","translations":{"en":9686},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=\/wp\/v2\/posts\/9686","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=9686"}],"version-history":[{"count":0,"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=\/wp\/v2\/posts\/9686\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=\/wp\/v2\/media\/9687"}],"wp:attachment":[{"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=9686"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=9686"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clinicalresearchpulse.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=9686"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}