A podcast on statistical science and clinical trials. Explore the intricacies of Bayesian statistics and adaptive clinical trials. Uncover methods that push beyond conventional paradigms, ushering in data-driven insights that enhance trial outcomes while ensuring safety and efficacy. Join us as we dive into complex medical challenges and regulatory landscapes, offering innovative solutions tailored for pharma pioneers. Featuring expertise from industry leaders, each episode is crafted to pro ...
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From financial and professional services to the public sector and social housing, ‘The Interim Leader’ podcast series offers top current and exclusive business insights and analyses from high-profile interim executives and independent consultants. Brought to you exclusively by Odgers Interim, part of the Odgers Berndtson Group, a global leader in interim recruitment and executive search.
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The Rumor of One Trial for Substantial Evidence
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40:11In this episode of "In the Interim…", host Dr. Scott Berry and frequent co-host Dr. Kert Viele, Senior Statistical Scientist at Berry Consultants, analyze the potential shift in FDA regulatory policy from requiring two independent trials to accepting a single trial as sufficient for “substantial evidence” in drug approvals. Reflecting on the statut…
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Communication for Scientists: A Discussion with Jenny Devenport
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39:37In this episode of "In the Interim…", Dr. Jenny Devenport, Global Head of Methods, Collaboration, and Outreach at Roche, joins Dr. Scott Berry for a detailed discussion on career evolution, statistical culture, and communication in the pharmaceutical industry. Dr. Devenport describes her transition from psychology in New Mexico to statistical leade…
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Navigating the Arena: Platform Trials
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50:27In this episode of "In the Interim…", Dr. Scott Berry delivers a metaphoric critique of single-question trial infrastructure through the sports arena analogy, illustrating the cost, patient burden, and data inefficiency of conventional clinical trials. He provides a methodical comparison of traditional trial models and the platform trial approach, …
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Jumping Hurdles: Interim Analyses for Funding Decisions
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42:19In episode 40 of "In the Interim…", Dr. Scott Berry examines the statistical, operational, and behavioral challenges of using interim analyses as triggers for funding in adaptive and seamless Phase II/III clinical trials. The episode presents a typical hypothetical scenario for rare disease drug development, contrasting conventional two-stage devel…
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Discussion with Kaspar Rufibach
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47:18In this episode of "In the Interim...", Dr. Scott Berry interviews Dr. Kaspar Rufibach, Co-Head of Advanced Biostatistical Sciences at Merck. The conversation tracks Rufibach’s evolution from academic training in actuarial and mathematical statistics through cancer research collaborations, postdoctoral work, and academic consulting, leading to appl…
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Bayesian Statistics in Clinical trials: The Past, Present, and Future
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1:07:17In this episode of "In the Interim…" guest host Cooper Berry moderates a detailed discussion on the evolution and practice of Bayesian methodology in clinical trials with fellow family members Dr. Don Berry, Dr. Scott Berry, Dr. Lindsay Berry, and Dr. Nick Berry. The panel outlines the foundational principles of Bayesian decision-making in medical …
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A Visit with Stroke Neurologist Dr. Jeff Saver
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36:59In episode 37 of "In the Interim…", Dr. Jeff Saver, Director of the UCLA Comprehensive Stroke and Vascular Neurology Program, details his shift from behavioral neurology to clinical stroke research after early engagement with multicenter trials like TOAST. The discussion covers the biology of acute ischemic stroke, quantifying neuronal loss, and th…
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The Saga of the Lecanemab Adaptive Phase II Trial
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51:46In Episode 36 of "In the Interim…", Dr. Scott Berry and Dr. Don Berry analyze the Phase II trial of Lecanemab (BAN2401) in Alzheimer’s disease, focusing on the application of adaptive Bayesian methods following persistent failures in Alzheimer’s drug development. The conversation covers the specific design features of five active arms, response ada…
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Teaching Statistics and Data Science through Sports with Dr. Jim Albert
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38:11On this episode of “In the Interim…”, which is co-sponsored by the Journal of Statistics and Data Science Education, Dr. Scott Berry talks with Dr. Jim Albert, Professor Emeritus at Bowling Green State University, whose extensive work encompasses Bayesian statistics and computation, sports analytics, and decades of exemplary teaching. Dr. Albert sh…
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In this episode of "In the Interim…", Dr. Scott Berry examines the concept of “digital twins” in clinical trials. He details how simulation of clinical trials is a direct analog of digital twin methodology, allowing for the in-silico modeling of the physical trial conduct, enrollment, dropouts, and patient outcomes under varied assumptions. Scott d…
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A Visit with Andrew Thomson
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43:37In this episode of "In the Interim…", Dr. Scott Berry interviews Dr. Andrew Thomson, owner and lead consultant of Regnitio. Thomson discusses his academic progression from mathematics at Cambridge to a Master’s at Southampton and advanced study with Prof. Sylvia Richardson at Imperial College, followed by doctoral work in cluster randomized trials …
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Moving Clinical Trial Goalposts
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37:13In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele analyze how regulatory, editorial, and science community standards often impose additional, inconsistent requirements for novel methods in clinical trial design, rarely applied to standard approaches. Examples from oncology, enrichment trials, platform studies, and endpoint an…
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The Not So Promising Zone Design
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39:39In this episode of "In the Interim…", Dr. Scott Berry examines the mathematical foundations and efficiency claims of the promising zone design for adaptive sample size in clinical trials. Scott unpacks the conditional power thresholds that trigger sample size increases without the need to adjust alpha, as originally presented by Mehta & Pocock. He …
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A Visit with Dr. Janet Wittes
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40:50Episode 30 of “In the Interim…” features Dr. Janet Wittes, Fellow of the American Statistical Association, past president of the Society of Clinical Trials, and founder of Statistics Collaborative, in discussion with Dr. Scott Berry. Dr. Wittes details her progression from Radcliffe biochemistry to Harvard statistics, shaped by targeted mentorship …
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Bayesian Clinical Trials with Frank Harrell
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47:20In this episode of "In the Interim…", Dr. Scott Berry chats with Frank Harrell, a professor of Biostatistics at Vanderbilt University and W.J. Dixon Award winner. Harrell describes his transition from frequentist to Bayesian clinical trial design, prompted by a decisive meeting with Dr. Don Berry, informed by David Spiegelhalter’s published work. T…
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A Visit with Dr. Derek Angus
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41:58In this episode of “In the Interim…”, Dr. Scott Berry interviews Dr. Derek Angus, Distinguished Professor and Chair of Critical Care Medicine at the University of Pittsburgh and Senior Editor at JAMA. The discussion addresses the decades-long controversy surrounding steroid use in community-acquired pneumonia (CAP) and sepsis. The episode delivers …
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The Mystery of Clinical Trial Simulation
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41:38Dr. Scott Berry hosts this episode of "In the Interim…", opening with statistical analysis of elite athletes before focusing on the misunderstood role of clinical trial simulation. He distinguishes simulation as a predictive tool from its use as an in-silico process that enables trial design exploration, iteration, and optimization. Clinical trial …
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Discussions on the ICH E20 Draft Guidance
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38:17In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele review the ICH E20 draft guidance on adaptive clinical trial designs, offering a technical yet accessible breakdown for trial sponsors, practitioners, and those interested in clinical development. Drawing on their practical experience in creating and presenting adaptive trial …
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A Discussion with Michael Proschan on Response-Adaptive Randomization
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44:45In this episode of "In the Interim…", Dr. Scott Berry and NIH’s Dr. Michael Proschan conduct a detailed discussion from opposing viewpoints on response-adaptive randomization (RAR) in clinical trials. The discussion focuses on where they agree – on the positives and negatives of RAR, and where they disagree on its scientific use. Key Highlights Pot…
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STEP Statistical Modeling
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33:43In this episode of "In the Interim…", Dr. Scott Berry, Dr. Elizabeth Lorenzi, and Dr. Amy Crawford discuss the STEP platform trial’s statistical methodology for evaluating which acute stroke patients benefit and which do not from endovascular therapy (EVT). The discussion critiques the inadequacy of traditional clinical trials powered for a single …
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Bayesian Approach in Clinical Trials
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43:43This episode of "In the Interim…" features Dr. Scott Berry, Dr. Kert Viele, and Dr. Melanie Quintana of Berry Consultants dissecting the technical and operational landscape of Bayesian statistics in clinical trial design. The episode discussed what is Bayesian statistics, the impact of informative and non-informative priors, and clarifies when and …
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Dr. Scott Berry and Dr. Kert Viele discuss the origins and implementation of the “time machine” modeling approach, beginning with sports analytics and progressing to adaptive platform clinical trials. The episode focuses on how techniques for comparing athletes across eras translate into methodology for platform trials. Key Highlights Sports analyt…
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The Legend of I-SPY 2 - Part B
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25:45In this episode, Dr. Don Berry and Dr. Scott Berry provide an in-depth account of I-SPY 2, focusing on the trial’s use of the “time machine” methodology—a Bayesian solution allowing bridging across arms to inform ongoing analyses. The discussion details how predictive probabilities and adaptive randomization shaped pivotal decisions, including the …
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The Legend of I-SPY 2 - Part A
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40:09In Episode 20 of Berry’s "In the Interim..." Podcast, The Legend of I-SPY 2 - Part A, Dr. Don Berry and Dr. Scott Berry discuss the origins and design of the I-SPY trials. Their conversation explains the inefficiency of traditional adjuvant breast cancer trials and details the shift to the neoadjuvant approach, where tumor response can be observed …
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The STEP Platform with Dr. Eva Mistry and Dr. Jordan Elm
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40:39This episode of "In the Interim..." features an in-depth discussion of the StrokeNet Thrombectomy Endovascular Platform (STEP), a multi-domain, multi-factorial, adaptive platform trial for acute stroke, anchored in the NIH StrokeNet network. Guests Dr. Eva Mistry (University of Cincinnati) and Dr. Jordan Elm (Medical University of South Carolina) j…
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A Statistician reads JAMA
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39:03Dr. Scott Berry applies a statistician’s review of a random trial result published in JAMA – the FAIR-HF2 clinical trial. Interrogating the frequentist paradigm and the focus on the binary outcome of the primary hypothesis test. He scrutinizes the Hochberg multiplicity adjustment, challenges the prevailing disregard for accumulated scientific evide…
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Seamless 2/3 Trial Designs
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45:48Scott Berry convenes co-authors Kert Viele, Joe Marion, and Lindsay Berry to discuss the statistical and developmental nuances of inferentially seamless phase 2/3 clinical trial designs. The group dissects the simple method for distributing alpha when including stage 1 data, whether it is a good idea to distribute alpha, and the optimal allocation …
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In this solo episode of "In the Interim...", Scott Berry, President and Senior Statistical Scientist at Berry Consultants, addresses deep-rooted confusion in the field of adaptive clinical trial design surrounding the concept of “spending alpha.” Drawing on practical experience and rigorous statistical foundations, Berry addresses the prevailing la…
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Prof Craig Ritchie: Looking Back at EPAD, moving forward in Alzheimer's Disease
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37:17Scott Berry, Founder of Berry Consultants, interviews Professor Craig Ritchie—specialist in brain health and neurodegenerative diseases, Chief Investigator of EPAD (European Prevention of Alzheimer Dementia), and CEO of Scottish Brain Sciences—for a broad discussion of platform trial methodology in Alzheimer’s Disease research as well as looking to…
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Drug Developers' Lessons from Sports: Regression-to-the-Mean
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41:09In this engaging episode of "In the Interim...", host Dr. Scott Berry is joined by Dr. Nick Berry to explore the intriguing statistical parallels between sports and drug development, focusing on the concept of "regression-to-the-mean." Presenting examples that seem clear in sports, they discuss how these insights can illuminate the challenges faced…
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DSMBs in Adaptive Trials with Roger Lewis
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37:36In this episode of "In the Interim…", host Dr. Scott Berry is true to the name of the podcast, as he discusses the unblinded world of adaptive clinical trials alongside Dr. Roger Lewis, a renowned expert in both statistical science and clinical medicine. Together, they explore the critical role of Data Safety Monitoring Boards (DSMBs) in safeguardi…
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Platform Trial in Psychiatry with Dr. Husseini Manji
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39:12In the latest episode of "In the Interim…", Dr. Scott Berry and Dr. Mike Krams sit down with Dr. Husseini Manji, to explore the potential of platform trials in advancing precision medicine within psychiatry. Listen as we discuss how an adaptive platform trial could transform drug development, paving the way for breakthroughs in understanding and tr…
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Implementing Adaptive Trials
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41:25In Episode 11 of "In the Interim…", we discuss the nuances of implementing adaptive clinical trials with Dr. Anna McGlothlin and Dr. Michelle Detry from Berry Consultants. Both Anna and Michelle, seasoned Directors and Senior Statistical Scientists, shed light on the critical role their team plays in innovative adaptive clinical trials. They descri…
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Revisiting Seamless 2/3 Trial for GLP-1 Agonist
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42:37In this episode of "In the Interim..." we revisit the ground-breaking seamless phase 2/3 clinical trial for the GLP-1 agonist, dulaglutide—better known as Trulicity. We discuss the intricacies of the adaptive trial design, and the unique features that helped expedite development by 12-18 months. Listeners will gain insight into how Bayesian algorit…
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I-SPY 2 to GBM AGILE and Beyond
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33:26In this episode of "In the Interim...," we sit down with Dr. Meredith Buxton to explore the evolution of platform trials from I-SPY 2 to GBM AGILE and Beyond. With a rich history in innovative trial design, Meredith shares the journey from pioneering adaptive clinical trials in breast cancer with I-SPY 2 to her current role at the Global Coalition …
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External Data in Clinical Trials
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28:35In this episode of "In the Interim...," Scott Berry and Kert Viele navigate the nuanced debate surrounding the integration of external data in clinical trials. Discover the implications and potential benefits and pitfalls of leveraging historical and real-world evidence in the analysis of clinical trials. Key Highlights: • Exploration of how extern…
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Remembering Jimmie Savage
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38:59In this episode of "In the Interim," Don Berry shares the life and work of Jimmie Savage, his advisor and a legendary figure in Bayesian statistics. Hosted by Scott Berry, the discussion reveals the personal and professional experiences that shaped Savage's groundbreaking contributions. Discover the intricacies of Savage's influence on statistical …
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The Art and Slog of Innovating
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27:55In this compelling episode of "In the Interim," Dr. Mike Krams, a seasoned expert in clinical trials and drug development, joins us to discuss the art and slog of innovation in pharmaceutical companies. With over 30 years in the field, Dr. Krams shares insights on leveraging Bayesian statistics and innovative designs to transform development approa…
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Religion, Politics, and Ordinal Outcomes
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30:18In this episode of "In the Interim," Dr. Scott Berry discusses the vital topic of ordinal outcomes in clinical trials—a subject as controversial as politics and religion at the dinner table. Using historical examples like James Lind's 1747 scurvy trial and Austin Bradford Hill’s pioneering randomized trial, the episode explores the complexities and…
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HEALEY ALS Platform Trial with Dr. Merit Cudkowicz and Dr. Melanie Quintana
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27:47In this episode of the podcast, we sit down with Dr. Merit Cudkowicz and Dr. Melanie Quintana to discuss the inception and execution of the Healy ALS Platform Trial, a revolutionary approach designed for efficiency and impactful data collection. With insights from both medical and statistical perspectives, this episode offers a comprehensive unders…
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FACTS 7.1 Release with Tom Parke
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27:33In this episode of "In the Interim," Berry's Director of Software, Tom Parke, takes us into the fascinating realm of clinical trial simulation. With Tom joining from the UK, we discuss the intricacies and updates surrounding FACTS, a sophisticated clinical trial simulation software. Learn about its significance in designing adaptive trial designs a…
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When should you use adaptive design clinical trials?
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30:59In this episode of "In the Interim," we consider the nuances of adaptive design clinical trials with distinguished guests Dr. Scott Berry and Dr. Kert Viele from Berry Consultants. The conversation centers around the vital question: when should these adaptive designs be implemented? Listeners will gain invaluable insights into the mechanics of adap…
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The Story of Berry Consultants
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36:26In the inaugural episode of Berry's "In the Interim...," we sit down with the founders of Berry Consultants, Dr. Don Berry and Dr. Scott Berry. Celebrating their 25th anniversary as a company, they explore the pioneering journey of their firm, known for transforming the landscape of clinical trials with their adaptive and Bayesian methodologies. Wi…
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Welcome to the new edition of the The Interim Leader podcast brought to you by Odgers Interim, the UK’s leading provider of interim management services. Grant Speed, Global Managing Director, will be bringing you the lessons learned every month from our wide range of experts about issues they’ve faced in their careers to date. Have you ever wondere…
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Transformation and Change: A discussion with Melanie Steele, Tony Martin and Jason Craker
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18:05Terry Noble, Principal and Head of the Odgers Interim Energy & Utilities practice, is joined by three guests to discuss the challenges of change and transformation across a variety of sectors. Melanie Steel is a Transformation Practitioner with a career in people change, Tony Martin is a sector agnostic Transformation Director focusing on large sca…
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Tackling Diversity & Inclusion in Social Housing: Why we still need to talk about it - with Sue Johnson
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27:45The latest episode in the popular podcast series "The Interim Leader" by Odgers Interim addresses the thematic of Diversity & Inclusion in Social Housing, and prompts us to reflect on why we are still talking the talk, but seem to struggle to walk the walk when it comes to implementing the core values of D&I. Join us for a stimulating and eye openi…
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Women in Leadership: An interview with MD, Brand Strategist and Author Flavilla Fongang
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31:50Ali Palmer, Partner and Head of the Odgers Interim Consumer and Telecoms Practice, talks to Flavilla Fongang, MD, Brand Strategist, Author, International Keynote Speaker, BBC Brand Advisor, Founder of TLA - Black Women in Tech. Talking to senior women across sectors reveals some fascinating insights into their journeys and what they are most passio…
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The Media & Entertainment Podcast: The race to scale-up, the battle for premium content and the media consolidation ‘bonanza’
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28:35Bambos Eracleous, Partner and Head of the Odgers Interim Media & Entertainment Practice, talks to media commentator and journalist Kate Bulkley. With extensive experience both on camera, in print and on stage, Kate is well known in the industry for analysing, writing and broadcasting on all things related to the worlds of media, tech and telecoms. …
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Women in Leadership: An interview with CEO Pamela Maynard
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33:26Ali Palmer, Partner and Head of the Odgers Interim Consumer and Telecoms Practice, talks to Pamela Maynard, CEO Avanade. Talking to senior women across sectors reveals some fascinating insights into their journeys and what they are most passionate about. Ali and Pamela reflect on many things including Pam’s achievements, her leadership style, her t…
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The “new normal” – A positive disruption towards a better way of working: An interview with HR Director Lis Allen & SJ Leatherdale
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24:14SJ Leatherdale, Partner and Head of the Healthcare Practice at Odgers Interim, talks to Lis Allen, HR Director Royal Brompton & Harefield NHS Foundation Trust, about the future of the workforce in the post-pandemic environment. In this latest episode of our podcast series “Interim Leader”, Lis and SJ reflect on several possible avenues for the retu…
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