Podcasts by DIA: Driving Insights to Action
DIA is a global, multidisciplinary, membership association of healthcare professionals that works towards the advancement of lifesaving medicines, therapies, and technologies around the world.
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Podcast on the topic Biowissenschaften
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Autumn’s Leukemia Story: Regimens, Recovery, and Realizations from 2023-12-04T14:08:40
A few years ago, 8-year-old Autumn noticed a lump on the side of her neck as she was preparing for bed one night. That quiet night opened a new chapter not only in Autumn’s life but in the life ...
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Retiring TGA Head Maps Australia’s Post-Pandemic Future from 2023-07-17T18:57:05
In April 2023, Professor John Skerritt retired after 11 years of exemplary public service as deputy secretary of the Health Products Regulation Group and head of the Therapeutic Goods Administra...
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Patient Engagement: Evolution of Who Knows What, Part 2 from 2023-06-14T11:54:44
In part two of this podcast, “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel) discuss new opportunities in the future of patient engagement in clinical research ...
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Patient Engagement: Evolution of Who Knows What, Part 1 from 2023-06-12T12:13:59
DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement ...
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Australian Clinical Trials Alliance Part 2 – Future Projections from 2023-03-27T12:36:19
“Healthcare systems obviously have as their primary role the delivery of healthcare,” says Steve Webb, Australian Clinical Trials Alliance board chair. “But we can see big improvements in health...
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ANVISA Explains Innovative Online Optimized Assessment Project from 2023-03-14T13:52:30
For regulators in Brazil, the pandemic’s aftermath includes a backlog of post-approval changes, delayed by emergency development of COVID-19 vaccines and therapies, related to biologic product q...
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Australian Clinical Trials Alliance Part 1 – Current Perceptions from 2023-03-06T19:26:09
“The pandemic had a substantial impact on community understanding of clinical trials. Having said that, the sort of ambient level of community knowledge of clinical trials is still substantially...
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Looking Back and Ahead: Translational Science Advances Impacting Patient Care from 2022-12-19T20:25:10
From microphysiological systems and digital pathology to next-generation-sequencing and diversity in foundational genomic data sets: In this iteration of our annual year in review podcast, Listen
Rwanda Welcomes African Medicines Agency Home from 2022-11-30T13:27:36
While the African Medicines Agency (AMA) plans and plants its inaugural headquarters in Rwanda, the European Commission, the European Medicines Agency (EMA), several EU Member States, and the Bi...
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Will Technology Solve the Research “People Problem”? from 2022-11-22T20:53:21
Clinical trials struggle to enroll eligible patients, while interested patients have difficulty finding pertinent clinical trials. Can technology help solve this people problem? “Typical patient...
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Why Trans/Nonbinary Research Benefits All Communities from 2022-11-18T18:10:35
Actions to increase patient diversity in clinical research initially addressed racial and ethnic demographics but are expanding to address gender identity. “Further research can only help us bet...
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Digital Revolutionizing Data-Driven Reimbursement from 2022-10-20T20:49:56
Digital technologies are rippling through clinical research and care, promising deeper links between healthcare research and delivery. In her interview with Global Forum’s annual review of new drug approvals in China has shown growth in both the number and types of new drugs approved in China from...
Listen![Global Forum](https://globalforum.diagloba...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/china-sets-new-record-for-local-drug-approvals-in-2021/">China Sets New Record for Local Drug Approvals in 2021</a><small> from 2022-09-15T19:11:02</small></h5>
<p class="card-text"><p>DIA <a href=){kind=link}
WHO Pilot Formalizes CSA Process to Assist Developers from 2022-08-02T15:23:07
The World Health Organization has initiated a Global Patient Safety A...
Listen![Global Patient Safety A...](https://www.who.int/activities/optimizing-research-and-development-processes-for-accelerated-access-to-health-products/who-coordinated-scie...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/medication-errors-emerge-as-global-patient-safety-issue/">Medication Errors Emerge as Global Patient Safety Issue</a><small> from 2022-07-28T21:17:44</small></h5>
<p class="card-text"><p>In 2021, the 74th World Health Assembly adopted the <a href=){kind=link}
What We Are Missing by Not Including ”Who?” from 2022-06-30T15:53:36
In April 2022, FDA issued new draft guidance on Global Forum Co-Editors Gary Kelloff and David Parkinson discuss translational science...
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Innovation Without Access Will Never Meet Patient Needs from 2021-12-14T13:17:36
Innovations in therapeutic product development will only be effective when patients can access and use them. But establishing and explaining the value and price of these innovations among so muc...
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Three Good Reasons to Use Artificial Intelligence in Pharmacovigilance from 2021-11-22T13:27:09
“There are good reasons to explore the use of artificial intelligence in pharmacovigilance. There are an increasing number of sources of drug safety information, and efficient screening, process...
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EU Regulatory Strategies Shaping and Shaped by Pandemic Response from 2021-10-13T17:17:56
COVID has demonstrated the importance of regulatory systems that ensure the safety and efficacy of therapeutic products as well as patient access to these products, especially in the complex net...
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Telehealth Emerging in Japan’s Clinical Research and Care from 2021-09-27T18:21:22
How are clinical research and clinical care industries in Japan responding to the new challenges emerging in the post-pandemic world? “During 2020, it became a very difficult time to initiate a ...
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Telehealth Emerging in Japan’s Clinical Research and Care from 2021-09-27T18:21:22
How are clinical research and clinical care industries in Japan responding to the new challenges emerging in the post-pandemic world? “During 2020, it became a very difficult time to initiate a ...
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Aligned Review Timelines Key to Co-Developing Companion Diagnostics from 2021-09-15T17:49:34
“We're moving toward an era of truly personalized medicine where research is uncovering the genetic basis for disease as well as mutations and biomarkers that can be targeted with drug and biolo...
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Early Access Programs Complicating Comparative Data Analyses from 2021-08-25T13:25:23
The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent expert body appointed by the Australian Government to recommend new medicines for listing on the Pharmaceutical Benefits S...
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New PAHO Report: Strength in Regulatory Reference and Reliance from 2021-08-04T12:02:16
In April 2021, the Pan American Health Organization (PAHO) issued Listen
![](https://www3.paho.org/en/documents/regulatory-system-strengthening-americas-lessons-learned-national-regulatory-authori...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/elabeling-more-than-moving-from-paper-to-digital/">eLabeling More than Moving from Paper to Digital</a><small> from 2021-08-02T13:33:55</small></h5>
<p class="card-text"><p>Electronic or digital documents helped manage and disseminate clinical research data and information during the pandemic and are now being explored for potential use at the other end of this pip...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/rim-whitepaper-v2-and-rim-reference-model-advancing-regulatory-science/">RIM Whitepaper V2 and RIM Reference Model: Advancing Regulatory Science</a><small> from 2021-06-17T21:13:44</small></h5>
<p class="card-text"><p>In April 2021, the Regulatory Information Management (RIM) Working Group of DIA’s Regulatory Affairs Community issued <a href=){kind=link}
Australia: Growing Clinical Trials Even in Pandemic’s Wake from 2021-05-11T20:32:32
DIA Global Forum Australia/New Zealand Regional Editor Richard Day (University of New South Wales, Medicine, St. Vincent’s Hospital) and John Ske...
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Remote Tools Keep Japan's Research Moving from 2021-04-26T11:32:23
Japan, the world’s third largest pharmaceutical market, has long been engaged in clinical research in every therapeutic area. “COVID-19 totally changed the world. The remote connection is the on...
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DIA Promoting Community, Pushing Back Misinformation from 2021-04-16T15:33:37
How has DIA responded to its communities’ educational and informational needs during the pandemic? “We've always gotten our inspiration and our motivation and our energy from working together, w...
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Japan Healthcare 2035: Focus on Basic Science&Economics from 2021-03-29T12:29:27
In 2015, Japan's Minister of Health, Labour and Welfare established an expert advisory panel to focus on Global Forum Translational Science Co-Editors Gary Kelloff and David Parkinson look back at 2020 and discuss milestones in the early detection an...
Listen![Global Forum](https://www.mhlw.go.jp/seisakunitsuite/bunya/hokabunya/shakaihoshou/hokeniryou20...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/darwin-eu-evolution-in-europes-use-of-big-data/">DARWIN EU: Evolution in Europe’s Use of Big Data</a><small> from 2021-02-26T20:26:55</small></h5>
<p class="card-text"><p>The HMA-EMA Big Data Task Force has proposed ten priority actions to help the EU’s medicines regulatory network make best use of big data to support public health. “The first one we mention is t...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/master-protocol-efficiencies-speeding-covid-19-treatments/">Master Protocol Efficiencies Speeding COVID-19 Treatments</a><small> from 2021-02-11T13:34:15</small></h5>
<p class="card-text"><p>“How can we find drugs to treat COVID as fast as possible? The master protocol is to me the obvious example,” suggests Lisa LaVange, Professor and Chair of the Department of Biostatistics at UNC...</p>
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<h5 class="card-title"><a href="/podcast/dia-driving-insights-to-action/found-in-translation-a-tumultuous-year-in-review/">Found in Translation: A Tumultuous Year in Review</a><small> from 2020-12-28T06:00</small></h5>
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Biosimilar Awareness, Access and Savings Continue to Grow from 2020-12-21T13:25:35
“As biosimilars receive FDA approval and more and more become available to patients, we're beginning to see a greater understanding and appreciation for these medicines as lower cost options,” e...
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R2D2 Aligning Regulatory and HTA Review to Quicken Patient Access from 2020-12-14T15:11:08
In 2017, Health Canada launched the Regulatory Review of Drugs and Devices (R2D2) initiative with the goal of creating a regulatory system that provides greater and faster access to therapeutic ...
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Jump In, Be Brave, Have the Conversation – Reducing Health Disparities among Minority Patients from 2020-11-17T14:55:13
For racial and ethnic minorities in the United States, health disparities take on many forms, including higher rates of chronic disease and premature death. Gaps persist even after differences i...
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CTD Speeding Medicines Registration in East Africa from 2020-10-14T12:58:50
David Mukanga, Senior Program Officer Regulatory Affairs, Africa Systems, Bill & Melinda Gates Foundation (and Africa Regional Editor for DIA Global Forum) explores the East African Community’s ...
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Biosimilar Savings and Their Price: BPCIA Turns Ten from 2020-09-28T15:52:51
2020 marks the tenth anniversary of the FDA’s Biosimilars Price Competition & Innovation Act, which created a regulatory approval pathway in the US for biosimilars designed to increase access to...
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Regulators Promote Reliance as 21st Century Best Practice from 2020-07-20T12:16:29
“How do you do the process of regulation? Not the science of regulation, but how do you do the process of regulation more flexibly and agilely?” asks Murray Lumpkin, Deputy Director Integrated D...
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Regulatory and Clinical Science Align to Fight COVID-19 from 2020-07-13T13:56:33
The focus on clinical trials to discover therapies that alleviate suffering caused by COVID-19 also spotlights the regulators responsible for monitoring patient safety and scientific rigor in th...
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DIA Keynote Calls for Expanded COVID-19 Trial Parameters from 2020-06-10T12:39:04
After her stage four metastatic cancer diagnosis in 2011, writer Mary Elizabeth Williams was selected to participate in one of the world’s first immunotherapy clinical trials. Twelve weeks later...
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Impact Philanthropy Accelerating Cures Within Reach from 2020-06-08T12:56:12
Cures Within Reach (CWR) was founded as a not-for-profit dedicated to repurposing drugs and other treatments to drive more treatments to more patients more quickly. “If you really think about th...
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FDA Guidance: Flexibility But No Compromise on Patient Safety from 2020-05-25T14:39:32
In late March 2020, FDA issued Guidance on conduct of clinical trials of medical products during COVID-19 public health emergency: Guidance fo...
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Digital Tools Powering More and Safer Clinical Trials from 2020-05-04T17:01:43
Even under COVID-19 quarantine, patients wearing remote sensors keep clinical research moving forward digitally. “Now suddenly, very suddenly, we're faced with an intense patient safety issue wh...
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Latin America's COVID-19 Regulatory Response from 2020-04-27T18:36
Latin America, a region of more than 640 million people, is experiencing significant outbreaks of COVID-19 since its first confirmed case on February 25, 2020. Health regulatory authorities are ...
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Partnerships Essential to SAHPRA Pandemic Response from 2020-04-13T13:27:27
The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating health products intended for human and animal use, the conduct of clinical trials, and other duties ...
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EFPIA Shares Industry View of EMA Regulatory Framework from 2020-03-31T03:05:28
Scientific advancements in pharmaceutical R&D are simultaneously benefiting patients and challenging industry and regulatory frameworks throughout Europe. “The pharmaceutical R&D of today is driven...
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Time to Press the Pause Button on Speedy Drug Approvals? from 2020-03-23T09:00
New drugs are getting through the FDA approval process faster. According to a study published in January 2020, the review time for standard drug applications has decreased from more than 36 months ...
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Reach More Patients While Improving Data Quality? from 2020-03-16T13:46:16
Digital tools that revolutionize information and communication technology are increasingly employed to transform the quality and quantity of clinical trial data. “The ability for us to reach patien...
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ATMPs May Deliver on Promise of Individualized Medicine from 2020-03-09T20:18:58
FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for assuring the safety and efficacy of biological products including vaccines, allergenic products, blood and blood product...
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