Episodes
Wednesday May 29, 2024
DIA: Going Beyond the Traditional Definition of Drug Development
Wednesday May 29, 2024
Wednesday May 29, 2024
In this DIA 60th anniversary interview, former Board President Ling Su shares his thoughts on the two most important aspects of DIA’s future for the next generation of members.
Tuesday Apr 23, 2024
GPP Experts Explain Authorship Algorithm
Tuesday Apr 23, 2024
Tuesday Apr 23, 2024
Good Publication Practice (GPP) experts explain the authorship algorithm designed to weigh each author's contribution relative to other authors' contributions in a study, and to define appropriate ways to establish the authorship byline.
Tuesday Apr 02, 2024
"Dossier in the Cloud" Democratizing Global Access
Tuesday Apr 02, 2024
Tuesday Apr 02, 2024
Accumulus Synergy CEO Francisco Nogueira shares expectations for the outcomes of a post-approval changes pilot led by Roche which utilizes the Accumulus platform and follows WHO principles of good regulatory reliance practices.
Thursday Mar 28, 2024
DIA: A Place Where You Can Make a Difference
Thursday Mar 28, 2024
Thursday Mar 28, 2024
Listen to former DIA Board President Minnie Baylor-Henry’s special message to DIA members as part of DIA’s 60th Anniversary celebration in 2024.
Monday Dec 04, 2023
Autumn’s Leukemia Story: Regimens, Recovery, and Realizations
Monday Dec 04, 2023
Monday Dec 04, 2023
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 of her entire family: Autumn had leukemia. In this interview, Autumn shares the story of her treatment and recovery as a girl who had not yet turned 11. Her experience was also captured in a documentary. When asked to share her advice to healthcare professionals and researchers as a pediatric oncology patient, Autumn explained: “Every patient is a different case, has a different body, and knows about their body. No matter how amazing you are at the job, keep in mind what children have to say instead of what you already know.”
Monday Jul 17, 2023
Retiring TGA Head Maps Australia’s Post-Pandemic Future
Monday Jul 17, 2023
Monday Jul 17, 2023
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 Administration in Australia. “What's really changed and what will persist after COVID? First, I think regulators have become a bit more comfortable in dealing with uncertainty. Uncertainty is the biggest challenge rather than benefit-risk,” he explains. “International regulatory collaboration became the basis of working together on these new products: We exchanged information on policies, on how the clinical data was developing, on the real-world performance of these drugs and vaccines, and on safety and post-approval requirements. These are going to persist.”
Wednesday Jun 14, 2023
Patient Engagement: Evolution of Who Knows What, Part 2
Wednesday Jun 14, 2023
Wednesday Jun 14, 2023
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 and care with DIA GAM 2023 Patient Engagement track chair Pujita Vaidya. “This advent and acceleration of artificial intelligence (which should be augmented intelligence) and digital biomarkers should not replace the physician-patient relationship but enhance it,” Stacy explains. “Lastly: If you want sustainable patient insights, don't only ask a patient, but invest in and hire patients as internal subject matter experts and full-time employees of your organization.” Listen to part 1.
Monday Jun 12, 2023
Patient Engagement: Evolution of Who Knows What, Part 1
Monday Jun 12, 2023
Monday Jun 12, 2023
DIA GAM 2023 Patient Engagement track chair Pujita Vaidya discusses the definition, history, and current state of patient engagement in clinical research and care with cancer survivors and “ePatients” Dave deBronkart and Stacy Hurt (Patient Advocacy Ambassador, Parexel). “Many people were trained for generations to think of patients as poor people who just don't understand how to save their own lives. I'm here to tell you, we are not only eager to help but we're tired of being treated as crash test dummies,” Dave says. “Engagement doesn't just mean invite me into your process. It also means listen to me as a thinking, intelligent person who might have some ideas that you haven't thought of.”
Monday Mar 27, 2023
Australian Clinical Trials Alliance Part 2 – Future Projections
Monday Mar 27, 2023
Monday Mar 27, 2023
“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 outcomes, combined with substantially better financial performance of the healthcare system, if the healthcare system has the dual role of treating patients as well as generating evidence about the most effective treatment options to guide that care.”
Tuesday Mar 14, 2023
ANVISA Explains Innovative Online Optimized Assessment Project
Tuesday Mar 14, 2023
Tuesday Mar 14, 2023
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 quality. ANVISA’s new Online Optimized Assessment Project has significantly resolved these pending requests. “The pandemic had already enabled use of online tools for remote assessment of applications and virtual meetings between ANVISA and applicants, and also helped us be closer to other reference regulatory authorities in the process of building trust,” explains project architect Elkiane Macedo Rama, an Adviser of ANVISA’s Third Directorate. “The Online Optimized Assessment Project was a way to gather all these tools in a strategy to speed up the review process of these applications.”