DIA and the Tufts Center for the Study of Drug Development (Tufts CSDD), in collaboration with 16 biopharmaceutical companies and CROs, conducted a study to map current use of and experience with artificial intelligence (AI) and machine learning (ML), and their ability to reduce time across activities, in the drug development lifecycle. “We benchmarked various applications of AI and ML to 36 activities within clinical operations and development. We focused on design and planning, execution, and ...
Jan 17, 2025•11 min•Ep. 200
This podcast by the Drug Information Association (DIA) highlights the significant benefits of investing in professional development programs for employees in the life sciences industry. They emphasizes how training and development initiatives accelerate product development, improve employee retention, and foster a strong workplace culture. It showcases DIA’s commitment to providing comprehensive learning solutions that address specific industry needs and equip professionals with the skills and k...
Nov 06, 2024•14 min•Ep. 199
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.
May 29, 2024•2 min•Ep. 198
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.
Apr 23, 2024•8 min•Ep. 197
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.
Apr 02, 2024•3 min•Ep. 196
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.
Mar 28, 2024•2 min•Ep. 195
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 pa...
Dec 04, 2023•20 min•Ep. 194
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 wo...
Jul 17, 2023•18 min•Ep. 193
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 sust...
Jun 14, 2023•14 min•Ep. 192
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 t...
Jun 12, 2023•18 min•Ep. 191
“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.”
Mar 27, 2023•15 min•Ep. 190
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 regula...
Mar 14, 2023•15 min•Ep. 189
“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 lower than it needs to be,” explains Australian Clinical Trials Alliance Board Chair Steve Webb. “Community awareness of the difference between evaluation of experimental interventions, about which relatively little is known regarding safety and effectiveness, compared with comparative effectiveness rese...
Mar 06, 2023•13 min•Ep. 188
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, Global Forum Co-Editors for Translational Science Gary Kelloff and Lanny Kirsch discuss emergent technologies and approaches that are upending clinical development, diagnostic, and patient care in oncology and beyond....
Dec 19, 2022•29 min•Ep. 187
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 Bill and Melinda Gates Foundation continue to mobilize more than €100 million in support. “The idea is to use the AMA as a platform that will further advance the capacities of the African continent to regulate medical products as a collective. It's a network approach to regulation of medical products on the...
Nov 30, 2022•43 min•Ep. 186
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 recruitment happens based on historical data at research sites and that usually does not help, given the number of competing clinical trials trying to reach out to the same patients,” explains Indegene Senior Vice President for Enterprise Clinical Solutions Ram Yeleswarapu. “But today, tools and techniqu...
Nov 22, 2022•20 min•Ep. 185
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 better understand the differences in our bodies and illnesses and how combinations of certain medications and existing treatments can improve everyone's lives,” explains Liam Paschall (Parexel, TransCanWork, DEIBA thought leader). “This will not only help transgender people. It's going to teach us about how ...
Nov 18, 2022•35 min•Ep. 184
Digital technologies are rippling through clinical research and care, promising deeper links between healthcare research and delivery. In her interview with Global Forum US Editor Ebony Dashiell-Aje (BioMarin), Digital Medicine Society CEO Jennifer Goldsack expresses concern about the lag between producing evidence that something is fit for purpose and the conversations that need to take pace with payers and HTA experts. “We don't want to demonstrate, using the best, most novel measures possible...
Oct 20, 2022•27 min•Ep. 183
DIA 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 2019 through 2021 : from 34 new chemical drugs and 19 biological products in 2019 to 37 new chemical drugs and 24 biological products in 2021. This podcast explores this growth in the context of the regulatory reform begun in China in 2015. “The annual number of new drug approvals reached a record high of 61 in 2021,” explains Global Forum China Regio...
Sep 15, 2022•17 min•Ep. 182
The World Health Organization has initiated a pilot coordinated scientific advice (CSA) procedure whereby product developers may obtain WHO advice on the most appropriate way to generate evidence on a product's benefits and risks. “WHO has been interacting with health product developers for many years but there wasn't a standardized or formalized approach to do it. We're quite well-positioned to be a coordinated and single entry point to initiate that dialogue,” explains WHO Science Division Uni...
Aug 02, 2022•15 min•Ep. 181
