"Dossier in the Cloud" Democratizing Global Access

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 regulatory submissions, and looked at time reductions from investments in the use of AI and ML in a typical development program,” explains Tufts CSDD Director of Sponsored Research Mary Jo Lamberti in this interview with Stephanie Rosner (Scientific Program Manager for AI, DIA). “We expect to see higher levels of full implementation across all activities over the next few years.” 

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 knowledge necessary for success.   Reach out to [email protected] for more information.    Audio generated by NotebookLM, OpenAI, October 29, 2024, https://notebooklm.google/

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.

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.

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.  

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.

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.”

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.”

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.

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.”