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...

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...

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...

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...

“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.”

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...

“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...

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.

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...

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...

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...

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...

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...

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...

In 2021, the 74th World Health Assembly adopted the Global Patient Safety Action Plan (GPSAP) 2021-2030 towards eliminating avoidable harm in healthcare. “Here in the United States, the Office of the Inspector General reports that one in four Medicare patients suffer harm in US hospitals,” says Sue Sheridan, a founding member of Patients for Patient Safety US, formed to advance this global plan in the United States. “Medication error is a huge global issue,” continues US founding member...

In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all contributed, but this draft was led by Project Equity from FDA’s Oncology Center of Excellence (OCE). “It is important that we be able to evaluate new therapies in the context of a diverse population that will use these medical products because...

The Cancer Moonshot launched in 2016 with a Blue Ribbon Panel Report featuring 11 recommendations, including creation of human tumor atlases and a national cancer data ecosystem, for improving cancer research and care in the US. In February 2022, the White House announced that the Cancer Moonshot was being reignited. “The ecosystem has vastly improved the efficiency of the nation's cancer research efforts. They're bringing powerful computational methods of vast amounts of data in an organized...

In March 2022, the Tufts Center for the Study of Drug Development (CSDD) issued an impact report that examines clinical trial budgets and factors that drive commonly observed variations and cost. “Part of the focus of all of these studies is to understand how complexity, how increased customization in our trials, more fragmentation as we have different parties involved, contributes to longer cycle times and larger budgets than comparable studies when we control by therapeutic area,” explains...

While COVID-19 sharpened global understanding of the importance of efficient medicines review and regulation, the Pan American Health Organization (PAHO) has been systematically assessing national medicines regulatory authorities in the Americas since 2010. "It's inevitable that we reflect on what happened during the pandemic but also that we take that as an enormous opportunity to move forward in a way that can take the lessons out of regulation in a time of crisis to prevent crisis,"...

“The ground is shifting in terms of how we will continue using randomized clinical trial data and real-world data in many different disease settings,” says Veronica Miller, co-author of Use of External Controls in FDA Regulatory Decision Making. In this research article, Miller (Forum for Collaborative Research) and Adora Ndu (Bridgebio Pharma, Inc.) describe where and how FDA has used external controls to support development and approval of drugs for rare and pediatric diseases. “We're...

In Part 2 of this interview, Chief Executive Officer Francisco Nogueira discusses the practicalities of data capture, data management, and machine learning within the framework of Accumulus Synergy’s proposed global cloud-based platform for regulatory submissions. “In terms of enthusiasm and shifting to database- from dossier-based submissions, this work had started before Accumulus was even conceived,” he explains. “Many companies already have data lakes in how they gather and collect and...

In January 2021, 10 of the world’s leading biopharmaceutical companies announced the formation of Accumulus Synergy, a nonprofit corporation intended to enable global, real-time collaboration and data exchange and submission between industry and health authorities. “Our aim is to be at the intersection of where those who develop medicines, and those who approve them, can interact differently,” explains CEO Francisco Nogueira. “Our technology will provide the ability for a sponsor to work with...