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

September 15, 2022

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 Regional Editor Ling Su (Shenyang Pharmaceutical University Yeehong Business School; Venture Partner, Lilly Asia Ventures). “In 2021, among the 61 new drugs approved, 31–slightly over 50 percent–were developed by local companies, and this was the first time that domestic companies received more new drug approvals than foreign companies in a given year.”

WHO Pilot Formalizes CSA Process to Assist Developers

WHO Pilot Formalizes CSA Process to Assist Developers

August 2, 2022

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 Unit Head Anna Laura Ross. “We have additional considerations around the needs of lower- and lower-middle-income countries or settings with limited resources,” says Science Division Technical Officer Mercedes Perez Gonzalez. “For example, the need for inclusion of specific populations, where you would find certain concomitant infections not necessarily present in higher income settings.”

Medication Errors Emerge as Global Patient Safety Issue

Medication Errors Emerge as Global Patient Safety Issue

July 28, 2022

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 Soojin Jun in this interview with Mary Stober Murray (National Minority Quality Forum).

What We Are Missing by Not Including ”Who?”

What We Are Missing by Not Including ”Who?”

June 30, 2022

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 diseases for which these products are intended present in variable fashion across the population and because populations respond variably to medical products,” explains OCE Project Equity Lead Lola Fashoyin-Aje. “But we should reconsider the question regarding why diversity in clinical trials is important. Because the question really ought to be: What are we missing when trials are not diverse, when the study population in the clinical trial is not diverse? What are the missed opportunities for advancing science or advancing clinical medicine and, ultimately, for driving improvements in population outcomes?”

Cancer Data Ecosystem Powering Moonshot Relaunch

Cancer Data Ecosystem Powering Moonshot Relaunch

May 18, 2022

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 fashion to enable treatment decisions and prevention,” explains Global Forum Translational Science Editor Gary Kelloff, special advisor to the National Cancer Institute, US NIH. “The ecosystem is complementary to the other efforts and provides the tools and methods to implement this sharing of large amounts of new data that's coming.”

Complexity Continues to Challenge Clinical Costs

Complexity Continues to Challenge Clinical Costs

May 2, 2022

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 Tufts CSDD Executive Director and Professor Ken Getz, who also serves as board chair for the Center for Information and Study on Clinical Research Participation. “Not only are we seeing longer timelines today, and larger budgets, but we see more variation around the mean for any of these measures, which means that it's getting more difficult for companies to predict or to anticipate and manage an expected timeline or an expected budget.”

Maximizing Regulatory Resources Across Latin America

Maximizing Regulatory Resources Across Latin America

April 25, 2022

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," suggests PAHO Medicines Health & Technologies Unit Chief Analía Porrás in this conversation with Susan Zavala Coloma (DIGEMID, Peru) and Global Forum Regional Editor for Latin America Cammilla Gomes (Roche). “The idea of the assessment is not just to showcase what's going well in a regulatory authority but, with the regulatory authority, to decide on the priorities for opportunities for improvement. We gained the trust of our regulatory authorities and our other stakeholders like the industry; with that trust, the authorities know that we're going to push them to be their best.”

Data Intersections Connecting Drug Development with Clinical Care

Data Intersections Connecting Drug Development with Clinical Care

February 7, 2022

“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 seeing, not just in rare diseases but in many other diseases, this coming together of what used to be totally separate silos. In part, that's facilitated through electronic health records and other mechanisms of capturing data and being able to follow data at a bigger level, but also just because of understanding the importance of clinical data.”

Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2

Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 2

January 14, 2022

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 house the data that they are working through today. What I'm seeing in the ecosystem, both our sponsors and nonsponsors, is a high level of enthusiasm and high level of engagement towards what we define as data-centricity.” Listen to Part 1 of this interview.

Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1

Sharing Cloud-Based Data as They Emerge: Accumulus Synergy Part 1

January 14, 2022

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 as many regulators as that sponsor chooses to in a much more streamlined fashion. We will enable the platform. We will enable it with the know-how and the technology. But ultimately the business rules remain with the business.” Listen to Part 2 of this interview.

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