Episodes
Monday Dec 19, 2022
Monday Dec 19, 2022
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.
Wednesday Nov 30, 2022
Rwanda Welcomes African Medicines Agency Home
Wednesday Nov 30, 2022
Wednesday Nov 30, 2022
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 continent,” explains David Mukanga (Deputy Director, Africa Regulatory Systems, Bill and Melinda Gates Foundation) in this conversation with EMA Head of International Affairs Martin Harvey Allchurch.
Tuesday Nov 22, 2022
Will Technology Solve the Research “People Problem”?
Tuesday Nov 22, 2022
Tuesday Nov 22, 2022
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 techniques to mine electronic health record data, clinical data, molecular data, allow us to look at sites and patients in a much more precise manner.”
Friday Nov 18, 2022
Why Trans/Nonbinary Research Benefits All Communities
Friday Nov 18, 2022
Friday Nov 18, 2022
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 the human body works.”
Thursday Oct 20, 2022
Digital Revolutionizing Data-Driven Reimbursement
Thursday Oct 20, 2022
Thursday Oct 20, 2022
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, that new therapies are making a meaningful change for patients in ways that we haven't been able to measure before but are critically important, then delay going to market because additional evidence is required by our payer colleagues because we haven't taken time to take them with us.”
Thursday Sep 15, 2022
China Sets New Record for Local Drug Approvals in 2021
Thursday Sep 15, 2022
Thursday Sep 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.”
Tuesday Aug 02, 2022
WHO Pilot Formalizes CSA Process to Assist Developers
Tuesday Aug 02, 2022
Tuesday Aug 02, 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.”
Thursday Jul 28, 2022
Medication Errors Emerge as Global Patient Safety Issue
Thursday Jul 28, 2022
Thursday Jul 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).
Thursday Jun 30, 2022
What We Are Missing by Not Including ”Who?”
Thursday Jun 30, 2022
Thursday Jun 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?”
Wednesday May 18, 2022
Cancer Data Ecosystem Powering Moonshot Relaunch
Wednesday May 18, 2022
Wednesday 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.”