Episodes
Thursday Feb 11, 2021
Master Protocol Efficiencies Speeding COVID-19 Treatments
Thursday Feb 11, 2021
Thursday Feb 11, 2021
“How can we find drugs to treat COVID as fast as possible? The master protocol is to me the obvious example,” suggests Lisa LaVange, Professor and Chair of the Department of Biostatistics at UNC Chapel Hill and former Director of the Office of Biostatistics at CDER, FDA. “They do require quite a bit more upfront planning but those that are launched and have been running for a while have been able to study a large number of drugs in a really smart way.” Lisa serves on the Therapeutics Clinical Committee and as Co-Chair of the Master Protocol Subcommittee for Accelerating COVID-19 Therapeutic Innovations & Vaccines (ACTIV) and was interviewed by Richard Zink, Vice President, Data Management, Biostatistics, Statistical Programming at Lexitas and Associate Editor of Therapeutic Innovation and Regulatory Science.
Monday Dec 28, 2020
Found in Translation: A Tumultuous Year in Review
Monday Dec 28, 2020
Monday Dec 28, 2020
Global Forum Translational Science Co-Editors Gary Kelloff and David Parkinson look back at 2020 and discuss milestones in the early detection and targeted therapy of cancer and other diseases as well as the impact of the coronavirus pandemic on clinical research.
Monday Dec 21, 2020
Biosimilar Awareness, Access and Savings Continue to Grow
Monday Dec 21, 2020
Monday Dec 21, 2020
“As biosimilars receive FDA approval and more and more become available to patients, we're beginning to see a greater understanding and appreciation for these medicines as lower cost options,” explains Dr. Hillel Cohen, executive director of scientific affairs in the Sandoz division of Novartis and Sandoz representative to the education committee of the US Biosimilars Council. “You are not being switched to a new medication. You're being kept on the same medication that's being made by a different manufacturer.”
Monday Dec 14, 2020
R2D2 Aligning Regulatory and HTA Review to Quicken Patient Access
Monday Dec 14, 2020
Monday Dec 14, 2020
In 2017, Health Canada launched the Regulatory Review of Drugs and Devices (R2D2) initiative with the goal of creating a regulatory system that provides greater and faster access to therapeutic products aligned with Canada's healthcare system needs. “One of our greatest achievements was setting up an aligned review process where a manufacturer can make a drug submission to the regulator and make a submission to health technology assessment at about the same time,” explains Megan Bettle, Director General, COVID-19 Regulatory Response Team at Health Canada. “By doing this, we're still making independent decisions but it's allowed those two separate processes to be brought together so you no longer have a prolonged regulatory review, HTA review, you have decisions being made much closer in time. It's making it more efficient for drugs to actually get to patients who need them.”
Tuesday Nov 17, 2020
Tuesday Nov 17, 2020
For racial and ethnic minorities in the United States, health disparities take on many forms, including higher rates of chronic disease and premature death. Gaps persist even after differences in health insurance, socioeconomic status, state and severity of the disease, comorbidities, and medical facility are taken into account, says Michelle Durham, Director, Psychiatry Residency Training at Boston Medical Center (BMC). The COVID-19 pandemic has highlighted, and in many cases widened, the gap in both health outcomes and access to quality care, unmasking long-standing inequities that pervade the healthcare system and society at large.
Wednesday Oct 14, 2020
CTD Speeding Medicines Registration in East Africa
Wednesday Oct 14, 2020
Wednesday Oct 14, 2020
David Mukanga, Senior Program Officer Regulatory Affairs, Africa Systems, Bill & Melinda Gates Foundation (and Africa Regional Editor for DIA Global Forum) explores the East African Community’s Medicines Regulatory Harmonization (EAC MRH) initiative with Margareth Sigonda, Head of Health Programs for The New Partnership for Africa's Development, the African Union development agency. “Before this initiative was launched in the EAC, each country had different requirements, different formats for dossier submission,” Margareth explains. “Therefore, adopting the CTD was really a game changer in terms of how now the countries were in a position to receive applications that were kind of in a similar format.”
Monday Sep 28, 2020
Biosimilar Savings and Their Price: BPCIA Turns Ten
Monday Sep 28, 2020
Monday Sep 28, 2020
2020 marks the tenth anniversary of the FDA’s Biosimilars Price Competition & Innovation Act, which created a regulatory approval pathway in the US for biosimilars designed to increase access to safe, effective and cost-effective biological treatment options for patients. “I have absolute confidence in these products as a scientist and seeing them work clinically, but we've got to make it work commercially,” explains Gillian Woollett (Avalere Health) in this interview with Anna Rose Welch (Chief Editor, Biosimilar Development, Life Science Connect). “I always say biosimilars offer savings–but be careful with that statement. That means somebody is not receiving the money they were previously receiving, and they don't want to forego that money.” Anna Rose will moderate the Short Course on Current Biosimilars Policy at DIA’s 2020 Biosimilars Conference.
Monday Jul 20, 2020
Regulators Promote Reliance as 21st Century Best Practice
Monday Jul 20, 2020
Monday Jul 20, 2020
“How do you do the process of regulation? Not the science of regulation, but how do you do the process of regulation more flexibly and agilely?” asks Murray Lumpkin, Deputy Director Integrated Development and Lead for Global Regulatory Systems Initiatives, Bill & Melinda Gates Foundation. “We certainly hope that the openness that regulators around the world have to this concept of reliance, of referencing, will evolve and strengthen because of what we're all going through now,” says John Lim, founding Executive Director of the Center of Regulatory Excellence at Duke-NUS Medical School in Singapore. (Listen to our previous Pandemic Vaccine Preparedness podcast with Dr. Lumpkin.)
Monday Jul 13, 2020
Regulatory and Clinical Science Align to Fight COVID-19
Monday Jul 13, 2020
Monday Jul 13, 2020
The focus on clinical trials to discover therapies that alleviate suffering caused by COVID-19 also spotlights the regulators responsible for monitoring patient safety and scientific rigor in these trials. “The common goal is to define better therapies for patients and needs. At the same time, we are driven by science, so we need to do what is right on a scientific perspective in order to not create additional burden for patients, for physicians, for communities, for payers, but to really deliver innovative products and medicines,” explains Dr. Max Wegner, Senior Vice President of Regulatory Affairs at Bayer. “What is the desire of the pharmaceutical industry? I think the desire is to have new products reaching patients. What is the desire of the regulators? I think it's the same.”
Wednesday Jun 10, 2020
DIA Keynote Calls for Expanded COVID-19 Trial Parameters
Wednesday Jun 10, 2020
Wednesday Jun 10, 2020
After her stage four metastatic cancer diagnosis in 2011, writer Mary Elizabeth Williams was selected to participate in one of the world’s first immunotherapy clinical trials. Twelve weeks later, she showed a complete response. Williams will explore the clinical trial process in her DIA 2020 Keynote Address. “If we are creating protocols for patients who, like me, are otherwise perfectly healthy and have no comorbidities, you're not in any way serving the people who are the most vulnerable,” she explains. “Look at who is most directly impacted by this virus: It's people who have pre-existing conditions and yet people with pre-existing conditions are routinely shut out of the clinical trial process.”