Dia: Driving Insights To Action

Informações:

Sinopsis

DIA is a global, multidisciplinary, membership association of healthcare professionals that works towards the advancement of lifesaving medicines, therapies, and technologies around the world.

Episodios

  • Early Access Programs Complicating Comparative Data Analyses

    25/08/2021 Duración: 20min

    The Pharmaceutical Benefits Advisory Committee (PBAC) is an independent expert body appointed by the Australian Government to recommend new medicines for listing on the Pharmaceutical Benefits Scheme. How have advanced therapies impacted the cost and cost effectiveness of pharmaceuticals, and the work of PBAC, in Australia? “Our decision making is becoming harder because we're being asked to make decisions with substantially more uncertainty about the benefits and safety and the value propositions because medicines are coming to market earlier,” explains PBAC Chair Andrew Wilson to Ric Day, Global Forum Regional Editor, Australia/New Zealand. “I don't think the quality of the information has fallen. It's just that we're seeing it earlier in the drug development program process to be considered, and so there is more uncertainty associated with it.”

  • New PAHO Report: Strength in Regulatory Reference and Reliance

    04/08/2021 Duración: 23min

    In April 2021, the Pan American Health Organization (PAHO) issued Regulatory System Strengthening in the Americas: Lessons Learned from the National Regulatory Authorities of Regional Reference to overview the Americas’ regulatory landscape and regulatory responses to COVID-19. “The pandemic has highlighted the crucial role that the national regulatory authorities need to play in a public health emergency,” explains PAHO Assistant Director Jarbas Barbosa to Cammilla Gomes, regulatory policy lead for Latin America, Roche, and DIA Global Forum regional editor for Latin America. “The regional pharmaceutical market is growing, products are becoming more complex, and countries are spending more in providing access to these products. Yet the resources and capacities are not growing at the same pace in most regulatory authorities, and we want to ensure that our countries are able to oversee and enforce the regulations to ensure the safety, effectiveness, and quality of all products.”

  • eLabeling More than Moving from Paper to Digital

    02/08/2021 Duración: 25min

    Electronic or digital documents helped manage and disseminate clinical research data and information during the pandemic and are now being explored for potential use at the other end of this pipeline: the product safety and other information in the (paper) package insert. “Whether we are speaking of paper or electronic formats, this is the basic right, at the end of the day, for patients: to allow them that access and informed decision making about the use of their product,” suggests Aimad Torqui, executive director, Global Regulatory Policy, MSD (The Netherlands), and chair, Product Information Inter-Association Task Force (PI IATF). “It sounds very easy to move from one format to another. But there’s a lot of details to go through: How do we do submissions? How do we do approvals? Where is it published? How do people get access to it?”

  • RIM Whitepaper V2 and RIM Reference Model: Advancing Regulatory Science

    17/06/2021 Duración: 26min

    In April 2021, the Regulatory Information Management (RIM) Working Group of DIA’s Regulatory Affairs Community issued Version 2.0 of the RIM Whitepaper that provides insights relating to eleven key regulatory capability areas including RIM implementation considerations, processes, and best practices. The Whitepaper also provides context for the RIM Reference Model in development. “One of the key aspects of the model is standardizing terminology and relationships between information,” explains IQVIA Senior Regulatory Affairs Director Donald Palmer in this conversation moderated by Ennov Director of Product Management Kathie Clark. “It puts the stake in the ground in terms of the basic data elements required to support regulatory in its business process and also other functional areas which depend on regulatory,” continues Venkatraman Balasubramanian, Senior Vice President, Life Sciences, Orion Innovation. “If we can put the best practices out there, we all align on the hope that this will allow industry to bri

  • Australia: Growing Clinical Trials Even in Pandemic’s Wake

    11/05/2021 Duración: 19min

    DIA Global Forum Australia/New Zealand Regional Editor Richard Day (University of New South Wales, Medicine, St. Vincent’s Hospital) and John Skeritt, Head of Australia’s Therapeutic Goods Administration (TGA), discuss regulatory strategies and other initiatives designed to help nurture clinical research and product development in Australia post-pandemic. With “Australia having had many fewer cases than comparable countries, we've actually become in very short time a very attractive global destination for clinical trials. And, in fact, because of our low numbers, the demand has significantly increased,” John explains. “For medicines, biologicals, and devices, for example, in the last six months of last year, July to December 2020, we actually had a 17% increase in the number of clinical trials, even though COVID was rife in some parts of Australia at that time.”

  • Remote Tools Keep Japan's Research Moving

    26/04/2021 Duración: 20min

    Japan, the world’s third largest pharmaceutical market, has long been engaged in clinical research in every therapeutic area. “COVID-19 totally changed the world. The remote connection is the only way for the CRAs and the sites to communicate and work together, so both the sponsors and the sites started using remote communication or remote monitoring gradually,” explains Eri Sekine, Region Head of Trial Monitoring Japan, Global Development Operations, Novartis Pharma KK, Japan. “So now it's the time to consider how to utilize modern technologies in clinical trials. I think, based on our experience, that people will start thinking more aggressively about digitalization, digital solutions, to make clinical trials easier for sites, sponsors, and for patients.”

  • DIA Promoting Community, Pushing Back Misinformation

    16/04/2021 Duración: 33min

    How has DIA responded to its communities’ educational and informational needs during the pandemic? “We've always gotten our inspiration and our motivation and our energy from working together, whether it's with our own team on projects or with subject matter experts and key opinion leaders in our stakeholder community. So that reuniting of the community is really central in our minds right now,” explains DIA Global Chief Executive Barbara Lopez Kunz. “One of the things that you're going to hear at the Global Annual Meeting coming up in June is this whole topic of misinformation. We've had this topic of anti-vaccine commentary in public spaces in our minds, and many of the people around the world in the regulatory community have asked me and our team to help address this. You're going to hear us talking about how we combat misinformation so that people actually understand what's going on in health and how they can protect themselves.” 

  • Japan Healthcare 2035: Focus on Basic Science & Economics

    29/03/2021 Duración: 16min

    In 2015, Japan's Minister of Health, Labour and Welfare established an expert advisory panel to focus on Japan Vision: Healthcare 2035 and plan ways to meet the challenges facing the country’s healthcare system over the next two decades. “Japan has been facing an unprecedented situation with fewer children and our aging society. The Japan policy of Healthcare 2035 actually focuses on this problem,” explains Kanmuri Kazuhiro, Ascent Development Services. “The balance of demand and supply will become a serious problem in the near future in Japan. The real question is: How do we manage financing and make the quality of the healthcare system good?”

  • DARWIN EU: Evolution in Europe’s Use of Big Data

    26/02/2021 Duración: 21min

    The HMA-EMA Big Data Task Force has proposed ten priority actions to help the EU’s medicines regulatory network make best use of big data to support public health. “The first one we mention is the establishment of a Data Analytics Real-World Interrogation Network, also called DARWIN EU, which we see as a natural evolution of what regulators have been doing for decades now,” explains Nikolai Brun, Co-Chair, HMA-EMA Steering Group on Big Data, in this conversation with Thomas Kühler, Head of Regulatory Science & Policy, EU/AMESA, Sanofi, and Global Forum Regional Editor for Europe. “Technological advances have enabled us to query data remotely and preserving patient privacy and anonymity. We can query data remotely in European databases with an intelligent probe, and this probe can ask a question to the database and return with the answer. That is the vision behind DARWIN EU.”

  • Master Protocol Efficiencies Speeding COVID-19 Treatments

    11/02/2021 Duración: 38min

    “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.

  • Found in Translation: A Tumultuous Year in Review

    28/12/2020 Duración: 38min

    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.

  • Biosimilar Awareness, Access and Savings Continue to Grow

    21/12/2020 Duración: 20min

    “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.”

  • R2D2 Aligning Regulatory and HTA Review to Quicken Patient Access

    14/12/2020 Duración: 07min

    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.”

  • Jump In, Be Brave, Have the Conversation – Reducing Health Disparities among Minority Patients

    17/11/2020 Duración: 30min

    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.

  • CTD Speeding Medicines Registration in East Africa

    14/10/2020 Duración: 36min

    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.”

  • Biosimilar Savings and Their Price: BPCIA Turns Ten

    28/09/2020 Duración: 32min

    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.

  • Regulators Promote Reliance as 21st Century Best Practice

    20/07/2020 Duración: 42min

    “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.)

  • Regulatory and Clinical Science Align to Fight COVID-19

    13/07/2020 Duración: 24min

    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.”

  • DIA Keynote Calls for Expanded COVID-19 Trial Parameters

    10/06/2020 Duración: 30min

    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.”

  • Impact Philanthropy Accelerating Cures Within Reach

    08/06/2020 Duración: 26min

    Cures Within Reach (CWR) was founded as a not-for-profit dedicated to repurposing drugs and other treatments to drive more treatments to more patients more quickly. “If you really think about the difference between de novo and drug repurposing, we think it falls into three key areas: the speed, the cost, and the success rate,” explains President and COO Barbara Goodman. “From de novo research, it takes about 13 to 15 years, it can easily take up to two billion dollars, and some would say it's five to ten percent success rate. In the drug repurposing side, it can be significantly shorter in five to eleven years, it can be $300 million, $350 million, with perhaps a 30% success rate. This happens because the safety, toxicity, pharmacology and other related studies are completed from the original indication.”