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 working together on these new products: We exchanged information on policies, on how the clinical data was developing, on the real-world performance of these drugs and vaccines, and on safety and post-approval requirements. These are going to persist.”

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 working together on these new products: We exchanged information on policies, on how the clinical data was developing, on the real-world performance of these drugs and vaccines, and on safety and post-approval requirements. These are going to persist.”

Retiring TGA Head Maps Australia’s Post-Pandemic Future

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 sustainable patient insights, don't only ask a patient, but invest in and hire patients as internal subject matter experts and full-time employees of your organization.” Listen to part 1.

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 <a href="https://www.diaglobal.org/en/flagship/dia-2023" rel="nofollow" target="_blank">DIA GAM 2023</a> 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 sustainable patient insights, don't only ask a patient, but invest in and hire patients as internal subject matter experts and full-time employees of your organization.” <a href="https://diapublications.podbean.com/e/patient-engagement-evolution-of-who-knows-what-part-1/" rel="nofollow" target="_blank">Listen to part 1.</a>

Patient Engagement: Evolution of Who Knows What, Part 2

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 crash test dummies,” Dave says. “Engagement doesn't just mean invite me into your process. It also means listen to me as a thinking, intelligent person who might have some ideas that you haven't thought of.”

<a href="https://www.diaglobal.org/en/flagship/dia-2023" rel="nofollow" target="_blank">DIA GAM 2023</a> 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 crash test dummies,” Dave says. “Engagement doesn't just mean invite me into your process. It also means listen to me as a thinking, intelligent person who might have some ideas that you haven't thought of.”

Patient Engagement: Evolution of Who Knows What, Part 1

“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.”

“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.”

Australian Clinical Trials Alliance Part 2 – Future Projections

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 regulatory authorities in the process of building trust,” explains project architect Elkiane Macedo Rama, an Adviser of ANVISA’s Third Directorate. “The Online Optimized Assessment Project was a way to gather all these tools in a strategy to speed up the review process of these applications.”

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 regulatory authorities in the process of building trust,” explains project architect Elkiane Macedo Rama, an Adviser of ANVISA’s Third Directorate. “The Online Optimized Assessment Project was a way to gather all these tools in a strategy to speed up the review process of these applications.”

ANVISA Explains Innovative Online Optimized Assessment Project

“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 research, is an important distinction often with limited understanding in the community, in government, and amongst policymakers.”

“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 research, is an important distinction often with limited understanding in the community, in government, and amongst policymakers.”

Australian Clinical Trials Alliance Part 1 – Current Perceptions

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.

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, <a href="https://globalforum.diaglobal.org/?_ga=2.145203060.1598158086.1639673102-473981677.1619533007" rel="nofollow" target="_blank">Global Forum</a> 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.

Looking Back and Ahead: Translational Science Advances Impacting Patient Care

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.

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.

Rwanda Welcomes African Medicines Agency Home

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.”

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.”

Will Technology Solve the Research “People Problem”?

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.” 

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.”

Why Trans/Nonbinary Research Benefits All Communities

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

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.”

Digital technologies are rippling through clinical research and care, promising deeper links between healthcare research and delivery. In her interview with <a href="https://globalforum.diaglobal.org/" rel="nofollow" target="_blank">Global Forum</a> 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.”

Digital Revolutionizing Data-Driven Reimbursement

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.”

DIA <a href="https://globalforum.diaglobal.org/" rel="nofollow" target="_blank">Global Forum</a>’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 <a href="https://globalforum.diaglobal.org/issue/may-2020/new-drug-approvals-in-china-in-2019/" rel="nofollow" target="_blank">2019</a> through<a href="https://globalforum.diaglobal.org/issue/may-2022/new-drug-approvals-in-china-in-2021/" rel="nofollow" target="_blank"> 2021</a>: 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.”

China Sets New Record for Local Drug Approvals in 2021

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.”

The World Health Organization has initiated a <a href="https://www.who.int/activities/optimizing-research-and-development-processes-for-accelerated-access-to-health-products/who-coordinated-scientific-advice-for-health-product-r-d" rel="nofollow" target="_blank">pilot coordinated scientific advice (CSA) procedure </a>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.”

WHO Pilot Formalizes CSA Process to Assist Developers

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).

In 2021, the 74th World Health Assembly adopted the <a href="https://www.who.int/teams/integrated-health-services/patient-safety/policy/global-patient-safety-action-plan" rel="nofollow" target="_blank">Global Patient Safety Action Plan (GPSAP) 2021-2030</a> 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).

Medication Errors Emerge as Global Patient Safety Issue

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?”

In April 2022, FDA issued new draft guidance on <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations" rel="nofollow" target="_blank">Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials</a>. 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?”

What We Are Missing by Not Including ”Who?”

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.”

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.”

Cancer Data Ecosystem Powering Moonshot Relaunch

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.”

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.”

Complexity Continues to Challenge Clinical Costs

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 &amp; 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.”

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 &amp; Technologies Unit Chief Analía Porrás in this conversation with Susan Zavala Coloma (DIGEMID, Peru) and <a href="https://globalforum.diaglobal.org/" rel="nofollow" target="_blank">Global Forum</a> 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.”

Maximizing Regulatory Resources Across Latin America

“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.”

“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 <a href="https://link.springer.com/article/10.1007/s43441-021-00302-y" rel="nofollow" target="_blank">Use of External Controls in FDA Regulatory Decision Making</a>. 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.”

Data Intersections Connecting Drug Development with Clinical Care

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.

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.” <a href="https://diapublications.podbean.com/e/sharing-cloud-based-data-as-they-emerge-accumulus-synergy-part-1/" rel="nofollow" target="_blank">Listen to Part 1 of this interview.</a>

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

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