The Latest Dose
Oracle Corporation
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Oracle Life Sciences Vice President of Global Innovation, Kathy Vandebelt, interviews industry experts and leaders on pressing topics in the Life Sciences industry.
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Sep 13, 2023
Ep. 43: Running regulatory and clinical operations in an AI world
Artificially intelligent tools are revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry. As the drug discovery and preclinical stages speed up and potentially produce more drugs to test in the clinical trial phase, how do clinical researchers prepare and respond to these challenging opportunities?
In this episode, Toban Zolman, Chief Executive Officer at Kivo will share his thoughts on how AI-enabled successes in drug discovery will affect clinical operations and regulatory operations. We will discuss how advancements in technology and data analysis are reshaping the way we conduct clinical research.
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Episode Transcript:
http://traffic.libsyn.com/thelatestdose/The_Latest_Dose-S01_E43.mp3
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Hi, everyone, and welcome to the Latest Dose, the podcast that explores the depth of innovation and human compassion in clinical research. I'm your host, Katherine Vandebelt, global vice president of Clinical Innovation at Oracle Health Sciences. Traditionally drug discovery is a notoriously time consuming and expensive process. A host of artificial intelligence tools, AI, are said to be revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry.
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According to the Boston Consulting Group, as of March 2022, “ biotech companies are using an AI first approach had more than 150 small molecule drugs in discovery and more than 15 already in clinical trials”. Once the drug discovery and preclinical stages speed up and potentially produce more drugs to test in the clinical trial phase, how do we prepare and respond to this exciting new and challenging opportunity?
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Today, our guest will share his thoughts on how AI enabled successes in drug discovery will affect clinical operations and regulatory operations. We will discuss how advancements in technology and data analysis are reshaping the way we conduct clinical research. Joining me today is Toban Zolman, Chief Executive Officer of Kivo. Toban has 20 years of experience in regulatory and clinical operations, drafting some of the first guidelines for electronic submission at Image Solutions.
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Toban has consulted with 45 of the top 50 pharma companies in the world. After working in regulatory, Toban ran product teams for several tech companies. Toban has been at the forefront of multiple tech revolutions, such as cloud computing and the Internet of Things. Toban thinks the time has come for clinical trial management to level up. Toban, it is great to speak with you today.
00;02;09;06 - 00;02;45;17
Welcome to the Latest Dose. Yeah, thank you. Great to speak with you as well. In the intro I mentioned that you believe the time has come for clinical trial management to level up. What do you mean by that? Well, let me give you some context maybe on where that comment is coming from. So, I spent a chunk of my career helping tier one pharma transition to electronic submissions and kind of the promise of electronic submissions was improved process, improved visibility, faster review times by regulatory agencies.
00;02;45;19 - 00;03;22;16
And the way that we went about that as an industry, you know, 15 to 20 years ago, was really to take this new challenge, process challenge, of managing a ten X increase in the amount of documents going back and forth to a regulatory agency and controlling that incredibly tightly. And so literally, you know, I spent years and in windowless conference rooms with committees trying to figure out how to manage every aspect of increasingly complex process.
00;03;22;18 - 00;04;03;13
And honestly, it was soul crushing. So, I left the industry and spent over a decade working in other industries that were kind of on the edge of major transformations. E-commerce, social, cloud, IoT, and eventually circled back to life sciences. And I think the thing that struck me the most as I came back into life sciences and started to talk to clinical and regulatory leaders who were dealing with all of these advancements in how clinical trials operate, as this was kind of the same song, new verse.
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The pace of clinical trials was accelerating. The complexity of tools was increasing. And the number of assets that they were having to manage that resulted from those advancements was also increasing. And the approach to managing all of that was to just have leaders in life sciences, you know, these pharma companies just literally tighten their grip on the process even more.
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And that's just not a model that works, and it's not a model that any other industry has embraced. And so, really, I think what we've really focused on, at Kivo, is helping companies loosen their control a little bit, not control of process, but really trying to manage everything in a monolithic top down approach and instead move to more nimble, more decentralized, more collaborative processes to manage this massive increase in the amount of activity that's happening in the clinical pipeline.
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Well, welcome back to the life sciences. So, you mentioned how these individuals are sort of holding on to the existing process. So, in preparation for this episode, I read a number of articles and they continued to talk about how pharmaceutical industry resists adopting digital tools, the need for them to change their strategic priorities, and also evolving the work place culture, perhaps in some of the ways you just mentioned.
00;05;41;18 - 00;06;08;08
What are your thoughts about these statements now that you're back? This is true? Are you seeing something else? What do you mean by that? Yeah, great question. So, yeah, I think you're correct in kind of meta level trends. Life sciences and especially folks that work in operations, whether that's clin ops, reg ops, etc., that are a very risk averse group of people and for good reason.
00;06;08;12 - 00;06;37;11
I'm not throwing shade on anyone. The nature of those jobs and their remit within the drug development process is fundamentally to be risk adverse, and that's what helps create safety in drugs. With that said, you know, Kivo is focused pretty much exclusively on working with emerging life science companies. And so, the vast majority of our customers do not have a drug in market yet.
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They have active clinical pipelines, but they are new companies, new in life science terms. Many are 15 years old. But I think they are hitting growth inflection points really in a post pandemic world. And that's been super fascinating to be involved in because I think these smaller companies that are growing rapidly and hitting inflection points post-pandemic are really leaning into decentralized teams and maybe not even by choice.
00;07;14;04 - 00;07;48;02
It's just the nature of how you scale a company now. But they're leaning into that workplace culture of small, decentralized teams, relying heavily on partners; whether that's CROs, contract medical writers, reg affairs shops, whatever it is. And they are figuring out how to scale organizationally, to scale technologically, and scale as well, their clinical trial process in that landscape.
00;07;48;04 - 00;08;21;19
And so, the conversations we have with leaders in those companies who are really building the organization from the ground up, differ significantly from the conversations we have with companies that reached a scale point, you know, a decade ago or even pre pre-pandemic. Where the workplace culture was centered around in-person, everyone working in the same office sort of a culture.
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And s…
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Aug 3, 2023
Ep. 42: Creating drugs at the speed of AI
Artificial intelligence (AI) is one of the most discussed technologies across all industries. Life science professionals working in the pharmaceutical industry strive to improve people’s lives tackling incredibly complex diseases. Drug development is often perceived as slow. As the pharma industry looks to improve the drug development process AI promises nothing less than a revolution.
Can AI help speed up the drug development process? Identify new drug molecules that have so far eluded scientists?
Will AI–designed medicines be safe for people? Have the desired effect on the disease? Meet the rigorous regulatory standards to actually be approved for human use?
In this episode, Andreas Busch, Ph.D., Chief Innovation Officer at Absci will answer these questions and shares the value generative-AI is providing drug development today.
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Episode Transcript:
00;00;00;00 - 00;00;31;24
Hi, everyone, and welcome to the Latest Dose, the podcast that explores the depth of innovation and human compassion in clinical research. I'm your host, Katherine Vandebelt, global vice president of Clinical Innovation at Oracle Health Sciences. Artificial Intelligence, AI, is one of the most popular technologies on the planet, and I find it referenced in most, if not all, industries.
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Those of us working in the pharmaceutical industry strive to improve people's lives. Can AI help scientists develop better medicines faster? Human bodies are incredibly complex. Drug development is slow. Since I've been engaged in drug development, many people, teams, organizations, and companies have been working tirelessly to improve the drug development process, the promise, is nothing more than a revolution for the pharmaceutical industry.
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The March 8th, 2023 Politico article states “nearly 270 companies are working in AI driven drug discovery”. Let's start learning more about AI driven drug discovery and discuss if or when the promise of AI will be realized. Can AI help speed up the drug development process? Identify new drug molecules that have so far eluded scientists?
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Can AI-designed medicines, be safe for people? Have the desire effect on the disease? Meet the rigorous regulatory standards to actually be approved for human use? You know, many of these questions can be answered today with my guest, Andreas Busch, Ph.D. Chief Information Officer at Absci. Andreas brings substantial R&D expertise to Absci’s leadership, a world renowned leader in drug discovery and has led R&D efforts for some of the globe's top pharma companies, including Sanofi, Bayer, and Shire.
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Andreas’ leadership has resulted in over ten commercial drugs starting from bench to FDA approval, with several more in late stage clinical development. Andreas holds the title of Extraordinary Professor of Pharmacology at the Johann Wolfgang Goethe University in Frankfurt, Germany, where he also received his Ph.D. in pharmacology. Andreas loves, real football a.k.a soccer, enjoys riding his motorcycle through Alps and playing with his beloved dogs Zorro.
00;02;37;07 - 00;03;04;28
Welcome, Andreas. Thank you for making the time to speak with me today. Hey, it's a pleasure talking to you Katherine. So, Andreas I have been taught that artificial intelligence, referred to as AI, are computer intelligence programs that can handle real-time problems and help organizations and everyday people achieve their goal. And AI is obviously a topic of discussion these days and getting way more attention with the release of the articles around ChatGPT.
00;03;04;28 - 00;03;33;22
Today I'd like to focus our discussion on generative AI, but I thought it would be helpful if you could share with me what's important for me to actually know about this type of AI. I'm glad to talk about it. I guess ChatGPT was certainly a breakthrough in AI and the use of AI for a general population and everybody knows now what AI can do through a GPT.
00;03;33;26 - 00;04;07;07
And if you look at generative AI, what we're trying to accomplish simply is to have artificial intelligence supporting us, creating drugs. And as you know, with ChatGPT, you have to give ChatGPT the right prompt in order to get ChatGPT to do the job for you. And this is similar with our generative AI. We need to give the prompt, which is we need to give our models the target, the mechanism we want to work on.
00;04;07;10 - 00;04;43;12
And then the model produces for us, in our case for Absci, a de novo designed antibody. So that's fascinating. How long have you been developing this approach with these prompts and these programs and actually been using this at your organization? I mean, Absci is actually a company which started as a cell line development company and realized then that for AI to be very productive, you need a ton of data and you need a ton of very consistent, high quality data.
00;04;43;14 - 00;05;14;24
So, these two things have to come together, you know, improvement of AI models, but feeding the AI models with plenty of data. So, the models can get better and better. And we've started really implementing AI for our E.coli expression systems for antibody a bit more than two years ago. And the progress we saw in our generative AI approaches were really very significant, very fast.
00;05;14;26 - 00;05;57;16
Already a year ago we were at a stage that we could optimize existing antibodies, so we basically gave the model the information of … look here is a known antibody, …. can you optimize it for affinity, … can you optimize it for immunogenicity and so forth. And we managed to do that. And just half a year ago, for the first time, give the model the information of the structure of a protein that we wanted to address, to produce for us a binding sequence completely de novo or without any idea of an antibody structure before. I think there was …. really for us …. the breakthrough.
00;05;57;19 - 00;06;28;16
And that is something which we have meanwhile even further progressed in the last half year. We extended this approach to more than one binding regions and we are ready now in a situation to address three of the binding regions of an antibody. And we are very, very optimistic that this progress is going to be extremely meaningful and helpful and what we believe disruptive in biologics research in the future.
00;06;28;18 - 00;06;49;01
So, this is exciting and extremely fascinating. So, I'm going to go to a statement you made about the data. So, can we talk a little bit about that? So where do these sources of data come from? What types of volume are you talking about? And I guess more importantly, as somebody who has worked with data for many, many years,
00;06;49;01 - 00;07;11;00
and one of the things that people will often ask about is ….should you use that data? Is that data appropriate? Is it reliable? Some people use the word quality. So, in order to achieve these impressive results, can you tell us a little bit about, more about, the data that's being used? Where does it come from and all those things?
00;07;11;03 - 00;07;36;13
Sure. To make it clear, what we're doing is, once we know the structure of a mechanism we want to address, let's assume whatever a membrane protein like a G protein coupled receptor, whatever you name it, we identify the region to which we want our antibody to bind and we give this information in the structure of this region to the model.
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The model then delivers to us a number of model hits. Artificial intelligence generated hits. Information about what the model thinks the binder should look like. And what we do then, and that's the very straightforward answer to your question of the quality, is we generate tho…
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Jun 28, 2023
Ep. 41: CancerX: Reducing incidence, burden, and disparities in cancer care
Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. President Biden has reignited the Cancer Moonshot initiative and set a new national goal: “if we work together, we can cut the death rate from cancer by at least 50% over the next 25 years and improve the experience of people and their families living with and surviving cancer”. “To achieve [the cancer moonshot goals], we must amplify digital innovation,” stated Dr. Catharine Young, Assistant Director of Cancer Moonshot Engagement and Policy, White House Office of Science and Technology.
CancerX, an initiative to rapidly accelerate the pace of cancer innovation in the U.S., will harness the power of innovation to reduce the burden of cancer for all people. Oracle is excited and honored to join Cancer Moonshot's new CancerX public-private partnership.
In this episode Jennifer Goldsack, Chief Executive Officer at Digital Medicine Society (DiMe), Santosh Mohan, Vice President, Digital at Moffitt Cancer Center with Moffitt Cancer Center, and Stephen Konya, Senior Advisor to the Deputy National Coordinator, and Innovation Portfolio Lead for the Office of the National Coordinator for Health IT (ONC) will share more about Cancer Moonshot, CancerX and the importance of digital innovation to achieve the goals.
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Episode Transcript:
00;00;00;00 - 00;00;34;26
Hi, everyone, and welcome to the latest dose, the podcast that explores the depth of innovation and human compassion in clinical research. I'm your host, Katherine Vandebelt, global vice president of Clinical Innovation at Oracle Health Sciences. Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, President Biden has reignited the Cancer Moonshot and set a new national goal.
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If we work together, we can cut the death rate from cancer by at least 50% over the next 25 years and improve the experience of people and their families living with and surviving cancer. In response to the White House Cancer Moonshot, CancerX is formed, an initiative to rapidly accelerate the pace of cancer innovation in the United States.
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CancerX will harness the power of innovation to reduce the burden of cancer for all people. Oracle is excited and honored to join Cancer's Moonshot New CancerX Public Private Partnership. Here with me today to share more about these inspirational initiatives, our Jennifer Goldsack, Santosh Mohan, and Stephen Konya. Jennifer, Jen, Goldsack is the CEO of the Digital Medicine Society, also known as DIME.
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Jen's research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, health care and health research. Jen is a member of the roundtable on Genetics and Precision Health at the National Academies of Science, Engineering and Medicine. Jen serves on the World Economic Forum Global Leadership Council on Mental Health. Previously, Jen spent several years developing and implementing projects with Clinical Trials Transformation Initiative, also known as CTTI.
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This is a public private partnership co-founded by Duke University and the FDA. Jen conducted research at the hospital of the University of Pennsylvania, helped launch the Value Institute, a pragmatic research and innovation center embedded in the large academic medical center in Delaware. Jen earned her master's degree in chemistry from the University of Oxford, England, her master's in history and sociology of medicine from the University of Pennsylvania and her MBA from George Washington University.
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Jen is a retired athlete, formerly a Pan American Games champion, Olympian, and world champion silver medalist. Santosh Mohan, vice president of digital at Moffitt Cancer Center, is also with us today. Santosh brings more than 15 years of digital health and health information technology experience to this role. Previously, he served as the managing director of the Innovation Hub at Brigham and Women's Hospital, where he led digital transformation through the use, development, evaluation and commercialization of digital health applications.
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Throughout his career, Santosh has worked to leverage data and analytics to create and design new programs and digital abilities, with a strong focus on emerging technology to advance care and improve the clinician and patient experience. Santosh holds a master’s degree in clinical informatics from Duke University’s Fuqua School of Business and a bachelor’s degree in bioinformatics from Vellore Institute of Technology in India.
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Santosh is a certified professional in healthcare information and Management Systems, a member of American Medical Informatics Association, a senior member and fellow of the Healthcare Information and Management Systems Society, known also as HIMMS. You will also hear from Stephen Konya, the senior advisor to the Deputy National Coordinator and the Innovation Portfolio Lead for the Office of the National Coordinator for Health I.T., also known as ONC, which is part of the U.S. Department of Health and Human Services, HHS.
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Stephen is shaping the agency's long term strategy. The primary liaison to the White House Office of Science and Technology Policy. The primary liaison to the external health care startup and investor community. Stephen leads the Digital Health Innovation Workgroup under the Federal Health I.T. Coordinating Council, an interagency collaboration community comprised of innovation representatives from 40 other federal agencies. Previously, Stephen has led several key ONC projects, including the HHS Pandemic X Innovation Accelerator, the National Health I.T. Playbook, the Agency Patient Engagement Playbook for Providers, the Smart App Gallery, the FHIR at Scale Task Force, also known as FAST, and is a founding co-chair of the Together.Health Collaborative Effort. Prior to his position with the federal government,
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Stephen served the state of Illinois in a variety of key positions and diverse responsibilities. Stephen holds a BBA in finance and international business from Loyola, University of Chicago, is fellow and mentor of the Mid-American Regional Public Health Leadership Institute Program at the University of Illinois-Chicago School of Public Health. Welcome, Jen, Santosh and Stephen to the Latest Dose and thank you so much for making time to speak with me today.
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When I hear the word cancer, it elicits fear and anxiety, at least in me. So, researching the cancer trends does not provide me with much comfort. According to the World Health Organization, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. Or stated another way, nearly one in six deaths. It appears that the medical community's understanding of cancer is growing,
00;06;01;06 - 00;06;27;21
yet the death rate remains so high. What do we need to do differently? Thanks, Katherine. Cancer is out every day at Moffitt. We come face to face with this terrible, very difficult disease. Every single day. But we also see the courage of our patients fighting it. And that really inspires us to bring hope to every patient we serve and deliver to them some of the best outcomes.
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Up to four times the national average. Now, cancer deaths in the US are actually falling, but they're not falling fast enough so the death rate needs to decline by a more rapid percentage to reach the Moonshot goal of reducing cancer deaths by 50% in the next 25 years. It's very clear that we need a multifaceted approach to tackle this complex issue.
00;06;52;2…
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May 30, 2023
Ep. 40: CancerX: Breaking down the barriers to digital innovation use in oncology
The US cancer death rate has fallen by 33% since 1991 with an estimated 3.8 million deaths averted. This is attributed to “good progress” improvements in cancer treatment, decreases in smoking, and increases in early detection. A recent rise in advanced cancer cases reported is believed to be an outcome of the COVID-19 pandemic which delayed screenings and treatment.
Access, equity, and inclusion when developing and deploying new solutions to combat this disease remain paramount. The impact of cancer on people’s lives and their families is profound. Many live with cancer for long periods and it is important to consider the morbidity caused by this disease. Cancer survivors are 2½ times more likely to declare bankruptcy than those without the disease.
CancerX is responding to the call of the White House by establishing a public-private partnership to boost innovation in the fight against cancer. This initiative brings many diverse stakeholders together to unleash the power of innovation needed to create a future free of the burden of cancer.
In this episode, Sarah Sheehan, Program Lead at the Digital Medicine Society (DiMe), Dr. Corinne Leach, Director of Digital Innovation for Research Excellence with Moffitt Cancer Center, and Dr. Grace Cordovano, co-founder of Unblock Health will unveil the goals and deliverables of the inaugural CancerX project, Advancing Digital Innovation to Improve Equity and Reduce Financial Toxicity in Cancer Care and Research.
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Apr 25, 2023
Ep. 39: Recruiting and retaining experienced principal investigators
The success or failure of clinical trials is dependent in large part on the engagement of the principal investigator (PI). PIs play an important role in trial selection, site activation, and study execution. This includes but is not limited to, the development and implementation of a strategy to maximize enrollment, optimize data quality, and ensure patient retention. The legal, regulatory, financial, and workload burden for site PIs has grown considerably over time. The benefits of serving as a site PI are becoming less evident. As a result, increasing dissatisfaction exists among physicians contributing to trials resulting in decreasing interest in trial participation.
According to the Tufts Center for the Study of Drug Development (Tufts CSDD) just over 32,000 active principal investigators are operating worldwide (as of Dec 2021). This number continues to grow but at a slower overall rate of 1.5% annually during the most recent 10-year period (2010 – 2020) compared to 4.6% annually in the prior decade. However, the number of FDA-registered studies during this same 10-year period grew at an average annual rate of 7%.
In this episode, Dr. Gerald Y. Minuk, Professor Emeritus at the University of Manitoba in Winnipeg, Canada, and CEO of Refuah Solutions will share his recommendations to ease the burden of the principal investigator and support the growth of these important leaders of clinical research.
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Mar 29, 2023
Ep. 38: Psychological aspects of clinical trials
Researchers use controls to help them understand what effect a new therapy or drug might have on a particular condition.
Clinical research practice favors placebo controls over usual-care controls. Sometimes a person can have a response, positive or negative, to the placebo control. These responses are known as the "placebo effect and nocebo effect”. The placebo effect demonstrates how positive thinking can improve treatment outcomes. Likewise, the nocebo effect suggests that negative thinking may have the opposite effect. But is this information impacting reported outcomes?
In this episode, Dr. Dominique Demolle, Chief Executive Officer of Cognivia will discuss the implications of the placebo and nocebo effect on clinical development and ways to understand the impact these effects have on the results of clinical trials.
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Feb 28, 2023
Ep. 37: Digital transformation: empowering or encumbering for research sites?
Clinical research professionals across all types of research organizations often struggled with implementing process improvements and the adoption of digital tools. When external factors (such as pandemic disruptions) force transformational process changes, the adoption of digital tools follows. At that point, the value of the new solutions suddenly becomes stunningly clear.
Patients and research sponsors continue to push for faster, more responsive, and more inclusive drug development. This enables new technologies and solutions to emerge to help meet those expectations. The clinical research professionals working at research sites are expected to embrace all of the changes coming their way. Research teams must quickly learn and understand the trial protocols, new capabilities, and work effectively in hybrid environments. Delivering on these expectations can be hampered by the transition from legacy processes and technologies, cybersecurity risks, or even just employees who are resistant to change.
In this episode, Beth Harper, Chief Learning Officer at Pro-ficiency, and Joseph (Joe) Kim, Chief Marketing Officer at ProofPilot Inc, industry leaders passionate about digitally transforming clinical research share their thoughts on how people, processes, and technology are successfully helping clinical research professionals handle the volume and complexity of trials and research programs.
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Jan 25, 2023
Ep. 36: Digital predictions for clinical research in 2023
Clinical research can make all the difference when it comes to saving people’s lives or improving their quality of life.
In this episode, Mathias Eichler-Mertens, Managing Director of Accenture Life Sciences R&D Europe, and Henry McNamara SVP and GM of Oracle Health Sciences, will discuss what can be done to boost innovation and productivity in the year ahead. Hear how to speed up clinical development, contain costs and generate the evidence needed to obtain regulatory approval for new medicines.
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Dec 7, 2022
Ep. 35: Converting to a patient-centric care model
The digital health ecosystem has helped create an infrastructure that supports the transformation of the organization-centered care model into a patient-centered care model. Various reports highlight the staggering investments and the market growth in digital health technologies supporting this change.
In this episode of the Latest Dose, Naomi Fried, PhD, Founder & CEO of PharmStars and Steve Prewitt, SVP, Global Head of Digital Innovation at Sumitovant Biopharma, share the importance and significance of new entrants into the market. They discuss how digital health start-ups will power a patient-centered care system that delivers multidisciplinary and collaborative health services.
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Nov 15, 2022
Ep. 34: Unmasking safety signals
Monitoring safety of biological products, drugs, and devices in healthcare is a priority for inventors, prescribers, regulatory authorities and of course patients. Safety data are collected and analyzed throughout product development and assessed prior to approval for commercial use.
In this episode, Dr. Joseph (Joe) Tonning medical and pharmaceutical consultant at ThinkTrends and practicing physician at Your Health Concierge educates us about signal detection, safety surveillance and analytic methods to identify potential risks. The statistical issue ‘the masking effect’ is discussed and what can be done to deal with it.
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Oct 25, 2022
Ep. 33: A leap forward in safety
"First, do no harm" is a popular saying amongst those involved in the healthcare, medicine, or bioethics field, and is a basic principle taught in health-related courses. To faithfully follow this principle, a health professional should help their patients by recommending tests or treatments for which the potential benefits outweigh the risks of harm.
In this episode, Michael Fronstin, Global Head of Clinical Regulatory & Safety Research and Consulting and Susanne Faber, Director, Advanced Methodologies Clinical Regulatory & Safety, both from Cerner Enviza, share the value and importance of real-world datasets containing de-identified, person-centric, longitudinal records to monitor safety.
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Sep 29, 2022
Ep. 32: Expanding our knowledge by embracing real-world evidence
On receiving news of a health concern there is an immediate thirst for knowledge to understand the condition, the care, and treatment options available.
As a healthcare professional assesses the health status of a person, it may be decided that prescribing a therapeutic drug is the best course of action. These treatments are assigned systematically, not randomly, to achieve an outcome goal. A much smaller number of healthcare professionals may discuss the opportunity for a person to participate in a clinical trial to find new and improved ways to treat, prevent or diagnose different illnesses. Clinical trials generally seek to isolate the pure treatment effect and do so by eliminating or balancing people across comparison groups. These care options are mainly assigned randomly.
In this episode, Jeremy Brody, Head of Global Strategy at Cerner Enviza, discusses when and how industry leaders are embracing both clinical research and real-world data to make care and treatments decisions.
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Aug 30, 2022
Ep. 31: Advancing patient informed consent
Patients are the most important constituent in clinical development and provide the necessary information to assess the safety and efficacy of new medicines. Participation in clinical research requires informed consent. The importance of informed consent cannot be overstated – participants must completely understand all that is involved in a clinical trial prior to providing their signed consent.
In this episode, Andrea Valente, Chief Executive Officer of ClinOne, shares her thoughts on consent, informed consent, and how the principles of consent management is an important emerging approach in clinical research – a topic of particular interest as we continue to hear stories in the industry literature concerning complicated study designs, variability in literacy levels and cultural diversity in clinical research.
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Jul 28, 2022
Ep. 30: Collaborating to scale the use of health sensor data
Access to relevant and trustworthy data to make accurate and timely healthcare decisions is critical. Cohesive industry collaboration is key to removing barriers to data access and increasing adoption of sensors in health science. In this episode, Jennifer Goldsack, Chief Executive Officer of non-profit Digital Medicine Society (DiMe) discusses a multistakeholder Sensor Data Integration collaboration designed to provide clear direction on how sensor data can fulfill its potential to enhance patient lives.
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Jun 28, 2022
Ep. 29: Debunking the myths of clinical trials; leveraging the realities
Clinical research is the study of health and illness in people. It’s about putting people – the participants and volunteers – at the center of finding out if a new treatment is safe and effective. What clinical research and clinical research participation means is often discussed and frequently shared. In this episode, Ken Getz, Executive Director and Professor of Tufts Center for the Study of Drug Development (CSDD), and Elisa Cascade, Chief Product Officer of Science 37, offer insights on the realities and complexities encountered in conducting clinical research around the world.
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May 18, 2022
Ep. 28: Celebrating clinical trial volunteers
International Clinical Trials Day, celebrated each year on May 20th, commemorates the day that James Lind began the first randomized clinical trial in 1747. It also provides an opportunity to recognize and thank everyone involved in clinical research. In this episode, Bruce Hellman, Co-founder and Chief Patient Officer at uMotif offers a practical perspective on what it means to be patient-centric in trial design - including diversity, digital literacy, and the availability of hybrid clinical trial models.
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Apr 25, 2022
Ep. 27: Using RWE to deliver better treatments for patients
The use of mobile devices, social media, wearables, and other biosensors continues to expand year on year. The curation and analyses of health-related data is accelerating, and these data provide the potential to answer questions previously thought infeasible. When a researcher is seeking answers to a health question, when is it appropriate to use real-world data (RWD) and when it is appropriate to conduct clinical research? In this episode, Dr. Susan Dallabrida, CEO, SPRIM Consulting, and Dr. Carla Rodriguez-Watson, Director of Research, Reagan-Udall Foundation for the FDA, share their extensive experiences with RWD and real-world evidence (RWE).
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Mar 28, 2022
Ep. 26: Facilitate clinical research in Europe
The European Union (EU) has been on a path to harmonize the clinical trial process and requirements since 2004 starting with the Directive. The next step came 10 years later, in 2014, with the Clinical Trial Regulation (CTR). This year, as of January 31, the Clinical Trials Information System (CTIS) went live and supports the flow of information between clinical trial sponsors, EU Member States, European Economic Area (EEA) countries and the European Commission. In this episode, Marieke Meulemans from GCP Central and Sebastian Payne from Deloitte share how clinical research and patient health in the EU will benefit from the streamlined regulatory processes and a new portal.
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Feb 23, 2022
Ep. 25: Raising awareness for unknown illnesses
There are more than seven thousand rare diseases in the world – 95% of which have no known treatment. The term rare diseases is a cruel misnomer – in fact they aren’t that rare, and importantly, the definition of what constitutes a rare disease differs by country. To raise awareness, Rare Disease Day is recognized on the last day of February annually. In this episode, industry leaders Joan Chambers, senior director of marketing and outreach at CISCRP, and Scott Schliebner, executive VP and chief strategy officer at M&B Sciences, discuss the importance of improving access to treatment and medical representation for individuals with rare diseases and their families.
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Jan 26, 2022
Ep. 24: Reimagining clinical research as new capabilities come to market
Life sciences organizations face intense pressure to speed clinical trials while boosting operational efficiencies to battle the rising costs of drug development. So what does the future of clinical trials look like?
In this episode, Dr. Avi Kulkarni, senior vice president of research and development at Cognizant, and Henry McNamara, senior vice president and GM of Oracle Health Sciences, share their views on what has been accomplished over the past 10 years, current trends, and their outlook for the future.
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Dec 9, 2021
Ep. 23: Finding strength in hardship – the story of Joey’s Little Angels
When Nicole and James Angiolino’s son Joey was diagnosed with the rare disease Hurler’s Syndrome at seven months old, they did everything they could to save his life. They left their eldest son Nicholas, their family, friends, and teaching careers behind and headed to Duke University Hospital in North Carolina to get him the care he needed. James and Nicole remained unwavering in their fight for Joey, living in the hospital to ensure that Joey got every treatment option available. Their motto became Motivation, Perseverance, and Strength (MPS), mirroring the acronym for the medical term Mucopolysaccharidosis, from which Joey suffered. But after a tremendous battle, sadly, Joey passed away on July 16, 2010, at just 15 months old in Nicole’s arms.
Instead of crumbling under the grief of such an immense loss, they vowed to maintain the positivity and strength that Joey demonstrated to them throughout his journey. While it was extremely difficult, they marched on in honor of their s…
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Nov 17, 2021
Ep. 22: Setting healthy boundaries for optimal health
Anxiety, stress, and exhaustion are on the rise and impacting many of us. With a lot happening in our world that we don’t have much control over, our routines have been disrupted and it’s affecting our overall health and mindset. Combine that with the stress holidays can bring, and you have a recipe for total burnout.
In episode 22, we wanted to cover how and why it’s so important to set healthy boundaries as a means of cultivating optimal health. For example, did you know sleep is the single most effective thing you we can do to re-set our brain and body? And yet, roughly 70 million people in the United States suffer from sleep disorders. Insufficient sleep can cost a nation anywhere from one to almost three percent of their GDP, and in the US, a staggering $411B of lost productivity is also due to not getting enough sleep.
Sit back, relax, and listen as CEO and Founder of the Ardelian Kuzma Group, Aneta Ardelian Kuzma, teaches us tips, tricks, and tools to help us take contro…
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Oct 27, 2021
Ep. 21: Changing the face of men’s health - “the mission behind the moustache”
Men across the globe are dying too young. In the US, three out of four suicides are men, and one in eight (around 10.8 million) will be diagnosed with prostate cancer and testicular cancer, the most common cancers in young men. Our fathers, partners, brothers, and friends are facing a health crisis that isn’t being talked about, and it’s time to speak up.
Since 2003, Movember has empowered over five million people to “challenge the status quo, shake up men’s health research, and transform the way health services reach and support men” for this global men’s movement. Through moustaches grown, connections created, and conversations generated, this charity has funded more than 1,250 men’s health projects in over 20 countries.
In episode 21 of The Latest Dose, Mark Hedstrom, the US executive director of Movember, joins us to talk about how they are tackling the three biggest health issues facing men: mental health and suicide prevention, prostate cancer, and testicular canc…
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Sep 29, 2021
Ep. 20: Collaborating with patients throughout drug development
There’s no question that clinical research is the backbone of healthcare invention, helping to improve the prevention, detection, diagnosis, and treatment of disease. But at the heart of it all you’ll find that patients are the true lifeblood of clinical research, keeping things moving and allowing researchers to save more lives every day.
With patients at the center of clinical trials, it only makes sense that they can (and should) be involved throughout the drug development process. Laws like the 21st Century Cures Act, and programs like the Medicines and Health Products Regulatory Agency (MHRA) pilot expect and encourage the patient perspective to inform product development.
To be clear, having patients contribute to bringing inventions to market is not new. However, it is often much more involved than simply identifying eligible, consenting candidates for a clinical trial.
In episode 20 of The Latest Dose, we discuss the ins + outs of collaborating with patients throughout d…
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Aug 25, 2021
Ep. 19, Part 2: Advancing patient health through medical devices
Medical devices are an integral part to many procedures and treatments, and last month we started to investigate the vast and innovative world of these types of technologies in a two-part series on The Latest Dose. In part one, our esteemed guests, Dr. Khaudeja Bano, the executive medical director of combination product safety, global patient safety & pediatrics at Amgen; Nada Hanafi, the chief strategy officer at Experien Group; and Shruti Iyer, senior software reliability engineer at Medtronic, took us through the guidance and regulations surrounding medical devices, and highlighted one of the biggest trends in the space, artificial intelligence.
In part two, our guests are back to talk about another significant trend: virtual, augmented, and extended reality in medical devices. These devices are becoming essential in clinical research and healthcare, and are increasingly more innovative with each passing year. They’ll also discuss how to safely and effectively bring these new sol…
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Jul 28, 2021
Ep. 18, Part 1: Advancing patient health through medical devices
From bandaging a sprained ankle and diagnosing HIV/AIDS, to implanting an artificial hip and monitoring your heart, medical devices are an integral part to many medical procedures and treatments.
There is a lot to unpack when it comes to medical devices, so we’ve invited industry leaders Dr. Khaudeja Bano, the executive medical director of combination product safety, R&D strategy & operations, and global patient safety & pediatrics at Amgen; Nada Hanafi, the chief strategy officer at Experien Group; and Shruti Iyer, senior software reliability engineer at Medtronic, to share their thoughts in a two-part series of The latest Dose that will focus both on regulations and trends in medical devices.
In part one of episode 18, we discuss the guidance and regulations surrounding medical devices, and highlight one of the hottest trends in this space, artificial intelligence.
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Jun 28, 2021
Ep. 17: Renovating ICH guidelines to support the evolution of clinical research
The clinical research ecosystem has undergone an evolution over the past 18 months, and many want it to continue. To help set the industry on a solid path forward, ICH has created guidelines that provide direction on behaviors and actions to take. Recently, a specific set of these guidelines, ICH E6 Revision 3 and E8 Revision 1, have been referred to as being under renovation in response to the way work is done today and in the future.
In this episode, Kathy speaks with Andy Lawton, director at Risk-Based Approach Ltd., Crissy MacDonald, vice president of client delivery at Avoca Group, and Erika Stevens, principal at Recherche Transformation Rapide, about these specific ICH guidelines to learn what is new and improved about the quality by design approach, how this will impact the future of clinical research, and what you need to do to prepare.
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May 20, 2021
Ep. 16: Clinical Trials Day – Thanking those that make clinical research possible
Aboard the HMS Salisbury of Britain’s Royal Navy on May 20th, 1747, surgeon James Lind performed what is often considered to be the first randomized clinical trial. Now, every May 20th, International Clinical Trials Day gives us a well-deserved occasion to honor and thank both the professionals and patients who make clinical research possible. It also gives us an opportunity to raise awareness of clinical research and show why it’s critical to the improvement of our health and wellness.
To help us celebrate Clinical Trials Day, we spoke with the Director of Patient Recruitment at Accellacare, ICON’s global clinical research network, Nazneen Qureshi. In this conversation, we discuss the role that volunteers and patients play in clinical research, how to recruit eligible people, and how to spread awareness and gratitude for clinical trial participants.
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Apr 29, 2021
Ep. 15: Embracing Telemedicine Now and in the Future
As a methodology that’s generally been underutilized in the past, the pandemic has brought telemedicine to the forefront as a way for doctors to care for their patients, without them having to come into an office or site. But how exactly is it being used in medicine and clinical research today, and will it still be widely used after the pandemic ends? In this discussion, Kathy speaks with Dr. Thomas Fiel and Everest Group's Nitish Mittal about how telemedicine is being used today, its benefits and challenges, how it impacts diversity in clinical trials, and if they think it will still be widely used post-pandemic.
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Mar 30, 2021
Ep. 14: Driving the Implementation of Decentralized Clinical Trials
Recently, Covance announced that they are transforming to a fully decentralized CRO – an exciting step in the life sciences industry. In this episode, Kathy speaks with Covance’s Director of Decentralized Trials, Jane Myles, and Vice President and Head of Decentralized Trials, Bola Oyegunwa, about how they’re driving the implementation of decentralized trials globally, and what they think the core tenants are that the industry should abide by when executing decentralized trials.
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Feb 26, 2021
Ep 13: Transforming Trials 2030
Clinical Trial Transformation Initiative (CTTI) announced on January 25, 2021, a new vision for clinical trial ecosystem and beyond, called Transforming Trials 2030. The pandemic has changed the way we perform clinical research, and many constituents have implemented new and efficient solutions, systems, and processes to conduct trials. CTTI members believe this passion and experience will help shape a future of smarter, faster research. In this episode, Kathy speaks with Dr. Pamela (Pam) Tenaerts, executive director at CTTI, about CTTI’s vision for the future of clinical research, Transforming Trials 2030.
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Jan 28, 2021
Ep. 12: Joining the #NoGoingBack Movement
The pandemic has created a lot of disruption in clinical trials, but not all of it has been negative. From accelerating the adoption of decentralized trials and speeding up the delivery of vaccines, to telemedicine and mHealth playing bigger roles in patients’ lives, opportunities have emerged to help us rediscover and recalibrate the way we perform clinical research. Many believe we can’t go back to the old way of doing things – so who’s leading the charge?
In this episode, we define what a movement is, learn how to be the “Dancing Man,” and discuss why the #NoGoingBack mission is so critical to preserving the progress we’ve made in clinical research. To talk about why this is so important, we've brought on two leaders of the #NoGoingBack movement, Maimah Karmo and Craig Lipset, to share what it means to them.
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Dec 17, 2020
Ep. 11: Spreading Joy to Those in Need – the Role of Therapy Dogs in a Clinical Setting
Research shows that animals can improve the mental, physical, and emotional wellbeing of their human companions. From this strong bond comes the concept of therapy animals, or in this case, therapy dogs.
But what is a therapy dog, and how are they being used today?
In this episode, Kathy speaks with Children's Hospital Los Angeles and the Alliance of Therapy Dogs about their therapy dog programs, what it takes to become a volunteer, how dog therapy works, and more.
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Nov 20, 2020
Ep. 10: Solving Problems in Clinical Trials with Innovation
What is the role of innovation in clinical trials and why is it important? In this episode, Kathy speaks with Craig Serra, who works in clinical technology and innovation at Novartis, about different types of innovation and how they're used in the pharma industry.
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Oct 23, 2020
Ep. 9: The Prix Galien – Honoring Pharmaceutical Research and Development for 50 Years
Every year, the brightest minds in pharmaceuticals and clinical innovation put on their best black-tie attire for the life science industry’s biggest event, the Prix Galien. In this episode, you’ll learn about the history of the Prix Galien Awards, why it is considered the “Nobel Prize” for pharmaceutical research and development, and find out the new additions to its program from its chair and co-chair, Bruno Cohen and Dr. Michael Rosenblatt.
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Oct 21, 2020
Ep. 8: Embracing the Future of Decentralized Trials and Remote Visits for Site Staff and Patients
The pandemic heavily disrupted clinical trials, pushing us to rethink how we conduct clinical research. In this episode, Kathy invites Casey Orvin, SVP of pharmaceutics relationships at StudyKIK and honorary president of SCRS to talk about the future of decentralized trials and remote visits from the patient and site perspective.
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Aug 27, 2020
Ep. 7: The Role of AI, Automation, and Touchless Case Processing in Patient Safety
In episode seven of The Latest Dose, our host Kathy Vandebelt invites two of Oracle’s safety experts, Vice President of Safety Product Strategy, Bruce Palsulich, and Senior Director of Safety Strategy, Michael Braun-Boghos, to explore areas in pharmacovigilance where AI, automation, and touchless case processing are having a significant and positive impact on managing patient safety.
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Jul 24, 2020
Ep. 6: Embracing Biometric Monitoring Technologies and Digital Measurement in Clinical Research
In this episode, host Kathy Vandebelt discusses how to get comfortable with the use of mobile technologies in clinical trials with our guest, Jennifer GoldSack. Jen serves as the Executive Director of the Digital Medicine Society (DiMe). She was also an Olympic athlete, and ties in her experience in the Olympics with the topic at hand – biometric monitoring.
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Jun 24, 2020
Ep. 5: Thanking the Clinical Trial Patient and Giving Back for the Greater Good
In this episode, our host Kathy Vandebelt brings back Greater Gift and PopUp Star Founder, Jennifer Byrne, to talk this time specifically about the importance of giving back to clinical trial participants. In this interview, Jennifer dives into what Greater Gift is, her motivation for founding it, why it’s important, and what they do to thank participants and other clinical research stakeholders.
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May 19, 2020
Ep. 4: Celebrating Clinical Trials Day and Bringing Awareness to Clinical Research
For Clinical Trials Day, we want to shine a light on the patients and people who bring awareness to clinical research. To do this, Kathy Vandebelt interviews two industry veterans, Greater Gift and PopUp Star Founder Jennifer Bryne, and Oracle Health Sciences’ Senior VP and General Manager Steve Rosenberg, about their personal experiences with clinical research, the history of Clinical Trials Day, what PopUp Star is, and how it's bringing awareness to clinical research.
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Feb 6, 2020
Ep. 3: Considering the Patient & Improving the Clinical Research Ecosystem
Kathy Vandebelt speaks with Joe Kim, Eli Lilly & Company’s Sr. Advisor, Digital Health Office, and host of Lilly’s podcast Elixir Factor, which explores the factors that inspire bold advances in science. He aims to improve the capabilities for one of humankind's biggest social issues - the development of new medicine. Hear Joe’s opinions on approaches, initiatives, & technology to make clinical research more patient-friendly.
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Feb 6, 2020
Ep. 2: Unifying the Old and New – How “Virtual” Components are Changing Clinical Trials
In this episode, Host Kathy Vandebelt discusses decentralized trials with Dylan Rosser, Executive Director of Global Development Operations at Amgen. Dylan brings to light the various virtual components that are used and can be stitched together in a trial. He also talks about the importance of the patient in clinical research, and highlights the benefits decentralized trials can bring to them.
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Feb 4, 2020
Ep. 1: Improving Clinical Research: Go it Alone, or Join Industry-Driven Initiatives?
In this episode, Oracle Health Sciences Global Head of Innovation, Kathy Vandebelt, speak with Allergan's Director of Global Study Start Up and Essential Documents, Lorena Gomez, about TransCelerate and her role since the beginning. Tune in to hear her opinions about industry initiatives, insights into the Shared Investigator Platform program, and what she thinks they should work on next.
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