Research in Action Oracle Corporation

What are the best ways to set up public, private, and academic clinical research partnerships? How do we get these public-private partnerships (PPP) to work most effectively? And who should be in charge of what in multistakeholder research collaborations? We will get those answers in more in this episode of Research in Action with our guests Rob King, President and CEO of FHI Clinical; and Dr. Kristen Lewis, Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.
 
---------------------------------------------------------
 
Episode Transcript:
 
00;00;00;01 - 00;00;22;22
What are the best ways to set up public-private clinical research projects? Where does and should the money for such research come from and who should be in charge of what? We'll get those answers and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.
 
00;00;22;22 - 00;00;50;05
I'm Mike Stiles. And today we're just trying to outdo ourselves by talking to not one, but two very interesting people. First is Rob King, president and CEO of FHI Clinical. FHI uses Oracle's clinical trial software for their clinical operations and partner with public entities like PATH, which brings me to Dr. Kristen Lewis, who is Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.
 
00;00;50;26 - 00;01;29;23
I could go through what each of these organizations do just to hear myself talk, But why do that when I have both of you here? So, Rob, tell us what FHI Clinical does. Yeah, I think Mike, so clinical in a contract, they were actually for profit and hearing of a large nonprofit called F8 had three ethically and while we are for profit empathy, our mission is to address unmet research needs and maximum social impact pouring into development of medical treatment around the world.
 
00;01;30;04 - 00;01;58;20
While we work globally, we tend to focus on the low and middle income country on the whole pharma and biotech client are also include nonprofits and government. Empathy. Well with biotech receive public funding and path having him be one of our client. Appreciate Kristen being here arguing that four years ago and I'm currently the CEO and I'm happy to be here.
 
00;01;58;20 - 00;02;22;19
Well great. Kristen what about PATH? Yeah, thanks for the introduction, Mike. It's a pleasure to speak with you and Rob today and have the opportunity to contribute to this discussion. So most people listening to this podcast may not be familiar with PATH. We're a nonprofit global public health organization with approximately 1600 employees worldwide. Our headquarters are in Seattle, Washington, and we have offices across the African and Asian continents and Europe.
 
00;02;22;19 - 00;02;53;00
Some of the locations we have offices in include Kenya, Ethiopia, Senegal, Uganda, Zambia, India, Vietnam, Ukraine. And I could go on, but I'll I'll hold hold it there. Our mission is to advance health equity through innovation and partnerships. We do this with the help of local and global partners by generating evidence, advancing innovation and strengthening local capacity to improve health in countries and communities that are experiencing disproportionate burdens of disease and barriers to well-being, specifically in low and middle income countries.
 
00;02;53;11 - 00;03;26;01
This includes working in over 70 countries across the African, Asian, Latin American, European and North American regions. Within Paths Center for Vaccine Innovation and Access, we drive the mission of achieving health equity using a three-pronged approach, including developing, facilitating and implementing global market and policy solutions to ensure sustainable supply and equitable access to vaccines. Supporting country led efforts to advance national health equity priorities, and to strengthen immunization system resilience and driving innovation and tech

How can patients and their families become more integral in the clinical research process? How can patient-led research become more accepted in the scientific community? How are inspiring groups forging new, collaborative paths for science and medicine, and reshaping how medical research is conducted?  We will tackle those questions and much more in this episode with Amy Dockser Marcus, a Pulitzer Prize-winning journalist and author of the recently published book, “We the Scientists: How a daring team of parents and doctors forged a new path for medicine.” Amy is a veteran reporter at the Wall Street Journal and won her Pulitzer Prize for Beat Reporting in 2005 for her series of stories about cancer survivors and the social, economic, and health challenges they faced living with the disease. She has covered science and health at the Journal for years, and she also earned a Masters of Bioethics from Harvard Medical School. 
--------------------------------------------------------
Episode Transcript:
00;00;00;00 - 00;00;24;19 

How can patients and their families become the centers of research? What is open science and who are citizen scientists? We'll explore those questions and more on this episode of Research and Action in the lead in. Hello and welcome back to Research and Action, brought to you by Oracle Life Sciences. I'm your host, Mike Stiles, and our guest is Amy. 

  

00;00;24;19 - 00;00;48;22 

Dr. Marcus That's right, that Amy Marcus, the Pulitzer Prize winning journalist, reporter at the Wall Street Journal, a Pulitzer Prize, was won for her series of stories in 2005 about cancer survivors and the social and financial challenges of living with cancer. Her beat, as you would imagine, has long been science and health. And she holds a master's of bioethics from Harvard Medical School, and she's an author. 

  

00;00;48;22 - 00;01;04;26 

Her book is We The Scientists How a Daring Team of Parents and Doctors Forged a New Path for Medicine. So this should be interesting as we talk about collaborative, open science and the rise of citizen scientists and patient led research. So thanks for being with us, Amy. 

  

00;01;05;01 - 00;01;06;22 

I'm happy to speak with you today. 

  

00;01;06;22 - 00;01;26;29 

Great to have you. In your new book, you take readers through some really, frankly, heart wrenching experiences that patients and their families have gone through with a rare and devastating disease called Niemann-pick. Hopefully I'm pronouncing that correctly. Tell us about the book and that disease and what fascinated you about this story. 

  

00;01;27;14 - 00;02;01;21 

The origin of the book really is a personal story, which is my mother got diagnosed with a rare type of cancer. And when I tried to do research on her behalf, I started to learn how challenging it is to develop drugs for rare diseases. After she passed away, I took some time off from the Journal. I had a research grant from the Robert Wood Johnson Foundation and I started traveling around the country looking to see if there were new models that might accelerate drug discovery. 

  

00;02;01;29 - 00;02;25;21 

And during the course of that research, I was introduced to a group of parents whose children have this rare and fatal genetic disorder, NIEMANN-PICK type C disease. It's a cholesterol metabolism disorder, so the cholesterol doesn't get out of the lysosome and that compartment in the cell and it starts to build up and it causes all kinds of problems. 

  

00;02;25;21 - 00;02;52;12 

And the children eventually lose the ability to walk and to talk and to feed themselves. But the parents that I met wanted to do something novel. They had found a group of scientists and researchers and clinicians and even some policymakers in the government that wanted to work together as partners and to see if they could accelerate the search for a cu

How can an extensive collection of real-world data help find more diverse and better participants for clinical trials? How do we create a continuously learning ecosystem that helps bridge the gap between clinical research and clinical care? And what are the biggest challenges to patient record standardization and personalized healthcare? We will learn that and more in this episode with Dr. Lu de Souza, Vice President and Executive Medical Officer of the Learning Health Network, which is a division of Oracle. Dr. de Souza leads a team that seeks to help health organizations integrate clinical research into everyday care. That means addressing clinical discovery cost, time, and patient inequities. She’s also a huge advocate for real-world data and bringing technology to bear for true healthcare advancements. Dr. de Souza has years of experience in health informatics and was the most recent CMO of Cerner in North America. She practiced pediatric hospital and emergency medicine until 2020 and has held multiple leadership and teaching positions. 
--------------------------------------------------------
Episode Transcript:
00;00;00;01 - 00;00;25;21 

How can an extensive collection of real-world data help find diverse participants for clinical trials? Are some organizations already using the concepts of a continuously learning ecosystem. And what are the biggest remaining challenges to patient record standardization and personalized health care? We'll find all that out and more on today's Research in Action episode. 

  

00;00;27;05 - 00;00;47;23 

Hello and welcome to Research in Action, brought to you by Oracle Life Sciences. I'm Mike Stiles and our guest today is Dr. Lu de Souza, vice president and executive medical officer of the Learning Health Network, which is a division of Oracle Life Sciences. In a nutshell, Dr. de Souza leads a team that seeks to help health organizations integrate clinical research into everyday care. 

  

00;00;48;03 - 00;01;11;28 

That means addressing clinical discovery, cost time and patient inequities. She's also a huge advocate for real-world data, bringing technology to bear for true healthcare advancements. Dr. de Souza has years of experience in health informatics and was the most recent CMO of Cerner in North America. She practiced pediatric hospital and emergency medicine until 2020 and has held multiple leadership and teaching positions. 

  

00;01;12;12 - 00;01;16;03 

Dr. de 'Souza, thank you so much for taking the time to be our guest today. 

  

00;01;16;14 - 00;01;20;12 

Now Thank you, Mike. It's really a pleasure to be here. And please feel free to call me Lu. 

  

00;01;21;02 - 00;01;29;21 

There's a lot of ground to cover here. But first, let's just find out about you. What was the life path that brought you to where you are today and doing what you're doing today? 

  

00;01;30;15 - 00;01;55;05 

You know, as you mentioned, I am a pediatrician who focused on taking care of sick kids in the hospital and the emergency department. And I really loved my job. But like many doctors, I felt frustrated by the inefficiencies of health care. And I felt very frustrated with the limitations of time and data that we suffer both of those things are super essential to make the fast decisions that we need to make. 

  

00;01;55;23 - 00;02;16;20 

So I started thinking about technology and the role that it could play in solving some of these foundational issues. And also, you know, we always want to see how many more patients we can help. So I felt like the pivot would allow me to take care of patients in a different way, but at higher numbers. It was not easy decision. 

  

00;02;16;20 - 00;02;41;20 

It was very hard for me to leave full time pediatrics, so much so that I stubbornly continue to practice for the first ten years that I was full time at Cerner. But at the tim

Research reveals that 95% of patients do not participate in clinical trials. How do we find better ways to connect willing and qualified participants to clinical trials? How do we ensure diversity in participant populations? And how can we make access to clinical trials more patient-friendly? We will get those answers and more in this episode with Brandon Li, Co-Founder at Power. Power is a fast-growing startup building a patient-friendly way to get access to clinical trials and is working to increase the diversity in clinical trials.
--------------------------------------------------------
Episode Transcript:
00;00;00;03 - 00;00;17;02 
Are there better ways to connect willing and qualified participants to clinical trials? How do you ensure diversity in participant populations? And why do 97% of patients not participate in clinical trials? We'll get those answers and more on this episode of Research in Action. 
  
00;00;18;07 - 00;00;19;19 
The need to. 
  
00;00;21;14 - 00;00;41;18 
Build the Hello and welcome to Research and Action, brought to you by Oracle Life Sciences. I'm Mike Stiles, and our guest today is Brandon Lee, co-founder at Power. Power is building a patient friendly way to get access to clinical trials, and they're working on increasing the diversity in clinical trials. Brandon, thanks for taking the time to be with us today. 
  
00;00;41;28 - 00;00;42;27 
Yeah, it's my pleasure. 
  
00;00;44;06 - 00;01;03;27 
Great. Well, looking forward to it. And we are going to be talking about some amazing stuff as always. But we also always like to get a feel for the person behind that amazing stuff. So what did you want to be when you grew up and how did you get from there to the field of clinical trials and technology and the kind of things you're doing now? 
  
00;01;04;06 - 00;01;13;12 
It depends on how far back you want to go, but I think that through most of my childhood, I probably wanted to be a like a professional trading card game player as. 
  
00;01;16;03 - 00;01;17;28 
Are you a Pokemon man or. 
  
00;01;18;11 - 00;01;29;24 
It was it was all of the above, right? It was like a Pokemon journey. Then there was like a, you know, journey. Then there was a magic. The Gathering journey. I kind of cycled through all of them, but I ended up landing on magic, I think, for most of it. 
  
00;01;30;15 - 00;01;32;25 
Well, check those old cards. You could be a millionaire. 
  
00;01;33;01 - 00;01;39;12 
I've been. I've been watching the the price of Charizard skyrocket with a lot of energy. You remember having plenty of money? 
  
00;01;39;23 - 00;01;43;08 
Well, great. Yeah, but obviously that's not what you wound up doing full on. 
  
00;01;43;23 - 00;02;12;07 
No, not at all. Yeah, I think the kind of journey here was. Well, at some point I became a consumer internet. Consumer marketplace person sometime between my my kind of professional trading card game times and and kind of coming out of college, I started thinking a lot more about consumer tech. So I spent a handful of years just doing things that look a lot like classic consumer marketplace work. 
  
00;02;12;07 - 00;02;33;14 
Thumbtack, Airbnb, Zillow, all kinds of kinds of products. And at one point I had a close friend of mine diagnosed with a brain tumor who had to go looking for a clinical trial on her own and, you know, that journey was brutal for her. She did everything that patients basically go and do today, which is backchannel the heck out of every doctor that she knows. 
  
00;02;33;14 - 00;02;55;08 
And eventually all roads ended up leading to clinicaltrials.gov. So she spent weeks there trying to figure out, okay, is there a trial that could make sense for me? Eventually, she finds one and the contact information is like the front desk of the hospital. So she's cold calling the hospital. The hospital's routing her internally. She's trying to find a

What does a data hippie believe about the democratization of data? What role do technology companies, government, academia, industry, and other stakeholders play in life sciences and discovery? And how might walking clinical trials lead to improved precision medicine? We will get the answers to those questions and more in this episode with Dr. Chris Boone, the GVP of Research Services at Oracle Life Sciences. Chris has held some prominent roles at AbbVie and Pfizer, influencing health economics, medical epidemiology, and real-world data and evidence. He is an adjunct assistant professor at NYU, engaged in national health data committees, and serves on several boards including the American Heart Association.
--------------------------------------------------------
Episode Transcript:
00;00;00;03 - 00;00;22;00 

What does a data hippie believe about the democratization of data? What role should tech companies, government and other stakeholders play in life sciences? Discoveries? And how might walking clinical trials lead to improved precision medicine? We'll get those answers and more on this episode of Research and Action in the lead. 

  

00;00;24;03 - 00;00;43;21 

Hello and welcome to Research and Action, brought to you by Oracle Life Sciences. I'm Mike Stiles. And today we're going right to the source when it comes to finding out what Oracle is doing in the life sciences space, what does a company like Oracle have to contribute? Why is it in the space? What does it and the rest of us have to gain from its involvement? 

  

00;00;43;21 - 00;01;09;03 

Those are the kinds of questions will be throwing at Dr. Chris Boon, newly appointed EVP of Research Services at Oracle Life Sciences. Chris has held some prominent roles at AbbVie and Pfizer, influencing health economics, medical epidemiology and real world data and evidence. He is an adjunct assistant professor at NYU, engaged in national health data committees and serves on several boards, including the American Heart Association. 

  

00;01;09;03 - 00;01;14;18 

So Chris, you're obviously a very busy person, so we really appreciate your time today. 

  

00;01;15;21 - 00;01;17;02 

Thanks, Mike. I'm happy to be here. 

  

00;01;17;11 - 00;01;30;01 

Before we get started, tell us about your new role at Oracle and how you see scientific and industry expertise as kind of a winning combination with technology. 

  

00;01;30;01 - 00;01;50;15 

Yeah, that's a great question. And I think this is a very fascinating point in our health care and life sciences history. I mean, it's about but I'll start a bit with who I am and what exactly I do as the group vice President of Research Services. I get the great honor and privilege of leading our research services organization formerly known as Cerner. 

  

00;01;50;15 - 00;02;17;14 

And these are within the Hawk Oracle Life Sciences Organization. This particular organization has been primarily focused on data analytics and research, right? So in many respects it represents the convergence, if you will, of scientific clinical industry and technology expertise, which I think is pretty much nirvana for where we are with the future of evidence generation in our industry. 

  

00;02;17;14 - 00;02;35;06 

And so I'm extremely excited and honored to be able to sort of usher this organization and Oracle into this new realm and fully integrate all the great technologies that Oracle has with all the expertise and expertise and capabilities that that we've had in this R&D as a team. 

  

00;02;35;26 - 00;02;53;21 

Yeah, it sounds like there's a lot of people involved and buy in as necessary from a lot of different areas, from researchers to academia to technology. How are you finding the the openness and the willingness to include Oracle in these major efforts? 

  

00;02;54;07 - 00;03;22;05 

You

What is the rare Gaucher disease and how does it impact patients, families, and life sciences? Is enough emphasis being placed on research and discovery for rare diseases? And what are the patient-centered approaches that best serve those battling rare diseases? We will get those answers and more in this episode with Tanya Collin-Histed, CEO of the International Gaucher Alliance. Tanya has been a longtime driving force in supporting patients with rare diseases and advocating for world-class healthcare. Her work has been nothing short of groundbreaking and she’s become the go-to person for patients, medical practitioners, industry, and governing bodies. As a mother of a child with Gaucher disease, she brings a unique, first-hand, and compassionate approach.  
--------------------------------------------------------
Episode Transcript: 
00;00;00;00 - 00;00;25;09 
What is the rare gosh disease? Is enough emphasis being placed on rare diseases? And what are the patient centered approaches that best serve those battling rare diseases? We'll get those answers and more on research in action in the lead to the world. Hello and welcome to another episode of Research and Action, brought to you by Oracle Life Sciences. 
  
00;00;25;09 - 00;00;49;25 
I'm Mike Stiles. And today we have a truly inspiring guest. Tanya calling his dad, CEO of the International Gosh Alliance, has been a long time driving force in supporting patients with rare diseases and advocating for world class health care. Our work has been nothing short of groundbreaking. She's actually become quite the go to person for patients, medical practitioners, industry governing bodies. 
  
00;00;50;03 - 00;00;52;01 
Tanya, thanks so much for being with us today. 
  
00;00;52;14 - 00;00;55;04 
Thanks, Mike. It's an absolute pleasure to be here. 
  
00;00;55;19 - 00;01;05;11 
Well, before we get into the incredible work you're doing, let's get a baseline understanding of exactly what Gaucher disease is and just how rare it is. 
  
00;01;06;00 - 00;01;37;11 
Okay. Well, as a caregiver, I'll give a lay lay version to you. So it's a genetic condition and it's inherited. It's caused by a storage disorder. And that is because people with Gaucher have a deficiency in an enzyme. And the function of that enzyme is that it's in the body to break down substances. And because there isn't enough of that enzyme, the substances store in different parts of the body. 
  
00;01;37;25 - 00;02;05;17 
And it really does depend on what type of disease you have to how the disease affects you. But all patients can have a large liver and spleen. They get anemia, they get bruising where the blood doesn't clot properly and bone pain and bone damage due to the cells being in their bone marrow where which is where the blood cells are made. 
  
00;02;06;02 - 00;02;42;09 
Now, for patients who have type two and type three, there's also brain involvement and that really ranges from patient to patient. But that can include things like cognitive impairment, seizures, hearing and sight loss, unsteadiness in their movements and tremors. Now, it's it's a rare disease, as you say, and roughly it's around one in 100,000. However, this will different differ from region to region and also from type to type. 
  
00;02;42;21 - 00;03;11;18 
So historically, type one cases, disease is the most prevalent. Then we go into type three and then type two is like what we would call ultra ultra. However, as we become a much more globally connected community, we are seeing that there are many more patients with type two and Type three in Asia, whereas in sort of Europe and the West, we see more Type one patients. 
  
00;03;12;05 - 00;03;27;29 
Yeah, well it sounds like just that one issue, the the deficiency of that enzyme can cause countless problems all over the body. It already makes it obvious why this is such a difficult disease to get a handle on.