The Latest Dose Oracle Corporation

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
 
00;00;00;00 - 00;00;40;25
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.
 
00;00;41;02 - 00;01;11;13
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?
 
00;01;11;15 - 00;01;42;17
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.
 
00;01;42;19 - 00;02;09;06
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 i

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.
 
00;00;31;26 - 00;00;59;16
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.
 
00;00;59;19 - 00;01;26;21
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?
 
00;01;26;23 - 00;02;02;02
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.
 
00;02;02;05 - 00;02;37;05
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

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.
 
00;00;34;29 - 00;00;56;27
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.
 
00;00;57;00 - 00;01;26;12
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.
 
00;01;26;15 - 00;01;56;08
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.
 
00;01;56;10 - 00;02;26;08
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.
 
00;02;26;10 - 00;03;04;24
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

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.

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.
 

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.