Ep. 37: Digital transformation: empowering or encumbering for research sites?
Release Date: 02/28/2023
Ep. 43: Running regulatory and clinical operations in an AI world
The Latest Dose
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...
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Ep. 42: Creating drugs at the speed of AI
The Latest Dose
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...
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Ep. 41: CancerX: Reducing incidence, burden, and disparities in cancer care
The Latest Dose
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....
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Ep. 40: CancerX: Breaking down the barriers to digital innovation use in oncology
The Latest Dose
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...
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Ep. 39: Recruiting and retaining experienced principal investigators
The Latest Dose
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...
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Ep. 38: Psychological aspects of clinical trials
The Latest Dose
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...
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Ep. 37: Digital transformation: empowering or encumbering for research sites?
The Latest Dose
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...
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Ep. 36: Digital predictions for clinical research in 2023
The Latest Dose
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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Ep. 35: Converting to a patient-centric care model
The Latest Dose
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...
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Ep. 34: Unmasking safety signals
The Latest Dose
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...
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