Real World Talk with COTA

In the latest episode of Real World Talk, host Sandy Leonard sits down with experts Laura Fernandes and Sesh Srinivasan to dive into the pressing issue of bias in clinical research. Sandy sets the stage by highlighting recent regulatory responses and the growing attention on the topic, emphasizing its significance in the realm of real-world data and evidence.Laura Fernandes, with her rich background at Cota and the FDA, shares an eye-opening instance where a company's oversight led to inflated tumor response data, resulting in a ripple of distrust in the community. She underscores the paramount importance of maintaining integrity in trials, ensuring that results presented are genuine and trustworthy.Sesh, from Deloitte, offers a brighter perspective by narrating a success story about the drug Koselugo. This drug, after a lengthy 17-year development timeline, showcases the potential of external control arms in expediting drug development, emphasizing the ultimate goal: delivering effective treatments to patients faster.

In this episode of Real World Talk, host Sandy Leonard sits down with Ulka Campbell, Head of Scientific Strategy at Aetion, and CK Wang, Chief Medical Officer at COTA. They dive into the Aetion CARE program, a cross-industry initiative aimed at understanding real-world data's role in evaluating oncology therapeutics.Campbell explains the importance of the CARE program, emphasizing the collaborative approach involving various stakeholders. The team is working on emulating trials, focusing on study design, data fitness, and documenting learnings. The goal is to support oncology therapeutic development, approval, and access.Wang adds insights into the differentiation between EHR and claims data sources, highlighting the specific needs in oncology trials. The conversation concludes with a look into the future of oncology research, leaving listeners with a clear understanding of the CARE program's significance and its potential impact on the field.

In this episode of Real World Talk, Sandy Leonard from COTA hosts a thought-provoking discussion with Laura Fernandes, Senior Statistical Director at COTA, and Sesh Srinivasan, Product Management Lead at Deloitte. The conversation revolves around the future of real world data and the exploration of external control arms (ECAs) in drug development.The guests delve into the intricacies of ECAs, discussing their types and how they differ from each other. They highlight the importance of clearly defining the scope and objectives of the research question at hand. They also shed light on the need for sponsors to consider the relevance, reliability, completeness, and timeliness of data when planning a study.The conversation concludes with a focus on the importance of diversity in clinical trials and how real-world data can enhance patient participation and adherence. The episode provides valuable insights into the evolving landscape of real-world data in clinical trials.

In the world of clinical trials, having a well-defined research question is key. And that's where fit-for-purpose data sets come in. But what are the factors for defining research questions?In this episode of the Real World Talk podcast, we get to hear from Seshamalini Srinivasan, Karla Feghali, Mandy Kelly, and Laura Fernandes. They talk about the criteria for defining research questions, the importance of fit-for-purpose data, and the other factors to consider in real-world data sources.

Real-world data holds great potential for clinical trials, and it can support clinical development and regulatory decision-making. But when working with data, we need to be conscious of potential biases. In this episode of the Real World Talk podcast, our host Christie Zettler welcomes Laura Fernandes, Senior Statistical Director at COTA. They talk about the JSM conference, AML response validation work, and how to account for potential biases when dealing with RWD.

Real world data (RWD) is data that's collected outside of clinical trials, whereas randomized controlled trials (RCTs) are conducted to measure the effectiveness of a specific medication or treatment. But how can these two work together to improve patient outcomes?In this episode of the Real World Talk podcast, our host Mandy Kelly welcomes Seshamalini Srinivasan, Laura Fernandes, and Karla Feghali to talk about the importance of combining RWD and RCTs to bring life-saving treatments to patients faster.

Real world data is changing the pharma industry and allowing companies to maximize value while minimizing the time and money spent. In addition, technology is evolving, and new methodologies are being developed, all of which contribute to the change. However, we still need to work on things such as diversity and inclusion.In this episode of Real World Talk, we are joined by Karla Feghali of Deloitte. Karla discusses the recent report her company published and the impact it has on the space. In addition, Karla and our host Zoe Li discuss the latest data-related trends in the pharma space and what it takes for pharma companies of all shapes and sizes to rebuild trust in underserved populations and introduce them to drug discovery studies.

Blood cancers make up more than 100 different diagnoses in the current classification system. And there are three main groups of blood cancer: leukemia, lymphoma, and myeloma. One of the most common leukemias in adults is chronic lymphocytic leukemia (CLL). In this episode of Real World Talk, our host Ming He welcomes Paul Barr, MD, the medical director of the Clinical Trials Office of the Wilmot Cancer Institute. They talk about the importance of Blood Cancer Awareness Month, the development of CLL treatments, and the potential use of real-world data in blood cancer research.

The healthcare ecosystem generates approximately a third of all the new data in the world. And it holds untapped potential for developing new therapies and giving people the opportunity to live longer and healthier.But these data sets are raw and need to be meticulously tabulated into meaningful, targeted information.In this episode of the Real World Talk podcast, our host Nick Ritter welcomes Miruna Sasu, the president and CEO of COTA. They talk about COTA's Vantage product and how it can help improve drug development in the oncology space.

Real world data and real-world evidence are powerful tools for scientific researchers, and they have an enormous potential to transform the healthcare space, especially oncology.But, we need to educate the entire ecosystem on the importance of real-world data to be able to reap its full benefits.In this episode of the Real World Talk podcast, we introduce our new CEO – Miruna Sasu. She talks about her plans for COTA, the role of real-world data in clinical trials and drug development, and much more.