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.

Data has become an inevitable part of every business regardless of its size and industry. But not all companies know how to use it to upgrade operations. Further, they mainly focus on third-party data, neglecting the power of first-party data. Therefore, it is of the utmost importance for companies to use both data types to support their overall businesses. In this episode of Real World Talk, Zoe Li welcomes Su Huang, the Head of Data Strategy at Datavant. Su and Zoe discuss the role of data in life science companies, the importance of building a data strategy that will support the company's business strategy, and why all teams using data should work together.

All data companies working in the healthcare industry are on a mission to help with the development of drugs and high-quality treatments while aiming for the best patient outcomes. But, unlike controlled conditions under which clinical trials are conducted, real world data is collected from a variety of different sources. It is an unregulated but critical area of clinical research. That's why many conversations around the standardization of this type of data have occupied data scientists’ attention. The FDA has recently released a document with guidance on how to use real world data for regulatory submissions. In this episode of Real World Talk, our host Zoe Li is joined by her colleagues, CK Wang, Laura Fernandes, and Andrew Belli, to discuss the changes this document will bring. They emphasize that it's still draft guidance, and it is yet to be seen in which direction it will go. However, they all agree that it is essential to establish standards regarding how companies collect, analyze, and use real-world data that will contribute to clinical research.

Almost 10% of the world's population suffers from a type of blood cancer. And despite popular opinion, there are actually hundreds of different types of blood cancer, not just leukemia and lymphoma. But are we doing everything in our power when developing clinical trials to improve cancer treatment? Could we include diversity and make trials more accessible to everyone? Our today's guest thinks we have more work to do in the blood cancer space. In this episode of the Real World Talk podcast, our host Miruna Sasu welcomes Dr.Gwen Nichols, Executive Vice President and Chief Medical Officer of The Leukemia & Lymphoma Society (LLS). We discuss the importance of making clinical trials more diverse and feasible for patients. We also get into Dr. Gwen's predictions for the future and why she thinks there's hope for earlier cancer detection and prevention.

In this episode of the Real World Talk podcast, Kevin Keogh talks to Matthew Ong, the Associate Editor at The Cancer Letter. With over eight years of experience in writing investigative and enterprise stories about oncology, cancer informatics, drug development, and medical devices, Matt has a direct insight into the industry and works alongside some of the smartest people in the field. Kevin and Matt discuss rapid tech advancements in oncology and how informatics and real-world evidence are shaping the industry. According to Matt, as long as we're careful about over-promising and we recognize the need for data sharing, technology will continue to help us deliver astonishing results. President Joe Biden’s recent $6.5 billion proposal to create a new, cancer-focused health agency within the National Institutes of Health presents an opportunity to accelerate the development of a comprehensive data federation for cancer, Matt said. ARPA-H, or Advanced Research Projects Agency-Health, is expected to complement the National Cancer Institute’s mission by funding more challenging, innovative initiatives that traditionally wouldn’t be taken on through basic research grants or by a biotech startup. Lack of diversity in clinical trial data is another challenge left to tackle—Matt shares some real-life examples of how lack of diversity in trial samples results in faulty findings. Matt's predictions for the future are optimistic, and we're looking forward to more groundbreaking developments in the fight against cancer.

In the period of crisis, what really makes a difference and gives hope is unity and partnership. The outbreak of coronavirus has shown us how valuable shared efforts are. The last year taught us many things and challenged us. However, it remains to be seen whether the healthcare system and we, as a community, will adopt these lessons in the future. In this episode of the Real World Talk podcast, Andrew Belli welcomes Jeff Allen, the president and CEO of Friends of Cancer Research. Jeff talks about his organization and its work during the pandemic. He also talks about real-world data pilot projects and says the partnership was the main component of their success.

In this episode of the Real World Talk podcast, Zoe Li talks to Paul Simms, a Managing Partner at Inpatient Health. For 17 years, Paul was running a company called IFA pharma. As he says, it was helpful because it put him in touch with everybody in the industry and allowed him to understand the trends and the beliefs. Paul and Zoe discuss why the pharma industry is science-centric and not patient-centric. Paul also says if we want to understand the problem, we need to experience it. The guest mentions problems he sees in leadership and healthcare. As he explains, leaders usually talk about present or past actions, and no one talks about the future. He also notices the lack of imagination and creativity within the industry and, as a solution, offers the model of four A's: ambition, attention, accountability, and action.

Episode Summary In this episode of the Real World Talk podcast, Emily Di Capua talks to Dr. William Cance, the Chief Medical and Scientific Officer of the American Cancer Society. Dr. Cance and his colleagues are focused on fighting cancer and finding solutions to provide health care, especially cancer care, to underserved populations. The host and guest discuss the inequity in cancer care. They also talk about ways of dealing with injustice when it comes to treating various types of populations. The doctor mentions the challenges and lessons they have learned in a period of crisis. Dr. Cance also talks about technical innovations in oncology and explains what he thinks cancer care will look like in the future. Episode Key Points Injustice in healthcare is the most inhumane. The inequity in cancer care in disparate populations is a big concern to the American Cancer Society, the doctor says. The most critical areas of concern include social-economic status, structural racism, and the global areas access. ''So what is ACS doing about it? So in our field or around the country, we have hope lodges where people can stay during their cancer treatment if they live far away, and we offer rides to the treatment.'' Real-world data is crucial in cancer care. Several reasons are proving the importance of real-world data in cancer care, the doctor explains. ''Screening is one area where we certainly need real-world data.'' It is also needed for establishing the best treatment regimen for every patient. A significant portion of real-world data also goes into drug development and trials. ''We want to get that in real-time, and there will need to be creative approaches to getting data and sharing data. Being able to get your electronic health record data and in a way that can be transmitted to other areas is so important.'' Cancer care will be different 50 years from now. Dr. Cance says science will understand a lot more at the molecular level. He also believes more effective treatments will be found. However, the doctor is not sure if there will be a cure for cancer. ''I believe that we can effectively cure cancers, but a global cure, the magic bullet that's going to end it, I don't believe it will be like that.'' But, he also thinks cancer will turn into more of a chronic, manageable disease like diabetes. Episode Highlights [00:04] Introduction — Emily Di Capua introduces Dr. William Cance, the chief medical and scientific officer of the American Cancer Society. [01:43] Translational research — It is a direct application to the patient. As a practicing surgical oncologist, Dr. Cance deals with tumors daily. He is in operating rooms; he is close to patients, which allows him to study tumors directly. That way, he discovers what factors/proteins drive the tumors and work on ways to target; and effectively drug some of those proteins. [02:47] The ACS's 2035 challenge goals — To reduce cancer mortality. In terms of numbers, 40% reduction in cancer mortality in the period between 2015 and 2035. Goals include policy aspects through society's advocacy network, research, and implementation in all 50 states. [04:20] Health inequity and cancer care — The ACS fights against inequity in cancer care. The areas of concern include social-economic status, structural racism, and the global areas access. [09:13] The role of patient navigators — A common thread between disparate populations is the need for navigation. As Dr. Cance explains, the ACS leads the navigation round table, where they bring in thought leaders of how to navigate patients from around the country, especially from underserved populations. [11:42] Hospital systems and a patient navigator program — Before the pandemic, the ACS sponsored navigators in many health systems. Unfortunately, they had to cut back on that program because of COVID. Now, they are looking for different approaches, and one of the areas they are focused on is the federally qualified health centers...

In this episode of Real World Talk, Nick Gritter talks to Barry Russo, CEO of The Center for Cancer and Blood Disorders. They discuss the benefits and challenges of value-based care (VBC), an approach that takes into account every aspect of a patient’s health instead of focusing on just one issue, like cancer. Getting enough data in a timely manner is one of the biggest challenges. “We can't keep track of everything going on without information and data: We can't look at trends, we can't identify opportunities without really good data,” Russo says. Real world data often analyzes outcomes drug manufacturers overlook, such as patients’ quality of life. “Having that outcome-based data is incredibly helpful in ensuring that you're making good decisions for the patients, but also cost-effective decisions,” Russo says. They also talk about the unique challenges of providing VBC in oncology settings, and Russo explains his concerns about COVID’s long-term impact on cancer treatment, and what the Center is doing to keep patients safe. Episode Key Points Episode Highlights Resources Nick GritterBarry Russo