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 SummaryIn 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 PointsInjustice 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 FQHC.[13:56] Return to screening — the ACS has just launched an initiative called a return to screening. It is a multifaceted program focused on getting people back to screening. [19:02] The most promising technology innovations in oncology — Different approaches in blood-based screening and new therapeutics. Also, the improvements in how doctors perform radiation and advances in surgery. The immunotherapy technological innovations and innovations in the digital space.[23:30] Real-world data and cancer care — The role of real-world data in cancer care is crucial. It influences drug development and success in clinical trials.[25:58] Working with patients again — Dr. Cance is hoping to become an adjunct professor at Morehouse school of medicine and to do some operations at Grady hospital. [27:15] Cancer care 50 years from now — It will be different, the doctor says. He believes treatments will be more efficient. Cancer will most likely turn into more of a chronic, manageable disease like diabetes.

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 Value-based care monitors every aspect of a patient's experience. Where oncology clinics typically focus only on treating cancer, value-based care encompasses every aspect of a patient's health. Risk assessment tools and a clinical pathway model help the Center's oncologists constantly check in with patients and standardize medical decisions. Each clinic has a triage site to help manage patients' symptoms and toxicities, which are sometimes deprioritized under other approaches. It takes a village to do value-based care. Looking at every health issue a patient is experiencing means connecting with other specialists, including physiotherapists, dieticians, social workers and genetic counselors. Since cancer care tends to be long term, it's more likely that cancer patients will also experience other health problems while under the care of their oncologists, compared to patients with acute conditions. This is one complication of value-based care in oncology. Oncologists value the insights real world data offers. Many of the cancer treatments used today have been around for a long time, so there aren't many new studies into them. Real world data provides an updated look at these treatments. In addition, real world data can look into outcomes that oncologists are really interested in but drug companies often don't study, such as a patient's quality of life and the long-term impacts of different medications. Episode Highlights [00:22] Introduction — Nick Gritter introduces Barry Russo, CEO of The Center for Cancer and Blood Disorders. [01:48] Value-based care — Russo explains that VBC has evolved into working on a patient's entire medical experience (and the cost of that) rather than simply focusing on treating their cancer. [03:24] How to do VBC — To do VBC, the Center had to set up an infrastructure to follow each patient and monitor their needs. For example, using clinical pathways that standardize processes, risk assessment tools, and electronic care to improve communication. [08:04] VBC benefits — Russo believes that a VBC approach offers a better standard of care to patients. Every aspect of their health is tracked, including issues outside oncology, and the Center communicates more effectively with other specialists. [10:44] Data challenge — One of the biggest challenges of VBC is getting data fast enough to make real-time decisions, especially on the payer side. [12:00] It takes a village — Another challenge of VBC is maintaining effective communication between the many experts the approach requires, who aren't involved when the focus is only on oncology. For example, dieticians, social workers, physiotherapists and cardiologists. [14:12] VBC will become the standard — Given that VBC is likely to become the standard approach to healthcare one day, it's better to implement it now and work through the various obstacles than get left behind. [17:04] RWD for VBC — Russo appreciates real world data because in many cases, cancer treatments are so established that there are no new clinical trials studying them. And the results go beyond the theoretical. [20:31] VBC for cancer — VBC oncology programs differ from those in other areas of medicine because the patient is under their care for longer. Patients are likely to experience non-oncological health issues during this time, which the oncology team is still responsible for managing. [24:37] Cancer is missed under COVID — The COVID-19 pandemic has seen drastic reductions in the rates of screenings for various cancers, which means cancers aren't being caught at the early stages, leading to a worrying rise in late-stage cases that are harder to treat (and more complex for VBC systems.) [26:57] Protective measures — The Center has introduced multiple precautions to keep patients safe at their clinics, including a touch-free COVID screening process before entry, UV filtration systems, limited telemedicine, and improved electronic communications. [33:19] The post-COVID clinic — Russo says the Center will likely keep some of the COVID measures even when the pandemic is over. For example, touch-free temperature checks, the UV filtration system, and more consistent electronic communication with patients. Resources Nick Gritter Barry Russo

In this episode of Real World Talk, host Kevin Keogh talks to Dr. Rafael Fonseca, a hematologist who specializes in multiple myeloma, and Interim Director of the Mayo Clinic's Cancer Center. They discuss the gulf between the idealized world of clinical trials and the reality experienced by patients with an incurable cancer like multiple myeloma — and how real world data can help bridge the gap. “I wish we all lived in a world where Phase III trials could be completed in one day and where we had Phase III trials for every patient situation, but we just don't,” Dr. Fonseca says. “You have to realize that there is a reality when it comes to how much you can actually do.” For example, weighing the clinical implications of giving a patient a follow-up treatment that may interact with previous drugs. “We can apply some of the real world datasets to see if the actual performance in the clinical practice really mirrors what we're seeing in the clinical trials,” Dr. Fonseca says. They also discuss calculating the real cost of treatments using a holistic method, and why Dr. Fonseca believes expensive drugs lead to more innovations in the long term.

In this episode of Real World Talk, host Emily Di Capua talks to Bruno Villetelle, Global Head of Data and Digital for pharmaceutical company Novartis. They discuss the ways real world data is being used to innovate drug development and delivery so that patients can benefit from new discoveries sooner. For example, real world data is especially valuable in clinical trials with small numbers of participants — something increasingly seen in cancer studies. “While efficacy and safety data collected through randomized clinical trials remain the gold standard, real world data can complement typical development programs by informing the selection of endpoints, the design and recruitment of studies — which can potentially accelerate timelines, reduce clinical trial costs and increase the probability of success,” Villetelle says. Since Di Capua and Villetelle are both involved in COTA and Novartis's respective diversity initiatives, they talk about the ways a diverse staff benefits companies. They also discuss Novartis's advances with decentralized trials and how COVID-19 has clarified the need for a modernized long distance approach.

In this episode of Real World Talk, host Zoe Li talks to Nancy Dreyer, Chief Scientific Officer of IQVIA, and COTA's own Chief Medical Officer, Dr. C.K. Wang. They discuss the interactions between real world data and clinical trials, and how the two approaches can complement each other. They also look at why the Lancet retracted a large study into the use of hydroxychloroquine to treat COVID-19 in June, after questions were raised about its curation and application of real world data. “Those standards that we apply to clinical trial data to see if it's a good clinical trial need to be in place for real world data as well,” Dr. Wang says. “Just because [COVID-19] is a novel situation, the way we think about what good research is and what good data is should not be thrown out the window.” They consider the circumstances in which real world data can make a difference in furthering research, and its possible limitations. They talk about implications that go beyond clinical uses to directly improve patient care.

Episode Summary During this episode of Real World Talk, host Emily Di Capua has a discussion with Lili Brillstein, the Chief Executive Officer of BCollaborative (Brillstein Collaborative Consulting). Lili works with Payers, Providers, Pharma, Start-Ups and other stakeholders to progress the movement from fee for service to patient-focused, value based care models. The conversation explores the complex world of healthcare payment models and highlights the industry's challenges when transitioning to a more value based care model. Episode Highlights Lili opens the conversation by setting the stage for those who are unfamiliar with healthcare payment models. She discusses the dominant form of payments, which is a fee for service model. She then discusses the core components of the value based care model. Lili discusses how there are a lot of different models under an umbrella, which is value based care. Terms often used include population health, bundled payments and episodes of care. The goal of value based care models is to really shift the focus from the care provided by one provider to all the care that's rendered to one particular patient across the full continuum of care. Lili talks about the model of value based care that she's most familiar with - the episodes of care model. This model really focuses on the specialists associated with a value based scenario and considers individuals who have some real clinical similarities. There are three main components to value based care models - improving outcomes, improving experiences and getting the most from limited resources. Providers often don't have a longitudinal view of a patient's care because they're just focused on what services they've delivered to the patient. In many cases, you often associate episodes with orthopedic procedures such as hip replacements or knee replacements because these are scenarios that are easier to define. There's a starting point and an end point. Lili talks about how it's important for providers and stakeholders to understand that payers are gigantic bureaucracies and are often sitting on systems that rely upon a fee for service model. Lili talks about how her goal as a partner is to often “build something that is clinically meaningful and also administrable by the payer and not burdensome for the providers and the other partners.” Lili's best advice around providers looking to engage with payers on value based care, is to engage with payers that have value based care activities already. One way to make this determination is by finding payers who have staff members with titles using words such as innovation, transformation, pophealth, etc. Lili provides some background on specific examples of episode programs, most notably mentioning CMS's OCM (oncology care management) model. When considering the trends of value based care, Lili feels it'll involve more tweaks and an overall evolution versus a jump. The level of risk will be shifted between payers, providers and patients. Lilii breaks down the components of a specialty care medical home model built around oncology - which was essentially a more hybrid model between the primary care medical home model and a specialty care episode model. Lili talks about a model created at Horizon which involved a maternity episode. The model first focused on moms with low risk pregnancies and then shifted to higher risk patients. When evaluating episodes, it's important to go beyond claims data, and focus on what success is for the patient as well as the provider and payer. In order to do this, you need clinical data, claims data, social data and the technology to analyze the data. Episode Key Points Lili draws a distinction between fee for service and value based care models, “Fee for service is a payment model that reimburses providers of care on a per service basis. So every service is paid for separate and apart from any other service that may be rendered to an individual patient. And reimbursement for the care provider then is increased when they provide them more services. So it...is a quantity over quality incentive in the model.” Lili talks about some of the major drawbacks of the fee for service model, “There is this sort of perverse incentive around quantity rather than quality, for patient outcomes, which often results in fragmented and or unnecessary care for individuals and results in really, less than optimal outcomes. As we've seen medicine continue to evolve and people are living longer and with more complex diagnoses and co-morbidities the fragmented fee for service model really does not work effectively to support these patients and individuals with these situations and certainly not to produce optimal outcomes or a thoughtful use of limited resources.” Lili mentions “And so one of the things I always say to providers and startups and tech vendors who are going in to talk to payers is you need to be thoughtful about what they can actually do and not do. And to listen to what they're telling you because they may not be saying no because they don't like your idea. They may be saying no because administratively it's difficult.” When discussing value based care models and the pandemic, Lili states “We're really interdependent upon one another to keep each other safe and protect ourselves. And those are precisely the principles at work in value based care. It's really about being respectful, and understanding that we all have a role to play in the care and the health care, of each of us.” Resources Lili Brillstein

Episode Summary During this episode of Real World Talk, host Zoe Li has a chat with Michelle Hoiseth, the Chief Data Officer of Parexel. Michelle talks about an exciting time for real world data and the opportunity that exists for the life sciences industry. She pinpoints some of the challenges involved with further adoption of RWD in clinical development and regulated uses and discusses how the industry can work together for the benefit of patients and their loved ones. Episode Highlights Michelle Hoiseth opens up the conversation by stating how she feels like, with real world data in clinical development, we're in an incredibly exciting time for change that we haven't really seen for 15 years. Michelle mentions how real world data has the opportunity to play a critical role in the clinical development continuum. According to Michelle, real world data is “showing up” in many places throughout the cycle, including up front in a clinical trial, during design, as a source of patient level data, during changes in the regulatory environment and in the prescribing environment. Leveraging the experience of groups like epidemiology, and health economics - that have had more experience with data in the clinical development end of the spectrum - is key to gaining more traction with real world data. Michelle covers some of the barriers to the adoption of RWD in clinical development and regulated uses. In the COVID environment, Michelle talks about how the industry has a lot of tolerance now to try new methods and it's forcing the industry to figure things out - like plumbing, traceability matrices and data lineage. Michelle talks about one of the positive results of organizing as a society around COVID includes changes on the healthcare provider side around data. Michelle mentions that for a long time, there was opacity in the data. This included a lot of variability and insufficient access to data. Technologies are now catching up and it's really changing the industry. Michelle mentions that protocol design is often the very first point of failure. Michelle discusses the key steps, as a drug developer, that must take place in order to rethink the planning of protocol design. Michelle discusses whether the current ecosystem is set up for using more real world data in clinical development. For CROs, many are exposed to study execution across a broader number of studies in a certain therapy area...but are not always brought in during the design stage. This means that a CRO's ability to spark discussion isn't always soon enough. Michelle talks about how, “we as patients and the loved ones of patients”, want the safest and most efficacious therapies available. And, this ultimately all comes down to trust. So much of trust is about transparency and that's why Michelle believes the life science industry must operate differently. Most of the time, there's a lack of transparency because there's a concern about intellectual property. Michelle highlights that no single organization is going to pierce through all of these data challenges and that it's important to come together as an industry. Episode Key Points According to Michelle, there are a number of barriers that have prevented the adoption of RWD, “There have been a number of barriers to the adoption of RWD in clinical development and regulated uses. And they have spanned from things like cost and budget to uncertainty about the reliability of the data to risk aversion coming from uncertainty of the regulatory acceptance of that as a data source. It has really spanned an array of issues.” Michelle states that “Being data agnostic matters, being clear about how you're going to use the data matters.” When asked whether the industry can collaborate better to bring in real world data, Michelle stated “It's a big heavy yes, because it's such a complex environment as we're, thinking about all the different players and in the way that we interact...the points of interaction today in our standard way of working. And it's complex in that we have a number of different industry initiatives going on around real world data that aren't necessarily coordinated or talking together. “ Michelle pointed out that, “...as we move into leveraging new sources of data, it's on us to be able to look any patient in the eye and say, ‘We've done the best job we can here. We stand behind this result and the analysis, and that's us all coming to the table together.'” Resources Michelle Hoiseth Parexel

Episode Summary During this episode of Real World Talk, host Kevin Keogh talks with Dr. Andrew Pecora of OMI (Outcomes Matter Innovations). In 2011, Dr. Pecora founded COTA and has been an innovator in the oncology space for over 25 years. Dr. Pecora talks about the origin of COTA after discovering 1 out of every $3 is wasted on healthcare. During the discussion, Dr. Pecora provides a story on how real world data works and COTA's promise to healthcare. He also takes a deeper dive into the challenges COVID-19 has on cancer patients and what the future holds for real world data and its adoption within healthcare. Episode Highlights In the first part of the episode, Dr. Andrew Pecora discusses his background and what motivated him to start COTA. Over the years, Dr. Pecora has been involved in the evolution of hematology oncology and stem cell biology and immunology - particularly their application in cancer. Because of Dr. Pecora's leadership in these fields, he was invited to participate in a group of people in the U.S. that analyzed the total cost of care issues the nation was facing. Dr. Pecora discusses the challenges the pandemic creates with the documentation of a patient's journey. Sheltering in place has created unintended consequences for cancer patients who are sitting at home - many with active cancers growing in their body and unlikely to seek care or early diagnosis. Since the colonoscopies have stopped during the pandemic, some professionals believe that there are already 150,000 undiagnosed cases of colon cancer in the U.S. Dr. Pecora describes COTA's collaboration with Hackensack Meridian Health and the use of their Epic system, which is an electronic medical record system, to extract large amounts of data for COVID-19 infected patients. Dr. Pecora discusses the challenges COVID-19 poses for the field of oncology, which include interruption in business flow, maintaining employment of highly trained professionals and simply covering the costs associated with running a practice. During the pandemic, those participating in the evidence accelerator (a collaboration between COTA, Hackensack Meridian Health and the Reagan-Udall Foundation), realized that each patient was a treasure trove of information and had the ability to extract massive quantities of data in a very short amount of time. The evidence accelerator provided an ability to answer fundamental questions for the CDC and FDA well in advance of other peer reviewed publications. Dr. Pecora builds a metaphor to discuss how COTA's solutions equate to the services Uber provides. COTA's promise is around the ability to have an overarching view of real world data and even determine the “best value-based road” for patients. Dr. Pecora discusses how organizations can prepare for a value-based care world. Dr. Pecora discusses the challenges a rise in healthcare creates, most importantly taking resources away from other necessities such as military, roads, education and more. At some point, there will be a tipping point with real world data and it'll come as companies work with the FDA to embrace real world evidence more and more. Dr. Pecora concludes the interview by discussing a point where CMS moves to utilizing real world data and evidence, “ultimately this will catch up to the point where CMS will be like, all right, well, you know, the country has moved, we're going to do it. And then, you know, when Godzilla says we're going, right, we're going right.” Episode Key Points According to Dr. Pecora, “...as more and more therapies come to market and people are living longer and aging, that total cost of care burden as a percentage of the total economy was becoming disproportionate.” Dr. Pecora discussed the origination of COTA, “we've in fact...may have been wasting one out of $3, in the application of healthcare. And so I started to think about the problem and realized that unlike the biology problems that I deal with...this was not a biology problem. This was an information technology problem.” When discussing the impact of COVID-19, Dr. Pecora stated “I have seen several examples of people presenting with way more advanced cancer than they otherwise would have presented with...had this COVID-19 problem not existed. You see most cancers double every 30 days. So two or three months is material in the amount of cancer in your body and how far it can spread.” Resources Dr. Andrew Pecora OMI

Episode Summary During this episode of Real World Talk, host Emily Di Capua leads a discussion with Jess Federer, a COTA confidant, advisor and board member for several healthcare and technology companies. Jess talks about some of her past experiences, including a role as the first ever Chief Digital Officer at Bayer. Jess covers topics around the innovation of “older” companies like Bayer, the impact real world data has on healthcare and the changes we're seeing with healthcare data as a result of the pandemic. Episode Highlights Jess Federer starts off the podcast with an introduction to her background and provides context on how she became a sought after corporate board member and advisor. Jess mentions how the primary way she made it to the board was through data and a relentless commitment to public health. She highlights how she convinced her undergraduate university to create a program for Public Health and subsequently became the first graduate at George Washington University with a Bachelor's of Science in Public Health. After periods of time with HHS and AHRQ, Jess went and obtained her Master's in Public Health at Yale. Jess moved to Germany and was part of the first team to roll out market access globally in her company. After spending some time in communications and policy, Jess ultimately made her way to become the first ever Chief Digital Officer at Bayer. When asked about Bayer's innovation, Jess discusses how larger, older businesses do not get enough credit for their innovation. According to Jess, the CDO is responsible for two primary things: 1) Cleanup of heterogeneous data and 2) Innovation. Emily asks Jess about the most exciting areas of development within the health tech sector today and Jess mentions how interoperability is one of the biggest areas of innovation. Jess talks about the rollout of EHRs did not lead to the expected innovation in the industry and now, with the current administration, there are efforts in place to unlock the data again. Jess is most excited about data coming together where it can be connected across healthcare systems (across prescribers, prescription data, wearables and more). Jess talks about the challenges of working with real world data and where advanced analytics are really the key to understanding unstructured data. The ability to use natural language processing to understand what's in the information. Emily poses a question to Jess about how the U.S. compares to other countries when it comes to fragmented healthcare data. Jess talks about how countries such as Germany or areas of Korea that have rebuilt their healthcare systems after wars and have more integration. Jess talks about how COVID has shifted the risk paradigm for healthcare companies. Traditionally, big pharma companies were very risk averse, but now everyone in the industry has to move much faster and innovate more quickly. As startups get to move quicker in this climate, the big challenge will be delivering on those promises in the marketplace. Jess mentions how she's never seen regulators move this fast and wonders if this speed is the “new normal”. Jess breaks down the process she used to become the first CDO at Bayer and standout among 120,000 global employees. Jess offers a few key pieces of advice for those building their careers. 1) Pick your boss, not the job. 2) Map up and build a roadmap for your career. 3) Hold the door open for others. Jess recommends listening to the Epidemic podcast led by Dr. Celine Gounder. Episode Key Points After graduating with a Master's from Yale, Jess joined industry. She mentions “I started in industry and regulatory affairs, which I can't recommend enough for anyone interested in drug development. Regulatory affairs gives you an incredible overview of the entire life cycle of both innovation and of the product. From when you're doing the research and working with regulators on the study design all the way through to when you have to stop making a product or maybe just continue making a product because it helps an underserved area in one country.“ As the first Chief Digital Officer at Bayer, Jess felt it was “really about using digital enablers to change a company, transform a company and not only improve the existing business models, but also create new ones.” According to Jess, “we now have the technology capabilities to analyze all of that [healthcare] data and make sense of it. Because of course you got to find the signal through the noise because nobody has time to go through all that information.” When talking about real world data, Jess highlights “This is a pretty fundamental evolution. This progression has been in the works for decades. This is a very meaningful, a very sustainable development with the right safeguards and the right management. This is going to be transformative, both for research and for care.” According to Jess, “I think we're starting to see some changes in how we view healthcare data in the U.S. that's going to bring us closer to the way healthcare data is seen and viewed, and actually secured and protected as well.” Jess mentions how startups are making fast moves in light of the pandemic, “And so we're seeing companies that used to have to knock on doors for 18 months, get deals done in seven days. And so the speed with which the technology is being adopted and integrated and put into strategic plans and put into operational studies is remarkable. I've never seen it moved this fast.” Resources Jess Federer Boston Millennia Partners Epidemic podcast

During this episode of Real World Talk, host Zoe Li leads a conversation with Dr. Amy Abernethy, Principal Deputy Commissioner and acting CIO of the FDA, and Mike Doyle, the CEO of COTA. In 2020, the FDA has been a central part of addressing a lot of challenges that have surfaced in healthcare. In the interview, the three individuals discuss what everyone has learned throughout the pandemic and highlight what impacts lessons learned have on the future. Highlights Dr. Abernethy first initiates the conversation with a description of how she feels in the midst of the pandemic - a combination of being tired, bored and “ready for all of this to be over.” Dr. Abernethy mentions that she's also “fairly hopeful about the things that we've learned in the middle of this pandemic and what that's going to teach [us] about the future.” Zoe mentions that she's seen a number of organizations come together to solve the pandemic and there's been quite a bit of collaboration between providers, drug manufacturers, academia and regulatory bodies. Dr. Abernethy mentions how the collaboration to the response to COVID has several layers and it's really a whole life sciences in response. Mike Doyle introduces the concept of the Evidence Accelerator - a project that involves both the FDA and COTA. Mike discusses how a collaborative effort between Friends of Cancer Research, the Reagan-Udall Foundation, the Accelerator, and the FDA analyzed the question of hydroxychloroquine and whether or not it was going to be effective against COVID. Dr. Abernethy discusses some of the questions you try to answer with real world data and how it's different from what you might see in a more traditional clinical trial. Dr. Abernethy mentions how real world data are data sets that are collected outside of the traditional clinical trial. Dr. Abernethy highlights how the FDA has been exploring the role of real world evidence in a number of different ways - mostly compelled by the 21st Century Cures Act. Dr. Abernethy talks about how real world evidence can help us understand the story of COVID-19, what treatments people are receiving and treatment pattern information. Real world data can also help answer questions as it relates to vaccines, once those roll out in response to COVID-19. At FDA, the organization has had a long history of thinking about and working with real world data and real world evidence - one of the primary examples of that include the organization's Sentinel program (an effort to try and continue to monitor drugs across time after they've been approved and look for safety signals). Dr. Abernethy discusses the Evidence Accelerator and how it helps to supplement current real world data and real world evidence with new data sets and new capabilities. Zoe Li poses the question “how do we maintain the agility in data collection and data curation while ensuring that we're also being compliant and still incredibly robust in our analyses”? Zoe mentions two COVID-19 studies based on real world data how to be retracted from high profile medical journals due to a lack of transparency into the data source. Dr. Abernethy introduces a concept of “deliberate agility” - an acknowledgement to work fast, but not sloppy. Dr. Abernethy places a focus on transparency in the data - a “ruthless” transparency that is gained from a shared mechanism amongst all parties involved with a study. Dr. Abernethy discusses the role of real world data and how it relates to recruitment for clinical trials. Zoe mentions how there are a lot of lessons learned from this extended disruption with COVID-19 that could inform great design and improve clinical trial designs going forward. Dr. Abernethy notes two key roles of real world data and how the FDA can shape this story around use cases. Key Points Dr. Abernethy notes that the vaccine is a focus, but the FDA has quite a few layers to their involvement - “...we're the FDA. So our food supply is a concern for the FDA. And so we're very involved and thinking about supply chain for food and how do we make sure that we are continuing to monitor for foodborne illness and other concerns? Also when you think about it, this is a time when we're worried about whether or not our pets can get COVID-19 and whether or not there's issues within the veterinary space related to COVID-19.” Mike Doyle discusses the collaboration between COTA, FDA and other entities - “I've been proud of the effort of the private sector in joining the public sector to do greater good. You know, one of the things that COTA has done in a small way, has stepped up our analytics capabilities and surveillance capabilities under the leadership of Friends of Cancer Research, the Reagan-Udall Foundation, the Accelerator, and the FDA to work hand in glove, to really look at early evidence to ascertain whether or not some of the experimental treatments and drugs we're using in the field, were going to be a value.” During the episode, Dr. Abernethy defines the types of real world data - “Real world data can be retrospective. So data that already existed in some system somewhere, and may be getting cleaned up and ready for use. Or it may be prospective, such as pragmatic clinical trials, where patients are randomized in highly generalizable settings to collect real world data.” Resources Dr. Amy Abernethy Mike Doyle Zoe Li Evidence Accelerator FDA Sentinel program FDA

In the first episode of Real World Talk, host Kevin Keogh speaks with Dr. CK Wang, COTA's Chief Medical Officer, and Dr. Ming He, our Senior Medical Director — the “internal and external medical voices of the company.” They discuss how COVID-19 has affected cancer research and treatment, including difficulties executing clinical trials and complications communicating with patients. They also look at the impact of real-world data (RWD) — especially in efforts to understand COVID-19. Federal agencies including CDC and FDA are increasingly turning to real-world data to better fight the disease. Looking forward, they suspect COVID-19 will increase the need for more standard telemedicine practices. They also discuss the changing oncology landscape, the increase of specialized practices and how using real-world data could shape the future of oncology. Highlights Kevin Keogh introduces Dr. CK Wang, COTA's Chief Medical Officer, and Dr. Ming He, the Senior Medical Director. Dr. Wang and Dr. He discuss their backgrounds in science and medicine and their roles at COTA. During COVID-19, clinical trials have been difficult, if not impossible, to execute, and Dr. Wang explains how using real-world data can help. The doctors talk about how COVID-19 has made it difficult for medical providers to effectively communicate with patients and provide the best care. Dr. Wang outlines the potential long-term effects of COVID-19 on patient care, including delays in cancer screenings and treatments. Doctors traditionally take a hands-on approach with patients, but Dr. He talks about how they've had to adapt since COVID-19, and she hopes it'll lead to more universal telemedicine standards. Dr. Wang explains why he decided to transition from a general oncologist to a specialized practice. Dr. He agrees specialized oncology has become more common and explains how the evolution of cancer care has shaped this trend. As more and more targeted therapies emerge, Dr. He emphasizes the importance of using data, especially in smaller communities. Dr. Wang explains COTA's disease-specific data dictionary and how it'll continue to evolve with cancer research. Looking forward, Dr. Wang addresses some potential challenges to curating data, including the nonstandard format doctors use to document patient information. Dr. He emphasizes the need for a standard electronic medical record (EMR) that includes clinical results documentation. Key Points COVID-19 has affected clinical trials and cancer treatments. Due to social distancing, clinical trials have been delayed, and cancer screenings and treatments have been put on hold. If more doctors could tap into real-world data, it could be leveraged to help find solutions for patients during this time. Oncology has become more specialized over the past decade, which means more practitioners would benefit from a centralized database. This is due, in part, to an increase in targeted drug therapies. As more and more of these therapies are developed, doctors will have more and more options. Having access to a national database of patient information can help them seek the best treatments. Challenges involved with collecting medical data persist. For example, many doctors have their own shorthand. Plus, EMRs don't require doctors to report clinical results. However, this could be a simple fix and something doctors would quickly get used to. Resources Kevin Keogh CK Wang Ming He