Real World Talk
August 11, 2020
An Exciting Time for Real World Data with Michelle Hoiseth of Parexel
During this episode of Real World Talk, host Zoe Li has a conversation with Michelle Hoiseth, the Chief Data Officer of Parexel. Michelle talks about this being an exciting time for real world data and the opportunity that exists for the life sciences industry. She highlights 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.
- 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.’”
August 4, 2020
The Origin of COTA and Using Real World Data During a Pandemic with Dr. Andrew Pecora
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.
- 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.”
July 28, 2020
How Real World Data Can Make a Difference in Healthcare with Jess Federer of Boston Millennia Partners
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.
- 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.”
July 21, 2020
Dr. C.K. Wang and Dr. Ming He Discuss COVID-19's Impact on Cancer Research
In this 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.
- 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.
- 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.
July 14, 2020
FDA's Dr. Amy Abernethy Explains How Real World Data Can Be Used in a Pandemic
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.
- 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.
- 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.”