Interview with Judy Barkal of M2Gen

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Judy Barkal currently leads Technology and Medical Informatics at M2Gen. She brings deep experience in strategy, innovation and complex business and technology transformation. Judy’s most recent role was Head of Information Strategy and Innovation at Knight Cancer Institute, Oregon Health and Science University. At OHSU, Judy established a cancer informatics strategic roadmap and, as PI, led the creation of a clinical data repository integrated with genomics data to serve multiple cancer researchers and programs. Read her full bio.

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Interview with Judy Barkal of M2Gen

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[et_pb_accordion_item title=”Q: Patient healthcare data aggregation and analysis is seen as both the panacea for tremendous breakthroughs in precision medicine and as one of its biggest challenges. Are both true and how so?”]

A: Certainly, aggregating and analyzing healthcare data is a big challenge, but when we succeed, there are big breakthroughs. M2Gen is currently addressing those challenges head-on, but not alone. We work in collaboration with our ORIEN (Oncology Research Information Exchange Network; ORIENcancer.org) members and pharma partners. Together, we have shown that aggregating and analyzing data does lead to breakthroughs as evidenced by our publications utilizing the Total Cancer Care Protocol and aggregated clinical and molecular data.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: What are the biggest hurdles today in getting people to share their health data?”]

A: Patients tell us that they want to participate in how to share their data. They do not want physicians or institutions to decide for them. Patients want to know who they are sharing their data with, what is being learned, and how can they ask informed questions of their care provider. Once patients decide to share their data, we must be good stewards of that data and ensure their data is secure and shared as promised.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: How can they be overcome? What is needed?”]

A: Asking patients for their consent before using their data is critically important. Providing patients with secure technical means to share their data and being transparent about who is going to see their data – even if deidentified – and for what purposes is also key. M2Gen does nothing until patients consent to the Total Cancer Care protocol. Once consented, patients need communication about how their data is being used for research and how this has led to new knowledge. When we do these things, patients find value in sharing their health data.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: What has worked? Can you provide some examples that demonstrate that patients and healthy people can successfully share their data where everyone benefits?”]

A: M2Gen is the “engine” behind the Oncology Research Information Exchange Network (ORIEN.) There are now 19 ORIEN member sites that represent academic cancer centers and institutions. Patient clinical and genomic data are shared and available for research projects and clinical trials across ORIEN. The data sharing may extend to research institutions outside of ORIEN and pharmaceutical companies who use the data for discovery, clinical trials development, and post-market surveillance. At ORIEN member sites, patients and are consenting to the Total Cancer Care Protocol, providing us with health data, and demonstrating that they are willing to participate in research so that we can all learn more.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: We have a long way to go. With clinical trials enrolling at 2-3% today and that number falling. What type and level of shift in culture, laws, collection methods, or other areas is going to be needed to accomplish widespread data sharing?”]

A: In partnership with the Oncology Research Information Exchange Network (ORIEN), M2Gen manages the administrative and coordination activities of the ORIEN Clinical Trials Network in order to accelerate the availability of clinical trials to patients. We do this by having a central IRB and single Scientific Review Committee (reviews protocols in accordance with Cancer Center Support Grant (CCSG) Guidelines) as well as a central point of contact for sponsors to work with 19 national cancer centers. This approach streamlines operations, helping to decrease R&D costs, run more effective clinical trials and accelerate drug development timelines.

For example, using the Total Cancer Care Protocol as a master trial-screening protocol, M2Gen was able to dramatically accelerate enrollment for an otherwise challenging Biomarker-Driven Clinical Trial in Gastric and Pancreatic Cancers.

M2Gen is also currently collaborating with leading biopharmaceutical companies in the development of “synthetic control arms.” One such example is a Phase 2 CAR-T clinical trial.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: How can participants be incentivized to share their health data and other data that researchers need to improve prevention and treatment and develop new therapies and health practices?”]

A: Total Cancer Care participants share their health data today and want the new knowledge derived from their data to impact other patients and healthcare for the next generation. We frequently hear that patients are seeking a trusted source of information about their disease. Patients want to know what we are learning about patients like them and want information that can help them as they ask questions and have care conversations with their physicians.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: Will there always be certain communities or populations that will not participate in research because of history or privacy issues?”]

A: Participation in research is an individual choice. Sometimes group norms can influence that choice, but the individual patient makes the decision. We begin with a patient’s consent to the Total Cancer Care Protocol before using their data for research because we respect the rights and privacy of every individual. ORIEN has formed a Patient Advisory Council providing a great source of wisdom about communicating with patients from a patient-centric perspective. We feel a sense of stewardship to make the best use of patient data once that patient has graciously consented to participate in Total Cancer Care.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: What role will personal technology play in scaling health data sharing and collection?”]

A: Patients tell us that making it easy and fast to share information is an imperative for engaging them in our research. Advances in personal technology bring new, convenient ways to collect data and new types of data that may not have been readily available before in standard health records. Patients consent to be contacted as part of Total Cancer Care Protocol so we can keep pace with emerging technology and some of the easiest means of collecting data directly from patients.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: What do you predict the landscape will look like in 10 years in terms of people sharing their health data? What are the determinants to making your vision a reality?”]

A: Our vision is that every cancer patient has the opportunity to participate in the Total Cancer Care Protocol. We must be good stewards of the healthcare data by sharing the data in a secure environment that is also accessible to researchers and other stakeholders who may use the data to improve patient outcomes. In addition to ORIEN, there are similar efforts and networks developing to share and learn from patient data. Ultimately, the networks may agree to partner in the development of standardized approaches to collect and organize data, resulting in a “network of networks”. Ideally, patients will reap the benefits of a vast network of stakeholders who have broadened the scope of precision medicine beyond treatment options to meet social, psychological, and financial needs of patients.

[/et_pb_accordion_item][et_pb_accordion_item title=”Q: Is there anything else you would like to share with the PMWC audience?”]

A: We, at ORIEN and M2Gen, are excited to be part of accelerating precision medicine. Our belief is that no single group can solve the many challenges with data aggregation and sharing, providing evidence for decision support, drug safety and efficacy and reimbursement. We believe that it will require networks of people willing to share and collaborate for shared value. If you are interested in learning more about M2Gen and ORIEN, please reach out to us. We’d be thrilled to have a conversation and learn more from you about how we might work together to accelerate precision medicine.

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