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Day 2 of Personalized Medicine World Conference (PMWC) 2017 at Duke Begins with Panel Discussion on Value of Data Sharing

Day 2 (May 25) of the Personalized Medicine World Conference (PMWC) 2017 at Duke began with a panel discussion of “The Value of Data Sharing,” moderated by conference co-chair Geoff Ginsburg, MD, PhD, Professor of Medicine and Director of the Duke Center for Applied Genomic and Precision Medicine. The distinguished panelists were Kathy Giusti, MBA, a multiple myeloma patient and founder of the Multiple Myeloma Research Foundation (MMRF) in 1998, and Faculty Co-Chair of the Harvard Business School (HBS) Kraft Precision Medicine Accelerator--this $20M program is endowed by Robert Kraft and the Kraft Family Foundation and its mission is to speed precision medicine across all cancers; Bill Dalton (photo), MD, PhD, CEO of M2Gen, a health informatics solutions company that seeks to accelerate the discovery, development, and delivery of personalized medicine—the company was founded was founded in 2006 at the Moffitt Cancer Center in Tampa, Florida to operationalize the Total Cancer Care® Protocol, a unique approach to studying patients throughout their lifetime--in this effort, the company partners with the nation’s leading cancer centers via the Oncology Research Information Exchange Network (ORIEN)--Dr. Dalton was previously President, CEO, & Center Director of Moffitt Cancer Center--Moffitt and M2Gen have developed one of the largest cancer tumor bio-repositories and data warehouses in the U.S. dedicated to the development of personalized medicine.; Robert Califf, MD, cardiologist and former Commissioner of the FDA—he was a tenured professor of cardiology at Duke and founding Director of the Duke Clinical Research Institute—he is now Vice Chancellor for Clinical and Translational Research at Duke University.; and Richard Klausner, MD, former Director of the National Cancer Institute, past Chief Medical Officer at Illumina, and a founder of GRAIL, Inc. (, a life sciences company whose mission is to detect cancer early, when it can be cured, using wide and deep DNA sequencing analysis of circulating cell-free DNA (cfDNA).

In opening remarks, Kathy Giusti noted the importance of “collective impact” as described by John Kania and Mark Kramer
( a philosophy that argues that large-scale social change requires broad cross-sector coordination, yet the social sector remains focused on the isolated intervention of individual organizations. She said that collaboration and the shared goal of helping patients among various stakeholders has driven the MMRF’s achievement of over ten approved drugs for MM and has also led to the establishment of the MMRF CoMMpass Study (– a landmark initiative in the field of cancer research – with the goal of enrolling 1,000 patients who will provide tissue samples when first diagnosed, and then each time there is a change in their treatment. By mapping each of these patient’s genomic profiles to clinical outcomes, the MMRF will develop a more complete understanding of patients’ responses to treatments.

Dr. Dalton also highlighted the importance of “collective impact,” and noted the birth of The Oncology Research Information Exchange Network (ORIEN) ( in 2014. ORIEN is a unique research partnership among North America’s top cancer centers that recognize that collaboration and access to data are the keys to cancer discovery. Through ORIEN, founders Moffitt Cancer Center in Tampa and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus leverage multiple data sources and match patients to targeted treatments. The goal of ORIEN is to accelerate cancer research discovery by sharing information and delivering hope through collaborative learning and partnerships. Dr. Dalton’s company M2Gen was founded in 2006 at the Moffitt Cancer Center to operationalize the Total Cancer Care® (TCC) Protocol, a unique approach to studying patients throughout their lifetime. In this effort, M2Gen partners with the nation’s leading cancer centers via ORIEN. TCC is one the world’s largest observational research studies in cancer. TCC represents a true partnership with patients who donate their clinical data and tissue so that the M2Gen may learn from their experiences and develop evidence-based approaches to meet their needs. Consented patients agree to be contacted for future studies, playing an active role in the study of their cancer and improving care for future generations.

Dr. Califf emphasized the importance of dollars and the levers of law and policy in making progress to help patients. He also highlighted the recent passage of the 21st Century Cures Act about which he wrote, while he was Commissioner of the FDA, “the 21st Century Cures Act, I am pleased to report, builds on FDA’s ongoing efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, with continued assurance from high quality evidence that they are safe and effective.” ( . He also mentioned the importance of sharing data and the effectiveness of requiring that data be shared or funding will be cut off. He also complimented the great work of Kathy Giusti and the MMRF with a personal story. He said that his own mother has multiple myeloma and has relapsed four times. Each time she relapsed there was a new drug available that put her back into remission, and now she is in complete remission. “Powerful stuff,” Dr. Califf said.

Dr. Klausner described four competing challenges confronting health tech companies and these were return on investment, social and ethical responsibility to share data, the desire to optimize the value of the data (which he argued is increased if shared), and the need to make participants in the data collection comfortable with the process. He highlighted the start-up company Mindstrong ( of which he is a co-founder. Mindstrong is seeking to transform behavioral healthcare by transforming how these disorders are diagnosed and managed to improve outcomes. Mindstrong was founded on the vision to redefine neuropsychiatric healthcare, transforming diagnosis and delivering precision therapy. Mindstrong has developed and patented a biomarker panel that measures brain function from interaction patterns captured passively and continuously from human-computer interfaces in ubiquitous mobile technology. Dr. Klausner also noted the start-up company GRAIL, of which he is Founder and Director, and which is seeking to use broad and deep DNA sequence analysis to identify cfDNA and enable the very early diagnosis of cancer, when the potential for cure might be greater. Key challenges for this company include developing standards for the huge amount of data that will be collected and separating signal from noise. He also emphasized the importance of gaining the patient’s trust in the process.

The opening remarks were followed by some back-and-forth amongst the panelists. Kathy Guisti emphasized the importance of putting money out there in the effort and also focused on the significance of working to have the patient understand the value of sharing their data. Communication with patients should be strong, simple, and engaging, she said. Dr. Califf noted that the task of getting patients to trust pharmaceutical companies is not an easy one. Dr. Dalton said that the need for trust is an imperative in the crucial data sharing effort, and emphasized the need for constant communication of information to stakeholders, including patients. It is key to give the data back to the patients and to let them know how it is being used, he said. Dr. Califf mentioned the difficult problem of universities and academic medical centers holding on to their data and not sharing it. This must be overcome, he said.

In closing, Kathy Giusti emphasized the importance of building networks and using accumulated data to create rational trial design. She noted the crucial importance of financing and leadership in efforts to improve the care and treatment of cancer patients. Dr. Dalton noted the importance of creating a network of networks. Dr. Califf focused on the need to leverage the laws and policies that are currently in place. Dr. Klausner said we should not presume that all is obvious and that there are risks going forward and there will be bumps in the road, as we move forward to a world of greater data sharing.

[PMWC 2017 Duke]