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By JONATHAN GOLDSTEIN

Medical Device Daily Israel Editor

The atmosphere in the Middle East might be heating up in a number of regions, and in Herzliyya (Israel) this week, the Personalized Medicine World Conference 2013 was repeatedly warning of an impending storm: the world of medicine is leaning towards a storm of personalization, and the winds of change towards more personalized (or precision) medicine are blowing just around the corner.

"Well, we've been looking for that corner for a while, and the storm that has not yet broken is somewhat inevitable," one conference attendee shared with Medical Device Daily. The U.S. healthcare system – as well as that of most Western economies – is top-heavy with expensive treatments, quality-of-life and ethical issues, to such an extent that associated costs can simply not be supported. While change is therefore needed, the question of how to promote/invite such change was not addressed. The focus of the event was a simpler set of discussions regarding what was achievable using today's technological advances (both scientific and hi-tech), in order to support the precision medicine environment in coming years.

A couple of presentations touched on technical scientific discoveries in the personalized space. Professor Ruth Katz MD, of the Division of Pathology and Laboratory Medicine, MD Anderson Cancer Center (Houston), described her research of circulating tumor cells (CTCs), and her methodology of using CTC analysis to help measure the cancer prognosis of the patient post-surgery. Katz told MDD that serial blood collections in lung cancer patients undergoing surgery exhibit features, both in terms of abnormal cell numbers and their immune-expression, which may predict patient outcome. Additionally, Iris Grossman PhD, Head of the Personalized Medicine and Pharmacogenomics Unit at Teva Global R&D (Petach Tikva, Israel) described Teva's research in the area of pain management. The team had identified a couple of rare pain-related genetic syndromes; using an analysis of these aberrations to learn about the genomic contributions to pain sensation was now enabling Teva to advance a broader perspective on pain management drugs and approaches in general.

Kim Popovits, CEO and founder of Genomic Health (Redwood City, California) explained that with today's costs out of control, quality treatment could only be maintained and improved by focusing on the individual patient in a more effective manner. This would save some of the $80 billion spent by the healthcare system on oncology drugs. Seventy-five percent of these cancer drugs offer no patient benefit, Popovits said, "so couldn't we set up a few clinical studies to help direct our medicine more precisely, with just a little of the $60 billion that we are wasting annually in oncology?" she reflected.

Paul Billings, Chief Medical Officer of Life Technologies (Carlsbad, California), echoed this sentiment. "We must find ways of investing in research, in order to create savings in the clinical setting," he told MDD. "It may require spending in the near term to save longer-term costs, but we must find a way out of this current self-imploding approach," he added.

Popovits explained how Israel has played a central role in terms of providing market access to Genomic health's products. "The Israeli health system payors immediately saw the benefit that the OncoType products offered the patient, and the healthcare system. As compared with the U.S. – where 2 in 5 women cannot get coverage for our OncoType DX test – in Israel 100% of women are eligible for such coverage."

MDD discussed this achievement with Nicky Lieberman, MD, Head of the Community Medical Services Division, in Israel's largest HMO, Clalit Health Services (Tel Aviv). "Clalit covered this new test here in Israel even before NCCN (National Comprehensive Cancer Network, Fort Washington, PA) published its positive guidelines, both for breast and colon cancers," Clalit felt that, while laying out extra funds for the diagnostic test was costly, Clalit patients would benefit clinically, and Clalit will benefit from the quality of its medical service. "In 2006, based on our clinical guidelines, we used to treat about 60% of our patients with chemotherapy; about 5% of those patients benefitted from the applied chemo-treatments. When we transferred to the OncoType DX approach, 84% of our patients showed that they did not require chemotherapy at all; and conversely, we discovered an additional 8% of patients whom we used to miss, and not treat, who seem to benefit from the drug approach. We should not be simply looking at the costs to the health system, but rather at the society costs of not advancing this precision medicine strategy," he explained.

Grossman of Teva agreed: With data suggesting that 66% of Phase II, and 30% of Phase III trials are failing (due to unsuitable drugs and/or trials), she informed the audience. "There needs to be a more precise and effective method of validating a drug in the market, including using a more refined subpopulation-specific approach to drug trials."

This concept of the 'more-suitable subpopulation' was a unifying theme across a number of the keynote speakers. This precision approach to medicine can only be performed when we have access to the relevant – and most well-defined – subgroups. "For this purpose," explained Anthony Magliocco, Chair of Anatomic Pathology, H. Lee Moffitt Cancer Center (Tampa, Florida)," at Moffitt, we have set up a registry of over 90,000 patients enrolled and over 30,000 tumors collected, a large dataset from which to locate, identify and validate specific subgroups' sensitivity to diseases and drug effects. This resource allows us to help other research groups and corporations to better access the relevant patients using our Total Cancer Care approach, which accompanies our trial patients from (pre) diagnosis through all stages of disease development and management." Moffitt – together with its national reach of allied centers – may have one of the largest databases of patients and annotated data. Similarly, M2Gen, its for-profit subsidiary, is actively seeking collaborations with industry, in order to leverage this increasingly valuable asset. "M2Gen is especially interested in leveraging the cases for clinical trial matching," he told MDD. "We are currently seeking more interactions with leading-edge companies and centers worldwide. My trip to Israel has certainly opened up my mind to a number of promising interactions." A further aspect of this segmentation and data tracking was presented to the conference by the relatively new players in improved health management, Oracle Health Sciences (Redwood Shores, California) and Qualcomm (San Diego). Jack Young, Managing Director of the $100 million Qualcomm Life Fund (QLF), spoke about the use of the ubiquitous personal phone or tablet as a means of connecting the patient to the world, and to relevant patient communities. "Together with suitable graphic and/or hardware interfaces, the phone can help us to monitor, guide and learn from a unique set of communities and large numbers of data sets. We create a subpopulation of users, whether related to a specific geographic region, disease or genotype, we have a set of specific members, who are worth the additional attention regarding clinical data, efficacy and outcome," he told MDD. "The more we use the handheld as a tool for sharing information, and for creating communities, the more we are enabling the health community to treat with precision."

While it may appear that the IT market is trying to 'buy into' the precision medicine storm, there may be great value here. Segmenting the market, in order to increase efficiency of healthcare delivery is where the industry must go; communications infrastructure and internet connectivity will likely be part of the solution. The power, for example, of linking the Qualcomm approach to the M2Gen-like system is indeed not a far-fetched idea.

An executive at Merck's Global Innovation Fund (Whitehouse Station, New Jersey) echoed the importance of IT's role in personalized medicine innovation. Rather than investing in another potential pharma group, his fund – while clearly viewing the industry from a pharma perspective – primarily invests in IT and infrastructure-type startups which can change the paradigms of healthcare. "We see the reduction of the Healthcare deficit the major burden of healthcare, and that what we see as the key target on the crosshairs," he shared with MDD.

If the market can leverage the power that information and communication technologies bring with them, and can increase the urgency of reducing wasted resources and imperfect treatments, then we could speed up that Precision Medicine Storm that looks like it may perhaps be about to take place.

Published: July 9, 2013

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