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New Trends and Emerging Technologies Are Focus of Morning Session on Day 2 of Personalized Medicine World Conference (PMWC) 2017 at Duke

After the morning’s opening panel discussion on “The Value of Data Sharing,” Day 2 of the Personalized Medicine World Conference (PMWC) 2017 at Duke continued with a high-energy, high-impact presentation by Mark Levin (photo), Co-Founder of Third Rock Ventures in the session on “New Trends and Emerging Technologies.” Other speakers in this session included John Mikszta PhD, Director of the Genomic Sciences Focus Area at BD Technologies; Lawrence David, PhD, Assistant Professor, Department of Molecular Genetics and Microbiology and Center for Genomics & Computational Biology at Duke University; and Panna Sharma, President and CEO, Cancer Genetics, Inc. Dr. Mikszta spoke on ”Single-Cell Genomics: Emerging Applications,” Dr. David spoke on “The Role of the Human Microbiome,”and Dr. Sharma spoke on “How AI Is Accelerating and Enabling Precision Oncology.” Mark Levin has been a life science leader for 40 years, most of them spent conceiving and launching biotechnology companies. Early on, Levin recognized that personalized medicine had the potential to benefit the patient and revolutionize both pharma and biotech. He strongly espoused that the only way the field would reach this potential was if all stakeholders banded together to overcome the many challenges it faced. To enable this, he helped conceive the Personalized Medicine Coalition. In 2007, Levin co-founded Third Rock Ventures, a different kind of venture capital firm that actively searched for disruptive medical technology and innovative science, to build into companies from the ground up. Many of these were based on personalized medicine, such as cancer epigenetics, gene therapy and molecular diagnostics. Then, he and his partners carefully selected the founding teams and instilled them with a sustainable culture. Third Rock hatched the ideas for most of its 36 portfolio companies including Foundation Medicine, Agios, BlueBird Bio, Editas Medicine, and Sage Therapeutics. Prior to Third Rock, Mark co-founded Mayfield Fund’s life science arm, where he was also founding CEO of companies such as Tularik, Cell Genesys/Abgenix, Stem Cells, and Millennium Pharmaceuticals, serving as CEO for 12 years. Earlier in his career, Levin was an engineer and project leader at Lilly and Genentech. He holds an M.S. in Chemical and Biochemical Engineering from Washington University.

In his highly spirited presentation at Duke, Levin rapidly outlined over a century of science history leading up to today’s focus on precision medicine. He highlighted the identification, in 1995, of the PKD1 gene for polycystic kidney disease (PKD) by a consortium including his company then, Millennium Pharmaceuticals. He cited this as an example of how relatively easy it now is to identify key genes, but how validating targets has been almost impossible, as there is still not a drug for PKD. He noted the recent real revolution of identifying targetable genes in cancers and mentioned the breakthrough drugs Gleevec and Iressa. He pointed out the important roles of electronic health records (EHRs) and machine learning in advancing precision medicine toward the goal of maximizing the health outcomes for patients. He emphasized the importance of precision medicine by noting that every investment undertaken today by Third Rock Ventures hinges on the application of precision medicine approaches.

DR. JOHN MIKSZTA

BD’s Dr. Mikszta emphasized the heterogeneity of the tumor environment and tumors themselves and noted the importance of analyzing single cells from this environment. He described three integrated BD products that are intended to enable such single cell analysis. These products include the high-throughput, low-volume BD Composite Liquid Cell (CLiC) system designed to automate the currently cumbersome process of NGS library preparation. He said that BD CLiC integrates the entire library prep workflow for NGS into a single instrument to give the user true walkaway library preparation. Reduced reaction volumes mean more libraries can be prepared for the same budget. The two other key products are the BD FACSMelody Cell Sorter and BD Precise kits. The BD FACSMelody cell sorter introduces a powerful combination of ease of use, high performance, and reproducible results. Founded on patented Molecular Index technology, BD Precise assay kits enable highly accurate RNA quantification with single cells or bulk RNA input.

DR. LAWRENCE DAVID

Dr. David, of Duke, then spoke on the significance of the human microbiome. He began by noting that there are approximately 100 trillion bacteria living in the human body and that there are 100 billion bacteria in a single gram of human fecal material. These bacteria, he said, are engaged in a ferocious competition for nutrients changes and the metabolism of all these bacteria can have significant effects on drug metabolism, among many other possible effects. Dr. David’s lab at Duke University develops computational and engineering tools for manipulating human-associated bacterial communities and he is currently working to create an “artificial gut” in which the effects of modulating specific bacteria can be studied in a systematic fashion.

PANNA SHARMA

Panna Sharma of Cancer Genetics, Inc (CGI),, spoke on how artificial intelligence (AI) must be embraced in order to enable and speed the advance of precision medicine. He said that AI will “transform the medical sector beyond recognition” and those who fail to embrace AI will be left behind. He cited two examples demonstrating CGI’s commitment to implementing AI in precision medicine.

First, he noted the company’s recently announced strategic partnership with Medel.ai, a company focused on using the Mendel.ai deep-learning engine to accelerate and constantly update clinical trial matching for patients. According to the April 3, 2017 press release announcing the agreement, the companies will be actively working together to integrate Mendel.ai capabilities for clinicians, oncologists, pathologist, as well as cancer centers and hospitals with CGI’s disease-focused reports and testing results. The companies expect that initial, early-access partners will be using the system during the second quarter of 2017 with wider rollout through the third and fourth quarter of this year.

“The world’s best cancer treatments are currently in trials, but that doesn’t assure that the patients that fit those trials are aware of their existence, even after identifying an actionable biomarker. Traditional navigation tools are no longer realistic as trials are becoming more selective and treatments are becoming both more complex due to combinations and more targeted,” said Karim Galil, MD, Founder and CEO of Mendel Health was quoted as saying in the release. “By integrating Mendel’s proprietary AI technology, CGI is the first diagnostic company able to augment the oncologist’s decision-making by continuously matching the patient’s data with emerging clinical trials – based on previous diagnostic tests and any shared clinical data or records. CGI’s clinical customers and the patients they serve today are able to make the most out of treatments being developed today, and not decades ago.”

In the same release, Dr. Sharma commented, “Changing patient outcomes can be significantly increased by allowing more patients and cancer care facilities access to artificial intelligence and deep-learning technologies such as Mendel.ai. Improving visibility, providing constant, machine-augmented matching, and accelerating access to the vast innovation in biotechnology and pharma trials is needed to raise survival curves and decrease the costs of cancer care. By incorporating our state-of-the art genomic and biomarker reports and data with the ability to integrate real-time clinical trial matching and available health information, we can change patient lives, change outcome curves at cancer centers, and improve the major gaps in oncology patient recruitment.”

At the PMWC meeting, Dr. Sharma also highlighted CGI’s recently announced strategic partnership with Lantern Pharma, Inc., a clinical-stage, precision therapeutics company developing innovative, molecularly-targeted precision oncology compounds for the treatment of cancer. CGI will collaborate on biomarker discovery, clinical trials, and genomics projects for Lantern’s lead clinical candidates.

The January 17, 2017 announcement of the partnership said that, according to the Tufts Center for the Study of Drug Development, typical drug discovery and development can take 10 to 12 years and cost more than $2.6 billion dollars to get through the trials and testing needed for approval.

Dr. Arun Asaithambi, co-founder and CEO of Lantern Pharma, a company focused exclusively on accelerating the drug approval process using artificial intelligence and big-data, commented in the release, “Oncology compounds have undergone tremendous advancement in design, but have lacked the systematic analysis leveraging big-data and precision trial design and testing, which has led to inefficient processes and lackluster approval rates.”

Dr. Asaithambi continued, “By developing targeted biomarker panels, in conjunction with Cancer Genetics, that can precisely sub-type patients based on the ability to be responsive to a treatment and then incorporating that into the selection and testing process, we can save years and tens of millions of dollars, thereby, making treatments more personalized and more accessible.”

“Our collaboration with Lantern and their expertise in AI-driven drug development will enable a new level of usage and evaluation of our predictive biomarker and NGS panels. Repurposing and rescuing promising drug compounds for accelerated clinical trials is a key component to precision medicine and improving the productivity of drug discovery,” commented CGI’s Dr. Sharma in the release. “By combining genomic and biomarker panels, in a systematic way, with big-data approaches to guide therapeutic use, we can pinpoint potential patient groups faster and cheaper across multiple cancers. Our collaboration with Lantern is a hallmark of where our industry is headed to achieve greater efficiency and more precision in oncology drug development.”

[CGI-Mendel.ai Press release] [CGI-Lantern press release] [PMWC 2017 Duke]