23andMe, Veeva Systems, Edico Genome, And More: News From October 2017

November 2, 2017 | October featured exciting new, products, and partnerships from around the bio-IT community from innovating companies, organizations, and universities, including 23andMe, Veeva Systems, Edico Genome, and more.

The Michael J. Fox Foundation for Parkinson's Research (MJFF) and 23andMe announced a collaboration to build a large, diverse cohort of both patients and control volunteers who have consented to participate in research. This cohort will provide researchers, drug makers, regulators, and payers critical insight into the lived experience, genetics, and variability of Parkinson's disease. The study, Fox Insight, is open to anyone 18 or older worldwide with or without Parkinson's disease and aims to recruit tens or even hundreds of thousands of patients to contribute data. "Fox Insight amplifies the patient voice in research and enables high-impact scientific collaboration toward patient-relevant outcomes," Todd Sherer, CEO of MJFF, said in a press release. "Our expanded partnership with 23andMe holds potential to illuminate new pathways to treatment breakthroughs by coupling genetic insights with the power of patient-reported phenotypic data." Press release

Veeva Systems announced Veeva Oncology Link, an enterprise data solution to centralize insights and intelligence on scientific leaders in oncology. Veeva Oncology Link consolidates thousands of global experts and millions of activities – including publications, clinical trials, and events – in a single, complete source of oncology data. Now, medical affairs and commercial organizations can better plan and engage top industry thought leaders and create deeper relationships with the global oncology community. Oncology is one of the largest, most diverse, and fastest-growing specialty areas in life sciences, and the ecosystem of oncology experts is equally large and complex. Information about key scientific leaders is typically managed in disparate data sources that quickly become out of date. This makes it difficult to gain an in-depth understanding of oncology expert profiles and interests. Veeva Oncology Link provides a single, global data source to bring together unique insights on scientific leaders for the life sciences industry. Companies can better identify and reach top scientists and researchers that are crucial to successful product development and launch of new cancer treatments. Rich, up-to-date profiles provide visibility into oncology experts’ interests, affiliations, publications, trial activity, and partnership opportunities. Data is continually kept current by utilizing both data science and Veeva’s oncology-specific data stewards. Press release

Edico Genome and Fabric Genomics announced their collaboration to provide an integrated solution for secondary and tertiary analysis of next-generation sequencing data. Through this partnership, users can seamlessly utilize Edico Genome’s DRAGEN Bio-IT platform with Fabric Genomics’ Opal Clinical variant interpretation platform to accurately gain biological insights for both inherited disease and oncology, with the goal of improving patients’ clinical care. The partnership is grounded in a successful implementation with Rady Children’s Institute for Genomic Medicine (RCIGM), which has utilized DRAGEN and Opal Clinical together for the past year. Press release

Edico Genome also announced with the Centre for Proteomic and Genomic Research (CPGR) the deployment of the first DRAGEN Bio-IT platform in Africa. Selected by CPGR to help drive adoption of precision medicine and genomics, DRAGEN will be made available to life science and biotech communities in South Africa. The DRAGEN card is integrated into a scalable and flexible 2U Dell EMC PowerEdge R730 server. CPGR is a non-profit organization dedicated to providing state-of-the-art 'omics' services to South Africa's life sciences and biotech communities, originating from an initiative by the South Africa Department of Science and Technology (DST). CPGR combines innovative, information-rich genomic and proteomic technologies with bio-computational pipelines to develop customized offerings for users in both academia and industry. CPGR hosts a suite of genomics and proteomics platforms that allow for the design and execution of projects using single or multiple 'omics' methodologies, with the goal of generating targeted and systems biological insights. CPGR will utilize DRAGEN to help advance the development of next-generation sequencing (NGS) applications and data analysis pipelines. Press release

The Parker Institute for Cancer Immunotherapy announced that researchers at Dana-Farber Cancer Institute have joined its network. Dana-Farber’s expansive clinical trial capabilities and strong immuno-oncology research approach will complement the current work at the Parker Institute, specifically in checkpoint inhibitor resistance. Leadership at both institutions have worked together to identify projects that support the Parker Institute’s strategic roadmap. Projects include those focused on basic mechanisms underlying checkpoint inhibitor resistance and immune activation and priming. Clinical research could include trials that integrate checkpoint therapies with cancer vaccines. In many cases, these projects will be collaborations with Parker Institute investigators at other institutions. Press release

Informa Pharma Intelligence and The Alliance for Regenerative Medicine (ARM) announced an expansion to their partnership to advance awareness and understanding of regenerative medicine and its potentially transformative impact on healthcare and society. Informa Pharma Intelligence analysts and tools provide comprehensive insight into global clinical trials, drug development pipelines and the regenerative medicine marketplace. By incorporating Informa Pharma Intelligence’s knowledge of the regenerative medicine pipeline with ARM’s sector expertise, the two organizations will work together to bring critical understanding of the quickly advancing regenerative medicine field to foster research, development, investment and commercialization of treatments for patients worldwide. Press release

Foundation Medicine announced that the company will present validation data for FoundationOne CDx, its comprehensive genomic profiling assay, at the International Association for the Study of Lung Cancer (IASLC) 18^th World Conference on Lung Cancer (WCLC). Data demonstrated high concordance with multiple companion diagnostics and other single marker assays currently used to match targeted therapies to people with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer. The availability of a comprehensive genomic profiling assay that is concordant with multiple companion diagnostics has the potential to advance personalized healthcare for all constituents by providing biopharma companies a platform for accelerated drug development and by improving efficient access to targeted therapies for patients. FoundationOne CDx is a comprehensive genomic profiling (CGP) assay that incorporates multiple companion diagnostics in a single platform with molecular profiling of the 320+ genes known to drive cancer growth. These validation data are also included in the Premarket Approval Application (PMA) for FoundationOne CDx which is currently under review by the U.S. Food and Drug Administration (FDA) and also by the Centers for Medicare & Medicaid Services (CMS) as part of their Parallel Review program for breakthrough devices. FoundationOne CDx is not commercially available at this time. Press release

Certara announced the launch of Phoenix 8.0. Included in this Phoenix rollout are Phoenix WinNonlin 8.0, Phoenix NLME 8.0, Phoenix Validation Suite 8.0, and Phoenix in vitro-in vivo correlation (IVIVC) Toolkit 8.0. Phoenix is used by 6,000 researchers at 1,500 biopharmaceutical companies and academic institutions in 60 countries. Phoenix is also employed by many global regulatory agencies for submittal review, including 11 divisions of the US Food and Drug Administration (FDA). “Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials,” said US FDA Commissioner Scott Gottlieb in a press release. “Phoenix is considered the gold standard in PK/PD modeling and simulation, and we take our responsibility to deliver continuous improvement and innovation very seriously. It has been only 12 months since the last Phoenix release, and we have added several important new features to the software to allow key drug development decisions to be made quicker,” David Munro, President of Phoenix Technologies at Certara, wrote in a statement. Press release

OnRamp BioInformatics has launched Rosalind, the first-ever genomics analysis platform specifically designed for life science researchers to develop insights that the platform then analyzes. Named in honor of pioneering researcher Rosalind Franklin, who made a major contribution to the discovery of the double-helix structure of DNA with her famous photograph 51, OnRamp’s Rosalind platform aims to simplify the practice of genomic data interpretation. Press release

Bioinformatics.org has opened their job marketplace for freelancing in research and development. Known as Scilancer.com, the service connects educated and trained individuals with organizations seeking short-term help for R&D projects. “Scilancer is a portmanteau of science and freelancer, and it's unique in that it's the only freelancing site devoted to the STEM fields,” J.W. Bizzaro, founder and president of Bioinformatics.org, told Bio-IT World via email. “It's also less expensive than generic freelancing websites and will offer higher quality projects by setting a minimum project budget and encouraging competitive quotes.”

Fluence Analytics announced the launch of ARGEN, a patented protein and polymer stability monitoring product. By utilizing continuous light scattering measurements, ARGEN yields a unique information stream which reduces discovery and formulation and development times. For more than a year, Fluence Analytics worked with university partners, biopharmaceutical companies, and industry leaders during beta testing to improve ARGEN’s measurements, user experience, and software features. ARGEN is engineered for precise, individual control of thermal and mechanical stressors of each of its 16 independent sample cells. By continuously analyzing the state of samples, ARGEN provides novel time series datasets with quantitative insights into the early detection of aggregation, degradation and particle formation. ARGEN allows users to swap samples in and out during experiments without affecting ongoing measurements in other cells. ARGEN data can also optimize lower throughput, standard characterization tests such as SEC. Press release

QIAGEN and CENTOGENE announced a collaboration and co-marketing agreement to provide customers more complete Sample to Insight research and clinical testing solutions in rare genetic diseases. CENTOGENE is a leading rare disease company providing insights into the complex interaction between genetics, biochemistry and clinical phenotypes of patients with hereditary disorders. More than 4,000 known genetic disorders are estimated to affect roughly 1 in 10 individuals. Press release

Inivata announced that it is collaborating with Genomics England to assess the quality of blood plasma samples and explore the potential of liquid biopsy to improve disease management and patient outcomes. In the first phase of a larger pilot, Inivata will analyze plasma samples donated by participants in Genomics England's 100,000 Genomes Project. As well as determining the suitability of plasma, the study will focus on the use of Inivata's world-leading liquid biopsy technology, InVision, to discover the mutations in the human genome that can lead to or demonstrate the presence of cancer. These results, and those from the two subsequent phases, will be shared with researchers in the UK and around the world - with the potential to develop less invasive sample collection techniques, more effective monitoring processes and, ultimately, better cancer care. Press release

ACD/Labs announced new updates across its ACD/Spectrus Platform, the company's suite of informatics software products. Version 2017.1 delivers improved functionality to a broad range of solutions including MetaSense, ACD/Labs' metabolite identification software introduced in 2016, and introduces Luminata, a new solution for the management of impurity data announced in the spring of 2017. ACD/Labs' v2017.1 software release includes the following updates: ACD/Spectrus—instrument format support across analytical techniques—a foundation of the platform—has been expanded and enhanced. With more customers in pharma and biotech working on biomolecules, the ability to easily draw peptides sequences and suggestions for spectral assignment have been well received. A new LC/MS deconvolution algorithm for high-resolution MS data also includes usability improvements. For those that work with mixtures, tools for analyzing samples by NMR and MS have been greatly enhanced. MetaSense—having listened to feedback from early customers, the updated version brings new metabolic pathways into the prediction algorithm and provides easier navigation of data in ways that are better aligned to scientists' workflows. Luminata—this new solution enables organizations to establish effective impurity control strategies through the assembly of analytical, chemical, and process information in a single enterprise informatics environment, following QbD principles. Press release

Takeda and HemoShear announced a partnership to discover and develop novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH). “The ability to study pathophysiology in a human multi-cell system is crucial for our understanding of disease and how to develop best-in-class therapies,” said Gareth Hicks, Head of the GI Drug Discovery Unit at Takeda, in a press release. “We see the HemoShear platform as an integral component in our overall liver disease strategy that focuses on a ‘human first’ approach to the identification and validation of novel targets in NASH and other liver diseases.” HemoShear’s proprietary disease modeling platform, REVEAL-Tx, applies principles of physiological blood flow to tissue derived from patients. REVEAL-Tx allows drug candidates to be studied at human concentrations and provides valuable insights into complex pathophysiological pathways by replicating human disease with great accuracy. REVEAL-Tx was recognized recently at the American Association for the Study of Liver Disease annual meeting where its NASH model received four Presidential Awards based on publications demonstrating the platform’s ability to replicate many clinical observations from clinical stage drugs. Press release

IDBS has announced the release of its next-generation bioanalytical informatics solution. Leveraging the IDBS E-WorkBook Cloud platform, the solution provides an out-of-the-box capability that enables any bioanalytical lab to take advantage of industry-standard laboratory practices. By providing the required bioanalytical workflows, sample tracking, reporting, and full implementation documentation (IQ/OQ) in a single packaged cloud offering, all bioanalytical laboratories will now be able to access the return on investments (ROI) that come from deploying The E-WorkBook Cloud. Press release

Tom Maniatis, one of the original founders of the New York Genome Center (NYGC), has accepted the Board’s offer to become the NYGC’s full-time Scientific Director and CEO. With the continued support of the Board, and in partnership with NYGC’s founding academic and medical institutions, Tom will continue to work to define the next phase of the NYGC’s strategy, and to realize the full potential of the NYGC through technology innovation, advances in personalized medicine, and community-driven research.