March 28, 2018 | March was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from goBalto, Medial EarlySign, Veeva Systems, and more.

goBalto announced that Worldwide Clinical Trials (Worldwide) has chosen goBalto's end-to-end platform for starting clinical trials. As part of the company's quest to improve value in pharmaceutical sponsor-CRO partnerships, Worldwide has invested in delivering an uncommon combination of emerging- to mid-size-sponsor focus, therapeutic-area expertise in central nervous system, cardiovascular, metabolic, immune mediated inflammatory disorders, oncology and rare disease research, and innovation to improve trial efficiency and effectiveness. The company's investment in the goBalto platform targets study startup, one of the most inefficient cycles currently facing clinical development operations. For many, the total end-to-end process from site identification through to site initiation has not changed in 10 years, taking nearly 7 months (31 weeks) on average, according to an industry survey report. Time savings in study startup have been reported by 80% of survey respondents who have invested in start-up technologies, like the goBalto platform, according to the START (Start-up Time And Readiness Tracking) II report. "The process of initiating clinical trials is unwieldy, challenging, and often behind schedule, making study startup one of the poorest performing aspects of clinical trials," said Jae Chung, goBalto's President and Founder, in a press release. "Worldwide is at the vanguard of change by focusing on study startup, the only part of a study's lifecycle which can significantly impact the overall timeline of clinical trial conduct. This focus leads to shortened timelines and reduced costs, all in an effort to speed sought-after therapies to patients across the globe." goBalto's workflow-driven Select and Activate, along with Analyze, a data analytics platform - optimize the many study startup steps, providing real-time insights into study status, a vast improvement from the manual, time-consuming methods still predominantly used across the industry. Press Release

Medial EarlySign announced completion of a $30 million Series B round of financing, bringing the company’s total funding to $50 million. Led by aMoon Fund, Marius Nacht’s (Check Point Software Technologies Ltd. Co-founder) investment arm in the life science sector. The deal also included participation of Horizons Ventures, and Nir Kalkstein, founder of high-speed trading firm Final and co-founder of Medial EarlySign. The funding highlights Medial EarlySign’s position as the leading healthcare AI company that can leverage existing blood test results and Electronic Health Record (EHR) data to provide precise insights to HCOs as they determine the best approach to improving patients’ health. “There is an incredible volume of meaningful routine healthcare data. Yet, while these data are electronically stored and available, they are still underutilized, and providers can glean much more actionable intelligence from it,” said Ori Geva, Co-founder and CEO of Medial EarlySign, in a press release. “This is where Medial EarlySign comes in. Our unparalleled expertise in these data and predictive health technology allows us to provide valuable insights and create improved actionable opportunities for early intervention, improved decision making, more effective care management, and physician and patient empowerment. This funding will allow us to further broaden our suite of solutions, and expand clinical research and global implementations of our clinically-supported technology. The insights we enable could bring added value to almost every interaction with the patient, with the potential to positively impact millions of lives.” Medial EarlySign’s machine-learning based models analyze dozens of factors residing in EHRs, including laboratory tests results, demographics, medication and diagnostic codes, to predict individuals at high risk of developing specific illnesses and to optimize care. The company is developing a suite of predictive models and algorithmic calculators to help healthcare organizations accurately stratify individuals, provide personalized insights to enhance decision making and create actionable opportunities for early intervention to delay – or even prevent – progression of illness, improving patient outcomes while reducing overall costs. Press Release

Six leading contract research organizations (CROs) and Veeva Systems introduced Align Clinical CRO, a new industry standards group dedicated to making it easier for sponsors and CROs to work together during clinical trials. Founding members, with input across the industry, plan to help create open technology standards intended to improve trial execution and collaboration with life sciences companies. For the first time, leading CROs, including ICON, Medpace, Pharmaceutical Product Development, PRA Health Sciences, Syneos Health, and UBC are coming together to develop open technology standards to transform clinical trial operations across the entire industry to speed product development. Align Clinical CRO will create open technology standards intended to help increase sponsor and CRO productivity, reduce operational costs, and run trials faster. The group’s first standard is anticipated to be an Operational Data Exchange standard to facilitate seamless information sharing between sponsors and CROs. This is expected to include the definition of a technical standard for data to be exchanged between a sponsor and a CRO relating to the operational execution of a trial, including key metrics and milestone information. Press Release

Strata Oncology announced that Aurora Health Care and University of Texas Health Sciences at Houston (UTHealth) have joined the Strata Precision Oncology Network. Formed in 2016 by Strata Oncology, the Network is accelerating precision oncology by providing advanced cancer patients routine access to tumor profiling and matching to a portfolio of biomarker-driven pharma-sponsored clinical trials, and has since expanded to 10 healthcare systems representing more than 85,000 new cancer patients annually. "We are excited to join a collaborative group of leading cancer centers across the country working to ensure broad, timely patient access to precision medicine," said Robert J. Amato, Acting Director of the Division of Oncology at UTHealth McGovern Medical School and the Chief of the Division of Oncology at Memorial Hermann Cancer Center-TMC, in a press release. Members leverage the StrataNGS test, an 87-gene assay that sequences both DNA and RNA, as the foundation of comprehensive, integrated solution to deliver precision oncology system-wide. StrataNGS is available to all advanced solid tumor and lymphoma patients at no cost through the Strata Trial, a nationwide observational study providing tumor profiling and trial matching for 100,000 patients with advanced cancer. The Network's additional members include: Christiana Care's Helen F. Graham Cancer Center & Research Institute (DE); Kaiser Permanente-Northern California; Kettering Health Network (OH); Metro Minnesota Community Oncology Research Consortium; Ochsner Health System (LA); UAB Comprehensive Cancer Center; UNC Lineberger Comprehensive Cancer Center; University of Wisconsin Carbone Cancer Center. Press Release

Certara announced the launch of its Quantitative Systems Pharmacology (QSP) Immuno-oncology Simulator Consortium. QSP combines computational modeling and experimental methods to examine the mechanistic relationships between a drug, the biological system, and the disease process. QSP integrates quantitative drug data with knowledge of the drug’s mechanism of action. It facilitates the evaluation of complex, heterogeneous diseases such as cancer, immunological, metabolic and central nervous system diseases that require multiple therapies. Modeled after Certara’s highly successful, Simcyp Consortium, this new QSP consortium brings together leading biopharmaceutical companies in a pre-competitive environment to develop cooperatively a QSP Immuno-oncology Simulator that can model clinical populations of cancer patients. The Consortium plans to capture the pertinent biology, pharmacology, and variation between individuals in sufficient detail so that the Simulator can guide and improve clinical development of immuno-oncology therapies. Recent successes with immune checkpoint inhibitors, such as PD1 and PD1L, have made immuno-oncology one of the most competitive and fastest-growing areas of pharmaceutical R&D. The global market for immuno-oncology therapies is expected to exceed $45 billion by 2025. But it is also a very complex, challenging field as illustrated by the clinical trial failures. This is Certara’s second QSP consortium. Its QSP Immunogenicity (IG) Consortium, which was launched in January 2017, is already producing great results. Immunogenicity, a vexing problem for the industry, is defined by the FDA as the propensity of the therapeutic protein product to generate immune responses to itself and to related proteins or to induce immunologically-related adverse clinical events. Certara released version 1 of its IG Simulator earlier this month and the Consortium leaders recently met with FDA staff members to update them on its progress. Certara’s IG Simulator can predict immunogenicity of biologics and its impact on their pharmacokinetics, efficacy and safety in diverse patient populations. Press Release

Bio-Optronics announced a new partnership with Synexus. This partnership is aimed at improving patient access to modern medicine and improving overall clinical trial efficiency by delivering high numbers of quality patients to clinical trials through the use of a unified CTMS across the entire Synexus network of more than 200 sites in eleven countries worldwide. “This partnership combines the unique breadth and depth of the Synexus site network with the advanced collaborative trial management tools of Clinical Conductor CTMS in order to bring unparalleled quality, efficiency and profitability to global research operations,” said Max Elbaz, VP of Sales and Marketing at Bio-Optronics, in a press release. “As the largest site network in the world, our partnership with Bio-Optronics is important to our future growth. Rolling out Clinical Conductor across our whole organization is the only way we can consistently manage over 200 sites with hundreds of studies,” states Marcin Gondek, Chief Financial Officer at Synexus, in a press release. “To us, Bio-Optronics are more than just a software vendor, they are a strategic partner who helps us find, manage, and care for over 150,000 patients per year.” Press Release

Clinerion has appointed Ian Rentsch as its new CEO. Rentsch brings more than 22 years of international experience in multinational pharmaceutical companies as well as in small/niche and global CROs. He joined the former Quintiles – now IQVIA – in 2012, as Head of Latin America Sales, and relocated to Europe to lead the Emerging Biopharma Segment in EMEA as Regional Head. Most recently, he took on the role of Global Demand and Business Operations Head of an E2E Strategic Alliance. Rentsch has a German-Argentinian background and is a lawyer (UBA) and Industriekaufmann (IHK) by training. Taking on leadership of Clinerion, Ian aims to solve the main industry challenge by bridging the divide between patients, sites, and drug developers. “Patients often lack access to clinical trials. Investigational sites struggle to identify the right patients and meet enrollment projections. Biopharma/CROs need to speed up the time-to-market, overcome study delays and leverage real-world and real-time data from real patients. Clinerion brings all three together on its technology platform,” Rentsch said in a press release. Press Release