April 28, 2017 | April was full of exciting news in the clinical trial and healthcare community, including partnerships and products from Bioclinica, Align Biopharma, Certara, and more.

Bioclinica eHealth Solutions division has released the industry’s only purpose-built, end-to-end, configurable randomization and trial supply management (RTSM) software platform. Bioclinica AGILE RTSM provides seamless clinical supply forecasting and management together with IRT to meet the industry’s demand for greater end-to-end efficiencies in the face of increasing time, cost and resource constraints. The flexible, intelligent RTSM platform combines the latest release of Bioclinica’s Trident Agile IRT and the advanced Optimizer clinical supply forecasting and management software to significantly cut time, effort and cost for even the most complex global trials. “Traditional, siloed and heavily customized systems create significant efficiency gaps, with costly re-work and drawn-out timelines,” wrote Bioclinica eHealth Solutions President Mukhtar Ahmed. “Our customers are able to view working IRT studies from their protocols in as little as 72 hours, and implement, test, and deploy within 7-10 days. Because the RTSM system also integrates with clinical, manufacturing and ERP systems, customers are reducing drug waste and study costs by millions of dollars, and identifying changing trial conditions months in advance to reduce patient and study risk.” Press release

Align Biopharma announced its first technology standard is available for industrywide review and input. A cross-functional team of domain experts developed Align Biopharma’s new identity management standard which defines the technical requirements for registration, verification, and authentication processes that solutions should follow to enable a single sign-on service for healthcare professionals (HCPs). The goal of the standard is to improve the HCP experience in accessing information and online content across various websites, portals, virtual events, or webinars for all life sciences companies. While its first standard is under public review, Align Biopharma will begin development of its second standard for consent and preference management. The consent and preference management standard will enable consistency in how healthcare professionals specify communication preferences with each life sciences company. Align Biopharma expects to post its second standard for public review and input later this year. Press release

Personalis announced the order of ten Illumina NovaSeq 6000 systems to continue to scale its operations in 2017. The first two instruments have now been delivered. Personalis is partnering with leading biopharmaceutical companies to accelerate cancer immunotherapy development with advanced next-generation sequencing (NGS) services for clinical trials and translational research. In particular, Personalis is a pioneer in the field of personalized cancer vaccines and is actively involved in numerous current and planned clinical trials which leverage the company’s ACE ImmunoID Next Generation Sequencing Platform. Personalis ACE ImmunoID provides a comprehensive assessment of a tumor and its immune microenvironment, which includes the identification and characterization of neoantigens, Class I and Class II antigen presenting machinery, tumor escape mechanisms and tumor-infiltrating lymphocytes (TILs). This detailed characterization of individual tumors supports the synthesis of customized therapeutics for each patient. Press release

Certara announced the launch of a new solution for preparing, analyzing and submitting PK data in Clinical Data Interchange Standards Consortium (CDISC) format. CDISC supports the acquisition, exchange, submission, and archiving of nonclinical and clinical data. “As the leader in PK modeling, Certara is committed to providing its clients with technology solutions that streamline both the drug development and the regulatory submittal processes,” wrote David Munro, president of Certara’s software division. “To that end, we have developed these new tools and services to remove the time-consuming task of converting data to CDISC format manually. Manual efforts are both time-consuming and more error prone, which can slow the drug approval process.” The US Food and Drug Administration (FDA) now requires that clinical and nonclinical study data for all new drug applications (NDAs), abbreviated NDAs (ANDAs), and biologics license applications (BLAs) be submitted electronically in CDISC format. On Dec. 17, 2017 that requirement will extend to all investigational new drug applications (INDs). Press release

 ePatientFinder and Rep Network announced an alliance that will expand clinical trial access to millions of additional patients across the country. The partnership provides the Rep Network’s team of more than 2,000 independent sales reps and distributors the ability to offer physicians access to ePatientFinder’s innovative Clinical Trial Exchange patient identification and enrollment platform, which leverages the power of the trusted physician-patient relationship and electronic health record (EHR) data. The platform enables neutral collaboration and community-building among physicians, clinicians, trial sponsors and EHR providers. ePatientFinder works directly with medical practices to assist physicians in identifying trial opportunities for protocol-eligible patients. The Clinical Trial Exchange platform uses a sophisticated three-tier filtering process that leverages both the patients’ EHR data and information on ongoing trials based on geography and specialty. Patients gain access to life-enhancing-and potentially life-saving-clinical trial opportunities, while physicians and providers are able to create new revenue streams for the time they spend referring patients. Press release

Certara announced that its d3 Medicine company has been selected to conduct a national audit of Australia’s medical countermeasures (MCM) product research and development (R&D) capabilities and capacity. MCM include vaccines, therapeutics and diagnostics against chemical, biological, and radiological threats; emerging infectious diseases and pandemics. DST Group is partnering with d3 Medicine to assess and then optimize Australia’s MCM research, development, and manufacturing capabilities. “Thorough preparation is the best way to prevent a health crisis becoming a disaster,” d3 Medicine President Craig R. Rayner wrote. “We are proud to help the Australian Government develop this comprehensive MCM preparedness approach, which is considered a priority under the Defence White Paper 2016.” This new activity builds upon an initial audit conducted by d3 Medicine and DST Group in 2012. It aims to assess the nation’s current level of MCM knowledge, research, products, infrastructure, and capability in both industry and academia. Press release

HealthUnlocked has appointed Nassim Azzi as Vice President of Business Development in the US. The new role will be instrumental in defining and implementing the wider commercial strategy within the US. Nassim brings with him a wealth of experience in business and the pharmaceutical industry, with a true focus on patient centricity. His expertise extends across clinical trial productivity, meaningful collaboration with patients and clinical research, having worked at eyeforpharma and trade association, The Society for Clinical Research Sites (SCRS). Based within their New York office, the role will build new commercial partners and help to define new value propositions, based on the millions of patient interactions that HealthUnlocked supports every month on its social network. Press release