February 27, 2019 | February was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Rhinogram, ZappRx, HEALTHeLINK, and more.

Rhinogram announced the seamless integration of their telehealth solution with the Cloud 9 practice management software. Through the collaboration with Rhinogram, Cloud 9 now offers practices the ability to communicate with patients in real-time via simple texts (SMS) and multimedia texts (MMS) or one-tap access directly from a practice’s Facebook ad, giving the practice the ability to better engage with patients while streamlining workflow. “We are excited to see the addition of Rhinogram as a certified Cloud 9 partner,” said Ken Swinney, Chief Technology Officer and co-Founder of Cloud 9 Software, in a press release. “Adding high-demand, integrated partners like Rhinogram furthers our commitment to making Cloud 9 the most accessible and widely used practice management system in orthodontics. Achieving this high level of integration between our companies brings our customers the efficiency, security, and confidence they expect.” Powered by Rhinogram’s HIPAA-compliant, telehealth solution, the Cloud 9 practice management software allows patients and practices to securely communicate via two-way texting including the exchange of documents and multimedia communication. The complete history of social media and SMS messages, which cannot be edited, are archived in the patient’s communication record within Rhinogram, allowing practitioners to quickly and conveniently reference past communication with their patients. Press release

Aetion announced it has attracted strategic investment from global leaders in biopharma and health care services, including Sanofi, UCB, McKesson Ventures, and Horizon Health Services, a Blue Cross Blue Shield of New Jersey company—four new strategic shareholders that join Amgen Ventures, an earlier investor. Existing venture capital investors also participated in this round, including NEA, Flare Capital, and Lakestar. The latest strategic capital infusion of $27 million reflects Aetion's substantial growth in customer adoption over the past year. Coupled with its prior funding in early 2018, the investment caps the total Series B funding at $63 million. This brings Aetion's total funding to $77 million since its 2015 launch. Investment funds will be applied to strengthen the Aetion Evidence Platform, extending its reach in therapeutic area-related intelligence, outcomes-based contracting for payers, and advancing the acceptance of standards for real-world evidence around the globe. "The time for real-world evidence is now," said Carolyn Magill, Chief Executive Officer of Aetion, in a press release. "We're entering a new era in which nearly the entire health care ecosystem—from biopharma and regulators to payers and technology companies—recognizes the importance of using real-world evidence to reduce the time and cost to bring new therapies to market. This funding demonstrates that the industry's leaders, who are using our technology to drive health care's most critical decisions, view Aetion as a trusted partner vital to their long-term success." Press release

ZappRx announced that it will work with Teva Respiratory in support of their specialty respiratory medication. The joint project will provide a more efficient approach to prescribe, obtain, and administer therapy necessary for patients to better manage their disease and symptoms. “By partnering with industry leaders such as Teva Respiratory, ZappRx is able to make life-changing medications more accessible to an underserved patient population,” said Zoë Barry, CEO and Founder of ZappRx, in a press release. “ZappRx is committed to helping patients first and foremost, and we are confident that working with Teva will help us to do exactly that.” ZappRx’s cloud-based platform streamlines what is currently a multi-step, manual prescribing process, often involving numerous platforms for each of several treatments, into a single, digitally-enabled format. This allows providers who treat severe asthma to focus more on patient care. Press release

HEALTHeLINK released its 2018 “Report to the  Community,” highlighting its focus on enhancing patient care through streamlining care coordination, improving the quality of data, and exploring how best to serve the health care community of the future through population health measures and reporting. “Making sure that providers have their patients’ most complete and correct clinical information at the point of care via HEALTHeLINK continues to be critical for improving care quality and mitigating health care costs,” said Dan Porreca, HEALTHeLINK’s executive director, in a press release. “With our health information exchange foundation well established here in Western New York, HEALTHeLINK is taking the next steps to ensure the quality of information for ongoing effective patient care and for advancing population health initiatives in our community.”  A few of the major highlights from HEALTHeLINK’s 2018 “Report to the Community” include: more than 350 practices continue to deepen their utilization by uploading patient data directly from their electronic health records (EHRs) to HEALTHeLINK, allowing for more complete patient medical records that other treating providers can access; HEALTHeLINK’s results delivery service, which enables practices and care coordination networks to receive their patients’ medical results directly into their EHRs from other linked sources, increased more than 50% over the last year; and more. Press release

Veeva Systems announced increasing numbers of life sciences companies are adopting applications in Veeva Vault RIM, the first unified suite of RIM applications on one cloud platform, to modernize their regulatory processes and systems. More than 150 companies are implementing Vault RIM applications, including four of the top 10 largest global pharmaceutical companies, to streamline submission development and provide greater visibility across end-to-end processes. Vault RIM brings together regulatory content and data on a single platform so teams have one authoritative source for submission documents, published dossiers, health authority interactions, and product registrations. With Vault RIM, life sciences companies can eliminate the need for multiple systems and manual tracking that slow execution and increase compliance risk. The latest addition to the Vault RIM suite of applications, Veeva Vault Submissions Publishing, is a new approach that brings together publishing activities with document planning, authoring, and approval in a single system to streamline the entire submission development process. This enables customers to significantly speed regulatory submission preparation and delivery. Vault Submissions Publishing enables a continuous publishing process to finish publishing steps sooner so validation issues are identified and fixed faster for greater efficiency and improved compliance. Continuous publishing eliminates the manual movement of documents between multiple systems and reduces the number of document transfers to one – when the dossier is transmitted directly to the health authority. Press release

Prognos announced the launch of a digital solution, Signal, that will help life science brands use real-world diagnostic alerts to treat patients more efficiently. Signal is the first clinically-relevant digital alert powered by AI that enables life science brands to extend reach and optimize programmatic advertising engagement with health care providers. It uses the Prognos Registry of more than 20 billion unique clinical records and advanced AI applications. "This is the first time life science brands are able to harness near-real time clinical insights to act while treatment decisions are being made," Matt Apprendi, Vice President of Digital Products for Prognos, said in a press release. "They can synchronize messaging to health care providers across personal, non-personal and digital advertising channels. Early adopters are using Prognos' Signal to gain a competitive advantage so they can be relevant and top of mind at the right time." The new product furthers Prognos' goal of improving health by predicting disease the earliest. "Prognos' Signal provides a compelling solution that marries timely diagnostic data with AI insights to power the digital strategies for life science brands," Theresa Greco, CCO of Prognos, added in an official statement. Press release

Navitas Life Sciences announced that it will be acquiring Life Sciences services player, DataCeutics in North America. The acquisition, as part of the 2021 growth strategy, spearheads the growth of Clinical business in accordance with the global Clinical market, which is expected to reach $32.9 B by 2020.  The company is poised to gain from the strategic acquisition of DataCeutics, a specialty Clinical Functional Service Provider (FSP), delivering quality statistical programming, clinical reporting and clinical data management. DataCeutics strengthens Navitas Life Sciences in its high-end Data Sciences capabilities which include Clinical Data Management, Biostatistics and Statistical Programming, Medical Writing, Data Standards and Conversions as well as bolstering relationships with major pharma companies in North America.  Navitas Life Sciences plans to complement DataCeutics' capabilities with its own AI-driven clinical platform and near real-time data insights and analytics to deliver improved outcomes for clients across safety, quality, compliance, cycle time and cost. The company has core Clinical FSP capabilities and experienced resources in Oncology, Cardiology, Pulmonology, Infectious Disease and CNS. Krishnan Rajagopalan, Chief Growth Officer, Navitas Life Sciences said in a press release, "We are delighted to begin 2019 on a high note with this key acquisition. DataCeutics strengthens our capabilities in Data Sciences and FSP / BPO services and widens our therapeutic expertise in Cardiology, Oncology, Pulmonology, CNS, Infectious diseases etc. The addition of these competencies translates to business expansion in North American, European and Asian markets." Press release

RenalytixAI announced the completion of a joint venture partnership agreement with AKESOgen. AKESOgen brings a state-of-the-art 14,000 square foot CLIA certified and CAP accredited laboratory facility that enables RenalytixAI to immediately scale operations to support additional business partnerships on a variable-cost basis without incurring additional fixed overhead. RENX AI Labs provides RenalytixAI with further operations outside of its recently configured New York City-based clinical laboratory operations in JLABS, a Johnson & Johnson Innovation center. The joint venture, named RENX AI Labs, significantly expands the operational capacity available to RenalytixAI. RENX AI Labs will provide services directly to health systems and pharmaceutical companies located in all regions of the United States. The joint venture enables RenalytixAI to support prospective revenue-generating contract research, clinical diagnostic and clinical trial services that are part of the Company's core business model with KidneyIntelX and other products under development. RENX AI Labs will help support the programs of pharmaceutical companies by applying AI-enabled diagnostics, beginning with KidneyIntelX, which is currently undergoing clinical validation, to improve patient characterization and enrich targeting of patients for drug clinical trials for renal disease. Better identification and characterization of enrolled patients has the potential to reduce trial cost and duration, and increases the likelihood of reaching successful outcomes. RENX AI Labs also has the capability to develop companion diagnostics under stringent quality-control processes. Press release

Clinerion announced it will offer its services to hospitals in Georgia, bringing them access to international clinical studies and the use of the Patient Network Explorer for academic research. Georgian Medical Software – MEDSOFT, will support Clinerion in expanding its footprint in Georgia. MEDSOFT supports hospitals and the medical community with innovative technology and dedicated services. More than 40 hospitals and medical centers in Georgia use MEDSOFT’s software. Their MEDWORK hospital information system (HIS) is integrated with the Georgian Ministry of Health, financial systems, and laboratory information systems, allowing costless and effective information management for the healthcare community. As part of their partnership, MEDSOFT will support Clinerion in integrating hospitals in Georgia in Clinerion’s international network of partner hospitals on its Patient Network Explorer platform. In turn, MEDSOFT hospitals will be able to use Patient Network Explorer’s real-world data solutions when running academic research. They will gain sophisticated tools to query their own HIS, allowing them to review and optimize protocols, and find and identify eligible patients for trials within their own hospitals. Joining the Patient Network Explorer platform will also make these hospitals visible to pharmaceutical companies seeking trial sites for clinical research of drugs in development. “Our System, MEDWORK, was developed with an easy-to-use interface and has the functionality and capability to fully provide support for the processes of receiving, keeping and processing data in any type of medical institution,” said Archil Kapanadze, CEO of MEDSOFT, in a press release. “This system uses latest and renewable programing technologies. We provide about 25% new features and capabilities annually for our customers.” “As a HIS provider with a strong presence in Georgia, we consider MEDSOFT an important partner in our expansion in the region, enabling Clinerion to reach more patients” Ian Rentsch, CEO of Clinerion, said in a press release. “Added to that is their strong technology capability, which ensures smooth integration of new hospital partners to Patient Network Explorer.” Press release

Twistle announced an expanded deployment of its two-way patient engagement platform with Providence St. Joseph Health (PSJH) to improve patient engagement around surgical episodes of care. Fourteen hospitals across the PSJH health system have decided to deploy Twistle for use in spine surgery, joint replacement, colorectal surgery, bariatric surgery, cardiovascular, and OBGYN following in-depth technology selection and pilot testing. Twistle’s platform allowed PSJH to innovate its surgery care pathway to engage patients through mobile apps, text messaging, email and interactive voice responses. PSJH will also be able to connect its own digital storefront to the Twistle platform. The Twistle patient engagement pilots were a collaboration between PSJH’s digital innovation group and clinical teams. “Our quest is to simplify health care journeys for patients, and we identified surgery as an area of unnecessary complexity that was ripe for improvement through a better digital experience,” Aaron Martin, Executive Vice President and Chief Digital Officer at PSJH, said in a press release. “We partnered with the clinical team to test how moving the doctor-patient experience to a digital patient engagement platform would help streamline interactions to build stronger relationships and trust.” “We’re embracing technology that patients already know and use in their everyday lives as a way to transform health and deliver high-value care,” said Amy Compton-Philips, Executive Vice President, Chief Clinical Officer PSJH, in an official statement. “For patients, surgery is anxiety-provoking and added to that is the complexity of navigating all the things you need to do and know through the entire episode of care. The pilots showed us that managing the flow of information and communication between care teams and patients in a single place made surgery a better experience.” Press release

Porex has been named a finalist in the medical category for its FORTRESS Pipette Tip Filter in the 2019 Edison Awards. The annual competition recognizes and honors the most innovative new products, services and business leaders from around the world. Named after Thomas Alva Edison, the Edison Awards will announce which level of award—gold, silver or bronze—each finalist will win at the Edison Awards Gala held Thursday, April 4, 2019 at the New York Academy of Sciences in New York City. The POREX FORTRESS Pipette Tip Filter is certified as the first pure liquid barrier filter, setting the industry's new standard for sample protection and accurate lab results. This new pipetting technology provides reassurance and reliability for more accurate test results within both manual and robotic liquid handling needs, making non-filter pipettes virtually obsolete. "We are excited and proud to be considered for a 2019 Edison Award," said Avi Robbins, Vice President, Global Product Development for Porex, in a press release. "Porex is at the forefront of designing and engineering innovations that are revolutionizing laboratory and clinical outcomes. There is no other pipette filter product on the market like FORTRESS that can deliver pure sample protection, aerosol containment, and sample retrieval in one component." Press release

Data recently published in Clinical Cancer Research demonstrate the advantages of using an ultra-high sensitivity test for detection of mutations which may predict therapeutic efficacy for hepatocellular carcinoma (HCC). Sysmex Inostics' OncoBEAM technology, a highly clinically validated technology for circulating tumor DNA (ctDNA) analysis, was used to determine RAS mutational status across a total of 1,318 patients screened for two phase II studies which evaluated the efficacy of refametinib monotherapy, and refametinib plus sorafenib in patients with RAS-mutant unresectable or metastatic HCC.  Building on evidence from a prior phase II clinical trial which showed that HCC patients whose tumors had a RAS-mutation exhibited a robust clinical response in comparison with patients who were wild-type for RAS, investigators planned a prospective cohort to evaluate RAS mutation status at the time of enrollment. Patients were enrolled from 80 study centers in 21 countries across Asia, Europe, and the US. A primary challenge of enrollment across the world is that patients with advanced or metastatic HCC do not typically undergo tissue biopsy due considerable risk of complications; therefore, molecular testing is not routinely performed in this cancer.  Further confounding enrollment is the low prevalence of RAS mutations in patients with HCC, estimated to be 5%. To overcome these challenges, investigators utilized OncoBEAM to screen patient plasma for RAS mutations, as plasma testing can overcome the need for a tumor biopsy procedure and deliver tumor mutational status via a blood draw. Similar to other previously published studies across various cancer types, OncoBEAM testing enabled investigators to obtain information they would not otherwise receive in order to inform eligibility for inclusion in these HCC studies. Press release