May 30, 2019 | May was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Caris, ICON, Parexel, and more.

Caris announced that it has acquired Pharmatech. "This acquisition allows Caris to facilitate interactions between drug developers who are seeking patients with specific cancer profiles and physicians who are seeking new treatment options for their patients," said David D. Halbert, Chairman and CEO of Caris, in a press release. "In addition, we have developed a new technology that allows us to identify twice as many fusions as with any other technology, assuring that every patient that is a candidate for a trial gets enrolled." Caris Molecular Intelligence assesses DNA, RNA, and proteins to reveal a molecular profile that can guide more precise and individualized treatment decisions for patients. This platform is used by oncologists to inform the treatment of tens of thousands of cancer patients every year. With the addition of Pharmatech's research-ready oncology trial network and Just-In-Time model, Caris will have the ability to further serve the physician and patient by bringing them clinical trial options with the patient identification and enrollment completed in as little as 10 days. Press release

Certara announced the introduction of Certara Integral, its next-generation data repository for collecting, managing, and storing multiple types of data sets for analysis, sharing and reporting of clinical pharmacology, pharmacometrics, and other relevant clinical data. "As the amount and accessibility of clinical and regulatory data has exploded, so has the need for systems and infrastructure that can streamline complex decision-making," Michael Eckstut, senior vice president and head of Certara's pharmacometrics software group, said in a press release. "In developing Integral, we combined the knowledge gained by our 175 drug development, clinical pharmacology and pharmacometrics scientific experts, with the software development skills of our pharmacometrics and scientific informatics teams to create a unique multi-functional product. We believe that Integral will follow the adoption curve established by Certara's other industry-leading technologies, such as Phoenix, D360, and Simcyp." Certara Integral combines the attributes of a software-agnostic data warehouse with a workflow-driven tracking and retrieval toolkit housed in a cloud-based, 21 CFR Part 11 compliant infrastructure. Data are highly organized and can be categorized by clinical study, project, and individual experiments, enabling users to ask 'what if' questions at all levels. Integral allows users, and their associated partners, to interact with multiple sources and types of data via client apps, plug-ins and APIs. Certara Integral is agnostic with respect to the type of analytical tool or data used by the customer. Press release

Inpharamo, a subsidiary of the Spanish multinational Semicrol, signed a collaboration agreement to support the entry of the Swiss company Clinerion, dedicated to optimizing the identification of patients who are candidates for participation in clinical trials in Mexico. The partnership was officially launched during the 2nd International Congress of Clinical Research, held in Guadalajara May 16-18. Semicrol will facilitate the entry of Clinerion into Mexico through its subsidiary Inpharamo. Inpharamo’s network of contacts will serve as the gateway for the Swiss company into the country. "Clinerion's entry into the clinical research field in Mexico provides great advantages when it comes to optimizing the creation of clinical protocols, making them based on real patient data in the clinical context of interest, and enables the most proactive selection of candidates eligible for participation in the trials," Ricardo Márquez Oñate, Medical Director of Inpharamo, said in a press release. "This saves time, minimizes costs and boosts the local research market. This will make Mexico a more attractive location when it comes to the selection of trial centers by collaborating institutions or sponsors." Press release

Kaia Health announced results from the first randomized controlled trial of its app-based therapy program for patients with non-specific low back pain. Detailed results of the study were published in the journal NPJ Digital Medicine and showed that patients using Kaia, a downloadable app for back pain, reported significantly lower pain levels compared to the control group treated with physiotherapy and online education. "This study can help add to the growing body of evidence that generally supports the use of multimodal treatments for chronic conditions," said Thomas R. Tölle, Head of Pain Medicine, Technical University Munich, Germany, in a press release. "Within this study, we saw a notable benefit for people managing low back pain when delivering multimodal treatment through the digital modality of the smartphone, as is done in the Kaia app." Press release

Parexel unveiled its Oncology Center of Excellence. The center combines the company's experienced, multi-disciplinary team specialized in oncology with early advisory services to bring breakthrough treatments to market faster for the patients who need them most. The center will be co-led by Amy McKee, Vice President of Regulatory Consulting Services, Parexel and former Deputy Director of the FDA’s Oncology Center of Excellence, and Todd Shuster, Corporate Vice President and Global Therapeutic Area Head of Oncology/Hematology, Parexel. With the unveiling of the Oncology Center of Excellence, Parexel is debuting its Early Advisory Service for oncology, through which sponsors have access to the expertise needed to optimize the development pathway at the earliest stages, including regulatory strategy, strategic consultation on study design, operational planning and development as well as the incorporation of evidence generation to quantify the value of an asset for market access. "In oncology drug development, the involvement of specialized experts and regulators early in the process is critical to success down the line," Amy McKee said in a press release. "Globally, we are seeing shifts in the regulatory environment that have produced increased opportunities for early collaboration with regulators. With the Oncology Center of Excellence, Parexel combines access to insights from former regulators as well as expertise in early protocol design and development to expedite, optimize and simplify trial design and execution." Press release

ICON announced that it has acquired a majority shareholding in MeDiNova Research, a site network with research sites in key markets in Europe and Africa, and that it has the right to acquire the remaining shares in the company by Quarter 3 2020. The acquisition further enhances ICON's patient recruitment capabilities in EMEA and complements ICON's existing site network in the US, PMG Research. Kumar Muthalagappan, Chief Executive Officer, MeDiNova Research, said in a press release: "MeDiNova sites are focused on being high enrollers coupled with high quality, to exceed our pharma clients' expectations. Our solutions are based on reducing start up times, early achievement of enrolment targets and high retention rates by delivering an excellent patient experience. Icon provides MeDiNova with a great opportunity for continued growth through scaling our knowledge, infrastructures and healthcare relationships. The MeDiNova-ICON combination will further enhance our highly productive models to deliver best in class site performance for the industry." Press release

Belong.life announced the availability of its Patient Engagement Platform (PEP) for all healthcare stakeholders. Designed to improve patient engagement, education, compliance, satisfaction, auto-care coordination and efficiency, the end-to-end solution provides patients, payers, providers, pharma and advocacy groups with hyper-personalized and configurable patient engagement tools, navigation and management services. The Belong Patient Engagement Platform (Belong PEP) leverages Belong's machine learning (ML) and artificial intelligence (AI) expertise to provide superior engagement, user acquisition and data insights. It is available as a software as a service (SaaS) solution or a fully managed service. "As the 'Belong - Beating Cancer Together' app has grown around the world, many representatives from top healthcare organizations have approached us asking for a similar patient engagement solution that could serve their audience and needs," Eliran Malki, Co-Founder and CEO of Belong, said in a press release. "The launch of our PEP is a natural move for us, as Belong's vision was always to help as many patients and medical professionals as possible. Now, we are extending our solution to provide new insight to additional communities of patients, across a range of different diseases, treatment, payers, providers and recovery processes." Press release

National Kidney Foundation (NKF) announced a comprehensive plan to develop first-ever national registry for patients at all stages of CKD called the NKF Patient Network. The NKF Patient Network will create an interactive community of chronic kidney disease (CKD) patients that link patient-entered data on their health history, outcomes and preferences with clinical and laboratory data obtained from electronic health records.  This unique combination of data collected will enable individualized educational resources, research, clinical care, and health policy decisions to be centered on the patient. "For the first time we will have a comprehensive collection of patient data which will enable us to better design patient education resources, more targeted care and more patient-centered clinical trials to discover new treatments for the disease," said Kerry Willis, Chief Scientific Officer, National Kidney Foundation, in a press release. "There is no other kidney disease registry in the world that combines patient-entered data with data from electronic health records and this pivotal combination will provide us with a 360-degree view of the patient we are working to help." Data collected in the NKF Patient Network will include demographics, medical history, diet, lifestyle, kidney disease stage and information about related comorbidities (such as heart disease, hypertension, diabetes), laboratory values for diagnostic tests, and medications. The specific goals of the NKF Patient Network are to provide patient education and support, individualized to patients' stage of disease and related health conditions; provide a large, diverse pool of patients for clinical trial recruitment, input on patient-centered trial designs and opportunities for post-trial surveillance; and to create a robust database of patient outcomes, perceptions, priorities and activities that will facilitate research, clinical care and policy decisions to improve patients' experience and outcomes. Press release

Cala Health announced it has completed a $50 million Series C financing. Cala Health will use the funds to introduce Cala Trio, a breakthrough therapy for hand tremors in people with essential tremor, to the market as well as expand its therapeutic pipeline. As part of the financing, industry veteran Stacy Enxing Seng will be joining Cala Health’s team as an Independent Director and Board Chair. New investors in the Series C financing include Novartis, Baird Capital, LifeSci Venture Partners, TriVentures, and others. All existing investors participated in the round, including Johnson & Johnson Innovation—JJDC, Lux Capital, Lightstone Ventures, Action Potential Venture Capital, dRx Capital, and GV. Press release