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Forte, Saama, N-SIDE, And More: News From March 2019



April 1, 2019 | March was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from Forte, Saama, N-SIDE, and more.

As part of Forte’s commitment to be the best-in-class technology partner for clinical research, the company is unveiling several new platform features: Comparative Analytics, Sponsor Scorecards, and Trial Data Exchange. Designed to support trusted data aggregation, exchange, and analytics, these new features are making the same information available for all stakeholders in order to improve site-and-sponsor collaboration. As data is the central focus of all clinical trials, Forte is supporting data transparency, collaboration and communication with its new Comparative Analytics feature. Comparative Analytics builds on Forte’s existing Benchmarks tool, which gives clinical research sites the ability to anonymously compare their performance to the aggregate of sites by looking at factors including study activation timeline. Comparative Analytics takes it a critical step further, by enabling sites and sponsors to engage in data-informed conversations based on site operational data from within the platform. Currently University of Michigan is collaborating with Forte and Sponsors Comparative Analytics to develop Sponsor Scorecards where sponsors track trial progress by viewing a dashboard of important metrics. The dashboard is accessible and identical to what research sites manage and see as they conduct research trials, with the consistent data and information ultimately facilitating and informing conversations that move projects forward. Forte’s Trial Data Exchange is an open, secure collaboration and data sharing platform feature that gives sites and sponsors the ability to collaborate seamlessly, share trial-specific data on demand, and structure necessary controls easily for access to regulatory and clinical source data. Transparent and secure connections between site and sponsor for trial data enables stakeholders to track trial progress in real-time and ensure better-informed, joint decision-making is possible. Pilot projects are already underway at Yale, University of Nebraska Medical Center, Moffitt and University of Florida using Forte’s Trial Data Exchange solution. Trial Data Exchange will begin rolling out to Forte’s customers later this year. Press release

Saama announced that it has closed a $40 million financing with Perceptive Advisors. The new funding will be used to support the expansion of Saama’s Life Science Analytics Cloud (LSAC), an AI-powered platform disrupting the planning, designing and conduct of clinical trials across various stages of clinical development. LSAC seamlessly ingests, integrates, curates, and harmonizes clinical trial operational and patient data from proprietary and external data sources to deliver actionable, regulatory-ready insights. LSAC’s novel deep learning approach significantly compresses clinical program timelines from clinical plan development to submission judgment for a New Drug Application (NDA). “The pharmaceutical industry, patients, advocacy groups, and global regulatory agencies are all eager for innovations that rapidly accelerate clinical trials while driving down costs. We are excited to lead that change with a differentiated data analytics platform. We intend to use the proceeds of this financing to strengthen our ecosystem of pharma and biotech partners, academia, data providers and CROs, and build a suite of collective innovations leveraging our LSAC platform,” Suresh Katta, Founder and CEO of Saama Technologies, said in a press release. “Perceptive Advisors understands the dynamic clinical development space and the need for adopting leading-edge technological solutions for enabling our pharma and CRO partners to drive sustainable and breakthrough clinical innovation.” The new financing brings the total Saama has raised since 2015 to $75 million. Torreya Partners served as financial advisor to Saama in conjunction with this transaction.  Press release

Trialbee and Linical Accelovance Group announced they will join forces to drive the next generation of digitally powered patient-centric clinical trials. Biopharma sponsors will now have access to a single point of contact delivering end-to-end next generation clinical trials, expediting clinical trial enrollment, retention and speed-to-market solutions. By interlinking digital capability and global clinical trial execution into one end-to-end support chain, this partnership has what it takes to positively disrupt clinical research and accelerate patient access to new treatments and improved outcomes. Patient-centricity is valuable to the entire clinical trial lifecycle. Patient and clinical data refine the feasibility process and help sharpen trial design. A digital recruitment strategy can then be deployed to reach the targeted patient population and enhance trial enrollment timelines. Furthermore, customized engagement solutions mitigate patient attrition, resulting in reduced site burden while maintaining data integrity, quality and project timelines. “Trialbee drives clinical trial success by combining in depth knowledge of clinical trial design and our digital outreach expertise to identify, connect, engage and offer patients access to relevant trials. By addressing patient-specific needs in a relevant manner, we bridge the gap between willing patients and available clinical trials, manage expectations, and connect well-informed and already engaged patients with investigational sites. In partnership with Linical Accelovance Group, a clinical research operations leader providing flexible and pragmatic drug development services, we can jointly deliver a world class recruitment and engagement model across the entire trial lifecycle, resulting in on-time delivery of quality data,” said Lars-Olof Eriksson, CEO of Trialbee, in a press release. Press release

N-SIDE announced the launch of the N-SIDE Suite for Clinical Trials. The new product is the only one on the market that optimizes the entire clinical trial supply chain management process from planning and production through to protocol design and delivery of supplies. State-of-the-art data analytics and machine learning algorithms optimize decision-making and future-proof design & planning. Managing clinical trials is becoming increasingly complex, with drug companies facing rising pressure to reduce drug waste and minimize costs while maintaining high levels of service for patients. It’s more important than ever that the uncertainty inherent in global trials can be managed in a safe and efficient way to ensure patients receive their medication on time. The N-SIDE Suite for Clinical Trials provides an innovative solution to these problems, giving pharmaceutical and biotech companies the power to future-proof their clinical trial planning by using an intelligent blend of advanced analytics technologies to produce reliable forecasts. Simulations are run 1000s of times allowing for informed production planning and proactive risk mitigation, ultimately resulting in reduced drug waste. Rather than stand-alone tools optimizing different components of clinical trials, N-SIDE offers a suite of ​integrated applications​​ to globally optimize clinical trial supply chain management from start to finish. The N-SIDE Production App optimizes strategic decisions to achieve the most efficient end-to-end production plan for each compound. The N-SIDE Supply App optimizes clinical trial supply management from protocol design through to operation of ongoing trials. The N-SIDE Dashboard App visualizes and allows interaction with data, providing feedback using current trial data and alerting users if studies deviate from the agreed uncertainty assumptions. It allows clinical supply chain teams to share latest status and relevant data with the whole organization, from management to finance. The N-SIDE apps feed into a single, centralized database allowing information to be shared easily and efficiently between different stakeholders, increasing transparency and communication across the organization and allowing collaborative decision making. Press release

WIRB-Copernicus Group introduced WCG SiteReady, a first-of-its-kind solution aimed at increasing the efficiency and profitability of clinical research for institutions and independent research sites. WCG’s newest offering helps researchers to optimize their performance, gain a competitive edge, and attract more opportunities for externally-funded clinical trials. The trusted partner of 2,800 institutions, 195 academic medical centers and 140,000 global investigators, WCG develops solutions that give all members of the research ecosystem greater visibility into and control over their research. Combining proven processes and techniques with robust technologies already successfully deployed in the market, WCG SiteReady is a comprehensive, end-to-end solution that makes research more efficient, easier to manage, and more profitable for institutions and independent sites. WCG SiteReady reduces the administrative burden of regulatory compliance, streamlines contract and budget negotiation, accelerates study start-up, and increases patient enrollment in clinical trials. “At WCG, we understand the unique challenges that institutions and independent sites face,” said Donald A. Deieso, Executive Chairman and CEO of WCG, in a press release. “The research ecosystem is changing rapidly; protocols are increasingly complex, research teams are stretched thin, and patients are more informed than ever. Biopharmaceutical companies are seeking investigators who can perform clinical studies at the highest level of efficiency and integrity. Conversely, leading investigative sites desire opportunities to participate in the exciting advances being developed by the industry. To succeed in this highly competitive landscape, investigators and site teams must continually position themselves for growth.” Press release

Accenture has agreed to acquire Enterprise System Partners (ESP), a consulting and manufacturing services provider for the life sciences industry that is headquartered in Cork, Ireland, serving clients around the globe. Upon close, ESP will join Accenture Industry X.0, which helps clients master the digital reinvention of industry, strengthening Accenture’s capabilities to transform manufacturing for pharmaceutical, biotech and medical device clients globally. ESP has long-standing industry experience in planning and implementing manufacturing solutions, with niche expertise in manufacturing execution systems (MES) and serialization. MES digitally track and document the production process, providing the groundwork for more automated and analytics-driven manufacturing and supply chains. Serialization allows life science companies to digitally track each saleable unit from the packaging line all the way to the patient. ESP will be the latest of several acquisitions Accenture has made recently to expand Accenture Industry X.0 in Europe and North America, including embedded software company Pillar Technology, hardware engineering firm Mindtribe, and strategic design consultancy designaffairs. The acquisition will complement others in life sciences that Accenture has made in recent years. This includes the acquisition of LabAnswer in 2017, now the Accenture Scientific Informatics Services (ASIS) business, which helps capture, manage, and analyze complex laboratory and scientific data. Press release

Biogen announced that it has entered into an agreement to acquire Nightstar Therapeutics, a clinical-stage gene therapy company based in London, United Kingdom, which is focused on adeno-associated virus (AAV) treatments for inherited retinal disorders. Under the terms of the proposed acquisition, Biogen will pay $25.50 in cash for each NST share. This offer represents a total transaction value of approximately $800 million on a fully diluted basis, after taking into account expected transaction expenses and anticipated cash at closing. “Ophthalmology is an emerging growth area for Biogen, and we are excited about the opportunity to work with the talented employees at Nightstar to advance potentially transformative gene therapy programs for rare retinal diseases,” Michel Vounatsos, Biogen’s Chief Executive Officer, said in a press release. “With this proposed acquisition, we are continuing to bolster our pipeline and further execute on our strategy to develop and expand a multi-franchise neuroscience pipeline across complementary modalities. Nightstar would accelerate our entry into ophthalmology by contributing two mid- to late-stage gene therapy assets, with the potential to create long-term shareholder value.” Press release

ReForm Biologics announced a collaboration with Astellas to reduce the viscosity of an Astellas clinical-stage biological pipeline program. ReForm’s technology platform transforms the formulation of biotherapeutics in order to enable alternative dosing, improve manufacturing efficiency and extend product life-cycles. Under the terms of the agreement, Astellas will provide funding for the collaboration and the work will be performed at ReForm Biologics’ facilities in Woburn, Massachusetts. “We are excited to initiate this collaboration with Astellas, a global leader in turning innovative science into value for patients. We appreciate the efforts of Astellas Innovation Management team in getting the agreement completed,” John M. Sorvillo, Chief Executive Officer, ReForm Biologics, said in a press release. “This collaboration will demonstrate how new formulation technologies can optimize dosing and support life cycle management in pharmaceutical drug development programs. We look forward to working with Astellas to support the development of this clinical-stage asset.” Press release

TrialAssure announced the limited release of ANONYMIZE DS, an all-new software-as-a-service (SaaS) application that allows sponsors to anonymize clinical trial data automatically. "In order to share data, it has to be done in a way that protects patient privacy. TrialAssure's ANONYMIZE DS solves an industry-wide problem of balancing this need while maintaining the data's utility," says Zach Weingarden, TrialAssure’s Product Solutions Manager, in a press release. "TrialAssure is one of the first groups to automate the anonymization of datasets, and we will continue to stay at the forefront of the market with new technology methods." TrialAssure ANONYMIZE DS transforms original data into anonymized data using industry-standard techniques that can be reused and customized for each dataset, assigns a risk score associated with the re-identification of this data based on thresholds set by the sponsor, is entirely configurable to sponsor specifications, was built from the ground up with input from data experts, and drives efficiency with modern machine learning technology in mind. Press release

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