January 30, 2018 | January was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from CluePoints, The Pistoia Alliance, Certara, and more.

CluePoints has launched the “CluePoints RBM and ICH E6 (R2) Starter Pack” to help small and medium-sized enterprises (SMEs) achieve regulatory compliance through a “risk-based” approach. The starter pack, which includes both consultation services and software, has been developed following CluePoints’ extensive market and industry research to better understand the challenges faced by clinical development organizations and CROs since the introduction of the ICH E6 (R2) addendum. The research undertaken by CluePoints highlighted the fact that many SMEs are unsure of how to embrace RBM and often how it might add significant value. The starter pack addresses this problem through the use of consultation on the ICH E6 addendum and RBM methodology. The aim is to help organizations fundamentally understand what the regulation wants, and demonstrate how a risk-based approach meets the compliance obligations and, at the same time, improves both cost and resource efficiencies. The consultation also details the key software elements included in the starter pack. The software provides the necessary tools for organizations to start implementing a risk-based approach without overcomplicating the process, and gives users the freedom and opportunity to implement further RBM activities as and when required. Included in the starter pack are a Risk Assessment (RACT) Starter Kit, Key Risk Indicator Starter Kit, Patient Profiles Starter Kit, access to CluePoints proprietary Signals and Actions Tracking Management System and CluePoints Central Monitoring Platform Training. Press Release

The Pistoia Alliance is calling on the pharmaceutical and technology industries to support greater collaboration around Artificial Intelligence (AI) in pharmaceutical R&D. The Pistoia Alliance surveyed the views of 374 life science professionals on AI, Machine Learning (ML) and Neuro-linguistic Programming (NLP). The survey found interest in these technologies is high, with almost half (44%) of respondents already using or experimenting with AI. However, a number of hurdles to their widespread application were also identified - with technical expertise the most cited barrier for AI (30%) and for ML/NLP (28%). The Pistoia Alliance believes collaboration between stakeholders is essential to overcoming these barriers; leading to “augmented” AI that works alongside humans for positive outcomes. In particular, given how crucial data is to building AI algorithms that reveal meaningful insights, collaboration over data standards, benchmark sets, and data access, will be essential. The survey found that beyond a lack of in-house technical expertise, issues around data are a particular stumbling block to AI projects. Specifically, respondents stated that access to data (24%) and data quality (26%) were two of the biggest barriers to AI projects within their organization. These same issues - access to data (26%) and data quality (19%) - were again cited when respondents were also asked about obstacles to ML and NLP projects. Life sciences and pharmaceutical R&D currently generates huge volumes of data, which is supplemented with growing data sets collected from mhealth devices and sensors connected to the Internet of Things (IoT). However, access to this data and the formats that data are stored in, vary wildly. Quality data is fundamental in ensuring AI gives accurate and true outputs; this is a significant finding, and one the industry will need to overcome in order for AI to assist researchers. “AI has the potential to revolutionize life sciences and healthcare - all the way from early preclinical drug discovery to selecting precision treatments for individual patients,” commented Steve Arlington, President of The Pistoia Alliance, in a press release. “Our survey data shows that while life science professionals are already exploring how AI, ML and NLP can be used - there are clear gaps in the knowledge, data, and skills, which will enable more pharma and biotech companies to achieve tangible results from AI. Impediments to success, such as a lack of industry-wide standards for data format, will need to be addressed, if the potential of AI and ML is to be realized. We urge those in the pharmaceutical, biotechnology and technology industries to explore ways in which they can collaborate now, to find answers to common problems of the future.” Press Release

Certara announced that the Brazilian National Health Surveillance Agency – ANVISA (Agência Nacional de Vigilância Sanitária) – is now also employing Certara’s Phoenix WinNonlin software for reviewing drug regulatory submissions. “Phoenix WinNonlin is used by many Brazilian organizations to determine bioequivalence. It is recognized for increasing productivity, improving workflows, and ensuring high accuracy for studies of drug action in the human body,” said Ellen Leinfuss, Certara’s Chief Commercial Officer, in a press release. “In addition, ANVISA’s adoption of this Phoenix software will help to ensure that reviewed studies follow good bioequivalence practices. Furthermore, analysis results generated by the organizations conducting bioequivalence studies and ANVISA will be completely compatible.” Phoenix WinNonlin is considered the industry standard for non-compartmental analysis, and pharmacokinetic/pharmacodynamic, and toxicokinetic modeling. It was purpose-built to automate and expedite many of the analysis steps required during the drug regulatory review process. Phoenix WinNonlin provides integrated data processing, post-analysis processing, table creation, and graphics tools for use in drug development projects. Press Release

Synzi announced a new investment from Kinderhook Industries forming a new separate entity from language services company, Stratus Video. Synzi’s cutting-edge platform brings together several methods of communications which enhance the telehealth marketplace. The platform improves patient interactions by leveraging mobile devices to strengthen engagement, optimize health outcomes and reduce costs. For health systems, the platform offers on-demand video capabilities that enable virtual consults for urgent care and mental health, as well as virtual visits which optimize care post-discharge. For health plans, the platform streamlines care management programming and increases engagement amongst members at risk for readmission. Uniquely, Synzi can also service limited English proficiency (LEP) and the Deaf/Hard-of-Hearing patient population with direct access to a video interpreter. Press Release

ERT announced that it has been named to the Journal of mHealth’s annual Global Digital Health 100, an international benchmark for mobile, digital and connected technologies in healthcare. The Global Digital Health 100 is one of the HealthTech industry’s foremost technology award programs. Celebrating innovation and entrepreneurship, it recognizes the health technology companies that are demonstrating the greatest potential to change the way that healthcare is delivered. ERT’s position on the Global Digital Health 100 list is fueled by the company’s digital solutions, which are used by researchers, patients, caregivers, and healthcare professionals to support real world and clinical research programs. The company’s award-winning offerings include patient support programs to help patients better manage their disease and set goals for themselves, communities where patients can share their experiences with each other, and mobile apps that enhance post-approval data collection programs. Other digital solutions include electronic Clinical Outcome Assessment (eCOA) systems that collect high-quality, regulatory compliant patient data anytime, anywhere via browser, tablet or smartphone as well as voice assistance technology that simplifies clinical trial participation to keep patients engaged, enrolled and compliant with the study protocol.  Press Release

Almac Group confirmed the successful completion of Health Products Regulatory Authority (HPRA) inspections of Almac Clinical Services Ireland and Almac Pharma Services Ireland at its European campus in Dundalk, Ireland. Almac previously confirmed that it secured new premises in Dundalk, Ireland in January 2017 as part of its ongoing global expansion strategy, to meet client demand and to address any potential challenges that may arise due to Brexit. Following these successful HPRA inspections, Almac Group look forward to being officially licensed to conduct QP batch certification and release for both clinical trial material and commercial drug product from its European campus in Dundalk. Ensuring the Group meets current and future client needs in the European Union marketplace, Almac has today announced further investment at the campus including a new QC laboratory and packaging facility for commercial drug products and a dedicated 79,000ft2 EU Distribution Centre for clinical trial supply. This investment will more than treble the GMP footprint at its European campus which is scheduled to be operationally ready by January 2019. Press Release

Gastroenterology Associates will begin providing clinical research services by partnering with Elligo Health Research, who improves clinical trial access by engaging the 97% of physicians currently not offering clinical research to their patients. By offering clinical trials as an option, the physicians at Gastroenterology Associates are able to introduce the latest advances in research to their patients. As a result, the practice’s patients have access — in the convenience of the physician’s office — to treatments they might not otherwise have. “To ensure we have better medicines and treatments for future generations, we need to have clinical research now,” said Scott Choi, of Gastroenterology Associates, in a press release. “With Elligo providing the framework, our practice can tap into this research to provide more treatment options for our patients. We look forward to being a part of the Elligo network.” Press Release

OWKIN announced a $11 million Series A funding round, led by Otium Venture with participation from Cathay Innovation, Plug and Play, and NJF Capital, bringing the Company’s total financing to $13.1 million in one year. OWKIN’s Series A funding round demonstrates the market’s appetite for a digital technology-driven approach to clinical development and medical research. OWKIN will use the funds to scale its innovative platform, OWKIN Socrates, cultivate high-value partnerships with leading healthcare organizations, and fuel internal growth. Bruno Raillard, partner at Otium Venture, will join OWKIN’s Board of Directors, which currently includes co-founders Gilles Wainrib and Thomas Clozel, and NJF Capital founder Nicole Junkermann. Press Release