April 29, 2020 | April was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from CluePoints, AiCure, as well as recent attempts to combat COVID-19.

The clinical research community has been working around the clock to address the COVID-19 pandemic. Companies and universities such as Duke-NUS Medical School, Maccabi Healthcare Services, and others have concentrated their efforts to studies related to children infected with the virus, a COVID-19 convalescent plasma study, and much more. Roundup

CluePoints announced that EPS have entered into an agreement with CluePoints to offer Risk Based Quality Management (RBQM) solutions to its sponsors to drive early risk detection, improve quality and enhance patient safety in a cost-effective and resource-efficient manner. EPS will be able to add a suite of RBQM tools to complement either new or existing RBM processes through the CluePoints Central Monitoring Platform. The platform offers a range of tools includes Risk Assessment, Key Risk Indicators, Data Surveillance, Patient Profiles, Data Visualizations, Duplicate Patients and Issues and Actions Management. The combination of these modules provides EPS and its clients with a systemic approach designed to increase the efficiency and effectiveness of study conduct. With guidance from EPS, sponsors are now able to choose the modules that will best suit their needs and that of their studies for successful implementation of RBQM. This approach is also being used by FDA, via a Cooperative Research and Development Agreement (CRADA), to select sites for regulatory inspection and to test treatment effect in different study populations. Press release

AiCure introduced to the market its digital biomarker platform to remotely detect subtle changes in a patient’s condition. The platform leverages computer vision and AI to gather and analyze visual and auditory cues directly through the patient’s smartphone camera, pinpointing critical patient responses and behavioral trends with the frequency and accuracy needed to elevate the integrity of clinical trial data. By aggregating clinically-sound insights in a patient’s natural environment, AiCure empowers pharmaceutical companies to improve their understanding of disease symptomology, drug dosing side effects, and stratified disease variations, ultimately supporting improved health and trial outcomes. “Many symptoms are visual or audible in nature. Knowing that someone with depression only took 2,500 steps tells us limited information, but knowing they look sadder than usual and their speech is slowed provides a much deeper understanding of their status and potential underlying conditions,” said Ed Ikeguchi, CEO of AiCure, in a press release. “For the past decade, pharmaceutical companies have trusted us to engage with patients via their smartphones to track medication adherence. We are now well-equipped to advance the measurement of behavioral and physical symptoms in the comfort of the patient’s own home, significantly improving the frequency and accuracy of measuring symptom progression.” In any clinical trial, the collection of accurate data of a patient’s response to treatment is critical to understanding the impact a drug actually has on patients. Often, clinical trials require several in-person patient visits where clinicians note any changes in a person’s emotional and physical condition. These visits, which can be burdensome for patients and expensive for trial sponsors, can be infrequent and subjective, especially as patient symptoms may not be visible at the time of the visit. AiCure aims to eliminate these blind spots by creating more frequent check-ins that take place in the comfort of a patient’s home, providing more accurate accounts of a patient’s holistic wellbeing. AiCure’s digital biomarker platform uses a person’s smartphone to ask the patient simple questions or have them complete brief tasks, and then uses AI to analyze behavior, such as response time, affect, physical movement and speech patterns. For example, many neurological conditions have significant visual symptom indications. AiCure’s platform can be used to measure the severity of facial tremors or eye twitches for a patient with Parkinson’s. This highly sensitive measurement of a patient’s response to treatment advances the validity of trial data when making claims regarding a drug’s impact. Press release

Brett Kleger has been named Chief Executive Officer of Datacubed Health. Dr. Paul Glimcher, Datacubed Health’s Founder and current CEO will shift to the roles of Chairman of the Board and Chief Scientific Officer. As Datacubed Health’s new CEO, Brett Kleger brings over 20 years’ experience as a life sciences industry executive and a proven track record of growing early stage tech companies into market leaders. As DrugDev’s Chief Commercial Officer, he took a company from its infancy to become the market leader in site-facing technologies to support clinical operations. He consistently increased sales, revenue, and EBITDA, which led to a high value acquisition via IQVIA in 2017.  Following the acquisition, he spearheaded the clinical technology growth across IQVIA Technologies. Previously, Kleger led Acurian’s products and services groups from its infancy through exponential growth, eventually leading to its acquisition by PPD. He also founded IMS Health’s first division focused on optimizing clinical trials.  In recognition of his career achievements in “Tackling the Impediments to Clinical Trials”, Kleger was named to the PharmaVoice 100 in 2018. Press release

New Zealand’s Health Research Council and Health Ministry are funding research on integrating two cutting-edge, mobile, genetic analysis technologies for use in the fight against the spread of COVID-19. The first tool is from New Zealand-based Ubiquitome. It is called Liberty 16 and is a handheld, battery-powered, real-time polymerase chain reaction (real-time PCR) device that can quickly test and relay sample data via an iPhone app. Liberty16 is already commercial with devices sold to research and clinical labs in Japan, US, Canada, United Kingdom and Germany. Protocols are now being worked up for COVID-19 testing and it is being trialled in two labs in New Zealand, as well as labs in the United Kingdom and United States. The research also responds to the shortage of reagents that is currently constraining many diagnostic facilities by validating minimal-extraction and extraction-less approaches for RNA sample preparation. These range from rapid buffer-based extraction protocols to simple heat-treatments that have shown promise in recent overseas studies. Use of such minimal extraction protocols also further reduces the time required to complete a test. The option of using different sample preparation and reagent options for testing is where open-system platforms, such as the Liberty16, are particularly valuable as the supply chain immediately becomes much broader. The second tool is the Oxford Nanopore Flongle. Pairing the Liberty and the Oxford Nanopore Flongle is an integral part of the research being done by Massey University senior genetics lecturers Dr. Olin Silander and Dr. Nikki Freed. The researchers say they aim to be able to enable a single person to screen more than 500 samples per day and obtain up to 24 whole genome sequences per day. Press release

eClinical Solutions announced the results of The Tufts-eClinical Solutions Data Strategies & Transformation Study. Conducted with the Tufts Center for the Study of Drug Development (Tufts CSDD), the study reveals the growing number and diversity of external clinical data sources have contributed to longer database lock cycle times, resulting in downstream delays in drug development. The study found that only a third of clinical trial sponsors currently have an established data strategy in place. Given the time-consuming and labor-intensive nature of handling more diverse data sources, the study highlights the opportunity the pharmaceutical industry has to adopt new technologies and methods for managing and analyzing data to speed the drug development process. Press release

Imvax announced that Mark Exley, PhD, has been appointed as Chief Scientific Officer (CSO). Dr. Exley was previously Vice President, Cellular Immunology for AgenTus. Reporting to Imvax Chief Executive Officer (CEO) John Furey, Dr. Exley joins the company as it is developing Imvax’s lead product candidate, IGV-001, for the treatment of newly diagnosed glioblastoma multiforme (GBM). “Mark brings a wealth of experience to Imvax in the regulation of the immune system to treat cancer and other diseases,” Furey said in a press release. “He will provide our team with invaluable insights and leadership as we continue to build on the current promise of our early clinical trial work with IGV-001 and execute on the future clinical development of this asset.” Dr. Exley’s areas of research have included natural and vaccine-supported immunity to cancers, immune responses to acute and chronic viral infections, suppression of graft-versus-host disease (a rare complication of bone marrow and stem cell transplants), obesity-associated diseases and other inflammations.  Dr. Exley has published over 120 articles in scientific journals and has received numerous research awards and grants. Prior to joining Imvax, Dr. Exley was on faculty at Harvard Medical School and at the University of Manchester, UK, where he retains honorary appointments, and was a scientist at Immulogic. Press release