This month’s roundup of equipment, decentralized technology, partnerships, and other items includes news from Medidata, PerkinElmer, Syneos, and more firms.
This month’s roundup of equipment, decentralized technology, partnerships, and other items includes news from Medidata, PerkinElmer, Syneos, and more firms.
Thermo Fisher Scientific has announced a research partnership with the West Coast Metabolomics Center of the University of California, Davis. The collaboration is aimed at providing the metabolomics community (aimed at identifying diagnostic biomarkers) with innovation, best practices and standards.
“We aim to provide advance training courses for early career community members as well as independent investigators and scientists, and this will be supported by state-of-the-art technology from Thermo Fisher,” said Oliver Fiehn, director of the West Coast Metabolomics Center. “This collaboration will drive the creation of innovative analytical approaches for both untargeted and targeted applications, providing the metabolomics community with advanced methodologies for their vital work.”
Medidata, a Dassault Systèmes company, has added video eConsent to its myMedidata suite of decentralized clinical trial tools. The capability enables patient participants to engage in remote, face-to-face conversations with trial staff during informed consent.
“The entire Medidata eConsent effort is driven by the need to provide the information patients require to make informed decisions about their healthcare in a convenient setting,” said Anthony Costello, CEO of patient cloud with Dassault Systèmes. “With this latest product release, we are replicating the on-site experience in a virtual setting so that patients and caregivers can easily engage openly in critical conversations about the study and consent form before agreeing to join a trial.”
Clinical AI company Sensyne Health has reached the milestone of building its dataset of clinical research, trial, and de-identified and anonymized data to more than 60m patients. The milestone reportedly was made possible by the company’s investment in virtual clinical development firm Phesi, and progress made by both firm in building their respective data platforms.
Sensyne Health CEO Paul Drayson said, “60m patients is an important milestone in our journey to create the world’s best data resource for medical research. However, it is the quality and depth of the data across many disease areas and the combination of both clinical research data, clinical trials data and longitudinal real world data from electronic patient records, that makes the database such a powerful tool for research professionals in both the life sciences and healthcare sectors.”
PerkinElmer has launched four ready-to-use AlphaLISA kits, intended to help researchers better understand complex KRAS protein structures and mutations. The technology is geared toward enabling scientists to quickly and precisely identify potential therapeutic candidates for various cancers.
Alan Fletcher, senior vice president of life sciences and technology at PerkinElmer, said, “Because KRAS mutations are found in numerous types of cancer, from lung to colorectal to pancreatic cancers, it’s a prime drug target; however, due to its complex protein structure, it’s been quite difficult to research for many years. We’re proud to help advance opportunities for researchers to learn more about KRAS mutations in the hopes of providing better treatment opportunities by bringing our AlphaLISA kits to market in this critical research space.”
Clinical trial technology firm Reify Health has announced an infusion of $220m USD in Series C funding from a group of investors. The latest funding round reportedly brings the company’s total valuation to $2.2b USD.
“What we’re doing, and the future of clinical trials overall, goes beyond decentralized trials,” said Michael Lin, executive chairman of Reify Health. “We need to have a global healthcare system proactively reaching out to patients everywhere and mobilizing the resources necessary to bring trials to them.”
Digital therapeutics firm Biofourmis has announced its BiovitalsHF heart failure digital therapeutic is the first such item to receive Breakthrough Device designation from the US Food and Drug Administration (FDA). Biovitals HF is a software application that augments guideline-directed use of medications to manage patients, in combination with traditional pharmacotherapy.
“This important breakthrough designation will help accelerate FDA’s final review of BiovitalsHF,” said Kuldeep Singh Rajput, CEO and founder of Biofourmis. “If approved at the end of this expedited process, we look forward to introducing a new virtual HF Care model that leverages the BiovitalsHF digital therapeutic to improve the use and dosing of Guideline-Directed Medical Therapy among patients with heart failure, for better patient outcomes and reduced healthcare expenditures.”
Syneos Health and Aetion have announced plans to work together toward providing regulatory-grade data and analytics-driven solutions to advance drug development and elevate patient outcomes. The collaboration reportedly will center on use of Syneos Health’s proprietary data collection and research solutions with Aetion Evidence Platform (AEP) to generate evidence through patient data curation and real-world data.
“Today’s dynamic health care landscape is challenging the product development process as regulatory authorities and payers demand faster and greater proof of value for therapies, and improved outcomes for patients,” said Christian Tucat, president of Syneos One and Real World Evidence for Syneos Health. “Integrating Syneos Health and Aetion’s solutions drives quality, transparency, and speed in the use of patient-level data by leveraging Aetion’s strong analytics platform and capabilities; this places the patient closer to the center of research, unlocking efficiencies across development and commercialization, speeding patient access, and maximizing the return on investment for our customers.”
Global CDMO Metrics Contract Services has expanded its novel oral solid-dose commercial production facility located in Greenville, North Carolina. The $10m USD expansion project (three years after an $80m expansion project) reportedly adds 3,760 square feet of production space and a range of new equipment.
“The new commercial production suites will accommodate our customers’ demand for increased flexibility and capacity; this trio of rooms will enable us to further tailor equipment trains to the applicable process, particularly those that require smaller batch sizes,” said John Ross, president of Mayne Pharma US and Metrics Contract Services. “Our clients will see immediate benefits through greater flexibility and improved potent handling.”
Antheia, a synthetic biology company focused on next-generation plant-inspired medicines, is partnering with Gingko Bioworks, a firm working on building a horizontal platform for cell programming, to accelerate development and production of essential medicines. Antheia reportedly plans to leverage Ginkgo's high-throughput enzyme design and screening capabilities to broaden its pipeline of critical active pharmaceutical ingredients (APIs) and key starting materials (KSMs).
“Antheia is committed to using synthetic biology to enable more equitable access to essential medicines," said Kristy Hawkins, CSO and co-founder at Antheia. "By partnering with Ginkgo Bioworks, a global leader in organism engineering, we are greatly increasing our ability to develop essential medicines at the speed and scale necessary to drive change in global pharma supply chains."
Health innovation firm Ashfield Health has announced the launch of Gravity.ai, a health intelligence data platform designed to support pharmaceutical, biotech, and other firms throughout a product’s life cycle. The platform uses artificial intelligence, predictive analytics, data modeling, and human consultancy.
“Gravity.ai ingests data from multiple sources in real time. It leverages advanced AI and machine learning along with our experienced data and disease-area specialists to find patterns and make predictions,” said Annemarie Crivelli, global director for experience at Ashfield Health’s Mind+Matter division, and Gravity.ai project lead. “We are working with clients on a range of different project types, from clinical trial recruitment and field-force sizing to omnichannel activation.”
Cancer informatics firm Inspirata has announced UK-based King’s Health Partners ECMC and Guy’s and St. Thomas’s NHS foundation trust will pilot its Trial Navigator software. The project is part of evaluations the organizations are conducting into how AI-based automation can improve matching cancer patients with early-phase trials.
“AI technology offers the potential to better match our patients to available trials, but we need to evaluate them first to prove that they can deliver on their promise,” says Danny Ruta, clinical artificial intelligence lead at Guy’s and St Thomas’ NHS Foundation Trust. “We hope that the intelligent automation afforded by Trial Navigator will prove to be an effective solution for identifying greater numbers of our eligible cancer patient population for clinical trials.”
