INDUSTRIAL IMPACT
TransPerfect Life Sciences | February 16, 2022
TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Innovaderm will scale their implementation of Trial Interactive to further enable and optimize remote clinical operations.
Innovaderm, a North America-based contract research organization (CRO) that specializes in clinical studies for dermatology, leveraged Trial Interactive remote monitoring rooms to drive research forward and continue helping partners discover new therapies during the COVID-19 pandemic. By incorporating customized Trial Interactive remote monitoring rooms into its service offering, Innovaderm allowed customers to access Trial Interactive’s Study Document Collaboration solution, enabling successful remote trial execution.
Innovaderm’s partnership with TransPerfect began several years ago with language translation services. To eliminate its paper-based approach for clinical trial document management, Innovaderm then implemented Trial Interactive’s eTMF. As Innovaderm further optimized its clinical research strategy, TI Study Start-Up replaced the CRO’s manual process for distribution and collection of essential documents from sites, resulting in a more transparent, efficient path for site activation and reduced timelines for starting new studies.
Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, and CRO companies effectively streamline product development life cycles. A connected eClinical experience, Trial Interactive improves speed, quality, and compliance across site identification, selection, and activation, as well as study teams and site personnel training, content management, eISF, eTMF management, CTMS, and closeout. The platform offers industry-leading, fast-to-implement, cost-effective solutions in a secure 21 CFR Part 11-compliant environment.
“Trial Interactive worked with us to ensure our remote monitoring room configuration met our key requirements so we could conduct our studies without interruptions, delays, or significant changes. As we’ve faced unexpected shifts in the way we run and monitor studies, Trial Interactive has been key to enabling us to perform remote monitoring visits.”
Isabel Dorion, Director of Clinical Operations at Innovaderm
Michael Smyth, TransPerfect Life Sciences Solutions Division President, stated, “We’re moving into an era where decentralized clinical trials are becoming more common, and conducting clinical research processes remotely is key to keeping trials moving forward and getting life-saving products to market faster. With our solution of remote monitoring rooms, Trial Interactive has been able to help clients like Innovaderm shift to remote processes without losing momentum for their studies.”
About Trial Interactive
TransPerfect’s Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author-to-archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and CTMS with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence.
About TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact.
About Innovaderm Research, Inc.
Innovaderm is a prominent contract research organization (CRO) collaborating with the biotech companies in the management of Phase 1 to 3 dermatology trials across many regions. Founded in 2000, the company provides a broad range of services including study design, protocol development, site selection, patient recruitment, regulatory and ethics submissions, clinical trial management, clinical monitoring, data management, biostatistics, medical monitoring, pharmacovigilance and medical writing. Committed to quality, Innovaderm is managing its activities in accordance to current Good Clinical Practice (GCP) from the International Conference of Harmonization (ICH), and being fully compliant with major international regulations such as the FDA (USA), Health Canada and EMA (Europe).
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CELL AND GENE THERAPY
AgeX Therapeutics | November 24, 2021
AgeX Therapeutics , Inc. a biotechnology company developing therapeutics for human aging and regeneration, announced that on November 17, 2021 it received a letter from the staff of the NYSE American indicating that AgeX does not meet certain of the Exchange’s continued listing standards as set forth in Section 1003(a)(i) and (ii) of the Exchange Company Guide in that AgeX has stockholders equity of less than $2,000,000 and has incurred losses from continuing operations and/or net losses during its two most recent fiscal years, and that it has stockholders equity of less than $4,000,000 and has incurred losses from continuing operations and/or net losses during three out of four of its most recent fiscal years. Pursuant to Section 1009 of the Exchange Company Guide and as provided in the Deficiency Letter, AgeX may provide the Exchange staff with a plan (the "Plan") by December 17, 2021 advising the Exchange staff of action AgeX has taken and will take that would bring AgeX into compliance with the Exchange’s continued listing standards by June 17, 2023. AgeX intends to submit a Plan by the December 17, 2021 deadline.
There is no assurance that the Exchange staff will accept the Plan. If the Exchange staff accepts the Plan, the Exchange staff will review AgeX’s compliance with the Plan on a quarterly basis and if AgeX does not show progress consistent with the Plan or is not in compliance with the Exchange’s continued listing standards by June 17, 2023, the Exchange will commence delisting procedures. If AgeX does not submit the Plan or if the Exchange staff does not accept the Plan, the Exchange staff will promptly initiate delisting proceedings.
AgeX intends to make arrangements to have its common stock quoted on an electronic interdealer quotation system if its common stock is delisted from the Exchange.
About AgeX Therapeutics
AgeX Therapeutics, Inc. is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeX’s PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem® is AgeX’s delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.
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MEDICAL
Felix Biotechnology | January 08, 2021
Felix Biotechnology reported the inception of CYPHY, a Phase 1/2 examiner started single focus preliminary at Yale University for focused phage treatment YPT-01 in the therapy of constant P. aeruginosa diseases in cystic fibrosis. This twofold visually impaired, fake treatment controlled study (NCT 04684641) will evaluate the wellbeing and adequacy of YPT-01 added to standard antimicrobial treatment in 36 patients. CYPHY will likewise evaluate the capacity of YPT-01 to lessen the harmfulness and anti-infection obstruction of P. aeruginosa, improving patient results and re-empowering utilization of conventional anti-infection agents against multi-drug safe strains. The lead specialist for this investigation, Dr. Jon Koff, Associate Professor and Director of Yale's Adult Cystic Fibrosis Program, is supported by an academic grant from the Cystic Fibrosis Foundation.
"This is a fantastic opportunity to show how effective phage therapy can be when deployed in an evolutionary framework. We know that pathogens evolve resistance to any antibiotic or therapy we use, so our approach turns that to our advantage," said Dr. Paul Turner, Professor of Ecology and Evolutionary Biology, co-inventor of YPT-01, and co-founder of Felix Biotechnology. "By targeting phage to mechanisms of virulence, we ensure that if pathogens evolve resistance to phage, they lose traits that make them effective pathogens, putting them in an evolutionary Catch-22."
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