HIV hidden in patients' cells can now be accurately measured

Medical Xpress | January 30, 2019

Researchers can now quickly and accurately count a hidden, inactive form of the human immunodeficiency virus (HIV) that lurks in patients' cells. This version of HIV embeds into cells' genomes and can persist despite otherwise successful therapies—thwarting attempts to cure the infection. Using a new genetic technique developed by Howard Hughes Medical Institute Investigator Robert Siliciano and colleagues, researchers will finally be able to measure just how much of this viral form is hiding in the body—a crucial part of evaluating the effectiveness of new treatments, Siliciano says. Previous tools overestimated the number of this HIV form by 10-to-100-fold, potentially obscuring meaningful declines produced by experimental therapies, according to his team's report in the journal Nature on January 30, 2019. "We may still be a long way from a cure," he says, "but now at least we can measure our progress."
Current HIV therapy involves combinations of antiretroviral drugs, each of which inhibits a specific stage of the HIV lifecycle. When drugs that block two or more stages are given to a patient simultaneously, the virus cannot replicate, and its presence in the bloodstream drops below detection limits. This relieves patients' symptoms and keeps them healthy for decades. But the virus sticks around in the body, in a latent form that's challenging to detect, much less count; HIV's genetic instructions, or template, remain integrated within the genome of certain cells.

Spotlight

There is now significant policy and academic interest in the governance of science and technology for sustainable development. In recent years this has come to include a growing emphasis on issues of public understanding of science and innovative processes of deliberative and inclusive policy-making around controversial technologies such as nuclear power and agricultural biotechnology.

Spotlight

There is now significant policy and academic interest in the governance of science and technology for sustainable development. In recent years this has come to include a growing emphasis on issues of public understanding of science and innovative processes of deliberative and inclusive policy-making around controversial technologies such as nuclear power and agricultural biotechnology.

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MEDTECH

Precision Coating Announces Merger with N2 Biomedical to Expand Medical Coatings Platform

N2 Biomedical | September 20, 2021

Precision Coating, a leading medical coatings service provider to interventional, orthopedic, and advanced surgical markets, is pleased to announce a merger with N2 Biomedical, a Bedford, MA-based company. N2 Biomedical, an Ampersand Capital Partners portfolio company, provides nano-engineered surface treatment and coating services to the medical device industry with its low-temperature Ion Implantation Surface Treatments and Ion Beam Assisted Deposition (IBAD) technologies. We are very excited to add N2's technologies and people to Precision Coating. N2 extends our coating platform technologies in ways that enhance our value proposition for customers. This is particularly true in orthopedics, where we can now offer engineered coating solutions across both instruments and implants. The two companies have a great deal of complementarity between market focus, customer overlap, product functional properties, and operational execution, not to mention geographic proximity. - Bill Ellerkamp, President of Precision Coating About Precision Coating For over 50 years, Precision Coating has collaborated with medtech partners to realize their product design and manufacturing goals by providing highly engineered coating and specialized finishing services. Among the portfolio of medical coatings and application solutions, GlideLine™ and InfiNiTiCoat™ coatings comprise the broadest offering of applied fluoropolymer (PTFE) coatings for interventional and advanced surgical devices, and the patented MICRALOX® portfolio is the recognized standard for superior aluminum anodizing finishes for barrier properties, corrosion resistance, and extended product life cycles, targeting orthopedic and advanced surgical instruments. Precision Coating partners with early-stage device innovators through major medical equipment manufacturers, deploying comprehensive solutions—from concept to commercialization—and offering flexible prototype work through high-volume coating application, finishing, and printing services. The company operates facilities in Massachusetts, Rhode Island, and Costa Rica, and serves customers worldwide, offering seamless supply chain support. About N2 Biomedical Established in 2013, N2 provides coating and surface treatment development and application services for implantable and other medical devices utilized in orthopedic, cardiovascular, and other healthcare end-markets. N2 is ISO 13485 certified, FDA GMP compliant, and operates in a 27,000-square-foot facility with laboratory, manufacturing, and cleanroom space to service all customer and regulatory requirements. The company leverages its proprietary processes and equipment to provide customized solutions that enhance the characteristics of various materials in critical applications, including lubricity, infection resistance, biocompatibility and tissue integration, and wear and corrosion resistance. About Ampersand Capital Partners Founded in 1988, Ampersand is a middle-market private equity firm with more than $2 billion of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors.

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INDUSTRIAL IMPACT

TransPerfect Life Sciences and Innovaderm Research Expand Trial Interactive Partnership

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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RESEARCH

PharmAbcine to Present Updated Interim Data from the Ongoing Phase Ib Trial of Olinvacimab and Pembrolizumab Combination Therapy

PharmAbcine | December 08, 2020

PharmAbcine Inc., a clinical-stage biotech organization focusing in on the improvement of completely human antibody therapeutics, declared today that the organization will introduce the refreshed break information from the continuous stage Ib trial of olinvacimab and pembrolizumab combination therapy in metastatic triple-negative breast cancer (mTNBC) patients at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020) occurring for all intents and purposes over December 8-11, 2020. Positive data from the progressing security and tolerability study will feature wellbeing and certain viability information including ORR (Overall Response Rate) and DCR (Disease Control Rate) from 11 patients diagnosed with mTNBC. "We are excited to present highly encouraging data from our ongoing trial in the biggest breast cancer symposium. These data offer important insights into future development of the combo therapy," said Dr. Jin-San Yoo, CEO of PharmAbcine.

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