GSK nabs speedy review for one of its top prospects

FierceBiotech | January 21, 2020

With a new research team, outlook and more than a little help from the tech world, GSK has been quietly going about shoring up its pipeline. After seeming to turn away from oncology R&D under its old CEO Sir Andrew Witty a few years ago, new CEO and R&D head Emma Walmsley and Hal Barron, respectively, have made powering their pipeline out of the slow lane the priority. Today, GSK announced that one of its top prospects (and a drug Barron has singled out in the past) has been handed an FDA priority review. The speedy appraisal is for its BCMA therapy belantamab mafodotin in relapsed or refractory multiple myeloma, after releasing initial results last summer where it hit its primary goal and demonstrated a “clinically meaningful overall response rate.”

Spotlight

Service Oriented Architecture (SOA) has radically changed the application integration landscape. However, the need for intelligent service discovery based on invocation context and service capability is still a challenge. Ontology based techniques are being experimented with as a possible answer for creating semantically enriched SOAs. In this paper, we discuss the ongoing experimentation with using ontology as a layer above Web services to achieve semantic integration. We have chosen an area of drug discovery called sample management where life sciences companies face application integration challenges.

Spotlight

Service Oriented Architecture (SOA) has radically changed the application integration landscape. However, the need for intelligent service discovery based on invocation context and service capability is still a challenge. Ontology based techniques are being experimented with as a possible answer for creating semantically enriched SOAs. In this paper, we discuss the ongoing experimentation with using ontology as a layer above Web services to achieve semantic integration. We have chosen an area of drug discovery called sample management where life sciences companies face application integration challenges.

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MEDTECH

Benchling is expanding into the early development market to accelerate the creation of breakthrough products

Benchling | September 17, 2021

Benchling , innovator of the research and development (R&D) cloud for the biotechnology industry, today announced its entry into the early development market. The company brings new solutions to market that enable scientists for the first time to work seamlessly from research to development in a single system. By expanding the range of services, the Benchling R&D cloud is designed to offer both the flexibility and speed required for research efficiency as well as the control and conformity required for compliance with regulations. The market and society are putting unprecedented pressure on R&D companies to develop new products and get them to market faster. Vaccines typically take years to develop. But in developing COVID-19 vaccines and therapies, researchers have been able to get them ready for clinical trials in a matter of months. Faster time to market for innovative biotech products can mean that patients can receive new treatments for life-changing diseases faster, such as the COVID-19 vaccines. It can also mean producing more food with less energy, enriching consumer lives with ethically sourced products, and making businesses more climate-friendly. The development of such complex, important products requires modern technologies. Different individual solutions for electronic laboratory notebooks (ELN), laboratory information management systems (LIMS) and laboratory execution systems (LES) form silos that exacerbate the challenges of complex collaboration. They force scientists to spend time comparing data between different systems instead of gaining important insights that accelerate product development. With more than 600 customers spanning a wide range of company sizes, industries and scientific use cases, Benchling relies on customer partnerships to expand its product range. Here are examples of benchling customers who have improved their development speed, scientific knowledge and collaboration within their R&D organizations: Syngenta is one of the world's largest producers of novel seeds. Worldwide, 35 percent of food is rendered unusable by pests and diseases. New biological solutions and better built-in defense mechanisms not only protect against food waste, but also reduce the need for harmful chemicals that pollute the environment. Syngenta's work relies on scaling, as our researchers: internally test hundreds of thousands of seeds in a variety of growing environments. When we discover viable varieties that meet the needs of farmers, we need to replenish our seed stocks quickly for testing in laboratories, greenhouses and field trials around the world,“Thanks to benchling, we said goodbye to paper. Our global seed R&D teams can efficiently work together on a single platform to standardize the development of seed varieties from the laboratory to the test field. This has enabled us to restructure much of our work and accelerate the time-to-market for new seed products. - Charlie Baxter, Head of Traits, Regulatory and Product Safety at Syngenta. New workflows: Benchling has expanded the workflows application to support collaboration between specialized R&D teams. Users can now coordinate tasks and processes across teams with full traceability, including methods, samples and inventory. Project managers gain insight into ongoing processes in order to reduce bottlenecks and increase productivity. Workflows help teams from research to development to work together more efficiently and to reach important milestones more quickly. Structured Templates: With Benchling's new, more structured templates, product development teams can easily create common, standardized processes for repeatable experiments, analytical tests, QC protocols and more. These procedures can be regulated in a targeted manner in order to meet compliance requirements. Validated cloud: At the beginning of 2021, Benchling switched to a validated cloud in order to be able to provide the platform for customers in a GxP environment. About Benchling Benchling is the pioneer for the R&D cloud, software that supports the biotechnology industry. Globally, more than 200,000 scientists in over 600 companies and 7,000 research institutions use Benchling's R&D cloud to make groundbreaking discoveries and bring the next generation of drugs, food and materials to market faster than ever before. The R&D cloud is helping these companies modernize their scientific processes and accelerate collaboration so they can transform the complexities of biology into world-changing results.

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MEDTECH

Halo Labs Launches the Aura GT™ for Gene Therapy Product Quality

Halo Labs | October 05, 2021

Halo Labs, a life science instrumentation company developing tools for biologics researchers, today announced it has launched its latest product, Aura GT. Aura GT is part of the next generation in Halo Labs' popular family of instruments. Using Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM), Aura GT can distinguish aggregated capsids from contaminants, carrier proteins, and other particles that might adversely harm patients. Unique to Aura GT is the fact that it can also identify DNA leakage in gene therapy products so the mechanism of aggregation can be determined and corrected. Aura GT is going to completely revolutionize gene therapy product development. Gene therapy products are inherently unstable, which is a huge challenge. Up until now, there has been no effective way to correlate capsid aggregation with DNA leakage or empty and full capsids, In one assay, Aura GT can quantify capsid aggregates, distinguish them from protein aggregates, and determine if the aggregation is exacerbated by DNA leaking. - Bernardo Cordovez, Chief Science Officer at Halo Labs. We are very excited to be launching our second instrument this year specifically developed for the cell and gene therapy market, Halo Labs has quickly become a leader in gene therapy analytics because we can answer many questions with very little volume. While other subvisible particle analyzers only do one thing, Aura systems offer a complete multi-assay platform that can be used to fully characterize gene therapy products from early development through lot release. - Rick Gordon, CEO of Halo Labs. About Halo Labs Halo Labs in Burlingame, CA is a venture-backed scientific instrumentation and consumable company that commercializes high throughput biopharmaceutical formulation, stability, and product quality control tools for aggregate and subvisible particle analysis using state-of-the-art custom optics and image processing techniques. Biopharmaceutical companies around the globe depend on Halo Labs for unprecedented insights into their drug products.

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CELL AND GENE THERAPY

Elastrin Therapeutics Announces Newly Formed Scientific Advisory Board

Elastrin Therapeutics Inc. | January 17, 2022

Elastrin Therapeutics Inc., a privately held biotechnology company leveraging a platform technology to develop therapeutics that render calcified tissue and organs supple again, announced the formation of its Scientific Advisory Board. The Board is comprised of leading industry and university experts in cardiovascular research and clinical development. Former CMO of Elastrin Therapeutics, Dr. Pedro M. Quintana Diez, will act as chairman. Elastrin Therapeutics’ lead asset ELT-001 is an EDTA-loaded nanoparticle conjugated with a proprietary monoclonal antibody for the treatment of vascular calcification. “We are fortunate to work with such an amazing group of medical scientists, cardiovascular experts and pharma executives on our Scientific Advisory Board,” said Dr. Matthias Breugelmans, CEO of Elastrin Therapeutics. “The members bring a remarkable understanding of cardiovascular research, as well as deep expertise in the development of clinical drugs.” “Elastrin is a prime example of what Kizoo is looking for in its investments: Not delaying an age-related disease but reversing it,” Patrick Burgermeister, Partner at Kizoo Technology Capital and member of Elastrin Therapeutics’ Board of Directors Elastrin Therapeutics’ Scientific Advisory Board is comprised of: Prof. Charles O'Neill, MD: Dr. O’Neill has had an active basic and clinical research program in vascular calcification for the past 20 years and has published over 45 articles on this subject. As a practicing nephrologist, he has a particular interest in vascular calcification in patients with chronic kidney disease. Current research is aimed at approaches to assess reversibility of calcification in animal models and to slow progression of calcification by altering hemodialysis prescription in clinical trials. Prof. Elena Aikawa, MD, PhD: Dr. Elena Aikawa is a Professor of Medicine at Harvard Medical School, and the Naoki Miwa Distinguished Chair in Cardiovascular Medicine and the Director of Heart Valve Translational Research Program at Brigham and Women’s Hospital. She was at the forefront in the discovery of inflammation-dependent mechanisms of cardiovascular calcification. Her studies contributed to the discovery of calcifying extracellular vesicles as a precursor of microcalcification. Prof. Frank Rutsch, MD: Frank Rutsch is an Associate Professor in Pediatrics at Münster University Children’s Hospital, Münster, Germany. After a postdoctoral research fellowship at the University of California, San Diego, he became the leader of an independent research group at Münster University Children’s Hospital in 2004. Dr. Rutsch’s main research interests are focused on the discovery of the underlying genetic defects and translational aspects in rare pediatric metabolic and autoimmune disorders. Dr. Klaus-Dieter Langner: Klaus-Dieter Langner is a life science expert with more than 32 years of experience in pharmaceutical industry. Klaus started his career as research scientist at Behringwerke/Hoechst focusing on the expression of recombinant human plasma proteins and immunomodulators. After 12 years, he moved to Grünenthal where he was appointed as Head of Research. In his last position, Klaus acted as Chief Scientific Officer and Member of the Corporate Executive Board. Prof. Linda Hands, MD: Linda Hands was appointed Clinical Reader in the University of Oxford and Honorary Consultant Vascular surgeon in 1992 after training in London, Oxford and Chicago. She was Clinical Director of Vascular and cardiothoracic surgery for three years and also served on the Health Authority and a NICE committee. Linda retired in late 2017 as Associate Professor and remain an Hon. Emeritus Professor at the John Radcliffe Hospital Oxford and Emeritus Fellow of Green College, Oxford. Dr. Pedro M. Quintana Diez, M.D.: Pedro is an internal medicine doctor with over 20 years of clinical development experience in the international biotech and pharmaceutical industry. Prior to joining Elastrin Therapeutics, Pedro served as CMO of Sensory Sciences LLC and held VP and leadership positions at Grunenthal, Abbvie and ParinGenix. Pedro managed Phase II and III developments in cardiovascular and lung diseases. His experience submitting INDs and CTAs will add further value to the company’s pipeline. Dr. Yuri Martina, MD, MBA: Yuri has more than 20 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. During his career, Yuri has worked actively in different therapeutic areas and he has led teams bringing multiple compounds from pre-clinical phase into clinical studies in both Europe and US, and achieved multiple successful NDA and MAA submissions and approvals. About Elastrin Therapeutics Inc. Elastrin Therapeutics is a South Carolina-based biotech developing novel therapies to reverse cardiovascular disease. Its underlying technology was developed by Dr. Naren Vyavahare during the last 20 years at Clemson University. The team built a proprietary platform that targets and restores degraded elastin by removing the harmful calcification that stiffens arteries. The platform significantly improves the efficacy of drugs and eliminates side effects by combining particle design with elastin targeting. About KIZOO Kizoo provides seed and follow-on financing with a focus on rejuvenation biotech. Having been entrepreneurs, VC, and mentors in both high-growth tech and biotech companies ourselves for many years with multiple exits and massive value created for the founders, Kizoo now brings this experience to the emerging field of rejuvenation biotech. We see it as a young industry that will eventually outgrow today's largest technology markets.

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