The Lynx Group Acquires Upstream Partners to Create a Dynamic Division Catering Directly to the Pharmaceutical and Biotech Space

The Lynx Group | August 14, 2020

The Lynx Group (TLG) has acquired Upstream Partners in an effort to create a dynamic division catering directly to the pharmaceutical and biotech space. The ability to leverage the deep experiences and broad networks of both companies with external healthcare decision-makers and influencers together, allows the new division of TLG to provide pharmaceutical and biotech clients with thorough, market-informed perspectives needed throughout a product's life cycle. These insights are invaluable from the earliest stages of clinical development, throughout the product life cycle to ensure success of any therapy or device. It's this need that TLG has met with the strategic acquisition of Upstream Partners. "The relationships that Burt Zweigenhaft and Upstream Partners have with the most respected and influential key opinion leaders in their respective specialties perfectly complement The Lynx Group's own channels and ecosystems," says Brian Tyburski, CEO, TLG. "Through this acquisition, customers of both companies will be able to interact with and receive expert advice in all areas of the pharmaceutical and biotech space—prelaunch, launch readiness, go-to-market strategies, and life cycle management—with viewpoints from all stakeholders involved in the care of patients.

Spotlight

Biotechnology has the power to increase human health, environmental sustainability and the wellbeing of consumers and farm communities globally. For example, higher yielding crops developed through agricultural biotechnology can contribute toward meeting the United Nation’s estimated need for a 50 percent increase in world food production by 2030.

Spotlight

Biotechnology has the power to increase human health, environmental sustainability and the wellbeing of consumers and farm communities globally. For example, higher yielding crops developed through agricultural biotechnology can contribute toward meeting the United Nation’s estimated need for a 50 percent increase in world food production by 2030.

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MEDICAL

Pfizer and BioNTech Begin Rolling Submission of Biologics License Application for FDA Approval of COVID-19 Vaccine in the U.S

Pfizer, BioNTech | May 10, 2021

Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA). The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval. Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA. Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose. BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries. The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner. About Pfizer At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world. About BioNTech Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.

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CELL AND GENE THERAPY

Ocean Genomics and Geninus Team Up to Develop RNA-Based Biomarkers and Advance Research.

Ocean Genomics, Geninus Inc | March 30, 2021

Ocean Genomics (Pittsburgh, PA), a world chief in AI-based gene expression analysis and RNA biomarker development, and Geninus (Seoul, South Korea), a main full-administration genomics laboratory, report an essential association with the end goal of co-creating RNA-based biomarkers and propelling exploration and clinical applications with emergency clinic, scholastic and biotechnology customers. The two organizations will dispatch in Korea Ocean Genomics' high level AI-based transcriptome analysis and biomarker stage (txome.ai) as both a cloud-put together and with respect to premises arrangement. Geninus will use the txome.ai stage to extend its CancerSCAN clinical diagnostics stage for its clinic clients, and for biomarker revelation administrations with scholastic and biotechnology customers. Ocean Genomics and Geninus will likewise accomplice on the co-development of a progression of RNA-educated multidimensional biomarkers for research and clinical use. “We are excited to embark on this partnership with Geninus” said Carl Kingsford, co-founder and CEO, Ocean Genomics. “Ocean Genomics’ expertise in AI and computational method development, together with Geninus’ translational experts and access to data is a powerful combination. Working together, we can advance the field and enhance the uses of RNA biomarkers in clinical and research applications – and provide essential insights for clinicians who care for cancer patients.” Dr. Woong Yang Park, CEO, Geninus, said, “Genome analysis for precision cancer medicine is becoming an essential process in hospitals. Gene expression analysis on tumor tissue RNA can deliver critical information for targeted therapy and immunotherapy. We expect to advance precision medicine by incorporating Ocean Genomics’ txome.ai into Geninus’ clinical diagnostics platform, CancerSCAN. We look forward to working with Ocean Genomics in co-developing biomarkers and expanding services to our academic and biotechnology customers.” About Ocean Genomics, Inc. Ocean Genomics’ mission is to enable drug development and personalized medicine by combining AI with advanced gene-expression analysis to determine rich gene expression signatures and develop RNA-informed multidimensional biomarkers. DNA is a predictor of what might happen in the future, while RNA reveals what’s happening now, making it an essential component in drug development, screening and monitoring, diagnosis and treatment selection. Analyzing RNA requires far more advanced software and computational methods than analyzing DNA. Ocean Genomics provides the required specialized expertise in AI and transcriptomic analysis and advanced computational software solutions required to power discovery and development programs with life sciences companies and academic researchers. Ocean Genomics provides a self-service, fully configured, cloud-based platform, txome.ai, which provides advanced transcriptome analysis and biomarker generation. About Geninus Inc. Geninus provides clinical genome analysis solutions for precision medicine clinics. CancerSCAN, a cancer genome diagnostics platform, is used to inform personalized cancer treatment with targeted therapeutics and immunotherapy in major hospitals in Korea and Japan. CancerSCAN includes an information management system, a bioinformatics pipeline, variant annotation, clinical reports, and datacenter. OncoSTATION, a user interface for CancerSCAN, can be installed within hospital information systems. In addition, Geninus operates a single cell genome analysis platform called Celinus for biomarker discovery. Through collaborations with clinicians and pharmaceutical companies, Celinus can unearth new druggable targets or diagnostic markers in tumor microenvironment cells.

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CELL AND GENE THERAPY

Sphere Fluidics Closes a $40 Million Funding Round Led by Sofinnova Partners and Redmile Group

Sphere Fluidics | October 29, 2021

Sphere Fluidics, a company that has developed and is commercialising single cell analysis systems underpinned by its proprietary picodroplet technology, announced today that it has closed a $40 million investment round. The round was led by Sofinnova Partner and Redmile Group investing on equal terms. Sphere Fluidics will use the funding to enable the expansion of the Company’s international sales activities in key markets and improving its support for customers. Furthermore, it will expand its product research and development programs, including novel applications for its proprietary Cyto-Mine® Single Cell Analysis System. The Cyto-Mine is an automated cost-effective platform which integrates single cell screening, sorting, dispensing, imaging, and clone verification and has been purchased by an international customer base including global pharmaceutical companies, biotech, CDMOs, and leading research institutions. The platform can process millions of samples per day, assessing and isolating rare or valuable cell variants or biological products, to simplify and improve throughput across antibody discovery, cell line development and single cell diagnostics. The funds raised will support ongoing commercialization, broadening the technology’s adoption into new, innovative research areas such as cell therapy, synthetic biology and genome editing, in addition to ongoing enhancements of the platform’s capabilities and performance. In conjunction with the financing, Sofinnova’s Tom Burt and Redmile Group’s Rob Faulkner will join the Board. “This is a transformational investment from two of the most respected specialist investment funds in the industry and a recognition of the untapped potential of the pioneering product and market development carried out by the Company to date. Andrew Mackintosh, Chairman of Sphere Fluidics Frank Craig, CEO, Sphere Fluidics, commented: “This funding round is not only testament to the potential of Sphere Fluidics’ single cell analysis technology, but also to the expertise of our team. The investment will underpin our growth strategy, enabling us to expand both our product range and our support to new and existing customers, globally. Tom Burt, Partner, Sofinnova Partners, commented: “We remain impressed by Cyto-Mine’s high-throughput, ease-of-use and accessible cost. In the growing markets of monoclonal antibody discovery, cell line development and cell therapy, we see a significant need for such an affordable and reliable single cell analysis system as Cyto-Mine, capable of performing multiple assays on tens of millions of individual cells per run.”

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