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Decentralized Clinical Trials Raise Concerns About Informed Consent

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Under pressure of the COVID-19 pandemic, multitudes of clinical trials of new medications and treatments have moved to a decentralized model, bringing them to the patients rather than having patients come to a central trial site such as an urban medical center.(1) At the same time, recent research shows a worrying lack of patients’ informed consent to the treatment they are undergoing.(2) “This,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “is not an acceptable situation. The extent to which patients comprehend the consent they grant is essential to the ethical conduct of medical research.”

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REGENXBIO Announces Initiation of Second Pivotal Trial in RGX-314 Clinical Program for the Treatment of Wet AMD Using Subre…

By News Archive

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ROCKVILLE, Md., Jan. 10, 2022 /PRNewswire/ —

  • ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada
  • Pivotal trials expected to support BLA submission for RGX-314 in 2024

REGENXBIO Inc. (Nasdaq: RGNX) today announced the initiation of ASCENTTM, the second of two Phase III pivotal trials to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD). ASCENT, the first trial to be initiated by REGENXBIO under the eye care collaboration with AbbVie, is currently active and screening patients. RGX-314 is being investigated as a potential  one-time gene therapy for the treatment of wet AMD.

A Biologics License Application (BLA) is expected to be submitted to the United States Food and Drug Administration (FDA) in 2024 based on two pivotal trials, ASCENT and the ongoing ATMOSPHERE trial.

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MIMETAS opens Phenotypic Screening Center

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Leiden, May 27, 2021 – MIMETAS, the global leader in human-relevant organ-on-a-chip models, has just opened their Phenotypic Screening Center. The center facilitates large-scale screening campaigns on Organ-on-a-Chip models, a powerful technology that improves the human physiological relevance of cultured tissues by utilizing microfluidic techniques. In contrast to other Organ-on-a-Chip platforms, the MIMETAS OrganoPlate® technology offers the scalability and the throughput needed for drug discovery studies.

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Are we witnessing the dawn of post-theory science? | Artificial intelligence (AI) | The Guardian

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Brain coloed sections 2021 08 26 18 50 01 utc

Isaac Newton apocryphally discovered his second law – the one about gravity – after an apple fell on his head. Much experimentation and data analysis later, he realised there was a fundamental relationship between force, mass and acceleration. He formulated a theory to describe that relationship – one that could be expressed as an equation, F=ma – and used it to predict the behaviour of objects other than apples. His predictions turned out to be right (if not always precise enough for those who came later).

 

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Hibiscus BioVentures Partners with the Barbara Ann Karmanos Cancer Institute to Advance Translational Cancer Research

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– Partnership aims to drive innovation and clinical development of novel therapeutics for cancer treatment –

ROCKVILLE, Md.–(BUSINESS WIRE)–Hibiscus BioVentures, a firm committed to building patient-focused companies around transformative technologies, today announced it has entered into a partnership agreement with the Detroit-based Barbara Ann Karmanos Cancer Institute (Karmanos). This partnership between Hibiscus’ venture studio, Hibiscus BioTechnology, and Karmanos seeks to leverage the combined resources of the two organizations to develop innovative therapeutics for the treatment of cancer. Karmanos is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country.

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A regional economic development strategy and why commercial real estate should care

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The U.S. Economic Development Administration announced last month the winners of $500,000 planning grants to 60 jurisdictions across the country for the $1 billion Build Back Better Regional Challenge. Winners of Phase 2 Build Back Better will be eligible for federal grants of up to $100M to create new science and technology parks and districts, accelerators, and other technology infrastructure across the country.

Funding for the technology infrastructure must go to a nonprofit, such as a university, but the nonprofit will need the commercial real estate industry to design, build and manage this technology infrastructure.

The District of Columbia/Maryland/Virginia (DMV) region submitted some very good bids, including ones in quantum technology, biotechnology, advanced manufacturing, and other topics but only Howard County for cyber security, Richmond, Virginia in bio manufacturing, and rural Southwest Virginia in transportation logistics won planning grants.

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NexImmune Announces Formation of Autoimmune and Infectious Diseases Scientific Advisory Board

By News Archive

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GAITHERSBURG, Md., Jan. 05, 2022 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced the formation of its Autoimmune and Infectious Disease Scientific Advisory Board (AI & ID SAB). The AI & ID SAB is comprised of distinguished academic and industry leaders in the fields of autoimmune and infectious diseases, translational research, immunology and T cell biology.

“As we continue to advance our AIM nanotechnology platform, we are grateful to have the input and guidance of these established experts,” said Jerry Zeldis, NexImmune’s EVP of R&D. “Their combined experience in autoimmune and infectious diseases, translational science and clinical development will help make informed decisions as we expand our pipeline and explore new therapeutic areas.”

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South Duvall Takes Next Step to Bring 45,000 Square Feet of Lab Space to Rockville

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ROCKVILLE, Maryland – January 6, 2022 South Duvall today announced that it has submitted construction plans for permit to bring 45,000 square feet of lab space to 1450 Research Boulevard in Rockville, MD. South Duvall will renovate the façade, create new building amenities and common areas, and install brand-new mechanical, electrical, and plumbing systems. Three move-in ready lab spec suites ranging from 2,800 square feet to 3,700 square feet range are expected to deliver by the fourth quarter of 2022 with two full floors of roughly 15,000 square feet available for tenant fit out now. Leasing will be handled by Scheer Partners. “The submission of construction plans for our lab conversion of 1450 Research Boulevard begins our timeline to deliver much needed lab space to the I-270 corridor in 2022,” said Matthew Brown, director of acquisitions, South Duvall. “Our design team took lessons we have learned from other similar projects and developed an exciting plan to deliver a unique, best-in-class lab building.”  

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Cursor and Horizon Therapeutics plc Announces Significant Expansion of East Coast Research and Development and Technical Operations Capability Horizon Therapeutics plc

Horizon Therapeutics plc Announces Significant Expansion of East Coast Research and Development and Technical Operations Capability | Horizon Therapeutics plc

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Cursor and Horizon Therapeutics plc Announces Significant Expansion of East Coast Research and Development and Technical Operations Capability Horizon Therapeutics plc

DUBLIN–(BUSINESS WIRE)–Jan. 6, 2022– Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. to be the first tenant at the Alexandria Center® at Traville Gateway campus in Rockville, Maryland. When completed, the state-of-the-art facility will serve as the company’s primary East Coast research and development and technical operations hub. Construction at the 192,000-square-foot site is underway and Horizon expects to start work on interior improvements in 2023. Additional terms of the agreement were not disclosed.

 

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