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Join us on an informative episode of BioTalk with Rich Bendis as we delve into the fascinating realm of computer systems validation (CSV) and its significant impact on quality assurance in the life sciences industry. Our guest, Mr. Gaurav Walia, Senior Global Director of Business Development at PQE Group and Principal SME of Computer Systems Validation, Computer Software Assurance, and Data Integrity and Sr. Associate Partner, brings extensive expertise in CSV and compliance consulting services.

Discover the essential role of CSV in ensuring the integrity, reliability, and compliance of computerized systems used in pharmaceutical and medical device manufacturing. Mr. Walia, a recognized authority in the field, will provide insights into CSV’s challenges and best practices, emphasizing the critical importance of regulatory adherence and data integrity.

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BioMADE Funding To Accelerate Capra Bioreactor Expansion and Technical Advancement, Aligning with New White House Bioeconomy Goals

MANASSAS, Va., April 24, 2023 (GLOBE NEWSWIRE) — Capra Biosciences is scaling up their novel bioreactor technology to produce sustainable chemicals in Northern Virginia. This project was funded through a special BioMADE Project Call focused on advancing bioreactor design and development, thanks to support from Schmidt Futures. The expansion will jump start Virginia’s bioeconomy and place the state on the map for biochemical production.

The Manassas-based company uses a biofilm-forming microbe and its proprietary bioreactors to transform low-cost feedstocks, such as agricultural byproducts or food waste, into a variety of chemicals, including their first product, retinol.

“Our bioreactor platform is meant to handle small- or large-scale production of chemicals efficiently without a negative environmental impact,” said Dr. Andrew Magyar, Capra Biosciences’ chief technology officer. “We’ve already proved its potential on a smaller scale, and we’re excited to scale it for more chemicals and larger volumes. The new contract not only allows us to create a bigger facility, it also funds work with groundbreaking partners who will improve the efficiency and predictability of the bioreactors.”

GERMANTOWN, Md., April 25, 2023 (Newswire.com) – Seraxis Inc., a pre-clinical stage company with a best-in-class islet replacement therapy for insulin-dependent diabetes, today announced the presentation of results from an efficacy study of Synthetic Replacement Endocrine (SRE) pancreatic clusters. These data were presented by William Rust, PhD, Chief Executive Officer at Seraxis, as an oral podium presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge, Massachusetts. The presentation included an introduction to Seraxis’ proprietary GMP process for manufacturing SRE clusters for nonclinical and clinical use.

Emmes collaborates with pharmaceutical companies as strategic partners, providing one-stop clinical trial services, reducing costs, and accelerating development.

SAN ANTONIO, TX. – April 25, 2023 – Frost & Sullivan researched the contract research organizations industry and, based on its analysis results, recognizes Emmes with the 2023 Global Competitive Strategy Leadership Award. Each year, Frost & Sullivan presents this award to the company that has leveraged competitive intelligence to successfully execute a strategy that results in stronger market share, competitive brand positioning, and customer satisfaction.

Emmes is a full-service, global Clinical Research Organization (CRO) committed to promoting public health and biopharmaceutical innovation. Its dedication to problem-solving, close collaboration with customers, and scientific excellence help its customers better understand complex research problems, generate higher-quality data, and enable better treatment options. The company has extensive therapeutic experience in common and rare diseases, which is backed up by specialized knowledge in biostatistics, biomedical data science and bioinformatics, and eClinical technologies.

The value of life-saving drugs for patients suffering from serious diseases is priceless. But the current economic environment is stifling the biopharmaceutical pipeline of up-and-coming clinical trials. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics and the visionary behind Jeeva eClinical Cloud, appreciates the significant innovations that emerging biotech companies bring to the pursuit of early clinical development of novel therapeutics. He recommends an active front-loading strategy to maximize operational efficiency of clinical trials

JLABS is taking the lead in exploring new and innovative approaches to vaccinations with their upcoming event, “Breaking Dependencies on Seasonal Vaccines to Address Infectious Diseases.” This forward-looking program is scheduled to take place on Wednesday, May 17, 2023, at JLABS in Washington, DC, from 11:00 AM to 2:00 PM.

The event aims to examine the potential of technology to break the dependence on annual or seasonal vaccinations and provide more durable and reliable solutions for preventing infectious diseases such as coronaviruses, influenza, and rhinoviruses. Through innovation, there is an opportunity to enhance the impact and acceptance of vaccinations, achieve more consistent and impactful outcomes, and limit the spread of infectious diseases across large populations, regardless of risk level.

Johns Hopkins University has launched a new, annual award to support promising business ventures developed by student entrepreneurs—and to encourage the creators of those startups to put down roots and grow in Baltimore.

The President’s Venture Fellowship, by far the largest award for student entrepreneurship ever offered by the university, is open to any full-time Johns Hopkins student, undergraduate or graduate, who seeks to continue pursuing a business venture in Baltimore after graduation. Up to two winners will be selected annually to receive a $100,000 award, with the lead of each venture also receiving a $40,000 salary stipend.