PharmiWeb Recruiter Blog

• UK site now set for clinical production of adeno-associated virus (AAV) vectors for gene therapy
• Highly experienced team ready to support ATMP innovators at all stages
• Offering comprehensive range of services from early process and analytical development through cGMP manufacturing for clinical trials

Stevenage, UK and Laupheim, Germany, September 13, 2023– Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), today announced that it has received the cGMP Manufacturing Compliance Certificate, following the successful inspection by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) at its UK site. The ATMP business was announced in early 2021 and the facility is located in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage.

Collaboration combines leading technologies to develop breakthrough, mRNA-enabled in vivo expressed TCER® molecules

As a life science recruiter, attracting senior executives to your roles can be challenging due to several factors. Firstly, the demand for top talent far outweighs the available pool of qualified candidates, resulting in talent scarcity. The life science sector requires professionals with specialised expertise, scientific knowledge, and regulatory experience, making it challenging to find individuals who possess the precise skill set required for these senior roles.

WALTHAM, Mass.--(BUSINESS WIRE)-- Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and the National Minority Quality Forum (NMQF), an independent not-for-profit research and education organization, today announced a collaboration to help bring clinical research to historically underserved patient populations through NMQF’s Alliance for Representative Clinical Trials (ARC). The collaboration supports biopharmaceutical and biotech customers in meeting regulatory expectations to enroll and retain patients in clinical trials who more fully reflect real-world populations experiencing the disease or health condition being studied, including U.S. Food and Drug Administration requirements around diversity action plans.

The collaboration aims to identify disease-modifying interventions, with the goal of improving standards of care for people living with type 2 diabetes and cardiac fibrosis

• Bigfoot developed Bigfoot Unity, a smart insulin management system that features the first and only FDA-cleared connected insulin pen caps that turn data from a continuous glucose monitor (CGM) into clear and reliable insulin dosing recommendations displayed right on the insulin pen cap
• Acquisition will bring together two leaders in different aspects of diabetes care: CGM and insulin injection support
• Together, Abbott and Bigfoot will continue to advance technology-driven solutions for making diabetes management even more personal and precise

ABBOTT PARK, Ill. and MILPITAS, Calif., Sept. 5, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes.

• Novel non-viral gene delivery platform to help advance tissue repair following orthopaedic surgery
• Funding from Innovate UK’s Transforming Medicines Manufacturing programme supporting innovative technologies for intracellular drug delivery

London, UK, and Nottingham, UK, 31 August 2023: TherageniX, a University of Nottingham spin out pioneering a dry powder gene therapy formulation for bone graft augmentation, and its collaborator, the University of Nottingham, have been awarded a £995,000 grant from Innovate UK, the UK’s innovation agency. The funding will support the development of the Company’s gene therapy in a powder, a non-viral gene delivery system to improve tissue regeneration following surgery. TherageniX will initially focus on orthopaedic applications, with the aim of improving the outcomes for patients undergoing bone grafting procedures.

Largest single investment in Crop Protection in Germany for 40 years / Focus on Environmental and Human Safety / State-of-the-art lab building and greenhouse / 5 floor main building; 28,000 m² gross floor area / R&D facility offers space for 200 employees / Early safety screens and A.I. help design the next generation of Crop Protection

• Powered by Sanofi, a new BioMed X research team will develop a computational platform designed to accelerate drug development.

Heidelberg, June 29, 2023. BioMed X, a German independent research institute, announces the start of its first research project in collaboration with Sanofi: “Next Generation Virtual Patient Engine for Clinical Translation of Drug Candidates” (VPE). The end goal of this research project is to develop a versatile computational platform that can predict the efficacy of first- or best-in-class drug candidates in virtual patient populations at unprecedented accuracy, thereby addressing one of the most critical bottlenecks of the pharmaceutical industry today: a 90% failure rate of new drug candidates during clinical development.

Caidya was honored at the CRO Leadership Awards held in Boston, MA at the end of June for their win in the Overall Capabilities category. The award is a recognition of Caidya’s outstanding global capabilities and the tireless work that the team does daily to fulfill our vision to ensure potential therapies have the best opportunity to reach patients in need.