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European Biopharmaceutical Review

Opportunities and Challenges in Cancer Innovations

Progress is being made in the long-standing battle to effectively treat and control cancer. The National Cancer Institute projects that nearly five million more US citizens are expected to survive cancer in 2026 than in 2016 (1). Therapeutic tools like nextgeneration sequencing and advances in immunotherapy are just two ways that fundamental scientific breakthroughs and innovative thinking are moving the potential for cancer treatment forward.

One of the most revolutionary breakthroughs in this new era is cell and gene therapy. At its most basic definition, gene therapy (also called human gene transfer) is the therapeutic delivery of nucleic acid into a patient’s cells as a drug to treat disease. According to The Journal of Gene Medicine, somewhere around 2,600 gene therapy clinical trials have been undertaken in 38 countries around the world as of November 2017 (2).

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Dr Ger Brophy is Executive Vice President of Biopharma Production at Avantor. In his current role, he is responsible for developing and implementing the company’s biopharma production and supporting the current and future needs of customers. Prior to joining Avantor, Ger held a variety of R&D, strategy, advanced systems, and business development positions in the healthcare space with GE Healthcare Life Sciences, GE Healthcare Medical Diagnostics, and Amersham for nearly 30 years. He earned a BSc in biotechnology as well as a PhD in molecular biology from Dublin City University, Ireland.
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Dr Ger Brophy
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MedPharm announce expansion of partnership with Palvella Therapeutics in developing a new treatment for the debilitating rare disease, pachyonychia congenita

MedPharm Ltd have announced the expansion of their partnership with Palvella Therapeutics, Inc., a Philadelphia-based biopharmaceutical company focused on developing and commercialising therapies for debilitating, rare genetic diseases. To date, MedPharm has employed its world-renowned specialist formulation expertise to support Palvella’s development of a novel, high-strength rapamycin topical formulation for application to the skin (PTX 022) as a disease-modifying treatment for pachyonychia congenita (PC). Most recently, MedPharm has made arrangements to manufacture the clinical (IMP) batches for use in Palvella’s upcoming Phase 2/3 clinical study.
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Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
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PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
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