Tag Archives: drug development

Syringes for Clinical Trials

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Today’s pharmaceutical and biotechnology companies are under pressure to remain competitive. To do so, they require innovative approaches to manage drug development, particularly early development work. Any competitive advantage in the development process is highly prized – and one approach is to begin the development of the compound in a prefilled syringe earlier in the process, rather than later. Traditionally, biopharmaceutical companies have almost exclusively used vials in drug development. There are good reasons for Read More >

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Alliance Development Meets Animal Biotechnology

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On June 3rd, 2014, BIO hosted a briefing entitled “The Untapped Potential of Advanced Modeling: How Animal Biotech Speeds Drug Development” to showcase the growing field of biomedical applications through animal biotechnology. Panelists specifically highlighted opportunities for GE animal models of human disease to help patients with devastating diseases. The panel included three experts in the field: Danielle Kerkovich, PhD, the Principal Scientist of Beyond Batten Disease Foundation, John Swart, PhD, President of Exemplar Genetics, and Read More >

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Washington Post: Crowdsourcing Medical Decisions

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On Monday, Ariana Eunjung Cha wrote about the difficult ethical issue of Compassionate Use, which allows a patient access to an unapproved treatment when others with similar requests are denied access. Arthur Caplan, director of the division of medical ethics at New York University’s Langone Medical Center, describes it as a moral dilemma that could not be ‘more troubling and impossible-to-resolve’. In the article, Caplan asserts that ‘it’s best for the company to focus on getting the Read More >

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TRIPs Has Delivered: Patent Agreement Increases Drug Development

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The TRIPs (Trade Related Aspects of Intellectual Property) Agreement, effective in 1996, has resulted in multiple benefits for public health. The last blog post reviewed Progressive Economy’s finding of TRIPS at 20. One additional benefit not mentioned in the article is the explosion of molecules in clinical development. The World Intellectual Property Indicators – 2012 Edition reveals an overall growth in patent applications around the world. The report finds that patent applications “worldwide doubled from Read More >

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BIO Patient and Health Advocacy Summit: Patient-Focused Drug Development

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Panelists in this morning’s opening session outlined strategies for the FDA to better engage the patient community to guide the drug development process. “Patients should be providing input and guidance throughout the entire drug review process,” said Marc Boutin, Executive VP and COO of the National Health Council. Boutin highlighted the improvements made through PDUFA V to open up and enhance the Agency’s interaction and engagement with patients. “Integrating our perspective into how drugs are Read More >

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