Category Archives: Events

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From Participant to Judge in the International BioGENEius Challenge

Sagar

My name is Sagar Rambhia, and I participated in the 2011 International BioGENEius Challenge. Three years later, I have come back to be a judge at the 2014 International BioGENEius Challenge. I am 19 years old, and since competing in the 2011 BioGENEius Challenge, I have started my own company and continued to conduct biomedical engineering research. Back in 2011, as part of the BioGENEius Challenge, I was given the life-changing opportunity to present my Read More >

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New Type of Prospective Survey Initiative

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Our industry is on the cutting-edge of science aimed at developing new therapies for devastating and life-threatening diseases. To help advance innovation and promote the development of the next generation of treatments and cures, we must acknowledge that the scientific method does not operate in a vacuum. Robust, interactive FDA-Sponsor communication is a key element of modern drug development. However, in order to improve the drug development enterprise and the FDA review process further, the Read More >

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Delivering the Right Dose, Less Often

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Biologics are a growing area of drug development, including life-threatening and life-changing disorders such as cancer and rheumatoid arthritis. However, many biologics have short half-lives, and need to be dosed daily. To make them more convenient to use, as well as safer and more effective, researchers are developing delivery systems that keep the biologics in the body for longer, reducing the frequency of dosing. Swedish company Affibody is using the natural affinity of a naturally-occurring Read More >

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Acts of Support

hahn

Because small biotechnology companies do not have product revenue, burdensome regulations have an outsized effect on them. One-size-fits-all compliance requirements – such as Section 404(b) of the Sarbanes-Oxley Act (SOX) – divert funds from the lab and slow the development process. We have already seen the benefits that positive legislative reform can have for capital formation for emerging growth companies (EGCs). The JOBS Act has led to a sea change in the regulatory landscape and Read More >

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In Memory of Sandi Dennis

inthememoryof

Last September, BIO and the industry lost a dear friend and one of the nation’s top regulatory attorneys – Sandi Dennis – after a long battle with cancer. Sandi served as the deputy general counsel for healthcare at BIO. She focused on educating biotechnology companies about emerging legal and policy issues affecting the development of ground-breaking new medicines, and advocating on their behalf with Congress and executive agencies to help expedite the approval of treatments Read More >

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