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Meta
Tag Archives: BIO
New BIO Survey on Effective FDA – Sponsor Communication During Drug Development
BIO is surveying members on their interactions with the FDA during the various stages of drug development prior to submitting an NDA/BLA. The survey can be accessed here. In an increasingly competitive and fiscally-constrained environment, it is more important than ever for all stakeholders to work together to promote effective R&D for innovative medicines. This initial survey is designed to assist in the implementation of the Prescription Drug User Fee Act (PDUFA V) program on Read More >
Evidence, Coverage, & Incentives: A PMC/BIO Solutions Summit Conference
Personalized medicine is changing the way medicine is practiced, and how drugs and biologics are developed. Systemic changes are needed to reflect this and support product development, but current economic, regulatory, and practice disincentives are impacting and slowing development. For example, medical advances often take years to be recognized in clinical care guidelines and cost containment policies often prevent new diagnostics from being priced at a level that supports innovation. The Personalized Medicine Coalition (PMC) and Read More >
BIO Travels to Brazil to Support the Ecosystem of Innovation
Government policies that support innovation are critical as the biotechnology industry seeks to develop innovative healthcare, agricultural, industrial and environmental biotechnology products and provide them to people all around the world. Innovation requires not only scientific research and commercial expertise, but also supportive and dynamic governments that help facilitate long-term growth of the industry. Brazil has recognized the value of innovation in maintaining a robust, diversified economy that can compete in the 21st century, and declared Read More >
BIO IP Counsels Conference Agenda Topics
Join us in Austin for BIO’s Intellectual Property Counsels Committee Conference on April 16-18. Agenda topics are below. The Decline of Process Patents: This session will examine the enforceability of process claims and how it has led to the recent controversy around divided infringement. Unlike claims to machines, manufactures, and compositions, process claims can be divided up by different actors, or by jurisdiction, and conceivably even by time. Right now the focus is on different Read More >
Mass. Governor Patrick Looking Forward to the BIO International Convention
In just six months, Boston will be welcoming more than 15,500 of the world’s leading biotech stakeholders to the biggest industry event of the year – the 2012 BIO International Convention. Both Massachusetts Governor Deval Patrick and Boston Mayor Thomas Menino attended a kickoff breakfast in October where they voiced their industry support: “It’s an honor to have BIO coming back so soon,” said Gov. Patrick. “By drawing the world’s attention once again to our Read More >
