Tag Archives: Biotechnology Industry Organization

New BIO Survey on Effective FDA – Sponsor Communication During Drug Development

BIO Logo Horizontal 4C copy

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 >

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FDA: How can we improve it?

Stephen Sherwin MD

By Stephen Sherwin, Former Chairman of BIO As Congress and the President work together to hammer out a new, national economic roadmap, it is important to point out to those working in, and interested in, our industry that we too have recently assembled a roadmap – one designed to fully realize the promise our industry holds for people everywhere. Several weeks ago, at the 2011 BIO International Convention in Washington, DC, BIO unveiled its first ever 5 Read More >

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How we are advancing American innovation to cure disease and save lives

JimGreenwood

Mankind’s need to cure disease, combat hunger and discover new forms of energy has never been more urgent. Yet despite the extraordinary hope offered by biotechnology to solve these problems, government policies and the capital formation environment necessary to support these goals are insufficiently conducive to allowing us to meet these critical challenges. During our 2011 BIO International Convention, we unveiled a strategic initiative to speed scientific breakthroughs, develop cures and grow the bio-economy. The Read More >

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BIO and USPTO Trace the Journey of Biotech Inventions

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S.patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.  The event will be held during the BIO International Convention on the morning of Thursday, June 30, at the Walter E.Washington Convention Center inWashington, D.C.  See the BIOtech Read More >

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BIO Hosts U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office and China’s State Intellectual Property Office

Press Release:   WASHINGTON, D.C. (Tuesday, April 05, 2011) – The Biotechnology Industry Organization (BIO) hosted a U.S./China Biotechnology Examiner Workshop with U.S. Patent and Trademark Office (PTO) and China’s State Intellectual Property Office (SIPO) on March 28, 2011 in Beijing, China. The workshop which was organized by BIO for SIPO examiners, focused on biotechnology patenting and encouraged bilateral cooperation between SIPO and the USPTO.“BIO recognizes the commitment on behalf of the Chinese Government and Read More >

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