BioPharma Dealmakers Science, strategy & innovation
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| | | BIO marches to Congress with growth package in hand September, 2011 Nature Biotechnology
On July 7, members of the Biotechnology Industry Organization (BIO)'s board of directors were invited to Capitol Hill to testify at a hearing on Prescription Drug User Fee Authorization (PDUFA) V. BIO attended the hearing, summoned by the House Energy and Commerce Subcommittee on Health, to help lay the groundwork for revising PDUFA IV (due to expire September 2012) and also to present ideas on what should be done to jump-start the drug innovation engine. BIO hopes its policy proposals (www.bio.org/sites/default/files/PromiseofBiotech.pdf) will be incorporated into new legislation, as Congress redraws PDUFA. But beyond regulatory reform, the industry association also highlighted strategies aimed at making more money available for early-stage innovator companies and to introduce rewards to US-based companies to keep innovation on American soil.
A few of the proposed changes “might make a critical difference,” says Washington attorney John Cohrssen, an Organisation for Economic Co-operation and Development (OECD; Paris) advisor who once worked on Capitol Hill.
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| | | Deal watch: Bristol-Myers Squibb invests in cancer antibody that targets the innate immune system September, 2011 Nature Reviews Drug Discovery
Bristol-Myers Squibb has acquired exclusive global rights to Innate Pharma's cancer candidate IPH 2102, which is in Phase I clinical trials for acute myeloid leukaemia (AML). Innate Pharma will receive US$35 million upfront and is eligible to receive up to $430 million in milestones.
IPH 2102 is a fully human monoclonal antibody that blocks the interaction between killer cell immunoglobulin-like receptors (KIRs) on natural killer (NK) cells and their ligands. NK cells are white blood lymphocytes of the innate immune system and are our first line of defence against pathogens or host cells that are stressed and/or cancerous. As Dr Jerry Thornthwaite (Director, Cancer Research Institute of West Tennessee, USA) explains: “All normal cells bear a self recognition protein called major histocompatability complex I (MHCI). NK cells recognize the MHCI by their KIRs and this interaction shuts down the ability of the NK cells to kill these cells. If a cell does not contain an MHCI or presents an altered MHCI — as in viral, infected or cancer cells — the NK cell will release proteins that will lyse and kill target cells.”
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| | | An Audience With: Joe Selby September, 2011 Nature Reviews Drug Discovery
As part of the Affordable Care Act of 2010, the US Congress created the Patient-Centered Outcomes Research Institute (PCORI). Just over a year since the creation of the comparative effectiveness research (CER) organization, the PCORI has now appointed its first Executive Director, Joe Selby. A physician who formerly directed research at Kaiser Permanente, northern California, Selby will now supervise the formation of the nascent institute's plan of action. And by 2014 he will be overseeing an expected annual research budget of US$500 million. Selby explained the case and agenda for the PCORI.
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| | | Proposed centralization of trial oversight stirs mixed reaction September, 2011 Nature Medicine
Over the last two decades, scientists have increasingly followed the mantra that "bigger is better" when planning drug trials. Large, multisite trials have become staples of clinical investigation, enabling wider enrollment and more statistically meaningful research results.
But, as the number of participating sites per study has grown, so has the administrative red tape. And, nowadays, dozens of local ethics committees—known as institutional review boards (IRBs)—are commonly involved in approving multisite studies, routinely suggesting changes to protocols and consent forms that then need to be reapproved by all the other parties involved. As a result, trials can take months to launch, delaying progress, and meaning that study participants don't benefit from the oversight of one central committee with ultimate responsibility for the research.
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| | Biotech in India: A Focus on South India November 2011 Nature Biotechnology The November issue of BioPharma Dealmakers will focus on the region of South India, where resources and policy are driving a new wave of innovation. This report will run in the print editions of Nature Biotechnology in November, which has a readership of 97,500+ internationally. Click here to learn more about placing an Advertising Profile or Display Advertisement. | | SciBX: Science-Business eXchange Recommend SciBX to your library today SciBx is a weekly publication that identifies and analyzes the most important translational research articles from over 40 journals. Find out which papers have real scientific and commercial potential, and why. Subscribe to SciBX and you won't miss the next big thing. For more information visit: www.nature.com/scibx | | | You have been sent this Table of Contents Alert because you have opted in to receive it. You can change or discontinue your e-mail alerts at any time, by modifying your preferences on your nature.com account at: www.nature.com/nams/svc/myaccount (You will need to log in to be recognised as a nature.com registrant). For further technical assistance, please contact our registration department For print subscription enquiries, please contact our subscription department For other enquiries, please contact our feedback department Nature Publishing Group | 75 Varick Street, 9th Floor | New York | NY 10013-1917 | USA Nature Publishing Group's worldwide offices: .London - Paris - Munich - New Delhi - Tokyo - Melbourne - .San Diego - San Francisco - Washington - New York - Boston | | | |
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