Wednesday, October 5, 2011

BioPharma Dealmakers: October 5, 2011


October 5, 2011

BioPharma Dealmakers
Science, strategy & innovation

Recent content exclusively made freely available to you
from Nature Biotechnology, Nature Reviews Drug Discovery and
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BIOPHARMA DEALMAKERS
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Top Stories

BIO marches to Congress with growth package in hand

Deal watch: Bristol-Myers Squibb invests in cancer antibody that targets the innate immune system

An Audience With: Joe Selby

Proposed centralization of trial oversight stirs mixed reaction


Events

BIA Research and Development Conference

Genesis 2011

5th annual BioPharma Asia Convention 2012


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.

Read the full story here



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.”

Read the full story here



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.

Read the full story here



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.

Read the full story here



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.

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Events

BIA Research and Development Conference - October 27, 2011 - London, UK


Genesis 2011 - December 1, 2011 - London, UK


5th annual BioPharma Asia Convention 2012 - March 19-22, 2012 - Singapore



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