Pfizer’s quarterly earnings fell sharply, with net income dropping 77 percent. The company’s R&D budget shank by five percent as part of a previously announced cost-cutting effort. Lipitor sales were also down by 5 percent. The financial picture was marred by a writedown for Pfizer’s inhaled insulin product, which will be discontinued at a cost of $2.8 billion. Said Jeff Kindler, Pfizer chairman and CEO: “Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.” Bright spots included robust growth in new products. The news release is here.
Separately, Pfizer is utilizing reverse auctions to support contract research organization (CRO) sourcing decisions, with significant cost savings experienced over the past three years. This method is used to select providers for services such as site monitoring, data management, clinical programming, clinical laboratory services, study management and project management. CROs and other service providers however, are less keen about using reverse auctions. One reason behind the service providers not being so supportive is that the reverse auction the process is as an example of how pharmaceutical companies are turning CROs complex business model into a commodity.
ICON has been named the favorite contact research organization (CRO) to work with in the third annual survey of pharmaceutical and biotech companies conducted by William Blair & Company and Thompson CenterWatch. The latter two surveyed executives from 21 large and medium pharmaceutical firms and biotechnology companies and “asked respondents to list their favorite CROs and which qualities they look for when selecting a vendor.” The survey identified the metrics used to define quality as; delivery within timelines, quality deliverables and budget maintenance. Peter Gray, CEO of ICON, commented: “We are delighted that our commitment to quality is being recognized by our customers. We believe the integration of these services can add value to our customers, enabling them to significantly expedite their drug development projects.”
Chesapeake Research Review (CRRI), which provides Institutional Review Board (IRB) services, and ethica Clinical Research, a full-service CRO based in Montreal, announced a partnership delivering collaborative research ethics review services for clinical research conducted both in the US and Canada. Felix Khin-Maung-Gyi, founder and CEO of CRRI stated, “We are very excited to partner with ethica, an AAHRPP-accredited organization. The combination gives us a unique geographic footprint which allows us to provide seamless high quality REB/IRB and human research protections oversight for subjects participating in research in the United States and Canada.” Janice Parente, founder and president of ethica, added that “Canadian research participants need to be assured that their rights and welfare will be protected by a group of individuals who understand local language, culture and laws.”
CRIX International, the Clinical Research Information eXchange, announced that Northrop Grumman will provide support and security services for the CRIX technology platform, a collaborative research environment for the drug development industry. Northrop Grumman will provide operational support for the platform, including hosting, security, scaling, credentialing users and help desk support for the CRIX platform. It will be fully operational in early 2008. The CRIX platform will provide life sciences organizations with services that will offer more efficient and cost-effective clinical work processes. It will also enable the standardization and electronic transfer of data that will speed the development and approval process of clinical trials. James Bland, executive director of CRIX International, said: “The CRIX platform will encourage the easy sharing of clinical research and information in order to speed new therapies to market.”
The SAFE-BioPharma Association has announced a change in the SAFE digital identity and signature standard will allow electronic documents to be signed with SAFE digital signatures from any location without tokens, smart cards or software stored on desktops. The change in the standard, permitting a roaming digital ID, allows SAFE user credentials to be stored centrally on a network and accessed from any location at any time. Cindy Cullen, CTO of SAFE-BioPharma Association and associate director of Digital Certificate Services at Bristol-Myers Squibb, said: “Just as cell phones freed people from relying on land lines, SAFE’s roaming digital ID will allow an electronic document to be signed without the user being tethered to specific preprogrammed hardware or software.”
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