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Cleanroom Microbiology for the Non-Microbiologist
November 7, 2011–November 8, 2011
King-of-Prussia, Pennsylvania
Quality Risk Management in Clinical Drug Development Conference
November 10, 2011–November 11, 2011
Berlin, Germany
The Digital Pharma Marketing Course
November 27, 2011–November 28, 2011
Brussels, Belgium
CPhI India
November 30, 2011–December 2, 2011
Mumbai, India
4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California
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FDA Establishes Two Centers for Regulatory Science
On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation. The centers, which will be located at the University of Maryland and at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices. 
President Obama Issues Executive Order to Reduce Drug Shortages
In response to the increase in drug shortages over the past three years, President Obama issued an executive order on Oct. 31, 2011 that directs FDA to take several steps to prevent and reduce drug shortages.
MHRA Drives for Regulatory Excellence
The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011. Seeking to greatly simplify and elucidate the law regulating medicines in the UK, the MHRA invited interested parties to contribute to legislation development.
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 Software centrally monitors process-control systems
Sparta Systems’s TrackWise Preclinical GLP and Clinical GCP Auditing Solutions includes a wide range of document-control functions that enable the transfer of attachments, through a web service, to other enterprise applications. The software is designed to manage all information securely in a centralized, scalable, and reliable enterprise system. It also generates reports to monitor and review auditor resource allocation and scheduling, draft and formal audit reports, and reports to track and trend findings and corrective actions to enable continuous improvement.
The system allows an administrator to define user roles, as well as specific permissions and assignments directly from pre-existing enterprise applications. The creation of user accounts for supplier and customer access portals and web forms can be automated. TrackWise can also interact with other enterprise software systems through a web services interface, thus enabling constant communication with enterprise resource planning, customer relationship management, laboratory information management systems, and manufacturing execution systems software.
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AgonOx has entered into an exclusive global partnership with MedImmune, the global biologics arm of AstraZeneca, to develop agonists using its OX40 platform. MedImmune will lead further preclinical and clinical studies of its tumor-specific T-cell immunity stimulator for the potential treatment of cancer. MedImmune will also support further OX40 research at Providence Cancer Center, where the foundational preclinical and clinical development of OX40 has been conducted.
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Bristol-Myers Squibb (BMS) and Gilead Sciences have announced a licensing agreement for BMS to develop and commercialize a fixed-dose combination containing BMS’s protease inhibitor Reyataz (atazanavir sulfate) and Gilead’s cobicistat, a pharmacoenhancing agent that increases blood levels of certain HIV medicines to potentially allow for once-a-day dosing. Gilead conducting a study of atazanavir and cobicistat in Phase II and III studies for HIV-1 treatment-naïve patients.
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Cobra Biologics, the biopharmaceutical manufacturing company has acquired the CMO Unitech Pharma Group and its bioproduction facility in Matfors, Sweden. Under the terms of the agreement, Cobra Biologics will acquire 100% of the shareholding in Unitech Pharma Group, which has a 600 L of clinical and commercial microbial GMP production capacity, and commercial aseptic fill–finish and lyophilization capability.
Lonza has announced a new development and manufacturing agreement with the biotechnology company Genmab. The agreement secures a development and cGMP manufacturing plan for Genmab to produce an antibody–drug conjugate (ADC) product targeting tissue factor (TF), a protein involved in tumor signaling and angiogenesis that is highly expressed on solid tumors. The project utilizes Lonza’s experts in both antibody production and drug conjugation, providing a harmonized solution for Genmab’s technology. Lonza will initiate process development and cGMP manufacturing for Genmab’s monoclonal antibody HuMax-TF in its Slough, United Kingdom, facility. The antibody has been expressed by Genmab in Lonza’s glutamine synthetase gene-expression system. The naked antibody will be conjugated by Lonza at its ADC plant in Visp, Switzerland, to a cytotoxic drug to form the antibody drug conjugate HuMax-TF.
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Pfizer has completed its $56-million acquisition of the biopharmaceutical company Icagen by merging its wholly owned subsidiary, Eclipse Acquisition Corp., with and into Icagen. Under the transaction, Icagen has become a wholly owned subsidiary of Pfizer, and each issued and outstanding share of Icagen common stock has been converted into the right to receive $6.00 in cash.
ShangPharma, a CRO, has acquired the assets in the drug-development company Charles River Laboratories’s Shanghai, China, research facility, through its subsidiary Shanghai ChemPartner. Under the transaction, ShangPharma will take over Charles River’s lease for the facility, which will provide the company with an additional 2972 m2 (31,990 ft2) of in vivo research facilities originally designed for GLP toxicology studies, and 1290 m2 (13,885 ft2) of lab and office space.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
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3M Drug Delivery Systems has appointed James Ingebrand as vice-president and general manager, following the retirement of his predecessor James Vaughn.
The CRO ICON has appointed Steve Cutler as group president of clinical research services. Cutler previously served as CEO of the CRO Kendle.
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Small-Molecule API Outsourcing
In your company for 2012, how do you anticipate the level of outsourcing for small-molecule API development and manufacturing will change compared with 2011?
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