NEWS
Merck & Co in partnership to establish California Institute for Biomedical Research
SOCMA News
SOCMA urges Congress to move CFATS forward
In testimony recently given before a House of Representatives homeland security panel, SOCMA has reiterated its strong support for the US’s chemical security standards while calling on the Department of Homeland Security (DHS) to increase collaboration with industry and be more transparent about its operations.
Bill Allmond, SOCMA’s Vice President of Government and Public Relations, stressed that the Chemical Facility Anti- Terrorism Standards (CFATS) is a success despite DHS’s management failings that recently came to light. He said that since the launch of the programme in 2007, more than 2,000 facilities had changed processes or inventories such that they are no longer considered high-risk under CFATS and that hundreds of other regulated facilities have already made significant proactive security investments. SOCMA says its members alone have invested about $515 million in safeguarding facilities. Allmond urged the DHS to embrace greater collaboration with industry, provide more operational transparency, simplify the ‘personnel surety
programme’ and avoid further discussion on mandating product substitution. He said it was evident that the DHS will also need to retrain and likely replace much of the staff that administers the CFATS programme. SOCMA supports a long-term extension of the standards to allow the DHS and the regulated community to come into compliance. “The key to fixing CFATS is vigorous oversight, not budgetary uncertainty or budget cuts,” stated Allmond.
Merck & Co has established collaboration with academic and biotechnology entrepreneurial partners to create the California Institute for Biomedical Research (Calibr), an independent, not-for- profit organisation with the aim of accelerating the translation of basic biomedical research into new disease treatments. Calibr will be led by chemist and biotechnology entrepreneur Dr Peter G. Schultz. Merck said the Institute would offer academic scientists, on a global basis, a streamlined, efficient and flexible path for translating their biomedical research into novel medicines.
“Calibr represents a new paradigm for early-stage translational research. By leveraging the drug discovery expertise and resources of Calibr, academic researchers will have the opportunity to maximise the potential therapeutic value of their research,” said Dr Schultz, a
professor of chemistry at The Scripps Research Institute and director of Calibr.
Calibr investigators will work with academic scientists to advance new discoveries to preclinical proof of concept at which stage commercial partnerships will be sought for further development. Merck will provide funding to Calibr of up to $90 million over a period of seven years. The company has an option to obtain an exclusive commercial licence to any proteins or small-molecule therapeutic candidates derived from work conducted by Calibr. For any projects not licensed by Merck, Calibr will be free to seek alternative sources of funding for further development. In addition, the Institute plans to access funds from government and non-government sources. Revenues derived from licences will be shared between Calibr and the collaborating institutions.
Project proposals from the scientific community will be chosen on the basis of novelty, biomedical impact and technical feasibility and reviewed by a scientific advisory board headed by Dr Christopher T. Walsh, Hamilton Kuhn Professor, Department of Biological Chemistry and Pharmacology, Harvard University. In addition, an independent board of directors headed by Dr John D. Diekman, founder and managing partner of 5AM Ventures, will oversee the activities of the Institute. Calibr will be located in San Diego, California, USA, in close proximity to leading research centres The Scripps Research Institute; Salk Institute; University of California, San Diego; and Sanford-Burnham Medical Research Institute. It will be equipped with high throughput screening and imaging, medicinal and protein chemistry and preclinical sciences capabilities.
Ranbaxy opens new manufacturing facility in Morocco
Ranbaxy Morocco has opened a new manufacturing facility in Casablanca, Morocco, giving the company a direct presence in North Africa.
The facility has been audited by the Moroccan health authorities, and Ranbaxy Morocco is now authorised to commence manufacturing at the facility. Ranbaxy said this development will enable the company to access what it estimates as a $1billion pharmaceutical market in Morocco. In addition to serving
UK-based biotechnology and personalised medicine company Epistem plc has formed a three- year biomarker collaboration with GlaxoSmithKline in the field of fibrosis research. The collaboration will focus on identifying key characteristics of diseased fibrotic tissue on which Epistem will apply its proprietary
10 sp2 Inter-Active March/April 2012
the Moroccan market, Ranbaxy also plans to extend supply from this manufacturing unit to other African countries over the coming years. With the addition of the Moroccan facility, Ranbaxy now has three manufacturing facilities in Africa; the others being located in Nigeria and South Africa. With five subsidiaries, five representative offices and a workforce of almost one thousand people, Ranbaxy’s distribution network serves 44 of the 54 countries on the continent.
Epistem in three-year fibrosis research deal with GSK
RNA-Amp technology to facilitate building an in-depth
understanding of the disease. RNA-Amp is a highly sensitive amplification technology that is able to provide gene expression information from small tissue samples and low of numbers of cells, for example those obtained from the bulb of cells at the base
of a single hair follicle, as well as laser captured microdissected (LCM) samples. Epistem’s broad technology platform allows expression biomarkers to be identified in disease pathways at an early stage of preclinical validation for translation to later- stage clinical validation and patient stratification.
Ranbaxy Laboratories Limited is India’s largest pharmaceutical company and produces a wide range of generic medicines. The company’s R&D efforts are focused on developing proprietary novel drug delivery systems (NDDS) and
technologies, which have led to a number of new product
approvals. The company has also further strengthened its focus on generics research and is increasingly working on more complex and speciality areas.
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