NEWS Events


9-13 January 2012 PepTalk 2012 San Diego, CA, USA www.chi-peptalk.com


6-7 February 2012 Developing Chemical Processes for Active Pharmaceutical Ingredients Mumbai, India www.scientificupdate.co.uk


14-17 February 2012 InformexUSA New Orleans, LA, USA www.informex.com


19-21 March 2012 Organic Process Research and Development San Francisco, CA, USA www.scientificupdate.co.uk


19-21 March 2012 BIO-E


Europe Spring


Amsterdam, Netherlands www.ebdgroup.com/bes/index.php


21-23 March 2012 CPhI Japan Tokyo, Japan www.cphijapan.com


21-23 March 2012 ICSE Japan Tokyo, Japan www.icsejapan.com


21-23 March 2012 P-M


MEC Japan


Tokyo, Japan www.pmec-japan.com


21-23 March 2012 BioPh Japan Tokyo, Japan www.cphijapan.com/bioph-japan


17-18 April 2012 Dynamic Outsourcing for Life Sciences Cambridge, UK www.avakado.eu


17-18 April 2012 The Peptide Conference 2012 Cambridge, UK www.avakado.eu


14-16 May 2012 Modern Synthetic Methods & Chiral Europe


Prague, Czech Republic www.scientificupdate.co.uk


12 sp2 November/December 2011


Lilly CEO calls for ‘appropriate assessment’ of benefits and risks in regulatory process


John Lechleiter, PhD, chairman, president and CEO of Eli Lilly and Company, has said that to sustain medical innovation, the FDA must accelerate the adoption of a benefit-risk framework to inform decision- making in the regulatory process. In an address at the FDA News Fourth Annual Risk Management and Drug Safety Summit, he called for a regulatory process that focuses both on recognising and appreciating benefits while identifying and minimising risks.


He said such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved.


Lechleiter said the upcoming reauthorisation of the Prescription Drug User Fee Act (PDUFA) V provided an important platform to address these issues. PDUFA, first enacted in 1992, sets the foundation for how the FDA will manage the drug review process for five years, beginning in


Protagen and Charles River form strategic partnership


Protagen AG, a GMP-certified specialist in the characterisation of protein drugs, and Charles River Laboratories International, a developer of high-quality research models and provider of preclinical and clinical support services, have formed a strategic marketing and sales alliance. Charles River Biopharmaceutical Services said that partnering with Protagen, a specialist in the fields


of in-vitro diagnostics and GMP- compliant protein analysis, would provide clients with services covering the full range of protein analytics from detailed protein characterisation to stability and lot release testing. The companies aim to offer analytical experience and their services through a single point of contact, which they say will provide more efficient project work and study design.


Oxford Gene Technology and Abcodia form pancreatic cancer detection partnership


Oxford Gene Technology has established a collaborative agreement with Abcodia, a specialist company engaged in the validation and discovery of biomarkers of cancer and other age-related diseases, aimed at improving the early detection of pancreatic cancer. As part of the collaboration, Abcodia will provide access to its large prospective serum biobank which


contains samples taken from individuals up to seven years before the diagnosis of pancreatic cancer. OGT will apply its functional protein array platform and its Genefficiency™ microRNA profiling array to identify pancreatic cancer specific biomarkers that can be used as diagnostic indicators of developing pancreatic cancer.


Ferring Pharmaceuticals acquires


Cytokine PharmaSciences Ferring Pharmaceuticals has purchased Cytokine


PharmaSciences Inc and its UK subsidiary Controlled


Therapeutics (Scotland) Ltd, a global biopharmaceutical company with a particular focus in obstetrics. Ferring is already well established in the field of reproductive health and believes


that the acquisition of CPSI/CTS will strengthen its position over the next few years. This is Ferring’s second major


investment in the therapeutic field in two years, having purchased the global marketing rights for LYSTEDA (tranexamic acid) for the treatment of heavy menstrual bleeding in May 2010.


October 2012. He stressed the importance of a non-partisan course for reauthorization: “As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics,” he said. “As Congress considers reauthorisation next year, we hope to see a ‘clean’ bill, one free of extraneous and controversial provisions that would politicise the bill and further complicate matters for all parties.”


Lechleiter said that even after PDUFA V, the regulatory system must continue to evolve to meet 21st century needs.


FDA accepts Roche’s NDA for skin cancer treatment


The FDA has accepted Roche’s NDA for vismodegib for the treatment of adults with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. The application has been granted Priority Review status and the FDA confirmed the action date is March 8, 2012. Vismodegib is an investigational, oral, targeted medicine designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90 per cent of BCC cases. Currently, there are no effective treatment options for advanced BCC. In order to provide appropriate candidates with advanced BCC access to vismodegib while in discussions with the EMA, Roche is conducting a Phase 2 safety study in the EU and other countries. Roche is developing the drug in collaboration with Curis, Inc. Vismodegib was discovered by Genentech and jointly validated by Genentech and Curis. Genentech, Roche and Chugai Pharmaceuticals are responsible for clinical development and commercialisation. Curis is eligible to receive cash payments upon achievement of development and regulatory approval milestones, as well as royalties upon commercialisation of vismodegib.


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