Another very busy day at CPhI Worldwide and co-located events with good meetings in every corner for all exhibitors.
If you missed yesterday’s blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011.
In other news, UBM Live announced its plans for ICSE USA, which will debut at the Pennsylvania Convention Centre in Philadelphia and run from May 22-23, 2012. Apparently, 60.2 % of ICSE Europe visitors indicated that North America is the main target for business development, and ICSE USA seeks to address this trend. “ICSE USA’s introduction, in conjunction with Pharmapack North America, EAST Pack and MD&M is a win-win across the board. The combined events offer a platform for US companies that are working to address the upcoming blockbuster drugs [patent] expirations to connect with global business contacts and partner with and vice versa,” said Haf Cennyd, brand director of ICSE in UBM’s Show Daily magazine.
RX-360 in 2012
In a press conference Oct. 25, Guy Villax, board member of the RX-360 Consortium and CEO of Hovione, Portugal, was pleased to discuss the recent activities of RX-360 and the positive feedback received from medicines agencies. RX-360 brings together industry and regulators to address the issues of counterfeits and other interruptions to the supply chain, ultimately to protect the safety of patients. Villas was keen to note that RX-360 is a transversal trade organisation that is open to everyone, referring to membership trends in waves, the first being pioneers, the second a flood of suppliers, and the suspected third wave a deluge of generics companies. With current membership at 70 organisations globally, RX-360 has been working closely with regulatory authorities, including the FDA, EMA and WHO, and seems to have won positive feedback from everyone with hopes to expand further afield; Brazil is a target for 2012.
Giving examples of potentially adulterated acetonitrile and the effects of the tsunami and subsequent radiation leaks in Japan earlier this year, one of RX-360’s aims is to provide early identification of issues followed by rapid response, disseminating information through the website and social media channels at virtually no cost.
RX-360 has recently concluded its Audit Pilot, which aims to improve efficiency in the system through two routes. Sharing of redacted supplier audits through a secure database is the first, with joint audits offering further opportunities; sponsor companies can plan ahead through RX-360 and request joint audits to be conducted by a vetted third party auditor. The audit campaign will be rolled in 2012, and is particularly relevant as the Falsified Medicines Directive (FMD) will make it mandatory to conduct audits of all API suppliers every three years.
EXCiPACT – International Pharmaceutical Excipients Certification
RX-360 also sets standards of quality and offers best practice examples, providing summaries of proposed, draft and enacted legislation. Notably, RX-360 has adopted the EXCiPACT standard for excipients, another NPO initiative whose representative, Folker Ruschatz, BASF Pharma presented at a press conference organised by the European Fine Chemicals Group (EFCG). Ruschatz, an EFCG board member, stressed that excipients need to be as closely monitored as APIs in the supply chain, and will also be impacted by the FMD. One of EXCiPACT main objectives is to make risk assessments easier, requesting an increase in periodical, physical audits whilst also reducing the economic burden. Ensuring that cGMP and cGDP standards are set for today and the future, the last year has seen EXCiPACT raising funds with plans to establish an advisory board and begin operations on Jan. 25, 2012. Once again, feedback has been very positive from regulatory bodies, and I hope to be able to report progress at PharmTech.com.
Finally, Guy Villax graced the stage for a second time on behalf of EFCG, this time to talk about the FDA’s proposed Generic Drug User Fee Act (GDUFA, seemingly pronounced ger-doo-fer), which seeks to raise funds of $299 million for FDA “to allow the FDA to do their job on a global scale.” This means, from the Vilax’ point of view, that FDA will be able to accelerate the approval process, promote faster access to lower-cost, higher-quality medicines, and level the playing field―all major steps forward for generics. Watch this space for news and upcoming information.
Thank you for reading, and see you in Madrid in 2012!