Looking Ahead - Rx-360 turns two years old this month, and the international supply chain consortium can look back on a host of achievements. The group now boasts over 50 organizations globally have joined either as members or observers. Rx-360 has also been in intensive talks with regulatory bodies around the world, including the U.S. Food and Drug Administration; the European Medicines Agency; the World Health Organization; the Irish Medicines Board; and the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme. Now that the group's infrastructure is set up, it is moving into its shared-audits phase. Brandi Schuster spoke with Rx-360's new chairwoman Lynne Byers about the group's visions for 2011.

CHEManager Europe: Ms. Byers, what are your goals for 2011 within Rx-360?

L. Byers: We are looking to complete our pilot audit program by May. This comprises about 36 audits to prove that the processes we have set up and the standards we have developed are working to our expectations. Once that's completed, we will move into the routine operation of shared audits. We hope to complete an additional 100 audits under the joint program as well as an additional 100 audits under the shared audit program in 2011.

We are also planning to make existing audit reports from company members available to our Rx-360 members. We now have approval from the U.S. Federal Trade Commission that sharing this information among our members is permissible from an anti-trust perspective. This means that audits that have been done by member companies will be redacted of any commercially sensitive information.

That means there's no risk of inside company information being leaked to competitors through the sharing of the audit reports?

L. Byers: Yes, and also the suppliers who has been audited will be asked to permission before the reports are shared with our members. It is then up to them to decide which companies can receive a copy of the report. For example, they probably wouldn't permit a competing supplier to have access to the information.

What are your goals as far as your membership numbers are concerned?

L. Byers: Of course we want to expand our membership, both on the supplier and manufacturer side; specifically, we'd like to expand our membership to a total of 75 members, including 10 pharmaceutical company members. Something else we are always working on is improving the worldwide knowledge and understanding of what Rx-360 does. We've been very focused on Europe and the U.S. during our first two years; now we want to extend our reach into Asia Pacific. Spe the

How specifically?

L. Byers: We are currently reviewing the possibility of holding conferences in China and India. We have shown presence there through members of our board who have presented at conferences in these regions. However, the time has come to consider running a conference ourselves. We are also planning on hosting an Asian Open Day in the fall.

A Japanese introduction is also planned ...

L. Byers: We are working with one of our members, Takeda, to brainstorm ideas on how Rx-360 can best approach the Japanese market. Introductions are very important in the Japanese culture, therefore it's vital for us to work with a company based there.

What other efforts is Rx-360 undertaking to intensify the activities between all of the stakeholders Asia?

L. Byers: The SFDA, which is China's state food and drug administration, participated in training in Puerto Rico a few months ago, and one of our board members had the opportunity to give a presentation to the regulators on what Rx-360 is doing. It's important for us that the SFDA is aware of our objectives, particularly because audits will also be done in China. The information presented was well received by the SFDA members in attendance.

Does Rx-360 have plans to boost membership on the supplier side?

L. Byers: We exhibited at the CPhI in October in Paris, which gave us the opportunity to speak with suppliers. Also, we were able to drum up interest for Rx-360 at the EFCG dinner that was held during the show. The dinner brings together the most important leaders and decision makers within the world of fine chemicals. We were also grateful to have the support of the EFCG's chairman Guy Villax, who spoke about our efforts during the dinner.

What part of the pharmaceutical supply chain do you consider to be most at risk?

L. Byers: I don't think there's any one part that's particularly at risk, but if I had to pinpoint one possible area, that could be the distribution from the manufacture to the pharmaceutical company. Understanding how materials are transported and finding out the answers to questions such as "Does the material go through an agent? Do they re-label or repack the material?" I think the real challenge is understanding all the facets of the supply chain and making sure every link in the chain is strong. It's also important that every link is assessed by Rx-360 or individual companies in order to further understand where any potential for risk may be.

What does Rx-360 do to raise awareness about possible weak points within the pharma supply chain? What can companies do to ensure that they are not this weak spot?

L. Byers: It's growing, unfortunately not completely unrelated to the series of tragic incidents we've seen over the last few years - adulterated glycerin with diethylene glycol found in cough syrup; contaminated Heparin; infant formula laced melamine, etc. Companies are now more aware of possible supply chain weaknesses and work to have a full understanding of the supply chain.

Regulating bodies, particularly in Europe, now expect companies to be able to write a risk assessment on the whole supply chain. While that is currently only a pilot program at the moment, that is the sort of thing we can expect to be seeing in the industry in the future.

How would you describe Rx-360's relationship with national regulatory bodies, such as the U.S. FDA or European Medicines Agency?

L. Byers: It's a very cooperative relationship. We've had many meetings with different regulators regarding our plans for going forward, which have been met with positive resonance. They want us to secure the supply chain.

About Lynne Byers
Lynne Byers has a degree in chemistry, is a chartered chemist and a fellow of the Royal Society of Chemistry. She has worked throughout her career in the pharmaceutical industry, both within industry, working for GlaxoSmithKline and UCB and also worked as head of Inspectorate and Licensing for the MHRA, the UK regulator. Her current role is Head of Quality Shared Services within GSK.