Welcome to our newly launched website and the first ever CEO Blog!

Mark Paxton shaking handsAs noted in the recently re-launched Newsletter, I mentioned a number of new initiatives and activities in which our Board and I have been engaged while simultaneously and seamlessly transitioning to our new organizational structure. Before I go into any detail on those initiatives, I’d like to first thank a couple of people for their vision, leadership, and commitment to the mission of Rx-360.

First and foremost, a shout-out to Martin Van Trieste, recently retired as Amgen’s Chief Quality Officer.  Importantly – and for damn good reason – Martin was recognized as the 13th most powerful person in 2016 in the Medicine Maker just prior to his retirement. Cited as one of the reasons, was his act in being a founder of Rx-360. All of us that move our vision forward through Rx-360, are indeed and forever, indebted to Martin. Many thanks Martin, and may your golf scorecard be inversely proportional to the number of patients you have positively affected.

Second on my list is Brian Johnson. Until January 1, 2017, Brian served as the immediate past-Chair of Rx-360. While still currently a prominent serving Board member, when he was Chairperson, it was Brian’s vision to move Rx-360 forward by transitioning the organization from where it was under its former self, to where it is today. Thank you very much Brian, as you, like Martin, had the right vision for the right reasons at the right time.

Third, we have to thank Guy Villax, CEO, Hovione, and, as of January 1, 2017, immediate-past Chair of Rx-360. As Brian and his Board set the path forward, Guy and his Board made it happen. Wow. What. An. Incredible. Effort. Guy, the thanks needed cannot be recounted here.  Muito obrigado!

Fourth, Lynne Byers, Novartis. Lynne, like me, is a former regulator. As the immediate past Treasurer – a role that Lynne willingly adopted (for still unknown reasons!) since first coming to Rx-360 early in its formation, she has served in this capacity. Under her financial guidance, a role that is not inherently attributable to a quality professional, Lynne made sure that this transition was financially feasible. Thank you so much Lynne for all that you have done!

Finally, while I have too many current and past Board Members engaged in the ultimate delivery of the new Rx-360 business structure to talk about in this first Blog, I have nothing but the deepest of respect for all of you. For those of you that I have had the great pleasure of working with, you have all demonstrated to me an unparalleled passion for what Rx-360 does. As an organization, we have been very, very fortunate to have all of their leadership skills and acumen available to Rx-360 and our Members!

Moving now to the exciting initiatives and activities we outlined in our recently re-launched Newsletter, I provide additional information that is important to our Members, Observers, and all others that believe in our mission to promote patient safety.

Since you are reading this Blog, I hope you have now had the opportunity to navigate our newly launched website! This is exciting. If so, we hope you have found it easy to navigate, with increased functionality for registered users that far exceeds prior capabilities. If you haven’t registered, or if you previously registered at our old website, please register (or re-register if that is the case). It takes less than 30 seconds. We also now have a robust Members Only log-in. If you are team member of one of the Rx-360 member companies, please click here to set up your member email address.

Consistent with our mission, Rx-360 is in the process of creating a much more impressionable footprint across the globe. Our Members are continuing to support our workshops covering Good Distribution Practices (GDP) in Africa, where our Members have already supported seven (7) different GDP (Good Distribution Practice) workshops directed at wholesalers and other logistics. We are also closely working with the China Food and Drug Administration, the Chinese Pharmaceutical Association for Plant Engineering (CPAPE) on piloting our Joint Audit Program for both GMP and GDP audits in China, and have the opportunity to work with the CFDA and the Chinese Federation for Logistics and Procurement (CFLP) on training programs for our downstream Supply Chain Security practices. Importantly, CFDA has requested that Rx-360 extend its proposal for piloting its Joint Audit Program to all members of the APEC Regulatory Harmonization Steering Committee (RHSC) which includes senior policymakers from National Regulatory Authorities from across the APEC, including US FDA. If accepted by the APEC RHSC, we will have opportunities to simultaneously work with national regulatory authorities from western Latin America and Asia-Pac.

Because Rx-360 Members are not the only organizations suffering from audit fatigue and increasing costs associated therewith, Rx-360 is now working closely with a new Observer – the Bill and Melinda Gates Foundation (BMGF) – to extend our Joint Audit Program to lesser-resourced organizations. This is exciting as the Rx-360 and BMGF missions for patients are very closely aligned. And of course, we are hopeful that other, exciting programs will follow. Similarly, we have been in preliminary discussions with the International Air Transportation Association for adoption of common air carrier standards for handling biopharmaceuticals, the Regulatory Affairs Professional Society for creating training and others. All of these activities will take time of course, but we will keep all of our Members and readers abreast as existing opportunities develop and new ones arise.

Finally, if you missed our Annual Conference November 4-5 at the Gaylord Conference Center in Washington D.C., you really missed something quite motivational for what we do as an organization. Without the need to say anything else, simply click here to watch videos taken at the Annual Conference and please feel free to explore and engage with us on our Facebook page.

Kind regards,

Mark Paxton, CEO