Big Pharma and Other Changes On the Way
The aisles were packed at this year’s Interphex conference in New York City with industry professionals seeking the latest and greatest in pharma manufacturing equipment—and so were the conference sessions. PharmTech presented three Signature Series sessions at this year’s show featuring officials from FDA, PharmSource’s Jim Miller, and Hovione CEO Guy Villax. Our staff was also busy at the Main Stage conducting live, videotaped interviews—be sure to check our site to watch us in action. Here’s a preview of the first day of vidcasts from the Interphex site.
I introduced Villax’s session on supply-chain security and he provided unique insight into what industry might expect in the decade ahead. For example—transparency, he said, is going to become far more necessary. Since the introduction last year of Rx-360, the supply chain consortium, many companies have been considering sharing audit reports to help ease their audit burden.
And as patients become more interested in what’s inside the drugs they are taking and where the drugs are coming from, companies are going to have to open up whether they like it or not. Villax said industry can also expect more “naming and shaming.” For example, if FDA or another regulatory agency issues a Warning Letter, industry may also see a press release with specific company and supplier names and locations listed—essentially alerting the public to which manufacturers or suppliers may have done something that’s noncompliant.
As manufacturers, patients, and regulators (FDA launched a transparency website in 2009) move toward a more open and flexible environment, we may be witness to a whole new industry 10 years from now.
Managing the supply chain is definitely integral to the performance of the drug, in terms of buying statistics. To that extent, my point of sharing audit reports and inter-managing the supply chain security was well endorsed by Guy Villax, the CEO of Hovione. That being said, I am not too open to the idea of industry players releasing press-releases on non-compliance by a manufacturer to FDA rules. To me, that is being a bit narcissist in perspective.