IPEC Regulatory Conference Coverage: More Calls to Action

Angie Drakulich PharmTech editorIPEC-Americas Chair Janeen Skutnik continued the call for more standards and regulation for the pharmaceutical excipients industry at yesterday’s IPEC Regulatory Conference afternoon session. “We’re not the Rodney Dangerfields of industry anymore,” she said, playing on the fact that many feel excipients are somehow a “lesser” part of the pharma industry because they’re “inactive” drug ingredients. “We need to work with Congress and regulators to put in place the right standards,” she said. Read more »

IPEC Regulatory Conference Coverage: We Want to be Regulated, Says Excipient Industry

Angie Drakulich PharmTech editor“We want to be regulated.” That seems to be the theme thus far at the IPEC Regulatory Conference, taking place today and tomorrow in Washington, DC. The morning session opened with IPEC Chair Janeen Skutnik talking about how busy the past year has been for the excipient industry and for IPEC itself. With work being done on pedigrees, functionality, GMPS, and GDPS, excipients are taking on all sorts of new lives. Read more »

Report: Online Drug Brand Abuse on the Rise

Alexis Brekke Pellek PharmTech editorPharmaceutical brands face an increased threat online, according to a new report by the brand-protection firm MarkMonitor. The study, Brandjacking Index: Summer 2009, focused on six leading drug brands and examined these key areas of pharmaceutical brand abuse online: illicit pharmacies, listings on B2B exchange sites, and cybersquatting, or the abuse of a trademark within a domain name. Read more »

FDA’s Sharfstein Addresses Industry

Angie Drakulich PharmTech editorThe 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration. Read more »

Securing the Global Supply Chain: FDA’s or Industry’s Responsibility?

danmatlisAt a joint session of the PharmTech Conference and the 4th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million and 346 FTEs toward Medical Product Supply Chain Safety and Security OversightThe globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time. Read more »

Building a “Better Mousetrap” for Biopharmaceuticals

Patricia Van Arnum PharmTech editor The high-profile case of contaminated heparin last year was reason not only to consider issues relating to supply-chain integrity, but it also reminded us how critical a production process is to the quality of a drug substance. Pharmaceutical-grade heparin, a sulfated glycosaminoglycan, is derived from the mucosal tissues of slaughtered meat animals such as pig intestines, and a synthetic route has been elusive. Researchers at the Rensselaer Polytechnic Institute (RPI) report on a potentially interesting solution that may not only be valuable for producing heparin, but may also be a relevant approach for developing other biopharmaceuticals. Read more »

Reports Point to Increased Counterfeit Drug Activity

Alexis Brekke Pellek PharmTech editorA new report released by OpSec Security, a provider of anticounterfeiting and brand protection services, found an increased amount of illicit behavior in sales of bulk pharmaceuticals and prescription drugs over the Internet. Read more »

An International Web May Trap Pharma Counterfeiters, but It Won’t Keep Them for Long

Angie Drakulich PharmTech editorOne of the International Criminal Police Organization’s (Interpol) six priority crime research areas is drugs and criminal organizations. As reported in the New York Times on July 20, the organization is working with an informal group of researchers and government officials in Africa, Asia, and the US to track counterfeit drugs that claim to treat malaria, a disease that takes nearly 1 million lives a year. Read more »

Predicting Gaps in the Supply Chain

Angie Drakulich PharmTech editor“Geopolitical environmental scanning” seems to be the new catch phrase in supply chain security. The term came up multiple times during the ISPE conference and during the launch meeting of the Rx-360 consortium, both of which took place in Washington, DC, the first week of June.

IPEC–Americas Chair Janeen Skutnik mentioned geopolitical environmental scanning as a way to detect, in advance, potential weaknesses in or disruptions to the supply chain that could lead to contamination, adulteration, or counterfeiting. Read more »

Is Industry Ready to Share Supplier Audits? Rx-360 Takes a Shot.

Angie Drakulich PharmTech editorThe buzz around Rx-360, an international pharmaceutical supply chain consortium headed by seven advisory panel members including Martin Van Trieste of Amgen, has been brewing for months. More than 125 people attended the consortium’s launch meeting in Washington, DC, last Friday, June 5—quite a few more than Van Trieste and his team originally expected. Clearly, the turnout demonstrated industry’s interest in working together to help improve supply chain security. Also demonstrating a yearning for cohesion were the results of the meeting’s live polling questions. Using devices to vote from their seats, 100% of meeting participants agreed that Rx-360 was needed. Most also said they would join or are considering joining the consortium. Read more »

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