This blog post was written by Ben Comer of Pharmaceutical Executive magazine.

Recognizing that traditional market forces – namely incentives related to intellectual property and a steady demand for products – have failed in developing countries, the World Health Organization (WHO) asked a member state-nominated group to come up with ways to fund R&D and pay for the treatment of neglected diseases in the world’s poorest nations. The group’s proposals will be discussed at the sixty-fifth session of the World Health Assembly, beginning today in Geneva. Dr. Paul Herrling, a member of the group and head of the Novartis Institute for Tropical Diseases, sat down with PharmExec to explain the group’s process, conclusions and next steps. Read more »

ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. Q11 was published as a draft in May 2011 and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organizations in the US, Europe, and Japan), have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies, including FDA, will publish the guideline as official guidance within their appropriate regions and implementation will begin. Read more »

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story). As a result, digital signatures are becoming more commonplace throughout laboratories, manufacturing sites, and offices as companies search for ways to track and file processes, SOPs, approvals, supply chain movement, drug applications, and more. Quality management systems, much like our personal lives, are becoming far more digital and far less paper-based.

PharmTech discusses this issue and related compliance issues in a recent webcast, available on-demand here.

FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total). She and Philip Merrill of IPEC wrote about the library last summer in PharmTech and Bushe gave an update on the program at the IPEC ExcipientFest Americas conference in late April 2012..

Hand-held instruments containing the libraries are being used at the borders to rapidly verify and authenticate materials via XRF, IMS, Raman, and NIR screening methods. Materials in question are then investigated at local FDA laboratories.

FDA has been collecting samples from the industry to add to the library but only has about 20% of its most wanted materials (see Table I in the July 2011 PharmTech article) thus far. Incoming materials must match a Hit Quality Index of 0.95. Bushe pointed out that the supplier or site of material used for the library has not had a significant or statistical impact on the library index to date. Samples are therefore being collected from various industry players and from various sites.

Looking ahead, FDA aims to fill its library with all the excipient samples it’s seeking and will work to finalize its classification and modeling strategies.

Jim Miller of PharmSource gave a keynote talk this week at Interphex 2012 in New York City on the state of the industry’s outsourcing environment. Miller is also a member of the PharmTech Editorial Advisory Board. Below are a few highlights from his talk. Read more »

PDA is hosting a few interesting workshops in the coming weeks on key topics facing the industry. PharmTech spoke to experts participating in the workshop plans and you can listen to the interview podcasts here.

The two events are: 1-PDA/FDA Virus and TSE Safety Conference (May 15-17, 2012, Bethesda, MD): Interview with Dayue Chen, a Research Advisor in Bioprocess Development at Eli Lilly and Company. The focus of the conference is on Proactive Approaches to Mitigate Virus & TSE Risk. 2-QbD and Vaccines: A PDA/FDA Workshop (May 14, Bethesda, MD): Interview with Sam Venugopal of Pricewaterhouse Coopers. The focus of the workshop is on Applying QbD Principles in Vaccine Development.

Chen and Venugopal discuss why these topics were selected, current challenges within these areas, and key questions to be addressed at the meetings.

Here at ExcipientFest 2012, in connection with IPEC, rooms are full of attendees listening for ways to better follow GMPs, for best testing practices, for ways to manage user-supplier relationships and more. Below are a few key points made thus far. Read more »

Here at ExcipientFest 2012 in San Juan, excipient manufacturers and users are debating how to move foward surrounding the issue of atypical visible particles found in excipients. A speakers panel was held yesterday afternoon featuring Dale Carter, chair IPEC Americas; Cindy Buhse with FDA; Dave Schoneker of Colorcon and IPEC; and Ann Van Meter with Dow Wolff and IPEC. Read more »

Today in San Juan, at ExcipientFest 2012 in partnership with IPEC, Michael Beatrice of Abbott spoke about the seven deadly sins of quality management. Beatrice heads Quality at Abbott and used to serve as deputy director of CBER at FDA. The seven items to avoid, he notes are: bureacracy, tradition (just because you’ve always done something a certain way doesn’t make it right), excess (too many priorities), isolation (lack of communication among groups and with public), deafness (not listening to employees at all levels), and complacency. Read more »

FDA’s Center for Drug Evaluation and Research (CDER) has been running an educational regulatory-based forum since 2005 to engage its international regulatory counterparts. This forum includes online learning and continuing education courses on how the Center organizes its drug-review process in the US. Read more »