On the final day of RDD Europe 2011 in Berlin, most of the focus turned to the abbreviated impactor method (AIM) and efficient data analysis (EDA), but the first session of the morning was devoted to advanced imaging methods for understanding drug delivery. The first speaker, Henk Versteeg of Loughborough University, described his method for studying transport of … [Read more...] about RDD Europe — Day 3
Features
RDD Europe–Day 2
The most intense discussions of Day 2 of RDD Europe occurred during an afternoon session on LABA and LABA/ICS postmarket trial design in which industry representatives differed with each other and with regulators over the usefulness of LABA safety trials such as those now demanded by the FDA. The afternoon culminated with a panel discussion that featured fairly blunt … [Read more...] about RDD Europe–Day 2
RDD Europe — Day 1
At the kickoff of RDD Europe 2011 in Berlin, Peter Byron of co-organizer RDD provided some attendance figures to the assembled delegates, telling the crowd that they number 470 in all, with ~85% of attendees representing pharmaceutical companies and ~9% coming from academia. A number of regulators are also in attendance. According to Byron, delegates have come … [Read more...] about RDD Europe — Day 1
Gateway Analytical holds grand opening
Gateway Analytical, a subsidiary of ChemImage Corporation, held a grand opening celebration at its new facility in Gibsonia, Pennsylvania on April 12, 2011. The 3,000-sq ft cGMP facility actually opened for business in October, 2010, offering services for the forensics, materials, and pharmaceutical industries. The festivities were meant to take place on February 1, … [Read more...] about Gateway Analytical holds grand opening
FDA approval times for OINDPs have decreased
A review of FDA approval times for OINDPs presented at the recent IPAC-RS conference verifies that the process has sped up considerably over the last decade. According to the poster authored by Ray Ormiston of IPAC-RS’s Global Regulatory Affairs and Outreach Committee, whereas most of the 20 OINDP submissions from 1992-2003 took 2-3 years for approval, and several … [Read more...] about FDA approval times for OINDPs have decreased
RDD Europe organizers expect largest meeting to date
RDD Europe 2011 will be the largest iteration so far of the European version of the Respiratory Drug Delivery meetings, says Richard Dalby of co-organizer RDD. Already, more than 400 people have registered for the May 3-6 meeting to be held at the Dorint Hotel Convention Center Berlin (formerly the Intercontinental). Anyone planning to register on site should know … [Read more...] about RDD Europe organizers expect largest meeting to date
Another FDA group seeks to review OINDPs
The 2011 IPAC-RS conference, held in Rockville, MD March 29-31, featured speakers from a number of FDA offices discussing the agency’s efforts relevant to orally inhaled and nasal drug products (OINDPs). Among those speakers was Ronald Kaye, Human Factors Pre-Market Evaluation Team Leader from the Office of Device Evaluation in the Center for Devices and Radiological … [Read more...] about Another FDA group seeks to review OINDPs
IPAC-RS conference — Day 2
Speakers representing the FDA and several IPAC-RS working groups dominated day 2 of the 2011 IPAC-RS conference, with presentations and panel discussions on the day's main topic, "Product Quality." The day began with the keynote address delivered by Prasad Peri of the FDA's Office of New Drug Quality Assessment and concluded with the announcement of the poster … [Read more...] about IPAC-RS conference — Day 2
IPAC-RS conference — Day 1
Day 1 of the 2011 IPAC-RS conference featured 13 talks and a panel discussion, covering two topics aligned with the conference theme of "Bring Value to the Patient in a Changing World." The morning focus, "Voice of the Customers," included presentations by clinicians, a patient education specialist, and the FDA Office of Special Health Issues, in addition to a report … [Read more...] about IPAC-RS conference — Day 1
Inhalation IP up for sale at live auction
On March 31, 2011, 150-200 prospective buyers will gather in a Beaux Arts ballroom in New York City for ICAP Ocean Tomo's Spring 2011 Live Auction. After having attended a welcome dinner the previous night featuring keynote speaker Malcolm Gladwell, the attendees will get down to the business of buying intellectual property amid the Corinthian columns and marble … [Read more...] about Inhalation IP up for sale at live auction