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 from almost 30 different countries, including India, Bangladesh, Singapore, Israel, New Zealand, Slovenia, and Uruguay. Europeans make up two thirds of the total number attendees, with the largest contingent being from the UK, and approximately one quarter of the delegates have traveled from North America.
The scientific portion of the meeting began with a plenary lecture titled “Genetics and Environment: Their Influence on Rational Aerosol Drug Therapy for Asthma.” Adnan Custovic, Professor of Allergy and Head of the Respiratory Research Group at the University of Manchester exhorted the RDD crowd in the manner of a television evangelist, preaching that the result of the past 50 years of asthma drug development has been “a big fat zero,” “a tremendous failure by both Pharma and academia,” and asking that the industry now undertake to “apply 21st-century technology to age-old problems.”
While he acknowledges some advances in formulation and drug delivery, Custovic derided the “one size fits all” approach to asthma treatment, asserting that medications must be tailored to asthma phenotypes in order to successfully treat patients. Asthma, he suggests, must be acknowledged as the sum of a number of diseases, not mistaken for a single disease. To that extent, his lecture echoed talks by clinicians at the recent IPAC-RS conference.
Dr. Custovic described a long history of failures in the identification of asthma phenotypes based on genetic or environmental factors, showing how numerous studies produced conflicting results. In example after example, he showed that separate studies have concluded that a particular factor such as cat ownership or a particular gene mutation confers protection, and that it increases risk, and that it has no effect.
Attempts to distinguish phenotypes of asthma, he argued, have been “grossly oversimplified,” and researchers need to stop trying to use epidemiology, which has failed to provide answers, and instead “embrace complexity” and recognize the non-linear relationships between genotype and phenotype. Custovic described his group’s approach using a “machine learning approach” with Bayesian inference techniques to identify how environmental factors may differently affect patients with particular genetic mutations. His group, for example, has found that hgh endotoxin exposure may be associated with protection against allergic disease in those with a specific genotype, but other patients will not receive that benefit.
After the plenary address, a session on Drug Development Challenges featured detailed descriptions of technical processes used in the development of formulations of inhaled drugs including vilanterol, indacaterol, ASM8, and liposomal ciprofloxacin. The last talk in the session described the adaptation of the Turbospin device for the high powder loads required to deliver tobramycin inhalation powder in what will be marketed as the TOBI Podhaler.
In the afternoon, delegates chose to attend up to four different workshops out of twelve offered. Workshops ranged from characterization of nasal spray plumes to techniques to accelerate Phase 1 clinical trials.
