Looking Forward

 I wanted to get out a brief blog just to let you know what I’m doing. As a follow-up to my last blog, I am interviewing key executives from large PhRMA to discuss incentives for antibiotic R&D. I conducted my first interview today – fascinating!  The next is in another week.  Stay tuned. We are all going to learn about reasoning in large pharmaceutical companies as far as these incentives are concerned.

For those of you who are not on John Rex’s mailing list, I want to point out a number of key upcoming FDA meetings and workshops.

March 19 - Statistical Methods and Trial Designs in Drug Development for Rare Diseases – https://healthpolicy.duke.edu/events/utilizing-innovative-statistical-methods-and-trial-designs-rare-disease-drug-development

March 20 - Promoting the Use of Complex Innovative Designs in Clinical Trials - https://www.federalregister.gov/documents/2018/02/26/2018-03804/promoting-the-use-of-complex-innovative-designs-in-clinical-trials-public-meeting-request-for

April 16 - Evaluating Inclusion and Exclusion Criteria in Clinical Trials - https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials

All of these could be relevant and important for antibiotic developers.