I am writing to invite you to our webinar on September 11, 2018. These webinars are part of a series – Clinical Development of Antibacterial Drugs for Non-Developers. They are designed with the discovery scientist, pharmacologist, microbiologist and others not directly involved in clinical trial design for new antibiotics. The goal is to provide a framework for those involved in antibiotic research to evaluate the potential development risk for various types of antibacterial products. Our first webinar was held in June, covered traditional (Tiers A and B) development and can be found here.
Our next webinar will cover the development of antibacterial drugs for specific pathogens like Acinetobacter and Pseudomonas. The development of antibiotics for species that commonly cause infections at specific sites like Staphylococcus aureus in skin and skin structure infections and Neisseria gonhorroea in sexually transmitted urethritis is relatively straightforward. But for much less common infections that occur at multiple body sites such as those caused by Pseudomonas and Acinetobacter, there remains considerable doubt around our ability to carry out and gain regulatory approval for products that target one of these pathogens specifically. Beyond regulatory approval, what data do we need to convince physicians, patients, payers, pharmacists and other stakeholders that such a product is valuable?
To discuss the clinical and regulatory approaches to these trials, we have convened a panel of true experts and regulatory authorities. In fact, I don’t think we could have a more authoritative group than this one. Yours truly will be moderating the discussion. Questions from participants are welcome and encouraged.
Sumathi Nambiar, Director, Division of Anti-Infective Products, Office of Antimicrobial Products, CDER, FDA
Mair Powell, Senior Clinical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency (UK)
Ian Friedland, Clinical consultant, Friedland Strategic Consulting, LLC
Drs. Nambiar and Powell have directed and been involved in interactions with sponsors around the design of such trials, have participated in or lead advisory committee meetings on this subject and have helped provide guidance documents on trial design and product labeling. Dr. Friedland has extensive antibiotic development experience and has lead clinical trials targeting specific pathogens (I-CARE for plazomicin) and has been intimately involved in discussions with regulatory authorities on this topic.
Our webinar will take place at 11 am Eastern Time. You can register here.
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