FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

Why Should You Attend:

Infection is a growing global problem once only addressed through the design of antibiotics. As has been well documented, bacteria frequently develop a resistance to antibiotics, and thus, researchers have explored new avenues to keep bacteria from harming human health.

This webinar will cover the approach the FDA has taken towards regulatory approval of new pharmaceutical agents to treat bacteria and how that approach is changing in light of the growing number of antibiotic resistant bacteria strains. It will also emphasize non-drug solutions as a way to obtain faster FDA approval for fighting infections.

Learning Objectives:

• Infection and how to treat infections
• What technologies (FDA and non-FDA) exist to fight infections
• What future directions and opportunities exist for fighting infections

Areas Covered in the Webinar:

• Fundamentals of infection and the use of materials/drugs to fight infection
• What is an infection
• Antibiotic-resistant infections
• How do you stop an infection
• Viruses versus bacteria
• Medical device mediated versus non-medical device mediated infections
• Material versus drug approaches
• FDA regulatory approvals for drugs and materials used to fight infection
• Currently approved drugs used to fight infection
• Currently approved materials used to fight infection
• FDA guidance documents for approaches to fight infection
• Future thoughts on approaches to fight infection
• Remaining hurdles
• Outlook for new technologies

Who Will Benefit:

• Scientists
• Industry personnel
• Students (all levels)
• Patent lawyers
• Clinicians
• All persons with an interest in improving how we treat infections

Instructor Profile:

Thomas J. Webster has degrees in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). In his 15 years in academics, Prof. Webster has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles (222) and/or conference proceedings (181), at least 567 conference presentations, and 32 provisional or full patents. Some of these patents led to the formation of 9 companies.

His research on nanomedicine has received attention in media publications including MSNBC, NBC Nightly News, PBS DragonFly TV, ABC Nightly News via the Ivanhoe Medical Breakthrough Segment, Fox News, and the Weather Channel. His work has been on display at the London and Boston Science Museums. He is the founding editor-in-chief of the International Journal of Nanomedicine, has helped organize 22 conferences emphasizing nanotechnology in medicine, and has organized over 53 symposia at numerous conferences emphasizing biological interactions with nanomaterials. He also chaired the 2011 Annual Biomedical Engineering Society Meeting and has organized numerous symposia for MRS, AIChE, and ASME conferences.

Prof. Webster has received numerous honors including, but not limited to 2013 Fellow, Biomedical Engineering Society and 2014 Fellow, Ernst Strugmann. He currently serves as the director of the Indo-U.S. Center for Biomaterials for Healthcare which serves to catalyze research between the U.S. and India in the area of biomaterial science with over 20 participating universities and industries. He was also recently elected president of the U.S. Society for Biomaterials.

Follow us :