Nanodrugs in the Post-Blockbuster World – Critical FDA Regulatory and Patent Issues

Date: 11/15/2013
Time: 1:00 pm – 2:00 pm
Location: 121 Snell Library
Speaker: Dr. Raj Bawa, President and Patent Agent, Bawa Biotech LLC

Nanodrugs in the Post-Blockbuster World – Critical FDA Regulatory and Patent Issues

Raj Bawa, MS, PhD

President and Patent Agent, Bawa Biotech LLC, Ashburn, Virginia, USA

Scientific Advisor, Teva Pharmaceutical Industries, Inc., Israel

Adjunct Professor, Rensselaer Polytechnic Institute, Troy, New York, USA

Founding Director, American Society for Nanomedicine, Ashburn, Virginia, USA

Nanomedicine is part of the high-risk, high-payoff global nanotechnology phenomenon. One of the greatest impacts of nanomedicine is taking place in the context of drug delivery where novel nanodrugs and nanocarriers are addressing various fundamental problems of traditional drugs ranging from poor water solubility, toxicity issues, low bioavailability and a lack of target specificity.

In today’s global economy, pharmaceutical companies are under enormous pressure to maintain profitability in light of numerous challenges ranging from revenue losses due to patent expirations on blockbusters to enhanced regulatory oversight to an ever-increasing challenge from generic manufacturers. This coupled with the fact that there are numerous market forces and drivers dictating a change in pharma’s quest for discovering, developing and delivering novel therapeutics, is altering the pharma landscape. Clearly, new ground rules and competitive business strategies are needed in the post-blockbuster world.

Emerging technologies, like nanomedicine, also bring with them concerns and uncertainties about how they should be regulated. While complex nanodrugs and nanosimilars hold great promise for addressing some of the most challenging issues in nearly every medical specialty, the US Food and Drug Administration (FDA) has yet to formulate “official” regulatory guidelines for these nanoproducts. The safety and efficacy of nanodrugs can be influenced by minor variations in their structure, composition and the bioenvironment of use – areas that are still poorly understood. Therefore, many experts believe appropriate characterization of these medicines may, in some cases, require clinical trials to ensure the safety of patients. It is generally accepted that regulation of nanomedicine must balance innovation and R&D with the principle of ensuring maximum public health protection. The FDA has struggled to handle the issue of nanogovernance. Clearly, guidance is critically needed to provide clarity and legal certainty to manufacturers, policymakers, healthcare providers and the consumer. However, the “baby steps” the FDA has undertaken over the past decade are generally considered inadequate and have contributed to regulatory uncertainty.

With this backdrop, my presentation will highlight, via pictures and animations:

•definition of nanotechnology and nanomedicine – hype, confusion, realities and trends

•size-driven innovations in pharma – benefits and properties of nanoparticles, FDA approved nanodrugs

•nanogovernance at the FDA – baby steps lead to regulatory uncertainty, combination products

•New Drug Applications (NDAs) vs. Abbreviated New Drug Applications (ANDAs) for nanodrugs

•critical issues and strategies relating to patenting nanodrugs – a primer for physicians and scientists

•the current “patent land grab” by “patent prospectors” in nanomedicine and the impact of emerging “patent thickets” on commercialization

•role and interplay of federal bodies (FDA, US Patent Office, US Congress) on commercialization efforts

•our converging world and the future of (nano)medicine in the age of personalized medicine