COIN hosts nanobiotechnology event on nanomedicines and the regulatory path

The Center of Innovation for Nanobiotechnology (COIN) today announced the upcoming NanoBio Executive Roundtable event to be hosted at RTP Foundation in Durham, NC on May 17, 2011. This Roundtable will tackle regulatory issues surrounding nanomedicine commercialization.  The “Nanomedicines and the Regulatory Path” Roundtable will kick off with a presentation from Katherine Tyner, Ph.D., a Chemist in the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA).

Dr. Tyner will speak generally on nanomedicine issues from a research perspective and how current FDA guidances apply to nanomedicine products. She will then join other experts in a panel session moderated by Don Alexander, Vice President of Life Sciences Development and Commercialization at Carlyle & Conlan. Joining the panel are Richard Phillips, Ph.D., a Global Regulatory Consultant with PPD Global Regulatory Consulting, and Lawrence Tamarkin, Ph.D., the CEO and Co-Founder of CytImmune.

Dr.  Katherine Tyner is a chemist in the Division of Drug Safety Research in the Center for Drug Evaluation and Research (CDER). After a PhD in Chemistry and a postdoctoral fellowship in a joint appointment between the Toxicology Program and the Chemistry Department at the University of Michigan she joined the FDA as a chemist specializing in nanotechnology. Her research involves assessing nanotechnology as it relates to the safety and efficacy of therapeutics.  Dr. Richard Phillips is a Global Regulatory Consultant for PPD Global Regulatory Affairs, providing strategic global regulatory strategies to optimize development and registration success and to identify and leverage available regulatory opportunities while mitigating regulatory risk. Dr. Phillips has extensive experience in the pharma and biotech regulatory space, with senior regulatory management roles at Cougar Biotechnology, AMGEN, Chugai Pharma, Pfizer, SGX Pharmaceuticals, Janssen Pharmaceuticals, Novartis, G.D. Searle & Co., and Baxter International. Dr. Lawrence Tamarkin is the CEO and Co-Founder of CytImmune, a clinical-stage company developing and commercializing gold-based nanomedicine cancer therapeutics. Dr. Tamarkin was previously the Head of the Psychoneuroimmunology Program at the National Institute of Mental Health, was a researcher at the National Cancer Institute and the National Institute of Child Health and Human Development, and an Associate Research Professor at the University of Maryland.

This NanoBio Executive Roundtable event series offers executives and entrepreneurs of North Carolina-based nanobiotechnology companies and others involved in this exciting field an opportunity to discuss key business issues and build relationships. In total, the previous three Roundtables have attracted over 400 attendees from eight states. Don Alexander says “The COIN NanoBio Roundtable events are meaningful in that they coalesce industry, academic and other professionals with relevant scientific, educational and commercial opportunities in the nanobiotech sector.  The knowledge and networking is excellent.”

COIN coordinates these Roundtables to stimulate dialogue in the community and be a catalyst for relationship-building that is critical for accelerating the commercialization of nanobiotechnology. COIN is a non-profit that is a single point of entry into the nanobiotech community and offers high-value programs and services that are designed to help accelerate innovation management and new product development and commercialization in the area of nanobiotechnology and nanomedicine.

Nanomedicines and the Regulatory Path is a key topic of discussion for the growing nanobiotechnology sector. COIN has invited these experts to discuss the nanomedicine commercial path. The NanoBio Executive Roundtable event will be held at the RTP Foundation (12 Davis Drive, Morrisville, NC) on May 17, 2011 from 5:30 to 6:45 pm, with registration opening at 5 pm. Attendees will also enjoy a gala networking reception that facilitates connections that lead to collaborations and new business relationships. There are several generous sponsors for the NanoBio Executive Roundtable series, including RTI International, McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), MEMSCAP, and Grant Thornton. Carlyle & Conlan have generously sponsored the networking reception at this Nanomedicines and the Regulatory Path event.

To register for this free event, please visit http://nanomedicinemay.eventbrite.com/ or contact Clare Valcore at [email protected].

www.nc-coin.org.