PharmaMedDevice Industry Blog

FDA Approves Neupro Patch

For those suffering from early signs of Parkinson's, there is now a simple and effective drug delivery system for treatment. Earlier this month, the U.S. Food and Drug Administration (FDA) announced the approval of the combination product Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease.  Neupro Patch is the first transdermal patch approved for the treatment of the signs and symptoms of early-stage Parkinson's disease and is manufactured by Schwarz Bioscience of Research Triangle Park, N.C.  Schwarz also intends to submit a New Drug Application to the FDA for the treatment of advanced Parkinson’s disease by the end of the year.

Rotigotine is delivered transdermally and is designed to mimic the action of dopamine, a naturally-produced neurotransmitter crucial for proper motor functions. The symptoms of Parkinson's disease result from

Combination Products Whitepaper

A newly announced white paper, "Combination Products: Navigating Two FDA Quality Systems," authored by Microtest Laboratories Inc's President and Chief Scientific Officer, Steven Richter, Ph.D, points out some of the challenges that manufacturers are facing when developing combination products. Many of you probably caught Richter's presentation "The Challenges of Testing Combination Products" at PharmaMedDevice this past April.

This paper is a great validation for many in the industry as it states that the FDA received 275 combo product submissions in 2005, and an estimated 30% of new products under development today are combo products.  It also reinforces that these innovative combination products bring a host of regulatory challenges and questions for manufacturers – related to testing guidelines, practices, and regulations unique to these products – and how manufacturers need to ensure that quality systems are in place and compliant with FDA regulatory requirements. This six page white paper is available for free download at http://www.microtestlabs.com/combinationpaper. Enjoy!

The Promise of Personalized Medicine - Innovation and Collaboration

Converging Biotechnology, Nanotechnology and Information Technology - Leading the Charge for Personalized Medicine -- A recent article in the Houston Chronicle discussed healthcare trends of the future with a focus on how biomedical innovations are likely to impact the promise of personalized medicine. It explores the convergence of the biotechnology, nanotechnology and information technology fields and addresses the sizable future markets for pharmaceuticals and medical devices made possible by these three converging technologies. Personalized medicine should not be considered a new business model, but rather a revolutionary combination of scientific breakthroughs resulting from collaborative life science research. As a patient, the promise of personalized medicine remains a highly attractive option. It introduces the concept of a personalized dose and treatment schedule based on one’s specific genetic and physical information. Customized medicines will essentially take out the guess work of treating patients and enhance patient outcomes.
And it is estimated that the demand for nanotechnology medical products will grow by more than 17% annually to reach $53 billion in 2011.*

It appears as though innovation and collaboration are becoming synonymous terms!

Harvesting for Combination Products

Do you see yourself as a thought leader in the converging medical device, pharmaceutical, and biologics industries?  Do you have an idea, innovative solution, unique application or success story that would benefit your colleagues?

Following on the success on the 2007 conference, PharmaMedDevice is looking for submissions of papers for the most comprehensive forum for the convergence of the medical device, pharmaceutical, and biologic industries. Share your expertise as the dynamic future of combination products and drug delivery technology continue to evolve for 2008. This conference will provide a dynamic knowledge-based platform for education, partnering, sourcing, and discovery of innovative new products – and a unique opportunity for cross-sector collaboration across these industries. The sessions will also address the exciting new technologies that are revolutionizing the healthcare industry – including personalized medicine, bionanotechnology, and novel drug delivery systems. We are looking for presentations in the following areas:

Changing of the guard at the OCP

The US Food and Drug Administration (FDA) has named Joanne Less as the acting director of the Office of Combination Products (OCP). Less recently replaced Mark Kramer, who recently resigned as FDA's director of the OCP. Less is currently the associate director for clinical research and government affairs in the Center for Devices and Radiological Health and is considered the expert on the laws, regulations, and policies governing the clinical investigation of medical devices. Less recently made her debut at PharmaMedDevice's Conference and Exhibition regarding the FDA's Premarket Review Process for Combination Products, where she gave great insight on strategic steps for bringing combination products through the FDA review process.

In step with this change, GE Healthcare has announced that Mark Kramer has joined as Vice President, Regulatory Affairs. Kramer brings a wealth of knowledge to this postion at GE with more than 17 years of experience from the FDA as well as insight on regulatory affairs and quality compliance relating to their product development. Read more at http://www.dotmed.com/news/story/3735/.

Congratulations to both and we are excited to see how this will positively impact the converging industries of pharma, medical device, and biologics.