PharmaMedDevice Industry Blog

Medical Technologies, Collaboration and the New Entrepreneur

I was recently made aware of a regional education and networking opportunity at Boston University’s School of Management taking place October 29 which I thought some of our readers may be interested in…The program is focused on innovation in the medical device sector and will feature panelists from some leading medical device companies, institutions and venture capital firms.  The evening program’s topic, entitled “Medical Technologies, Collaboration and the New Entrepreneur” incorporates a lot of the same topics that PharmaMedDevice continues to focus on – “Life Science Industry Convergence and Collaboration” – and I’m always open to sharing similar industry resources that may be of value our audience.  For details, see http://boston.tie.org/TGS/otherFiles/tieboston/file_LS_BU_Event%20details2_Oct%2029,200911s37m0810232007.pdf or register at http://www.tie-boston.org/TGS/EM/viewevent/viewEventPT?id_event=1470+.

Calling all Regulatory Affairs Professionals!

As you know, the role of today’s regulatory affairs professional is changing as the life science industries continue to converge.  It is becoming increasingly more difficult to remain solely a “medical device” or “pharma” person as combination products continue to become more mainstream.  Individuals who can apply their multi-modality expertise across the life science industries are a real asset to the combination products market. According to RAPS research, the number of regulatory professionals involved in combination products has increased from an estimated 12% in 1999 to nearly 30% in 2006.

Continued Advancements for Diabetes Treatments – Intranasal Drug Delivery

Bentley Pharmaceuticals recently announced positive findings from Global Phase II Clinical related to a new intranasal insulin spray - NasulinTM.
The findings were encouraging – with the product showing results equivalent in many key measures when compared with traditional injectable insulin.  The healthcare market has made significant advancements related to improving the treatment options for the millions of Americans who treat diabetes on a daily basis.  Bentley is currently seeking collaboration partners to help conduct additional clinical studies.  This new product would not require constant refrigeration and the delivery device is small enough to discretely fit into a pocket or purse for added convenience and improved patient compliance.  For diabetic patients who suffer from COPD or asthma, the intranasal delivery route represents a new option for those who are not candidates for pulmonary delivery devices. 

Original Press Release link:  http://www.bentleypharm.com/pdfs/pressreleases/pr-062507.pdf

First International Study of Paclitaxel-coated Stent for Use Outside the Heart

Cook Medical recently announced that the first US patients involved in a Phase II clinical trial of the Zilver PTX Stent were treated at Tri-City Medical Center in Oceanside, CA.   The Trial is taking place at 28 US locations and represents the first medical device trial conducted simultaneously in the US and Japan.   Based on clinical data results collected, Cook Medical will be seeking regulatory approval in both markets.   This stent is intended to treat peripheral arterial disease (PAD), which affects more than 10 million Americans each year. Stent implementation is an exciting option because patients can often avoid surgery and get back on their feet much more quickly after having a stent implanted.  It will be interesting to see if the same drug-eluting technology found in cardiovascular stents can be used to treat blockages in arteries outside of the heart – or if any of the long-term clotting concerns will be raised with these products as they have with the cardiovascular stents. 

PharmaMedDevice On Demand

I’m excited to share the news about PharmaMedDevice On Demand – a new webcast library featuring presentations from the recent PharmaMedDevice Conference in New York.   

The library features two complimentary webcasts so listeners can get a sample of the valuable, industry content offered – The Future of Device-Biologics (Presented by AnneMarie Moseley, CEO, Aggregate Therapeutics) – and Bionanotechnology and Drug Delivery (Presented by Raj Bawa, President, BAWA Biotechnology Consulting LLC; Ola Nerbrink, Principal Scientist, Novo Nordisk; and Alan Minsk, Parnter and Leader Food and Drug Practice Team, Arnall Golden Gregory LLP).