PharmaMedDevice Industry Blog

Home-Brewed Beer Sparks Notion for Exciting Biomaterials

There was something more to the batch of home-brew when David Masters, Founder and CEO of Gel-Del Technologies, was about to use skim milk as a glue for his beer labels. The chemical reaction transforming it into glue got him thinking about the chemical make-up of skim milk, and how such a combination of protein, milk and carbohydrates might be converted into a natural biomaterial used for more effective drug delivery.

This concept, along with Master’s research at Harvard University and the Mayo Clinic developed into Gel-Del Technologies’ MasterGel products and over 25 patent applications for medical uses ranging from diagnostic and ort hopedic to neurological and vascular. MasterGel, a protein and carbohydrate biomaterial, mimics the human body’s tissues and is being applied to several products in development, including an injectable wrinkle treatment,

Do your combination product homework

by Christopher Delporte, Group Editor, Medical Product Outsourcing

No matter how promising the therapy an innovative drug-device combo offers, regulatory waters still must be navigated and the nature of the category presents unique challenges. The FDA’s Office of Combination Products (OCP) was created in 2002 to facilitate the review process by helping to determine which agency branch would best evaluate a product.

The OCP evaluates the product’s primary mode of action and assigns review to the center within the FDA with primary jurisdiction over that component. Because manufacturers bringing a new product to market often face

FOI- Oh Boy!

FOI Online is an interesting website being shared for those in need of FDA regulatory documents. FOI maintains a library of more than 150K FDA documents in all categories of products regulated by the agency, including combination products. Documents can be downloaded right away using FOI Online. There is no charge for the service, and you can call to check availability of what you are looking for at no charge, and they even offer a free document of the week. You can find an extensive list of more industry links here. Happy Searching!

When Smoking is Good for You (and Business!)

A new player in the pharmaceutical market has developed a pulmonary route delivery system that uses heat to quickly vaporize a drug, Alexza Pharmaceuticals – forming a small particle aerosol which is inhaled by patients.  Studies have shown that this novel delivery system hits the bloodstream much quicker than other alternatives, with a therapeutic effect often within seconds! 

Patients activate the “heat” by simply inhaling on the device – which heats the drug within a half a second to convert the drug from a solid form to vapor.  The air then rapidly cools the drug, which condenses into pure aerosol particles and inhaled into the patients lungs.










Courtesy of drugresearcher.com

VIP Club Membership

Let’s face it, attending a trade show is serious business if you want to get the most out of an visit! It involves some planning and effort and possibly even sore feet. The trade show industry has made great strides in developing technologies to simplify and streamline the business of planning a visit. These include online searches for exhibitors and products, e-badges, and networking portals that let you network with fellow attendees, suppliers and others before, during and after the event. Hopefully you have an

Better Than A Poke in the Eye

By Jack Powers, editor, HealthcareNBIC.org

With increased longevity, millions of people are aging into the risk of a new epidemic of Age Related Macular Degeneration (ARMD). In the U.S., an estimated 1.7 million of the 34 million Americans over age 65 have some visual impairment from ARMD,  according to the National Eye Institute, and  on average over 35%  of folks over 80 suffer from some form of the disease.

The good news is that new drug therapies are helping opthamologists fight the effects of macular degeneration. The bad news is that many of these therapies require intravitreal injections, hypodermic needles into the eye as depicted at left by the medical illustrators at Jireh Design . A needle to the eye every month, maybe for the rest of your life,  is a lot to ask of your 85 year-old grandparent.

SurModics is applying its existing knowledge of drug-eluting coatings in the field of ophthalmology to improve the delivery of drugs

Market to watch - Implantable/injectable drug delivery

When it comes to getting a flu vaccine would you rather face a large needle or simply apply a patch to your arm? Alternative drug delivery systems are offering patients new, safer and more effective methods for getting the treatments they need, leading to increased patient compliance. According to a report by Kalorama Information, the growing demand for novel drug delivery technologies generated record revenues of $9.8 billion worldwide in 2006. Further research indicates that this burgeoning market will reach revenues of $12.6 billion by 2010.

These statistics suggest that as innovative drug delivery technologies continue to evolve, the method of administration is becoming