MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

PHARMALIVE EXAMINES NEXT-GENERATION DRUG-DELIVERY TECHNOLOGIES AND THE TRENDS, COMPANIES, AND STRATEGIES DRIVING GROWTH

May 21, 2010 – Newtown, PA – Canon Data Products Group and PharmaLive.com announce the release of a new Special Report, “Drug-Delivery Review and Outlook 2010.” This report provides professionals working in or serving the pharmaceutical, biotechnology, and medical-device industries with analysis of the drug-delivery market, opportunities for growth, technological advancements, and more.
 
Patients and healthcare providers continue to seek treatments that have improved safety and efficacy profiles, are easy to use, and offer cost savings – ultimately improving patient compliance and disease management. Pharmaceutical companies are turning to drug-delivery partners to help differentiate their products and defend against generic competition. Novel patented delivery systems are becoming key to extending products’ proprietary positioning and securing patient preference. The incentive for pharma companies to invest in these technologies is strong – adding an extra five years to patent life could generate 50% to 100% in additional revenue.
 
Drug-delivery companies that can meet the combined needs of consumers, healthcare providers, and pharmaceutical companies with multiple technology platforms and products are positioned for rapid growth. The U.S. demand for drug-delivery systems is predicted to grow 10% annually through 2012.
 
“Drug-delivery technology is one of the most dynamic, diverse, and fastest-growing sectors within the pharmaceutical, biotechnology, and medical-device industries,” says Andrew Humphreys, editor in chief of Canon Data Products Group. “New types of pharmaceuticals and biological proteins and peptides require more-advanced delivery systems than traditional modes of administration. These revolutionary breakthroughs are helping propel growth in the extremely competitive and quickly developing drug-delivery arena.”
 
This PharmaLive Special Report concentrates on the market leaders and technologies expected to head this sector in years to come. This compilation’s prescription-product pipeline details the following information for each medicine:
  • Chemical or substance composition
  • Intended indication
  • Class of drug
  • Clinical status
  • Region of development
  • Product developer/intended marketer

In addition, the pipeline status details preclinical development, Phase I through Phase III, and awaiting approval. Regions of development include the United States, Europe, and Japan. A directory of prescription-drug developers and marketers is included.
 
Also provided in this report is a listing of drug-delivery medical devices, sorted by device class, as well as a directory of medical-device companies associated with this industry sector.
 
This PharmaLive Special Report is available at www.PharmaLive.com/specialreports
 
For more information, contact Sandra Baker at 215-944-9836 or [email protected].
 
About Canon Data Products Group
Canon Data Products Group, a division of Canon Communications LLC, publishes PharmaLive and Appliance Special Reports, which provide financial, company, and product statistical data and qualitative analysis for the global pharmaceutical, biotechnology, medical device, and appliance industries; maintains eKnowledgeBase, a comprehensive market intelligence tool serving the pharmaceutical, biotechnology, and medical-device sectors; and manages company-wide Site Licenses for PharmaLive.com, Med Ad News, and R&D Directions.



Can Medical Device Makers Share?

This is pretty controversial because stent companies rely on their patents for unique shapes in a stent (truthfully, however, noted Bonsignore, the differences in shapes are functionally insignificant). Providing open geometry for stent design could foster better data collection on use, especially in university settings where many labs spend time designing a new stent shape simply to avoid patent infringement—costing unnecessary resources. Bonsignore has plans to approach FDA on feasibility of his ideas and is writing a book.

In the medical sector, having a plan to introduce “communism” (Bonsignore’s word) to a blockbuster technology is bold, to say the least. The benefits could be significant, but the challenge would be to convince notoriously secretive medical device companies to contribute.

New Report Examines the Drug-Delivery Market

A special report titled, "Drug-Delivery Review and Outlook 2010," has been released by PharmaLive.com and the Canon Data Products Group, which are both operated by Canon Communications, the publisher of MPMN. Serving professionals in the medical device, pharmaceutical, and biotech industries, the report provides an analysis of the drug-delivery market, identifies growth opportunities, and highlights technological advancements.

Poised for growth, the drug-delivery market is expected to increase 10% annually through 2010, according to the report. "Drug-delivery technology is one of the most dynamic, diverse, and fastest-growing sectors within the pharmaceutical, biotechnology, and medical device industries," says Andrew Humphreys, editor-in-chief of the Canon Data Products Group. "New types of pharmaceuticals and biological proteins and peptides require more-advanced delivery systems than traditional modes of administration. These revolutionary breakthroughs are helping propel growth in the extremely competitive and quickly developing drug-delivery arena."

The special report focuses on market leaders and the key technologies associated with drug-delivery applications. Included in the report is a run-down of drug-delivery devices, sorted by device class, as well as a directory of medical device OEMs involved in the sector. In addition, it details pharmaceutical information that encompasses the chemical or substance composition; intended indication; drug class; clinical status; region of development; and product developer of major prescription drugs. Pipeline status for these products also include details on preclinical development, Phase I through Phase III, and awaiting approval. A directory of drug developers is provided as well.

To find out more about the market report, click here.

DNA-Based Robot Could Eventually Find Use in Therapeutic Devices

A molecular nanorobot (dyed green) moves on a DNA origami scaffold toward its goal (dyed red) by cleaving the visited substrates. Such DNA robots could eventually be used in therapeutic devices. (Photo courtesy of Paul Michelotti)

A team of scientists has programmed an autonomous molecular "robot" made out of DNA to start, move, turn, and stop while following a DNA track. This technology could eventually lead to molecular systems that might one day be used for medical therapeutic devices and molecular-scale reconfigurable robots. A paper describing this work appears in the journal Nature.

Shrinking robots down to the molecular scale would provide the same kinds of benefits that classical robotics and automation provide at the macroscopic scale. In theory, molecular robots could be programmed to sense the presence of disease markers on a cell, decide to neutralize the diseased cell, and deliver drugs. The power of robotics lies in the fact that once programmed, the robots can carry out their tasks autonomously, without further human intervention.

"In normal robotics, the robot itself contains the knowledge about the commands, but with individual molecules, you can't store that amount of information, so the idea instead is to store information on the commands on the outside," says Nils Walter, professor of chemistry and director of the Single Molecule Analysis in Real-Time (SMART) Center at the University of Michigan (Ann Arbor).

"We were able to create such a programmed or 'prescribed' environment using DNA origami," explains Hao Yan, professor of chemistry and biochemistry at Arizona State University (Tempe). DNA origami is a type of self-assembled structure made from DNA that can be programmed to form nearly limitless shapes and patterns. Exploiting the sequence-recognition properties of DNA base pairing, DNA origami is created from a long single strand of DNA and a mixture of different short synthetic DNA strands that bind to and "staple" the long DNA into the desired shape. The origami used in the Nature study was a rectangle roughly 2 nm thick and 100 nm long.

The researchers constructed a trail of molecular "bread crumbs" on the DNA origami track by stringing additional single-stranded DNA molecules, or oligonucleotides, off the ends of the staples. These represent the cues that tell the molecular robots what to do.

To build the 4-nm-diameter molecular robot, the researchers started with a common protein called streptavidin, which has four symmetrically placed binding pockets for a chemical moiety called biotin. Each robot leg is a short biotin-labeled strand of DNA, "so this way we can bind up to four legs to the body of our robot," Walter says.

"It's a four-legged spider," notes Milan N. Stojanovic, a faculty member in the division of experimental therapeutics at Columbia University (New York City). Three of the legs are made of enzymatic DNA, which is DNA that binds to and cuts a particular sequence of DNA. The spider also is outfitted with a "start strand"--the fourth leg--that tethers the spider to the start site (one particular oligonucleotide on the DNA origami track). "After the robot is released from its start site by a trigger strand, it follows the track by binding to and then cutting the DNA strands extending off of the staple strands on the molecular track," Stojanovic adds.

"Once it cleaves," Yan remarks, "the product will dissociate, and the leg will start searching for the next substrate." In this way, the spider is guided down the path laid out by the researchers. Finally, explains Yan, "the robot stops when it encounters a patch of DNA that it can bind to but that it cannot cut," which acts as a sort of flypaper.

Although other DNA walkers have been developed before, they've never ventured farther than about three steps. "This one," says Yan, "can walk up to about 100 nm. That's roughly 50 steps."

"In the current system," Stojanovic says, "interactions are restricted to the walker and the environment. Our next step is to add a second walker, so the walkers can communicate with each other directly and via the environment. The spiders will work together to accomplish a goal." Erik Winfree, associate professor of computer science, computation and neural systems, and bioengineering at the California Institute of Technology (Pasadena), adds, "The key is how to learn to program higher-level behaviors through lower-level interactions."

For more information, see the article "Spiders at the Nanoscale: Molecules that Behave Like Robots."

Judge Says Guidant Settlement Is Not in Best Interest of Justice

According to the StarTribune, the federal judge rejected the settlement between Guidant and the U.S. Justice Department last month, saying that it failed to serve the public interest. He suggested that Guidant should pay damages to help such programs as Medicare. Additionally, the judge said that a presentence investigation report would be helpful in determining whether Boston Scientific would be affected by any unintended consequences.

Shuren Lends an Ear on Regulatory Tour

For example, some speakers said that the FDA approval process lacked predictability, which can be harmful for start-up companies looking for funding. Several others highlighted lengthy timelines and unhelpful agency staff.

For his part, Shuren listened carefully and patiently. He started the meeting by outlining his initiatives for the center, and later said, "I can say without reservation that we have no intention to scrap the 510(k) program." Shuren noted that some changes to the 510(k) process will be announced in a few weeks. We can't wait to find out what they are.


Microneedles Incorporating Antimicrobial Agents Could Be the Wave of the Future

A scanning electron micrograph shows an array of biodegradable polyethylene glycol-based microneedles with antimicrobial properties.

Microneedles are known to minimize pain, tissue damage, and skin inflammation, making them potentially suitable for future portable medical devices for the treatment of chronic diseases such as Parkinson's and diabetes. However, the possibility of infection associated with microneedles has prevented their widespread adoption. Addressing this issue, researchers at North Carolina State University (NC State University; Raleigh) have developed two approaches for incorporating antimicrobial properties into microneedles that could prevent infection.

The first technique involves the incorporation of microneedles into permanent or semipermanent medical devices such as glucose monitors. In this case, the microneedles are coated with silver--an antimicrobial agent--using a laser-based vapor deposition process. By modifying the surface of the microneedles with the antimicrobial coating, the scientists found that they can prevent microbes without adversely affecting skin-cell growth.

The second technique involves degradable microneedles for single-use drug-delivery applications such as vaccine delivery. In this method, the antimicrobial agent is incorporated into the microneedle material itself. When the microneedle dissolves, the antimicrobial agent is released.

"We expect these findings to result in more-widespread use of microneedles in outpatient treatments and technologies," remarks Roger Narayan, professor in the joint biomedical engineering department of NC State's college of engineering and the University of North Carolina at Chapel Hill. "For example, microneedles could be used as a relatively pain-free and user-friendly alternative to conventional needles in diabetes treatment. They may also figure into new technologies pertaining to the delivery of anticancer drugs." A paper focusing on this research, "Two Photon Polymerization of Microneedles for Transdermal Drug Delivery," will be presented May 24 at the First International Conference on Microneedles in Atlanta.

For more information on this project, see "New Microneedle Antimicrobial Techniques May Foster Medical Tech Innovation."

This Week In Brief: May 18, 2010

 Eastman Chemical Co. (Kingsport, TN) last week celebrated the grand opening of a plant dedicated exclusively to the production of its Tritan copolyester. The facility will allow the company to better serve target markets, including the medical device industry, by expanding production of the material, which features such properties as clarity, toughness, and heat and chemical resistance.

This year's Innovation Days 2010 event presented by DMG/Mori Seiki USA (Chicago) will take place at the company's headquarters and Chicago Technical Center on May 24 to 26. In addition to presentations, technical seminars, peer learning sessions, and product demonstrations, the event will include the launch of the NZL2500 lathe, which features two turrets and offers high productivity of small-diameter workpieces.

Serigraph Inc. (West Bend, WI) was the recipient of two awards at the 10th annual Graphics Excellence Awards presented by the Printing Industries of Wisconsin trade association. A specialist in full-service printing, molding, and custom graphic for a range of industries, including the medical device market, the company beat out nearly 800 companies to earn the two honors.

Produced by Henkel Corp. (Rocky Hill, CT), Loctite medical device adhesive training workshops will be held in Rosemont, IL, on June 9, and in San Diego, CA, on June 22. The workshops will address the design and assembly of medical devices, including proper joint design for adhesive assembly, selecting the appropriate adhesive technology, and processing equipment requirements.

Laserdyne Systems (Champlin, MN) has announced a training series for its line of multiaxis laser systems entitled "Empowering Laserdyne Users to Go Beyond Others." Designed to increase user productivity, keep system operators current, and optimize system production, the two-day training programs cover laser applications, beginner and advanced; system programming, beginner and advanced; laser maintenance; and motion system maintenance.

Sebra Becomes Vante

As part of a corporate development plan, Sebra has changed its name to Vante (Tucson, AZ). The employee-owned, global technology company designs and produces products for the manipulation of medical plastics. It is focused on catheter development and manufacturing, biopharmaceutical products, and related engineering services.

"Last year we sold our blood collection and processing division and the brand name Sebra," says Roger Vogel, the company's chairman, president, and CEO. "This sale provided us with substantial capital to grow our medical device manufacturing product portfolio to serve customer and industry needs and develop and bring to market the latest innovations and solutions for the global medical device manufacturing industry. These are exciting developments for Vante."

Vante has a worldwide direct-channel sales system to OEMs and distributors. It has also initiated various innovative strategic partnerships with companies in the medical field, partnering with ASG Medical Systems to produce an automated tipping system, conducting contract research and development work with Haemonetics, and establishing product development and engineering partnerships with major industry players.

"We're changing our name, but we're not changing the outstanding products, services, and support we've provided our customers for over 30 years," remarks Vogel. "Our mission remains the same—to help our customers improve efficiencies and reduce total operating costs while producing best-in-class products."

Eastman Expands Plant Capacity for Tritan Copolyester

It's rapid adoption necessitated the additional capacity. Company executives said that the new copolyester's properties are comparable to polycarbonate, but noted that Tritan is easier to process than polycarbonate.

“At Eastman, our philosophy is inspiring innovation to benefit our customers,” said Dante Rutstrom, vice president and general manager of Eastman's specialty plastics business. Rustrom said the company has worked closely with its customers to develop the BPA-free coployester to meet market demands. He said medical applications include rigid medical packaging and other medical products that require chemical resistance and easy processability. The company has also just released results of new third-party testing that confirm that the polymer is free of BPA and estrogenic activity.

The grand-opening celebration included tours of the new facility for local government officials, as well as select customers and employees, and presentations by Eastman executives, including Jim Rogers, president and CEO, and Mark Costa, executive vice president, specialty polymers, coatings and adhesives, and chief marketing officer.