According to Alan Shortall, CEO of Unilife, one of the fastest growing sectors of the $200 billion pharmaceutical market is lyophilized drugs and vaccines that require reconstitution at the point of delivery. The supply of therapies in a lyophilized, or dry drug powder form, says Alan Shortall, is common where the molecule is either not suitable for liquid stable form or the pharmaceutical company is seeking to fast-track time to market.
With macromolecule biologics comprising an increasingly large part of the development pipelines of pharmaceutical companies, one in every three novel drugs approved by the FDA since 2008 has been launched in a lyophilized form, reports Alan Shortall.
In this interview, Alan Shortall, Unilife’s CEO, discusses some of the unmet needs and potential solutions for this fast-growing market for drug reconstitution.
Question: Welcome, Alan Shortall. Would you please explain how lyophilized drugs are typically delivered into the market?
Alan Shortall: “Traditional methods for drug reconstitution are extremely time intensive, making them largely unsuitable for use by patients. You need several pieces of equipment including a vial for the lyophilized drug, a vial for the diluent, two needles and a syringe. It can require ten distinct steps just to reconstitute the drug, let alone its delivery to the patient.
Question: Does this explain the growing popularity of dual chamber prefilled syringes?
Alan Shortall: “Dual chamber prefilled syringes represent a far more convenient delivery system for lyophilized drugs and vaccines. In one chamber, you have the lyophilized drug. And in another chamber is the diluent. But there are still problems with conventional dual chamber technologies”.
Question: Alan Shortall, can you describe some of these unmet market needs?
Alan Shortall: A dual chamber prefilled syringe should ideally be as simple as two key steps…Reconstitute the drug, and inject the dose. But conventional dual chamber prefilled syringes can involve multiple steps that make them non-intuitive for use by either trained clinicians or patients. Another problem is that conventional dual chamber prefilled technologies requiring vents that can….
Finally, there is no dual chamber prefilled syringe with integrated safety features.
Question: How are Alan Shortall and the Unilife team looking to make a difference?
Alan Shortall: “We are very much driven to address unmet market needs. You see an increasing number of biotech molecules that are not liquid stable. We have developed a unique technology platform of drug reconstitution delivery systems that can address the needs of pharmaceutical customers, healthcare workers and their patients. We are now bringing these technologies to market in conjunction with interested pharmaceutical partners.”
Question: What are the key points of differentiation between Unilife’s technology and the status quo for dual chamber prefilled syringes?
Alan Shortall: The EZMix is the only prefilled syringe that combines efficient drug reconstitution with integrated safety features. It features two drug chambers in a single delivery system that is easy for either healthcare workers or patients to use. It can store either liquid-liquid or liquid-powder combinations. There are really only two key steps of use…reconstitution and injection. And at the completion of the full dose, a retraction mechanism is automatically activated that allows the operator to control the speed at which the needle is withdrawn directly from the body into the barrel where it’s locked in place. So EZMix is a drug reconstitution system, a primary drug container, a safety device and a needle containment system all rolled into one.
Question: What stage of development is the EZMix?
Alan Shortall: We have developed the EZMix in direct response to the unmet needs of some of the pharmaceutical companies we regularly collaborate with. And since we announced the initial development of the EZMix in 2011, we’ve been flooded with additional pharmaceutical companies seeking further information. As with all of our products, the device can also be customized to address any specific requirements the customer may have.
Question: What types of drugs do you see being administered by EZMix?
Alan Shortall: The EZMix offers a revolutionary solution to the reconstitution and injection of a wide variety of lyophilized drugs and vaccines. The devices can be supplied either with a staked (fixed) needle for subcutaneous injections, or with interchangeable needles of up to 1.5 inches in length. The current technology can accommodate up to 1mL of diluent volume. With so many emerging therapies being developed that can be enabled or enhanced by delivery in the EZMix, we see a very big future for this technology.
Alan Shortall can be contacted at email@example.com or www.unilife.com.
Although Unilife recently moved their offices to the United States from Australia, the firm is still publicly traded in its country of origin. Unilife may be found on both the NASDAQ as well as the Australian Stock exchange. Founder and CEO of Unilife Alan Shortall says that the transition from Australia to the United States happened between 2008 and 2010; the firm has offices in both countries.
Unilife Australia Street Address
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The following segment aired on O2 Media’s The Balancing Act on Lifetime Television. Joining the show was Chef Don McMillian to talk about a healthy cooking with Green Mountain Gringo Salsa.
O2 Media: We love salsa. I know a lot of you our there consider yourself to be connoisseurs when it comes to the texture, the flavor, and, of course, the spiciness and freshness of it. We have one of those connoisseurs with us today, Chef Don McMillian from the Stocked Pot Cooking School, to show us what good salsa is really made of and some rocking recipes you can make with it. So, I read some disturbing news the other day that salsa can have a lot of preservatives in it. Can you tell us about this?
Don: Many salsas have a large amount of preservatives in them. But our Green Mountain Gringo Salsa has none. It’s so fresh, and you can actually see the tomatoes, the onions, the jalapeños, the tomatillos. It’s all in there.
O2 Media: Chef Don, you can really see the difference. It seems like a pretty healthy snack.
Don: It’s a wonderful, healthy snack. But just read the label. I mean, that tells the story, “No preservatives, fat free, low salt, gluten free, no allergens.” And you know what? It tastes good. It’s won multiple awards for taste. In fact, Women’s Day and Vegetarian Times said it’s the best-tasting salsa.
O2 Media: Well, my husband loves salsa. And you’ve made some incredible recipes using salsas in great ways that we can incorporate it in our meals.
Don: I sure did. These recipes are so easy. We just seasoned some chicken breasts, broiled them for just a little bit, placed them with our Green Mountain Gringo Salsa, tossed it up, plated it on our Green Mountain Gringo Tortilla Strips, added a little bit of avocado, some cheese – it’s done.
O2 Media: My husband really likes the really spicy salsa. But I’m a little bit more of a mild girl, I admit it. Do you have different flavors?
Don: We have something for everybody. Check this out – we have roasted chili pepper, roasted garlic. Everyone loves garlic. Mild, medium, and for your husband, hot, yes. One of my favorite recipes is Green Mountain Gringo rice. It’s so easy. A jar of Green Mountain Gringo Salsa, a cup of rice, a little bit of chicken stock – it’s done.
O2 Media: That’s it? Great for working women that are on the go all the time.
Don: Another recipe is to take our Green Mountain Gringo Strips, roll them in a little plastic bag with a rolling pin, put a little bit of olive oil on some salmon, season it up with the Green Mountain Gringo Strips, put it on a plank, 350 degrees in the oven, and our sauce is the Green Mountain Gringo Salsa. Plus, it’s only 10 calories per serving.
O2 Media: Only 10 calories? I love that. It’s kind of like a new spin because a lot of people use bread crumbs, but I’m sold on the tortilla strips. Where can I find these Green Mountain Gringo products?
Don: You can find them at your local supermarket in either one of three sections – the natural-food section, the Hispanic section, or the salty snack section. It’s really worth looking for.
About O2 Media
With over a decade of satisfied clients in their portfolio, O2 Media is a television production company and marketing firm with a reputation for delivering results. Services include writing, production, and editing of filmed pieces as well as implementation of interactive user websites, which all work together to create positive brand awareness. The firm is uniquely positioned to achieve the greatest results as they operate their own production studio and own two well-received and nationally broadcast shows, The Balancing Act and Designing Spaces.
O2 Media provides unmatched marketing value to its clients while producing quality content for its growing national viewership through Brandutainment®. Household brands and blue chip companies alike, continue to depend on O2 Media for effectively communicating their message to consumers. For more information, visit http://www.o2mediainc.com.
Flulike symptoms in men may signal prostatitis, cautions Paul Perito MD.
According to Paul Perito MD, acute prostatitis, simply stated, is inflammation of the prostate gland. Acute prostatitis is characterized by the sudden onset of one or more symptoms, says Dr. Perito. Prostatitis generally presents after bacteria travels up the urethra, either by sexual contact or as a result of otherwise benign germs that live in the body. Of the men develop prostatitis, Paul Perito MD points out that the majority of them have a normal prostate. Since the gland gets larger with age, older men are more susceptible to acute prostatitis. Prostatitis and prostate cancer are not linked, says Paul Perito MD.
Symptoms of prostatitis are similar to a urinary tract infection with a few major differences. Paul Perito MD says that while both UTIs and acute prostatitis may cause cloudy urine, fever, a burning sensation when urinating, or difficulty passing urine, prostatitis may also present flulike symptoms (which include fatigue, weakness, and muscle aches) and pain in or surrounding the scrotum or rectum.
According to Paul Perito MD, if acute prostatitis is suspected, a rectal exam will be performed by gently sliding a gloved finger into the rectum. This allows the physician to determine whether or not the prostate is swollen. Paul Perito MD says that, during the exam, is not uncommon to have pain or experience an urgent need to urinate, as slight pressure will be put on the gland. Additional examinations may also be performed to determine if other organs, like the kidneys, are affected, says Paul Perito MD. He also notes that a urine specimen will be collected to test for white blood cells and or bacteria. Blood tests can check kidney function, as well as blood cell count, points out Paul Perito MD. If a urinary obstruction is suspected, a CT scan or an ultrasound may be ordered.
Antibiotics are the preferred treatment method for acute prostatitis, says Paul Perito MD. The antibiotics are given either intravenously or in a pill form, which must be taken for several weeks. Paul Perito MD explains that a hospital stay may be required if IV antibiotics or catheterization is needed. Catching the infection early will increase the likelihood that it will respond expediently to treatment. Paul Perito MD points out that as a rule prostatitis is not a preventable condition but safe sex will ensure that bacterium is not introduced by an outside party.
Acute prostatitis responds well to treatment though irritation while urinating may persist for a short while. Paul Perito MD says that although the course of antibiotics is longer than for other infections, their completion is a vital to ensure a full recovery.
Urological surgeon Paul Perito MD has devoted his entire professional career to treating men suffering from Erectile Dysfunction. He is the founder and namesake of Miami’s Perito Urology, where he conceived and initiated the world’s first minimally invasive approach to penile implantation. Paul Perito MD has performed over 3000 of these procedures on men across the globe that enjoy a shorter recovery time and less scarring than traditional implantation methods. Since 1995, Paul Perito MD and Perito Urology have become synonymous with effective erectile dysfunction treatment and world-class service unparalleled anywhere in the nation. He is a graduate of the University of Maryland Medical School as well as a frequent contributor to text published by medical journals nationwide.
The information contained in this article is provided by Paul Perito MD for educational purposes only. It is not intended to treat or diagnose any condition.
Throughout history, penis size has been the subject of many jokes, including the catchy phrase, “Does size matter?” According to Dr. Paul Edward Perito MD, penile enhancement procedures have been performed since the 1971, with varying results. There are risks and benefits to the procedure, Dr. Paul Edward Perito MD says, but for many patients, the psychological benefits outweigh the risks.
“Normal” penis size is subjective, but Dr. Paul Edward Perito MD has seen patients struggling with concerns about having either insufficient length or girth. Whether these patients’ concerns are unfounded or not, Dr. Paul Edward Perito MD points out that the American Urological Association does not sanction procedures to lengthen penile size or expand penile girth. Because no studies have yet been able to prove the safety of these procedures, they are currently labeled ‘experimental,’ and patients should proceed with caution, Dr. Paul Edward Perito MD warns.
Dr. Paul Edward Perito MD points to a variety of factors that can affect penis size. Genetics play a large part in the formation of a man’s penis, Dr. Paul Edward Perito MD says. A condition called congenital micropenis can result in a member that is approximately 2 inches when erect but otherwise normally shaped. Radiation treatment for certain cancers can shorten penis size, Dr. Paul Edward Perito MD says, and treatment for Peyronie’s Disease can also cause a slight shortening.
Studies have also shown a connection between impotence and penis length, according to Dr. Paul Edward Perito MD. When patients are rendered impotent, as seen in radical prostatectomy, they can lose between .5 and 5 cm’s every 14 months in penile size. Studies have surmised that a loss of elasticity and infrequent stretching of the tissues that cover the erectile bodies as possible causes, Dr. Paul Edward Perito MD states.
What is a “normal” penis size? Dr. Paul Edward Perito MD often hears that question and points to a study in the Journal of Urology found that the average penis length was 5.1-5.9 inches with a diameter of 1.54 inches and circumference of 4.85 inches when fully erect. Over the years, penis size has become associated with masculinity, with some men feeling they are somehow inadequate if they don’t measure up to today’s definition of adequate penis size.
Penis lengthening surgery is often seen by the patient as the only alternative for men concerned about length and girth. But according to Dr. Paul Edward Perito MD, this surgery has associated numerous risks, one of which is actual shortening of the penis after surgery. This is thought to be caused by the penis attaching to the pubic bone and surgeons often minimize this risk by placing fat between the pubic bone and affected ligaments to prevent this.
Loss of sensation is another risk of penile lengthening procedures, according to Dr. Paul Edward Perito MD. The penis could also take on a downward angle due to insufficient support. Scarring is a risk, as well.
For men concerned about penis size, penile lengthening or girth enhancement may be a possible route of treatment. However, Dr. Paul Edward Perito MD warns patients of the risks and strongly encourages patients to research as thoroughly as possible before undergoing this procedure.
Dr. Paul Edward Perito MD may be contacted online by visiting www.peritourology.com
The information contained in this article is provided by Dr. Paul Edward Perito MD for educational purposes only. It is not intended to treat or diagnose any condition.
Through a special fund, Kummetz Corporation will now provide support to both the disabled and orphans in Brazil. This is the latest in a series of initiatives that Kummetz Corporation has undertaken to help assist with economic development in needy areas of that country.
Licensed in 2005 in Nevada, Kummetz Corporation has provided help in East Africa, South America, and other locations by helping build houses and provide economic opportunities to boost those areas’ economies. Through its Kummetz World Foundation, Kummetz Corporation is working to help foster educational development for a well-educated workforce, as well as create more hospitals for better medical care and help boost agricultural development.
With this fund, Kummetz Corporation will specifically target the disabled and orphans, providing educational opportunities and scholarships to individuals in need. Kummetz Corporation will also help provide housing to help families affected by disability and other economic hardships, in an effort to ensure every citizen has a place to live.
According to a spokesperson at Kummetz Corporation, the Company also believes that affected citizens need emotional support as well. For this reason, Kummetz Corporation will use funds to help provide counseling services. These services will include psychological evaluations and working with individuals who have behavioral disorders, Kummetz Corporation says.
Brazil has an estimated 20,000 homeless residents, which may in part be due to a deficiency in housing in the country. By helping build low-cost, environmentally-friendly housing to Brazil’s population, Kummetz Corporation hopes to give citizens the basics they need to get back on their feet.
Education is especially important, according to Kummetz Corporation. By giving educational opportunities where they previously have not existed, Kummetz Corporation hopes to build a better educated workforce, which will in turn strengthen the country’s economy and provide future educational opportunities.
In addition to education and housing, Kummetz Corporation is also involved with boosting the country’s access to healthcare. By working with companies that can build these hospitals, Kummetz Corporation hopes to provide better access to medical treatments for citizens throughout Brazil. Kummetz Corporation is also working on projects to develop biofuels and mine elements in the area in an effort to provide environmentally-friendly experts to help boost economic development.