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| Adverts: Protein Modification Technologies Paving the Way for New Therapeutics |
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 Anonymous writes "New Report by Applied Data Research Analyzes the Impact on Commercialization
(Amherst, NH) – The availability of therapeutic proteins for the treatment of human diseases is changing the practice of medicine by providing treatment options for previously refractory diseases and untreatable conditions. But therapeutic protein candidates often have to overcome a number of obstacles in order to be viable therapies, including short half-lives and rapid clearance. By modifying proteins in a site-specific manner, the stability and therapeutic life of protein drug candidates are being improved, and drug candidates that would otherwise fail to survive pre-clinical development are being commercialized.
Collaborations between market sector participants and pharma companies are at an all-time high. The value of commercial protein drugs that have been modified to improve their therapeutic value exceeds $6 billion, and this total will double by the end of the decade. As the pace of new biological drug candidates emerging from automated discovery programs accelerates, the scenario for modification technology companies and their pharmaceutical partners is highly favorable. In this climate, strategic positioning and IP access takes on increased importance, a dynamic underscored by the recent acquisition and investment decisions of several pharma companies.
These findings are examined in a new and comprehensive report from Applied Data Research. The report concludes that proprietary platforms for site-specific protein modification will become integrated into the drug development process as emerging protein drug candidates are targeted to increasingly challenging therapeutic targets. More information is available at www.applieddata.org .
About Applied Data
Applied Data Research is a drug therapeutics consulting firm focused on medical market strategies, product commercialization, venture development, and market research. We assist medical market participants in achieving their business objectives through the creation of detailed business development strategies, product commercialization programs, and comprehensive market and technology research and analysis.
Contact:
Greg Stone
Voice: 603-595-6225
Fax: 603-804-0466
www.applieddata.org
Source: Applied Data Research
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| Adverts: HGH Supplements - Facts and Fiction |
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Anonymous writes "Now things start to get fun. It is time to separate fact from fiction and look at some of the products out on the market today. Is it possible to increase HGH levels by taking dietary supplements? Let's find out...
Every web site claims they have a simple supplement that will cause my HGH levels to skyrocket. Do these supplements work?
For the most part - no! I hate to be the one to break the news to you, but most companies in the HGH market are out to make a quick buck with exaggerated claims. Here are some claims you will see on the web and our feeling on their accuracy...
- Claim: HGH will give you a 8.8% increase in muscle mass and a 14.4% loss of fat - without dieting or exercise!
This is the old bait and switch. Technically, they are not lying when they quote Dr. Rudman's number. With HGH Injections, Dr. Rudman did see a 8.8% increase in muscle mass and a 14.4% loss of fat. The problem is, they are not selling HGH Injections! These companies do not provide any evidence that their pill, powder or spray will have the same results as HGH Injections. So, they bait you with all the positives of HGH injections and then switch you to their untested supplement.
- Claim: Our spray/pill/powder contains real HGH!
This statement is at best a tremendous exaggeration and at worst a complete lie. There are a couple of reasons why companies who claim to have a significant amount of HGH in their products are not being truthful. First, HGH is a prescription drug. If you put significant amounts of HGH in a dietary supplement it is no longer a supplement - it is a drug. As a drug it must meet FDA approval and only sold with prescription. So, the phrase HGH dietary supplement is an oxymoron. If a product has a significant amount of HGH, it is a drug.
If you remember from our HGH definitions page, HGH is a delicate and complex 191 amino acid hormone. This brings up the second problem with the above claim - you can not take HGH orally. So, even if a company wanted to break the law and sell HGH as a pill/spray or powder - it would not work because the HGH would break down before it ever reaches the bloodstream.
Finally, you have a financial problem with the above claim. Give Eli Lilly a call and see how much 200 micrograms (the amount a 40 year old secretes each day) of recombinant GH cost. You will quickly find out that the math just doesn't work. How can they sell a 1 month supply for $100 when the raw material would cost over $1,000 a month?
There is a case when the above claim can be true - but very exaggerated. The FDA has determined that if there is less than 2001 nanograms (ng) of the HGH drug present in a supplement - it is NOT considered a drug. The theory is that in such small trace amounts, the drug has no impact so it is not classified as a drug. Let's look at what a nanogram is...
1,000 nanograms (ng) = 1 microgram (µg)
1,000,000 micrograms = 1 gram
So, even a product that had the highest legal amount of HGH would only have 2 micrograms. Dr. Rudman gave his patients 49,500 microgram - three times a week! What this means is that technically and legally you could make the claim that your product contains real HGH. The problem is, that claim is pure marketing hype. It is not a significant source of HGH.
We defined homeopathic medicine back on the definitions page. As you recall, the homeopathic approach works by using miniscule amounts of a substance. So, some homeopathic HGH remedies could contain up to 2000 ng of real HGH. In honest homeopathic products the goal is not to replace your HGH with the HGH in the bottle (this would be impossible). The theory is that even the smallest amount of HGH can stimulate your own body to produce more HGH. This stimulation theory may be valid and we will discuss it more on our HGH enhancer article.
- Claim: Our product is FDA approved!
There are no FDA Approved Dietary Supplements. The simple truth is that the FDA does not approve or disapprove of Dietary Supplements. The Dietary Supplements Health and Education Act (DSHEA) of 1994 says that Dietary Supplements do not need FDA approval. This is why there are so many supplements on the market - there is no approval process. The best advice is buyer beware.
Are there any supplements worth taking?
Luckily, yes. I know this article has been pretty depressing so far, but if you search through all the misinformation out there, sometimes you find the needle in the haystack.
Research indicates that the best way to elevate HGH levels is to stimulate the body to produce more HGH. Rather than introduce more HGH into the body, you can stimulate your own pituitary gland to produce more HGH. Remember that studies have shown that an old pituitary gland has the same capacity to produce HGH as a young pituitary gland. If we can find a way to stimulate our pituitary gland we will have the best of all worlds. You are not introducing a foreign GH, so you eliminate the side effects. Also, our body is very good at self regulating - it will not produce an excessive amount of HGH which could be harmful. In effect, you body knows best what the correct dosage of HGH is to release for your body.
The Article is Published here: http://www.advice-hgh.com/supplements.html"
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| Adverts: Iontophoresis Systems Hold Promise for Drug Developers |
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Anonymous writes "New Survey by Greystone Associates Examines Technology Advances and Market Potential
(Amherst NH) - Growth of transdermal delivery has been restricted by the need to limit candidate drugs to molecules small enough to passively migrate through the stratum corneum, a limitation that excludes passive transdermal patches as a viable option for the growing number of protein and peptide therapeutic compounds that will represent an increasing share of future NCEs. To expand the limits of transdermal drug delivery, developers are employing electrical current - a technique called iontophoresis - to affect active transport through the skin. This technique can increase the upper molecular size limit dramatically, opening up a host of opportunities for transdermal delivery.
Iontophoresis products are positioned to make a significant impact in selected therapeutic areas. New wearable designs that are user-friendly and conform to the user's physique are improving outcomes in pain management. Prefilled disposable devices are user-friendly and improve compliance. A number of researchers are investigating iontophoresis for gene delivery. Other important near-term applications include neurology, women's health and dermatology.
These findings are contained in a new and comprehensive report: Iontophoresis: Devices, Drugs and Delivery Strategies. The survey concludes that iontophoretic drug delivery systems will gain traction at the expense of injection and passive transdermal patches, particularly among emerging biologics.
More information is available at
http://www.greystoneassociates.org
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org
Source: Greystone Associates
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| Adverts: Discovery and Technology Create New Therapies in Reproductive Medicine |
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Anonymous writes "Greystone Associates Analyzes Evolving Therapeutic Landscape
(Amherst, NH) – The convergence of target-specific biological drugs, formulation science, and patient-friendly delivery technology are creating therapeutic opportunities that will have a significant impact on the practice of female reproductive medicine. This evolution in care is occurring at a time when women in virtually every age group are struggling to cope with real or perceived medical conditions. From the side effects of hormone replacement therapy to the life-style driven increase in the incidence of HPV and infertility, women are seeking answers to their medical needs from a healthcare industry that has been sending hopeful, albeit sometimes confusing, messages.
With the increasing availability of drugs that improve therapeutic outcomes and in some cases address previously untreatable conditions, opportunities for participants in the reproductive medicine sector are starting to emerge. Recombinant proteins that produce powerful metabolic responses are replacing small-molecule drugs. Novel formulation strategies and delivery technologies are contributing to growth prospects by reducing dosing frequency, minimizing patient administration requirements and improving compliance. These developments will lead to strong growth in industrialized regions, as a growing number of women in these countries seek therapeutic solutions to gender-specific conditions.
These findings are contained in a new and comprehensive report. The report – Reproductive Medicine: Emerging Therapeutics, Expanding Opportunities - contains in-depth analysis of the drugs, pipeline candidates, technology, and market participants that are shaping the future of female reproductive medicine.
More information is available at
http://www.greystoneassociates.org
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org
Source: Greystone Associates
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| Adverts: Metered Dose Inhalers Still the Workhorse of Respiratory Drug Delivery |
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Anonymous writes "Greystone Associates Analyzes MDIs Evolving to Meet Market Requirements
(Amherst, NH) – With the exception of the insulin syringe, inhalers for the treatment of upper respiratory ailments such as asthma and chronic obstructive pulmonary disease are arguably the most mission-critical drug delivery device class currently on the market. These combination products are relied upon by tens of millions of Americans – out of a total worldwide market of approximately 300 million – for the treatment of debilitating and life-threatening respiratory conditions. For the majority of these patients, the device in their pockets, purses, and cabinets has been and is the metered dose inhaler.
The MDI has gone through a re-birth of sorts over the last five years, as regulatory requirements and efficacy issues related to variability in patient use of MDIs have fostered design changes at both the drug and device level. The market for MDIs will remain a dynamic one, as business factors related to direct-to-consumer marketing, patent expiry-driven generic competition and the changing regulatory climate create new risks and opportunities. At the same time, the convergence of socioeconomic and technology factors is driving interest in pulmonary drug delivery technology and devices as an alternative to oral and parenteral routes of administration for systemic drugs. With insulin delivery MDIs wending their way through the clinical trial process serving as path-finders, MDIs are expected to compete in the future market for systemic pulmonary drug delivery.
These factors are analyzed in a new and comprehensive report – Metered Dose Inhalers: Devices, Drugs and Delivery Strategies. The report analyzes the key factors and market forces that are shaping this evolving market segment.
More information is available at www.greystoneassociates.org
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org
Source: Greystone Associates
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| Adverts: Drug Device Designers See Opportunities Expanding with Biologicals |
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Anonymous writes "(Amherst, NH) – Drug delivery is the fastest growing segment of the pharmaceutical industry. The number of companies entering the industry is rapidly increasing, alternative drug delivery methods are being created, and new therapies are emerging. The potential of drug therapy to impact the quality of life is now seen as exponential, as biotechnology techniques and computational drug modeling combine with the genomic knowledge base and bioinformatics to provide powerful tools to researchers. The result of this convergence of drug discovery and design technology will be an escalating pace of new drug PMAs in the U.S. and similar activity internationally.
The trend toward combining functionality and packaging in drug delivery systems is strong and will continue as new therapeutic substances are introduced at an increasingly rapid rate. These innovative drug delivery systems allow pharmaceutical companies to differentiate themselves in the long-term from competitors. This is essential at a time when many patents are running out and competition among the manufacturers of generic medicines is increasing. Success no longer only depends on the medication itself but also on achieving a patient-friendly form of application.
While exciting advances are occurring across a number of drug delivery technologies, each approach – whether injection, transdermal, inhalation or next-gen oral – have unique challenges to overcome as a diverse population of end-users become accustomed to administering their own medication. Greystone has compiled information on seventeen distinct drug delivery technologies and is making this catalog of information sources available for download.
The publications contained in the Drug Delivery Insights Summer 2006 Catalog provide a uniquely focused analysis and comprehensive assessment of key segments that comprise the Drug Delivery sector - insight that can be instrumental in achieving business goals and financial targets for market participants.
More information is available at :
http://www.greystoneassociates.org/summer_2006_catalog.htm
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology assessment.
More Information on Greystone is available at:
http://www.greystoneassociates.org
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org
Source: Greystone Associates
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| Adverts: Active Transdermal Drug Delivery Coming of Age |
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Anonymous writes "New Survey by Greystone Associates Analyzes Market and Technology Factors
(Amherst, NH) – Compliance concerns have driven and continue to drive investment in new drug delivery technologies. The transdermal patch and implantable drug reservoirs are two prominent examples of this impact. As work with passive transdermal systems has progressed, so too has the realization of the true extent of the barrier to drug delivery presented by the stratum corneum, the skins outer layer of dead, hydrophobic, keratinized cells. Passive permeation of compounds through the skin became a major problem and very soon restricted the choice of compounds that were eligible for delivery in that manner.
To expand the limits of transdermal drug delivery, developers are employing energy sources such as ultrasound, heat and electrical current to affect active transport through the skin. Another approach is the modification or removal of surface skin layers, a group of technologies collectively referred to as microporation, which can be used alone or in conjunction with energy-enabled devices to expand the size and type of drug molecules capable of transdermal delivery. These techniques can increase the upper molecular size limit dramatically, opening up a host of opportunities for transdermal delivery.
These findings are examined in a new and comprehensive survey written and researched by Greystone Associates. The survey concludes that to take full advantage of these evolving dynamics, active transdermal delivery participants must deal with a number of economic and market forces influencing the way drug companies develop and commercialize their products. Success will favor those sector participants willing to incorporate patient-centric design features and drug-device combination engineering paradigms into their product development programs.
More information is available at www.greystoneassociates.org .
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org Source: Greystone Associates
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| Adverts: Converging Factors Driving Growth in Prefilled Syringes |
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Anonymous writes "Greystone Associates Analyzes the Migration from Vials to Combination Products
(Amherst, NH) – The administration of therapeutic drugs via injection is an indispensable delivery method for numerous drugs critical to patient health and well-being. Now this segment is evolving in response to changing patient populations, new classes of powerful therapeutic drugs, and healthcare administration initiatives. Population demographics and efforts by managed care providers to control healthcare costs are driving the growth in drug self-administration, particularly for chronic conditions, introducing a new class of naïve users to parenteral drug delivery. User-friendly syringe and injection device designs and the availability of an increasing number of drugs in pre-filled insertable and disposable cartridges are propelling the growth of prefilled syringes for self-administration.
Improved patient compliance, efficient delivery of high-priced biologicals, and patient & caregiver safety are key market drivers in this sector. The cost of biologicals such as recombinant proteins has created interest in prefilled syringes to reduce cost and waste associated with the handling of vial-packaged drugs. Partnerships between device designers and drug developers are an essential element in the success of prefilled devices, particularly for patient self-administration.
Important prefilled syringe applications include chronic diseases such as diabetes, autoimmune disorders, and hormone replacement. Other growth segments include reproductive health and the administration of antivirals, as well as wellness programs and vaccine administration.
These findings are contained in a new and comprehensive report: Prefilled Syringes: Drugs, Devices and Delivery Strategies. More information is available at www.greystoneassociates.org .
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org Source: Greystone Associates
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| Adverts: Treating the Growing Pains of Transdermal Drug Delivery |
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Anonymous writes "Transdermal Delivery Companies Switch Focus to Pain Management, CNS Disorders for Growth
Amherst, NH - (March 23, 2006) – For more than a decade, transdermal drug delivery has been touted as being on the verge of explosive growth. But issues with consistency, topical side effects and bioavailability have slowed progress, and today the full potential of this technology is yet to be fulfilled. Developers of transdermal drug delivery systems have existed on a handful of proven applications such as hormone replacement, hypertension and, more recently, contraception. But companies in this sector have long realized that sustainable growth will require expanding transdermal technology into new therapeutic areas.
While a handful of mostly smaller companies are taking a homerun approach, investigating blockbuster applications such as transdermal insulin delivery, the ability to deliver large molecule drugs including proteins and peptides transdermally is now seen by many as a long-term strategy at best. To achieve growth in the near-term, several transdermal system developers are focusing on small molecule therapeutics for a short but attractive list of therapies.
“We’re seeing transdermal systems in late stage clinical development for a new set of diseases and conditions such as osteoarthritis, migraine, Alzheimer’s, depression and Parkinson’s disease that are expanding the reach of this technology,” explains George Perros, Greystone Associates Managing Director. Several of the promising new transdermal delivery applications are being led by next-generation transdermal technologies, such as iontophoresis and microporation, that incorporate sound or electrical energy or - in the case of microporation - microneedles, lasers or RF, to improve drug flux across the outer skin layer. “Extending the reach of transdermal delivery technologies into the realm of large-molecule biologics will require further improvements in the reliability, consistency, and packaging of these so-called active transdermal drug delivery systems,” adds Perros.
More information is available at www.greystoneassociates.org .
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org
Source: Greystone Associates
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| Adverts: Microneedle Drug Delivery Systems Hold Promise for Drug Developers |
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Anonymous writes "New Survey by Greystone Associates Examines Technology Advances and Market Potential
(Amherst, NH) - Advances in materials processing - technologies that include micromachining, nanoprocessing and structured film forming - are creating new devices and new opportunities for minimally invasive drug delivery. These advances have led to the development and introduction of devices that employ very small needles – microneedles – that deliver drugs by mechanically perforating the outer skin layer and allowing for transdermal absorption of the active compound. The processing techniques incorporate one or more technologies that enable the precise machining, extrusion, casting, and/or forming of from one to an array or grid of microneedles.
Microneedle technology is attaining commercial viability at a time when drug developers are faced with new challenges as they assess ways to administer a new class of compounds with significant therapeutic potential. The widespread availability of rapid throughput screening is accelerating the discovery of large-molecule therapeutic compounds that cannot tolerate passage through the digestive system, requiring pharmaceutical companies to forego oral formulations and select alternate routes of administration.
“By penetrating the stratum corneum, microneedle delivery systems can effectively deliver drugs systemically with minimal discomfort,” explains George Perros, Greystone Associates Managing Director. “Evolving microneedle systems will be well-positioned to address a significant segment of the large–molecule biological drugs expected to emerge from the convergence of automated discovery and genome mapping.”
These findings are contained in a new and comprehensive report: Microneedle Drug Delivery: Technology, Markets, and Prospects. The survey concludes that microneedles and microneedle arrays will gain traction at the expense of injection and passive transdermal patches, particularly among emerging biologics.
More information is available at www.greystoneassociates.org .
About Greystone
Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.
Contact:
Mark Smith
Voice: 603-595-4340
Fax: 603-804-0466
www.greystoneassociates.org
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