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2018 || Market | Dermatology Therapeutics Market to 2018 - Novel || Aarkstore.com

aakrutikv — Fri, 19 Oct 2012 05:52:55 +0000

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Dermatology Therapeutics Market to 2018 – Novel Biologics Targeting Interleukin-17 Receptor Presents New Options in Psoriasis Treatment

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GBI Research, the leading business intelligence provider, has released its latest research, Dermatology Therapeutics Market to 2018 – Novel Biologics Targeting Interleukin-17 Receptor Presents New Options in Psoriasis Treatment”. The report provides insights into the dermatology therapeutics market including market forecasts up to 2018. It provides an in-depth analysis of the major dermatological indications, which include psoriasis, acne, rosacea, atopic dermatitis, herpes and alopecia, as well as insights into the dermatology therapeutics R&D pipeline. The report provides in-depth analysis of the unmet needs, drivers and barriers that affect the global dermatology therapeutics market.

Scope

- Annualized market data for the dermatology therapeutics market from 2004 to 2011, forecast forward to 2018.
- Analysis of the leading therapeutic segments. These include acne, psoriasis, alopecia, atopic dermatitis, rosacea and herpes.
- Analysis of the dermatology therapeutics market in the leading geographies of the world, which includes the US, the UK, Germany, France, Italy, Spain, and Japan.
- Analysis of the dermatology therapeutics market in India, China and Australia.
- Market characterization of the dermatology therapeutics market including market size, annual cost of treatment, and treatment usage patterns.
- Key drivers and barriers that have a significant impact on the market..

Reasons to buy

- Align your product portfolio to the markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the potential region and dermatology therapeutics market segments poised for strong growth.
- Create a more tailored country strategy through the understanding of key drivers and barriers of the global dermatology abuse therapeutics market.

Table of contents:

1.1 List of Tables 10
1.2 List of Figures 12
2 Dermatology Therapeutics Market to 2018 – Introduction 14
3 Dermatology Therapeutics Market to 2018 – Market Overview 15
3.1 Revenue 15
3.2 Annual Cost of Treatment 16
3.3 Treatment Usage Pattern 17
3.3.1 Diseased Population 18
3.3.2 Treatment-Seeking Population 18
3.3.3 Diagnosed Population 18
3.3.4 Prescription Population 18
3.4 Recently Approved Product 18
3.4.1 Fabior (Tazarotene) 18
3.5 Key Trends 19
3.5.1 Potential New Treatment for Skin Diseases 19

List of Figures

List of Tables are also include.

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Active Pharmaceutical Ingredients (API) Market in Asia-Pacific to 2016 – The Merchant Market for Generics Continues to Grow as the Competition Increases

Visible Light Communication (VLC) – A Potential Solution to the Global Wireless Spectrum Shortage

Wireless Charging Market to 2016 – Standardization to Increase Uptake and Drive Growth

Near Field Communication (NFC) Market to 2016 – Increased Availability of NFC Embedded Handsets Key for Higher Market Penetration

DECT Ultra Low Energy (ULE) Market to 2016 – Existing Internet Gateways and Demand for VoIP-Based Home Automation Products to Drive Technology Adoption

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The Old or Something New?

Ra Ra Rad Me — Tue, 16 Oct 2012 18:37:13 +0000

“You’re at the highest dose,” my rheumatologist told my husband and me yesterday afternoon and continued, “but, I’m on the fence as to how to move forward. I’m not sure if we should wait and see the full effects of the methotrexate or to try something else.” I’ve been on 20mg of methotrexate for 6 weeks and have not seen the change I had hoped for. In fact, the major change has been that I am sick 2.5 days of 7 from the medication and feel it wear off, as my hands and feet (etc.) feel tight, and puffy on Friday afternoons. So that gives me about three days a week where things are potentially okay (depending on the day/week). My doctor repeated, “The goal is no stiffness and pain.”

As an ending note, my doctor decided biologics with a lower dose of methotrexate may be the next step. I have to have a chest x-ray and he will be contacting my insurance to see what they will cover. I can’t help but feel terrified all over again. There is something oddly comfortable about consistency. I know what to expect and, although it is not great or even good, I find comfort in the known.

The idea of giving myself shots, further poisoning my body, and adding new risks make me feel uneasy, actually terrified for now. But, on the other hand perhaps my body will respond better and I will get days back? The statistics aren’t awesome and I feel myself wallowing in sorrow at the loss of my health and poisoning of my body, again. It comes and goes. Thankfully, pity party ice cream was readily available. Chocolate covered peanut butter filled pretzels in vanilla ice cream swirled with peanut butter. Yummmmmmy. I owe you that recipe.

I find myself daydreaming about medical remission. It happens, right? Is it good to be hopeful? One day at a time. That’s all we can do. I do know I am not in absolute agony anymore and am thankful to come this far.

October 2012 - Table of Contents

dermatologyjournal — Mon, 15 Oct 2012 15:08:18 +0000

Volume 18 Number 10

October 2012

Review

1. Interleukin-23 and interleukin-17: Importance in pathogenesis and therapy of psoriasis
Parvathi Mudigonda, Tejaswi Mudigonda, Ashley N Feneran, Habibollah S Alamdari, Laura Sandoval, Steven R Feldman

Case Reports

2. Congenital self-healing reticulohistiocytosis: Concern for a poor prognosis
Larissa Larsen, Melissa Reyes Merin, Thomas Konia, April Wang Armstrong

3. Facial chromoblastomycosis in sub-Himalayan region misdiagnosed as cutaneous leishmaniasis: Brief report and review of Indian literature
Santwana Verma, Ghanshyam K Verma, Gagandeep Singh, Anil Kanga, Vinita Sharma, Neha Gautam

4. Disseminated Lyme Borreliosis preceded by hepatitis in an African American male
Ramin Fathi, William Wei-ting Huang, Katherine Brown

Case Presentations

5. Primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma: Transformation from indolent to aggressive phase in association with CCR7-positive conversion
Akira Kasuya, Satoshi Hirakawa, Yoshiki Tokura

6. Eosinophilic pustular folliculitis in infancy: Report of a new case
L Alonso-Castro, B Pérez-García, C González-García, P Jaén-Olasolo

7. Ulcerated plaques in the pelvic region of an adult female
Benjamin Barrick, Brian Matthys, Garth Fraga

8. Dermoscopy of black-spot poison ivy
Ryan K Rader, Ruipu Mu, Honglan Shi, William V Stoecker, Kristen A Hinton

9. Fatal Henoch-Schonlein Purpura in an adult related to bowel perforation: Report and review of the literature
Una Miniter, Yoon-Soo Cindy Bae-Harboe, Jennifer G Powers, Shannon M Campbell, Lynne J Goldberg

10. Oral pemphigus vegetans: A case report
Marcio Augusto de Oliveira, Fabiana Martins e Martins, Silvia Lourenço, Marina Gallottini, Karem L Ortega

11. An inflammatory verrucous epidermal nevus concomitant with psoriasis: Treatment with adalimumab
Mustafa Özdemir, Ali Balevi, Hasan Esen

Unknown

12. Unknown: A congenital nodule on the scapula
Goretti Lacruz, Maria Antònia González-Enseñat, Mariona Suñol, Asunción Vicente

Photo vignettes

13. Isolated single digit Porokeratosis of Mibelli: An unusual case
Samuel Odeyinde, Harry Belcher

14. Clear cell acanthoma induced by a dermatofibroma
David Silverstein, Ashfaq Marghoob

Commentary

15. Caution advised in interpretation of US FDA risk classification for dermatological medications during pregnancy
Jillian W Wong, Misha M Heller, Jenny E Murase

Letters

16. Vascular malformation of the glans penis succesfully treated with Nd:YAG laser
Verónica López, José M Ricart, Inmaculada López, José M Martín, Davide Marton, Carmen Ortega, Salvador Costa

Dermatology Online Journal

Editor: Barbara Burrall MD
Managing Medical Editor: Emanual Maverakis MD
Managing Editor: Matthew Yasner MBA
Founder and Publisher: Arthur C Huntley MD
Associate Editor: Ted Rosen MD
Associate Editor: Miguel Sanchez MD
Associate Editor: Noah Scheinfeld MD
Dermatopathology Editor: Maxwell Fung MD
Dermatopathology Editor: Sate Hamza MD
Editor for Portuguese Articles: George Leal MD
Editor for Spanish Articles: Mauricio Goihman MD

Editorial Board

Ronald J Barr		Art Huntley
Barbara Burrall		Sheraz Jamal Khan
William Danby		George Leal
Joseph Eastern		Fu-Tong Liu
Haines Ely		Ted Rosen
Steven Emmet		Miguel Sanchez
Steve Feldman		Noah Scheinfeld
Phil Fleckman		Kevin Smith
Max Fung		Mohamed-Hany el Tonsy
Ignacio Garcio		Shyam Verma
Mauricio Goihman-Yahr		Guy Webster
Sate Hamza		Edward Zabawski Jr

Technical Editors

Carl Blesius MD
Robert Horton PhD
Morton Taragin PhD
Ken Weiss MBA

Guest Post: The New India Guidelines on Similar Biologics

pixeljayanta — Wed, 10 Oct 2012 09:33:00 +0000

The Government of India has recently announced certain guidelines regulating the approval of ‘similar biologics’ also known as bio-similars. The bio-similar market is going to be a huge market opportunity for the generic drug industry. Given the complexity of the products themselves, the regulatory regime for bio-similars is also rather complex. Since none of us on the blog had a detailed understanding of the guidelines, we invited our frequent guest blogger Mr. Christopher Ohly to write us a guest post on the topic. Mr. Ohly, a Partner at Schiff Hardin LLP is a seasoned American litigator in several fields including IP and regulation. As you can see from below Mr. Ohly, has done an exhaustive analysis of the guidelines in contrast to the position in the U.S. He has prefaced that discussion with a brief introduction to the idea of bio-similars and their importance to India.

Since it is difficult to run footnotes on blogger, I’ve removed all of them from this post but readers who want to read the entire article, footnotes included can download the same from our website over here.

The New India Guidelines

On Similar Biologics

Regulatory and Market Authorization Requirements

By, Christopher Ohly,

Partner Schiff-Hardin

October 8, 2012

Overview[i]

Biological products are any virus, therapeutic serum, toxin, antitoxin, vaccine, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide) or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man. Biological products are generally produced using a living system or organism, but increasingly may be synthesized using chemical and computational techniques. While “small molecule” drugs have well-defined chemical structures that can be readily and fully characterized, and are “are ideal for replication as generics,” biological pharmaceutical products are not yet as readily replicable in identical forms. Biological pharmaceutical products are usually large, complex molecular structures, whose chemical composition and conformation are important to activity, effectiveness and toxicity.

Biologic products are both therapeutically and economically important. In contrast to other therapeutic agents, such as chemotherapies, biologic products, particularly monoclonal antibodies, are highly selective, offering effective treatments against dreaded diseases with fewer side effects. More than 150 “reference product” biologics have been approved for marketing in the United States. There are more than 370 biopharmaceutical drug products and vaccines in clinical trials targeting more than 200 diseases including cancer, Alzheimer’s disease, heart disease, multiple sclerosis, AIDS, and arthritis.

Of the top 10 pharmaceutical products in 2011, by global sales, three (Humira, Enbrel and Remicade) were biologics. In 2010, the combined sales of the top 12 biologic products in the U.S. approached $30 billion. Biologic products are expensive. In the US in 2011, it was estimated that the average cost of a biologic product was $16,000 per year, with the costs for biologic therapies for treatment of some cancers costing as much as $10,000 a month. According to one prediction, by 2014, seven out of the top ten best-selling drugs will be biologic drugs, with sales exceeding $50 billion. The trend will continue, with biologic products increasingly replacing “small molecule” products as the largest generators of sales revenues, if not the preferred therapeutic method.

These market and therapeutic opportunities have led to development of “biosimilars,” or “follow-on biologics,” which are produced by cellular means, not “identical” but therapeutically equivalent (in safety and efficacy) to reference products, and, hopefully, made and sold at substantially lower cost. Current U.S. law defines biosimilarity to mean “that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”

Biologics and Biosimilars in India

According to a 2010 report, more than 40 biologics are marketed in India, of which 25 are biosimilars manufactured in India, including insulin, epoetin, filgrastim, streptokinase, and rituximab. Another 25 biosimilar products are in development. The same report states that there “are more than 130 companies in the biopharmaceutical market in India, but “only 7-10 companies are involved in the manufacture of recombinant products.” Although, in the short term, some Indian companies are reportedly targeting unregulated and “semi-regulated” markets, including India itself, price advantages will lead to entry in highly regulated markets, including the EU and United States.

At the same time, changes are coming in the Indian market, as larger pharmaceutical and biologic manufacturers enter the growing Indian market, sometimes in competition and sometimes in joint ventures (or mergers) with Indian pharmaceutical manufacturers:

In 2001 India liberalized foreign direct investment (FDI) norms for the pharmaceutical sector. As a result, 100% FDI was allowed through the ‘automatic route’ (without prior permission) in pharmaceutical manufacturing (except in sectors using recombinant DNA technology).

* * * * *

In recent years there have been a number of high-profile MNC acquisitions of Indian pharmaceutical companies, starting with the takeover of Matrix Laboratories by US generic manufacturer Mylan Inc in 2006. This was followed by the Japanese corporation Daiichi’s acquisition of India’s largest pharmaceutical company Ranbaxy. At times MNCs offered purchase prices which were many times higher than the actual sales turnover of the acquired firms. For instance, Abbott paid $3.7 billion for Piramal Healthcare, whose sales revenue was reported to be approximately $400 million. …

The same period witnessed a series of strategic alliances between MNCs and Indian pharmaceutical companies. … Generally speaking, these strategic alliances take place in any one of the following areas: research and development (R&D), marketing and contract manufacturing. Of the three categories, the dominant form is in the field of contract manufacturing.

The impact of these market changes in India is uncertain, particularly as litigation over patents covering important and expensive products, including biologics, works its way through the Indian courts. Nevertheless, it is inevitable that Indian manufacturers will enter the burgeoning global biosimilars market, and that foreign manufacturers will continue to penetrate the growing Indian market for biologic drugs.

India’s New Biosimilar Guidelines

On June 20, 2012, at the BIO2012 conference in Boston, India’s Department of Biotechnology (DBT) and its Central Drugs Standard Control Organization (CDSC) announced the release of final guidelines for approval of “similar biologics.” The guidelines became publicly available on the Internet a short time later. At BIO, DBT Secretary Maharaj Bhan stated,

“We don’t want the global and local industries to be in conflict all the time, there needs to be a more harmonious relationship. It [the guidelines] will give a very clear message to everyone….that the Indian regulatory system is capable of taking a scientific view of things and not necessarily worrying about trivial advantage in one direction or the other.”

India’s new guidelines describe a regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic. They address pre-market regulatory requirements including the “comparability exercise” for quality, preclinical and clinical studies and describe detailed post market regulatory requirements. They also contain requirements relating to manufacturing processes and quality control. These requirements are themselves similar in many respects to comparable regulatory guidelines in the United States and the EU. While harmonization is far from complete, it appears that, at least in his area, science will dominate and bring different regulatory systems into significant conformity.

Basic Principles

The Indian guidelines define a “similar biologic” as a “biological product/drug produced by genetic engineering techniques and claimed to be ‘similar’ in terms of safety, efficacy and quality to a reference biologic, which has been granted a marketing authorization in India by DCGI on the basis of a complete dossier, and with a history of safe use in India.” This definition is not substantively different from definitions offered in US and EU laws and regulations. Unlike US law, neither Indian nor EU guidelines or law distinguish between a “biosimilar” and an “interchangeable” product, leaving choice about therapeutic substitution of a biosimilar for a reference product to physicians and their patients. Unlike US law, neither Indian nor EU law or regulations provide any a period of market or data exclusivity to a biosimilar manufacturer that is able to demonstrate that its product may be freely “switched” for a reference product in any given patient,” without increasing “the risk of using the reference product without such alternation or switch.”

Analytical Studies

Like the “stepwise approach” taken in the US and EU, India has adopted a “sequential approach” to its consideration of applications to market biosimilars.

According to India’s biosimilar guidelines, “[s]imilar biologics are developed through [a] sequential process to demonstrate the similarity by extensive characterization studies revealing the molecular and quality attributes with regard to the reference biologic.” Through this stepwise approach, “extensive structural and functional characterization of both the proposed product and the reference product” using advance analytical techniques to identify and compare “physico-chemical and biological properties, such as higher order structures and functional characteristics,” not only of “the drug substance of a protein product, but also excipients and product- and process-related impurities,” serves as the “foundation of a biosimilar development program.”

The India Guidelines set forth specific and highly technical requirements for “routine analytical tests” to be employed in a “comparability exercise,” including analytical methods for determination of structural and physicochemical product properties, biological activity, immunological properties, characterization of impurities, and stability testing. Taking this sequential approach, the India Guidelines suggest that the results of such analytical testing may reduce the potential requirement of human and animal clinical testing of biosimilars candidates:

Although the extent of testing of the similar biologic is likely to be less than that required for the reference biologic, it is essential that the testing of the similar biologic be sufficient to ensure that the product meets acceptable levels of safety, efficacy and quality to ensure public health.

Generally, a reduction in data requirements is possible for preclinical and/or clinical components of the development program by demonstration of comparability of product (similarity to authorized reference biologic) and the consistency in production process, which may vary depending on the characteristics of the already authorized reference biologic.

Correspondingly, the India Guidelines, like the US and EU guidances, leave ultimate requirements to science, defined by discussions between product sponsors and regulators.

Clinical Testing

Under US procedures, after evaluating results of analytical testing that characterizes both the reference product and a proposed biosimilar, the FDA will then determine on a case-by-case basis how much animal and clinical data are required and evaluate the application based on the totality of the evidence. Under the India Guidelines, some information is provided about potential animal studies to be conducted with the approval of India’s Institutional Animal Ethics Committee (IAEC), if such approval is available. The guidelines clearly state that, when characterizing the “immunological properties” of a proposed biosimilar product, “evaluation by animal studies should be performed.”

In case of in vivo toxicity studies, at least one repeat dose toxicity study in a relevant species is required to be conducted. The duration of the study would be generally not less than 28 days with 14 days recovery period. However the duration may vary depending on the dosage and other parameters on case by case basis.

Regarding the animal models to be used, the applicant should provide the scientific justification for the choice of animal model(s) based on the data available in scientific literature. However if the relevant animal species is not available and has been appropriately justified, the toxicity studies need to be undertaken in two species i.e. one rodent and other non rodent species, as per the requirements of Schedule Y with due permission from the RCGM.

Human clinical testing will ordinarily follow analytical and clinical testing. Under the India Guidelines a biosimilars applicant must submit an application to conduct a clinical trial in accordance with previously published CDSCO guidelines. Once such an application is approved, a biosimilar sponsor will be required to conduct several studies designed to establish comparative safety and efficacy in relevant patient populations.

Comparative pharmacokinetic studies should be conducted “in healthy volunteers or patients to demonstrate the similarities in pharmacokinetic characteristics between similar biologic and reference biologic on case to case basis.” Such PK (pharmacokinetic) studies must be performed using dosages “within the therapeutic dose range of reference biologic.” The India Guidelines continue:

A parallel arm design is more appropriate for biologics with a long half life or for proteins for which formation of antibodies is likely or if study is being done in patients. In case of short half life, cross over design may be considered with a scientific justification.

Multiple-dose, comparative, parallel arm steady state PK studies are required for a similar biologic that is used in a multiple dose regimen, where markedly higher or lower concentrations are expected at steady state than that expected from single dose data PK measurements, and where time-dependence and dose-dependence of PK parameters cannot be ruled out.

Similarly, the India Guidelines require human pharmacodynamic studies:

Comparative, parallel arm or cross-over, PD study in most relevant population (patients or healthy volunteers) is required for detecting differences … If PD marker is available in healthy volunteers, PD in healthy volunteers can be done. … The relationship between dose/exposure, the relevant PD marker(s) and response/efficacy of the reference biologic should be well established and used to justify the design. The acceptance ranges for the demonstration of similarity in PD parameters should be predefined and appropriately justified.

Such PD studies are “recommended” when “the PD properties of the reference biologic are well characterized with at least one PD marker being linked to the efficacy of the molecule.”

The India Guidelines appear to mandate at least some additional human clinical trials “to demonstrate the similarity in safety and efficacy profiles between the similar biologic and reference biologic.” To establish similarity, “equivalence trials with equivalence designs (requiring lower and upper comparability margins) are preferred.” Hence, in India, unlike the US, it would seem to be possible, in some circumstances, to employ non-inferiority tests to establish efficacy and aspects of safety in addition toimmunogenicity.

As in the US and EU, assessment of adverse events occasioned by administration of a biosimilar product is a critical component of human clinical testing. Hence, the India Guidelines state that the “nature, severity and frequency of adverse events should be compared between the similar biologic and reference biologic and should be based on safety data from a sufficient number of patients treated for an acceptable period of time.” These guidelines add that [e]fforts should be made to ensure that comparative clinical studies have a sufficient number of patients treated for acceptable period of time in order to allow detection of significant differences in safety between similar biologic and reference biologic.”

The India Guidelines add specific post-market surveillance requirements that seemingly will augment or, perhaps, substitute for extensive pre-approval human clinical testing requirements. First, the guidelines require institution of a post-approval Risk Management Plan, designed to monitor and detect both known inherent safety concerns and potential unknown safety signals that may arise from the similar biologics. Such a risk management plan must be submitted along with a biosimilar sponsor’s Market Authorization Application. The Plan must include at least one non-comparative post-marketing clinical study with focus on safety and immunogenicity, designed to confirm that the similar biologic does not have any concerns with regards to the therapeutic consequences of unwanted immunogenicity. However, the India Guidelines provide, “[i]f immunogenicity is evaluated in clinical studies, it is not mandatory to carryout additional non-comparative immunogenicity studies in post-marketing studies.”

The importance of shifting human clinical testing requirements to the speed of approval of a biosimilar may be demonstrated by the experience of Dr. Reddy’s Laboratories (DRL) in approval of its Reditux® (rituximab) biosimilar product. During the November 2010 pre-guidance FDA hearing, a speaker for DRL reported that pre-approval testing of DRL’s rituximab biosimilar required administration of the proposed product to a mere 67 patients, with many more reported in post-market surveillance. Post market surveillance did not show “a single case of immunogenic response in any patient,” with more than 1000 patients treated with DRL’s Reditux after market approval, by the time of the presentation.

Extrapolation

The FDA guidances indicate that data derived from a clinical study sufficient to demonstrate safety, purity, and potency in an appropriate condition of use, potentially may be extrapolated to allow the biosimilar to be licensed for one or more additional indications for which the reference product is licensed. For example, relying on clinical testing of a Humira® or Remicade® biosimilars in patients with rheumatoid arthritis, it may theoretically be possible to obtain licensing for sale and use of such biosimilars in patients suffering from psoriasis or Crohn’s disease, which, like rheumatoid arthritis, are thought to be conditions associated with inflammation caused by the production of TNFα (tumor necrosis factor-α) in humans, without substantial or any additional clinical testing.

The India Guidelines state that “[i]n case the reference biologic is used for more than one indication, the efficacy and safety of the similar biologic has to be justified and if necessary demonstrated separately for each of the claimed indications.” They add that [j]ustification will depend on clinical experience, available literature data and whether or not the same mechanism of action is involved in specific indications.” The guidelines thus state that, in India, “extrapolation of the safety and efficacy data of a particular clinical indication (for which clinical studies has been done) of a similar biologic to other clinical indications may be possible,” if certain conditions are met. The list of conditions for consideration of extrapolation is not as long as the list in US guidances, but it is similar in content.

Reference Product

The India Guidelines define a “reference biologic” as “the comparator [used] for head-to-head comparability studies with the similar biologic in order to show similarity in terms of safety, efficacy and quality.” The definition requires that “[o]nly a product that was licensed on the basis of a full registration dossier can serve as reference biologic.” Under the guidelines the reference biologic must be used in all “comparability exercise[s] with respect to quality, preclinical and clinical considerations.”

Under the India Guidelines, the reference biologic “should be licensed in India and should be innovator product.” It should be “licensed based on a full safety, efficacy and quality data.” Hence, “another similar biologic cannot be considered as a choice for reference biologic.”

While the reference biologic must be licensedin India and should be innovator product, it is not necessary, under the India Guidelines for the reference product even to be sold or marketed in India. The India Guidelines may simply recognize that some foreign manufactured biologic products are simply not yet available in India, if only for economic reasons. The India Guidelines appear to permit use of foreign reference biologic products in a comparability exercise, whether or not the reference product is marketed or, under some circumstances, even licensedin India. The critical issue will be whether Indian biosimilar developers and manufacturers are able to obtain sufficient quantities of a foreign reference product to enable all of the required analytical, animal and human clinical testing required by Indian regulators. While this seemingly has not been an extraordinary impediment to date, legal developments may make acquisition of reference product more difficult in the future.

Manufacturing

The India Guidelines set forth a series of quality considerations applicable to manufacturing of biosimilar products. Among other things, these guidelines state that the “manufacturing process for similar biologic should be highly consistent and robust.” They set standards for cell lines used in the biosimilar manufacturing process, as well as standards for fermentation and downstream process development, analytical methods, product characterization, stability and specifications. The guidelines generally require that “three consecutive standardized batches which have been used to demonstrate consistency of the manufacturing process should be used” in the quality comparability study. The guidelines mandate that “[h]ead-to-head characterization studies are required to compare the similar biologic and the reference biologic at both levels of drug substance and drug product,” adding that “[d]ifferences … should be evaluated for their potential impact on safety and efficacy of the similar biologic and additional characterization studies may be necessary.” The India Guidelines provide that such a “quality comparison … should employ state-of-the-art analytical techniques, including the analytical methods that are sensitive enough to detect the possibilities of changes to the product,” providing a list of routine analytical tests to be included in the quality comparability exercise.

Concluding Comments

The India Guidelines represent a major step forward in establishing a rigorous, science-based regime for approval of biosimilars pharmaceutical products, especially for sale and therapeutic use in India. The guidelines mirror similar efforts in the US and EU and, like those “regulated market” guidances, consciously rely upon other guidance documents issued by the International Conference on Harmonization, with a view toward encouraging the manufacture of safe and effective biologic products in India, perhaps at lowered costs, to ensure access to life-saving drugs for many.

Like their counterparts in the US, EU and perhaps elsewhere, the India Guidelines will contribute to harmonization efforts, perhaps ultimately resulting in a globally consistent approach to biologic development and manufacture, reducing the need for redundant clinical trials. The guidelines will likely also contribute enabling certainty to the efforts of both Indian drug manufacturers and others who may enter the burgeoning Indian market, that contemplate significant investment in research, manufacturing facilities, and new means of product marketing.

All of this may well lead Indian manufacturers to become effective competitors in the global market for biologic medicines, both as suppliers of biosimilar products and, soon thereafter, of “biobetters” and innovative new medicines. That contribution to global health, whether encumbered or unencumbered by disputes over exclusivities and patent protection, will be welcomed by all.

[i] The views, positions and opinions expressed in this article are those of the author alone and do not necessarily reflect the views of any of the other partners in Schiff Hardin LLP, or the views of any of the firm’s clients. Nothing in this article is intended to provide legal advice. No attorney-client relationship is established by virtue of this article.

Video Glossary: What is Tuberculosis and why is testing needed to start biologic drugs?

Nadia — Tue, 09 Oct 2012 11:35:33 +0000

Prior to starting biologic drugs such as Humira, Remicade, or Cimzia your physician will require some medical testing to ensure you are well enough to begin the drug regimen. One such test is a Tuberculosis test. I recently was put on Cimzia and had to take a TB skin test. The results luckily came back negative, but it piqued my curiosity as to why a patient must undergo these tests. The following video glossary talks about TB testing and why it is important to have it before starting biologics.

“We keep moving forward, opening new doors, and doing new things, because we’re curious and curiosity keeps leading us down new paths.” ~Walt Disney

~Nadia

Question: Have you have a Tuberculosis test before? Which test did you have and what was the result?

Biosimilar Approval

AAPS Blog — Fri, 28 Sep 2012 14:57:17 +0000

Kim Brown is the AAPS communications and social media manager in the Public Outreach Department.

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Where to Buy Black Friday American Biologics - Ultra Inf-Zyme Forte, 180 tablets Special Offer! Cyber Monday Sale

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Aubagio wins FDA approval

healthworldnews — Sun, 16 Sep 2012 14:04:49 +0000

Aubagio won FDA approval for treatment of multiple sclerosis on Wednesday. Aubagio has a lower cost (treatment will is priced at around $45,000 per year) but not a lower rate of relapse (30%) than its rivals, such as Tysabri, which has a relapse rate of 23%. It’s the first oral medication for multiple sclerosis, which might help its sales. Sanofi is moving Aubagio to Genzyme, its Cambridge-based biologics arm. CEO Chris Viehbacher has been pushing for an overhaul in Sanofi’s R&D unit. Layoffs are about to hit the French division of Sanofi, and employees were striking last week. The approval should give Viehbacher a stronger hand in moving his vision forward.

Healthinnovations on Thomson Reuters: New Techniques in Drug Discovery.

Healthinnovations — Fri, 24 Aug 2012 11:27:55 +0000

“When you discover something novel the medical imperative is to come up with a good use for it

Steroids use and higher infection rates in children with juvenile arthritis

uptodatemedical — Sun, 12 Aug 2012 10:28:17 +0000

Children with juvenile idiopathic arthritis (JIA) were shown to have higher rate of infection than those without arthritis. The higher rate of infection was associated with the use of steroids and not with the use of methotrexate or TNF inhibitors. Arthritis and Rheumatism

Tofacitinib in Rheumatoid Arthritis

uptodatemedical — Sat, 11 Aug 2012 09:20:47 +0000

Tofacitinib, the new rheumatoid arthritis drug, appears to be just as effective as Humira for treatment of Rheumatoid Arthritis. However, the side-effects of this treatment may limit its usefulness and these include lowering of white blood cell count, elevated cholesterol, as well as infections. This drug could still be useful in patients who have failed other biologic therapies. NEJM.

A Possible New Oral Medication for Rheumatoid Arthritis

joannakolasa — Thu, 09 Aug 2012 20:16:02 +0000

Tofacitinib is a new drug made by Pfizer seeking approval from the FDA for the treatment of rheumatoid arthritis. It is a novel approach since tofacitinib is taken twice daily by mouth compared to injectable biologics. It works uniquely by blocking janus kinase (JAK) enzymes inside cells. New studies, paid for by Pfizer, were published in the New England Journal of Medicine showing a reduced number of swollen and painful joints compared to placebo. Common side effects include upper respiratory tract infection, headache, increased LDL and diarrhea. Some serious adverse effects include reduced white blood cell count, as well as a weakened immune system. Are you excited about this new convenient route of administration? Do you think this drug will help with patient compliance?

http://www.webmd.com/rheumatoid-arthritis/news/20120808/pill-instead-needle-may-soon-be-option-for-ra

Rheumatoid Arthritis

editoretanica — Sun, 05 Aug 2012 13:57:04 +0000

This is a disease that affects millions worldwide. It used to be a very disabling condition. But thanks to the latest scientific discoveries that has determined the cause of this disease, powerful and extremely effective treatments have been developed that has revolutionized the care of this disabling disease. The biggest problem now is getting the treatment to the patient with early diagnosis and overcoming the cost of these medications especially for patients overseas. Timely diagnosis is very crucial in controlling this disease and minimizing it’s damage. Joint deformities are almost becoming a rarity for this disease that only ten years ago was leaving patients crippled for life.

Ann Arbor's NSF Buys D.C.-Based FDA Consulting Firm

Matt Roush — Thu, 02 Aug 2012 14:38:17 +0000

ANN ARBOR — NSF International, an independent global public health and safety organization which develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration-regulated industries, specifically medical devices, pharmaceuticals and biologics.

Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, “Good Manufacturing Practices” and “Good Laboratory Practices” testing, certification, R&D and auditing services for the pharmaceutical, dietary supplement and medical device industries.

“The partnership between NSF International and Becker comes at a time when the U.S. FDA is actively warning manufacturers and patients about the need for enhanced systems to ensure the safety of medical devices and pharmaceuticals,” said Ron Ginor, M.D., CEO of Becker & Associates Consulting. Dr. Ginor will continue to lead the organization, adding that, “With NSF’s role at the forefront of public health for 68 years and its global capabilities, we will be able to enhance and expand the scope and range of services we can offer to our customers.”

Ron Johnson, president of Becker Consulting and former director of compliance at FDA’s Center for Devices and Radiological Health, also will continue his leadership of quality systems and compliance activities for the firm, directing the company’s expanding activities in North America, India, China and South America.

“The medical device and pharmaceutical sectors are in a period of flux following a number of significant regulatory changes,” Johnson said. “As part of NSF’s Health Sciences Division, we are able to help our clients not only meet FDA compliance but to educate their professionals to stay in compliance by leveraging the vast experience and resources of NSF International.”

For more than 20 years, experts at Becker Consulting have helped client companies meet and exceed FDA requirements for developing, testing and marketing innovative health care products. They have helped resolve some of the most difficult clinical, regulatory and scientific challenges within the rapidly evolving life science sector. Becker teams operate throughout the world, helping to assure the safety and efficacy of drugs and medical devices, re-establishing manufacturing facilities after natural disasters, designing manufacturing processes for complex biologics, building systems for protecting blood banks, and developing testing protocols and clinical programs for the evaluation of novel drugs and devices, among other roles.

This acquisition complements NSF International’s other health science services to the pharmaceutical, biotech, medical device and dietary supplement industries, including:
* Training and education for the pharmaceutical, biotech and medical device industries
* Consulting in quality systems, GMP and compliance/enforcement actions
* Clinical and regulatory consulting
* Analytical testing
* Bioanalytical testing for clinical trials
* Product testing and certification

“This is a singular opportunity for both NSF International and Becker to expand our global biotech, medical device and life science services,” said Kevan P. Lawlor, NSF International president and CEO. “Combining Becker’s market-leading FDA experience with NSF International’s unsurpassed training, education, testing and certification expertise will further position NSF as a vital resource in the global pharmaceutical and medical device industries and as a critical partner in the assurance of safer drugs and devices for the public.”

More at www.becker-consult.com or www.nsf.org/business/health_sciences/index.asp.

Human Genome Project

ThinkWorth — Tue, 24 Jul 2012 00:36:40 +0000

It’s alive! Scientists create first 100% realistic virtual sex disease bacteria inside a computer – and it could pave the way for artificial life forms

By Rob Waugh

Breakthrough moment for artificial biology
100% realistic simulated bacteria ‘lives’ inside PC
Simulation could be used to design new medicines – or even life forms
Could pave way for scientists to design bacteria using 3D modelling tools

The first-ever complete computer model of a tiny, sexually transmitted bacteria is now ‘living’ inside a computer.The ‘complete’ model of the ‘Mycoplasma genitalium’ bacteria behaves exactly like the real thing – based on data from 900 scientific papers.

The discovery could pave the way for scientists to design new bacteria in the same way we design cars or 3D models now.

Every chemical change inside the bacteria is simulated at the molecular level – a breakthrough that could be a a stepping-stone towards creating tailor-made life forms.

It’s alive! The ‘complete’ model of the ‘Mycoplasma genitalium’ bacteria behaves exactly like the real thing – based on data from 900 scientific papers

Stanford bioengineering graduate student Jayodita Sanghvi says, ‘You don’t really understand how something works until you can reproduce it yourself.’

Mycoplasma genitalium is a humble parasitic bacterium known mainly for showing up uninvited in human urogenital and respiratory tracts.

But the pathogen also has the distinction of containing the smallest genome of any free-living organism – only 525 genes, as opposed to the 4,288 of E. coli, a more traditional laboratory bacterium.

ARTIFICIAL LIFE? THE BOOM IN DIY ‘BIO-HACKERS’

The field of ‘synthetic biology’ came into being in 2010 when billionaire scientist Craig Venter added synthetic DNA to a bacteria cell to create a ‘new’ life form. An Oxford ethicist warned that it opened the door to ‘the most powerful bioweapons imaginable’.

Since then, the field has changed.

Worryingly, enthusiasts calling themselves ‘biohackers’ – and calling the field DIYBio – have begun experimenting with their own ‘synthetic biology’ projects, such as MIT graduate Kay Aull’s reprogramming of E Coli’s genome.

The Stanford discovery will have impact in the longer term – but could lead to artificial life being ‘designed’ as easily as cars are now.

‘This achievement demonstrates a transforming approach to answering questions about fundamental biological processes,’ said James M. Anderson, at Stanford University.

‘Comprehensive computer models of entire cells have the potential to advance our understanding of cellular function and, ultimately, to inform new approaches for the diagnosis and treatment of disease.’

Being able to ‘simulate’ life will allow researchers to perform far more complex experiments than were previously possible.

By ‘mutating’ virtual life forms, scientists can answer questions that would be impossible with other methods.

Billionaire entrepreneur Dr Craig Venter-a controversial figure known as ‘Darth Venter’ to his colleagues- created a life form two years ago

‘Many of the issues we’re interested in aren’t single-gene problems,’ said Covert. ‘They’re the complex result of hundreds or thousands of genes interacting.’

‘The goal hasn’t only been to understand M. genitalium better,’ said co-first author and Stanford biophysics graduate student Jonathan Karr. ‘It’s to understand biology generally.’

Even at this small scale, the quantity of data that the Stanford researchers incorporated into the virtual cell’s code was enormous.

The final model made use of more than 1,900 experimentally determined parameters.

Much of the model’s future promise lies in more applied fields.
CAD – computer-aided design – has revolutionized fields from aeronautics to civil engineering by drastically reducing the trial-and-error involved in design.

But our incomplete understanding of even the simplest biological systems has meant that CAD hasn’t yet found a place in bioengineering.

Computational models like that of M. genitalium could bring rational design to biology – allowing not only for computer-guided experimental regimes, but also for the wholesale creation of new microorganisms.

Once similar models have been devised for more experimentally tractable organisms, Karr envisions bacteria or yeast specifically designed to mass-produce pharmaceuticals.

Bio-CAD could also lead to enticing medical advances – especially in the field of personalized medicine. But these applications are a long way off, the researchers said.

‘This is potentially the new Human Genome Project,’ Karr said. ‘It’s going to take a really large community effort to get close to a human model.’

Source: Daily Mail, UK

From NPR: Tissue Tracking and Health Risks

intelleflex — Wed, 18 Jul 2012 23:17:22 +0000

During my drive to the office this morning I heard an interesting story on NPR’s Morning Edition titled Little Regulation Poses Problems Tracking Tissue. You can listen to or read the entire story here. According to the story, each year in the United States, almost 1.5 million medical products are used for surgeries made with tissue taken from cadavers. Despite this vast number, fortunately there have been few issues or problems so far associated with using human tissue but, when there is an issue, it can be tricky to catch and the consequences can be life threatening.

1.5 million medical products are used each year for surgeries made with human tissue

The story describes a case where tissue contaminated with Hepatitis C was accidentally distributed for use by patients. Hospitals had to be alerted and the race was on to find where the tissue had been sent. The story states: In this case, 44 ligaments, tendons and other donated tissue were sent to hospitals and clinics around the country. Unlike organs, which are quickly transplanted, tissue can be saved and stored for use at a much later date. A month later [Italics are mine], the CDC found 15 people already had been implanted, but didn’t contract the disease. That’s because their tissue was scrubbed with strong chemicals. But there was one infection: A child in Boston received a heart patch, and because heart tissue can be cleaned only lightly, that child contracted Hepatitis C. The child’s current health condition hasn’t been made public.

According to the story, the FDA says it continues to evaluate the need for new regulations and has started requiring tissue banks to do limited tracking but, once the tissue is sold to hospitals, clinics and doctors, it is voluntary for those surgeons to report back what tissue gets transplanted into which patient. And, as the business grows globally and tissue comes to the U.S. from countries around the world, keeping track of tissue is even harder.

Matthew Kuehnert, a doctor at the CDC whose job it is to protect donated blood, organs and tissue suggests the process of receiving tissue should be similar to buying cereal at the grocery store. Said Kuehnert, “It has a bar code on it, and it can be tracked back if there is some sort of problem with it in terms of quality,” he says. “You can’t do that with tissue right now. And that is a gap.”

While I get where Dr. Kuehnert is going with his cereal analogy, I think it comes up a bit short. Unlike cereal, tissue is temperature sensitive. You not only need to be able to track where it has come from and where it is going but also monitor and track the condition that it’s been stored in along the way. If tissue isn’t stored at the right temperature, it can also cause problems that can lead to health implications. Bar codes can’t monitor for that. Fortunately, RFID temperature sensors can, while also storing the information about the tissue and help improve track and trace capabilities. You can read about this here.

Kevin Payne

Senior Director of Marketing

Shocking Trade in Skin, Bones & Tissue

ThinkWorth — Wed, 18 Jul 2012 16:38:23 +0000

Skin and Bone: the Shadowy Trade in Human Body Parts

Human Corpses are Prize in Global Drive for Profits

The business of recycling dead humans into medical implants is flourishing.

By Kate Willson, Vlad Lavrov, Martina Keller, Thomas Maier and Gerard Ryle

On Feb. 24, Ukrainian authorities made an alarming discovery: bones and other human tissues crammed into coolers in a grimy white minibus.

Investigators grew even more intrigued when they found, amid the body parts, envelopes stuffed with cash and autopsy results written in English.

What the security service had disrupted was not the work of a serial killer but part of an international pipeline of ingredients for medical and dental products that are routinely implanted into people around the world.

The seized documents suggested that the remains of dead Ukrainians were destined for a factory in Germany belonging to the subsidiary of a U.S. medical products company, Florida-based RTI Biologics.

RTI is one of a growing industry of companies that make profits by turning mortal remains into everything from dental implants to bladder slings to wrinkle cures.

The industry has flourished even as its practices have roused concerns about how tissues are obtained and how well grieving families and transplant patients are informed about the realities and risks of the business.

In the U.S. alone, the biggest market and the biggest supplier, an estimated two million products derived from human tissue are sold each year, a figure that has doubled over the past decade.

It is an industry that promotes treatments and products that literally allow the blind to see (through cornea transplants) and the lame to walk (by recycling tendons and ligaments for use in knee repairs). It’s also an industry fueled by powerful appetites for bottom-line profits and fresh human bodies.

In the Ukraine, for example, the security service believes that bodies passing through a morgue in the Nikolaev district, the gritty shipbuilding region located near the Black Sea, may have been feeding the trade, leaving behind what investigators described as potentially dozens of “human sock puppets” — corpses stripped of their reusable parts.

Industry officials argue that such alleged abuses are rare, and that the industry operates safely and responsibly.

For its part, RTI didn’t respond to repeated requests for comment or to a detailed list of questions provided a month before this publication.

In public statements the company says it “honors the gift of tissue donation by treating the tissue with respect, by finding new ways to use the tissue to help patients and by helping as many patients as possible from each donation.”

‘Our Misfortune’

Despite its growth, the tissue trade has largely escaped public scrutiny. This is thanks in part to less-than-aggressive official oversight — and to popular appeal for the idea of allowing the dead to help the living survive and thrive.

An eight-month, 11-country investigation by the International Consortium of Investigative Journalists (ICIJ) has found, however, that the tissue industry’s good intentions sometimes are in conflict with the rush to make money from the dead.

Inadequate safeguards are in place to ensure all tissue used by the industry is obtained legally and ethically, ICIJ discovered from hundreds of interviews and thousands of pages of public documents obtained through records requests in six countries.

Despite concerns by doctors that the lightly regulated trade could allow diseased tissues to infect transplant recipients with hepatitis, HIV and other pathogens, authorities have done little to deal with the risks.

In contrast to tightly-monitored systems for tracking intact organs such as hearts and lungs, authorities in the U.S. and many other countries have no way to accurately trace where recycled skin and other tissues come from and where they go.

At the same time, critics say, the tissue-donation system can deepen the pain of grieving families, keeping them in the dark or misleading them about what will happen to the bodies of their loved ones.

Those left behind, like the parents of 19-year-old Ukrainian Sergei Malish, who committed suicide in 2008, are left to cope with a grim reality.

At Sergei’s funeral, his parents discovered deep cuts on his wrists. Yet they knew he had hanged himself.

They later learned that his body parts had been recycled and shipped off as “anatomical material.”

“They make money with our misfortune,” Sergei’s father said.

Awkward Silence

19-year-old Ukrainian Sergei Malish, whose body parts were recycled into “anatomical material” without his parents’ consent.

During the transformational journey tissue undergoes — from dead human to medical device — some patients don’t even know that they are the final destination.

Doctors don’t always tell them that the products used in their breast reconstructions, penis implants and other procedures were reclaimed from the recently departed.

Nor are authorities always aware of where tissues come from or where they go.

The lack of proper tracking means that by the time problems are discovered some of the manufactured goods can’t be found. When the U.S. Centers for Disease Control and Prevention assists in the recall of products made from potentially tainted tissues, transplant doctors frequently aren’t much help.

“Oftentimes there’s an awkward silence. They say: ‘We don’t know where it went,’” said Dr. Matthew Kuehnert, the CDC’s director of blood and biologics.

“We have barcodes for our [breakfast] cereals, but we don’t have barcodes for our human tissues,” Kuehnert said. “Every patient who has tissue implanted should know. It’s so obvious. It should be a basic patient right. It is not. That’s ridiculous.”

Since 2002 the U.S. Food and Drug Administration has documented at least 1,352 infections in the U.S. that followed human tissue transplants, according to an ICIJ analysis of FDA data. These infections were linked to the deaths of 40 people, the data shows.

One of the weaknesses of the tissue-monitoring system is the secrecy and complexity that comes with the cross-border exchange of body parts.

The Slovaks export cadaver parts to the Germans; the Germans export finished products to South Korea and the U.S.; the South Koreans to Mexico; the U.S. to more than 30 countries.

Distributors of manufactured products can be found in the European Union, China, Canada, Thailand, India, South Africa, Brazil, Australia and New Zealand. Some are subsidiaries of multinational medical corporations.

The international nature of the industry, critics claim, makes it easy to move products from place to place without much scrutiny.

“If I buy something from Rwanda, then put a Belgian label on it, I can import it into the U.S. When you enter into the official system, everyone is so trusting,” said Dr. Martin Zizi, professor of neurophysiology at the Free University of Brussels.

Once a product is in the European Union, it can be shipped to the U.S. with few questions asked.

“They assume you’ve done the quality check,” Zizi said. “We are more careful with fruit and vegetables than with body parts.”

Piece of the Action

Inside the marketplace for human tissue, the opportunities for profits are immense. A single, disease-free body can spin off cash flows of $80,000 to $200,000 for the various non-profit and for-profit players involved in recovering tissues and using them to manufacture medical and dental products, according to documents and experts in the field.

It’s illegal in the U.S., as in most other countries, to buy or sell human tissue. However, it’s permissible to pay service fees that ostensibly cover the costs of finding, storing and processing human tissues.

Almost everyone gets a piece of the action.

Ground-level body wranglers in the U.S. can get as much as $10,000 for each corpse they secure through their contacts at hospitals, mortuaries and morgues. Funeral homes can act as middlemen to identify potential donors. Public hospitals can get paid for the use of tissue-recovery rooms.

And medical products multinationals like RTI? They do well, too. Last year RTI earned $11.6 million in pretax profits on revenues of $169 million.

Phillip Guyett, who ran a tissue recovery business in several U.S. states before he was convicted of falsifying death records, said executives with companies that bought tissues from him treated him to $400 meals and swanky hotel stays. They promised: “We can make you a rich man.” It got to the point, he said, that he began looking at the dead “with dollar signs attached to their parts.” Guyett never worked directly for RTI.

Smoked Salmon

Human skin in use at Queen Astrid Military Hospital in Brussels. Photo: Mar Cabra

Human skin takes on the color of smoked salmon when it is professionally removed in rectangular shapes from a cadaver. A good yield is about six square feet.

After being mashed up to remove moisture, some is destined to protect burn victims from life-threatening bacterial infections or, once further refined, for breast reconstructions after cancer.

The use of human tissue “has really revolutionized what we can do in breast reconstruction surgery,” explains Dr. Ron Israeli, a plastic surgeon in Great Neck, N.Y.

“Since we started using it in about 2005, it’s really become a standard technique.”

A significant number of recovered tissues are transformed into products whose shelf names give little clue to their actual origin.

They are used in the dental and beauty industries, for everything from plumping up lips to smoothing out wrinkles.

Cadaver bone — harvested from the dead and replaced with PVC piping for burial — is sculpted like pieces of hardwood into screws and anchors for dozens of orthopedic and dental applications.

Or the bone is ground down and mixed with chemicals to form strong surgical glues that are advertised as being better than the artificial variety.

“At the basic level what we are doing to the body, it’s a very physical — and I imagine some would say a very grotesque — thing,” said Chris Truitt, a former RTI employee in Wisconsin.

“We are pulling out arm bones. We are pulling out leg bones. We are cutting the chest open to pull the heart out to get at the valves. We are pulling veins out from the inside of skin.”

Whole tendons, scrubbed cleaned and rendered safe for transplant, are used to return injured athletes to the field of play.

There’s also a brisk trade in corneas, both within countries and internationally.

Because of the ban on selling the tissue itself, the U.S. companies that first commercialized the trade adopted the same methods as the blood collection business.

The for-profit companies set up non-profit offshoots to collect the tissue — in much the same way the Red Cross collects blood that’s later turned into products by commercial entities.

Nobody charges for the tissue itself, which under normal circumstances is freely donated by the dead (via donor registries) or by their families.

Rather, tissue banks and other organizations involved in the process receive ill-defined “reasonable payments” to compensate them for obtaining and handling the tissue.

“The common lingo is to talk about procurement from donors as ‘harvesting,’ and the subsequent transfers via the bone bank as ‘buying’ and ‘selling,’ ” wrote Klaus Høyer, from the University of Copenhagen’s Department of Public Health, who talked to industry officials, donors and recipients for an article published in the journal BioSocieties.

“These expressions were used freely in interviews; however, I did not hear this terminology used in front of patients.”

A U.S.-government funded study of the families of U.S. tissue donors, published in 2010, indicates many may not understand the role that for-profit companies play in the tissue donation system.

Seventy-three percent of families who took part in the study said it was “not acceptable for donated tissue to be bought and sold, for any purpose.”

Few Protections

There is an inherent risk in transplanting human tissues. Among other things, it has led to life-threatening bacterial infections, and the spread of HIV, Hepatitis C and rabies in tissue recipients, according to the CDC.

Modern blood and organ collection is bar-coded and strongly regulated — reforms prompted by high-profile disasters that had been caused by the poor screening of donors. Products made from skin and other tissues, however, have few specific laws of their own.

In the U.S., the agency that regulates the industry is the Food and Drug Administration, the same agency that’s charged with protecting the nation’s food supply, medicines and cosmetics.

The FDA, which declined repeated requests for on-record interviews, has no authority over health care facilities that implant the material. And the agency doesn’t specifically track infections.

It does keep track of registered tissue banks, and sometimes conducts an inspection. It also has the power to shut them down.

The FDA largely relies on standards that are set by an industry body, the American Association of Tissue Banks (AATB). The association refused repeated requests over four months for on-record interviews. It told ICIJ during a background interview last week that the “vast majority” of banks recovering traditional tissues such as skin and bone are accredited by the AATB. Yet an analysis of AATB accredited banks and FDA registration data shows about one third of tissue banks that recover traditional tissues such as skin and bone are accredited by the AATB.

The association says the chance of contamination in patients is low. Most products, the AATB says, undergo radiation and sterilization, rendering them safer than, say, organs that are transplanted into another human.

“Tissue is safe. It’s incredibly safe,” an AATB executive said.

There is little data, though, to back up the industry’s claims.

Unlike with other biologics regulated by the FDA, agency officials explain, firms that make medical products out of human tissues are required to report only the most serious adverse events they discover. That means that if problems do arise, there’s no guarantee that authorities are told.

And because doctors aren’t required to tell patients they’re getting tissue from a cadaver, many patients may not associate any later infection with the transplant.

On this point, the industry says it is able to track the products from the donors to the doctors, using their own coding systems, and that many hospitals have systems in place to track the tissues after they’re implanted.

But no centralized regional or global system assures products can be followed from donor to patient.

“Probably very few people get infected, but we really don’t know because we don’t have surveillance and we don’t have a system for detecting adverse events,” the CDC’s Kuehnert said.

The FDA recalled more than 60,000 tissue-derived products between 1994 and mid-2007.

The most famous recall came in 2005. It involved a company called Biomedical Tissue Services, which was run by a former dental surgeon, Michael Mastromarino.

Mastromarino got many of his raw materials from undertakers in New York and Pennsylvania. He paid them up to $1,000 per body, court records show.

His company stripped bodies of their bones, skin and other usable parts, then returned them to their families. The families, ignorant of what happened, buried or cremated the evidence.

One of more than 1,000 bodies that were dismembered was that of the famous BBC broadcaster and Masterpiece Theatre host Alistair Cooke.

Products made from the stolen human remains were shipped to Canada, Turkey, South Korea, Switzerland and Australia. More than 800 of those products have never been located.

It later came out in court that some of the tissue donors had died from cancer and that none had been tested for pathogens like HIV and hepatitis.

Mastromarino falsified donor forms, lying about causes of death and other details. He sold skin and other tissues to several U.S. tissue-processing firms, including RTI.

“From day one, everything was forged; everything, because we could. As long as the paperwork looked good, it was fine,” said Mastromarino, who is serving a 25-to-58-year prison sentence for conspiracy, theft and abuse of a corpse.

Global Sheriff

Each country has its own set of regulations for the use of products made from human tissue, often based on laws that were originally intended to deal with blood or organs.

In practice, though, because the U.S. supplies an estimated two-thirds of the world’s human-tissue-product needs, the FDA has effectively been left to act as sheriff for much of the planet.

Foreign tissue establishments that wish to export products to the U.S. are required to register with the FDA.

Yet of the 340 foreign tissue establishments registered with the FDA, only about 7 percent have an inspection record in the FDA database, an ICIJ analysis shows. The FDA has never shut one down due to concern over illicit activities.

The data also shows that about 35 percent of active registered U.S. tissue banks have no inspection record in the FDA database.

“When the FDA registers you, all you have to do is fill out a form and wait for an inspection,” said Dr. Duke Kasprisin, the medical director for seven U.S. tissue banks. “For the first year or two you can function without having anyone look at you.”

This is backed by the data, which show the typical tissue bank operates for nearly two years before its first FDA inspection.

“The problem is there is no oversight. The FDA, all they require is that you have a registration,” said Craig Allred, an attorney previously involved in litigation against the industry. “Nobody is watching what is going on.” The FDA and industry players “all point the finger at each other.”

Yet in South Korea, for example, the booming plastic surgery market uses FDA oversight as a selling point.

In downtown Seoul, the country’s capital, Tiara Plastic Surgery explains that human tissue products “are FDA-approved” and are therefore safe.

Some medical centers advertise “FDA-approved AlloDerm” — a skin graft made from donated American cadavers — for nose enhancement.

Le Do-han, the official in charge of human tissue for the South Korean FDA, said the country imports 90 percent of its human-tissue needs.

Raw tissue is shipped in from the U.S. and Germany. This tissue, once processed, is often re-exported to Mexico as manufactured goods.

Despite the complicated movements back and forth, Le Do-han acknowledges that proper tracking hasn’t been put in place.

“It is like putting tags on beef, but I don’t even know if that is possible for human tissues because there are so many coming in.”

Teaming Up

In its U.S. Securities and Exchange Commission filings, publicly traded RTI provides a glimpse of the company’s size and global reach.

In 2011, the company manufactured 500,000 to 600,000 implants and launched 19 new kinds of implants in sports medicine, orthopedics and other areas. Ninety percent of the company’s implants are made from human tissue, while 10 percent come from cows and pigs processed at its German facility.

RTI requires its human body parts suppliers in the U.S. and other nations to follow FDA regulations, but the company acknowledges there are no guarantees.

In 2011 securities filings, RTI said there “can be no assurances” that “our tissue suppliers will comply with such regulations intended to prevent communicable disease transmission” or “even if such compliance is achieved, that our implants have not been or will not be associated with transmission of disease.”

Like many of today’s for-profit tissue companies that were once non-profits, RTI broke away from the non-profit University of Florida Tissue Bank in 1998.

Internal company files from Tutogen, a Germany medical products company, show that RTI teamed up with Tutogen as early as September 1999 to help both companies meet their growing needs for raw material by obtaining human tissue from Eastern Europe.

The companies both obtained tissue from the Czech Republic. Tutogen separately obtained tissues from Estonia, Hungary, Russia, Latvia, Ukraine, and later Slovakia, documents show.

In 2002, allegations surfaced in the Czech media that the local supplier to RTI and Tutogen was obtaining some tissues there improperly. Though there is no suggestion that Tutogen or RTI or its employees did anything improper.

In March 2003, police in Latvia investigated whether Tutogen’s local supplier had removed tissue from about 400 bodies at a state forensic medical institute without proper consent.

Wood and fabrics, replacing muscle and bone, were put into the deceased to make it look like they were untouched before burial, local media reported.

Police eventually charged three employees of the supplier, but later dismissed the charges when a court ruled that no consent from donors’ families was necessary. Again, there was no suggestion Tutogen acted improperly.

In 2005, Ukrainian police launched the first of a series of investigations into the activities of Tutogen’s suppliers in that country. The initial investigation did not lead to criminal charges.

The relationship between Tutogen and RTI, meanwhile, became even closer in late 2007, when they announced a merger between the two companies. Tutogen became a subsidiary of RTI in early 2008.

Officials at RTI declined to answer questions from ICIJ about whether it knew about police investigations of Tutogen’s suppliers.

Two Ribs

In 2008 Ukrainian police launched a new investigation, looking into allegations that more than 1,000 tissues a month were being illegally recovered at a forensic medical institute at Krivoy Rog and sent, via a third party, to Tutogen. Joseph Düsel, the Chief Prosecutor in Bamberg, said in 2009 that “what the company is doing is approved by the administrative authority by which it is also monitored. We do not currently see any reason to initiate investigation proceedings.”

Nataliya Grishenko, the judge prosecuting the case, revealed during subsequent court proceedings that many relatives claimed they’d been tricked into signing consent forms or that their signatures had been forged.

However, the main suspect in the case — a Ukrainian doctor — died before the court could deliver a verdict. The case died with him.

Tutogen “operates under very strict regulations from German and Ukrainian authorities as well as other European and American regulatory authorities,” the company said in a statement while the case was still pending. “They have been inspected regularly by all of these authorities over their many years of operation, and Tutogen remains in good standing with all of them.”

Seventeen of Tutogen’s Ukrainian suppliers have undergone an FDA inspection. The inspections are announced, according to protocol, six to eight weeks in advance.

Only one — BioImplant in Kiev — received negative feedback. Among the findings of the 2009 inspection: not all morgues could rely on hot running water and some sanitation procedures were not followed.

FDA inspectors also identified deficiencies with RTI’s Ukrainian imports when it visited the company’s facilities in Florida.

RTI had English translations, but not original autopsy reports, from its Ukrainian donors, FDA inspectors found during a 2010 audit. Those were often the only medical documents the company used to determine whether the donor was healthy, inspectors noted in their report.

The company told inspectors it was illegal under Ukrainian law to copy the report. But following the inspection it began maintaining the original Russian-language document along with its English translation.

In 2010 and 2011, FDA inspectors asked RTI to change how it labeled its imports. The company was obtaining Ukrainian tissue, shipping it to Tutogen in Germany, then exporting it to the U.S. as a product of Germany.

While the company agreed to change its policies, there is some indication that it may have continued labeling some Ukrainian tissue as German.

Security services footage shows harvested human tissues in Ukraine labeled “Made in Germany”.

This past February, Ukrainian security services launched a raid as officials at a regional forensic bureau in Nikolaev Oblast were loading harvested human tissues into the back of a white minibus. Footage of the seizure shows tissue labeled “Tutogen. Made in Germany.”

In this case, the security service said forensic officials had tricked relatives of the dead patients into agreeing to what they thought was a small amount of tissue harvesting by playing on their pain and grief.

Seized documents — blood tests, an autopsy report and labels written in English and obtained by ICIJ — suggested the remains were on their way to Tutogen.

Some of the tissue fragments found on the bus came from 35-year-old Oleksandr Frolov, who had died from an epileptic seizure.

“On the way to the cemetery, when we were in the hearse, one of his feet — we noticed that one of the shoes slipped off his foot, which seemed to be hanging loose,” his mother, Lubov Frolova, told ICIJ.

“When my daughter-in-law touched it, she said that his foot was empty.”

Later, the police showed her a list of what had been taken from her son’s body.

“Two ribs, two Achilles heels, two elbows, two eardrums, two teeth, and so on. I couldn’t read it till the end, as I felt sick. I couldn’t read it,” she said.

“I heard that [the tissues] were shipped to Germany to be used for the plastic surgeries and also for donation. I have nothing against donation, but it should be done according to the law.”

Kateryna Rahulina, whose 52-year-old mother, Olha Dynnyk, died in September 2011, was shown documents by investigating police. The documents purported to give her approval for tissue to be taken from her mother’s body.

“I was in shock,” Rahulina said. She never signed the papers, she said, and it was clear to her that someone had forged her approval.

The forensic bureau in Nikolaev Oblast, where the alleged incidents happened, was, until recently, one of 20 Ukrainian tissue banks registered by the FDA.

On the FDA’s website the phone number for each of the tissue banks is the same.

It is Tutogen’s phone number in Germany.

This story was co-reported by National Public Radio (USA)

Source: The International Consortium of Investigative Journalists

Boxing Day!

bioDesigner — Sun, 15 Jul 2012 23:14:21 +0000

Michael Gulen and myself are just so thrilled. Here they are, our first order for Hemoglobin! Mike and I checked everything over, put the final polish on the bases, and boxed each unit up. 50 down, 50 more to go

Here’s what the hemoglobin model and base look like going into the box

Check back with us again if you are interested in purchasing your own Hemoglobin Kit!

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In 2007 GBC (General Binding Corporation) replaced the CombBind C100 with a new updated model. That new model was the C110 and it featured new styling and several new features. Today we are going to take a look at the New GBC C110 manual comb binding machine, its features, its limitations and its construction. Let’s take a look…

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July 2012 - Table of Contents

dermatologyjournal — Fri, 13 Jul 2012 17:20:57 +0000

Volume 18 Number 7

July 2012

Review

1. Vasculopathy related to cocaine adulterated with levamisole: A review of the literature
Timothy Pearson, Matthew Bremmer, Jared Cohen, Marcia Driscoll

Case Report

2. Two cases of steatocystoma simplex in infants
Mari Sunohara, Toshiyuki Ozawa, Kuniyuki Morimoto, Chiharu Tateishi, Masamitsu Ishii

Case Presentations

3. Nocardia nova mycetoma over forehead in a lepromatous leprosy patient
M Dhingra, N Kaistha, N Bansal, LS Solanki, J Chander, GP Thami, WW van de Sande

4. Keratoacanthoma arising in nevus comedonicus
Sara Zarkik, Jamila Bouhllab, Aicha Methqal, Yassir Afifi, Karima Senouci, Badreddine Hassam

5. Fibroepithelioma of Pinkus induced by radiotherapy
Maura J Holcomb, Kiran Motaparthi, Sarah J Grekin, Theodore Rosen

6. Pioderma gangrenoso em lactente – Relato de caso (Pyoderma gangrenosum in an infant: Case report)
Camila Colombari Medeiros, Milena Lacerda Colombari, Priscila Wolf Nassif, Ana Cristina Gurgel, Aissar Eduardo Nassif

7. Verrucous herpetic infection of the scrotum and the groin in an immuno-competent patient: Case report and review of the literature
Yoon-Soo Cindy Bae-Harboe, Amor Khachemoune

8. Facial angiofibromas in a mosaic pattern tuberous sclerosis: A case report
Jasem M Alshaiji, Christopher R Spock, Elizabeth A Connelly, Lawrence A Schachner

Photo Vignette

9. Multiple poromas in a bone marrow transplant recipient: A case report
Bichchau T Nguyen, David N Lortscher, Robert A Lee

10. Cutaneous cholesterol embolization syndrome: A case report
Nibedita Patro, Renu George, Pradyumn Singh, George Joseph

11. Unknown: A middle-aged woman with a solitary targetoid lesion on her shin
Farideh Jowkar, Nasrin Saki, Fatemeh Sari Aslani, Dorna Motevalli, Mohammad Reza Saki

Surgical Pearl

12. Hyperpigmented burn scar improved with a fractionated 1550 nm non-ablative laser
Daniel Q Bach, Miki S Garcia, Daniel B Eisen

Letters

13. Intestinal heterotopia in urethral caruncle
Slim Charfi, Saloua Makni, Meriem Amouri, Sameh Ellouze, Hamida Turki, Tahya Sellami Boudawara

14. Alopecia areata during ustekinumab administration: Co-existence or an adverse reaction?
Constantinos Verros, Efstathios Rallis, Mark Crowe

15. Lichenoid eruption induced by etanercept
Nuria Barrientos, Sagrario García-Sánchez, José D Domínguez

16. Tinea capitis in infants in their first 2 years of life: A 12-year study and a review of the literature
Inès Zaraa, Abdelmohti Hawilo, Sondes Trojjet, Dalenda El Euch, Mourad Mokni, Amel Ben Osman

Dermatology Online Journal

Editor: Barbara Burrall MD
Managing Medical Editor: Emanual Maverakis MD
Managing Editor: Matthew Yasner MBA
Founder and Publisher: Arthur C Huntley MD
Associate Editor: Ted Rosen MD
Associate Editor: Noah Scheinfeld MD
Associate Editor: Steven Emmet MD
Dermatopathology Editor: Maxwell Fung MD
Dermatopathology Editor: Sate Hamza MD
Editor for Portuguese Articles: George Leal MD
Editor for Spanish Articles: Mauricio Goihman MD

Editorial Board

Ronald J Barr		Art Huntley
Carl Blesius		Sheraz Jamal Khan
Barbara Burrall		George Leal
William Danby		Fu-Tong Liu
Joseph Eastern		Douglas Patton
Haines Ely		Ted Rosen
Steven Emmet		Noah Scheinfeld
Steve Feldman		J Graham Smith
Phil Fleckman		Kevin Smith
Max Fung		Mohamed-Hany el Tonsy
Ignacio Garcio		Guy Webster
Mauricio Goihman-Yahr		Edward Zabawski Jr
Sate Hamza

Technical Editors

Carl Blesius MD
Robert Horton PhD
Morton Taragin PhD
Ken Weiss MBA

Hello world!

bioDesigner — Thu, 12 Jul 2012 16:00:16 +0000

Hello World, we’re Biological Design. We’ve created something brand new for you, a way to transform x-ray crystallography data of tiny little proteins into plastic models large enough to hold in the palm of your hand. Designed according to any educational or aesthetic need, these models bring to life the most significant information contained within protein data, isolating by color and structure any amino acid or atom of interest. Here’s our first biological design: Hemoglobin (ID: 1HHO)

Study Documents RFID Safe for Biopharmaceuticals

intelleflex — Wed, 11 Jul 2012 00:28:00 +0000

A study published this week in the July/August edition of the Parenteral Drug Association’s PDA Journal documents research that showed that in vitro test results for more than 100 biopharmaceutical products from eight major drug companies demonstrated no non-thermal effect by radio frequency radiation.

RFID is OK for Tracking and Monitoring Biopharmaceuticals

What does this mean? The research conducted by researchers at The University of South Florida, Blood Center of Wisconsin, Abbott, Georgia Institute of Technology and the Madison RFID Lab at the University of Wisconsin documents that using RFID in conjunction with biologics is safe. The thermal effects of RFID on biologics have been well understood (no impact) but there had, to this point, been limited research on the non-thermal effects (RF radiation) of RFID on product integrity.

Why is this important? Pending ePedigree laws in California (going into effect in 2015 and ultimately impacting the entire industry) are likely to require a combination of RFID and 2D barcoding systems. Some had questioned whether or not RFID was safe to use for these types of applications but this report (available to PDA members on the PDA website) demonstrates RFID’s safety, enabling technology companies, pharmaceutical manufacturers, shippers, 3PLs and health care providers to move forward more aggressively on developing solutions for ePedigree and documenting the safe and authentic shipments of biopharmaceutical products. But, RFID can add even more value. Temperature sensor RFID tags, beyond providing the ability to document track and trace records for ePedigree can also be used to monitor and manage the temperature (and related safety and efficacy) of drugs as they move through the supply chain to reduce waste and improve cold chain operations.

You can learn more about Intelleflex solutions for pharmaceuticals here.

Kevin Payne

Senior Director of Marketing

Report on China’s Veterinary Biologics Industry Investment

bharatbookblog — Tue, 10 Jul 2012 10:43:12 +0000

This report will provide a detailed analysis of the above questions and, on the basis of an exposition about the status quo of China’s veterinary biologics industry in 2011, make an in-depth analysis of the development environment, enterprises structure and scale, as well as the circulation and marketing of China’s veterinary biologics industry. Besides, the report will also make a detailed and objective analysis of the development trend of China’s veterinary biologics industry, aiming to be of help to the scientific judgment of the investment value of China’s veterinary biologics industry.

China’s Veterinary Biologics Industry Development Course and Direction
1.1China’s Veterinary Biologic Industry Development Course
1.2Position and Market Share of Biological Products in China’s Veterinary Heath-care Industry
1.3 Comparison between Global and China’s Veterinary Biologics Industry
1.4 China’s Veterinary Biologic Industry Development Direction
2 Policy Environment of China’s Veterinary Biologics Industry
2.1 Production Policy for China’s Veterinary Biologic Industry (including taxation, supporting policy and subsidy policy)
2.2 Planning of China’s Veterinary Biologic Industry
2.3 Impact of Compulsory Immunization Policy on China’s Veterinary Biologic Industry
2.4 Trade Policy for China’s Veterinary Biologic Industry
2.5 Circulation Policy for China’s Veterinary Biologic Industry
2.6 Impact of China’s Veterinary Biologic Industry Policy on Future Industry Development
3 Market Scale and Development Trend of China’s Veterinary Biologics Industry
3.1Scale of China’s Veterinary Biological Products by Types
3.1.1 Market Scale of Compulsory Immunization Vaccine
3.1.2 Market Scale of Domestic-produced Conventional Vaccine
3.1.3 Market Scale of Imported Conventional Vaccine (China’s Import of Veterinary Biologics and Scale)
3.2 China’s Hog Biological Products Market Scale and Estimation
3.2.1 Occurrence of Hog Diseases and Development Trend in China
3.2.2 Status quo of China’s Hog Biological Products Utility and Market Demand
3.2.3 Major Products and Market Share of China’s Hog Biological Products
3.2.4 Estimation of China’s Hog Biological Products Market Growth（2009-2016）
3.3China’s Poultry Biological Products Market Scale and Estimation
3.3.1 Occurrence of Poultry Diseases and Development Trend in China
3.3.2 Status quo of China’s Poultry Biological Products Utility and Market Demand
3.3.3 Major Products and Market Share of China’s Poultry Biological Products
3.3.4 Estimation of China’s Poultry Biological Products Market Growth （2009-2016）
3.4 China’s Ruminant Veterinary Biological Products Market Scale and Estimation
3.4.1 Occurrence of Ruminant Animal Diseases and Development Trend in China
3.4.2 Status quo of China’s Ruminant Veterinary Biological Products Utility and Market Demand
3.4.3 Major Products and Market Share of China’s Ruminant Veterinary Biological Products
3.4.4 Estimation of China’s Ruminant Veterinary Biological Products Market Growth （2009-2016）
3.5 China’s Aquatic Veterinary Biological Products Market Scale and Estimation
3.5.1 Occurrence of Aquatic Animal Diseases and Development Trend in China
3.5.2 Status quo of China’s Aquatic Veterinary Biological Products Utility and Market Demand
3.5.3 Major Products and Market Share of China’s Aquatic Veterinary Biological Products
3.5.4 Estimation of China’s Aquatic Veterinary Biological Products Market Growth （2009-2016）
3.6 China’s Pet Veterinary Biological Products Market Scale and Estimation
3.6.1 Occurrence of Pet Animal Diseases and Development Trend in China
3.6.2 Status quo of China’s Pet Veterinary Biological Products Utility and Market Demand
3.6.3 Major Products and Market Share of China’s Pet Veterinary Biological Products
3.6.4 Estimation of China’s Pet Veterinary Biological Products Market Growth （2009-2016）
4 Analysis of China’s Veterinary Biologics Industry Chain
4.1 Research and Development (R&D)
4.1.1 Major Research Institutions of Veterinary Biological Products in China
4.1.2 Technical R & D Capability of China’s Veterinary Biologics Industry
4.1.3 Mechanism of Technical R&D Investment in Veterinary Biologics Industry in China
4.2 Production
4.2.1 Output Capacity and Output Value of China’s Veterinary Biological Products Market
4.2.2 Production Profit of China’s Veterinary Biologics Industry
4.2.3 Price Trend of China’s Major Veterinary Biological Products
4.2.3.1 Price Trend of China’s Major Hog Veterinary Biological Products
4.2.3.2 Price Trend of China’s Major Poultry Veterinary Biological Products
4.2.4 Structure and Locations of China’s Major Veterinary Biologics Enterprises
4.2.5 Concentration of China’s Veterinary Biological Products Market

For more information kindly visit :
Report on China’s Veterinary Biologics Industry Investment

Bharat Book Bureau
Tel: +91 22 27810772 / 27810773
Fax: + 91 22 27812290
Email: info@bharatbook.com
Website: www.bharatbook.com
Follow us on twitter: http://twitter.com/#!/Sandhya3B
Our Blogs: http://bharatbook.blogactiv.eu/
http://biotechnologymarketreports.blogspot.in/

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2018 || Market | Dermatology Therapeutics Market to 2018 - Novel || Aarkstore.com

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The Old or Something New?

October 2012 - Table of Contents

Volume 18 Number 10 October 2012

Review

1. Interleukin-23 and interleukin-17: Importance in pathogenesis and therapy of psoriasisParvathi Mudigonda, Tejaswi Mudigonda, Ashley N Feneran, Habibollah S Alamdari, Laura Sandoval, Steven R Feldman

Case Reports

2. Congenital self-healing reticulohistiocytosis: Concern for a poor prognosis Larissa Larsen, Melissa Reyes Merin, Thomas Konia, April Wang Armstrong

3. Facial chromoblastomycosis in sub-Himalayan region misdiagnosed as cutaneous leishmaniasis: Brief report and review of Indian literature Santwana Verma, Ghanshyam K Verma, Gagandeep Singh, Anil Kanga, Vinita Sharma, Neha Gautam

4. Disseminated Lyme Borreliosis preceded by hepatitis in an African American male Ramin Fathi, William Wei-ting Huang, Katherine Brown

Case Presentations

5. Primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma: Transformation from indolent to aggressive phase in association with CCR7-positive conversion Akira Kasuya, Satoshi Hirakawa, Yoshiki Tokura

6. Eosinophilic pustular folliculitis in infancy: Report of a new case L Alonso-Castro, B Pérez-García, C González-García, P Jaén-Olasolo

7. Ulcerated plaques in the pelvic region of an adult female Benjamin Barrick, Brian Matthys, Garth Fraga

8. Dermoscopy of black-spot poison ivy Ryan K Rader, Ruipu Mu, Honglan Shi, William V Stoecker, Kristen A Hinton

9. Fatal Henoch-Schonlein Purpura in an adult related to bowel perforation: Report and review of the literature Una Miniter, Yoon-Soo Cindy Bae-Harboe, Jennifer G Powers, Shannon M Campbell, Lynne J Goldberg

10. Oral pemphigus vegetans: A case report Marcio Augusto de Oliveira, Fabiana Martins e Martins, Silvia Lourenço, Marina Gallottini, Karem L Ortega

11. An inflammatory verrucous epidermal nevus concomitant with psoriasis: Treatment with adalimumab Mustafa Özdemir, Ali Balevi, Hasan Esen

Unknown

12. Unknown: A congenital nodule on the scapula Goretti Lacruz, Maria Antònia González-Enseñat, Mariona Suñol, Asunción Vicente

Photo vignettes

13. Isolated single digit Porokeratosis of Mibelli: An unusual case Samuel Odeyinde, Harry Belcher

14. Clear cell acanthoma induced by a dermatofibroma David Silverstein, Ashfaq Marghoob

Commentary

15. Caution advised in interpretation of US FDA risk classification for dermatological medications during pregnancy Jillian W Wong, Misha M Heller, Jenny E Murase

Letters

16. Vascular malformation of the glans penis succesfully treated with Nd:YAG laser Verónica López, José M Ricart, Inmaculada López, José M Martín, Davide Marton, Carmen Ortega, Salvador Costa

Dermatology Online Journal

Editorial Board

Technical Editors

Guest Post: The New India Guidelines on Similar Biologics

The New India Guidelines

On Similar Biologics

Regulatory and Market Authorization Requirements

Overview[i]

Video Glossary: What is Tuberculosis and why is testing needed to start biologic drugs?

Biosimilar Approval

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Aubagio wins FDA approval

Healthinnovations on Thomson Reuters: New Techniques in Drug Discovery.

Steroids use and higher infection rates in children with juvenile arthritis

Tofacitinib in Rheumatoid Arthritis

A Possible New Oral Medication for Rheumatoid Arthritis

Rheumatoid Arthritis

Ann Arbor's NSF Buys D.C.-Based FDA Consulting Firm

Human Genome Project

It’s alive! Scientists create first 100% realistic virtual sex disease bacteria inside a computer – and it could pave the way for artificial life forms

By Rob Waugh

Breakthrough moment for artificial biology

100% realistic simulated bacteria ‘lives’ inside PC

Simulation could be used to design new medicines – or even life forms

Could pave way for scientists to design bacteria using 3D modelling tools

ARTIFICIAL LIFE? THE BOOM IN DIY ‘BIO-HACKERS’

Source: Daily Mail, UK

From NPR: Tissue Tracking and Health Risks

Shocking Trade in Skin, Bones & Tissue

Skin and Bone: the Shadowy Trade in Human Body Parts

Human Corpses are Prize in Global Drive for Profits

By Kate Willson, Vlad Lavrov, Martina Keller, Thomas Maier and Gerard Ryle

‘Our Misfortune’

Awkward Silence

Piece of the Action

Smoked Salmon

Few Protections

Global Sheriff

Teaming Up

Two Ribs

This story was co-reported by National Public Radio (USA)

Source: The International Consortium of Investigative Journalists

Boxing Day!

Biologics Psoriasis - Psoriasis Free For Life - How to Cure Psoriasis Easily, Naturally and For Life Psoriasis Free For Life Review

Aarkstore.com announces, The Latest market research report is available in its vast collection:

Dermatology Therapeutics Market to 2018 – Novel Biologics Targeting Interleukin-17 Receptor Presents New Options in Psoriasis Treatment

Volume 18 Number 10

October 2012

1. Interleukin-23 and interleukin-17: Importance in pathogenesis and therapy of psoriasis
Parvathi Mudigonda, Tejaswi Mudigonda, Ashley N Feneran, Habibollah S Alamdari, Laura Sandoval, Steven R Feldman

2. Congenital self-healing reticulohistiocytosis: Concern for a poor prognosis
Larissa Larsen, Melissa Reyes Merin, Thomas Konia, April Wang Armstrong

3. Facial chromoblastomycosis in sub-Himalayan region misdiagnosed as cutaneous leishmaniasis: Brief report and review of Indian literature
Santwana Verma, Ghanshyam K Verma, Gagandeep Singh, Anil Kanga, Vinita Sharma, Neha Gautam

4. Disseminated Lyme Borreliosis preceded by hepatitis in an African American male
Ramin Fathi, William Wei-ting Huang, Katherine Brown

5. Primary cutaneous aggressive epidermotropic CD8+ T-cell lymphoma: Transformation from indolent to aggressive phase in association with CCR7-positive conversion
Akira Kasuya, Satoshi Hirakawa, Yoshiki Tokura

6. Eosinophilic pustular folliculitis in infancy: Report of a new case
L Alonso-Castro, B Pérez-García, C González-García, P Jaén-Olasolo

7. Ulcerated plaques in the pelvic region of an adult female
Benjamin Barrick, Brian Matthys, Garth Fraga

8. Dermoscopy of black-spot poison ivy
Ryan K Rader, Ruipu Mu, Honglan Shi, William V Stoecker, Kristen A Hinton

9. Fatal Henoch-Schonlein Purpura in an adult related to bowel perforation: Report and review of the literature
Una Miniter, Yoon-Soo Cindy Bae-Harboe, Jennifer G Powers, Shannon M Campbell, Lynne J Goldberg

10. Oral pemphigus vegetans: A case report
Marcio Augusto de Oliveira, Fabiana Martins e Martins, Silvia Lourenço, Marina Gallottini, Karem L Ortega

11. An inflammatory verrucous epidermal nevus concomitant with psoriasis: Treatment with adalimumab
Mustafa Özdemir, Ali Balevi, Hasan Esen

12. Unknown: A congenital nodule on the scapula
Goretti Lacruz, Maria Antònia González-Enseñat, Mariona Suñol, Asunción Vicente

13. Isolated single digit Porokeratosis of Mibelli: An unusual case
Samuel Odeyinde, Harry Belcher

14. Clear cell acanthoma induced by a dermatofibroma
David Silverstein, Ashfaq Marghoob

15. Caution advised in interpretation of US FDA risk classification for dermatological medications during pregnancy
Jillian W Wong, Misha M Heller, Jenny E Murase

16. Vascular malformation of the glans penis succesfully treated with Nd:YAG laser
Verónica López, José M Ricart, Inmaculada López, José M Martín, Davide Marton, Carmen Ortega, Salvador Costa

Volume 18 Number 7

July 2012

1. Vasculopathy related to cocaine adulterated with levamisole: A review of the literature
Timothy Pearson, Matthew Bremmer, Jared Cohen, Marcia Driscoll

2. Two cases of steatocystoma simplex in infants
Mari Sunohara, Toshiyuki Ozawa, Kuniyuki Morimoto, Chiharu Tateishi, Masamitsu Ishii

3. Nocardia nova mycetoma over forehead in a lepromatous leprosy patient
M Dhingra, N Kaistha, N Bansal, LS Solanki, J Chander, GP Thami, WW van de Sande

4. Keratoacanthoma arising in nevus comedonicus
Sara Zarkik, Jamila Bouhllab, Aicha Methqal, Yassir Afifi, Karima Senouci, Badreddine Hassam

5. Fibroepithelioma of Pinkus induced by radiotherapy
Maura J Holcomb, Kiran Motaparthi, Sarah J Grekin, Theodore Rosen

6. Pioderma gangrenoso em lactente – Relato de caso (Pyoderma gangrenosum in an infant: Case report)
Camila Colombari Medeiros, Milena Lacerda Colombari, Priscila Wolf Nassif, Ana Cristina Gurgel, Aissar Eduardo Nassif

7. Verrucous herpetic infection of the scrotum and the groin in an immuno-competent patient: Case report and review of the literature
Yoon-Soo Cindy Bae-Harboe, Amor Khachemoune

8. Facial angiofibromas in a mosaic pattern tuberous sclerosis: A case report
Jasem M Alshaiji, Christopher R Spock, Elizabeth A Connelly, Lawrence A Schachner

9. Multiple poromas in a bone marrow transplant recipient: A case report
Bichchau T Nguyen, David N Lortscher, Robert A Lee

10. Cutaneous cholesterol embolization syndrome: A case report
Nibedita Patro, Renu George, Pradyumn Singh, George Joseph

11. Unknown: A middle-aged woman with a solitary targetoid lesion on her shin
Farideh Jowkar, Nasrin Saki, Fatemeh Sari Aslani, Dorna Motevalli, Mohammad Reza Saki

12. Hyperpigmented burn scar improved with a fractionated 1550 nm non-ablative laser
Daniel Q Bach, Miki S Garcia, Daniel B Eisen

13. Intestinal heterotopia in urethral caruncle
Slim Charfi, Saloua Makni, Meriem Amouri, Sameh Ellouze, Hamida Turki, Tahya Sellami Boudawara

14. Alopecia areata during ustekinumab administration: Co-existence or an adverse reaction?
Constantinos Verros, Efstathios Rallis, Mark Crowe

15. Lichenoid eruption induced by etanercept
Nuria Barrientos, Sagrario García-Sánchez, José D Domínguez

16. Tinea capitis in infants in their first 2 years of life: A 12-year study and a review of the literature
Inès Zaraa, Abdelmohti Hawilo, Sondes Trojjet, Dalenda El Euch, Mourad Mokni, Amel Ben Osman