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The cost of clinical trial data bias/loss, FDA’s new job and the need for bold leadership.

§ September 30th, 2012 § Filed under Nano Medicine Comments Off on The cost of clinical trial data bias/loss, FDA’s new job and the need for bold leadership.

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The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.


Before you right this post off as the stuff of conspiracy theories, fear-mongering, and ‘alternative world views’ consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.


Here’s the underlying premise as succinctly described by author Ben Goldacre:

“Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.

When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.”

Authors M. Todwin and J. Abramson summarize it thusly:

“Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.”

Here is a great list of very recent resources that may convince you of the merits of this concern:

Yesterday, the US Secretary of Health and Human Services announced (in an FR notice) that the FDA was now charged with ensuring all organizations comply with the heretofore enacted but relatively unenforced  requirement to submit all relevant clinical trial data to http://www.clinicaltrials.gov

For further commentary on this move see the following reports from:
What is abundantly clear to me is that the FDA is left almost powerless – and if not powerless than certainly without sufficient resources – to successfully enforce its new power.  This requires collective industry leadership.  Bold, industry-initiated standards, infrastructure and old-fashioned peer pressure.

Here’s what I wish.  

I wish that as a cell therapy industry we – through organizations like ISSCR, ARM, ISCT, etc and leading publishers of some of our leading journals like Regenerative Medicine, Cytotherapy, Cell Stem Cell, Stem Cells, etc – would take a leadership position on an issue like this.

I believe that as a relatively small and nascent sector of the biopharma industry we are more likely capable of collaborating on something important like this than larger, more established [entrenched] and diverse sectors.  Of course it requires the political will and cajones.

The payoff from our sector in taking a leadership role on this issue could potentially be enormous in terms of providing our sector with truly transparent and useful data.  Perhaps even more important would be the public profile such leadership would provide the sector.  Such a move requires bold leadership, pain, and cost but this is the kind of stuff that moves the needle and goes down as critical pivot points in history. 

Just my thought for the day…

–Lee

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Size matters: Researchers warn nano-polyphenols may have reversed effects

§ September 17th, 2012 § Filed under Nano Medicine Comments Off on Size matters: Researchers warn nano-polyphenols may have reversed effects

The beneficial effects attributed to antioxidants such as polyphenols could be reversed when they are used in nano-forms, according to new research.

The UK-based researchers have suggest the antioxidant effects of green tea polyphenols could be reversed when the compounds are used in nano-formulations after research published in Nanomedicine compared the effects of different polyphenol forms on white blood cells.

Led by Professor Diana Anderson from the University of Bradford, UK, the researchers revealed that the known antioxidant properties of polyphenols such as epigallocatechin gallate(EGCG) and theaflavins can be reversed when they are used in their nanoparticle form.

The findings showed that when used in bulk form, these polyphenols exhibited their anticipated antioxidant responses, but the nanoform at higher concentrations had the reverse effect and exhibited statistically significant pro-oxidant effects, which can cause increased DNA damage.

Both the compounds in the bulk form produced statistically significant concentration-dependent reductions in DNA damage, revealed the authors. In contrast, when used in the nano-particle form both theaflavin and EGCG, although initially causing a reduction, produced a concentration-dependent statistically significant increase in DNA damage.

“We didn’t expect these changes,” explained Anderson. “When my PhD student came to me with the results, she assumed she’d made a mistake. But it struck me that I’d seen this happen before – in a study we published in 1994 describing a dose-related switch of properties in Vitamin C in the presence of hydrogen peroxide.

At the time I didn’t think much about it, but this is the first time I’ve seen this happen with the nano-form of a compound,” explained Anderson.

Study details

During the research, Anderson and her colleagues used white blood cells (lymphocytes) from healthy volunteers and cancer patients to assess the potential anti-cancer effects of tea polyphenols. The polyphenols were presented in both bulk and nano- forms and compared against of anti-cancer drugs to measure their protection against DNA damage.

The authors explained that many previous studies have suggested polyphenols to be increasingly useful as anti-cancer compounds, and may also offer beneficial effects to healthy, non-cancer cells due to their antioxidant properties that can quench free radical species.

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Size matters: Researchers warn nano-polyphenols may have reversed effects

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Two lessons I learned this week.

§ September 16th, 2012 § Filed under Nano Medicine Comments Off on Two lessons I learned this week.

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I learned two valuable things this week I thought I’d pass on in a Friday afternoon post.  Actually strictly speaking these are likely things I’ve learned before but needed to re-learn or to be ‘reminded’ of their importance.
Please pardon a little stroll away from the typically strict focus on cell therapy — but in a way that’s the theme of today’s post.
1.  Take time each week to read something from outside your specific profession or job focus.  
I’m not talking here about the importance of escaping in the evening with a fiction novel (also very important) but rather reading something professional but from well outside your area of focus.  Here are my examples.

I always read WIRED magazine.  Aside from GEN it’s the only magazine I read.  Just reading something outside of cell therapy or biotech often infuses me with an idea that otherwise would have never occurred to me like the need for a cell therapy X Prize or cellular aggregates as microcarriers or tissue-engineered memory and processing devices or even just the conviction to better represent cell therapy to the broader world out there of scientists, engineers, journalists, policy-makers, or perhaps people with too much money looking to be inspired and wanting to make a difference.

Similarly, on a flight this week I reached into the seat pocket in front of me and discovered a recent copy of the Journal of the American Medical Association.  I read a fascinating article that has me excited about an idea for how we as a cell therapy industry might lead the way in addressing clinical trial and data transparency that would put our sector in a leadership position, lend the industry a much-needed spotlight, and has the potential to facilitate the kind of meta-analysis and data-mining that could only be done through data aggregation.  I believe the concept has the potential to be disproportionately significant for a sector defined by so many small, under-powered trials.
The idea may never see the light of day but the point is the source of the inspiration.  In order to ‘think’ outside the box one typically has to ‘be’ outside the box.  Lesson?  Spend some time outside your box.
2. It often takes something very small to make a disproportionately significant impact on someone.  
I was reminded recently through an exchange of simple kindnesses just how little it sometimes takes to make a big difference in someone’s life.  For you what might be so easy to give might be of unparalleled value to someone for whom that is so unattainable.  
Lesson?  When the opportunity knocks for you to give something small or simple, take it.  This kind of charity almost always has the potential to be mre impactful than you might ever imagine.
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ClassOne Equipment Donation Supports the Nanotechnology Mission at Georgia Tech

§ September 6th, 2012 § Filed under Nano Medicine Comments Off on ClassOne Equipment Donation Supports the Nanotechnology Mission at Georgia Tech

ATLANTA, GA–(Marketwire -09/06/12)- The applications of nanotechnology are vast and have potential to revolutionize medicine, environmental protection methods, and lead to the development of new and innovative systems and devices based on nano materials and processes.

On April 24th, 2009, the Georgia Institute of Technology dedicated the new Marcus Nanotechnology Building; named after its prime sponsor, Mr. Bernie Marcus of the Marcus Foundation. The building is dedicated to exploring new fields of science, technology, and engineering for the benefit of humankind. It is also the headquarters for the Georgia Tech Institute of Electronics and Nanotechnology (IEN).

This signature facility embodies Georgia Tech’s dedication to improving the human condition through advanced science and engineering.

In support of this mission, ClassOne Equipment, a leading supplier of high quality refurbished equipment to the semiconductor, MEMS, LED, wireless, and emerging technology markets, has made a significant contribution of key process equipment.

“We appreciate this significant contribution of equipment that is now contained within the Marcus Organic and Inorganic Cleanroom Laboratories,” said Mark Allen, executive director of the IEN.

ClassOne has core expertise in Suss Microtec, EVG, SPTS, Oxford, Plasmatherm, Semitool, and KLA-Tencor equipment. They can provide a turn-key solution which includes full refurbishment to original specifications, 6-month warranty, and full installation and training by experienced factory trained technicians. ClassOne currently has 40 full-time employees. ClassOne engineers and technicians have worked in technical positions at Suss Microtec, EVG, Semitool, STS, and KLA-Tencor. Since its founding in 2002, ClassOne has refurbished and sold over 2,000 pieces of equipment to more than 500 satisfied customers around the world, including some of the best-known institutes and semiconductor industry labs. In addition to its headquarters in Atlanta, GA, ClassOne has offices in California, Germany, UK, and China.

The IEN is a Georgia Tech interdisciplinary research center designed to enhance support for rapidly growing research programs spanning biomedicine, materials, electronics and nanotechnology.

The IEN is comprised of multiple Electronics and Nanotechnology research units, each offering a unique intellectual focus ranging from basic discovery and innovation to systems realization for academic, industry and government sponsors. Faculty leadership within the IEN centers includes global experts, several of whom are Eminent Scholars and National Academy of Engineering members. IEN faculty and researchers are capable of providing a broad spectrum of research and development activities ranging from basic discovery to systems prototypes.

These research programs are enabled by the IEN Nano, Micro, and Bio Cleanroom Laboratories valued in excess of $400M. These open-user, fee based laboratories are available to global academic, industry, and government clientele, offering a unique and comprehensive laboratory and teaming environment. For more information about IEN please visit: http://www.ien.gatech.edu/

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Research and Markets: Nanomedicine: Technologies and Applications

§ September 6th, 2012 § Filed under Nano Medicine Comments Off on Research and Markets: Nanomedicine: Technologies and Applications

DUBLIN–(BUSINESS WIRE)–

Research and Markets (http://www.researchandmarkets.com/research/svn5wb/nanomedicine_tech) has announced the addition of Woodhead Publishing Ltd’s new book “Nanomedicine: Technologies and applications” to their offering.

Nanotechnology is at the forefront of advances in medicine. Nanomedicine: Technologies and applications provides an important review of this exciting technology and its growing range of applications.

After an introduction to nanomedicine, part one discusses key materials and their properties, including nanocrystalline metals and alloys, nanoporous gold and hydroxyapatite coatings. Part two goes on to review nanomedicine for therapeutics and imaging, before nanomedicine for soft tissue engineering is discussed in part three, including organ regeneration, skin grafts, nanotubes and self-assembled nanomaterials. Finally, nanomedicine for bone and cartilage tissue engineering is the focus of part four, with electrically active biocomposites for smart scaffolds investigated alongside cartilage and bone tissue engineering, regeneration and replacement.

With its distinguished editor and international team of expert contributors, Nanomedicine: Technologies and applications is an indispensible guide for all those involved in the research, development and application of this exciting technology, whilst providing a comprehensive introduction for students and academics interested in this field.

Key Topics Covered:

PART 1 MATERIALS, PROPERTIES AND CONSIDERATIONS

Introduction to nanomedicine

Trends in nanomedicine

Biomedical nanocrystalline metals and alloys: structure, properties and applications

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Product classification in Southeast Asia

§ September 2nd, 2012 § Filed under Nano Medicine Comments Off on Product classification in Southeast Asia

By Wai Mun Poon, Regional Regulatory Manager, EAS Strategic Advice, http://www.eas.asia

As scientific evidence on the relationship between foods, physiological function and disease has grown, so has the functional/fortified food and food supplement market in Southeast Asia. Along with this, many regulatory authorities in Southeast Asian countries have started to pay attention to the controls of these products on the market. The challenge when regulating functional/fortified food products is in classifying these products, as they often fall into the grey zone between medicinal products and foods. While across the region national authorities take varying approaches to controlling these products, in general, the common factors taken into consideration for classification are:

  • Product presentation forms
  • Intended use
  • Ingredients/composition

Product presentation forms

Functional/fortified food products presented in a conventional food forms, such as yogurts, fruit juices and tea are generally regulated under the food regulations in South East Asia. Food supplements presented in pharmaceutical dosage forms such as capsules and tablets, on the other hand, present a very different picture. There is no common approach for regulating these products. Therefore, the same product may be regulated as a food product in one country, but falling under medicinal law in another. In Malaysia, for example, food supplements are regulated according to the Sales of Drug Act and other relevant regulations, whereas in Thailand they fall under the food act [1,2]

Intended use

The intended use of the product is generally considered to be the most important factor in determining the classification of functional/fortified food and food supplement products. The intended use may include recommended amounts, duration of use, targeted groups of users and product claims. If the product does not have a defined duration of use; is suitable for the general population, and has no limits to the amount consumed, it will most likely be considered as a food product in Southeast Asia. If there are limits on any of these however, the product may be classified as a food supplement or in the medicinal product category.

Because food supplements have defined dosages just like medicinal products – for example two capsules per day – and may be targeted at specific groups, product claims play an important role in the determination of whether the product should be a food supplement or medicinal product. Across Southeast Asia there are broadly common requirements on the use of claims on food supplement products: in general these must not bear claims that imply the treatment or prevention of disease. In Malaysia and Singapore, for example, to help companies determine whether a claim is considered medicinal or not, the relevant authorities have published a list of diseases and conditions for which food supplement products are not permitted to bear claims. Examples include cardiovascular and joint diseases.[3] In general, claims relating to diseases and conditions are also not permitted for functional/fortified foods, which tend to be regarded as food products in most Southeast Asian countries.

Ingredients/composition

The choice of ingredients and product composition is also important in the determination of the product category, but there is no common approach to the requirements for the functional/fortified food and food supplement ingredients and compositions across Southeast Asia. Again, some ingredients are allowed for food supplements and functional/fortified foods in some countries, but regarded as medicinal in others. Ingredients most likely to fall into the medicinal product category are botanical ingredients, since many botanicals used as food are known to possess medicinal properties, for example rosemary. To help companies determine the classification of the ingredients, some countries have compiled lists of permitted list of food or food supplement ingredients. In Singapore, for example, the Agri-Food and Veterinary Authority has issued a list of ‘Chinese Medicinal Material commonly use in Food’ to guide companies in the selection of botanical ingredients for their products [4]. Some ingredients in this list include Angelica sinensis, Citrus reticulata and Ginkgo biloba. In Thailand, the Food and Drug Administration has also established list of permitted botanicals and other bioactive substances in food, which includes Garcinia cambogia, Aloe Vera (gel), coenzyme Q10 and royal jelly. In Thailand, products are likely be regulated as medicinal products if these ingredients exceed the permitted levels. However, in some cases companies may apply for special permission to use ingredients not on the list, by submitting safety information to the Thai FDA for approval.

Another approach taken to guide companies in classifying their products based on ingredients and product composition, is through a decision tree. Malaysia follows this approach. According to the decision tree, the following is controlled by Malaysia’s Drug Control Authority:

  • Single and/or combination of bioactive substances, such as dietary fibres, vitamins, minerals and plant stanols
  • Substances that are used strictly for therapeutic purpose, such as pearl powder and gypsum fibrosum
  • Natural ingredients that are not traditionally used as food and have medicinal properties, such as alfafa

However, if the product is presented in a food matrix with more than 80 percent of food ingredients and less than 20 percent of the above three categories of active ingredients, it can be reviewed by the food control authority in terms of classification.[5]

Besides botanicals and other bioactive substances, differences also exist in the requirements for other commonly used functional/fortified food and food supplement ingredients, such as vitamins and minerals, especially when it comes to permitted levels of use. For example, the maximum levels for vitamins and minerals in food supplements in the Philippines and Thailand are based on the recommended daily intake of the nutrients, while most other Southeast Asia countries base them on the levels derived from safety assessments.

It is important, therefore, for manufacturers to consider all of the determination factors: product presentation, intended use, and choice of ingredient and product composition, when determining the appropriate classification of a product. Also noteworthy is that the classification of the product will vary among the different Southeast Asia countries due to different requirements in each of the three consideration factors. Reviewing each country’s regulatory environment and understanding the regulatory boundaries is imperative before planning for product launch and marketing. Companies also need to be clear on the intended usage of product during the product development stage, because if the product cannot be classified, it may not be permitted.

The differences in requirements for functional/fortified food and food supplements cause significant trade challenges. Therefore the Southeast Asian countries are working to harmonise regulatory requirements for various products. One of the product working groups active in the development of common regulatory requirements is the “Traditional Medicine and Health Supplement Product Working Group”, which aims to have common regulatory requirements ready by the end of 2012 to be fully implemented across the Southeast Asian countries by 2015. A key area for harmonisation is maximum levels of vitamins and minerals, which is being developed using a risk-based approach rather than recommended daily intake. It means that in the near future, food supplement products currently classified as medicinal products in some countries due to vitamin and mineral levels higher than the recommended daily intake could be regulated as food supplements across the Southeast Asia region. [6]

References

  1. Ministry of Health Malaysia. National Pharmaceutical Control Bureau. Drug Registration Guidance Document (May 2012). http://portal.bpfk.gov.my/
  2. Thailand Food and Drug Administration. Ministry of Public Health Notification No. 209 (A.D. 2007) Dietary supplement.
  3. Health Sciences Authority Singapore. Guidelines for Health Supplement (March 2012).http://www.hsa.gov.sg/
  4. Agri-Food & Veterinary Authority of Singapore. List of Chinese Medicinal Material (CMM) commonly used in food. Download
  5. Ministry of Health Malaysia. Guide to Classification of Food-Drug Interface Products (June 2011). Download
  6. Associations of South East Asia Nations. Harmonization of Standards and Technical Requirements in ASEAN. http://www.aseansec.org

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Are some cell counts too good to be true? Why some companies’ product data may mislead.

§ September 2nd, 2012 § Filed under Nano Medicine Comments Off on Are some cell counts too good to be true? Why some companies’ product data may mislead.

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This is a cautionary tale about the need for robust product characterization and release specifications for all cell therapy products.
Background
While our food often has a list of ingredients, our drugs don’t.  We rely on our regulatory agencies to rule on the safety of our drugs.  These agencies require drug manufacturers to submit to them the composition of their therapeutic compounds and then to comply with the product specifications.  It is this composition and these specifications which formed the basis of the clinical data evaluated by the agency and upon which the marketing approval is based.  Any deviation from those specifications requires a submission to the regulatory agency for review. Any deviation without such a submission is punishable.   
At the manufacturing site, as products come off the line they are subjected to a panel of product release tests to ensure each batch complies with the product specifications.
Specification compliance is a direct function of the consistency of the raw and ancillary materials, equipment, and operating procedures used in the manufacturing process.



Cell therapies present unique challenges when complying with this paradigm for several reasons only two of which I will mention here.  Firstly, it is not possible to achieve the level of product purification as one might with other therapeutic products.  Secondly, the product characterization is at a cellular rather than molecular level.

Autologous cell therapies present another set of unique challenge in this paradigm because of the notable patient-to-patient variability where the patient is also the donor of the raw material.  This often means there is a wider tolerance of heterogeneity in the product but it still must be within what has been proven to the regulatory agency as a safe and effective range.  


In cases where an autologous cell therapy is centrally manufactured, they are most often subjected to product release testing similar to that described above.  One notable difference, particularly for fresh products, is that the products may be shipped to the clinic and even administered before the full panel of test results are obtained.  This wold be considered highly unusual (if ever acceptable) with other types of products but is tolerated because of the time-sensitivity of these products and their high safety profile.


In the case of autologous cell therapy products produced at the bedside there is often not the same kind of product release discipline.  Often the regulatory agencies deal with the product consistency and specification compliance issue by ensuring that the cell processing device used point-of-care is validated to ensure the cellular product output is always within a specified range shown to be clinically safe and effective.


The Varying Degree of Product Characterization/Specification of Autologous GTP Cell Therapy Products


However – and now I get to the point of this blog post – for cell-based products, procedures and/or devices/kits which are not mandated to be formally approved by a regulatory agency before they can be commercially marketed, there is no product specification rigor.  Compliance with the Good Tissue Practice regulations and guidance is deemed to ensure safety.  In the United States, cell-based products which are deemed to be “minimally manipulated” and intended for “homologous use” are typically allowed to go straight to market with no formal approval.  Safety and clinical data is not required but is practically necessary to support physician adoption and, where applicable, reimbursement.  


This means that for these products there is a great deal of variability in terms of how much rigor companies apply in characterizing their product and then ensuring that each batch complies with the specifications they themselves have determined to be safe and effective. Again, where such products are manufactured in a centralized facility the likelihood of some release testing is greater.  However, those companies relying on a point-of-care processing kit or device business model that has not been deemed to require formal market approval, rarely (if ever) include product release testing.


The common criticism of these companies is that they simply do not know what they are injecting into patients because of the combination of the patient-to-patient donor variability, the lack of any disciplined product characterization or dosing studies, and the absence of any product release testing.  


This criticism is not equally levied at all autologous GTP products or companies – even those relying on point-of-care processing.  Of course some companies care and do a lot to try to ensure their product is well-characterized and that each batch complies with product specifications. This may involve the use of product release tests but can also involve the combination of pre-market research into the product characterization, safety, and dosing along with validation of the device/kit output.  In this way a company can say that within a very small margin, the output will be within the product specifications the company knows is safe and efficacious.


However, in a rush to get their device/kit to market some companies appear to care very little about the cell product characterization, validation of the output of their device/kit, or tying this data to optimal dose.


More concerning are those companies that appear to provide such data but it is wrong or meaningless.  What follows appears to potentially be a case study of precisely this problem. 


The INCELL Study 


This week I came across a fascinating white paper from Incell Corporation analyzing the output of adipose tissue processing kits of MediVet-America apparently demonstrating the inaccuracy of their cell counts (a common type of cell therapy product characterization) and calling into the question the cell count claims of Intellicell Biosciences (New York, NY) and Adistem (Hong Kong).


At the heart of the critique is the claim that the cell counting (product characterization) techniques employed by these companies counts as cells things (namely acellular micelles) which are not cells.

I encourage you to read the white paper in its entirety.  They corresponding author told me to watch for one or more papers which they are preparing for submission to peer-reviewed publications shortly.  Presumably these will rely on a larger data set and perhaps test other methodologies or technologies.


For the purposes of this blog, I’ve pulled what I believe are the most salient excerpts below:

Intrigued by the high cell numbers  (5 to 20 million cells/gram)  reported by kit/device manufacturers such as MediVet-America (Lexington, KY), Intellicell  Biosciences (New York, NY), and Adistem, Ltd. (Hong Kong) in adipose stem cell therapy compared to other methods (e.g., 
Chung,Vidal, and Yoshimura), INCELL staff conducted a research study to  investigate the high apparent yield of stem cells.  This initial work was focused  on SVF cells from the MediVet Kit, which is marketed to isolate adiposederived canine SVF and stem cells.

The cell yields reported for the Medivet Kits are five to more than ten times higher than the yields routinely obtained by INCELL from freshly harvested human or animal adipose tissue using our adipose tissue processing methods.  These yields are also tenfold or higher than those reported in the literature by most academic researchers (Chung-canine, Vidal–equine, Yoshimura–human).  Since these  cell counts are used to support stem cell dosing recommendations and cell banking, it is important to better understand why the cell numbers are higher.

A comparative analytical study of three dog donors of adipose tissue was designed to evaluate the cell yields using the MediVet Kit as an example of this class of isolation system. All  kit procedures were followed as per the instructions provided.  A brief overview of the different cell counting methods used, and the resultant cell counts, observations and explanations of the results observed, are described below

.

This study shows that incorrect counting of adipose derived SVF cells and the subset of regenerative stem cells can subsequently result in inaccurate dosing, both in direct therapeutic applications and in cryostorage of cells for future use.  The DAPI-hemocytometer cell count (manual) was considered the most accurate, but there are various sources of technical difficulties that  can lead to incorrect  cell numbers. The nature of adipose tissue itself with variability in dissociation by enzymatic digestion can all contribute to the outcomes. Fat tissue has a propensity to form acellular micelles and oils upon tissue disruption. Processing methods or reagents (e.g., Solution E or lecithins) can generate micelles that may be  erroneously  counted as cells. Autofluorescence and dye trapping or uptake by the micelles can lead to very high inaccurate cell counts when automated cell counting is used. 


In this study the most inaccurate counting came from the Cellometer. When used according to kitrecommended guidelines and on-site training provided by Nexelcom for counting  cells by the MediVet procedure, the Cellometer overstated the DAPI-hemocytometer cell count by up to 20X or more. The Coulter Counter protocols also led to incorrect, high cell numbers. Although the cell counts were still a bit high, the authors recommend the NucleoCounter, or similar equipment, as more acceptable for automated counting.  The manual hemocytometer-DAPI method is the most accurate, but requires a highly experienced cell biologist or technician to make accurate counts and  is not suitable for routine clinical use. 

Other companies also have claims of very high cell numbers when their processes are used. Adistem, like MediVet, states they add an emulsifying agent to their kits to assist in cell release, and they also use a light activation system. Their kits were not tested in this study but it is possible that the high cell numbers reported by Adistem are also incorrect and result from the same problems highlighted in this paper for the MediVet procedure. Ultrasonic energy, which is commonly used to manufacture micellular  liposome  structures and to disrupt and lyse cells, is  another potentially problematic procedure for counting and verifying viable, regenerative cells.  Intellicell 3uses ultrasonic energy to release cells from adipose tissue, and it is possible that resultant micelles or cell fragments contribute to the higher than expected cell numbers.  This assumption could be verified with additional studies.  

In summary, the authors caution that great care must be taken when using kits and automated cell counting for stem cell dosing and cryobanking of cells intended for clinical use. Overestimated  cell numbers would be a major confounding source of variation when efficacy of stem cells injected are compared as doses based on cell number and when cryostored cells are aliquoted for use based on 

specific cell numbers as a treatment dose.  Hopefully, this study will lead to more  reproducible counting and processing methods being reported in the literature, more inter-study comparability of cell doses to clinical outcomes,  more industry diligence to support claims, and more accurate counting for dosing stem cell therapies to patients.

Chung D, Hayashi K, Toupadakis A, et al.  Osteogenic proliferation and differentiation of canine bone marrow and adipose tissue derived mesenchymal stromal cells and the influence of hypoxia.  Res Vet Sci, 2010; 92(1):66-75. Vidal MA, Kilroy GE, Lopez MJ, Johnson JR, Moore RM, Gimble JM. Characterization of equine adipose tissue-derived stromal cells: adipogenic and osteogenic capacity and comparison with bone marrow-derived mesenchymal stromal cells. Vet Surg, 2007; 36:613–622.  Yoshimura K, Shigeura T, Matsumoto D, et al:  Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirate.  J Cell Phys, 2006; 205:64-76.

 In Conclusion

Despite some of their other challenges, Intellicell, MediVet-America, and AdiStem (and others) have scored credibility points with some of my colleagues who have been impressed by the fact that they have incorporated product release criterion and testing technologies into their business model where their peer companies have not bothered.  This credibility may be quickly eroded if it turns out the results of their cell counts have been misleading.  For now it is a word of caution to do your own due diligence and/or not to fall into a similar product development/characterization trap.  Meanwhile, we will watch for the peer-reviewed papers.

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Researchers pioneer world's first HIV/AIDS nanomedicines

§ August 30th, 2012 § Filed under Nano Medicine Comments Off on Researchers pioneer world's first HIV/AIDS nanomedicines

Public release date: 29-Aug-2012 [ | E-mail | Share ]

Contact: Sarah Stamper sarah.stamper@liv.ac.uk 01-517-943-044 University of Liverpool

Scientists at the University of Liverpool are leading a 1.65 million project to produce and test the first nanomedicines for treating HIV/AIDS.

The research project, funded by the Engineering and Physical Sciences Research Council (EPSRC), aims to produce cheaper, more effective medicines which have fewer side effects and are easier to give to newborns and children.

The new therapy options were generated by modifying existing HIV treatments, called antiretrovirals (ARVs). The University has recently produced ARV drug particles at the nanoscale which potentially reduce the toxicity and variability in the response different patients have to therapies. Drug nanoparticles have been shown to allow smaller doses in other disease areas which opens up possibilities to reduce drug side-effects and the risk of drug resistance. Nanoscale objects are less than one micron in size a human hair is approximately 80 microns in diameter.

Professor Steve Rannard, from the University’s Department of Chemistry, said: “Nanomedicines are being used daily to treat a range of conditions around the world. There are, however, no current nanoparticle HIV therapies that are providing this kind of patient benefit. This project is the first step towards taking the nanomedicine options that we have developed out of our labs and into the clinic, representing a significant milestone in the development of new HIV treatments.

“If we can demonstrate real potential from our planned clinical work with healthy volunteers at the Royal Liverpool University Hospital, then our collaboration partner, IOTA NanoSolutions, will take forward the further development and clinical validation of the ARV drug particles in HIV patients. We also aim to test new formulations for children in developing countries, offering HIV patients around the world the prospect of safer, more effective treatments.”

Professor Andrew Owen, from the University’s Department of Molecular and Clinical Pharmacology, added: “We have integrated an assessment of pharmacology and safety early in the research and this has allowed us to rapidly progress lead options for clinical trials. The work has been conducted with the Medical Research Council (MRC) Centre for Drug Safety Science also based at the University.”

“Our data so far looks really exciting, offering the potential to reduce the doses required to control the HIV virus. This work builds on initiatives by Mdecins Sans Frontires and other groups to seek ways to improve ARV therapy and could have real benefits for the safety of ARVs globally. Importantly we also hope to reduce the costs of therapy for resource-limited countries where the burden of disease is highest.”

HIV continues to increase in prevalence, with 34 million people currently infected worldwide. The new HIV therapies offer particular hope for treating children with HIV which affects 3.4 million children under the age of 15 years in Sub Saharan Africa. About 90% of infected infants acquire the virus through mother-to-child transmission. Without treatment one third of children die within their first year of life.

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Researchers pioneer world's first HIV/AIDS nanomedicines

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Fifth edition of Bangalore Nano on December 6, 7

§ August 29th, 2012 § Filed under Nano Medicine Comments Off on Fifth edition of Bangalore Nano on December 6, 7

It is important to focus on nanotechnology field

The fifth edition of Bangalore Nano, the annual nanotechnology conference-cum-trade show organised by the Karnataka government, will be held on December 6 and 7.

C.N.R. Rao, scientific adviser to the Prime Minister, said that it was a matter of pride that his city, Bangalore, was at the forefront of leading and nurturing innovation in the field of nanotechnology. He spoke about his visit to Israel where he met a young researcher who wanted to use exhaled air and analyse molecules to detect cancer. Years later, Prof. Rao got to know that the researcher came up with a product called the nano nose that helps detect cancer. Such are the possibilities of nanotechnology, and this is why it is important to focus on this emerging field, he said.

Criticising the resistance among academia to collaborate on research work, Prof. Rao said that working together is imperative to move forward.

Nano, a game changer

Chief Secretary S.V. Ranganath said that Karnataka has taken an early lead in science and technology, and compared the nanotechnology scene now to what IT was two decades ago. Nano is going to be a game changer, and it presents a unique challenge as it applies across disciplines. He said that Karnataka has 396 research and development organisations and over 2,100 IT companies, and that over 40 per cent of software exports come from here.

The two-day event includes several plenary sessions on healthcare and medicine, aerospace and defence, electronics, food and agriculture, energy and environment, water management solutions and advanced materials.

The event organisers claim that over 100 leading international and domestic companies are slated to participate. A poster presentation session will display at least 120 posters, and 450 graduate level students will attend the event. As part of the conference, the Research Industry Collaboration Hub will be organised.

The pre-event schedule includes a pre-conference tutorial session on December 5 for delegates.

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Fifth edition of Bangalore Nano on December 6, 7

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Foreword to Summer 2012 Issue

§ August 19th, 2012 § Filed under Nano Medicine Comments Off on Foreword to Summer 2012 Issue

Asignificant number of super food and nutritional supplement products contain some ingredients produced from botanicals that are wild collected by local, rural or indigenous people in remote areas with sensitive ecosystems. They are biodiversity products not obtained from controlled cultivation. Some of the most famous medicinal super fruits are mainly harvested in the wild or from semi-wild managed areas including açai (Euterpe oleracea) from the Amazon Basin, amla (Phyllanthus emblica) from forests of India, baobab (Adansonia digitata) from African savannahs, bilberry (Vaccinium myrtillus) from European heaths and forests, camu-camu (Myrciaria dubia) from semi- to fully-flooded areas in Brazil and Peru, saw palmetto (Serenoa repens) from dense thickets of coastal Florida, and schisandra (Schisandra chinensis and S. sphenanthera) from thickets and forests of China. But fruits are the easiest of all plant parts for sustainable management. Subterranean plant parts (roots, rhizomes and stolons) and tree barks are another story, often requiring many years to reach maturity before the first harvest is possible. Developing new products with ingredients made from wild roots or barks should cause one to think and plan in terms of decades rather than single seasons.

In order to develop and launch a truly useful natural product that aims to be more than just a flash in the pan, commanding an increasing share of shelf space for years to come, product developers ought to concern themselves, more than ever, with the implementation of sustainability (ecological, economical, and social) standards for assurance of uninterrupted supply into the future, traceability and transparency. This may require relationship building and close collaboration with the local people who are the stewards of the ecosystems that yield the most unique natural ingredients. If your new product is projected to be a big success, buying botanical ingredients anonymously through import/export traders without also establishing relationships with the producers may be a risk to consider. This is not to suggest that product companies should bypass their qualified ingredient suppliers but rather to collaborate with them to strengthen relationships with the producer communities with a mutual goal of long-term sustainable production and supply.

More and more natural product companies are setting admirable but ambitious goals to demonstrate a 100% sustainable supply chain in the foreseeable future. Some are learning quickly that this may be easier said than done as they look deeper and beyond the assurances of their immediate supplier of processed ingredients. The implementation and management of sustainability standards for harvesting botanical ingredients is complicated and takes a whole ecosystem approach; people, plants and animals are all considered in an effective management plan.

If your company does not have the resources to invest directly in the implementation of sustainability standards at the producer level you may be able to interest your supplier in collaborating on certain important botanical raw materials. At a minimum, new product development teams can aim to specify product components to be sourced from producers already holding eco + social sustainability certifications. Developing, maintaining and sustaining reliable and trusting trade relationships between all stakeholders (the certified operation/ producer, the processor/supplier, and finished product manufacturer) can build over time. Indeed, if your new product is based on biodiversity-derived natural ingredients and is projected to succeed big in the market you will need effective sustainable resource management planning to be certain that the producer organizations are stable and able to scale-up sustainably in line with your growth projections.

Many of the independent inspection and certification organizations have online searchable databases or lists where you can determine during your product development due diligence process whether certain interesting ingredients are commercially available with ecological and social certifications. These databases can serve as a useful lead for your team and your qualified supplier to contact the producers directly. Here is a short list of some organizations providing listings of certified operators along with examples of selected certified botanical ingredients commercially available under each scheme:

  • Ecocert Fair Trade (http://www.ecocert.com/equitable-solidaire-responsable-esr): acai berry (Euterpe oleracea), argan kernel oil (Argania spinosa), baobab oil (Adansonia digitata), devil’s claw root tuber (Harpagophytum procumbens or H. zeyheri), shea nut and butter (Vitellaria paradoxa);
  • Fair for Life – Social & FairTrade Certification Programme (http://www.fairforlife.net): aloe gel, juice and leaf (Aloe vera), golden berry (Physalis peruviana), maca root (Lepidium meyenii), passion fruit (Passiflora spp.), Peruvian pepper (Schinus molle), shea nut and butter (Vitellaria paradoxa), yerba maté (Ilex paraguariensis);
  • FairWild Certified (http://www.fairwild.org): bilberry (Vaccinium myrtillus), hawthorn berry (Crataegus pentagyna), juniper berry (Juniperus communis), raspberry leaf (Rubus idaeus), rose hip (Rosa canina), stinging nettle leaf (Urtica dioica);
  • FLO-CERT (http://www.flo-cert.net/flo-cert/29.html): agave (Agave tequilana, A. salmiana) ginger rhizome (Zingiber officinale), golden berry (Physalis peruviana), roselle flower (Hibiscus sabdariffa), stevia leaf (Stevia rebaudiana), vanilla fruit (Vanilla mexicana, V. fragrans, V. planifolia).

Josef Brinckmann
VP of Sustainability Traditional Medicinals Inc.

Source:
http://www.nutraceuticalsnow.com/articles/feed/

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Fibre just got smarter

§ August 19th, 2012 § Filed under Nano Medicine Comments Off on Fibre just got smarter

How PROMITOR™ Soluble Gluco Fibre is shifting perceptions of healthier eating

If you could sum up the traditional consumer attitude to dietary fibre, it would be ‘good for you but boring’. Fibre is perceived as delivering desirable health benefits, but high-in-fibre foods are sometimes still considered bland and unpalatable.

For food and beverage manufacturers, dietary fibre is where the consumer trend for healthy eating meets equally strong demand for pleasurable tastes and textures. With Tate & Lyle’s new PROMITOR™ Soluble Gluco Fibre, it seems consumers really can have the best of both worlds: fibre-packed foods that taste great and have a satisfying texture.

In this article we look at the European consumer trends and needs around dietary fibre identified by Tate & Lyle’s research, how the company is meeting those needs, and the opportunities this brings to food and beverage manufacturers.

Research by Tate & Lyle as far back as 20091 shows that, while European consumers recognise the value of fibre in their diets, they are concerned that they are not consuming enough. This may be due to a number of reasons. Taste has already been mentioned; consumers may also be unsure which foods to eat, or choose foods which they think contain a significant amount of fibre but actually don’t.

Tate & Lyle also found that 40% of respondents rated fibre as an important benefit when purchasing products; and 72% would be willing to pay extra for fibre-enriched products.

Responding to this clear need, Tate & Lyle opened a soluble fibre dedicated production line in The Netherlands, in 2010. The facility is producing a range of easy-to-use, low-calorie and cost-effective soluble fibres. The aim was, and remains, to help food and beverage manufacturers create the appealing, affordable, fibre-enriched products their consumers are seeking, as well as developing reduced calorie foods that taste great, another functionality for which fibres are used a lot.

This article is available in full in the Summer 2012 issue of Nutraceuticals Now

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Training for a Culture of Quality

§ August 19th, 2012 § Filed under Nano Medicine Comments Off on Training for a Culture of Quality

The Dietary Supplement industry is facing increased scrutiny from the U.S. Food and Drug Administration (FDA) and the mainstream media — remember Dateline NBC’s March 2012 exposé of an alleged “dry lab” serving the dietary supplement industry? Since late 2011, the FDA has seized products and shut down several manufacturers for violations of 21 CFR 111 Good Manufacturing Practices (GMPs). Federal courts are handing down hefty fines and contempt sentences to dietary supplement manufacturers and executives found to be willfully violating federal regulations. While many say this negative attention damages the industry’s reputation, others argue it’s actually good for the industry. By shining a light on the very few manufacturers who are willfully ignoring the law, reputable companies with robust quality management systems have a golden opportunity to differentiate themselves in the marketplace. If your company has embraced a culture of quality and is adhering to the current GMPs, now is the perfect time to talk publicly about it. You’ll find plenty of consumers, retailers, media and legislators ready to listen.

But what if your company hasn’t integrated quality management into every aspect of its operations? Perhaps you are the lone champion of quality in your organization. If so, there’s never been a better time to make your case for a corporate investment in quality. While it’s difficult to calculate the precise return on investment (ROI) of quality, the cost of high-profile consent decrees, FDA fines, legal battles and product recalls make a compelling financial case.

This article is available in full in the Summer 2012 issue of Nutraceuticals Now

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‘Nanojackets’ for treating breast cancer could be game changer for cancer care

§ August 15th, 2012 § Filed under Nano Medicine Comments Off on ‘Nanojackets’ for treating breast cancer could be game changer for cancer care

A novel nanotechnology drug delivery system under development to infiltrate breast cancer tumors could pave the way for treating other diseases.

Penn State College of Medicine received a $1 million grant from a state research fund set up with money from its tobacco settlement to assess the drug treatments commercialization potential.

The principal investigator for the nanotechnology delivery system is Mark Kester, a professor of pharmacology and director of the Penn State Center for NanoMedicine and Materials. He has been working for the past five to six years with Jim Adair of Penn States department of material sciences and engineering, and Keystone Nano, a nanotechnology company spun out of Penn State University led by Jeff Davidson, the founder of the Biotechnology Institute and Pennsylvania Bio industry association.

The next generation of cancer-fighting drugs specifically target cancer proteins rather than attack cancer and noncancer cells indiscriminately. Although companies have recognized the ability of small interfering RNA as a small molecule that can be directed to interfere with the production of cancer cells, the toxicity of siRNA has proved a challenge in its use. Biotechnology companies and institutions have been studying ways to use different nanotechnology particles to house the toxic molecule.

In an interview with MedCity News, Kester explained that the team has developed nontoxic nanojackets that use calcium phosphocillate nanoparticles, material that makes up teeth and bones, to deliver the toxic siRNA safely to the gene mutation. In this case, the one that causes overexpression of an oncogenic protein in breast cancer patients.

Getting to this stage has taken five to six years. Kester estimates it will take another one-and-a-half years to get to the point where it will have enough data to submit an IND application. During that time it will work with contract research organizations across Pennsylvania to conduct preclinical trials using the nanojackets.

Even if the companys IND application is approved, it will take another five to eight years to get the technology to the point where it can be submitted for FDA approval.

A cursory search on Clinicaltrials.gov revealed that 10 clinical studies are using siRNA to combat diseases in clinical trials. The one that is using them to fight breast cancer uses fat cells to house the toxic molecule.

If successful, the siRNA molecule could theoretically be delivered to any protein mutation and destroy it, a development that would revolutionize not only cancer treatment but one that could lead to treating Alzheimers and Parkinsons disease and other unmet needs.

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‘Nanojackets’ for treating breast cancer could be game changer for cancer care

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Is the cell therapy sector outperforming the major indices?

§ August 12th, 2012 § Filed under Nano Medicine Comments Off on Is the cell therapy sector outperforming the major indices?

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So here’s what I did today.  I built a portfolio of public companies focused exclusively or predominately in the cell therapy space.  I excluded any companies that are in the sector but their products/services constitute less than a significant majority of their revenue and/or expenses.  The portfolio sits at 29 companies.  Here’s the list:


Here’s how the portfolio performs against the Dow Jones, Standard and Poor’s, and NASDAQ indices so far this year.


When looking at the period 1 January 2012 to 10 August 2012, the cell therapy portfolio is up 42%, Dow Jones up 8%, Standard and Poor’s up 12% and NASDAQ up 16%.

In the context of how much we hear about how harsh this sector is or has been on investors, I found today’s analysis interesting and, honestly, pleasantly surprising.

This snapshot is useful but has its limitations. I’m relying on Google Finance for accuracy of the information provided.  Do your own due diligence. Invest accordingly.  I hope this helps.

–Lee

This snapshot has been brought to you by Cell Therapy Group: all cell therapy, all the time! 🙂

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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European researchers identify materials at the nanoscale

§ August 2nd, 2012 § Filed under Nano Medicine Comments Off on European researchers identify materials at the nanoscale

Spanish and German researchers have made a new instrumental development that solves a key materials science and nanotechnology question: how to chemically identify materials at the nanometre scale.

One of modern chemistry and materials science’s main goals is to achieve the non-invasive chemical mapping of materials with nanometre-scale resolution.

Although a variety of high-resolution imaging techniques currently exist, such as electron microscopy or scanning probe microscopy, their chemical sensitivity cannot meet the demands of modern chemical nano-analytics. And despite the high chemical sensitivity offered by optical spectroscopy, its resolution is limited by diffraction to about half the wavelength, thus preventing nano-scale-resolved chemical mapping.

But now the European team has come up with a new method called Nano-FTIR, as they explain in the journal Nano Letters.

Nano-FTIR is an optical technique that combines scattering-type scanning near-field optical microscopy (s-SNOM) and Fourier Transform infrared (FTIR) spectroscopy.

The team illuminated the metallised tip of an atomic force microscope (AFM) with a broadband infrared laser, and analysed the backscattered light with a specially designed Fourier Transform spectrometer. This meant they could demonstrate local infrared spectroscopy with a spatial resolution of less than 20 nanometres.

Lead study author Florian Huth from Spanish research centre nanoGUNE, based in San Sebastin, comments: ‘Nano-FTIR thus allows for fast and reliable chemical identification of virtually any infrared-active material on the nanometer scale.’

To boot, nano-FTIR spectra match extremely well with conventional FTIR spectra. The spatial resolution is increased by more than a factor of 300 compared to conventional infrared spectroscopy.

Rainer Hillenbrand, also from nanoGUNE, says: ‘The high sensitivity to chemical composition combined with ultra-high resolution makes nano-FTIR a unique tool for research, development and quality control in polymer chemistry, biomedicine and pharmaceutical industry.’

For example, nano-FTIR can be applied for the chemical identification of nano-scale sample contaminations.

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European researchers identify materials at the nanoscale

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FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012)

§ July 29th, 2012 § Filed under Nano Medicine Comments Off on FDA 1. RSI 0. Regenerative Sciences (Regenexx) vs FDA (2012)

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As followers of this blog will know I’ve been blogging about Regenerative Sciences and predicting their eventual run-in with the FDA since my first post in September 2008 (Cell Therapy is Not the Practice of Medicine) and again in February 2009 (Regenexx vs the FDA 2009).  When the FDA finally proceeded with an injunction against RSI in August 2010,I helped spread the news (here).

I’ve watched the development of the fight between RSI and the FDA with interest.  In September 2001 I posted a rather lengthy commentary about the potential impact of the case (Potential far-reaching implications of the ongoing fight over point-of-care autologous cell therapy.

Since then I have welcomed other bloggers and commentators who are now following and commenting on the case much more closely and frequently than I including @LeighGTurner (on Twitter) and Paul Knoepfler (@PKnoepfler on Twitter and his Knoeplfer Lab Stem Cell Blog).  Recently I enjoyed being interviewed by Paul on the issue of unregulated stem cell activity and touched on the case for his blog.

Consequently I read with interest yesterday’s federal court ruling upholding the FDA’s injunction against RSI and the immediate commentary from the New Scientist, Stanford’s Scope Blog and Knopfler’s multiple posts (here and here). As a long-term follower of this case, I’ve been asked to comment.  Here is my brief reaction:

This is a case that was always destined for the appellate courts regardless of which way the initial court ruled.    The fact the federal court ruled in the FDA’s favor certainly now sets the onus on RSI and what is anticipated to be a gamut of intervenors but taking this case to the appellate courts is what the legal team have anticipated and legal arguments designed for all along.

This is just the beginning of what will be a long and interesting battle.  The ruling was nothing more than the granting of an injunction in response to the government’s motion for summary judgement.  In granting the injunction the court  agreed with the government’s position that it was acting under the authority given it under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(g) but it provided little-to-no rationale for its ruling.

The court chose, in its wisdom, not to address the bulk of the RSI’s legal arguments which are largely jurisdictional in nature. These are the kinds of arguments which the lower courts prefer be dealt with by appellate courts and frankly the judge did us all a favor by ruling quickly, succinctly and punting the case where we all knew it was inevitably headed.

In my opinion, other than chalking one up in the government’s win column there is little to be gleaned from this ruling in terms of how RSI’s arguments will be received in appellate court.  The interesting day is yet to come.

In terms of a short-term practical impact, frankly I see very little.  RSI has already ceased distributing Regenexx within the US so there will be little-to-no impact there.  As for the potential impact on other companies or clinics who might be operating on the fringes of FDA regulation within the US, I suspect it will be business as usual.

Most of the clinics/companies offering cell-based treatments/products which are arguably in contravention of FDA regulation are operating under the clear knowledge of what they are doing and where the FDA stands with respect to the treatments/products they offer and yet they persist and continue.


 For the truly fraudulent there is the risk of criminal charges and/or litigation but for those companies or practitioners who are operating in this shade of grey which are not shady (and they do exist), the  risks associated with this practice are barely higher than in the routine practice of medicine. 


In reality, with the exception of the most fraudulent examples, it takes a fair long-time for the FDA to catch up with these folks and there is good money to be made in the interim.  When they get caught, they will stop. If they’ve recouped their initial investment (which is nominal and the margins are high) there is very little penalty to this course of action.  Perhaps they set up shot elsewhere or simply enjoy the proceeds.  I doubt we will see much of a slow-down of this kind of activity.  Indeed it may strengthen the resolve of those committed to the cause.

In my opinion yesterday’s ruling was in interesting and important milestone in a continuing evolution in the debate of how best to regulate the use of cells in treating people but I’m not sure it’s the seminal pivot point that some believe.  I suspect we will not see any radical shift in terms of FDA or industry activity until (if then) the appellate courts rule.

Just my two cents….

–Lee

http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

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Tracing the nano-landscape

§ July 25th, 2012 § Filed under Nano Medicine Comments Off on Tracing the nano-landscape

Mumbai, July 25:

How big is small? Nano technologies are igniting innovations across the world. And tracing this nanoscape the complex pathways from nanoventing to the commercialisation of nanovations is the book Nanotechnology Intellectual Property Rights: Research, Design, and Commercialization.

The inclusive nature of nanotechnology gives it a very special status as it mothers innovations to deliver inventions in nanobiotechnology, nanostructures, nanocomposites, nanomedicine, nanotaggants for security systems, nanoelectronics, nanodevices etc, according to excerpts from the book written by intellectual property experts Dr Prabuddha Ganguli and Dr Siddharth Jabade. The book is slated for launch in Hyderabad this week.

Nanotechnology allows scientists to dabble at the small, building-block atomic or molecular level. And while the technology is not without its sceptics, a section of the scientific community believes that nanotechnology would help develop break-through newer applications in several fields.

Illustrating this nano-inclusiveness, the authors say, the protection of intellectual property is important to the nanotechnology industry because of its complex knowledge matrix.

Driving the nano to success will require cross-disciplinary expertise to contemplate, foresee and address as many social, legal including intellectual property rights, cultural, ethical, religious, philosophical and political implications of the nanoworld, tomorrow and the days after, the book says.

The book caters to a diverse readership that may not have an insight into the legal nuances of IP rights, and it seeks to articulate techno-legal aspects of nano-related innovations, illustrated with case-studies, to aid integration into businesses, says Dr Ganguli.

The book is published by the CRC Press (Taylor and Francis Group), USA, and priced in India at Rs 2,943.

jyothi@thehindu.co.in

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Companies selectively targeting cancer stem cells

§ July 22nd, 2012 § Filed under Nano Medicine Comments Off on Companies selectively targeting cancer stem cells

Today, I posted this to Twitter:

3 Innovative Cancer Treatments…But Which Is The Best Bet? seekingalpha.com/a/fjed $GSK $IMUC $VSTM #cancerSC via @seekingalpha — Jim Till (@jimtill) July 17, 2012

The article is about three companies that are working on treatments designed to target cancer stem cells (CSCs). The companies are OncoMed, Verastem and ImmunoCellular Therapeutics. The article is interesting.

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Princeton scientists using nanotech to make cancer 3 million times more detectable

§ July 17th, 2012 § Filed under Nano Medicine Comments Off on Princeton scientists using nanotech to make cancer 3 million times more detectable

Scientists at Princeton University say they have used nanotechnology to make tests to detect diseases, like cancer and Alzheimer’s disease, 3 million times more sensitive.

That means what researchers are calling a breakthrough in nanotechnology and medicine could enable doctors to detect these illnesses at much earlier stages, when they are more treatable.

“This advance opens many new and exciting opportunities … in disease early detection and treatment,” said Stephen Chou, a Princeton engineering professor, who led the research team. “You can have very early detection with our approach.”

Princeton researchers used nanotechnology to improve a biological test called an immunoassay, which measures the concentration of a substance in a body fluid sample, and is used to find markers for cancers and Alzheimer’s, in patients. The test produces a fluorescent glow when the disease is detected. The stronger the presence of the disease, the brighter the test glows.

However, if only faint, early-stage, traces of the disease are present, the glow can’t be detected and the disease could be missed.

The Princeton researchers used nanotechnology to amplify the fluorescence, which gave them a 3-million-fold improvement in detection. It means the test now can detect disease with 3 million times fewer disease biomarkers present.

The earlier a cancer can be detected, the sooner treatment can begin, and the better chance a patient has of survival.

The key to the breakthrough, according to Princeton’s researchers, lies in a new nanomaterial they call D2PA. The nanomaterial, which was developed in Chou’s lab, consists of a thin layer of gold nanostructures surrounded by glass pillars that are 60 nanometers in diameter. About 1,000 of the pillars can be laid side-by-side and still only be as wide as a human hair.

Each pillar, spaced 200 nanometers apart, is capped with a gold disk. Each pillar also is speckled with even smaller gold dots. The pillars boost the collection and transmission of light by a billion-fold, Princeton said.

The university noted that Chou is focused on using the new technology to detect early-stage breast and prostate cancers. He also is working with researchers at the Memorial Sloan-Kettering Cancer Center in New York to develop tests to detect proteins associated with early stage Alzheimer’s disease.

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Princeton scientists using nanotech to make cancer 3 million times more detectable

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Researchers use nanotech to make cancer 3M times more detectable

§ July 10th, 2012 § Filed under Nano Medicine Comments Off on Researchers use nanotech to make cancer 3M times more detectable

Scientists at Princeton University say they have used nanotechnology to make tests to detect diseases, like cancer and Alzheimer’s disease, 3 million times more sensitive.

That means what researchers are calling a breakthrough in nanotechnology and medicine could enable doctors to detect these illnesses at much earlier stages, when they are more treatable.

“This advance opens many new and exciting opportunities … in disease early detection and treatment,” said Stephen Chou, a Princeton engineering professor, who led the research team. “You can have very early detection with our approach.”

Princeton researchers used nanotechnology to improve a biological test called an immunoassay, which measures the concentration of a substance in a body fluid sample, and is used to find markers for cancers and Alzheimer’s, in patients. The test produces a fluorescent glow when the disease is detected. The stronger the presence of the disease, the brighter the test glows.

However, if only faint, early-stage, traces of the disease are present, the glow can’t be detected and the disease could be missed.

The Princeton researchers used nanotechnology to amplify the fluorescence, which gave them a 3-million-fold improvement in detection. It means the test now can detect disease with 3 million times fewer disease biomarkers present.

The earlier a cancer can be detected, the sooner treatment can begin, and the better chance a patient has of survival.

The key to the breakthrough, according to Princeton’s researchers, lies in a new nanomaterial they call D2PA. The nanomaterial, which was developed in Chou’s lab, consists of a thin layer of gold nanostructures surrounded by glass pillars that are 60 nanometers in diameter. About 1,000 of the pillars can be laid side-by-side and still only be as wide as a human hair.

Each pillar, spaced 200 nanometers apart, is capped with a gold disk. Each pillar also is speckled with even smaller gold dots. The pillars boost the collection and transmission of light by a billion-fold, Princeton said.

The university noted that Chou is focused on using the new technology to detect early-stage breast and prostate cancers. He also is working with researchers at the Memorial Sloan-Kettering Cancer Center in New York to develop tests to detect proteins associated with early stage Alzheimer’s disease.

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Researchers use nanotech to make cancer 3M times more detectable

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