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Nanotechnology for Drug Delivery : Global Market for Nanocarriers

§ February 13th, 2012 § Filed under Nano Medicine Comments Off on Nanotechnology for Drug Delivery : Global Market for Nanocarriers

NEW YORK, Feb. 13, 2012  /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Nanotechnology for Drug Delivery : Global Market for Nanocarriers

http://www.reportlinker.com/p0770731/Nanotechnology-for-Drug-Delivery---Global-Market-for-Nanocarriers.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Delivery_Technology

Nanocarriers will account for 40% of a $136 billion nanotechnology-enabled drug delivery market by 2021. We forecast the total market size in 2021 to be US$136 billion, with a 60/40 split between nanocrystals and nanocarriers respectively, although developing new targeted delivery mechanisms may allow more value to be created for companies and entrepreneurs.

Of the 10 nanocarrier technologies studied, liposomes and gold nanocarriers account for 45% of the total addressable market. Liposomes will offer the largest addressable market ($15 billion) in 2021 while gold nanocarriers will see the highest compound annual growth rate (CAGR)—53.8%—in the next decade.

Drugs are loaded into nanocarriers (also called nanoshells or nanoparticles, between 1 and 100 nm), then transported through the body to the target site. This kind of targeted drug delivery for the treatment of cancers is one of the most anticipated and discussed benefits of nanotechnology-enabled medicine as it offers a level of accuracy in delivering drugs that far surpasses present methods. Typically over 90% of a drug is wasted in the body, which leads to unwanted side effects. Modern chemotherapy bombards patients with drugs in the hope that tumorous cells will be destroyed. The lack of specificity of current drug delivery techniques mean patients' healthy cells are destroyed indiscriminately along with cancer cells.

Using nanotechnology to combat cancer is not new. Abraxane, the first nanoparticulate drug delivery product for the treatment of breast cancer, launched six years ago. There are now hundreds of new nanotech-based treatments under development, ranging from reformulation of existing drugs to enhance their efficacy to radical new "magic bullet" therapies.

The healthcare market is changing. We are seeing a paradigm shift away from blockbusters and a 'one-size fits all' approach to a more personalised medicine based on an individual's unique genome and immune response. The more scientists learn about the molecular causes for disease the more targeted and effective nanotechnology-enabled drug delivery therapies will become.

Table of ContentsTABLE OF EXHIBITS 7

EXECUTIVE SUMMARY 12

CHAPTER 1 - INTRODUCTION 17REPORT SCOPE 17

METHODOLOGY 18

Procurement 18

Calculation of CAGR 19

THE NANOSCALE 20

Two biological examples that illustrate nanoscale: 20

CHAPTER 2 – NANOTECHNOLOGY IN MEDICINE AND BIOMEDICINE 22OVERVIEW OF NANOTECHNOLOGY IN MEDICINE AND BIOMEDICINE 22

Why is Nanotechnology A Critical Application for Medicine and Biomedicine? 22

Why Nanotechnology Is Needed for Medicine and Biomedicine 24

WHAT ARE THE KEY DRIVERS FOR ADOPTION OF NANOTECHNOLOGY IN MEDICINE AND

BIOMEDICINE? 27

The Aim Of Drug Targeting 27

Rapid Market Growth 28

Market Drivers For Enhanced Drug Delivery 28

Increasing Proportion of The Ageing Population 29

Demand For More Affordable Health Care 31

Public Health – Ending disease 31

Demand for More Innovation 31

Social responsibility 31

THE KEY APPLICATIONS OF NANOTECHNOLOGY IN MEDICINE AND BIOMEDICINE 32

How Nanotechnology Can Benefit Drug Delivery 33

Nanotechnology in Medical and Biomedical Diagnostics 34

Nanotechnology in Regenerative Medicine and Tissue Engineering 34

Other Applications For Nanomaterials In The Medical And Pharmaceutical Sector 34

PROMISING EXAMPLES OF NANOTECHNOLOGY ENABLED DRUG DELIVERY 35

Case Study 1 – Magnetic Field Acts as "Remote Control" to Deliver Nanomedicine 35

Case Study 2 - Adaptive Micro and Nanoparticles: Temporal Control Over Carrier

Properties to Facilitate Drug Delivery 36

Case Study 3 – Fabrication of a Nanocarrier System Through Self-Assembly of Plasma

Protein And Its Tumour Targeting 39

Case Study 4 – IBM And The Institute of Bioengineering And Nanotechnology Find

Breakthrough For MRSA 39

CHAPTER 3 – RISK & REGULATION 43THREE KEY BARRIERS TO THE ADOPTION OF NANOTECHNOLOGY IN MEDICINE AND

BIOMEDICINE 43

Nanotoxicity Nanopollution and Nanosafety 43

Ethical Considerations Of Nanotherapies 45

Delayed Nanoregulation 46

FIVE CURRENT & FUTURE CHALLENGES IN THE ADOPTION OF NANOTECHNOLOGY IN

MEDICINE AND BIOMEDICINE 48

Current & Future Challenges of Nanosafety And Risk Management 48

Current & Future Challenges of Nanoregulation 51

Current & Future Challenges for the Nanomedicine Industry 53

Current & Future Challenges of Sustained Innovation 54

Current & Future Challenges of Cooperation 54

CHAPTER 4 – MARKET FOR NANOCARRIERS 57GLOBAL MARKET ANALYSIS: 2000-2010 (WITHOUT SEGMENTATION) 57

GLOBAL MARKET FORECAST: 2011-2021 (WITHOUT SEGMENTATION) 60

DISCUSSION OF NANOPARTICLES & NANOCARRIERS 63

Overview of The Key Nanotechnologies Used in Drug Delivery Sorted by Applications 63

Nanopharmaceuticals 63

Nanotechnology In Drug Delivery 63

Nanobiotechnology In Drug Delivery 64

Analytical Techniques For Nanoparticle Drug Delivery 65

Properties 65

Production of Nanoparticles 65

Measuring Dispersion of Nanoparticles 66

Characterisation of Carrier Systems 67

Nanocarriers 68

Classification of Nanocarriers 68

Multifunctional Nanocarriers - Drug Delivery And Medical / Biomedical Diagnostics 69

Nanocarriers as Drug Carriers 69

What Can Nanoparticles do in Drug Delivery? 69

Polymer-Based Nanocarriers (Polymeric Nanoparticles) 73

Lipid-Based Nanocarriers 75

Organic Nanocarriers 78

Inorganic Nanocarriers 78

Disadvantages Associated With Nanocarriers 79

The Most Relevant Technologies in The Key Area of Nanotechnology in Drug Delivery 80

Stage of Development of Key Nanotechnologies Used in Drug Delivery 80

Clinically Approved Nanocarrier-Based Drug Formulations With Presence on The Market

The First Nanoparticle Drug Delivery System Reaches The Market 81

Present And Future Applications 84

TECHNOLOGY ADOPTION ROADMAP 86

Projected Product Pipeline For Nanocarrier-Based Drug Formulations In Drug Delivery

Market 86

Available Applications Of Nanoparticles In Drug Delivery 87

Semapimod® (cytokine, pharmasciences) 89

Paxceed™ 89

Theralux™ 90

Nucryst® 90

iSPERSE™ 91

ANALYSIS OF TAM FOR NANOCARRIERS: 2000-2010 93

TAM FORECAST FOR NANOCARRIERS: 2011-2021 99

APPENDIX 108

PUBLISHING ACTIVITY BY ORGANIZATION (2000-2010) 108

To order this report:Drug Delivery Technology Industry: Nanotechnology for Drug Delivery : Global Market for Nanocarriers

More Market Research Report

Check our Industry Analysis and Insights

Nicolas Bombourg
Reportlinker
Email: nbo@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626

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Arrowhead Reports Fiscal 2012 First Quarter Financial Results

§ February 13th, 2012 § Filed under Nano Medicine Comments Off on Arrowhead Reports Fiscal 2012 First Quarter Financial Results

PASADENA, Calif.--(BUSINESS WIRE)--

Arrowhead Research Corporation (NASDAQ: ARWR - News), a nanomedicine company with development programs in oncology and obesity, today announced financial results for its fiscal 2012 first quarter ended December 31, 2011.

“The first quarter of fiscal 2012 saw transformational change for Arrowhead,” said Dr. Christopher Anzalone, President and Chief Executive Officer. “With the acquisition of the Roche’s RNAi assets and facility, we now have a more complete set of capabilities to advance our own RNAi therapeutic pipeline products and are positioned as a more attractive partner to larger companies interested in this area. We have also made important progress on our obesity program which has been cleared by the FDA to initiate human clinical trials.”

Fiscal 2012 First Quarter and Recent Company Highlights

Pipeline Highlights Acquired Roche’s RNAi assets including Dynamic Polyconjugate (DPC) delivery technology, select licenses and state-of-the-art research facility; Published a white paper on the effectiveness and safety of Dynamic Polyconjugates™, one of the technologies acquired from Roche; Reported results using Adipotide™ that demonstrated substantial weight loss and reduction in body mass index and abdominal circumference in obese rhesus monkeys in the prominent peer-reviewed journal, Science Translational Medicine; Received FDA clearance to initiate an Adipotide Phase I clinical trial; Executed a collaboration and joint licensing agreement with Alnylam, a leading RNAi therapeutics company, which allows Arrowhead to develop a DPC-enabled RNAi therapeutic candidate targeting hepatitis B virus (HBV) and allows Alnylam to utilize DPC delivery technology for one RNAi therapeutic product. Financial Highlights Received $1.5 million from the issuance of Common Stock and a further $0.5 million from the sale of an investment; Recorded an additional $3.9 million in subscriptions receivable from announced financings over the next several months; Established an equity line of credit with Lincoln Park Capital to provide financing of up to $15 million that may be drawn down over three years, as needed; Implemented a 1-for-10 reverse stock split to decrease the number of common shares outstanding and regain compliance with Nasdaq continued listing standards. Company Appointments Bruce Given, M.D., as Chief Operating Officer; Brendan P. Rae, Ph.D., J.D., as Chief Business Officer; David Lewis, Ph.D., as Vice President of Biology; David Rozema, Ph.D., as Vice President of Chemistry; Michael S. Perry, DVM, Ph.D. to Board of Directors.

Selected Fiscal 2012 First Quarter Financial Results

Due to the added costs associated with the research facility we acquired from Roche and its people and research programs, operating expenses increased significantly during the quarter ended December 31, 2011. The Company anticipates these costs will increase throughout fiscal 2012 as research and development efforts are accelerated.

For the quarter ended December 31, 2011, Arrowhead reported revenues of $23,958, compared to revenue of $296,139 in the quarter ended December 31, 2010. Total operating expenses for the quarter ended December 31, 2011 were $4.1 million, compared to $3.6 million during the quarter ended December 31, 2010.

Net loss attributable to Arrowhead for the quarter ended December 31, 2011 was $2.5 million, or $0.25 per share based on 10,121,069 weighted average shares outstanding. This compares with a net loss attributable to Arrowhead of $1.4 million, or $0.20 per share based on 7,177,941 weighted average shares outstanding, for the quarter ended December 31, 2010.

The Company's net cash used in operations for the quarter ended December 31, 2011 was $2.7 million, compared with $0.9 million for the quarter ended December 31, 2010. Cash provided by investing activities was $0.5 million, primarily due to cash received from the sale of investments. Cash provided by financing activities was $1.4 million, primarily due to the issuance of Arrowhead common stock. As of December 31, 2011, Arrowhead had cash and cash equivalents of $6.8 million and stockholders' equity of $15.7 million. Arrowhead expects to collect an additional $3.9 million in subscriptions receivable from announced financings over the next several months.

Conference Call

Management will host a conference call today, Thursday, February 9, 2012 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). To participate in the conference call, please dial 877-317-6789 (toll free from the US and Canada), or 412-317-6789 (for international callers). Investors may also access a live audio webcast of this conference call on the Company's website at http://www.arrowheadresearch.com.

A replay of the webcast will be available approximately two hours after the conclusion of the call. The webcast archive will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be made available until Thursday, February 16, 2012. The audio replay can be accessed by dialing 877-344-7529 (toll free from the US and Canada), or 412-317-0088 (for international callers) and entering Event ID 10009858.

About Arrowhead Research Corporation

Arrowhead Research Corporation is a clinical stage nanomedicine company developing innovative therapies at the interface of biology and nanoengineering. Arrowhead’s world-class capabilities and intellectual property covering nucleic acid delivery, siRNA chemistry, and tissue targeting allow it to design and develop therapeutic agents for a wide range of diseases. The company’s lead products include CALAA-01, an oncology drug candidate based on the gene silencing RNA interference (RNAi) mechanism, and AdipotideTM, an anti-obesity peptide that targets and kills the blood vessels that feed white adipose tissue. Arrowhead is leveraging its proprietary Dynamic PolyConjugateTM (DPC), Liposomal Nanoparticle (LNP), and RONDELTM delivery platforms to support its own pipeline of preclinical and clinical candidates and to secure external partnerships and collaborations with biotech and pharmaceutical companies. For more information, please visit http://www.arrowheadresearch.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Arrowhead Research Corporation's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

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NanoMEDICINE and human upper limit – Video

§ February 8th, 2012 § Filed under Nano Medicine Comments Off on NanoMEDICINE and human upper limit – Video

02-11-2011 04:30

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A tool to track the intracellular trafficking of nanomedicines – Video

§ February 7th, 2012 § Filed under Nano Medicine Comments Off on A tool to track the intracellular trafficking of nanomedicines – Video

17-11-2011 10:03 Example of dual-color live-cell acquisition of a human RPE cell, expressing EGFP-flotillin-2 (green), 4.5 hours after exposure to DNA-polyplexes (red). The movie takes 10 minutes and is acquired at a frame rate of 2 fps, which is speeded up here fivefold to 10 fps. The field of view is 40 by 19.5 µm. Read more: http://www.nanowerk.com

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Nanomedicine Panel BioEurope 2011 – expiration of patents – Video

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15-12-2011 06:47 Nanomedicine: The Path to Personalized Medicine? What about patent and generic aspect of nanomedicine?

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Bertrand Loubaton – Contribution of Nanomedicine to the global societal challenges – Video

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05-12-2011 08:59 Bertrand, Loubaton, Contribution, Nanomedicine, global, societal, challenges, GE, Healthcare, etpn,

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Nanomedicine Panel BioEurope 2011 – Introduction by Laurent Levy – Video

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13-12-2011 08:52 Nanomedicine: The Path to Personalized Medicine?

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Dan Peer – New therapeutic paradigm based on nanodrugs – Video

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13-01-2012 03:39 A presentation from Dan Peer at the Nanomedicine Day 2011 in Paris.

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Warren Chan – Nanomedicine (part 1) – Video

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18-01-2012 03:18 A presentation from Warren Chan during Nanomedicine Day 2011 in Paris.

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Warren Chan – Nanomedicine (part 2) – Video

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19-01-2012 03:25 A presentation from Warren Chan during Nanomedicine Day 2011 in Paris.

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Andalusian Centre for Nanomedicine and Biotechnology, BIONAND – Video

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25-01-2012 12:00 The Andalusian Centre for Nanomedicine and Biotechnology, BIONAND, is a mixed centre with stakes held by the Regional Ministry of Innovation, Science and Enterprise, the Regional Ministry of Health and the University of Malaga with the purpose to promote and encourage the development of an andalusian centre for excellence research in Nanomedicine.

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Funding for Personalized Medicine Research

§ February 5th, 2012 § Filed under Nano Medicine Comments Off on Funding for Personalized Medicine Research

The Cancer Stem Cell Consortium (CSCC) is a partner in the 2012 Large-Scale Applied Research Project Competition of Genome Canada, in collaboration with the first phase of the Personalized Medicine Signature Initiative of the Canadian Institutes of Health Research (CIHR). Genome Canada is leading the research competition. An excerpt from Fact Sheet: The Potential of Personalized Medicine:

Funding of $67.5M will come from Genome Canada ($40 million), CIHR ($22.5 million) and the Cancer Stem Cell Consortium ($5 million). Projects will be funded for a maximum of four years. To qualify for funding, researchers must obtain matching funding that at is least equal to that provided through the competition, which will bring the total investment in this research area to close to $140 million. Matching funding is typically derived from provincial, academic, private sector or international sources.

Details about the competition are available here.

Press releases, dated January 31, 2012, about the federal government's support for personalized medicine, are available here and here.

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PRWEB: Absorption Systems Expands In Vivo Drug and Medical Device Testing Capabilities

§ February 5th, 2012 § Filed under Nano Medicine Comments Off on PRWEB: Absorption Systems Expands In Vivo Drug and Medical Device Testing Capabilities

Preclinical contract research organization renovates facility, adding state-of-the-art technology and upgrading ocular testing services.
Exton, PA (PRWEB) January 31, 2012
Absorption Systems announces the latest in a series of milestones in the continuing expansion of its AAALAC-accredited and GLP-compliant facility in San Diego, CA. The facility is undergoing extensive renovations to upgrade and expand the company’s in vivo testing capabilities for drugs and medical devices, including the construction of a dedicated ocular testing laboratory with state-of-the-art equipment, including a Heidelberg Spectralis® optical coherence tomography (OCT) unit. This instrument produces detailed digital images of the retina, enabling precise monitoring of the efficacy and toxicity of drugs and medical devices. Absorption Systems’ San Diego facility, in the midst of a major expansion of staff, equipment, and capabilities in the specialized area of preclinical ocular drug and device testing, continues to see significant growth year-over-year early in 2012.
Glenwood Gum, M.S., Ph.D., who joined Absorption Systems in 2011 as Associate Director, Preclinical Studies, commented, “This OCT technology gives a huge boost to our ocular testing capabilities, which will immediately benefit our rapidly expanding client base.” Dr. Gum is an expert in preclinical ocular studies, having developed or co-developed many of the preclinical models of glaucoma, age-related macular degeneration (AMD), retinoblastoma, uveitis, and diabetic retinopathy that are used all over the world for drug testing. His expertise, along with dedicated staff and the addition of state-of-the-art equipment and facilities, are key to Absorption Systems’ strategy to aggressively pursue new business opportunities in the preclinical ocular testing arena.
Dr. Gum will be a featured speaker on Preclinical Glaucoma and CNV Models at the 4th Ocular Diseases and Drug Discovery conference in Las Vegas, NV February 27-28, 2012.
Patrick Dentinger, President and CEO of Absorption Systems, said, “For Absorption Systems, being a market leader in whatever endeavor we pursue is a cornerstone of our business philosophy. This requires scientific expertise, state-of-the-art equipment and facilities, and access to emerging technologies. These factors, combined with Absorption Systems’ customer-centric approach, make our commitment to being a top-tier ocular service provider a reality in 2012.”
Absorption Systems’ preclinical ocular test portfolio includes in vivo ocular pharmacokinetics, efficacy, and safety in multiple species, as well as in vitro ocular permeability and metabolism. For example, the human corneal orb is a unique in vitro permeability model available as a service platform only through Absorption Systems. The corneal orb, cultured from human pluripotent stem cells, was developed by Lifeline Cell Technology, Inc., a wholly-owned subsidiary of International Stem Cell Corporation, and has been validated by Absorption Systems as an in vitro corneal permeability test system.
About Absorption Systems
Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies® platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment. Absorption Systems has facilities near Philadelphia, PA, and San Diego, CA, and serves customers throughout the world. For information on the company's comprehensive contract services and applied research programs, please visit http://www.absorption.com.



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Nanomedicine Panel BioEurope 2011 – clinical development – Video

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13-12-2011 10:03 Nanomedicine: The Path to Personalized Medicine? Is the development of a nanoparticle different from a classic drug?

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Nanomedicine – YouTube.flv – Video

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04-01-2012 19:10 A brief lecture about nanomedicine

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IdeasLab: Breakthroughs in Nanomedicine – Sonia Trigueros – Video

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20-12-2011 08:29 http://www.weforum.org Get sick every time you fly?

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Nanomedicine Panel BioEurope 2011 – importance of safety in nanomedicine – Video

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15-12-2011 05:00 Nanomedicine: The Path to Personalized Medicine? What importance do you lend to the aspect of safety in developing nanomedicine?

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Nanomedicine Panel BioEurope 2011 – choice to work in nanomedicine – Video

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13-12-2011 09:20 Nanomedicine: The Path to Personalized Medicine?

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Nanomedicine Panel BioEurope 2011 – communicate with regulatory agencies – Video

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15-12-2011 05:32 Nanomedicine: The Path to Personalized Medicine? How do you deal with regulatory agencies concerning nano?

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2011 EMA Committee for Advanced Therapies (CAT) classification record. What can be learned?

§ January 1st, 2012 § Filed under Nano Medicine Comments Off on 2011 EMA Committee for Advanced Therapies (CAT) classification record. What can be learned?

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What follows is the record of "classifications" done by the ATMP CAT in 2011 related to anything I would call "cell therapies". 


In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.


I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date.  I'll post an update here when I have something useful.
______


In January, the following product was classified as a tissue engineered product - not combined:

  • Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions



In April, the following product was classified as a tissue engineered product, combined: 

  • Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology



In May, the following product was classified as a somatic cell therapy medicinal product: 

  • Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis



In July, the following product was classified as a Tissue Engineered Product, non-combined:

  • Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures. 



In September, the following product was classified as a Tissue Engineered Product, non-combined:

  • Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy

     and the following product was not classified as an ATMP: 

  • Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)



In October, the following product was classified as a somatic cell therapy medicinal product: 

  • Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma



In November, the following products were classified as tissue-engineered products:

  • Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
  • CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI



In December, the following product was classified as somatic cell therapy medicinal product:

  • Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.
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