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Newsletter January 2012

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News: HSCI Receives Approval To Market Neovasculgen – The First Russian Gene Therapy Drug For Treatment Of Peripheral Arterial Disease
The Human Stem Cells Institute (“HSCI”, MICEX: ISKJ), Russia’s biotech company, announced today that it has received state approval for Neovasculgen® – the first Russian gene therapy drug to treat Peripheral Arterial Disease. The approval was received by HSCI on December 7, 2011, with the decision by the Russian Ministry of Healthcare and Social Development to include Neovasculgen® in the State Registry of Medications dating back to September 28, 2011. The decision was based on findings on the drug’s efficacy and safety reached during the pre-clinical and clinical trials carried out by HSCI. The Phase IIB/III clinical trials for Neovasculgen® were completed in Q2 2011, and in July HSCI submitted the relevant documentation to the Ministry for approval.
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Poll: The development of which type of adenoviral vector for (solid) cancer gene therapy treatments is most promising and should be supported?
Gene Therapy Net started a new poll regarding the development of adenoviral vectors for cancer gene therapy. What do you think? Vote now!
1- Suicide gene therapy adenoviral vectors expressing HSV-TK, or
2- Tumor specific replication competent adenoviral vectors (like CrAd), or
3- Immuno stimulating adenoviral vectors (like GM-CSF expressing), or
4- Tumor antigen expressing adenoviral vectors (like Mart-1 for melanoma)

Vote now...

Conference

Phacilitate's Cell & Gene Therapy Forum 2012, January 30 - February 1,
The Grand Hyatt, Washington, DC, USA.

Just 2 weeks to go - register here 

Dear subscriber,

It’s been a mixed year to say the least for the gene therapy industry.

Major scientific and technological advances, and some very positive preclinical and early-phase clinical data, have been tempered by some disappointing pivotal trial failures. And, with some notable exceptions, the funding environment remains challenging.


Would it be helpful to have the companies and organizations involved with the most important successes and failures in gene therapy in 2011 share with you the motivations behind the key strategic decisions they took? To take home the specific (often painful) lessons these companies learned and use them to inform your own corporate, R&D, regulatory and manufacturing strategies?

 

This is precisely what the Phacilitate Cell & Gene Therapy Forum 2012 promises to deliver.

Over the course of 3 days (January 30 – February 1 in Washington, DC) you can discover how gene therapy companies are pushing the maturation of regulatory, manufacturing, R&D and commercial strategies. Visit the website at www,phacilitate.co.uk/cgt

Limited places remain - register now to guarantee your place. Visit www.phacilitate.co.uk/cgt


Attend and learn from and network with these leading speakers and more

  • Dr James Faulkner, Vice President, CMC & Supply, GlaxoSmithKline Rare Diseases
  • Dr Jörn Aldag, CEO, Amsterdam Molecular Therapeutics (AMT) BV
  • Dr Paula Salmikangas, Vice-Chair, European Medicines Agency Committee for Advanced Therapies (CAT) & Senior Researcher, Finnish Medicines Agency (FIMEA)
  • Richard Murray, PhD, Senior Vice President, Biologics Research, Merck Research Laboratories
  • Alain Rolland, PhD, Executive Vice President, Product Development, Vical
  • Dr Gabor M. Rubanyi, Chief Scientific Officer, Cardium Therapeutics
  • Dr R. Jude Samulski, Director, Gene Therapy Center, University of North Carolina
  • Steven S. Oh, PhD, Team Lead, Device & Combination Product, OCTGT, CBER, US Food & Drug Administration
  • Dr Roger J. Hajjar, Co-founder, Celladon Corporation; Director, Cardiovascular Research Center, Mount Sinai School of Medicine
  • Mitchell H. Finer, PhD, Chief Scientific Officer, bluebird bio
  • Dr Jeffrey M. Ostrove, President & CEO, Ceregene, Inc

View the speakers


Challenges to be discussed include:


- Late-stage gene therapy product candidates: Strategic insights into the ‘do’s and don’ts’ when preparing for and conducting pivotal trials - how to ensure that your pivotal trial is sufficiently highly powered to achieve a clinically meaningful result?

 

- Securing financing: What are the options for gene therapy companies seeking to bridge the translational ‘valley of death’? Assessing appetites moving forward for both dilutive and non-dilutive financing of the gene therapy industry


- Updates from regulators from both sides of the Atlantic on the development of regulatory pathways for gene therapy products - how to move from a positive IND meeting with the regulator to a positive approval situation?

 

- How to optimize preclinical studies and “translational medicine” to inform successful clinical outcomes for gene therapies?

 

- How to successfully advance into the clinic as a gene therapy start-up with limited core competency in key areas, such as regulatory affairs?

 

- How to continue the positive progress made by AAV-vectored therapies in recent times?

 

- The role of devices in gene therapy delivery: How and when to engage? And with whom?

 

- Assessing the commercial opportunities in pursuing rare disease indications with gene therapy


View the online agenda
or download the brochure

 
The online pre-event partnering system, allowing attendees to contact one another and set up meetings in advance, is now live.
Register now to make the most of this easy to use tool

We offer reduced rates for small companies, group bookings, and 1 and 2 day attendance – for more information and all other enquiries please email This email address is being protected from spambots. You need JavaScript enabled to view it. or call +44 (0)20 7067 1867. 

Confirmed sponsors and exhibitors include:

* Accelovance  * Advanced Bioscience Laboratories  * Aptar  * BD Medical - Pharmaceutical Systems  * BioLife Solutions  * BioSpherix  * Boyd Consultants  * CaridianBCT  * CellGenix  * Cellular Technology Limited  * Charter Medical  * DynPort Vaccine Company, LLC, A CSC Company  * ERA Consulting Group  * Fisher BioServices  * Florida Biologix  * Health Protection Agency  * Invetech Pty Ltd  * LABS, Inc.  * Lonza Walkersville  * Marken  * MaxCyte  * Medicago  * Meridian Life Science  * Miltenyi Biotec  * Novozymes  * Paragon Bioservices  * Pfenex  * Progenitor Cell Therapy  * PwC  * ReGenX Biosciences  * Regional Clinical Research  * Sangamo BioSciences  * Stabilitech  * TAP Biosystems  * Thermo Scientific  * Vibalogics  * Vivalis  * Waisman Biomanufacturing  * WuXi AppTec.

For more information on sponsoring please contact This email address is being protected from spambots. You need JavaScript enabled to view it. on +44 (0)20 7370 8304, or email This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Conferences
- 30 January - 1 February 2012, Phacilitate 8th Annual Cell & Gene Therapy Forum 2012, Washington DC, MD
- 2 -5 February 2012, Up Close and Personalized, International Congress on Personalized Medicine, Florence, Italy
- 9 March 2012, Annual conference of the British Society for Gene Therapy (BSGT), London, UK
- 15 - 17 March 2012, 18th Annual Meeting of the German Society for Gene Therapy (DG-GT), Frankfurt/Main, Germany
- 16 – 19 May 2012, American Society of Gene and Cell Therapy (ASGCT) 15th Annual Meeting, Philadelphia, PA
- 21 – 23 May 2012, 2012 World Gene Therapy Congress Europe, London, UK
- 5 – 8 June 2012, International Society for Cellular Therapy (ISCT) 18th Annual Meeting, Seattle, WA
- 28 – 30 June 2012, The 18th Annual Meeting of the Japan Society of Gene Therapy (JSGT), Kumamoto University, Kumamoto, Japan
- 5 – 6 October 2012, International Society for Cell & Gene Therapy of Cancer - 2012 Singapore Conference, Singapore
- 22 – 24 October 2012, International conference on Genetic Syndromes & Gene Therapy, Chicago
- 26 – 29 October 2012, European Society Of Gene & Cell Therapy (ESGCT) XXth annual meeting and the French Society of Cell and Gene Therapy (SFTCG) collaborative Congress 2012, Versailles, France

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Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines. Other information websites created and maintained by the owner of Gene Therapy Net are Dengue Virus Net, Influenza Virus Net and Chikungunya Virus Net.
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