ROCKVILLE, Md.--(BUSINESS WIRE)-- Advanced BioScience Laboratories, Inc. (ABL) will perform process development and cGMP manufacturing of recombinant scuPA, an enzyme therapy candidate for patients with pleural loculation or scarring surrounding the lung. scuPA reverses a defect in clot clearance that characterizes pleural loculation. The program is led by Dr. Steven Idell of The University of Texas Health Science Center at Tyler. ABL will develop the production cell line and manufacturing process followed by scale-up and manufacture of toxicology and cGMP clinical materials. The materials produced at ABL will be used to support an IND, and will be used in clinical trial testing. This project is being funded in whole with federal support from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) in the Department of Health and Human Services (DHHS), under the Science Moving TowArds Research Translation and Therapy (SMARTT) program (Contract No. HHSN268201100014C). ABL is the biologics production facility for the five-year SMARTT program. The program is designed to fill product development gaps to propel clinic-ready products. SMARTT consists of the biologics production facility at ABL, a production facility for non-biologics and small molecules, a pharmacology/toxicology center, and a coordinating center. … Continue reading →

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research. New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models. "The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies." Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies. Key challenges to market development relate to reimbursement, ethics and … Continue reading →

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research. New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models. "The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies." Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies. Key challenges to market development relate to reimbursement, ethics and … Continue reading →

13 June 2012 Last updated at 08:31 ET Japanese stem cell scientist Dr Shinya Yamanaka has been awarded the Millennium Technology Prize. His award is for discovering how to reprogram human cells to mimic embryonic stem cells, which can become any cell in the body. Called induced pluripotent stem (iPS) cells, these now aid research into regenerative medicine. He was joint-winner with Linus Torvalds, who created a new open source operating system for computers. This is the first time the prize has been shared by two scientists - they will split the 1.2m euros ($1.3m; 800,000) award. My goals over the decade include to develop new drugs to treat intractable diseases by using iPS cell technology and to conduct clinical trials using it on a few patients with Parkinson's diseases, diabetes or blood diseases. The President of the Republic of Finland, Sauli Niinisto, presented the prize at the Finnish National Opera in Helsinki. Dr Ainomija Haarla, President of Technology Academy Finland - the foundation which awards the prize every two years - said: "The International Selection Committee has to judge whether an innovation has had a favourable impact on people's lives and assess its potential for further development to benefit … Continue reading →

Public release date: 12-Jun-2012 [ | E-mail | Share ] Contact: Steve Yozwiak syozwiak@tgen.org 602-343-8704 The Translational Genomics Research Institute SCOTTSDALE, Ariz. June 12, 2012 Vismodegib, a new skin cancer drug for patients with advanced basal cell carcinoma tested by TGen, Virginia G. Piper Cancer Center at Scottsdale Healthcare and Mayo Clinic, is hailed as "the greatest advance in therapy yet seen" for advanced basal cell carcinoma in an editorial in the New England Journal of Medicine. Vismodegib (marketed under the name Erivedge) was administered for the first time in the world on Jan. 23, 2007 in a Phase I clinical trial at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with the Translational Genomics Research Institute (TGen). This is the first drug tested under the Scottsdale Healthcare-TGen partnership to receive FDA approval, and is the first to receive FDA approval to treat inoperable basal cell carcinoma. Successful early trial results led to additional study sponsored by Genentech. The successful Phase I study at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, headed by Scottsdale Healthcare Chief Scientific Officer and TGen Physician-In-Chief Daniel Von Hoff, M.D, led to a broader study, published June 7 … Continue reading →

Public release date: 12-Jun-2012 [ | E-mail | Share ] Contact: Steve Yozwiak syozwiak@tgen.org 602-343-8704 The Translational Genomics Research Institute SCOTTSDALE, Ariz. June 12, 2012 Vismodegib, a new skin cancer drug for patients with advanced basal cell carcinoma tested by TGen, Virginia G. Piper Cancer Center at Scottsdale Healthcare and Mayo Clinic, is hailed as "the greatest advance in therapy yet seen" for advanced basal cell carcinoma in an editorial in the New England Journal of Medicine. Vismodegib (marketed under the name Erivedge) was administered for the first time in the world on Jan. 23, 2007 in a Phase I clinical trial at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with the Translational Genomics Research Institute (TGen). This is the first drug tested under the Scottsdale Healthcare-TGen partnership to receive FDA approval, and is the first to receive FDA approval to treat inoperable basal cell carcinoma. Successful early trial results led to additional study sponsored by Genentech. The successful Phase I study at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, headed by Scottsdale Healthcare Chief Scientific Officer and TGen Physician-In-Chief Daniel Von Hoff, M.D, led to a broader study, published June 7 … Continue reading →