Novartis breast cancer drug gets FDA fast track, takes on Pfizer, FDA Officials Share Best Practices for Biosimilar Development, Novogen Acquires Glioblast, Licenses GBM Candidate from Genentech, Nanoparticles deliver Gene Therapy that alleviates thalassemia in mice, Ebola Evolved Into Deadlier Enemy During the African Epidemic, and OncoVent Initiates Clinical Development Program for Anti-MUC1 MAb AR20.5 for Treatment of Pancreatic Cancer.

Cell Culture Events

Webinars:

Human Pluripotent Stem Cells (hPSC) – An Overview of Morphology and Culture Methods

November 17, 2016, 11:00AM ET

Speaker: Lia Thornberry Kent, Technical Training & Scientific Support, Biological Industries USA

This webinar will provide a comprehensive overview of human pluripotent stem cell (hPSC) culture methods. Attendees will learn about the cells’ basic culture requirements and how aspects of the culture environment have developed over time, ultimately to defined culture systems widely used in disease research, and clinically-relevant systems amenable to downstream therapeutic applications. A review of various culture environments in use today will provide a high-level overview of the field and a basic understanding of the requirements for maintaining these unique cells.

This webinar is the first in a series of hPSC tips and techniques – Register Now

Presenting a case study that reduces MAb clinical trial development costs by up to 65% using different agarose Protein A chromatography resins

Wednesday 7th December | 14:00 GMT

Conferences:

November

• 2^nd Annual Cell & Gene Therapy Congress – November 3-4, 2016 – London, UK – http://www.celltherapy-congress.com/Over 250 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions.Over 20 presentations and case studies focused on the key issues in cell & Gene Therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing2 interactive streams:Cell & Gene Therapy: Development, Clinical Trials & CommercialisationCell Therapy Bioprocessing and ManufacturingCo-located with the established 5th Annual Cell Culture & Bioprocessing Congress and 3rd Annual Stem Cell CongressFree Pre-Congress WebinarAdvances In Gene Editing Technologies
  Presented by Richard Morgan, Vice President, Immunotherapy at Bluebird Bio. – Register for free today >>
• 5th Annual Cell Culture & Bioprocessing Congress – November 3-4, 2016 – London, UK – http://www.cellculture-congress.com/Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production4 interactive streams:Early Cell Line DevelopmentProcess DevelopmentLate Stage Cell Line DevelopmentBiological Production14 pre-scheduled one to one meetings, exhibition and informal networking opportunitiesCo-located with the 3rd Annual Stem Cell Congress and the 2nd Annual Cell & Gene Therapy Congress

If you are attending, don’t miss the  Reception on Thursday evening.

• TIDES Europe – November 14-17, 2016 – Berlin, Germany – http://get.knect365.com/tides-europe/TIDES Europe is the place where oligo and peptide experts go to meet and build successful partnerships to accelerate products from early discovery through late stage development and commercialisation. In 2015 Tides Europe attracted a 40% increase in attendance across the oligo and peptide audience.
• World Immunotherapy Congress 2016 – November 14-16, 2016 – Basel Switzerland http://bit.ly/1rbnrYy

• World Precision Medicine – November 14-15, 2016 – Washington DC

The World Precision Medicine Congress USA is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as precisionFDA and NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there.

Can you afford to miss this gathering of precision medicine leaders? Pharma, big data, and healthcare providers will be there attending sessions on Gene Therapy, Cell Therapy, personalized medicine, and genomics.

Download the brochure: http://bit.ly/1N3Y0vI

Register to attend: http://bit.ly/1ObpkNV

December

• ASCB – December 3-7, 2016 – San Francisco, CA http://ascb.org/meetings/

• World Stem Cell Summit & RegMed Capital Conference– December 6-9, 2016 – West Palm Beach, Florida http://worldstemcellsummit.com/

• Antibody Engineering and Therapeutics – December 11-15, 2016 – San Diego, CA http://www.ibclifesciences.com/AntibodyEng/overview.xml

• Global Biomanufacturing Summit – December 12-14, 2016 – San Diego, CA http://biomansummit.com/

Headlines:

“Novartis breast cancer drug gets FDA fast track, takes on Pfizer,” Reuters

“The U.S. Food and Drug Administration gave fast-track review status to Novartis’s medication ribociclib in first-line treatment of postmenopausal women with advanced breast cancer as the Swiss company seeks to challenge Pfizer’s Ibrance drug.”

If you like this story, please see our blog titled “Cool Tool – ClinEss® – A tissue preservation and transportation medium provides protection of cells and allows for tissue to be stabilized without fixation”

“FDA Officials Share Best Practices for Biosimilar Development,” Regulatory Focus

“With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs.”

If you like this story, please see our blog titled “Non-Invasive Stem Cell Characterization and Predicting Differentiation using Luminex Assays”

“Novogen Acquires Glioblast, Licenses GBM Candidate from Genentech,” Genetic Engineering News

“Novogen has acquired Glioblast, saying its capabilities will help it develop a Phase II-ready glioblastoma multiforme (GBM) candidate it is licensing from Genentech, a member of the Roche Group.”

If you like this story, please see our blog titled “Boston Biotech Week 2016 – Downstream Coverage – In case you missed it!”

“Nanoparticles deliver Gene Therapy that alleviates thalassemia in mice,” Fierce Biotech

“Researchers led by Yale University have corrected a gene mutation in mice that causes thalassemia, thus alleviating symptoms of the blood disorder. This could lead to a similar Gene Therapy to help humans with the condition.”

If you like this story, please see our blog titled “Gain Productivity in Protein Purification through Column Loading Optimization”

“Ebola Evolved Into Deadlier Enemy During the African Epidemic,” The New York Times

“The Ebola epidemic that tore through West Africa in 2014 claimed 11,310 lives, far more than any previous outbreak. A combination of factors contributed to its savagery, among them a mobile population, crumbling public health systems, official neglect and hazardous burial practices.”

If you like this story, please see our blog titled “Predicting Differentiation and Characterizing Pluripotent Stem Cells Using Non-invasive Multi-analyte Luminex® Assays”

“OncoVent Initiates Clinical Development Program for Anti-MUC1 MAb AR20.5 for Treatment of Pancreatic Cancer,” PR Newswire

“OncoQuest Inc. (“OncoQuest’), a biopharmaceutical company focused on the development and commercialization of immunotherapeutic products for the treatment of cancer, today announced that its Joint Venture Partner in China, OncoVent Co., Ltd. (“OncoVent”) has launched its clinical development program for Anti-MUC1 MAb AR20.5 for the treatment of pancreatic cancer. Based on previous clinical experience and recently announced positive pre-clinical data on combinatory immunotherapy in the pancreatic cancer model, OncoVent has started implementing its clinical development plan, and has signed an agreement with a U.S. based cGMP cell culture bioproduction facility, Cell Culture Company (C3), located in Minneapolis US, to manufacture clinical grade MAb AR20.5. The manufactured antibody is intended to be used to support a planned U.S. clinical trial for the treatment of pancreatic cancer, followed by additional studies worldwide, including China.”

If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”