This week’s biotechnology news headlines include, EMA conditionally approves AbbVie’s leukemia drug, Illumina, Genentech and BIO weigh in on FDA draft guidance for companion diagnostics, FDA grants 23 million to rare disease research, FDA grants accelerated approval to Lilly’s soft tissue sarcoma drug, surgeons use nose cells to repair damaged knee joints, eight medicines win CHMP support, and Vertex and CF Foundation Therapeutics expand R&D collaboration. .
Cell Culture Events
Tuesday, November 1, 2016-Wednesday, November 2, 2016 at 8:00 AM – 5:00 PM EST
Marriott Long Wharf, 96 State St., Boston Massachusetts 02109
Bioprocess Insights Webinars
The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the overall business strategy.
In this webinar series, four renowned subject matter experts will share their insights into four areas of bioprocessing: upstream, vaccines, downstream, and single-use technology. We will present tangible, recently developed data that can help you in developing modern, cost-efficient, and sustainable bioprocesses.
Don’t miss these on demand webinars – http://www.bioprocessintl.com/sponsored-content/bioprocess-insights-webinars/
- 2nd 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
- 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/
“AbbVie Inc won the conditional backing of an advisory committee of the European Medicines Agency (EMA) on Friday for a drug to treat a form of blood cancer. The drug, venclyxto, or venetoclax, is aimed at chronic lymphocytic leukaemia (CLL) patients with a genetic mutation known as 17p gene deletion, a marker for a particularly aggressive form of the disease.”
If you like this story, please see our blog titled “CRISPR Technology Where it Stands and What the Future Holds”
“Illumina, Genentech and BIO Weigh in on FDA Draft Guidance on Companion Diagnostics,” Regulatory Focus
“The six public comments on the US Food and Drug Administration’s (FDA) draft guidance on companion diagnostics were mostly positive, with Genentech calling the draft “crucial for the advancement of personalized medicine,” while Illumina said it was “worth the wait,” though all commenters expressed interest in more clarity from FDA.”
If you like this story, please see our blog titled “Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation”
“The FDA says it has granted $23 million in a siloed fund for industry and academic groups to help bolster early- and later-stage research into a host of rare diseases.”
If you like this story, please see our blog titled “Cool Tool – Cadence Single Pass TFF Provides in-line Concentration, Enables Continuous process”
“The U.S. Food and Drug Administration on Wednesday granted accelerated approval to Eli Lilly and Co’s drug for treating adults with advanced soft tissue sarcoma (STS).”
If you like this story, please see our blog titled “Particulates in Cell Therapy Products – An important issue for commercialization”
“Swiss surgeons successfully used an experimental technique, which includes harvesting cells from the nasal septum, to repair damaged knee joints in patients. Two years later, these patients report improvements in pain and knee function, according to a study published Thursday in the journal The Lancet.”
If you like this story, please see our blog titled “Predicting Differentiation and Characterizing Pluripotent Stem Cells Using Non-invasive Multi-analyte Luminex® Assays”
“Eight medicines have taken a big leap towards being approved in Europe having won the support of the European Medicines Agency’s Committee for Medicinal Products for Human Use.”
If you like this story, please see our blog titled “Reduce Cell Line Development Time by 30% and Simplify Proof of Clonality – A Case Study”
“Vertex says it has updated an R&D collaboration with Cystic Fibrosis Foundation Therapeutics (CFFT) stretching back more than a decade. Under the updated Research, Development and Commercialization Agreement, disclosed in a regulatory filing yesterday, CFFT—the Foundation’s nonprofit drug discovery and development affiliate—agreed to pay Vertex $75 million upfront, as well as up to $6 million annually toward development funding.”
If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”