This week’s biotechnology news headlines include, Takeda joins effort to develop Zika vaccine, BIO launches ad campaign to defend pricing, Fate Therapeutics and MSK to develop off the shelf T-Cell immunotherapies, FDA to review Merck’s Keytruda as first-line treatment for lung cancer, Moderna to seek permission to test Zika vaccine in humans this year, UK launch for Biogen’s biosimilar infliximab, and Selexis SA enters into commercial cell line license agreement with Pieris pharmaceuticals for immuno-oncology bispecific drug candidate.
Cell Culture Events
VISION leadership course is uniquely tailored for the bioindustry to capture the synergies between bioscience, technology and business practice – Keck Graduate Institute, Claremont, CA – September 14-16, 2016
UCL Biochemical Engineering in collaboration with Keck Graduate Institute is announcing its 2016 VISION Leadership Programme. Designed for talented high impact individuals, VISION provides executive leadership insights tailored for present & future leaders in the bioindustries through rigorous intellectual analysis & intensive, practical, peer-to-peer action-based learning giving you the tools required to drive innovation, entrepreneurship & global leadership in your organisation.
KEY BENEFITS AND IMPACT:
- Know how to make the transition from science & engineering based decision making towards company- wide strategic resolutions
- Build an invaluable network with elite peers & experts from academia & industry who challenge, stimulate & inspire you
- Gain perspectives on leadership challenges & critical business issues facing the bioindustry globally & formulate actions to address these
- Learn from real life cases studies to succeed in making difficult decisions & implementing strategies to secure a more robust future for your business
- Access & share best practices on how to be a good leader & avoid pitfalls in constantly evolving market
- Achieve your personal development & career objectives
- Evaluate the impact of key innovative research & technologies on the future of business & manufacturing
CONFIRMED SPEAKERS FOR 2016
Barry Buckland, CEO, BiologicB
Charles Cooney, Professor, MIT
Nigel Darby, former VP, GE Healthcare
Parrish Galliher, CTO, GE Healthcare
Phil Gomez, Principal, PricewaterhouseCoopers
Ljiljana Minwalla, Senior Legal & Patent Counsel, Mesoblast, Inc.
Andrew Ramelmeier, Senior VP, Portola Pharmaceuticals
Rahul Singhvi, COO, Takeda Vaccines
WHO SHOULD ATTEND
- Managers & practitioners fast tracked for executive roles or intending to move into leadership positions
- Current executives intending to interact with fellow leaders & expert speakers to debate & exchange novel thoughts & opinions
- Funding agencies wanting to interact with present & future thought leaders to gain insights into the sector trends & skills required to navigate the changing bioindustry landscape
VISION combines innovative management thinking with cutting edge research to ensure high flyers perform optimally
For more information contact email@example.com and visit www.ucl.ac.uk/biochemeng/visionprogramme
Date: Wednesday, September 21, 2016
Time: 1:00 PM Central Standard Time
As Stem Cell Research moves closer toward therapeutic application, there is a recognized need to increase the quality and consistency of pluripotent stem cells and their derivatives. While variability in the efficiency of stem cell differentiation can undermine data interpretation and slow research progress, the ability to quickly monitor changes in cell phenotype without sacrificing yield continues to be a challenge. In this webinar, Richard Feurstenberg and Joy Aho discuss Luminex technology, its power as a non-invasive tool for monitoring stem cell differentiation, and its utility for troubleshooting and optimizing stem cell culturing and differentiation conditions.
Case Study: FinVector Presents Process Development and Large-Scale GMP Production of Adenovirus in the iCELLis® 500 Fixed-Bed Bioreactor
Date: Thursday, September 22, 2016
Time: 10:00 AM Eastern Daylight Time
FinVector Vision Therapies Oy (Kuopio, Finland), a contract development and manufacturing organization, has developed an iCELLis process for Phase III production of an adenovirus type 5 vector in adherent HEK 293 cells. Process development at bench-scale in the iCELLis Nano bioreactor was transferred to the large-scale iCELLis 500 bioreactor. Several consistent clinical batches have been manufactured. An Investigational New Drug Application for material made in the iCELLis bioreactor was submitted to the US Food and Drug Administration and is now in effect.
This webinar will review the design and operation of the iCELLis bioreactor and present this case study of FinVector’s process development and scale-up.
Register to Learn:
- How an iCELLis bioreactor can replace up to 786 10-layer or 278 36-layer cell culture vessels for large-scale vector production.
- Details of how FinVector developed a large-scale production process using the iCELLis platform.
- How iCELLis bioreactors control pH, DO and temperature for consistent virus production at large-scale.
Date: Thursday, September 22, 2016
Time: 02:30 PM Eastern Daylight Time
Duration: 1 hour, 30 minutes
Exosomes encapsulate and transport a wide variety of molecules generated by their cell-of-origin, a process now thought to be a form of cellular signaling. Exosome signaling is common across cell types and species, but it is of particular interest in diseases with an inflammatory component. While exosome isolation and analysis is useful to understanding the mechanisms behind these multifaceted diseases, exosomes may also be exploited for their therapeutic potential. The Scientist is bringing together a panel of experts to review the current knowledge on exosomes in inflammation, and to explore the potential for exosome-based therapeutics. Attendees will have the opportunity to interact with the experts, ask questions, and seek advice on topics that are related to their research.
Topics to be covered:
- The exosomal cargoes released during inflammation, and their potential as therapeutic targets
- How inflammatory diseases are uniquely suited to exosome analysis
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/
- BioAnalytical and Formulaiton Summit – September 14-15, 2016 – Berlin, Germany https://lifesciences.knect365.com/bioanalyticalandformulation The Bioanalytical & Formulation Summit provides the ultimate opportunity to discuss your current challenges in analytical methods for biologics, with 2 streams dedicated to:
- Protein Characterisation and Post Translational Modifications
- Formulation for Biologics
Join your peers for expert insight, new data, and the latest technology updates for formulation and QC strategies, to inform your methods and improve your product quality and efficacy.
- CAR-TCR Summit – September 13-16, 2016 – Boston, MA – http://car-tcr-summit.com/ If you are attending the CAR-TCR Summit, please stop by Roche Custom Biotech at booth 33 to see their showcased products and capabilities:
- Cedex HiRes automated cell counter
- Cedex Bio and Bio HT nutrient/metabolite analyzers
- MycoTOOL Mycoplasma Real-Time PCR Kit
- GMP Proteases portfolio
- Bioprocessing International Co-Located with Cell Therapy Bioprocessing – October 4-7, 2016 – Boston Convention Center and Exhibition Center – Boston, MA http://www.ibclifesciences.com/BPI/overview.xml
- World Vaccine Congress Europe – October 10-12, 2016 – Barcelona, Spain http://www.terrapinn.com/conference/world-vaccine-congress-europe/index.stm
- Adoptive T-Cell Therapy Summit Europe 2016 – October 10-11, 2016 – London, UK www.tcellsummit.com
- Bioproduction – October 14-15, 2016 – Dublin, Ireland http://www.informa-ls.com/event/bio-production14
- 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 Manufacturing
Free Pre-Congress Webinar
Advances 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 Development
Late Stage Cell Line Development
14 pre-scheduled one to one meetings, exhibition and informal networking opportunities
- 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/
“Japanese drugmaker Takeda Pharmaceutical Co (4502.T) on Thursday said it is developing a vaccine to prevent the Zika virus, which has been linked to severe birth defects, and has secured funding from a U.S. government agency.”
If you like this story, please see our blog titled “Cool Tool – Optimize Stem Cell Differentiation in Less Time by Utilizing a Nano Gradient Surface”
“A top pharmaceutical lobbying group is launching an ad campaign to defend drugmakers that have been under fire for their pricing practices. “We’re under pressure and scrutiny like never before,” said Jim Greenwood, chief executive officer of the Biotechnology Innovation Organization. The campaign, called “Innovation Saves,” says new drugs can save both lives and costs to the health-care system. BIO is spending “low- to mid-seven digits” on the ads, according Greenwood, or about $1 million to $5 million.”
If you like this story, please see our blog titled “Cool Tool –Smart Cell Culture Monitoring, Transform single cell parameters into cell culture intelligence”
“Fate Therapeutics said today it will partner with Memorial Sloan Kettering Cancer Center (MSK) to develop off-the-shelf T-cell product candidates using engineered pluripotent cell lines, under a three-year collaboration whose value was not disclosed.”
If you like this story, please see our blog titled “Cell Therapy for Parkinson’s Disease – An update on the move toward clinical trials”
“The U.S. Food and Drug Administration will review Merck & Co.’s immunotherapy cancer drug Keytruda as a first-line treatment for patients with the most common form of lung cancer, the company said Wednesday.”
If you like this story, please see our blog titled “Ten Years of Induced Pluripotent Stem Cells: A Look Back”
“Cambridge-based Moderna Therapeutics is joining a select few biotechs around the world in the hunt for a vaccine for the Zika virus, thanks to an $8 million award from the federal government.”
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”
“Biogen has launched Flixabi – a biosimilar of Johnson & Johnson’s blockbuster infliximab – across the UK for use in a range of chronic inflammatory conditions. The drug won approval in May this year for adults with Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and psoriasis. It can also be used to treat children and adolescents aged six to 17 years with severe, active paediatric Crohn’s disease or severely active paediatric ulcerative colitis.”
If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”
“Selexis SA Enters into Commercial Cell Line License Agreement with Pieris Pharmaceuticals for Immuno-Oncology Bispecific Drug Candidate,” Pipeline Review
“Selexis SA, a pioneering life sciences company and a global leader in mammalian (suspension-adapted CHO-K1) cell line generation, announced today the signing of a license agreement that provides Pieris Pharmaceuticals with access to Selexis SUREtechnology Platform™ and SURE CHO-M Cell Line™ to advance the development of PRS-343, Pieris’ lead bispecific immuno-oncology drug candidate. PRS-343 is a CD137/HER2 bispecific that is designed to promote CD137 clustering by bridging CD137-positive T cells with HER2-positive tumor cells, thereby providing a potent costimulatory signal to tumor antigen-specific T cells.”
If you like this story, please see our blog titled “Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation”