This week’s headlines include, drug prices and value, immune therapy for cancer, CIRM gives more stem cell awards, Amgen to persue T-Vec approval, Repligen to buy Refine Technologies, improve genome editing, and FDA believes drugs can reach patients faster and cheaper.
Annual Meeting of the International Society for Stem Cell Research – June 18-21, 2014, -Vancouver, Canada
CellCulture Dish will be blogging from this event with daily updates. If you are attending, don’t miss:
Reprogramming somatic cells using Sendai virus technology
Laurence Daheron, Harvard Stem Cell Institute
Thursday, June 19th 11:30 am – 12:00 pm
STEMCELL Technologies, Booth #817
An Integrated Workflow for the Isolation, Expansion, and Characterization of Hematopoietic Progenitors and their Conversion to Induced Pluripotent Stem Cells in Defined Culture Conditions
Wing Chang, PhD, Scientist
Steve Szilvassy, PhD, Director, Hematopoietic Products
Thursday, June 19th, 8-8:30am
Hematopoietic stem and progenitor cells are undoubtedly the most well studied tissue-specific precursor cells and now are commonly used for generating iPSCs. This presentation will describe the isolation, expansion, and characterization of human blood-derived CD34+ progenitors and erythroid cells, and methods for subsequent reprogramming of these cells to iPSCs using defined culture conditions. The tutorial will highlight STEMCELL Technologies integrated workflow for manipulating hematopoietic development in vitro and the generation of iPSCs from these precursors.
Efficient cell specific differentiation systems for iPSC
Mohan Vemuri, Ph.D., R&D Leader (Cell Biology)
Wednesday, June 18th, 8:45 am – 9:30 am
Life Sciences Solutions Group, Thermo Fisher Scientific
Single-Use Applications for Biophamaceutical Manufacturing – June 09-10, 2014 · Boston Park Plaza Hotel · Boston, MA
Antibody Drug Conjugates 2014 – June 17 – 19 2014, Hotel Fira Palace, Barcelona, Spain
At Informa’s Life Sciences Antibody Drug Conjugateswe’ll be providing scientific-led case studies from over 25 of the leading ADC companies including Genentech, Pfizer, Immunogen, Roche, Takeda, Genmab, Spirogen and more. Discover more about the latest clinical studies from the leading pharmaceutical companies and benefit from:
– Essential data on how to best assess and enhance ADC mode of action
– Establish reliable and reproducible ADC preclinical models
– Seamlessly translate ADCs into the clinic through critical data analysis
Simply quoteCQ3515CCD when booking your place.
Recombinant & Bispecific Antibodies 2014 – June 17 – 19 2014, Hotel Fira Palace, Barcelona, Spain
At Recombinant & Bispecific Antibodies event 2014 we’ll be exploring the latest developments and cutting edge technologies in engineered antibodies, including the latest advances in antibody fragments, antibody domains, ADCs and nanobodies with case studies from Affirmed Therapeutics, National Institute of Health and Cresendo Biologics.
The Recombinant & Bispecific Antibodies conference is part of the Empowered Antibodies Congress, collocated with Antibody Drug Conjugates. Join us to hear preclinical and clinical updates, advances in immunology and expert guidance on how to get your product into the clinic.
Simply quoteCQ3514CCD when booking your place.
BIO International Convention – June 23-26, 2014 – San Diego, CA
Informa Life Sciences’ 7th Annual Viral Safety for Biologicals 2014– June 24-25, 2014 – Pullman Hotel, Cologne, Germany
Informa Life Sciences’ 7th Annual Viral Safety for Biologicals 2014 conference will provide you with the latest technological developments and practical strategies to screen and detect new adventitious agents, optimise viral clearance and implement upstream and downstream viral risk mitigation measures to manage and prevent potential contaminations as quickly as possible.
Informa Life Sciences’ 3rd Annual Biopharmaceutical Raw Materials 2014 – June 24-25, 2014 – Hotel Pullman Cologne, Cologne, Germany
Effective raw materials and supply chain quality management is crucial to ensure appropriate material quality and to enhance the safety and consistency of a pharmaceutical product. Informa Life Sciences’ 3rd Annual Biopharmaceutical Raw Materials is Europe’s only dedicated conference focused on optimising raw material and supply chain quality, with 10+ industry experts and first-hand regulatory advice from Paul-Ehrlich-Institut.
“A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, the nation’s chief drug regulator said today. The program, approved in 2012, can cut the time needed for approval by years, a gain for companies that may be reflected in pricing, said Food and Drug Administration Commissioner Margaret Hamburg. The agency is also trying to work more in parallel with the Centers for Medicare and Medicaid early in the approval process to help companies better understand issues surrounding the value of their potential products.”
If you like this story, please see our blog titled “CHO Cell Culture – Ten Tips from the Experts on Expression, Media and Bioprocessing”
“The annual meeting of the American Society of Clinical Oncology is the venue where the pharmaceutical industry showcases its new drugs for cancer. For the last several years, these have been highly-anticipated events where stunning progress has been reported in treating a disease against which President Nixon declared war back in 1971. And each year’s crop of wonder drugs makes it look as if we are at last making decisive progress against the enemy. Indeed, it is no longer unusual to hear about therapies that provide years of survival.”
If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”
“Transfection is commonly used to deliver all manner of nucleic acids into cells—everything from simple reporter vectors to inhibitory RNAs. Most recently, transfection has been used to alter cells’ endogenous nucleic acids via gene editing for applications such as gene repair and the creation of disease models. However, gene-delivery difficulties have been hindering the use of these new tools in relevant cellular models such as stem cells and primary cells.”
If you like this story, please see our blog titled “Improving the Efficiency and Performance of your Transfection”
“Back in April, Amgen’s ($AMGN) cancer-fighting viral vaccine stumbled in Phase III, missing on overall survival (OS), a secondary endpoint. But that won’t stop the California company from seeking regulatory approval, it announced early this week.”
If you like this story, please see our blog titled “Highlights from the 14th World Vaccine Congress – A Cell Culture Perspective”
“Repligen, a Waltham biotech firm that’s seen fast growth since deciding to focus on products used to make biologic drugs, has acquired a 17-employee New Jersey company for cash and stock worth $24.5 million. The company announced today that it will pay $20.5 million in cash plus 215,000 shares of stock to Refine Technology, a company that makes a device to significantly increase the product yield during the fermentation step of the biologic drug manufacturing process. Repligen may also pay up to $8.75 million in revenue-based milestones through the year 2016, and royalties of up to $2.15 million for above-target sales during the same period.”
If you like this story, please see our blog titled “Aastrom CEO Discusses How Recent Acquisition Strengthens Current Manufacturing Capability and Clinical Pipeline”
“A new class of medicines that help the body’s own immune cells fight tumors could target a wide set of cancers, opening a $35 billion market for Merck (MRK:US) & Co., Bristol-Myers Squibb Co., AstraZeneca Plc and Roche (ROG) Holding AG. The drugmakers will use the world’s largest meeting of cancer doctors, the American Society of Clinical Oncology, to stake their claim on the new technology, which aims to interrupt cancer’s ability to switch off immune system cells that might otherwise attack it.”
If you like this story, please see our blog titled “10 Things You Should Know About Dry Shippers Before Shipping High Value Biologics”
“HIV, Spinal Cord Treatments Win $20 Million in Stem Cell Agency Awards,” San Francisco Business Times
“Experimental HIV and spinal cord injury treatments under commercial development by two Bay Area companies won a combined $20 million in funding from California’s Stem Cell Research funding agency Thursday.”
If you like this story, please see our blog titled “Key Tools and Technology Hurdles in Advancing Stem-Cell Therapies – Part I”