This week’s headlines include, Scientists work with DNA, FDA’s latest biosimilars guidance, FDA updates, Astra Zeneca products new data, stem cell trial for stroke shows lasting benefits, brodalumab meets goals in Phase 3, and research to make drugs more efficient.
Cell Culture Events
Annual Meeting of the International Society for Stem Cell Research – June 18-21, 2014, -Vancouver, Canada
Cell Culture Dish will be blogging from this event with daily updates. If you are attending, don’t miss:
Induction of a Native State in Human Pluripotent Stem Cells
Huck-Hui Ng, PhD, Executive Director, Genome Institute of Singapore
Thursday, June 19, 11:30am-12pm
In contrast to traditional hPSC cultures, native or naïve hPSCs are more primitive, resembling cells of the pre-implantation blastocyst. Beyond their importance for studying early development, naïve cells may accelerate pluripotent cell therapies, owing to their single-cell passaging compatibility, robust growth and amenability to genetic manipulation. Dr. Ng will discuss his ground-breaking research on induction and maintenance of a novel state in established human embryonic stem cell lines using mTeSR™1 medium and small molecules.
World Stem Cells Regenerative Medicine Conference – May 20-22, 2014 – London, UK
Bioconjugates: From Targets to Therapeutics –June 04-06, 2014 · Grand Hyatt Hotel · San Francisco, CA
IBC Life Sciences’ Bioconjugates: From Targets to Therapeutics is taking place June 4-8, 2014 at the Grand Hyatt Hotel in San Francisco, CA. Increase your market share with the latest conjugation design and manufacturing science. This event brings together protein engineers with medicinal chemists in an interdisciplinary forum to foster innovation. Download a copy of the brochure today to see what this year’s event has to offer.
Next Generation Protein Therapeutics Summit –June 04-06, 2014 · Grand Hyatt Hotel · San Francisco, CA
IBC Life Sciences’ Next Generation Protein Therapeutics Summit is taking place June 4-8, 2014 at the Grand Hyatt Hotel in San Francisco, CA. Cross-fertilize ideas from multiple disciplines and turn promising new molecules into differentiated products. This event attracts world-renowned academics and industry visionaries to share ideas, clinical updates, and best practices. Download a copy of the brochure today to see what this year’s event has to offer.
Protein Aggregation, Oligomerization, Stability & Solubility –June 04-06, 2014 · Grand Hyatt Hotel · San Francisco, CA
IBC Life Sciences’ Protein Aggregation, Stability & Solubility is taking place June 4-8, 2014 at the Grand Hyatt Hotel in San Francisco, CA. Reduce protein degradation and safeguard your product’s efficacy with this new scientific meeting dedicated to minimizing protein aggregation from discovery through bioprocessing. Download a copy of the brochure today to see what this year’s event has to offer.
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.
“Drug companies are researching ways to boost the power of existing drugs—a path to better medicine at a time when inventing new drugs is increasingly difficult. If medicine can stay active in the body longer, patients can take lower doses, saving money and potentially reducing side effects. They also may be able to take a drug less frequently, which could have particular benefits for therapies that require injections.”
If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”
“Scientists reported Wednesday that they had taken a significant step toward altering the fundamental alphabet of life — creating an organism with an expanded artificial genetic code in its DNA. The accomplishment might eventually lead to organisms that can make medicines or industrial products that cells with only the natural genetic code cannot. The scientists behind the work at the Scripps Research Institute have already formed a company to try to use the technique to develop new antibiotics, vaccines and other products, though a lot more work needs to be done before this is practical.”
If you like this story, please see our blog titled “10 Things You Should Know About Dry Shippers Before Shipping High Value Biologics”
“AstraZeneca, fighting a $106 billion bid approach from Pfizer, received a fillip on Monday as four experimental drugs for rheumatoid arthritis, lupus and asthma showed promising results in mid-stage clinical trials. Mavrilimumab produced a rapid improvement in signs and symptoms of rheumatoid arthritis, while sifalimumab reduced disease activity in patients with lupus in Phase IIb tests, the drugmaker said.”
If you like this story, please see our blog titled “CHO Cell Culture – Ten Tips from the Experts on Expression, Media and Bioprocessing”
“An antibody drug under development by Amgen Inc and AstraZeneca Plc met the goals of a Phase 3 study in patients with moderate-to-severe plaque psoriasis, the companies said on Friday. The 661-patient trial of brodalumab met all primary and secondary endpoints for both of the evaluated doses, they said. It showed that 83 percent of patients given the highest dose, and 60 percent of patients on a lower dose, achieved at least a 75 percent reduction in disease severity after 12 weeks, compared with about 3 percent of placebo patients.”
If you like this story, please see our blog titled “Highlights from the 14th World Vaccine Congress – A Cell Culture Perspective”
“Bringing life-saving drugs to market isn’t cheap – the capitalized cost of bringing a typical drug to market is around $1.2 billion and continues to grow every year. And thanks in no small part to heavy-handed FDA regulations, this cost is slated to keep growing, especially for new, highly targeted medicines for diseases ranging from cancer to type 2 diabetes. Much of the cost of drug development lies in what economists refer to as “fixed” or “sunk” costs – this covers the gamut of everything from machinery to rent to regulatory costs (filing fees and time spent conducting clinical trials for example). This situation creates a classic underinvestment problem – companies invest significant amounts of money to develop a product (with large social benefits) where they will be unable to capture much of the total benefit (social+private); in economic terms, an externality. The way that we overcome the problem of large sunk costs is by granting companies a temporary monopoly on production and sale of a product (in essence, a patent that creates “intellectual property”), that allows society to encourage investment in high-value, high fixed cost products that may not have been developed otherwise. Patents are granted for a 20 year period in all countries that have signed the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).”
If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”
“People who received the world’s first stem cell treatment for strokes have shown measurable reductions in disability and handicap a year after the injection into their damaged brains. Some can move limbs and manage everyday tasks that were impossible before they received an injection of neural progenitor stem cells, which were clones of cells originally taken from the cortex of a donated fetus. Apart from physical rehabilitation, there are few treatments for people left severely disabled by a stroke. Demand for more options is high, with 800,000 new cases each year in the US and 150,000 in the UK.”
If you like this story, please see our blog titled “Aastrom CEO Discusses How Recent Acquisition Strengthens Current Manufacturing Capability and Clinical Pipeline”
“FDA’s Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing,” Regulatory Focus
“The US Food and Drug Administration (FDA) has unveiled a new guidance document on biosimilars, this time explaining how to use clinical pharmacology data to show similarity to a reference product.”
If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”