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The Dish’s Weekly News Wrap Up – May 2, 2014
This week’s headlines include, more healthcare deals coming, one analyst predicts bubble, embryonic cloning for diabetes, BrainStorm gets ok for ALS trial, Takeda gets $70 for H5N1, and promising results in dengue fever trial.
Cell Culture Events
Thursday May 8th, 10:00 AM PDT, 1:00 PM EDT Induced pluripotent stem (iPS) cell-based models hold tremendous potential for the study of human neurological disease. Advances in technologies, including improvements in the ease and efficiency of generating neural progenitor cells from iPS cells, have resulted in increased adoption of these models by the neuroscience community. Learn how iPS cell-based models can enable you to increase the physiological relevance of your research, by watching this free webinar.
Webinar – “Achieving FDA Acceptance and Releasing your Bio Product with Rapid PCR Mycoplasma Testing”
Thursday May 15, 6:00 AM PDT, 9:00 AM EDT Validation of release methods and approval by authorities can be a lengthy, technically complex and sometimes costly process involving lots of misunderstandings along the way. Mycoplasma is the most common reason for contamination in cell culture and can greatly impact the quality and end-result of cell-based biopharmaceutical products. In this free webinar, Roche Custom Biotech will discuss FAQs asked by regulatory authorities and showcase how Roche Pharma addressed all these questions during validation of the MycoTOOL Test, including the experiments performed and the results that were presented to the FDA.
13th Annual Biological Production Forum 2014 –May 12-14, 2014 – Citywest Conference & Golf Resort, Dublin, Ireland
The 13th Annual Biological Production Forum addresses the need to identify and locate the optimum upstream, downstream & manufacturing excellence solutions whilst tackling the challenges of heightened regulatory pressures. Attend and network with over 100 senior-level pharmaceutical professionals. The agenda is organised around a schedule of highly targeted, pre-arranged 1-2-1 meetings between key corporate buyers and service providers. Each meeting is pre-planned and based on the detailed profile information supplied by each attendee and the sponsors.
TIDES – May 12-15, 2014 – Rhode Island Convention Center – Providence, Rhode Island
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 model
- 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.
Annual Meeting of the International Society for Stem Cell Research – June 18-21, 2014, -Vancouver, Canada
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.
“The deal-making frenzy sweeping through the healthcare industry should continue apace in 2014, as companies look to stock up new drug pipelines, bolster existing businesses and diversify into new areas, Moody’s Investors Service said on Tuesday. Deals totalling more than $153 billion have been struck in the sector so far this year, the highest year-to-date level since Thomson Reuters began tracking such data. Credit ratings agency Moody’s said acquisition activity should remain high as makers of branded drugs look to buy companies with complementary or high-potential pipelines, while generic drugmakers seek to build scale and diversify.” If you like this story, please see our blog titled “Biologics Still on Top in Best Selling Drugs of 2013”
“BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration approved the start of a mid-stage clinical trial of its adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS). The Phase II trial will be launched initially at Massachusetts General Hospital in Boston and the University of Massachusetts Memorial Hospital in Worcester. Dana-Farber Cancer Institute’s Connell O’Reilly Cell Manipulation Core Facility will manufacture BrainStorm’s NurOwn cells for these two clinical sites. The trial will also be conducted at the Mayo Clinic, the Israel-based company said on Sunday. The trials are expected to start soon.” If you like this story, please see our blog titled “Stem Cell Therapy Indications for Cardiovascular Disease in Phase II/III Clinical Trials”
“When David Einhorn speaks, the world usually listens. That doesn’t mean what he says is particularly new or even insightful. “Now there is a clear consensus that we are witnessing our second tech bubble in 15 years,” the founder of hedge fund Greenlight Capital wrote last week to his investors. “What is uncertain is how much further the bubble can expand and what might pop it.” As Einhorn so eloquently put it, predicting what will pop a bubble and when it will happen is beyond the reach of even superstar investors. There are plenty of people today who deny a bubble even exists. It’s as if the dot-com bust in the early 2000s never happened. This time, the bulls cry, it’s different.” If you like this story, please see our blog titled “CHO Cell Culture – Ten Tips from the Experts on Expression, Media and Bioprocessing”
“The French pharmaceutical company Sanofi said on Monday that its experimental vaccine for dengue fever had succeeded in its first late-stage clinical trial. The results could help pave the way for the introduction of the first vaccine to prevent a disease that afflicts an estimated 50 million to 100 million people a year. Sanofi said the vaccine reduced the incidence of dengue fever by 56 percent in a trial involving more than 10,000 children in Southeast Asia. Outside experts said they were hoping for even greater effectiveness, but some said the vaccine could still be useful.” If you like this story, please see our blog titled “Highlights from the 14th World Vaccine Congress – A Cell Culture Perspective”
“FDA Approves Roche Genetic Test as an Alternative to Pap Smear for Cervical Cancer Screening,” Star Tribune Minneapolis-St. Paul
“Federal health regulators have cleared a genetic test from Roche as a first-choice screening option for cervical cancer. It was a role previously reserved for the Pap smear, the decades-old mainstay of women’s health. The Food and Drug Administration approved Roche’s cobas HPV test to detect the human Papillomavirus, or HPV, in women 25 and up. HPV causes nearly all cases of cervical cancer.” If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”
“For the second time in recent weeks researchers said they used cloning technology on adult tissue, rather than from a fetus or infant, to create stem cells that potentially could be used to treat a range of diseases. Scientists said Monday in the journal Nature they created an embryonic clone of a 32-year-old woman with diabetes, extracted healthy stem cells from the clone, and then changed those cells into ones that produce insulin. The experiment marks another advance in the quest to generate patient-matched tissue. The long-term hope is to transplant new insulin-producing cells back into a patient and treat diabetes, which occurs when the body’s natural ability to produce insulin is impaired.” If you like this story, please see our blog titled “Pluripotent Stem Cell Culture – A Discussion about Successful Culture”
“Last month, Takeda snagged Japanese approval for its cell-cultured influenza vaccine for H5N1, and it’s about to have more space to make it. The Japanese government has selected the pharma for a supplemental subsidy of ¥7.2 billion ($70.2 million), which will help expand production for an additional 8 million people in the event of a pandemic. The subsidy will help Takeda bump up capacity at its Hakari Plant, a state-of-the-art facility Takeda established after receiving another public subsidy–this one for ¥7.2 billion–in 2009. With the expansion, Takeda should be able to supply the government with vaccines to protect 33 million people if needed. If you like this story, please see our blog titled “Flexible Facilities for Biopharmaceutical Manufacturing”