This week’s headlines include, promise of faster drug approvals, bone derived from skin cells, potential biosimilar market growth, Takeda buys Inviragen, some big biotechs are accelerating their R&D spending, and GSK and Merck give discount on HPV vaccine.
New Cell Culture Dish Feature – Ask the Expert:
On Monday we are launching a new feature at the Cell Culture Dish – Ask the Expert. In each Ask the Expert session industry or academic experts answer the questions you submit on the topic of the week. A range of topics will be covered and suggestions for future Ask the Expert sessions are welcome.
Our First Session – Serum-Free Conditions
Most of us want to be serum-free or move in this direction, but transitioning to a serum-free media can be a daunting task. Some are struggling with how to plan their transition to serum-free conditions. Some have already transitioned to serum-free but are not getting the results that they want or that they achieved with serum containing media. Still others are stuck in the process of transitioning with cells that just won’t cooperate in serum-free conditions. If this describes your current cell culture situation, you are not alone. Please join us for our Ask the Expert session on cell culture in serum-free conditions.
This Ask the Expert Session is Sponsored by Life Technologies and hosted by Timothy Fawcett, Ph.D. Dr. Fawcett has been in the biotechnology business for over 30 years. Trained as a biochemist he has held senior positions in both academics and industry and has been a mentor to many young scientists throughout his career. For the last 12 years Dr. Fawcett has been the Director of the BioTechnical Institute of Maryland (BTI) a non-profit institute located in Baltimore, Maryland. He is also the Founder and Director of BioSciConcepts, a social venture of BTI that provides hands-on training for professional scientists in cell culture, baculovirus based expression, as well as topics such as molecular biology, PCR and real-time PCR. BioSciConcepts is an internationally recognized provider of expertise in the biological sciences and has provided consultation services to several small and large biotechnology companies.
Please take advantage of the opportunity to ask our expert a question and participate in a lively discussion of serum free media!
Cell Culture Events:
World Stem Cells & Regenerative Medicine Congress 2013 is now in its 8th year and is Europe’s largest and most senior conference for the industry. Covering everything from streamlining clinical development, commercializing a stem cell-based therapy and exploiting alternative sources of funding you’ll be sure to find the solutions to your challenges and the right business development contacts to implement them.
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“A pickup in new drug approvals, the promise of faster regulatory decisions and more targeted medicines have quickened the pulse of the pharmaceutical industry as a big wave of patent expiries recedes. Manufacturers are producing more targeted medicines, designed to treat very specific groups of patients, thanks to a new understanding of the genetic basis of many diseases – most notably cancer.”
If you like this story, please see our blog titled “Biologics Have a Robust Pipeline According to Latest PhRMA Report”
“Human bone grown in a laboratory dish has been successfully transplanted into living mice, according to a study published Monday in the Proceedings of the National Academy of Sciences. The successful transplant represents an important step in the effort to repair human bones. In the past, scientists have approached the problem of repairing human bones by using synthetic materials or bone transplants, techniques that so far have produced limited results.
“If you like this story, please see our blog titled “Best Practices in Cell Therapy Manufacturing”
“The head of the U.S. Centers for Disease Control and Prevention says the current strain of bird flu that is causing illness and deaths in China cannot spark a pandemic in its current form – but he added that there is no guarantee it will not mutate and cause a serious pandemic. In an exclusive interview at the Reuters Health Summit in New York, Dr. Thomas Frieden, director of the CDC, said more than 2,000 people have been in contact with infected individuals, and only a handful have become ill. Virtually all of the rest have had direct contact with poultry, the identified cause of the virus.”
If you like this story, please see our blog titled “Interesting Late Stage Viral Vaccine Candidates”
“The R&D numbers for the top 10 biotechs may only amount to a fraction of what you’ll find in Big Pharma. But unlike the giants, which are trying to keep a lid on multibillion-dollar budgets, you’ll find a much faster crowd when you turn your gaze to the biotechs. All 10 reported increases in their research spending for last year. And a few of them slammed their foot on the gas pedal. Altogether the top 10 biotechs spent $11.8 billion on R&D in 2012, according to our research, a hefty 15% average increase over their 2011 performance. Compare that to the stable year-over-year record in Big Pharma, where doing more with the same amount of cash has become an industry mantra.”
If you like this story, please see our blog titled “Continuous Processing: From Cookie Preparation to Cell-Based Production”
“The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study. The study, by British market research firm Visiongain, forecast that the $2.445 billion market size marked more than 20% of growth from 2012 and would account for about 2% of the overall market for biologics. The market is expected to grow rapidly through 2023 as biosimilars hit the market in the United States and European Union. The fastest growth will be in biosimilar monoclonal antibodies and insulins, and two products submitted for regulatory approval in the European Union last year by Hospira and Celltrion are expected to launch there next year, according to the report. Meanwhile, the launch of biosimilar erythropoietin and filgrastim products in the United States will drive growth starting next year.”
If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012”
“Inviragen, a privately held biopharmaceutical company based in Fort Collins, said Tuesday it has agreed to a sale to Takeda Pharmaceutical Co. for $35 million in cash. Takeda, through its subsidiary Takeda America Holdings Inc., could pay an additional $215 million, depending on the progress of Inviragen’s vaccines to treat infectious diseases. Inviragen is testing vaccines in clinical trials to treat hand, foot and mouth disease, as well as to prevent dengue infections, which cause an estimated 100 million illnesses a year and 20,000 deaths, mostly children.”
If you like this story, please see our blog titled “Interesting Products Featured at Interphex 2013”
“Social issues have held back uptake of GlaxoSmithKline’s ($GSK) and Merck’s ($MRK) human papillomavirus (HPV) vaccines in the U.S., but globally the problem is more fundamental–the shots cost too much. But it is these low-income countries–where 85% of cervical cancer cases occur–that need the vaccines most. This disconnect between who can afford the vaccines and where they are needed has held back Merck’s Gardasil and GSK’s Cervarix. Now both manufacturers have agreed to deep discounts to get the vaccines into countries where they can do the most good. The GAVI Alliance is paying $4.50 a shot for Gardasil and $4.60 for for Cervarix. In comparison, the lowest price paid by the public sector previously was $13, and privately a jab costs upwards of $100. GAVI identified this as a problem as far back as 2011, when Merck agreed to offer Gardasil at $5 a shot.
If you like this story, please see our blog titled “New Vaccines Coming Soon to a Doctor’s Office Near You”