This week’s headlines include, MannKind receives approval for inhaled insulin, new patent ruling, cancer immunotherapy market on the rise, Novartis’ cell treatment, FDA’s patient outreach, NIH working on undiagnosed diseases, and naming of follow-on biologics.
Cell Culture Dish – Ask the Expert:
Our Next Session – Efficient cell specific differentiation systems for iPSC
The promise of human pluripotent stem cells will be realized only when these cells are successfully coaxed into different cell types found in the human body, through the process of directed differentiation. This is critical to getting the desired cell types and numbers needed for drug screening, translational Cell Therapy and regenerative medicine applications. Most of the existing methods of differentiation are suboptimal, involving laborious mechanical and manual steps leading to issues of reproducibility and reduced efficiency in downstream processing of functionally mature lineages. The complex developmental process of differentiation and the challenges associated need to be efficiently deciphered in order to successfully direct the hPSC differentiation to target cell types.
During this Ask the Experts session, we will be discussing the challenges associated with hPSC differentiation to neural and cardiac lineages, how Thermo Fisher Scientific can address how these processes can be efficiently simplified with tools and cGMP cell culture media systems for robust, efficient and scalable differentiation of these two critical cell lineages. Use of these reagent systems will enable researchers to precisely control and direct the differentiation to terminal lineages in a relatively easy manner, and speedily with high efficiency.
Join Dr. Mohan C Vemuri, the Director of Research and Development for Cell Biology at Thermo Fisher Scientific, to explore differentiation systems for iPSC.
Don’t miss this chance to have your differentiation questions answered!
Cell Culture Events:
The Bioprocessing Summit – August 18-22, 2014 – Renaissance Waterfront Hotel – Boston, MA
Cell Line Development & Engineering – September 8-10, 2014 – Doubletree by Hilton Berkeley Marina Berkeley, CA
Cell Culture World Congress USA – September 15-16, 2014 – The Westin Copley Place – Boston, MA
Stem Cells Regenerative Medicine Conference –
World Cord Blood Congress –
“Guidelines that forbid patents on a wide array of natural products, phenomena and principles have many in the biotechnology and pharmaceutical industries worried about the future of their business.”
If you like this story, please see our blog titled “CHO Cell Culture – Ten Tips from the Experts on Expression, Media and Bioprocessing”
“Swiss drugmaker Novartis said on Monday U.S. health regulators have granted its personalised Cell Therapy CLT019 “Breakthrough Therapy” status, meaning the treatment will be fast-tracked within the U.S. regulatory system.”
If you like this story, please see our blog titled “Reducing Footprints and Increasing Output in Adherent Cell Culture”
“The market for cancer immunotherapy in major world markets is set to grow from a value of $1.1 billion in 2012 to nearly $9 billion in 2022, soaring by an annual average of 23.8% and driven by the expected market entry of nine novel immunotherapies in new oncology indications and/or patient populations, say new forecasts.”
If you like this story, please see our blog titled “Single-use Technology for Microbial Fermentation”
“The National Institutes of Health (NIH) is giving six additional medical centers a total of $43 million to take part in its Undiagnosed Diseases Network, through which the agency is supporting research to unravel the causes of prolonged, mysterious conditions. The network is an extramural expansion of the agency’s Undiagnosed Diseases Program, which is headquartered at the Clinical Center on the NIH campus in Bethesda, Maryland.”
If you like this story, please see our blog titled “PCR Release Testing for Mycoplasmas Gaining Ground versus Conventional Methods”
“There is an ongoing debate over whether biosimilars and interchangeable biologics should share the same nonproprietary name as their reference biologics. As patents covering biologics expire, companies other than the original manufacturers will seek to market their own versions of the originators’ biologics as biosimilars, “bio-betters,” or interchangeable biologics. The commercial opportunities for these follow-on products are potentially enormous: It is predicted that by 2016 eight of the top 10 bestselling drug products will be biologics, and biologics with combined revenues of $79 billion are expected to go off-patent by 2018.”
If you like this story, please see our blog titled “Part II – Key Tools and Technology Hurdles in Advancing Stem-Cell Therapies”
“MannKind Corp. (MNKD:US) won U.S. approval to sell its inhaled insulin, culminating an almost decade-long effort, with a warning that the product shouldn’t be used by those with asthma or a serious lung disease.”
If you like this story, please see our blog titled “Aastrom CEO Discusses How Recent Acquisition Strengthens Current Manufacturing Capability and Clinical Pipeline”
“Is the FDA doing enough to incorporate the patient perspective in the drug review process? This was the key question considered at a panel of regulatory experts held at last month’s annual BIO International Convention in San Diego. The consensus: while FDA deserves high marks for effort, both in reconciling the diversity of patient organization views and interpreting the often vague stipulations to engage found in the 2012 FDA Safety and Innovation Act (FDASIA), it is not enough.”
If you like this story, please see our blog titled “Using Induced Pluripotent Stem Cells to Model Human Disease”