This week’s headlines include, news about immunotherapies to treat cancer, Pluristem’s study on clinical hold, Mideast flu declared an emergency, new diagnostic test requirements, and new stem cell line restrictions.

Cell Culture Dish Feature – Ask the Expert:

Our Next Session –Stem Cell Manufacturing

There are an increasing number of promising new stem Cell Therapy candidates in development and many are showing promising results in clinical studies. As more stem cell therapies move from the lab to the clinical setting, there is increased interest in identifying best practices for stem cell manufacturing. Many researchers have specific questions about scaling up stem cell production, optimizing culture media, selecting the right manufacturing equipment, and the regulatory requirements for clinical production. If you have questions regarding stem cell manufacturing, then please join us next week for a special Ask the Expert session “Clinical Stem Cell Manufacturing.”

Hosting this week’s session is Ronnda Bartel, Ph.D., Chief Scientific Officer, Aastrom Biosciences. Aastrom has successfully moved stem cell therapies from lab scale to clinical manufacturing and we are fortunate to have Ronnda’s expertise for this Ask the Expert session. Ronnda joined Aastrom in 2006 and is responsible for the scientific direction of the company, including research, development and technical operations. She has more than 20 years of research and product development experience and most recently was executive director, biological research at MicroIslet and vice president, scientific development at StemCells Inc. Earlier in her career, she was senior principal scientist and director of research at Advanced Tissue Sciences and was involved in the development and approval of some of the first cell-based products approved by the FDA. She has also worked as senior director, science and technology at SRS Capital, LLC evaluating life science investments and has held positions in clinical development, drug delivery, business development and manufacturing. Ronnda holds a PhD in biochemistry from the University of Kansas, has completed postdoctoral work at the University of Michigan and received a BA in chemistry and biology from Tabor College.

For more information, please see Ronnda’s previous guest blog “From Product Candidate to Product – The Road to Commercialization in Regenerative Medicine.”

Please take advantage of the opportunity to ask our expert a question and participate in a discussion about manufacturing stem cells. Discussion starts Monday!

Cell Culture Events:

ESACT (European Society for Animal Cell Technology) June 23^rd-26^th, Lille, France

If you are attending, please visit our sponsors:

ATMI LifeSciences – Booth number C7

GE Healthcare – Platinum Sponsor, Booth number 30

Headlines:

“Evidence Mounts for Immunotherapies to Treat Cancer,” The Wall Street Journal

“Researchers presented more evidence Saturday that using drugs to harness the body’s immune system to fight tumors may prolong lives for certain types of cancer. An experimental Bristol-Myers Squibb Co. drug, nivolumab, helped patients with a deadly form of skin cancer, melanoma, live an average of nearly 17 months in a clinical trial. It was the first survival data for a drug that has generated excitement among doctors and investors. The early-stage study didn’t have a comparator arm—so researchers stopped short of saying it prolonged survival—but the survival duration topped historical norms for advanced melanoma.”

If you like this story, please see our blog titled “Biologics Take Top Spots in Best Selling Drugs of 2012”

“Pluristem says FDA puts Muscle Pain Drug Study on Clinical Hold,” Reuters

“Pluristem Therapeutics Inc. said a mid-stage trial of its experimental muscle pain drug was put on clinical hold by the U.S. Food and Drug Administration due to a serious allergic reaction in a patient. The company, which develops therapies based on placenta-derived stem cells, said the patient required hospitalization after the reaction. Pluristem said the study consisted of 74 patients and this was the first incident of a serious allergic reaction.”

If you like this story, please see our blog titled “Part III – Fifteen Cell and Stem Cell Therapies in Phase III Clinical Trials”

“Administration Declares Mideast Flu a Potential Public Health Emergency,” The Hill

“The Obama administration on Tuesday designated a respiratory disease now found in the Middle East as a potential threat to public health and national security. The move gives officials the authority to fast-track the approval of treatments and tests for Middle East respiratory syndrome coronavirus (MERS-CoV), which causes flu-like symptoms and has killed 30 people since April of last year. Because this is a new strain of coronavirus there are no federally approved ways to test for it. Department of Health and Human Services Secretary Kathleen Sebelius made the designation on Wednesday, allowing the Food and Drug Administration (FDA) to quickly approve testing devices for U.S. citizens living overseas without going through the normal process.”

If you like this story, please see our blog titled “Interesting Late Stage Viral Vaccine Candidates”

“FDA Commissioner Hints at New Diagnostic Test Regulations,” Forbes

“The Food and Drug Administration will take new steps to enforce regulations against certain kinds of diagnostic tests, including some used for personalized medicine, to which it previously took a laissez-faire attitude. The announcement was made in a speech by Margaret Hamburg, the FDA Commissioner, here at the annual meeting of the American Society of Clinical Oncology (ASCO). The main point of the speech was to honor Richard Pazdur, who is receiving an award for ASCO for his role in approving cancer drugs. But toward the end of prepared remarks provided to the FDA by Forbes, Hamburg goes into a discussion of the FDA’s role in regulating diagnostic tests, including those that are used to identify in which cancer patients genetically targeted medicines will prove effective.”

If you like this story, please see our blog titled “Companion Diagnostics – The Power of Personalized Medicine”

“Scientists Chafe at Restrictions on New Stem Cell Lines,” Scientific American

“The California Institute of Regenerative Medicine is rethinking its rules in the wake of a recent breakthrough involving the creation of stem cell lines from a cloned human embryo. The announcement last month of a long-awaited breakthrough in stem-cell research — the creation of stem-cell lines from a cloned human embryo — has revived interest in using embryonic stem cells to treat disease. But US regulations mean that many researchers will be watching those efforts from the sidelines.”

If you like this story, please see our blog titled “Identifying Options for Stem Cell Based Therapy Scale-Up”

“What Makes a Breakthrough Cancer Drug,” The Wall Street Journal

“In the eyes of Richard Pazdur, a breakthrough cancer drug should be “transformative.” His view is important because Dr. Pazdur is the head of the U.S. Food and Drug Administration’s office of hematology and oncology products, which helps decide whether experimental cancer drugs are sufficiently safe and effective to go on the market. Under a new law that took effect last year, the agency has been designating certain drugs in development as “breakthroughs,” based on preliminary clinical evidence that suggests the drug could be a substantial improvement in treating serious or life-threatening diseases.”

If you like this story, please see our blog titled “Continuous Processing: From Cookie Preparation to Cell-Based Production”

“Analysis: New Cancer Breakthroughs add Pressure to Control Costs,” Reuters

“An exciting class of new cancer drugs may boost patients’ odds for survival, but healthcare providers and insurers will be under pressure to find savings elsewhere to pay for the high price tags of the new treatments. Doctors at this week’s annual meeting of the American Society of Clinical Oncology heard groundbreaking data on a new class of immune system boosters that some believe will become the main treatment for more than half of all cancers in the next 10 years. They included drugs from Bristol-Myers Squibb and Merck & Co that shrank tumors in patients with advanced melanoma and lung cancer.”

If you like this story, please see our blog titled “Cool Tool – ATMI’s Helium Integrity Testing HIT System”