This week’s biotechnology news headlines include, FDA approves Gilead Sciences’ HIV drug cocktail, Roche partners with Cellular Dynamics, Amgen’s biosimilar shows clinical equivalence with Humira, AstraZeneca buys ZS Pharma, Sanofi shows work on improving flu vaccines, Astellas buys Ocata, and GSK lupus drug hits phase III targets.

Cell Culture Events

Webinar:

Predicting clinically-relevant drug disposition and drug-drug interactions using micropatterned co-cultures

Wed, Nov 18, 2015 10:30 AM – 11:30 AM PST

Abstract: Metabolism by the liver accounts for the overall clearance of ~70% of marketed drugs. Thus, accurate prediction of in vivo human drug clearance using in vitro hepatic clearance data can help identify compounds with poor pharmacokinetic characteristics. An ideal culture platform for such purposes uses as few limited primary hepatocytes as possible in a reproducible/miniaturized format; maintains high levels of drug metabolism enzymes with proper hepatocyte polarity to allow incubations with drugs that interact with multiple pathways, including transporters; is compatible with multiple cryopreserved hepatocyte donors for on-demand screening; and, can be used to predict clearance of compounds with a wide range of turnover rates, including slowly metabolized compounds (i.e. low turnover). Additionally, the ability to interrogate effects of drug incubations on hepatocyte enzyme levels and subsequently victim drug disposition is important for modeling clinical drug-drug interactions. In this presentation, I will describe how micropatterned co-cultures (MPCCs) containing cryopreserved hepatocytes in multiwell plates approximate the aforementioned features and thus have been shown to be useful for CYP phenotyping, drug clearance prediction, metabolite identification and to model clinically-relevant drug-drug interactions. The ability to evaluate drug disposition in MPCCs created using hepatocytes from different species allows for selection of the most appropriate animal species for downstream in vivo investigations. In the future, MPCCs can be used to reduce drug attrition and prevent harm to patients in the clinic.

Please join for a webinar presented by Dr. Salman Khetani, co-inventor of the HepatoPac technology. He will discuss his recent publication, “Prediction of Drug Clearance and Drug-Drug Interactions in Microscale Cultures of Human Hepatocytes”. He will also discuss additional data that has been generated using MPCCs (HepatoPac).

Register here – https://attendee.gotowebinar.com/register/6932216674196134145

Conferences:

December

• Cell Therapy Manufacturing & Gene Therapy Congress – December 1-4, 2015 – Sheraton Brussels Airport Hotel Discover the latest technical, manufacturing and commercial strategies driving the cell and gene revolution. ISCT together with Informa’s has developed the  Cell Therapy Manufacturing and Gene Therapy Congress agenda  bringing together key players from the industry to discuss the critical issues facing the development, scale-up and manufacture of cell-based and gene therapies, all in line with international regulations, from scale-up to scale-out, characterisation to process release, freeze/ thaw to needle-to-needle logistics. http://www.informa-ls.com/event/celltherapy15
• Antibody Engineering and Therapeutics – December 7-10, 2015 –San Diego Convention Center –  IBC’s Antibody Engineering & Therapeutics is the largest and most trusted antibody engineering and therapeutics event in the industry! Join us in San Diego to hear and learn from an impressive collection of world-renowned and highly-published academic and industry scientists, as they share the latest science, strategies and preclinical/clinical development efforts. http://www.ibclifesciences.com/AntibodyEng/overview.xml
• Vaccine Development and Production Summit – December 8-9, 2015 – Hilton Boston Back Bay, Boston, MA IBC’s Vaccine Development & Production Summit continues to bring you new data on ways to achieve your development and production goals. This year, hear the challenges and triumphs of product developers who continue to advance their innovations to combat emerging and infectious diseases. – http://www.ibclifesciences.com/Vaccines/overview.xml
• World Stem Cell Summit & RegMed Capital Conference– December 10-12, 2015 – Hyatt Regency, Atlanta, Georgia-The World Stem Cell Summit, produced by the Genetics Policy Institute (GPI), is the largest interdisciplinary, networking meeting of stem cell science and regenerative medicine stakeholders, uniting the diverse community. With the overarching purpose of fostering biomedical research, funding and investments targeting cures, the Summit is the single conference charting the future of this burgeoning field. – http://worldstemcellsummit.com/about-summit/
• ASCB – December 12-16, 2015 – San Diego Convention Center, CA – The 2015 ASCB meeting overarching theme is about making connections at different scales, from the intracellular level to the tissue level, to the organism level all the way up to the macrocosmic level, all in the light of big data and information integration. This integration will help us ask the right questions and find answers to the challenging problems in medicine, living systems, and ecosystems.- http://www.ascb.org/2015meeting/

Headlines

“FDA approves Gilead Sciences’ HIV drug cocktail,” Reuters

“Gilead Sciences Inc said the U.S. Food and Drug Administration had approved its HIV drug cocktail, Genvoya, to treat patients aged 12 and above.”

If you like this story, please see our blog titled “Cool Tool – Allegro™ Microcarrier Delivery System: Streamline Processes, Increase Productivity”

“Cellular Dynamics in Roche deal worth up to $83 million,” Milwaukee Business Journal

“Cellular Dynamics International Inc. said Tuesday that it will supply its induced pluripotent stem cell-derived iCell products to Swiss pharmaceutical company Roche under a partnership that could provide up to $83 million in revenue for the Madison biotech firm.”

If you like this story, please see our blog titled “Culturing Hematopoietic and Progenitor Stem Cells – Key Tips and Tools”

“Amgen’s biosimilar shows clinical equivalence with Humira,” PMLive

“Amgen’s biosimilar ABP 501 has demonstrated clinical equivalence with AbbVie’s Humira in patients with moderate to severe rheumatoid arthritis.”

If you like this story, please see our blog titled “BioProcess International Conference (BPI) 2015 – An Overview For Anyone Who Missed It!”

“AstraZeneca buys ZS Pharma for $2.7 billion, pips Actelion,” Reuters

“Britain’s AstraZeneca said on Friday it had agreed to buy U.S biotech company ZS Pharma for $2.7 billion, pipping Swiss firm Actelion to the prize in the latest bout of deal-making for the hyperactive healthcare sector.”

If you like this story, please see our blog titled “Cool Tool- Hybridoma cell growth and performance in reduced serum + Zap-SR”

“Sanofi unveils its work on improving flu vaccines,” Fierce Vaccines

“The shortcomings of flu vaccines have been well documented in recent years, with strain drift and mutations often reducing the effectiveness of seasonal shots. Numerous institutions have put their resources behind improving flu immunization techniques, and this week Sanofi Pasteur revealed its own activity in the field.”

If you like this story, please see our blog titled “Exosomes: A Major Phenomenon Flying Under the Radar”

“With $379M Deal For Ocata, Astellas Buys Stem Cells For Eye Diseases,” Xconomy

“Japanese drug firm Astellas Pharma announced late Monday it has agreed to buy Ocata Therapeutics (NASDAQ: OCAT), which is developing regenerative medicines for eye diseases. It’s an all-cash deal worth $379 million, with the Astellas offer of $8.50 a share representing a 79 percent premium to Ocata’s share price at the end of November 6.”

If you like this story, please see our blog titled “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”

“GSK’s lupus drug Benlysta hits PhIII targets,” PharmaTimes

“A subcutaneous formulation of GlaxoSmithKline’s Benlysta has hit targets in a Phase III trial involving patients with active, autoantibody-positive systemic lupus erythematosus.”

If you like this story, please see our blog titled “You can teach an old dog new tricks: Vero cells for virus-based cancer vaccine therapies”