This week’s biotechnology news headlines include, Ebola shows efficacy in small clinical trial, FDA approves UCB’s seizure drug, seven pharma companies join to fight Parkinson’s, Teva offers concessions over Allergan deal, industry wants more leniency in FDA draft guidance, Amgen and UCB osteoporosis drug meets goal in clinical trial, and ViiV completes acquisition of BMS’ HIV assets.
Cell Culture Events
Ask the Expert:
Bioprinting is now a word most people have heard of, but might not really understand. Because there is a lot of hype regarding what is possible and what has already been accomplished, the term likely conjures up images of Frankenstein, a mouse with an ear growing on its back, glow-in-the-dark animals, or cyborgs.
The industry has come a long way from the time when researchers hacked into a desktop printer to experiment with printing out living cells. Researchers are now able to create vascularized tissue constructs that have proven viable when implanted into animals. But while printing of whole organs remains elusive (and probably won’t happen for many years), there are many applications for bioprinting that are commercially feasible and applicable today.
Pharmaceutical companies are faced with expensive, time-consuming, failure-prone clinical trials in order to get their drugs approved and on the market. A whole textbook could be written on why they are so expensive and risky, and companies must innovate their drug discovery and development processes. Izumi International, Inc. has been working with some of the top names in the pharmaceutical industry to optimize their drug discovery and production processes and incorporate bioprinting into their workflows. This will ultimately contribute to a much more streamlined and productive development framework, as the data generated from 3D assays vastly outperforms that from traditional 2D workflows.
This Ask the Expert session is hosted by Katie Golson of Izumi International, Inc. Katie joined Izumi in 2014 as a Biomedical Automation Application Engineer where she helps develop customized laboratory automation and bioprinting solutions for companies and universities all over the world. She holds a Master’s in Bioengineering from University of California, San Diego and a Bachelor’s in Industrial Design from Georgia Institute of Technology. Her prior experience running automated liquid handling at Vertex Pharmaceuticals
Ask your questions about bioprinting starting Monday!
ISBioTech 6th Spring Meeting – March 7-9, 2016 -Washington, DC
Three concurrent programs on:
– Cellular Therapies
– Viral Vectors & Vaccines
– Baculovirus Expression Technology
BPI West – March 14-March 17, 2016 – Oakland Marriott City Center, Oakland, CA
World Vaccine Congress – March 29-30, 2016 –Grand Hyatt– Washington D.C.
Progress in Continuous Biomanufacturing – June 27-28, 2016 – Robinson College, Cambridge, UK
The conference is enhanced by the participation of several leading industrial technologists, scientific, vendors and also leading academics from Europe and USA. They have come forward to share their experience and knowledge to provide a better understanding of the current technologies and their application in continuous biomanufacturing. There is also a plenary lecture by a distinguished professor in the field of bioprocessing, and you will also benefit from access to unpublished data. This meeting will address several advancements and their successful application with data in the Technology both Upstream and downstream and also on Initiatives to process developments and project to the future direction of the industry. By joining with us you can benefit from the current state of-the-art advancements in continuous manufacturing and also learn about the successful organisations that are developing and applying these methods in-house.
Check out the Top Blogs, Top Ask the Expert Sessions and Top Cool Tool Features of 2015 –
“The drug ZMapp, viewed as perhaps the most promising potential treatment for Ebola, seemed to prevent death from the disease in its first rigorous clinical trial, researchers reported on Tuesday.”
If you like this story, please see our blog titled “Cool Tool – Mitigating Risk beyond Xeno-Free: Virus Stabilization during Culture and Final Formulation”
“The U.S. Food and Drug Administration (FDA) approved Belgian drugmaker UCB SA’s drug as an add-on therapy to treat partial seizures caused by epilepsy.”
If you like this story, please see our blog titled “The Use of Animal Serum in the Clinical Translation of hMSCs”
“AstraZeneca, Pfizer and Eli Lilly are among seven major pharmaceutical companies linking into a “ground-breaking” consortium striving to streamline and accelerate the development of new therapies for Parkinson’s disease.”
If you like this story, please see our blog titled “3D Bioprinting and 4D Bioprinting – Applications and Technologies”
“Teva Pharmaceutical Industries Ltd (TEVA.TA) has offered concessions to allay EU antitrust concerns over its $40.5 billion bid for Allergan’s (AGN.N) generics unit which will cement its position as the world’s largest generics drugmaker.”
If you like this story, please see our blog titled “2015 FDA New Drug Approvals – 13 Biologics Receive Approval”
“Industry Seeks More Leniency in FDA Draft Guidance on Safety Assessments for INDs,” Regulatory Focus
“A number of drugmakers are calling on the US Food and Drug Administration (FDA) to be more flexible with sponsors in developing guidance on safety assessments for investigational new drug (IND) applications, according to comments published Wednesday on the draft document.”
If you like this story, please see our blog titled “Cool Tool – New Robust Kit for Efficient Generation of Functional Pancreatic Progenitor Cells”
“Amgen Inc and Belgium-based UCB SA said on Monday that their osteoporosis drug met all the primary endpoints by reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis in a late-stage study.”
If you like this story, please see our blog titled “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”
“ViiV Healthcare has completed its acquisition of Bristol-Myers Squibb’s portfolio of HIV research and development assets, having secured antitrust clearance from authorities in the US.”
If you like this story, please see our blog titled “Enabling High Density Cell Banking using a Single-Use, Closed-System”