This week’s biotechnology news headlines include, Clinton wants to cap prescription drug costs, biosimilar approvals, Opdivo gets Breakthrough status, Ebola drug gets FDA Fast Track, and Alector gets immune-based neuro drug development.

Cell Culture Events Webinars:                     Single-use equipment extractables testing: a look forward

Tuesday, October 6, 2015  |  10:00 AM / 1:00 PM / 4:00 PM EST

Learn about the industry’s progress towards creating a standard for the design and execution of extractables studies for single-use equipment. The webinar attempts to place the discussion into a wider context. Assuming the industry adopts such a standard, what problems would this solve and what are the next questions the industry should consider for collaborative discussions and resolution?

More information can be found on this registration page here: https://cc.readytalk.com/cc/s/registrations/new?cid=pyhfva4hnjw7

Conferences:

September

• Cell Therapy Bioprocessing – September 30 – October 2, 2015 – The Hilton Alexandria Mark Center, Alexandria, VA http://www.ibclifesciences.com/CellTherapy/overview.xml

Roche Custom Biotech will be exhibiting at the Cell Therapy Bioprocessing Annual meeting in Alexandria, VA, September 30-October 2. Visit us in booth #8 to learn more about our range of solutions for Cell Therapy applications, including Liberase enzyme blends for dissociating cells from primary tissues, bio-analytical instrumentation, downstream proteases, and quality control testing kits. To learn more see Roche Custom Biotech Conference Activities

If you are attending Cell Therapy Bioprocessing, please use the #IBC_CTB15 hash tag to post information and to follow conference activites.

October

• Bioproduction – October 14-15, 2015 – Dublin, Ireland – http://www.informa-ls.com/event/bio-production14Benchmark technological developments and explore best practices in biomanufacturingThe biopharmaceutical industry is making a capital investment of approximately $8 billion in new facilities in Ireland, most of which has come in the last 10 years, representing close to the biggest wave of investment in new biotech facilities anywhere in the world.Join us at BioProduction 2015 in Dublin this October to see why so much is being invested in this area and to network with leading players within this growing industry!BioProduction 2015: Europe’s leading and largest event for a comprehensive update on all aspects of large scale biological manufacturing. Providing insights on the latest technologies, upstream/downstream processing, process analytics, the implementation of continuous manufacturing, facility design, flexibility facilities and single use systems to reduce inefficiencies during the biomanufacturing process.4 Conferences – 1 Exhibition – 1 Congress
  • Conference 1: Continuous Manufacturing
  • Conference 2: Upstream Processing – Production, Development & Analytics
  • Conference 3: Manufacturing Strategy & Technology
  • Conference 4: Downstream Processing

  For more information on the 2015 event please visit the event website at http://www.informa-ls.com/CQ3531BioproductionCellEL

• Bioprocessing International – October 26-29, 2015 Hynes Convention Center Boston, MA http://www.ibclifesciences.com/BPI/overview.xml

Don’t miss this interesting talk at BPI this year:

Innovating mAb Production to Support the Immunotherapy Revolution
A new paradigm in cancer therapy is emerging with the recent success of the antibody mediated, immune tumor killing response for melanoma. Evaluations have expanded to include a range of tumor types. In addition new alternatives and combinations are aimed at improving patient non responsiveness to PD-1. These foundational efforts of emerging cancer treatment need to be supported by agile antibody supply solutions that meet the capacity demands, while improving global access and lowering costs. Technology solutions have been implemented to speed process development and shorten the critical time to first in human clinical studies. Innovative approaches towards the ‘process of the future’ will be shown that support flexible multi product lower cost manufacturing. Continuous processing enabled by single use provides an integrated solution and the implementation challenges will be discussed.
David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc.

November

• Bioproduction Summit 2015 – November 2-3, 2015 – Hilton San Francisco Airport Bayfront – Burlingame, CA Bioproduction Summit 2015 will focus on quintessential topics in Biotech field, such as technology advances in protein production, Cell culture, Bioprocess Development and Novel protein therapeutics. http://www.bioproductionsummit.com
• World Vaccine Congress – November 3-5, 2015 – Sheraton Brussels Airport Hotel – Brussels, Belgium –  For 15 years the World Vaccine Congress in Europe has been the leading event to talk about scientific advances and find new business opportunities within the vaccine sector and this year is no exception. http://www.terrapinn.com/conference/world-vaccine-congress-europe/index.stm
• FAST: Functional Analysis & Screening Technologies Congress – November 9-11, 2015 – Renaissance Waterfront Hotel – Boston, MA -Cambridge Healthtech Institute (CHI) is pleased to announce the Third Annual FAST: Functional Analysis and Screening Technologies Congress. Now in its third year, the FAST Congress brings you the latest technologies and research in cellular screening. – http://www.fastcongress.com/

Headlines

“732,000: American Lives Saved by Vaccination,” The New York Times

“The vaccination of children from 1994 to 2013 will prevent 732,000 early deaths in the United States, according to a recent estimate by the Centers for Disease Control and Prevention.”

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”

“Not Up for Debate: The Science Behind Vaccination,” The New York Times The Upshot

“Whenever I sit down to watch a presidential debate, I have one sincere hope: that vaccines won’t come up at all. Besides the fact that there really is no “debate” when it comes to the science of how they work or how they may harm, merely talking in public about denying vaccines often leads to the solidifying of people’s views.”

If you like this story, please see our blog titled “Vaccines – An interesting discussion of past, present and future with Dr. Paul Offit”

“Over 2,000 Businesses Send Letter To Congress Demanding Attention To Tax Extenders Bill,” Forbes

“Last year, the Senate waited until just over two weeks left in the calendar year to pass a bill that extended certain tax provisions through December 31, 2014 (retroactive to January 1, 2014).”

If you like this story, please see our blog titled “New Report Forecasts Sustained Growth in the Pharmaceutical Market through 2020”

“Department of Health and Human Services, AstraZeneca to develop antibiotics,” Reuters

“The U.S. Department of Health and Human Services (HHS) said on Wednesday it signed a deal with British drugmaker AstraZeneca Plc to develop antibiotics.”

If you like this story, please see our blog titled “Quality by Design – Maintaining Strict Control of Bioprocess Conditions”

“Evotec, Pfizer hook up for fibrosis research,” Pharma Times

“Evotec and Pfizer have entered a four-year research pact to explore innovative approaches to the treatment of multi-organ fibrosis.”

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

“Cardiologist Nominated to Be Head of F.D.A.,” The New York Times

“The Obama administration on Tuesday nominated Dr. Robert Califf, a cardiologist and clinical researcher long affiliated with Duke University, to be the commissioner of the Food and Drug Administration.”

If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”

“Actelion in talks with ZS Pharma amid surge in biotech deal-making,” Reuters

“Swiss drugmaker Actelion Ltd has initiated talks that could lead to a bid for U.S. biotech company ZS Pharma Inc, marking the latest bout of deal-making in a healthcare sector that has seen a wave of recent takeovers.”

If you like this story, please see our blog titled “Achieving control and reproducibility of cell culture by eliminating serum”