This week’s biotechnology news headlines include, gene tests identify breast cancer patients who can skip chemotherapy study says, Pfizer boosts cancer drug roster with $14 billion Medivation deal, Eli Lilly and Astra Zeneca get Fast Track status for Alzheimer’s drug, Gov. Jerry Brown again weighs access to experimental drugs for the terminally ill, Regeneron wins up to $8.9 from BARDA toward MERS therapies, PhRMA and BIO offer growing support for PDUFA VI performance goals, and CRISPR takes the wraps off joint venture with Bayer.

Cell Culture Events

Workshops:

VISION leadership course is uniquely tailored for the bioindustry to capture the synergies between bioscience, technology and business practice – Keck Graduate Institute, Claremont, CA – September 14-16, 2016

UCL Biochemical Engineering in collaboration with Keck Graduate Institute is announcing its 2016 VISION Leadership Programme. Designed for talented high impact individuals, VISION provides executive leadership insights tailored for present & future leaders in the bioindustries through rigorous intellectual analysis & intensive, practical, peer-to-peer action-based learning giving you the tools required to drive innovation, entrepreneurship & global leadership in your organisation.

KEY BENEFITS AND IMPACT:

• Know how to make the transition from science & engineering based decision making towards company- wide strategic resolutions
• Build an invaluable network with elite peers & experts from academia & industry who challenge, stimulate & inspire you
• Gain perspectives on leadership challenges & critical business issues facing the bioindustry globally & formulate actions to address these
• Learn from real life cases studies to succeed in making difficult decisions & implementing strategies to secure a more robust future for your business
• Access & share best practices on how to be a good leader & avoid pitfalls in constantly evolving market
• Achieve your personal development & career objectives
• Evaluate the impact of key innovative research & technologies on the future of business & manufacturing

CONFIRMED SPEAKERS FOR 2016

Barry Buckland, CEO, BiologicB
Charles Cooney, Professor, MIT
Nigel Darby, former VP, GE Healthcare
Parrish Galliher, CTO, GE Healthcare
Phil Gomez, Principal, PricewaterhouseCoopers
Ljiljana Minwalla, Senior Legal & Patent Counsel, Mesoblast, Inc.
Andrew Ramelmeier, Senior VP, Portola Pharmaceuticals
Rahul Singhvi, COO, Takeda Vaccines

WHO SHOULD ATTEND

• Managers & practitioners fast tracked for executive roles or intending to move into leadership positions
• Current executives intending to interact with fellow leaders & expert speakers to debate & exchange novel thoughts & opinions
• Funding agencies wanting to interact with present & future thought leaders to gain insights into the sector trends & skills required to navigate the changing bioindustry landscape

 VISION combines innovative management thinking with cutting edge research to ensure high flyers perform optimally

For more information contact naveraj.gill@ucl.ac.uk and visit www.ucl.ac.uk/biochemeng/visionprogramme

Webinars:

The Role of Exosomes in Inflammatory Disease: Pathogenesis and Treatment

Date: Thursday, September 22, 2016

Time: 02:30 PM Eastern Daylight Time

Duration: 1 hour, 30 minutes

Exosomes encapsulate and transport a wide variety of molecules generated by their cell-of-origin, a process now thought to be a form of cellular signaling. Exosome signaling is common across cell types and species, but it is of particular interest in diseases with an inflammatory component. While exosome isolation and analysis is useful to understanding the mechanisms behind these multifaceted diseases, exosomes may also be exploited for their therapeutic potential. The Scientist is bringing together a panel of experts to review the current knowledge on exosomes in inflammation, and to explore the potential for exosome-based therapeutics. Attendees will have the opportunity to interact with the experts, ask questions, and seek advice on topics that are related to their research.

Topics to be covered:

• The exosomal cargoes released during inflammation, and their potential as therapeutic targets
• How inflammatory diseases are uniquely suited to exosome analysis

Register here

Bioprocess Insights Webinars

The biopharmaceutical industry has developed into a multi-billion dollar market in just 30 years. Making decisions and setting up strategies in a rapidly changing environment can be challenging. The difference between a good and a great decision can have extensive implications for the future of a company. In this environment, knowledge and experience are what make the difference. Good insights about, for example, technical advancements, process economy implications, and sustainability aspects can help improve the individual decisions and strengthen the overall business strategy.

In this webinar series, four renowned subject matter experts will share their insights into four areas of bioprocessing: upstream, vaccines, downstream, and single-use technology. We will present tangible, recently developed data that can help you in developing modern, cost-efficient, and sustainable bioprocesses.

Don’t miss these on demand webinars – http://www.bioprocessintl.com/sponsored-content/bioprocess-insights-webinars/

Conferences:

September

• BioAnalytical and Formulaiton Summit – September 14-15, 2016 – Berlin, Germany https://lifesciences.knect365.com/bioanalyticalandformulationThe Bioanalytical & Formulation Summit provides the ultimate opportunity to discuss your current challenges in analytical methods for biologics, with 2 streams dedicated to:
  • Protein Characterisation and Post Translational Modifications
  • Formulation for Biologics

  Join your peers for expert insight, new data, and the latest technology updates for formulation and QC strategies, to inform your methods and improve your product quality and efficacy.

October

• Bioprocessing International Co-Located with Cell Therapy Bioprocessing – October 4-7, 2016 – Boston Convention Center and Exhibition Center – Boston, MA http://www.ibclifesciences.com/BPI/overview.xml

• World Vaccine Congress Europe – October 10-12, 2016 – Barcelona, Spain http://www.terrapinn.com/conference/world-vaccine-congress-europe/index.stm

• Adoptive T-Cell Therapy Summit Europe 2016 – October 10-11, 2016 – London, UK www.tcellsummit.com

• Bioproduction – October 14-15, 2016 – Dublin, Ireland http://www.informa-ls.com/event/bio-production14

November

• 2^nd Annual Cell & Gene Therapy Congress – November 3-4, 2016 – London, UK – http://www.celltherapy-congress.com/Over 250 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions.Over 20 presentations and case studies focused on the key issues in cell & Gene Therapy development, updates in regulatory pathways, commercialisation, bioprocessing and manufacturing

  2 interactive streams:

  Cell & Gene Therapy: Development, Clinical Trials & Commercialisation

  Cell Therapy Bioprocessing and Manufacturing

  Co-located with the established 5th Annual Cell Culture & Bioprocessing Congress and 3rd Annual Stem Cell Congress

  Free Pre-Congress Webinar

  Advances In Gene Editing Technologies
  Presented by Richard Morgan, Vice President, Immunotherapy at Bluebird Bio. – Register for free today >>

• 5th Annual Cell Culture & Bioprocessing Congress – November 3-4, 2016 – London, UK – http://www.cellculture-congress.com/Over 170 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions50 presentations, case studies and panel discussions focused on the key issues in cell line optimisation, process development and biological production

  4 interactive streams:

  Early Cell Line Development

  Process Development

  Late Stage Cell Line Development

  Biological Production

  14 pre-scheduled one to one meetings, exhibition and informal networking opportunities

  Co-located with our 3rd Annual Stem Cell Congress and our 2nd Annual Cell & Gene Therapy Congress

• TIDES Europe – November 14-17, 2016 – Berlin, Germany – http://get.knect365.com/tides-europe/TIDES Europe is the place where oligo and peptide experts go to meet and build successful partnerships to accelerate products from early discovery through late stage development and commercialisation. In 2015 Tides Europe attracted a 40% increase in attendance across the oligo and peptide audience.
• World Immunotherapy Congress 2016 – November 14-16, 2016 – Basel Switzerland http://bit.ly/1rbnrYy

• World Precision Medicine – November 14-15, 2016 – Washington DC

The World Precision Medicine Congress USA is bringing together big pharma, big data, and healthcare providers to discuss the scientific, economic, and policy goals towards producing precise and genomic-based medicines. Partnered with forward-looking industry leaders such as precisionFDA and NantWorks, this event will fast-track our momentum into the future paradigm of healthcare by spurring the important discussions to get us there.

Can you afford to miss this gathering of precision medicine leaders? Pharma, big data, and healthcare providers will be there attending sessions on Gene Therapy, Cell Therapy, personalized medicine, and genomics.

Download the brochure: http://bit.ly/1N3Y0vI

Register to attend: http://bit.ly/1ObpkNV

December

• ASCB – December 3-7, 2016 – San Francisco, CA http://ascb.org/meetings/

• World Stem Cell Summit & RegMed Capital Conference– December 6-9, 2016 – West Palm Beach, Florida http://worldstemcellsummit.com/

• Antibody Engineering and Therapeutics – December 11-15, 2016 – San Diego, CA http://www.ibclifesciences.com/AntibodyEng/overview.xml

• Global Biomanufacturing Summit – December 12-14, 2016 – San Diego, CA http://biomansummit.com/

Headlines:

“Gene Tests Identify Breast Cancer Patients Who Can Skip Chemotherapy, Study Says,” The New York Times

“When is it safe for a woman with breast cancer to skip chemotherapy? A new study helps answer that question, based on a test of gene activity in tumors. It found that nearly half of women with early-stage breast cancer who would traditionally receive chemo can avoid it, with little risk of the cancer coming back or spreading in the next five years.”

If you like this story, please see our blog titled “Poster: Flow Electroporation Provides a Highly Efficient, Flexible and Scalable Transient Protein Expression System”

“Pfizer boosts cancer drug roster with $14 billion Medivation deal,” Reuters

“Pfizer Inc (PFE.N), beating out numerous other bidders, said it agreed to buy U.S. cancer drug company Medivation Inc (MDVN.O) for $14 billion in cash, adding its blockbuster prostate cancer drug Xtandi to the company’s growing oncology roster.”

If you like this story, please see our blog titled “Cool Tool –Smart Cell Culture Monitoring, Transform single cell parameters into cell culture intelligence”

“Eli Lilly, AstraZeneca Get Fast-Track Status for Alzheimer’s Drug,” The Wall Street Journal

“AstraZeneca PLC said Monday that the Alzheimer’s drug it is codeveloping with Eli Lilly & Co. has received fast-track designation from the U.S. Food and Drug Administration, a status designed to speed up the development of promising new medicines.”

If you like this story, please see our blog titled “Cell Therapy for Parkinson’s Disease – An update on the move toward clinical trials”

“Gov. Jerry Brown to again weigh access to experimental drugs for the terminally ill,” The Los Angeles Times

“For the second consecutive year, Gov. Jerry Brown will have to decide on a measure that would allow gravely ill patient access to experimental drugs. The Assembly on Tuesday gave final legislative approval to Assemblyman Ian Charles Calderon’s so-called “right-to-try” legislation, which authorizes drug and medical device manufacturers to make their products available to terminally ill patients, even if the products have not yet been cleared by the federal Food and Drug Administration.”

If you like this story, please see our blog titled “Increase Protein Yield by Striking the Right Balance between Cell Density and Protein Productivity”

“Regeneron Wins Up to $8.9M from BARDA toward MERS Therapies,” Genetic Engineering News

“Regeneron Pharmaceuticals said today it will manufacture and study two antibody therapies for potential prevention and treatment of Middle East respiratory syndrome (MERS) under an up-to-$8.9 million agreement with the U.S. Biomedical Advanced Research and Development Authority (BARDA).”

If you like this story, please see our blog titled “Reduce Cell Line Development Time by 30% and Simplify Proof of Clonality – A Case Study”

“PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals,” Regulatory Focus

“More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022.”

If you like this story, please see our blog titled “Gene Therapy Strengthened by Recent Successes”

“CRISPR takes the wraps off joint venture with Bayer,” The Boston Globe

“Eight months after striking a $335 million partnership deal, startup CRISPR Therapeutics and Germany’s Bayer AG are taking the wraps off the new company formed to develop drugs using CRISPR’s gene editing technology.”

If you like this story, please see our blog titled “Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation”