This week’s biotechnology news headlines include, Pfizer and South Africa to produce pneumococcal vaccine, specialty drugs, Pfizer and Allergan in merger talks, orphan drug guidance, Sanofi and BioNTech launch cancer immunotherapy collaboration, BMS acquiring Cardioxyl, and Sanofi expects first dengue vaccine license in Q4.

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:

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/

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

“Pfizer partners with South Africa to produce pneumococcal vaccine,” Reuters

“Global pharmaceutical company, Pfizer, has partnered with South Africa’s Biovac Institute to produce a potentially life-saving pneumonia vaccine for infants, a cabinet minister said on Tuesday.”

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

“Myths And Facts About Specialty Drugs,” Forbes

“The ongoing debate over specialty drugs — reflecting conflicting motives of buyers and sellers — neglects important insights about the impact of these new technologies, their value to society, and the economics of medical R&D.  We here disentangle the facts from the myths surrounding these products.”

If you like this story, please see our blog titled “Enabling High Throughput 3D Cell Culture Using Automation”

“Pfizer, Allergan drug merger talks raise tax hackles in U.S.,” Reuters

“Pfizer is already facing political pushback at home that is only likely to intensify with the U.S. presidential campaign underway, as candidates take aim at high prescription drug prices and companies looking to avoid paying U.S. taxes.”

If you like this story, please see our blog titled “Cool Tool – STEP Technology for the rapid generation of very high producing stable CHO cell lines”

“Industry Seeks More Specifics on FDA’s Flexibility With Orphan Drug Guidance,” Regulatory Focus

“Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its “regulatory flexibility” with orphan drug reviews.”

If you like this story, please see our blog titled “Part II – A Look at the State of Cell Therapy – Current Manufacturing Options and Opportunities for Further Advancements”

“Sanofi, BioNTech Launch Up-to-$1.5B Immuno-Oncology Alliance,” Genetic Engineering News

“Sanofi and BioNTech have launched an exclusive collaboration to discover and develop up to five cancer immunotherapies, the companies said today, in a deal that could generate more than $1.5 billion for BioNTech.”

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

“BMS to acquire heart drug group Cardioxyl in $2bn deal,” PharmaTimes

“Bristol-Myers Squibb is acquiring private US biotech Cardioxyl in a deal that could be worth more than $2 billion.”

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

“Sanofi expects first dengue vaccine license in Q4,” Fierce Vaccines

“After Sanofi’s ($SNY) sizable investment into its dengue vaccine program, new company CEO Olivier Brandicourt said on the Q3 call that the French pharma expects its first license to market the vaccine by year end, FiercePharmaAsia reported.”

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