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Aspen Alert

Issue # 3332 | November 18th, 2020      

   News Alert

CEO of BIO Says Industry May Sue to Stop Proposal to Lower Drug Prices

The CEO of BIO warned this week that the industry could sue to try to stop a proposal from the Trump administration to lower drug prices. The Trump administration could move forward as soon as this week on a proposal to lower certain Medicare drug prices by tying them to lower prices paid in other wealthy countries, an idea fiercely opposed by drug companies, which are now mobilizing both to try to stop the rule and plan for a fight if it does go forward. “I would say all tools would be at our disposal because it would just have such a devastating impact on our ability to bring new cures for patients,” Michelle McMurry-Heath told The Hill on Tuesday. 
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FDA Unexpectedly Rejects Alkermes Schizophrenia Drug, Citing Manufacturing Concerns 

The U.S. FDA has handed Alkermes another setback, citing manufacturing issues in refusing to approve the company's new schizophrenia medicine. Alkermes emphasized the agency raised no issues with data in the company's application for the drug, known as ALKS 3831, and hasn't requested any new studies. The FDA singled out tablet coating problems with specific development batches of the drug that have since been resolved, the company said. Data are available to address the FDA concerns, and the company is preparing a submission for regulators, Alkermes said. Chief Medical Officer Craig Hopkinson added the company sees "a clear path to resolution”.
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FDA Delays Decision on Bristol Myers Cancer Therapy Due to COVID-19 Travel Curbs 

Bristol Myers Squibb announced this week that the U.S. FDA has deferred a decision on an experimental blood cancer therapy that it acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions. This comes after the FDA  was unable to inspect a third-party manufacturing facility in Texas, a step required before the approval of the drug liso-cel, the company said. The health regulator warned earlier this year its level of timely reviews and approvals of marketing applications could be impacted by the COVID-19 crisis. The agency’s approval of liso-cel by Dec. 31, 2020, is one of the remaining milestones required for Celgene investors to receive a conditional payment of $9 per share.
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   Quote Alert

   On This Day Alert

 1883 - Railroads Create the First Time Zones 

At exactly noon on this day, American and Canadian railroads begin using four continental time zones to end the confusion of dealing with thousands of local times. The bold move was emblematic of the power shared by the railroad companies.
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  TED Alert

How to Co-Parent as Allies, Not Adversaries 

When Shaka Senghor and Ebony Roberts ended their relationship, they made a pact to protect their son from its fallout. What resulted was a poetic meditation on what it means to raise a child together, yet apart. In this moving and deeply personal talk, Senghor and Roberts share their approach to co-parenting -- an equal, active partnership that rolls with the punches and revels in the delights of guiding their child through the world with thought and intention.
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  Poll Alert

Are you worried about losing your job?

► Yes
► No

Previous Poll Results:

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  Bioprocess Alert

Embracing the Digital Transformation

When technology groups add consulting services to their portfolio, some customers are initially skeptical. The inevitable question is whether a major corporation like Siemens can offer advice independently of its own products and technological solutions. Siemens Digitalization Consulting has already accompanied numerous decision-makers at pharmaceutical companies on their path to digitalization. Its team of experts with backgrounds in industry, IT, and automation enables consultants to work closely in partnership with customers to develop and define their digitalization roadmap. The roadmap is based on the customers’ existing infrastructure and landscape – IT, IoT (Internet of Things), and OT (operational technology), among others – and is tailored to their business challenges and drivers. 
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Survey Alert

Do you currently have more than one supplier of Silicone and/or TPE bioprocess tubing qualified? 

► Yes
► No

Previous Survey Results:

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  Upstream Alert

Mass Transfer in Aerated Culture Media Combining Mixed Electrolytes and Glucose

The combined effects of mixed electrolyte species and glucose on oxygen transfer were studied in a bubble column with aqueous solutions. Of particular interest was the presence of electrolytes containing ions which are prone to present solute–solute interactions or to crystallize. Without and at low concentration of glucose (≤ 5 g/L), the increasing concentration of electrolytes (nominal ionic strength: 0–0.43 M), up to a critical value, enhanced the volumetric mass transfer coefficient (kLa) and the availability of specific interfacial area (a), due to the inhibition of bubble coalescence.
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Event Alert

Digital Transformation: Agility for a Changing Business Environment  

Thursday, November 19th, 2020

Abhay Kini
Director of Product Management, IDBS


No business is immune to change. A strategic approach to embracing technology can dramatically enhance an organization’s ability to respond to a dynamic business climate.  Such changes have forced every organization to accelerate their digital transformation to build a more agile and adaptable workforce. 
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 Downstream Alert

The Evolution of Overexpression and Protein Purification

In this presentation the host interviews NEB Scientists Mehmet Berkman and Paul Riggs about the lessons that New England Biolabs has learned about protein expression and purification over the last 40 years.
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  Podcast Alert

Modernizing Phage Therapy to Kill Multidrug Resistant Bacteria 

Bacteriophages have long been used to treat infections. These naturally occurring virus are capable of killing bacteria, but each strain of phage is highly specific. Because of their unique mechanism of action, they provide a potential to address the growing threat posed by multidrug-resistant bacteria, but to treat someone, the right phage must be matched to each patient’s infection. Adaptive Phage Therapeutics believes it’s found a way to create phage therapies suited to treat patients with drug-resistant infections by building a bank of targeted and genomically-screened bacteriophage and testing individual patient’s bacterial colony against that to determine the appropriate phage to treat them. We spoke to Greg Merril, co-founder and CEO of Adaptive Phage Therapeutics, about the origins of the company, how its technology works, and the regulatory hurdles for producing customized therapies to treat individual patients.
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  Regulatory Alert

FDA Commits to Data Transparency in COVID EUAs

As the time draws near for the leaders in the global race for a vaccine against COVID-19 to submit emergency use authorization (EUA) authorizations to the US FDA, the agency has proclaimed a new commitment to transparency. With a stated goal of disclosing information from COVID-19-related EUA review documents “as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals,” the FDA also reserved to itself the ability to redact trade secrets or other information that would be exempt from disclosure under the Freedom of Information Act (FOIA) or protected from disclosure by other legislation.
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  Discovery Alert

More than Half of In-Hospital Deaths from COVID-19 Among Black, Hispanic Patients, Study Finds

More than half of all in-hospital deaths due to COVID-19 during the first six months of 2020 were among Black and Hispanic patients, according to a new study led by researchers at the Stanford University School of Medicine and Duke University. The researchers did not find any racial or ethnic differences in mortality rates among people hospitalized with the disease. Yet a disproportionate number of Black and Hispanic people became sick enough to require hospitalization, and they made up 53% of inpatient deaths. Fatima Rodriguez, MD, assistant professor of cardiovascular medicine at Stanford, is the lead author of the study, which was published this week in Circulation.
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  Project Alert

Caris Life Sciences Adding 65,000 Sq. Ft. in Arizona 

Caris Life Sciences, which is currently operating out of three different office and lab spaces around Phoenix, has recently announced the signing of a new lease. This latest lease of roughly 65,000 square feet is expected to create 300 new jobs
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  Patent Alert

Multimodal Anion Exchange Matrices 

A U.S. Patent for "Multimodal Anion Exchange Matrices" was awarded to Cytiva on October 27th, 2020. The present invention discloses a separation matrix which comprises a plurality of separation ligands, defined by the formula R.sub.1-L.sub.1-N(R.sub.3)-L.sub.2-R, immobilized on a support, wherein R.sub.1 is a five- or six-membered, substituted or non-substituted ring structure or a hydroxyethyl or hydroxypropyl group; L.sub.1 is either a methylene group or a covalent bond; R.sub.2 is a five-or six-membered, substituted or non-substituted ring structure; L.sub.2 is either a methylene group or a covalent bond; R.sub.3 is a methyl group; and wherein if R.sub.1 is a hydroxyethyl group and L.sub.1 is a covalent bond, R.sub.2 is a substituted aromatic ring structure or a substituted or non-substituted...
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  Solution Alert

Cell Culture

Real-Time Characterization of Mammalian Cell Culture Bioprocesses by Magnetic Sector MS
 
Mammalian cell culture processes were characterized upon the analysis of the exhaust-gas composition achieved through the on-line integration of a magnetic sector MS analyzer with benchtop bioreactors. The non-invasive configuration of the magnetic sector MS provided continuous evaluation of the bioreactor's exhaust gas filter integrity and facilitated the accurate quantification of O2 and CO2 levels in the off-gas stream which ensured preserved bioreactor sterility prior to cell inoculation and provided evidence of the ongoing cellular respiratory activity throughout the cultures. Real-time determination of process parameters such as the Respiratory Quotient (RQ) allowed for precise pin-pointing of the occurrence of shifts in cellular metabolism which were correlated to depletion of key nutrients in the growth medium, demonstrating the suitability of this technology for tracking cell culture process performance.
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  Fact Alert

The Mandarinfish is one of only two species known to produce cyanophores, which are blue-pigmented, light-reflecting cells, to achieve its blue coloring. 

Other animals that appear to be blue, such as peacocks, don’t actually produce a blue pigment. They have colorless cells which reflect light making it appear blue.
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   Career Alert

RemeGen Biosciences
Manager/Director, CMC Regulatory Affairs
South San Francisco, CA

This role requires you to interact across all development functioins at RemeGen, including process development, analytical development, manufacturing, quality control and quality assurance. Learn More

Molecular Templates
Senior Scientist, Upstream Process Development
Austin, TX
Molecular Templates is seeking an experienced and dynamic professional to design and scale-up fermentation processes from the laboratory through pilot plant and manufacturing. Learn More

Emerson
Sr. Life Sciences Industry Consultant - Automation, Digitalization, Manufacturing
Royersford, PA
The ideal candidate will be able to analyze clients’ needs, business objectives, and challenges to define a solution roadmap that meets objectives and present an impactful value message to the client’s business and technology leadership. Learn More

Bayer
Protein Purification Scientist II
Chesterfield, MO
The primary responsibilities of this role are to conduct research and contribute to research projects, technologies, publications, intellectual property or trade secrets. Learn More

CHO Plus
Senior Scientist / Director Cell Engineering
South San Francisco, CA
This is a high-level molecular biologist position with responsibility for cutting edge cell line creation and contact with customers and partners. Learn More

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