LabConnect, LLC, a leading global provider of central laboratory and support services for biopharmaceutical, medical device and contract research organizations, has completed phase one of an 11,000+ square foot facility expansion in Johnson City, Tennessee. The new space will significantly increase the capacity for peripheral blood mononuclear cell (PBMC) processing and allow LabConnect to better serve its clients.
As a response to its 30 percent growth since 2017, LabConnect’s facility expansion is essential to serving increasingly complex studies and the related demand for corresponding services. Phase one expanded the company’s clinical sample kit-building and storage capabilities. Phase two of the facility upgrade will add more offices and project management space, while phase three will build out the PBMC laboratory capabilities.
“We have grown every year since our founding in 2002, and we are committed to maintaining our facilities with cutting-edge technology,” said Eric Hayashi, president and CEO of LabConnect. “It is an exciting time to be building our business, constantly improving sample testing services to meet clients’ needs and helping to save lives while supporting clinical trials.”
LabConnect’s expansion will be complete in September 2018. A detailed moving plan has been developed to ensure seamless business continuity, regulatory compliance and sample integrity.
AveXis, a Novartis company based in Illinois, is investing $55 million to build a new manufacturing facility in Durham, North Carolina. The facility will create 200 jobs.
AveXis will use the new plant to make its first product candidate, AVXS-101, a gene therapy to treat three types of spinal muscular atrophy (SMA). SMA Type 1, also known as Werdnig Hoffmann disease, is a severe form of SMA. It usually is seen before six months of age and includes worsening muscle weakness and hypotonia (poor muscle tone) because of the loss of lower motor neurons in the spinal cord and brain stem. There are also feeding and breathing problems. The disease is caused by mutations in the SMN1 gene. Currently the only treatment approved by the U.S. Food and Drug Administration (FDA)is Biogen’s Spinraza (nusinersen).
Durham was competing with the state of Illinois for the site. Illinois approved tax credits of almost $8 million to bring the jobs to Libertyville, Illinois. But AveXis took a $3 million incentive package in North Carolina.
“It’s notable that AveXis has chosen to expand its manufacturing operations in North Carolina,” North Carolina’s Secretary of Commerce, Tony Copeland, said in a statement. “Life science companies understand the many advantages of our state offers manufacturers, particularly the investments North Carolina has made in education and workforce training for the biotechnology industry.”
The new jobs will be in engineering, manufacturing and supply chain. They will have minimum average salaries of $103,449, compared to the average wage in Durham County of $67,537.
In addition to AVXS-101, AveXis plans to develop other therapeutics for rare neurological diseases, including Rett syndrome and a genetic type of amyotrophic lateral sclerosis caused by mutations to the SOD1 gene.
“The transformation of gene-based technologies into economic impact in North Carolina continues to be a focus of the Biotechnology Center, not only for human health but also for animal health and agriculture,” said Bill Bullock, senior vice president of statewide operations & economic development with the North Carolina Biotechnology Center,” reportedWRAL TechWire.
Pfizer also recently announced it was investing $100 million and adding gene therapy capabilities to its manufacturing campus in Sanford, North Carolina. Bluebird bio, also in Durham, has done the same.
AveXis acquired rights to its gene therapy technology in 2015 from Asklepios BioPharmaceutical (AskBio), a company based in Chapel Hill, North Carolina. AskBio received an upfront payment and is eligible for milestone payments and royalties based on AveXis progress and possible commercialization.
On April 9, AveXis announced it had agreed to be acquired by Novartis for $218 per share or a total of $8.7 billion in cash. This was an 88 percent premium on its April 6, 2018 closing price. Both companies’ boards unanimously approved the merger. The close is expected in mid-2018.
“The commitment, drive and expertise of the entire AveXis team has created significant stockholder value, and we are pleased that Novartis recognizes that value in the potential of AVXS-101, our first in class manufacturing capabilities and our gene therapy pipeline, all of which serve to transform the lives of people devastated by rare and life threatening neurological diseases such as SMA, Rett syndrome and genetic ALS,” said Sean Nolan, AveXis’ president and chief executive officer, in a statement at the time. “With worldwide reach and extensive resources, Novartis should expedite our shared vision of bringing gene therapy to these patient communities across the globe as quickly and safely as possible.”
After a two-year wait, AstraZeneca finally has employees under one roof in the Bay Area. The U.K.-based company moved employees from several subsidiaries located across the area into a 163,000-square-foot facility in South San Francisco known as The Cove at Oyster Point.
AstraZeneca’s new facility will have employees from subsidiary companies Acerta Pharma, MedImmune, Pearl Therapeutics and AstraZeneca’s TIDE (Technology Innovation & Delivery Excellence) working side-by-side on their therapeutic missions. The parent company moved about 400 employees into The Cove this week.
Sean Bohen, head of global medicines development and AstraZeneca’s chief medical officer, called the opening of the new site a milestone for the company. He said it enabled employees from four organizations under the AstraZeneca umbrella to “work side-by-side at the center of where biotechnology and high-tech industry intersects.”
“This is a demonstration of our commitment to a strong and visible presence in California, our continued growth through science- and collaboration-led innovation, and our dedication to being a great place to work for current and future employees,” Bohen said in a statement.
Bahija Jallal, president of MedImmune, agreed with Bohen. Jallal said collaboration is a “key driver of innovation” and added that it was at the core of the company’s culture.
“The opening of our new South San Francisco site brings together the best of both worlds — a shared drive across our employee base to advance great science and bring new treatments to patients, while providing an opportunity to tap into the Bay Area’s transformative biotech ecosystem, helping to foster great progress internally and externally,” Jallal said in a statement.
The Cove, a project of HCP Life Science Estates, broke ground in 2015. When the spades first bit into earth The Cove was billed as South San Francisco’s first ground-up multi-tenant life science development in nearly a decade. The campus design consists of seven buildings ranging in size from 102,000 square feet to 158,000 square feet in both single- and multi-tenant building configurations. In addition to AstraZeneca, other companies who have space in The Cove include LakePharma, Five Prime Therapeutics, Denali Therapeutics and CytomX Therapeutics.
But AstraZeneca isn’t alone among the big pharma companies taking over space in the Bay Area. Two years ago Merck cut a deal with Alexandria Real Estate Equities, Inc. to build a nine-story, 294,000 square foot facility with research space and office space in the 200 block of East Grand Avenue. Construction began on the project last year and is anticipated to be ready for occupancy next year.
The South San Francisco area has about 10 million square feet of life science research spacenow, with more than half of that already in use. A number of developments have sprung up in the area to provide homes for these innovative companies, including BioMed Realty’s Gateway of the Pacific project — a proposed 1.3 million square foot campus that will include ample office and laboratory space. The first phase of the project is scheduled to develop about 500,000 square feet.
The 1987 Montreal Protocol is widely touted as an environmental success story, one that staved off expansion of the ozone hole above Antarctica (pictured). But someone is cheating on that international agreement, The Washington Post reports. Scientists have detected a 25% uptick in emissions of CFC-11—an ozone-destroying chemical—since 2012. CFC-11 was once commonly used in insulating foams, but it’s now banned under the Montreal Protocol and reported production is close to zero. The startling resurgence of the chemical, reported in Nature, will likely spark an international investigation to track down the mysterious source.
Police in the German state of Bavaria now have the authority to analyze forensic DNA samples to predict the geographical ancestry and physical characteristics—hair color, eye color, skin color, and age—of an unknown suspect who poses an imminent danger. The controversial law, which passed the Landtag, the state parliament in Munich, on 15 May, is the first in Germany to allow what has been dubbed DNA phenotyping, and it has sparked renewed debate here and in other countries about the advantages—and risks—of such methods.
German federal authorities, and police in the country’s 15 other states, are only allowed to perform DNA fingerprinting, in which they look for an exact match between crime scene DNA and samples in a database of known criminals or from a suspect. DNA phenotyping and ancestry prediction, however, have been used in the Netherlands, France, the United Kingdom, Canada, and several U.S. states. Some of those jurisdictions have explicit laws permitting and regulating the practice. In others, police have begun to use DNA phenotyping without explicit regulation. Well-publicized success stories—and advances in the science—have fed interest in the method. Switzerland, like Germany, does not allow such use of DNA, but lawmakers there are considering reversing that ban.
Traces of DNA from items at a crime scene can predict a person’s hair, eye, and skin color—and more, some say.
PHOTO: ISTOCK.COM/D-KEINE
Some critics caution that although the underlying science connecting genetic markers to certain physical features is solid, DNA phenotyping and ancestry prediction can still be easily misunderstood by police and the public. Proponents “exaggerate the numerical certainties,” says Veronika Lipphardt of the Albert Ludwigs University of Freiburg in Germany, who studies the history and uses of population genetics. “That creates the impression that it’s clear-cut what race someone is or where someone comes from, and that’s not true.” One U.S. company is even using DNA phenotyping to create facial sketches of suspects, which goes beyond what many scientists now consider credible.
“You would need a lot of training of police forces to use [DNA phenotyping] responsibly,” says legal scholar Carsten Momsen of the Free University of Berlin, who worries the technique could lead to the targeting of minority groups. Bavaria’s new law doesn’t cover investigations of crimes that have already been committed; those are still ruled by federal law. Instead, it allows DNA phenotyping in situations of “imminent danger,” when police suspect someone is planning a serious crime. For example, authorities could analyze trace DNA found on stashes of weapons or bombmaking materials. The uncertainties in the technique can be especially problematic in such high-pressure situations, Momsen says.
Geneticist Manfred Kayser of Erasmus University Medical Center in Rotterdam, the Netherlands, who has developed several of the DNA phenotyping techniques permitted under the new Bavarian law (Science, 18 February 2011, p. 838), acknowledges that “there has to be education and training involved. You have to be able to work with probabilities.” Still, Kayser notes that police constantly have to decide how trustworthy various kinds of evidence are. At least investigators can quantify the uncertainty in results from DNA analyses, he says. “With eyewitness testimony you have no idea if it’s right or wrong.”
The techniques attempt to wring information out of traces of blood, skin, semen, or other DNA-containing cells found at a crime scene. They read single-nucleotide polymorphisms (SNPs), individual DNA bases that can vary between people and directly influence or correlate with differences in certain physical features. From databases of SNP variants and people’s appearances, scientists can build computer models that predict someone’s likely hair, eye, and skin color from their DNA. They can also use age-related chemical changes in DNA to estimate a person’s age to within about 4 years.
The accuracy of the results depends on several factors, including the quality—and quantity—of the sample tested and whether the genetic variants found in the sample are well-represented in the model databases. Kayser and his colleagues in Rotterdam and at Indiana University-Purdue University Indianapolis recently released their latest iteration of a tool called HIrisPlex-S. The test returns probabilities for three eye colors (blue, brown, or green/hazel); red, blond, brown, or black hair; and five skin shades, ranging from “very pale” to “dark-black.”
In April, they reported in Forensic Science International: Genetics that the test correctly predicted all three characteristics for 17 out of 19 simulated crime scene samples. (Two samples did not have high enough quality DNA to make a prediction.) The test also correctly identified five out of six other samples as having cells from two or more people, although it could not say what they looked like. Police in the Netherlands and France have used the test for eye and hair color in several cases. Ancient DNA researchers have also used it to predict characteristics of people known from archaeological remains.
Going beyond skin, hair, and eye color to predicting geographical ancestry is harder. Computer programs can compare a suspect’s SNP patterns to those in databases from multiple populations. But some populations may be missing from the databases and others may be indistinguishable because of mixing. Telling whether a person’s ancestors were East Asian, African, Native American, Western Eurasian, or from Oceania is fairly straightforward. But predicting whether someone has northern European versus Middle Eastern ancestry is sometimes impossible.
Still more controversial is Parabon NanoLabs in Reston, Virginia, a company that generates facial shape profiles in addition to skin, eye, and hair color and geographical ancestry. Ellen Greytak, its director of bioinformatics, says the firm starts with a standard face based on the person’s DNA-derived ancestry and sex. Further analysis of genetic markers leads to a face that “emphasizes the features we predict will be distinctive” about the person, she says.
That goes too far, Kayser says. “The science is not there at all.” The company has not published its methods or systematic validation tests, he notes. Greytak says the company doesn’t claim to produce an exact portrait. “It’s not going to point to an individual. It’s going to exclude people. … The vast majority of people are not going to fit the description.” The company’s website describes several cases where its phenotyping helped authorities find a culprit.
Ironically, DNA phenotyping might have been of little use in the case that helped prompt the new Bavarian regulations. In late 2016, a medical student was raped and murdered in Freiburg; an asylum seeker, originally from Afghanistan, was convicted of the crime. But some authorities complained that they could have narrowed their search more quickly if they had been able to use trace DNA to predict what the culprit looked like and where they might be from.
The crucial evidence in the Freiburg murder case, however, was nongenetic: a strand of hair with an unusual dye pattern—dark at the root, blond at the ends. Police spotted the suspect, who had the same dye pattern, in surveillance video from a tram stop near the crime scene. A DNA test would have only indicated dark hair, not enough to pick out the suspect in the video footage. Kayser agrees that the case wasn’t well suited to argue for a law to allow DNA phenotyping. “It was the wrong case to make that claim,” he says.
Baxter International Inc. (NYSE: BAX), a leader in innovative technology for medication delivery, announced the U.S. Food and Drug Administration (FDA) clearance of the Spectrum IQ Infusion System with Dose IQ Safety Software. The Spectrum IQ system is the first-of-its-kind designed specifically for bi-directional electronic medical records (EMR) integration with new exclusive features to help ensure the correct medications and fluids are delivered to the patient. The Spectrum IQ system also builds upon proven Spectrum infusion pump technology and Baxter’s comprehensive approach to patient safety to help make drug library compliance, protection for high-risk infusions and auto-programming more consistently achievable for health systems (see also Baxter International Inc.).
“EMR integration is an important step in making infusions safer, which is why Baxter designed the Spectrum IQ system with features that simplify EMR integration and help customers overcome EMR integration adoption barriers,” said Scott Luce, general manager, U.S. Hospital Products, Baxter. “These features set a new standard for medication administration, helping enhance both patient safety and clinician efficiency.”
The Spectrum IQ system provides the broadest range of auto-programming workflows and feature sets as well as embedded on-screen barcode technology that helps eliminate the need for a sticker barcode and provides clinicians with scan prompts to help maintain or increase auto-programming compliance and automatically document infusion data into the EMR. In addition, the Spectrum IQ pump is the only infusion pump to feature Line Check Notification technology* that supports line management by providing a visual notification matching the infusion pump and the medication being infused.
For the Spectrum IQ Infusion System, Baxter has partnered with First Databank (FDB) to integrate FDB Infusion Knowledge™-an evidence-based library of IV medications-into Dose IQ Safety Software to help make delivery of infusions safer. FDB, a leading provider of drug and medical device knowledge, supports healthcare professionals in making informed decisions at the point of care, intended to improve the quality of patient care.
“Creating and maintaining drug libraries used for configuring smart pumps requires substantial research and development time,” said Charles Tuchinda, MD, MBA, president, FDB. “Dose IQ Safety Software powered by FDB Infusion Knowledge helps save time by providing a knowledge base of suggested infusion parameters for the Spectrum IQ Infusion System, including dose limits, concentrations and durations. Integrating evidence-based practices into the clinical workflow helps facilitate improved patient safety, expedited drug library creation and efficient deployment and implementation of the Spectrum IQ pump, which helps protect more infusions.”
The Spectrum IQ pump also includes leading features designed to help drive the highest levels of drug library compliance in the industry, such as automatically defaulting to the installed drug library without requiring clinicians to take extra steps to utilize the safety features and wireless drug library updates without interrupting clinical workflow. Baxter’s Spectrum systems-including the Spectrum IQ system-are the only infusion pumps with a built-in Dose/Rate Change Error Prevention Feature, which helps clinicians protect high-risk infusions during titrations, and helps allow pharmacists to customize dose change limits for individual drugs.
Pfizer will have to cut the price of its leukaemia drug Mylotarg to get regular funding from the NHS, after Englands NICE said it could only be used in about 35% of eligible patients.
NICE said it was limiting use in draft guidance because Mylotarg (gemtuzumab ozogamicin) is slightly too expensive for a subgroup of patients with acute myeloid leukaemia (AML).
Mylotarg is approved for people aged 15 years or older with newly-diagnosed AML in combination with chemotherapy, if they have CD-33 positive disease.
But NICE has only recommended Mylotarg in patients who clearly have the mutation present if there is any doubt NICE said the drug is not cost-effective.
According to Pfizer around 65% of eligible patients will not have their treatment funded by the NHS as a result of the ruling.
However NICEs appraisal of Milotarg shows that for this group, Milotarg would cost 31,709 per QALY gained in patients with intermediate cytogenetic status, just above NICEs 30,000 upper threshold.
This suggests that a small discount from the already-confidential list price could swing things in Pfizers favour.
Craig Eagle, head of oncology at Pfizer, said the company will continue working with NICE to ensure that all patients who are eligible to benefit from this treatment are able to access it once a final recommendation is issued.
NICE is consulting on the draft guidance until 18 June, ahead of a final draft due later this year.
Mylotarg was first approved in 2000 and was the worlds first antibody-drug conjugate, consisting of a cancer-seeking antibody bound to a cytotoxic compound unleashed when the drug binds to its target.
But Pfizer voluntarily withdrew in 2010 in AML, after concerns about its safety that emerged in confirmatory trials.
Mylotarg was also the first drug approved conditionally by the FDA on the basis of earlier stage data.
However oncologists put pressure on Pfizer to get the drug back on the market with new clinical evidence, which has been enough to sway first regulators in the US and Europe
A rare and aggressive blood cancer, the average life expectancy in AML is less than 10 months if left untreated, Mylotarg has been shown to vastly improve outcomes compared with chemotherapy.
The goal of treatment is complete remission, and trial data showed that 81% of patients achieved remission when treated with Mylotarg.
There was also statistically significant improvement in event free survival 17.3 months in patients treated with Mylotarg, compared with 9.5 months in those treated with chemotherapy.
