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.
More than 10 million employment-related drug tests in 2017 showed a drop in opioid-positive results, but an increase in positive results for amphetamine use.
Overall, there was a 12 percent drop in the total of positive results among New Jerseyworkers when compared to 2016, according to the nation’s largest diagnostic services provider.
In a May report from Secaucus-based Quest Diagnostics, the annual overall percentage of positive employment-related drug tests in the state fell to 3.6 from 4.1 percent on the back of decreases in positive tests for opiates, marijuana and PCP.
Quest Diagnostics used more than 10 million urine-based drug tests results from 2017 when compiling its annual survey of workplace positivity rates.
Many of the urine-based tests used in the Quest report were assigned for cause, records show. Some other tests were part of pre-employment, post-accident, random, and screenings for the general workforce and federally-regulated employees.
In New Jersey and nationally, the opiate positivity rate within the employment-related testing dropped by 17 percent compared to 2016.
“The depth of our large-scale analysis supports the possibility that efforts by policymakers, employers and the medical community to decrease the availability of opioid prescriptions and curtail the opioid crisis is working to reduce their use, at least among the working public,” said Kim Samano, scientific director at Quest.
Opiate crackdown
North Jersey’s 2017 Quest opiate positivity rates peak around Paterson in Passaic County. The report shows the positivity rate skews higher than the state average of 0.23 percent.
Northern towns in Passaic, Bergen, Sussex and Morris counties have recorded considerable declines in opiate positivity, however, the Quest report shows. The data shows opiate positivity rate range halved in zip codes starting in 074 from 2016 to 2017. Towns with 074 include Allendale in Bergen County (07401), Bloomingdale in Passaic County (07403), Butler in Morris County (07405).
A statewide clampdown on prescription opiates is making those drugs harder to find, said Eugene “Skip” McLaughlin of New Life Recovery Center in Pompton Lakes. However, what may seem good news can be a double-edged sword, he said.
“Because they are not as prevalent as they used to be, the price goes up. And those who are cut off from the pills will switch over to the heroin,” McLaughlin said.
At the rehab and detox level, medical doctor Jeffrey Berman, with Soba College Recovery of Fairfield said his lab is not seeing a decrease in clients with opiate additions. More clients are just being admitted for addictions that start with street heroin instead, he said.
“The kids that would have started with prescription opioids are now going to heroin,” Berman said.
McLaughlin said more than 80 percent of his clients with opiate addictions started with pills. About 80 percent of them ended up switching over to street heroin, he added.
Others are now starting with street heroin of uncertain purity due to the limited availability and high cost of prescription pills to sometimes deadly effects, McLaughlin said.
Overall decline
New Jersey’s overall work-related drug positivity decline of 0.5 percent from 2016 (4.1 percent) was aided in part by declines in positive tests for opiates (down 17 percent) and marijuana (down 5 percent), records show. PCP positivity rates were also down nearly 10 percent in a state where the rate was nearly 50 percent higher than the national average of 0.020 percent, records show.
However, as positivity rates for several drugs fell, there were increasing numbers of workers in New Jersey testing positive for cocaine (up 4 percent) and amphetamines (up 6 percent) in 2017. The positivity rate for a heroin metabolite also increased from 0.058 to 0.068.
The changes in the state’s positivity rates mirror trends on the national scene, where varying usage patterns may be hindering attempts to curb drug use, said Barry Sample, senior director of science and technology with Quest Diagnostics.
Drug use trends
Between 2013 and 2017, Quest Diagnostics has recorded a 150-percent increase in methamphetamine positivity in New Jersey, New York, and Pennsylvania.
Over the last two years, SOBA College Recovery has seen the number of its clients with methamphetamine use problems rise from about 2 to 5 to 6 percent or more, Berman said. Many are coming from North Jersey’s more rural areas, Berman said.
