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Sensyne Health launches diabetes app in the UK

Sensyne Health launches diabetes app in the UK

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UK digital health company Sensyne Health has launched a new smartphone app to help people across the diabetes spectrum manage their condition.

The app – called DBm-Health – can help users to monitor their blood glucose levels and send readings, notes and medication information to their healthcare practitioner to assess remotely.

It is a follow-on to Sensyne’s GDm-Health product, which is used for remote monitoring of diabetes during pregnancy and was recently made available for free to all NHS Trusts in the UK for one year to assist with monitoring and managing this high-risk group during the COVID-19 pandemic.

GDm-Health has been a success since launch, says the company, which claims a market share of 47% across all NHS Trusts in England. That has prompted the company to accelerate the roll-out of DBm-Health for the wider diabetic community.

Other uses for DBm Health include cancer patients with pre-diabetes, who are known to be at elevated risk of developing full-blown diabetes if they are given high-dose steroid treatment.

It could also help patients with diabetes who are shielding in order to reduce their risk of coronavirus infection – which is important as diabetics are thought to be more vulnerable to severe COVID-19 than non-diabetic people.

There is also evidence suggesting COVID-19 may trigger the onset of diabetes in healthy people and cause poor control for existing diabetes sufferers. Sensyne recently launched a web-based app, CVm-Health, to assist individuals in monitoring coronavirus symptoms.

The new app will be piloted in three NHS Trusts over the next few months, to see if it provides the promised health-economic and operational benefits, and is also due to be launched in the US later this year as part of Sensyne’s push for overseas expansion.

Sensyne says that unlike other diabetes apps, DBm-Health provides a patient’s clinician with information on their status and whether any additional treatment may be required.

Managing the 3.9 million people living with diabetes costs the NHS around £9.8 billion a year, according to the charity Diabetes UK. There are also more than 34 million people with diabetes in the US, adding $327 billion to the cost of healthcare.

In light of the coronavirus crisis, the NHS has moved rapidly to offer remote consultations, particularly for those with co-morbidities such as diabetes which puts a person at particular risk of severe infection.

“We are responding to the urgent need of NHS Trusts for new digital technologies to optimally care for patients with diabetes,” commented Dr Lucy Mackillop, Sensyne’s chief medical officer.

“DBm-Health will help ensure the highest quality information is securely available to clinicians from patients who are particularly vulnerable to COVID-19 and are advised to stay at home during the pandemic,” she added.

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Epigenetics Links Severe Inflammatory Syndrome in Children to COVID Infection

Multisystem Inflammatory Syndrome in Children (MIS-C) is related with the epigenetic deregulation of a set of immune-controlling genes. A new study in…

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Scientists from the Josep Carreras Leukemia Research Institute and the Bellvitge Biomedical Research Institute (IDIBELL), say they have identified an epigenetic signature associated to the development of the Multisystem Inflammatory Syndrome in Children (MIS-C) after a SARS-CoV-2 virus infection. The signature has been named EPIMISC, in line with previous studies on the epigenetics of COVID-19 from the same team, which published this recent study, “Epigenetic profiling linked to multisystem inflammatory syndrome in children (MIS-C): A multicenter, retrospective study,” in eClinicalMedicine.

One of the puzzles of infection with the virus has been the remarkable resilience of children to exhibit severe COVID-19. However, a small percentage of the pediatric population affected by the virus experienced a serious health condition called MIS-C, also known as pediatric inflammatory multisystem syndrome (PIMS), that require admission to intensive care unit in around 60% of cases.

In MIS-C, different parts of the body can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. The factors associated with the appearance of MIS-C beyond the presence of the virus are unknown.

“Most children and adolescents infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remain asymptomatic or develop a mild coronavirus disease 2019 (COVID-19) that usually does not require medical intervention,” write the investigators.

“However, a small proportion of pediatric patients develop a severe clinical condition, multisystem inflammatory syndrome in children (MIS-C). The involvement of epigenetics in the control of the immune response and viral activity prompted us to carry out an epigenomic study to uncover target loci regulated by DNA methylation that could be altered upon the appearance of MIS-C.

Manel Esteller, MD, PhD, and Aurora Pujol, MD, PhD, served as the coordinators of the research about epigenetic alterations associated with Multisystem Inflammatory Syndrome in Children (MIS-C), a rare disorder that could appear in pediatric COVID-19. [Josep Carreras Leukemia Research Institute]
“Peripheral blood samples were recruited from 43 confirmed MIS-C patients. 69 non-COVID-19 pediatric samples and 15 COVID-19 pediatric samples without MIS-C were used as controls. The cases in the two groups were mixed and divided into discovery (MIS-C = 29 and non-MIS-C = 56) and validation (MIS-C = 14 and non-MIS-C = 28) cohorts, and balanced for age, gender, and ethnic background. We interrogated 850,000 CpG sites of the human genome for DNA methylation variants.

“The DNA methylation content of 33 CpG loci was linked with the presence of MIS-C. Of these sites, 18 (54.5%) were located in described genes. The top candidate gene was the immune T-cell mediator ZEB2; and others highly ranked candidates included the regulator of natural killer cell functional competence SH2D1B; VWA8, which contains a domain of the Von Willebrand factor A involved in the pediatric hemostasis disease; and human leukocyte antigen complex member HLA-DRB1; in addition to pro-inflammatory genes such as CUL2 and AIM2.

“The identified loci were used to construct a DNA methylation profile (EPIMISC) that was associated with MIS-C in both cohorts. The EPIMISC signature was also overrepresented in Kawasaki disease patients, a childhood pathology with a possible viral trigger, that shares many of the clinical features of MIS-C.

“We have characterized DNA methylation loci that are associated with MIS-C diagnosis. The identified genes are likely contributors to the characteristic exaggerated host inflammatory response observed in these patients. The described epigenetic signature could also provide new targets for more specific therapies for the disorder.”

“The COVID-19 disease in adults is characterized by difficulty breathing, while the studied rare syndrome associated with the same virus in children affects many more organs and can have severe consequences,” said Manel Esteller, MD, PhD, director of the Josep Carreras Leukemia Research Institute (IJC), ICREA Research Professor, and professor of genetics at the University of Barcelona. “As the bases for the disorder are unknown, we decided to compare the epigenome of healthy children, children with COVID-19 without MIS-C, and children with COVID-19 who experienced MIS-C.

“We found that MIS-C is characterized by a specific deregulation of epigenetic cellular programming that leads to a landscape of hyperinflammation that can damage tissues.”

The results of the study showed that specific genes were affected in patients, such as those associated with the activation of T lymphocytes, natural killer cells, the recognition of antigens and coagulation. This pattern of epigenetic deregulation was also observed in Kawasaki Syndrome, another inflammatory disease that peaked in 2009 and possibly linked to infection with the influenza virus A H1N1.

Interestingly, two of the 33 DNA methylation events that define the EPIMISC signature are also characteristic of adults without comorbidities who develop severe COVID-19 disease, as previously defined in the EPICOVID signature found by the same team last year.

This fact confirms that both processes, MIS-C in children and severe acute respiratory distress syndrome in adults, are inflammatory post-infectious complications and could be treated in a different way than the initial phase of the viral infection. On this regard, researchers hypothesize that pharmacological inhibition of the CUL2 gene, a mediator of inflammation, could be useful for MIS-C patients since it is known to protect against hyperinflammatory responses.

“It is interesting to see that two disorders that exhibit similar clinical manifestations, MIS-C and Kawasaki, also share a common epigenetic signature, which is different to the epigenetic signature caused by other viruses including HIV,” noted Aurora Pujol, MD, PhD, IDIBELL.

In the same line, Esteller concludes that “it seems that in both syndromes, MIS-C and Kawasaki, there is an exaggerated reaction of the children’s immune system against a viral attack. Knowing the mechanisms triggering both diseases will give us better tools to diagnose and treat them.”

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CUNY Graduate Center wins National Science Foundation award to give graduate students a head start in bio-inspired nanotechnology

From photosynthesis to the collective behavior of ants, natural phenomena inspire both discovery and innovation. Now, thanks to breakthroughs in computing,…

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From photosynthesis to the collective behavior of ants, natural phenomena inspire both discovery and innovation. Now, thanks to breakthroughs in computing, engineering, molecular biology, biochemistry, and complexity science, scientists are finding new ways to mimic and adapt nature, creating nanoscale materials and devices that bring powerful, sustainable solutions that advance health care, renewable energy, and space exploration.

Credit: Shanté Booker

From photosynthesis to the collective behavior of ants, natural phenomena inspire both discovery and innovation. Now, thanks to breakthroughs in computing, engineering, molecular biology, biochemistry, and complexity science, scientists are finding new ways to mimic and adapt nature, creating nanoscale materials and devices that bring powerful, sustainable solutions that advance health care, renewable energy, and space exploration.

With a new $3 million National Science Foundation (NSF) Research Training grant, faculty at the CUNY Graduate Center and its Advanced Science Research Center (CUNY ASRC) are launching Nanoscience Connected to Life to train diverse Ph.D. students for careers that integrate aspects of life sciences with nanoscience. This comprehensive program, which is connected to Understanding the Rules of Life (one of 10 NSF “big ideas”), will provide Graduate Center students who are in Biochemistry, Chemistry, and Physics Ph.D. programs and conducting bio-nanotechnology research with funding, research training, mentorship, and professional-development internships at industry and government labs.

“In combining training in world-class, cross-disciplinary nanoscience research with an equally valuable emphasis on career engagement, this needed program will prepare CUNY’s diverse graduate students to lay the groundwork for rewarding careers in high-demand industries,” said Chancellor Félix V. Matos Rodríguez. “The program’s great promise to drive innovation while expanding the participation of students from traditionally underrepresented groups in CUNY’s Ph.D. programs and diversifying the STEM fields, leverages the unparalleled strengths of the Graduate Center and of CUNY itself. We thank the NSF for its substantial investment.”

“This NSF Research Training program will strengthen the Graduate Center as a powerhouse of interdisciplinary science, particularly nanoscience and its applications,” said Robin L. Garrell, president of the Graduate Center. “Faculty at the Advanced Science Research Center and throughout our STEM doctoral and master’s programs are working across disciplines to find new ways to generate energy, diagnose and treat diseases, and address climate change. By engaging students of all backgrounds in cutting-edge, team-based research, we are preparing the next generation of scientists to lead innovation in academia and industry.” ​

“The nanoscale is the size range where biology’s functionality plays out at its most basic level,” said Professor Rein V. Ulijn, the principal investigator of the NSF grant, the founding director of the Nanoscience Initiative at the CUNY ASRC, and the Einstein Professor of Chemistry at Hunter College. “By bringing together knowledge from various disciplines, we can develop an understanding of the engineering approaches of biological systems. We can then apply this knowledge broadly to create new green technology that rivals the versatility of the structures of the living world. This is an area of much promise and growth, and now is the perfect time to significantly expand our research in it.”

The field of nanotechnology continues to grow and find applications in technologies that impact our everyday lives. Students who are trained through this program will be prepared to lead research and innovation in a variety of fields, including the growing area of green manufacture, where products such as clothing and cosmetics are increasingly bio-derived and fully biodegradable. Nanoscience also merges with the life sciences to enable the development of vaccines, medical devices, and diagnostic testing kits. The lipid nanoparticles used for delivering mRNA COVID-19 vaccines to human cells are one example of these nature-inspired nanoscale solutions.

The Nanoscience Connected to Life training program will expand research in bio-nanotechnology by providing direct funding to 25 Ph.D. students and by involving an additional 125 Biochemistry, Chemistry, and Physics students in its events and opportunities. The trainees will benefit from dissertation research mentoring by faculty from multiple disciplines, helping students gain experience in interdisciplinary and team-based research. Cross-disciplinary teams will collaborate to address urgent societal challenges related to environmental instabilities and health crises. Career development and networking activities are embedded throughout the programming, and are designed to prepare students for mentorship, leadership, and entrepreneurship in industry, startups, academia, government, and nonprofit organizations. An overarching goal is to prepare diverse students — future leaders — by creating a learning community of systems thinkers who can exchange knowledge and communicate across disciplines. 

The training program has a strong focus on diversifying STEM and will leverage its position within CUNY, the nation’s largest and most diverse urban public university system. The program aims to attract diverse students to Graduate Center science Ph.D. programs. Program faculty will work closely with admissions to recruit underrepresented minorities, women, and members of the LGBTQ community from within CUNY and from historically Black colleges and universities (HBCUs).

“Diversity enhances science,” said Joshua Brumberg, dean for the sciences at the Graduate Center and interim executive director of the CUNY ASRC. “By drawing more diverse students into our Ph.D. programs, we are fulfilling the mission of CUNY to serve the whole people, and we are bringing needed new perspectives and ideas into some of the most exciting areas of science and technology. We all stand to benefit from this inspired initiative.”


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How prepared is biopharma for the cyber doomsday?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.
Perakslis, who was head of Takeda’s R&D Data…

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One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

Eric Perakslis

He had not. While he was knee deep in the review, a ransomware later known as WannaCry ripped through the globe at breakneck speed, descending on a quarter million computers in more than 150 countries. One of the hardest hit groups was the United Kingdom’s National Health Service, which saw tens of thousands of devices — computers, MRI scanners, blood-storage refrigerators and other equipment — compromised, bringing many hospitals to a standstill for several days. By the time the NHS sorted through the rampage, government officials estimated the attack had cost them £92 million, or $120 million, both in direct costs and lost output — including more than 10,000 canceled appointments.

For Perakslis, looking back, the coincidental timing was almost eerie. But having first called on the healthcare industry to take cyber threats seriously in 2014, Perakslis had already warned others something like this could happen.

“I wasn’t surprised at all,” he told Endpoints News. “It’s not validation. It’s just like … I hate to be right.”

Five years and a pandemic later, as the whole world got a crash course on battling a highly contagious virus, the issue of defending oneself against malicious, insidious cyberthreats appears to have quietly taken root in biopharma. It came largely thanks to a confluence of factors, from the new reality of remote work to realizations about how dangerous it could be when, say, the rollout of a lifesaving vaccine is compromised.

Even as some warn industry is woefully unprepared for coordinated attacks, in many ways, drug developers are heeding the call to pay serious attention.

“I actually think that most of the pharmas are getting there,” said Perakslis, who’s since moved to the chief science and digital officer role at Duke Clinical Research Institute. “Do I think they’re meeting the threat? No. But I think they’re doing a good job trying to get there.”

Multiple biopharma companies declined to comment, citing the fear of becoming a target. But experts offered advice on how to navigate the ever-evolving threats of cybersecurity, which can ripple well into the future, in an industry where security is tough in a connected ecosystem of universities, research centers, labs, patient groups and hospitals.

“We need to focus on really defining and explaining what we need to protect,” said Kathryn Millett, a researcher at the UK-based NGO Biosecu.re.

War, crime and others

In 2017, Merck fell victim to NotPetya, an attack instigated by the Russian government that affected multiple big companies. But the aftermath of the attack continued to generate new headlines in 2022.

A court ruled earlier this year in the pharma giant’s favor, deciding that it should be awarded $1.4 billion in insurance payout for the damages it suffered when the malware wiped out years of research, disrupted sales operations and crippled Gardasil 9 production facilities, forcing the company to dip into the US national stockpile.

Bob Maley, chief security officer at the cyber risk monitoring service firm Black Kite, describes it as a “watershed moment.”

It was useful not just in illuminating what could happen when a drugmaker gets swept up in a large-scale cyberattack, but in helping define what people mean when they talk about cyberthreats in the biopharma space. For one, NotPetya illustrated the difference between cybercrime, where the ultimate goal often is to extort money, and cyberwar, which is always meant to be destructive.

“Those things do happen, but I think that for most business purposes, that kind of event — there’s not much we can do about that,” Maley said, referring to NotPetya. “If those state actors decided they’re going to do something in a cyber warfare, they’re going to do it.”

Other, more mundane kinds of attacks, though, can be just as devastating. The potential consequences vary widely, as do the points or modes of attacks, straddling the precarious line between the corporeal and the digital.

Jean Peccoud

The sheer range of possibilities for cyberattacks in life sciences led a group of researchers to propose the term “cyberbiosecurity” in 2017 “as a formal new enterprise which encompasses cybersecurity, cyber-physical security and biosecurity as applied to biological and biomedical-based systems.” Although that was credited by some for kicking off the conversation, Jean Peccoud, a synthetic biology researcher and professor at Colorado State University who co-authored that paper, noted it’s still a broad definition.

“This is a loosely defined field,” Peccoud said in an email to Endpoints.

Depending on who you are and what you are working on, the concerns could be vastly different. Peccoud himself, for instance, believes what’s unique to life science is the “dual representation of DNA sequence”: They exist as both molecules and as computer records, and translating or even transcending the two is increasingly convenient. That’s why for him, the scariest thing that could happen would be a biosecurity incident caused by an engineered organism, possibly with malicious DNA sequences designed in software, which could affect people’s health.

Some may be most worried about confidential data getting leaked; others may fear getting brought to a standstill when hackers lock down operations, demanding a ransom. For many, the nightmare scenario happens when attackers are lurking within company data, and no one knows about it — giving bad actors free reign to tamper with, to take an extreme example, the formula or quality control tests for a drug and thereby endangering patients.

“The state of play as it stands is that the problem of cyberbiosecurity itself is so large and nebulous that we cannot yet provide any clear messaging, guidance or solutions,” Millett of Biosecu.re said.

With bigger data…

While the threats of cyberattack are ubiquitous, security researchers, advocates and vendors have long warned that biopharma was a much greater target than other sectors.

“These industries offer an attractive target for cyberattacks because of their substantial investment in research and development, valuable intellectual property, connected IT and operational networks, and sensitive stores of data,” an MIT group wrote in 2018.

Emil Hewage

Emil Hewage is co-founder and CEO of BIOS Health, a Y Combinator-backed startup striving to personalize neural medicine through real time reading of patients’ neural code.

“In the discovery ecosystem we generate every week more data than that has been generated by public research efforts,” he said. “So we’re talking about many terabytes of brand new data sets per week.”

BIOS is but one player riding on a tidal wave of new discovery technologies generating data at unprecedented scale, which is often accompanied by the requisite analysis tools to interpret them. At the same time, research, development and manufacturing operations are all turning to more sophisticated technologies and data systems to measure and monitor performance on an ever-growing list of indicators.

Kelvin Lee

“The growing emphasis on cybersecurity is occurring at the same time that the industry is arguably changing to one driven by data,” said Kelvin Lee, director of the Manufacturing USA National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), in an email.

Biopharma companies are also somewhat unique in how they are entangled in a complex ecosystem of universities, research centers, labs, patient groups, hospitals and more. That’s not to mention regulators, who impose an additional layer of compliance requirements.

“It’s not just a matter of number of systems, but also number of integrations between those systems,” said Adin Stein, head of engineering operations, IT and cybersecurity at cell therapy developer Lyell.

Then there are more ways for hackers to target companies. Businesses in general have been using more devices and connecting them, exponentially expanding the number of what security folks call “attack surfaces.”

“This is more data to lose or more subtle ways for that to be extracted and exhibited privily now,” Hewage said.

Perakslis and Peccoud also both point to a concept in the cyber space known as asymmetry: For any corporation, cybersecurity is a cost that executives try to minimize. Hackers, on the other hand, stand to gain immensely from an attack, and one person can theoretically take down an entire company (even though they usually work in groups these days).

The good thing about general problems is that general solutions exist, such as employee training and cyber hygiene.

At Black Kite, Maley said his team has gone through a long list of recommended cyber practices to try and predict which companies are most at risk of becoming victims of ransomware.

“What we found was that the bad actors, out of all those hundreds of things that could be exploited, they were only exploiting a very small subset,” he said. “What’s shocking to me is so few things that a company could do to reduce their likelihood of being a victim, for some reason, they just don’t do.”

They include patching the systems on old servers to get rid of vulnerabilities, configuring emails so that it’s harder for hackers to send phishing emails, mandating multi-factor authentication and asking employees not to use the same passwords for everything — lest their login information end up on the dark web and become easy keys for hackers in attacks dubbed credential stuffing.

“Basic, basic, basic kind of things,” Perakslis said. “It doesn’t protect you from the really hard stuff. But again, it’s like driving without a seat belt, you know. Seat belts are not going to keep you out of an accident. But it’s dumb if you get into an accident, you didn’t have one on.”

Building defense

When Kathryn Millett at Biosecu.re first conducted a pilot survey of biotech and cybersecurity leaders, all respondents agreed that cyberbiosecurity risks posed a “real and current threat.” In a follow-up survey that’s still ongoing, she’s heartened to find that the awareness has “trickled down to lab practitioner level.”

“I think there’s been enough sort of news out there, you know, and enough big stories that biotech is really taking notice, and recognizing that there’s a lot at stake and they don’t want to be part of that story,” Stein, the Lyell exec, observed.

Even if biopharma companies don’t go around boasting about it, plenty of signs point to a greater emphasis on cybersecurity. Big Pharma is increasingly bringing chief information officers into the executive suite when in the past they might have reported to the CFO. By Perakslis’ count, budgets are also increasing.

A report by cybersecurity solution provider Fortinet last year found that 98% of pharmaceutical companies surveyed “experienced at least one intrusion,” and around half of them saw between three and five intrusions. But importantly, business-critical data or intellectual property were among the least impacted.

Troy Ament

“With the uptick of these intrusions in general, companies have likely gotten better about protecting business-critical data, but that’s not to say cyberattacks targeting these pharmaceutical organizations are not serious, but it is possible that data is better segmented to prevent cascading impact if an intrusion happens,” said Troy Ament, Fortinet’s chief information security officer.

Lee, the NIIMBL director and University of Delaware professor, noted that while the leading pharma companies are sophisticated in the space, performance is also uneven.

“Smaller companies in the field that have just a few years of experience usually do not have strong cybersecurity protocols or the funding to invest in third-party analysis and compliance services,” Alex Zhavoronkov, co-CEO of the AI drug discovery company Insilico, wrote to Endpoints. “This sometimes worries me a lot.”

At companies that do allocate enough resources, cybersecurity often consists of three pillars: cutting-edge technology that cements every system update patching vulnerabilities; outside experts who provide intelligence and an assessment of risk levels; and a framework to integrate the handling of cyberattacks into the rest of the risk management system.

“One of the best cybersecurity strategies starts with assuming you’ve already been hacked because what happens when you’re hacked, you’re going to look for data that’s leaving,” Perakslis said, and he noted companies are getting better about using real time threat surveillance data to identify and jump on issues.

Alex Zhavoronkov

Biopharma could also learn from other industries, Maley said, learning from case studies such as the breach experienced by Colonial Pipeline, where a mix of exposed remote access ports and credential stuffing led to catastrophe.

For smaller players, Hewage noted, it’s best to start thinking about cybersecurity before they lay their hands on sensitive data. Alternatively, Zhavoronkov noted Insilico decided to lower the risk by minimizing the amount of patient data its platform relies on — while carefully following compliance protocols demanded by Big Pharma partners and engaging providers to perform stress tests.

“I think as you think about particularly emerging biotech, one of the key lessons that I’ve picked up on through the community is the idea of security by design,” Stein said. “It is easier to put a security program in place and develop a culture of security than it is to go back and retrofit.”

Still, no defense is permanent.

“While the industry has certainly taken notice, being on alert never ends,” Ament said.

Culture of secrecy

After a cyberattack, biopharma companies are reluctant to share what happened with other drugmakers, losing what could be teaching moments. Maley said what to disclose has been an issue even going back to a 2006 cybersecurity conference that he attended.

“We’re still talking about it 16 years later,” he said.

To this day, Merck has kept public statements about the NotPetya attack to a minimum. And while others, from Dr. Reddy’s to Roche to Bayer to more recently Novartis, have reported cyber intrusions, they often don’t offer any details beyond whether any sensitive data were compromised.

There are legitimate reasons for staying mum, Perakslis said: “One of the important reasons is that you would never give an adversary your playbook.”

There are also few laws requiring disclosure, while board members do have a fiduciary responsibility to shareholders — which often means to limit bad press.

“I think most companies when they experience these things, one of the first questions that management asks is, well, who do we have to tell? Not who should we tell,” Maley said.

But conversations do happen, Stein said, where specifics are kept confidential and lessons are shared, whether through speaking engagements at conferences, consulting vendors or contributing to the creation of industry standards.

“I wouldn’t assume that if you’re not hearing from a particular organization, they’re not contributing very heavily to quite complex discourse,” said BIOS CEO Hewage. “And in some senses, it’s best to trust really heavily peer reviewed and vetted, industry wide conversation.”

Government agencies can sometimes play that middleman role. The US Department of Homeland Security, for instance, has established Information Sharing and Analysis Centers for early information sharing; the Department of Health and Human Services set up the Health Sector Cybersecurity Coordination Center to do something similar and alert stakeholders to threats; and the UK is also reviewing its biosecurity strategy.

That said, it is nearly impossible to truly tell how prepared a certain company is against cyberattacks — and even with options for sharing, companies tend to be selective about what they say. As a pharma insider told Endpoints, “There’s no prize for naiveté.”

Finding a balance

Even those who are most steeped in cyberbiosecurity advocacy tend to acknowledge that cybersecurity cannot, and should not, be the sole focus of biopharma companies. Their stated mission, after all, is to develop new vaccines and treatments for diseases.

With all the other projects, plans and needs vying for attention, Perakslis said it’s all a matter of prioritization and resource allocation — thinking through how much money to spend on things that are likely but low impact, versus those that are unlikely but high impact.

Understanding the risks and impact thoroughly, then, becomes key.

Finding reference in other areas, Peccoud noted that the aviation industry has an incident reporting system that’s essential to develop its safety culture. Voluntary reporting is shielded from prosecution, which, along with the National Transportation Safety Board, provides material that can be discussed in training or to develop regulation.

“Without transparency the bad guys will always have the edge,” he said.

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