Cybersecurity for Drug Development: What Every CISO Needs to Know

Want to see blood pressure spike? Ask a drug developer’s CISO about data security

They have plenty of reasons to be nervous. About 5 million of them, on average. 

According to IBM Security’s latest Cost of a Data Breach report, that’s how much pharmaceutical and biotech companies typically lose each time they suffer a cybersecurity failure. That makes drug developers the third biggest money-losers of all industries in the report, right behind healthcare and financial services. 

Believe it or not, that’s down from 2022. And that’s only the immediate financial cost: data breaches can also cause a cascade of operational, legal, and reputational repercussions that can vastly compound the true cost of a single incident. Just ask Sun Pharma, Novartis, Eisai, and Merck, to name a few.

So if you’re a data security stakeholder at a pharma or biotech organization, and you’ve noticed how much more melatonin you need to take every night, there’s a good chance cybersecurity threats are why. They’re also why our team is obsessed with safeguarding our customers’ data: We know how critical it is to their core operations, business valuation, investor profile, and much, much more. We treat their chemistry, manufacturing, and controls (CMC) information like the precious resource resource it is.

So what can drug developers do to keep their data as safe as it is in QbDVision? Like any vigilant cybersecurity team, ours has identified a number of key steps IT teams can take to keep their infrastructure and information as secure as possible. Here are a few of the essentials.

Cyber risk assessments: Do them often, then do them again very soon

Even with the most cutting-edge cyber threats, one of the oldest rules still applies: an ounce of prevention is worth, well, in this case, millions of dollars of cure. Good cybersecurity starts with knowing and mitigating your vulnerabilities – but also with knowing that risk assessment is no one-and-done chore.

One of the many bedeviling facts about cybersecurity threats is  they change constantly. Phishing scams, DOS attacks, malware, ransomware, CATO – cybercriminals never stop refining the art of illegally accessing and extracting data. Data security teams need to be every bit as proactive when it comes to identifying, prioritizing, and addressing vulnerabilities that may expose the company to criminal activity.

$5 million is only the immediate financial cost of a data breach: cybersecurity incidents can cause a cascade of operational, legal, and reputational repercussions that can vastly compound the true cost of a single leak. Just ask Sun Pharma, Novartis, Eisai, and Merck, to name a few.

Here are several important steps that need to be a part of every protocol for regular risk assessment:

Identify high-value assets

The first step in thwarting cybercriminals: knowing what they’re most likely on the hunt for.

For drug developers, that’s typically product and process IP, but can also include CMC assets like ingredients lists, manufacturing materials, suppliers, sources and their locations, and run timelines – all juicy targets for anyone who wants to steal a competitive edge or take critical information hostage. You want to know exactly where this information is stored, how and where it’s handled, and who has access to it under what conditions.

Define assessment scope and methodology

To ensure rigorous security reviews – and also that no vulnerabilities slip through the digital cracks – assessment protocols need to be crystal clear and consistently implemented.

That means:

  • Establishing exact assessment intervals
  • Specifying exactly which teams and stakeholders are involved
  • Clearly defining the role of internal teams vs external assessors
  • Selecting appropriate tools and frameworks to be used
  • Defining exact access privileges associated with every level of the organization.

At QbDVision, these steps are a core part of our security review, which is performed annually at minimum.

Select standardized risk analysis frameworks

Multiple international standards have been established to help organizations evaluate and verify their cybersecurity readiness. Ensure your team has selected an appropriate framework for your organizational structure, data infrastructure, and level of security investment.

Most software enterprises start with either ISO 27001 or SOC2 (we comply with both). Either of those standards will help you get an Information Security Management System (ISMS) up to define the guardrails of your cybersecurity program.

Develop proactive risk mitigation plans

Stopping threats before they arise will always be the best way to mitigate cybersecurity threats. Put strategies in place for how your team should act first and prepare in advance.

Those strategies can factor in many different components, including: 

  • Regular internal security evaluation, including penetration testing and well-defined monitoring protocols
  • Deploying patching software
  • Implementing new technical and access controls
  • Develop a detailed incident response plan
  • Robust employee training

Make sure your security team is 100% clear on how steps like these should be managed and implemented – both before and after threats are identified.

Monitor and track ongoing risks

Cyberthreats never take so much as a quick nap, much less sleep. Guarding against them is a continual process, one that needs to evolve and adapt even faster than attackers and their toolkits can. 

To keep your security program a step ahead, stay tuned to industry publications, attend cybersecurity conferences, and jump into any of the many active online communities dedicated to safeguarding data and IP. Treat every internal risk assessment as a learning opportunity, too: don’t wait to adapt your policies, procedures, and infrastructure in the face of ever-emerging new threats.

Access control: Managing who can access what, how, and why

Another timeless rule that still holds true in cyber realms: you can’t steal what you can’t get to. Carefully matching roles and access is a vital step for any effective security program.

At QbDVision, we strongly recommend a role-based access control (RBAC) strategy that follows the principle of least privilege. Simply put, that means giving users access to no more information than they need to perform their role or complete a specific task. 

Cyberthreats never even take a quick nap, much less sleep. Guarding against them is a continual process, one that needs to evolve and adapt even faster than attackers and their toolkits can.

To put an effective RBAC strategy in place:

Carefully assess employees’ access needs

Define exactly which data and systems are required for each role in the organization, and limit access privileges to those essential sources. 

Restrict highly sensitive data

Grant access only to stakeholders who have a clearly defined and specifically limited need to access them. 

Regularly review and update RBAC policies

Roles change and company structures shift. Make sure access privileges evolve and realign whenever your business does.

Implement strong security checks

For critical systems, a strong password policy and multi-factor authentication (MFA) should come standard. Physical, hardware authentication keys are an increasingly common and popular security measure too.

Have a plan for both onboarding and offboarding

Know exactly what access new employees need to fulfill their role, and also when and how to retract that access after they move on. Ensure you have a process for disabling or removing inactive accounts (a favorite target of many phishing attacks).

At QbDVision, access audits are a critical part of our security review, performed at least annually.  A minimum of once a year, we conduct a comprehensive scrub of our admin list to verify it’s clean, clear, and the right people have access to no more than exactly the right amount of information.

Compliance requirements: Know how they’re changing and what it means for your security program

In our world of ever-evolving cyber threats, regulators are also acutely aware that security standards, best practices, and expectations need to evolve as quickly as the dangers they’re intended to mitigate. Staying up-to-date on these requirements is a critical and continuous task for security leaders. 

Focus on these essential steps to help ensure your team stays current and compliant:

Know who’s responsible

Make sure designated staff members know it’s their responsibility to track updates and changes to relevant standards, guidance, and regulations. Your go-to compliance person should be clear that their role includes following regulatory bodies, tracking new release, revision, and retirement announcements, and keeping the rest of the team abreast of what that means for your security program.

Review and analyze all updates

Any time regulators update their standards or frameworks, review them in detail to identify new requirements and modifications and determine what steps you may need to take to integrate those changes into your security program. At QbDVision, we use a simple rubric of “new, updated, retired” to categorize, prioritize, and action regulatory updates.

Revise and update compliance programs

When regulatory changes require updates to your program, don’t wait to make the changes needed to stay compliant. Prioritize updates to critical resources like your technical and access management controls, as well as your risk assessments.

Document all reviews and changes

In our highly regulated industry, your organization is likely required to document all compliance-related changes for relevant authorities. 

At QbDVision, we create and manage these records within our own highly secure, validated platform. It’s a safe, centralized, and collaborative space to maintain records showing the compliance updates we’ve reviewed and the modifications made to ensure compliance. Other solutions like a document management system can work as well.

Educate staff on changes

Once your security team has fully reviewed and integrated new compliance requirements, it’s also critically important to ensure all relevant stakeholders in the organization are aware of how new changes may impact their workflows. Changes to access privileges and processes are particularly common, and especially important to communicate.

Monitor compliance and effectiveness

As soon as one new set of regulatory updates is in place, it’s often time to start planning for the next one – cybersecurity standards can move that fast. Make sure your team is always closely monitoring relevant standards and requirements, and proactively preparing to make further updates when new gaps, threats, and requirements arise. 

Independent auditors and consultants can often be a useful addition to this effort. They can provide valuable outside perspective and feedback to help refine your strategies and strengthen your data safeguards.

Want to see these best practices at work? Head over to our Trust Center.

When it comes to cybersecurity, we practice every word we preach. To learn how, check out our Trust Center to learn how we’ve built robust cybersecurity into our platform – and how we rigorously evaluate and maintain our compliance with multiple gold-standard security frameworks.


Learn more about cybersecurity best practices for your transformation strategy.

Reach out to our team of experts any time to start a conversation about how you can protect your mission-critical product and process data.

Shameek Ray

Head of Quality Manufacturing Informatics, Zifo

Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.

Max Peterson​

Lab Data Automation Practice Manager, Zifo

Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.

Michael Stapleton

Board Advisor, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering

Matt Schulze is currently leading Digital for Pioneering Medicines which is focused on conceiving and developing a unique portfolio of life-changing treatments for patients by leveraging the innovative scientific platforms and technologies within the ecosystem of Flagship Pioneering companies.

Daniel Matlis

Founder and President, Axendia

Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.

Kir Henrici

CEO, The Henrici Group

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board

Oliver Hesse

VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals

Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.

John Maguire

Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

Chris Kopinski

Business Development Executive, Life Sciences and Healthcare at AWS

As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.

Blake Hotz

Manufacturing Sciences Data Manager, Sanofi

At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.

Anthony DeBiase

Offering Manager, Rockwell Automation

Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.

Andy Zheng

Data Solution Architect, ZÆTHER

Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.

Sue Plant

Phorum Director, Regulatory CMC, Biophorum

Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.

Yash Sabharwal​

President & CEO, QbDVision

Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.

Joschka Buyel

Process & Knowledge Management Scientist, Bayer Pharmaceuticals | Ph.D., Drug Science

Joschka is responsible for the rollout and integration of QbDVision at Bayer Pharmaceuticals. He previously worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

Luke Guerrero

COO, QbDVision

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.

Gloria Gadea Lopez

Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

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