Home | Industries | Life Sciences & Pharmaceuticals

Life Sciences & Pharmaceuticals

Solution by Industry.

The protection of  Personally Identifiable Information (PII), trade secrets, and Intellectual Property (IP) with effective data governance continues to be a critical challenge facing pharmaceutical and life science businesses. The Research & Development sector utilizes sensitive technology, techniques, and proprietary compounds. Within the ecosystem of hospitals, insurers, and service providers, sensitive patient health information is accessed and used, running the risk of wrongful disclosure.  

Dow Customer Story

Learn how Dow enforces export control and protect intellectual property for global collaborations

Pharmaceuticals and Life Sciences

Discover methods for safeguarding highly sensitive intellectual property and automating GxP compliance by implementing real-time automated policies

Active Control for ePHI Access and Handling

Explore how Active Control module mitigates ePHI access and misuse risks by deploying predefined best-practice policies for effective compliance

Challenges

Hazardous Materials and Controlled Substances

Chemical companies must comply with EH&S regulations and manage controlled substances, which includes reporting information about hazardous materials, chemical weapons, emission details and employee health to government agencies. Leakage of such information can severely harm public safety, ruining an organization’s credibility and trust.

Supply Chain IT Loopholes

There are many external vendors and supply chain partners in chemical operations, causing malicious actors to target third-party networks in critical infrastructure. Actors can exploit the access that subcontractors may have to the primary organization and download critical data. This exploitation of trust in third party collaborators can impact organizations that are otherwise highly secure.  

Complex IP Protection

Companies must protect both company-owned and customer-specific IP across a complex web of global parties. This involves securing sensitive formulas, methods and designs within internal teams and external business partners, across JVs and suppliers. Such exchanges are often governed by stringent non-disclosure agreements, where failure would lead to contractual breaches and heavy financial losses.

Insider Risk

Privileged users, such as employees and contractors with access to proprietary formulas, production techniques, and client data, are essential in daily operations but can inadvertently become a high-risk vector. Often, the real threat lies not in the malicious misuse of data, but in these privileged users’ potential for human error and their lack of security training or awareness.

The Formula to Securing Chemical Company Data

To overcome the challenges surrounding regulatory compliance, third party risk and insider threats, chemical companies need to apply automation as well as enforce security controls to prevent unauthorized access. A comprehensive and proactive approach to data security should contain 

Distributed Policy Engine

A distributed policy engine can enforce centrally managed policies anywhere and everywhere. Need-to-know policies are consistently applied across all environments, regardless of user or location. This enables companies to manage complex access control and IP protection requirements across the organization, partners, and the extended enterprise.  

Data-Centric Security Enforcement

Through policy enforcement, companies can implement ABAC (Attribute-Based Access Control) and data-centric security controls such as digital rights management (DRM). This approach secures sensitive data at rest, in use and in transit throughout its lifecycle, mitigating risks associated with third-party networks and persistently protecting IP when it is shared. 

Automation and Prevention

Chemical companies can use the policy engine to automate security controls, preventing data breaches before they happen. Given the highly dangerous nature of controlled substances data, companies cannot allow leaks to happen in the first place. Therefore, a preventive strategy is far more effective and efficient compared to a “detect and respond” approach.  

Real-time Logging and Visibility

It is crucial for chemical companies to log and monitor all data access activity in real time. Enhanced visibility in a chemical company helps identify anomalies and potential risks in supply chain activities. This approach is also key in managing insider risks, especially among privileged users who have access to highly sensitive or proprietary chemical data. 

Challenges

Compliance and Governance

Many pharmaceutical companies rely on manual controls for data gathering, monitoring, and reporting, making it difficult to remain in compliance. Manual approaches also do not scale well in light of rising data volumes and the need to secure sensitive IP.

Regulations Include

  • HIPAA regulates patient health information 
  • FDA regulates the production of pharmaceuticals

Protecting Healthcare Information

Basic access controls do not adequately differentiate the user roles and business conditions that determine proper data access rights. This can lead to excessive access or unnecessary restrictions, impacting security and operational efficiency.

Common Data Governance Mistakes

  • Management overhead 
  • Lack of coordination  
  • Lack of User education 
  • Human error  

Secure Collaboration

To optimize corporate resources and minimize development expenses, many pharmaceutical companies rely heavily on collaboration, which increases the risk of exposing trade secrets or other core intellectual property

Stakeholders include

  • Suppliers 
  • Academic research institutions 
  • External scientific partners  
  • Joint ventures and partnerships with other companies 

Approach to Overcome Challenges

To overcome the challenges surrounding regulations, supply chain security, insider threats and globalization, A&D companies need to segregate Controlled Technical Data (CTD) across the organization, apply consistent controls to prevent unauthorized access. A comprehensive and proactive approach to data security must contain the following elements:

Robust Data-Security Policies

Policies that cover data classification, access controls, data retention, and data breach response, while remaining up-to-date and effective.

Data-Centric Security

An approach that ensures data is persistently protected throughout its lifecycle, from creation to disposal enabling companies to keep their sensitive data secure.

Continuous Monitoring & Response

Companies must have real-time visibility into their data and network activity to identify and respond to potential threats.  

Compliance Auditing

Compliance audits must cover data security policies, data access controls, data handling procedures, and employee training. With regular audits, companies can identify and address vulnerabilities in their security controls.

Automation & Prevention

By automating the process of defining, updating, and enforcing data security policies, enterprises can prevent breaches before they happen, reduce compliance costs and data security risks.     

NextLabs Solution

Robust Data-Security Policies

Nextlabs’ policy management platform CloudAz, assists companies with creating and implementing data security policies. These policies can apply regulatory controls applicable to the user, data, and environment in real-time. 

Data-Centric Security

NextLabs solutions provide data-centric security controls that protect sensitive data at all times, regardless of its location. These solutions can encrypt data at rest and in transit, control data access based on policies, and apply dynamic data masking to protect sensitive data. Companies can define and enforce granular data access policies based on user roles, locations, and devices.

Continuous Monitoring & Response

CloudAz, monitors using real-time visibility allowing data access and usage to detect security incidents. This policy management platform provides alerts based on security gaps and policies, enabling rapid response to security incidents. 

Compliance Auditing

CloudAz provides centralized auditing and reporting capabilities that enable companies to demonstrate compliance and ensure the integrity of their data security policies. Compliance reports can include data access, data handling, policy enforcement, and insights into potential security gaps.

Automation & Prevention

With dynamic authorization and ABAC, the NextLabs platform automates the enforcement of data access policies, improving data security by reflecting changes in attribute values immediately and reducing the cost of policy management.  This allows enterprises to reduce the operational expenses of R&D and COGS as well as decreases the time to market.

NextLabs Solution

CloudAz Centralized Policy Platform

NextLabs’ unified policy management platform, CloudAz, enables companies to author and centrally manage security policies that are enforced dynamically in real-time. It offers simplified policy authoring with business-friendly policy language, preserving policy integrity with approval workflows and version control. This streamlines the management of complex data protection requirements for chemical companies, protecting sensitive data anywhere and everywhere.  

CloudAz Dynamic Authorization Policy Engine

When a subject requests access to sensitive information on controlled substances, CloudAz’s Dynamic Authorization policy engine evaluates security policies and real-time attributes to make the authorization decision. This enables consistent policy enforcement across multiple applications, automatically preventing unauthorized disclosure of sensitive information, which is key to maintaining compliance and trust with employees, regulators, investors, and the public. 

SkyDRM Digital Rights Management

SkyDRM is an enforcer and DRM solution that enables secure collaboration among multiple vendors and supply chain partners. Users can apply digital rights like View, Edit, Print, and more, to files shared with external personnel. This ensures that sensitive data remains protected in cases where a network is comprised. Even when files are downloaded by subcontractors, SkyDRM enforces controls over what actions they can perform with the data. 

DAE Dynamic Data Masking

DAE (Data Access Enforcer) helps companies manage IP protection within the complex network of global collaborations, obfuscating the value of sensitive data in unauthorized fields. Centrally managed policies define masking patterns and rules to determine who, what, when, where, and why to mask field(s) in real-time. This secures sensitive information such as chemical formulas and methods shared among internal teams and external business partners. 

CloudAz Report Server

CloudAz’s centralized monitoring provides real-time visibility into data activity and events, enabling organizations to vigilantly monitor data access and usage, especially regarding potential security incidents involving privileged users. CloudAz helps identify anomalies and provide alerts when it comes to risky behavior. It addresses not only malicious data misuse, but also mitigates risks associated with human error and lack of awareness among insiders.  

NextLabs Resources