The NextLabs Pharmaceuticals and Life Sciences solution provides:
- Internal Collaboration Barriers to ensure drug design and process IP from one project does not leak into designs of competing products.
- Change Control Automation and Approval Compliance for gaining project approvals and complying with change management procedures.
- Confidentiality across the Extended Enterprise preventing improper disclosure across the extended supply chain.
- Endpoint Data Loss Prevention to ensure intellectual property can only be downloaded from approved locations, and only exported to removable media, printed, copied, or uploaded if authorized.
- Communication and Distribution Data Loss Prevention to avoid leakage.
Innovate and collaborate in new drug R&D, while protecting trade secrets and patient information in compliance with regulations of the FDA, federal health care, and other programs
New drugs are expensive and time-consuming to test and develop. Much research relies upon sensitive technology, techniques, and proprietary compounds that require protection as trade secrets. The protection of trade secrets and intellectual property is a critical challenge facing pharmaceutical and life science businesses.
Trade secrets, including new product formulas, innovative manufacturing processes, marketing plans, clinical trial data, and test results, must be protected in compliance with corporate governance. Confidential patient information from participants in new drug trials must be protected in compliance with privacy regulations.
To optimize corporate resources and minimize development expenses, many pharmaceutical companies rely heavily on collaboration with suppliers, outside scientists and other drug companies. However, collaboration presents a strong risk of exposing trade secrets or other intellectual property (IP).
The loss, leakage, or inadvertent exposure of this sensitive information may help competitors and damage business prospects. Leaking details relating to ongoing drug research may introduce bias into drug trials or possibly halt the development of life-saving drugs. Trial results leaked in an untimely manner to the investment community may disrupt confidence in the integrity of the securities market, leading to catastrophic consequences for the company.
Unfortunately, today's basic access controls do little to prevent intellectual property loss after authorized user access is granted. Problems include:
- Files are uploaded to FTP sites without proper approvals.
- IP access and handling cannot be comprehensively monitored.
- Information is easily uploaded to unapproved websites or portals.
- Trade secrets or IP are copied to unapproved removable media, such as USB devices.
- Trade secrets or IP are being sent over email and IM to improper recipients.
Preventing misuse of trade secrets and IP is difficult when devices, data, and users are mobile, or if users, customers, partners, and the supply chain are spread across multiple locations. It is unrealistic to expect users to always follow manual procedures to protect IP. Management overhead, a lack of coordination, and human error all increase the risks of losing sensitive data.
The NextLabs Pharmaceuticals and Life Sciences solution protects trade secrets and confidential information to enable safe collaboration and communication during research and development of new drugs. The solution offers applications with best practice controls, compliance procedures, information policy objects, data protection libraries and reports. Policy sets can be easily customized to the environment or used as templates to create new policies.
Companies can now protect intellectual property by ensuring safe and appropriate data access, use, and disclosure. The solution applies business policies across repositories where IP is stored, and at endpoints where applications are used. The solution enforces controls across heterogeneous applications and systems, such as molecular modeling or design, and other chemical and bioinformatic computational tools, to protect trade secrets and IP throughout its entire lifecycle.
Companies can now unify access entitlements and data handling policy. The solution educates users about policies and procedures, and automates protection when drug design and delivery teams collaborate, while remaining transparent to normal business. Policies are enforced by evaluating context, such as identity, data type and activities, and business conditions, in real-time, to apply precise controls. The solution includes:
- Internal Collaboration Barriers. Protection includes conflict of interest activity monitoring and controls to ensure drug design and process IP from one project does not leak into designs of competing products.
- Change Control Automation and Approval Compliance. Automated data handling processes and procedures are applied, including initiating proper workflow processes for gaining project approvals and complying with change management procedures.
- Confidentiality across Extended Enterprise. Protection is maintained when IP is shared outside the project, including preventing improper disclosure across the extended supply chain. Safe and approved channels are enforced to maintain data integrity in transit, and protection is applied while IP is used at the destination.
- Endpoint Data Loss Prevention. IP checkout or download must be to approved locations, and only exported to removable media, printed, copied, or uploaded if authorized. Policy Assistants help to automate safe access and handling, and also to educate users about using data properly.
- Communication and Distribution Data Loss Prevention. IP distribution and communication are restricted to secure, approved applications and channels to avoid leakage
Auditing & Reporting
Comprehensive audit and reporting capability achieves centralized visibility to ensure project life-cycle and program confidentiality, and compliance with standards and contractual agreements. Forensic analysis features help discover and identify abnormalities during the life-cycle. The solution's auditing and reporting capabilities let you answer such questions as:
- What are the primary repositories that contain trade secrets and intellectual property?
- What are the user exception cases for copying and printing?
- Where are the attempts to e-mail intellectual property outside of designated client or project domains occurring?
- How often are files uploaded or FTP'ed to locations outside of project boundaries?
- Where and how are information leaked at endpoints (USB, copying, uploaded, etc.)?
- When were drug design documents accessed and used, including tracing the lineage of documents during their lifecycle?