Executives in the pharmaceutical industry are often torn between competing objectives. On one hand, the market is thirsting for new medicines to satisfy unmet patient needs. On the other, shareholders are looking for cost savings for more profitable growth. Executives find themselves looking for ways to alter their business and operating models, searching for solutions that will reduce costs but also expedite the time to market for new remedies.
The Need: Disruptive Technologies
Most pharmaceutical companies realize that the only way resolve their conflicting objectives is to adopt new, disruptive technologies. If a technology could protect ever-so-important intellectual property or improve the commercialization model, then it would be a game-changer.
The right technology would need to address the industry’s most pressing drivers:
- Intellectual Property (IP) and Patent Protection
- Regulatory Changes and Compliance
- Pricing Constraints and Outcomes Measurement
- Data Storage
Defending IP and Supporting Patents
In the increasingly competitive global marketplace, intellectual property is always at risk. Foreign countries have been known to hack into databases, steal data, and bring drugs to market before the companies who made the discoveries have a chance to act. In addition to securing data, new drug formulas must be awarded patents – which have become progressively difficult due to recent Supreme Court rulings. Without patents, companies cannot justify costly R&D investments.
Abiding by Regulations
New government initiatives are pushing for the sharing of patient data across agencies and institutions to speed up R&D – and thus time to market. Unfortunately, sharing data brings privacy concerns and even more challenges when it comes to data security. Regulators are also constantly looking into whether or not pharmaceutical companies have disclosed the appropriate safety risks, leaving companies scrambling to find and report adverse effects (AEs) that are now streaming in from non-traditional sources – like patient support programs and even social media. Finally, as of January 2015, the Federal Drug Quality and Security Act mandates that manufacturers must integrate product transaction data into a single electronic or paper document. This means that every time ownership changes, it must be documented – and that transaction history must be maintained for at least six years.
Saving Money and Legitimizing Pricing
The heart of saving money lies within changing the commercialization model. The faster companies can get through R&D and into the marketplace, the better. Counterfeit drugs are also hurting pricing; the issue has become a worldwide problem, taking sales away from legitimate drug makers and causing potentially deadly side effects in consumers. As pharmaceutical manufacturers strive to defend product pricing, they will need to utilize advanced analytics to track outcomes and provide insight. Outcome-based contracts (or risk-sharing agreements) frequently seen in Europe may be headed to the United States soon. These contracts measure performance in the real world, linking reimbursement and coverage to the product’s efficacy.
The world’s population is aging, and with age comes chronic diseases. While the aging population presents a great opportunity for pharma companies, it also means more R&D, more clinical trials, and more data. Storing and archiving data is expensive on old infrastructures, but having to recreate work and research would be incalculable. Companies need affordable storage solutions that can meet their massive data needs while providing secure disaster recovery services.
The Solution: keeperSAFE with IDMT
Keeper Technology has the disruptive technology that pharmaceutical companies need to protect, manage, and store their data. By implementing the keeperSAFE (kSAFE) storage appliance with Intelligent Data Management Technology (IDMT), the pharma industry can save money while resolving data concerns.
The key to IDMT is metadata. Metadata is automatically extracted from data as it is ingested into the system, and it can be augmented manually or programmatically. With metadata, companies can make sense of the massive content needed to successfully discover new formulas, conduct clinical trials, and then bring life-changing drugs to market.
Access management protects
IDMT offers granular access management that goes well beyond groups and projects. Users can be restricted from seeing files, or may only be granted read-only access, based on any number of metadata fields. IP can be protected from unauthorized entry, and formulas and compounds would be safe from tampering – even within the organization. IDMT can also deliver the data environment pharmaceutical companies need to comply with regulations, allowing simplified access administration between third parties and other entities with whom data must be shared.
Metadata tracks and provides audit trails.
As data enters the system, IDMT uses metadata to establish inalterable audit trails, giving users unprecedented data tracking abilities. File versioning would be straightforward, enabling efficient workflow supervision. These audit trails could also help to provide the documentation necessary to prove the discoveries and new compounds that are required to obtain patents. The faster the patent can be obtained, the faster the time to market – helping bottom lines and budgets. To follow federal laws, IDMT would enable companies to produce transaction data easily. It can also ensure audit trails for the AEs and security risks that are placed into the system.
IDMT offers a robust analytics engine.
As the AEs are tracked, they can be analyzed via IDMT’s powerful query engine to develop insights from non-traditional data sources. The engine can also make connections between data, potentially shortening R&D by drawing conclusions that may have been missed altogether. Lastly, as outcome-based contracts begin to gain traction in the US, IDMT would be ready to crunch numbers and justify reimbursement levels.
Scalable storage handles data loads with no downtime.
kSAFE can be integrated with existing legacy hardware, meaning no pricey forklift migrations. It offers future-proof, infinitely scalable storage that is agile and on-demand. IDMT provides policy-based tiering capabilities, so data can be stored and archived where it makes the most sense – both for capacity and for cost. RAID and erasure-coding are supported for disaster recovery solutions, and maintenance and updates can be performed while the system is live, alleviating the risk of costly downtime.
Keeper Technology and Pharma: The Perfect Formula
By understanding the data requirements of the pharmaceutical industry, Keeper Technology can offer companies the transformative technologies that they need to meet their objectives. Pricing pressures, demands for innovation, and an ever-changing regulatory environment can all be addressed with kSAFE and IDMT. When Keeper and pharma join together, companies will find their formulas for success.