CIO Applications: Top 10 Bioinformatics Solution Providers - 2019

Info Sheet

Bioinformatics has become a powerful component in the field of science, and its induction to the global industry has marked a turning point in many areas, such as healthcare, gene technology and medicine.

With various applications in the areas of biotechnology, pharmaceuticals and medicine, among many others, bioinformatics solutions provide scientists with the instruments needed to analyze and handle large amounts of information. As the sector becomes more data-driven, bioinformatics will facilitate the analysis and interpretation of biological data from heterogeneous sources. Bioinformatics solutions will also assist businesses to automate their biological data integration, creation of algorithms and bioinformatics pipeline analysis.

In this scenario, it is important for the companies to know the nature of the current bioinformatics industry, its key players, as well as the various business opportunities in the market. Many solution providers operating within the bioinformatics industry provide robust software packages to analyze and interpret biological data, while some provide instrumentation and supplies for various biological analysis and researches.

With the growing number of solution providers in the bioinformatics domain, companies often find it challenging to select the best provider that suits their requirements. To help companies in this endeavor, a distinguished selection panel, comprising CEOs, CIOs, CTOs, industry analysts and the editorial board of CIO Applications has selected top ten bioinformatics solution providers that exhibit competence in delivering best-in-class solutions.

We present to you CIO Applications’ “Top 10 Bioinformatics Solution Providers- 2019.”

Skyland Analytics

The Quintessential Data Management Boost

 

Skyland Analytics is a software company that develops intuitive, cloud-based, SaaS data analytics and data management solutions for clients in the life sciences space. Based out of Boulder, CO and established in 2015,the company’s mission is to provide life science drug sponsors and manufacturers with a collaboration platform for managing and analyzing process, product, and patient data.

In an engaging conversation with Robert Di Scipio, the CEO of Skyland Analytics, he spoke about the company’s industry-leading product Skyland PIMS® and the advantages that it offers drug companies and their contract development and manufacturing partners (CDMOs).

Expound on the emerging trends and challenges in the life science industry.

The life sciences industry is in a state of flux as products and processes become more complex, management of critical data becomes more difficult, and nearly all drug inventors are relying on CDMOs for the development and/or manufacturing of their therapeutic products. One trade association study found that CDMOs produce nearly 50% of all drugs sold in the US. Meanwhile, the FDA is increasing its scrutiny of companies that rely on external outsourcing partners and is also examining how the industry manages generally complex product and process data. A substantial amount of critical data resides on paper and in spreadsheets, which makes it challenging to address business and regulatory requirements.

In order to remain competitive and compliant with regulatory agencies, product and process data management will need to be improved as well as the collaboration between life sciences companies and their suppliers. Cloud-based systems such as Skyland PIMS are designed to meet the precise data and operational requirements of the industry.

How does Skyland PIMS help overcome the challenges and what are the benefits clients can gain through its deployment?

Skyland PIMS provides the data aggregation, analytics, reporting and secure data sharing functionalities required by drug sponsors and their contract manufacturers and also enables accelerated and right-first-time tech transfer and onboarding of drug production.

Once deployed, our solution provides intuitive workflows that help enterprises organize product specifications, manufacture control limits and batch data efficiently. As production unfolds, Skyland PIMS contextualizes recipe information and specifications with batch data to enable push-button control charting and qualitative analysis. For drug companies who have extensive reporting obligations, Skyland PIMS prepares much of the data and many of the charts required to make reporting faster, easier and more accurate. Serving as the master repository or data hub where users can rapidly create and retrieve product formulas, specifications, recipes and process flow, Skyland PIMS supports the analysis of batch and
quality information along with critical patient and clinical data.

Skyland PIMS is a hosted application and easy to use, lowers total cost of ownership and can be deployed and ready for data entry or uploads in a matter of hours. Customers can connect their digital lab and manufacturing systems, ERP, and their data warehouses to the Skyland PIMS platform as their IT architecture matures, creating further efficiencies in the aggregation of data.

“With our extensive experience in life sciences, manufacturing, IT systems, data analytics, and product quality, combined with our modern technology approaches, I do not believe there is another company with the domain expertise required to meet the precise demands of data management in the life science industry.”

What distinguishes Skyland Analytics from other players in the market?

With our extensive experience in life sciences, manufacturing, IT systems, data analytics and product quality, I do not believe there is another company better prepared to meet the precise requirements for data management in the life science industry.

We created the industry standard 20 years ago, serving companies such as Abbott, Novartis, Eli Lilly, Biogen, Samsung, Takeda, Baxter, Bristol Myers and Amgen, and now offer an enhanced solution with Skyland PIMS. PIMS offers use cases for all companies developing or manufacturing pharmaceutical products including small molecule, biotech and cell and gene therapy across all stages of maturity. As a result, Skyland is participating in an industry-wide effort to develop and publish written standards for data management in the cell and gene therapy sector. PIMS provides value to companies of all sizes and with varied technology infrastructures. This includes global companies with their own manufacturing, as well as emerging companies that are 100% reliant on third parties for product development and manufacturing. Our team has designed an intuitive workflow system-ready for manual data entry, Excel uploads or digital connectivity to a multitude of data sources.

Skyland Analytics has created a simplified licensing approach. PIMS is licensed by-product where all users, whether from the drug inventor or the CDMO, are covered without upcharge. Our licensing approach encourages all constituents in the supply chain to leverage the PIMS data collaboration platform.

Tell us about an instance where Skyland Analytics’ unique methodology successfully helped a client in scaling operations and mitigating their problems.

Recently, a leading cell and gene therapy company engaged with us to help manage complex data coming from multiple sources within its operations and from development partners. We collaborated with the customer to deploy Skyland PIMS, and this provided data transparency across their supply chain and enabled rapid preparation of Continued Process Verification (CPV) and Annual Product Review (APR) reports.

Like many industries, traditionally—the life science sector has relied extensively on paper records and Excel spreadsheets to record data before they have a digital system, or if their products do not yet justify the financial and human resources required for the implementation of digital manufacturing systems. Skyland PIMS helps them move past manual processes into a robust, FDA-compliant data system that remains the central data hub as additional digital data sources are adopted in the captive manufacturing operation or external network. As customers require more analytical capability, Skyland PIMS complements and connects to manufacturing systems and other reporting tools to help ensure a coherent organization of data. With its pre-configured workflows, PIMS helps companies shift efficiently into a digital system while reducing the errors that come with manual data entry. Thus, accelerating the preparation of required business and regulatory reports related to the control of drug quality and manufacturing.

Where do you see Skyland heading in the near future?

Since the inception of the company, Skyland Analytics has set a new standard in the space through our approach in designing easy to deploy and easy to use software. We will continue to focus on developing specialized features and workflows that provide efficiencies at a lower cost than legacy solutions. Skyland PIMS has received special notice in the fast-growing and complex regenerative medicine segment, owing to its ability to manage and analyze aspects of the patient medical record that may be relevant to process and product development and manufacturing. There will be continued enhancements in incorporating and analyzing relevant patient data, which is fundamental to the development of effective, precision therapies. Our firm plans to expand the capabilities of Skyland PIMS to aggregate data from more cloud-based and on-premise data silos and add more analytical tools for use in manufacturing and R&D.

 

Find out more about smarter drug manufacturing process data management.

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