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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 advantagesthat it offersdrug 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 percent 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 processdata management will need to be improved as well asthe collaborationbetween 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-timetech transfer and on-boarding 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 contextualizesrecipe 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 andprocess flow, Skyland PIMSsupports the analysisof 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.
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 percent 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 islicensed 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 helpeda 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 reliedextensively 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 themmove 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, PIMShelps 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, SkylandAnalytics hasset a new standard in the space through our approach in designing easy to deploy and easy to usesoftware. 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.