“Some manufacturers seek a single vendor, hoping it can provide software for all enterprise functions,” says Robert Di Scipio, CEO of Skyland Analytics, Inc. “Others develop their own software, but struggle to keep up with desired functionality, best practices and software validation requirements.”
The Skyland Analytics team helps manufacturers overcome these challenges, leveraging their experience in life science manufacturing, data science, IT, quality management systems and legal and business operations. Skyland experts helped pioneer informatics in the manufacturing arena and played key roles in the development of Discoverant® software (Discoverant is a registered trademark of Dassault Systemes SA) to meet the specific functionality and validation needs of life science manufacturing. Team members have completed IT and analytics projects for more than 20 of the world’s leading life science companies.
Skyland’s manufacturing informatics services include software search, selection and validation, as well as manufacturing process optimization. The company also offers a manufacturing risk assessment that gives clients an independent, data-rich perspective on risks present in their internal and external manufacturing operations. This assessment can add great value to the manufacturer’s compliance and enterprise risk management initiatives.
“Our experts assess GxP, product and process performance, IT systems, cyber security, IP strategy and protection, contracts with external partners and other risk factors,” adds Di Scipio. “We dig deep into data from multiple corporate, manufacturing and quality systems to understand if, where and why risk exists. Our findings and recommendations are presented in a risk scorecard. The goal is making it easier for clients to understand where their strengths and vulnerabilities lie, so they’re better positioned to mitigate risk and optimize operations.”
The goal is making it easier for clients to understand where their strengths and vulnerabilities lie, so they’re better positioned to mitigate risk and optimize business operations
The Skyland team pays special attention to the risks associated with FDA and SEC compliance.
“Although manufacturers focus on FDA—and EMA— compliance, many are not fully aware of the increased scrutiny the SEC is payingto their space,” states Di Scipio. “We help our clients identify risks associated with manufacturing operations and assess whether they are material, in which case disclosure may be required under SEC regulations.”
Skyland also helps clients select manufacturing partners and structure the key business terms that define those relationships.
“It’s been our experience that CMO agreements tend to have a strong focus on cost and supply, but often leave drug owners without sufficient protection in areas such as ownership of IP, data visibility and future competition from the CMO. With our guidance, clients can develop agreements that protect their key business interests and reduce compliance risks,” adds Di Scipio.
Looking ahead, Skyland expects their manufacturing risk assessment to become a standard enterprise risk management procedure for life science companies. The company’s near-term focus is on educating life science manufacturers, their business partners and advisors about the potential FDA and SEC risks present in their operations. On the informatics side of the business, Skyland sees an increase in the implementation of specialized software that meets the needs of the quality, compliance and manufacturing functions.