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With ever-increasing pressure among lifescience companies to develop treatments andmedicines faster, more and more are outsourcingmany of their core business processes. During thepast few years, this has given way to the growingpopularity of virtual pharmaceutical modelswherein companies rely extensively on externalcapabilities, especially for manufacturing. In fact, virtual companies have become a major

presence in the industry, developing more of thenew drugs in the pipeline than many formerblockbuster drug companies.1

These organisations are developing moretreatments with minimal fixed assets and staff,which keep operational costs low and enable themto move with greater speed from developmentthrough to commercialisation.Karyopharm Therapeutics, for instance, relies

on the virtual manufacturing model and partnerswith a sizable team of contract manufacturingorganisations (CMOs). It focuses on the discovery,development and subsequent commercialisation ofnovel first-in-class drugs for nuclear transport andrelated targets for the treatment of cancer andother major diseases. Although Karyopharm has thrived with a

purposefully limited staff and more than a dozenpartners since its founding 8 years ago, itexperienced challenges to maintain singular,authoritative oversight of all the differentdocuments exchanged with CMOs. Without continuous and transparent content

management, sponsor companies may not beaware of issues until near the end of themanufacturing process — potentially increasingthe negative impact. Reviewing informationearlier means issues can be detected sooner in theprocess, mitigating risks and enabling companiesto be more proactive. Sponsors typically send large quantities of

documentation and detailed information betweenthem and their CMOs to maintain control, oftenvia non-secure document sharing. This can causeversioning confusion and makes it difficult forsponsors to establish a reliable audit trail, all of

which introduces compliance and product qualityrisks, as well as impacting process efficiency.To overcome these challenges, and to create a

single, always up-to-date source of truth with adetailed audit trail that both its internal team andcontract partners can rely upon, Karyopharmadopted a cloud-based quality solution. Thecompany recently shared its story at the VeevaR&D Summit in Philadelphia (PA, USA).

Compliance and data integrityCraig Gassman, Associate Director of RegulatoryOperations at Karyopharm, explained: “We usedto work across five or more different channels toshare documents with our CMOs, making itdifficult to find information, maintain visibility onthe status of processes, and determine whichexchanged documents were the most current.” “In addition, it was crucial for our organisation

to ensure a clear chain-of-custody — not only forcompliance purposes, but also to help ensure dataintegrity. Collaboration and access among globalstakeholders is critical to compliance and drivingoperational alignment,” he added. Almost immediately upon implementation,

Karyopharm provided Canada-based CMO,Piramal Healthcare, with access to its qualitysystem. Karyopharm first began working withPiramal in 2011, contracting with the company forpreclinical services and sample preparationthrough toxicology, as well as Phase I clinical trialmaterial supply. The company also providesPhase III and commercial support. According toPiramal, intensifying regulatory requirementsregarding the oversight of partners broughtadditional challenges.“Sponsors assume additional regulatory

demands because they must take fullresponsibility for the work being done at CMOfacilities. This has led to an increase in theexchange of information. Karyopharm is noexception,” explained Leslie Aucoin, ProgrammeManager at Piramal.“Thanks to Karyopharm’s new cloud solution,

we can stay fully aligned on projects at all times

Virtual manufacturingmodels and the power ofthe cloudHow a cloud-based quality solution is transforming relationships with CMOs forKaryopharm Therapeutics

38 manufacturing chemist March 2017

“Virtualcompanies havebecome a majorpresence in thepharmaceuticalindustry

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and have information at our collective fingertipsfor regulatory needs and project planning. Best ofall, Karyopharm won’t have to come back to usyears later to request documents.”According to Karyopharm, the cloud-based

solution has significantly improved its ability towork efficiently with external partners andenabled the organisation to successfully implementa virtual model. Some of the benefits include thefollowing:

Quality control: With a single source of truth,Karyopharm no longer needs to do time-consuming manual checks to ensure the CMO isfollowing guidelines and testing to the right levels.

Increased visibility: The cloud enablesapproved vendors to view documents at all times,ensuring that both Karyopharm and its partnersare in sync.

Time savings: In the past, Karyopharmestimates it may have spent 20 minutes to huntfor one document. Now it takes less than two. “Wedon’t have to retrace our steps — or a ghost’ssteps, if a staff member leaves — to finddocuments,” added Gassman. In addition,Karyopharm’s new solution has acceleratedregulatory filing. With the cloud, all relevantdocuments and related information are easilyfound and linked directly into submissions.

Improved compliance: Karyopharm now has aclear chain of custody, so it can see who reviewedand accepted information to support the batchrelease process. It’s proof for authorities that allissues have been resolved before release.

ConclusionFor Karyopharm, the most substantial advantageof moving to the cloud has been more streamlinedcollaboration with its partners, resulting in a 30%increase in operational efficiency. “Modern cloudtechnology enables our organisation to seamlesslyincorporate vital manufacturing partners into ourquality processes, and link processes to relevantdocumentation for improved compliance,” saidMaria Conklin, Quality Control Manager atKaryopharm.“If we investigate a non-conformance, for

instance, we can now just link the testing reportsto the change control document and confidentlyclose out the investigation. We have a completepackage to demonstrate to regulatory authoritiesthat nothing was skipped and that the situationwas resolved. And all of this is accomplished fasterand more efficiently than we ever could in thepast,” she adds.

REFERENCE1. A. Shanley, “New Business Models Attract Virtual Pharma,”Pharmaceutical Technology, www.pharmtech.com/new-business-models-attract-virtual-pharma (2016).

FOR MOREINFORMATIONRobert GaertnerEuropean Director of Strategy Veeva Systemswww.veeva.com/eu

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March 2017 manufacturing chemist 39

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