1 of 2
PCI
Jane Sanderson, executive director global laboratory services, Packaging Coordinators, Inc.
2 of 2
PCI
About the blogger: Jane Sanderson, executive director global laboratory services, Packaging Coordinators, Inc. Sanderson serves as the director of laboratory services for PCI’s North American site located in Rockford, Illinois, after relocating from PCI's UK site located in Hay-on-Wye, Wales. She previously headed up AndersonBrecon’s European laboratory services and offers extensive experience in laboratory services and analytical development. Prior to her tenure with PCI, Sanderson served as laboratory operations manager for the UK laboratory services of Cardinal Health (Catalent).
In today’s dynamically changing environment, innovation and cost efficiency in drug development is crucial; costs of R&D are growing aggressively with an average investment of $1.3 billion (£0.8/€0.9 billion) required to successfully initiate a new drug to market1 and an average 12 years to bring a new molecule from laboratory to approval. Furthermore, approximately 1 in 5,000 candidates entering preclinical testing make it to market2. Drug development timelines are under constant attack with speed to market paramount to success. Continual internal and external pressures mean traditional approaches to drug development are difficult to sustain and more and more pharmaceutical companies are relying on outsourcing to achieve their goals.
Analytical testing is one area where pharmaceutical companies look for expert support from a third party. The process of testing and packaging is a niche, technically specialist service, requiring state-of-the-art equipment, quality assurance and extensive expertise. When selecting an outsourcing partner, a company must conduct extensive research to ascertain that their chosen partner has the expertise and experience to support their drug development requirements and meets the appropriate regulatory obligations.
Selecting the optimal outsourcing laboratory can provide benefit both in expediting the development process as well as reducing potential risk to the overall development timeline. In selecting a partner laboratory, the drug company needs to qualify the laboratory’s breadth of services, experience and expertise. High performance laboratories can bring significant insight and knowledge from their collective experiences to benefit the drug company’s specific programme. These insights are invaluable in overcoming the hurdles common to drug development. Laboratories physically located adjacent to other services, such as manufacturing or packaging sites, can provide additional benefit in reducing risks inherent in shipping test samples around the globe.
Outsourcing to offsite laboratories is often the chosen method; however, with shipping costs rising as well as drug transportation regulations becoming more stringent, the conveying of drug samples can present unnecessary risk. Not only is there a potential timelines extension to account for transit time, there is also the risk that samples are not representative of the batch owing to differences in shipping and storage conditions. As a result, outsourcing to offsite analytical laboratories can increase both cost and lengthen project timelines.
Many of the challenges encountered during this outsourcing process can be alleviated by the selection of a partner that can manage the entire continuum, from analytical and clinical packaging to commercial packaging requirements, under one roof. Choosing the right supplier is about more than comparing product and services or price. Ensuring that business needs and project objectives are met is vital and therefore selection of one, carefully targeted partner can deliver a wealth of benefits.
Trust and expertise
The relationship built during a strategic partnership benefits both sides. Outsourcing partners work hard to become an extension of your own team, utilising experience and drawing on learned best practices to deliver the optimal results for both businesses. The experience gained working with a variety of clients and projects ensures a consultative approach to developing customised solutions, working together to alleviate risk and adding value across the whole project lifecycle.
Speed to market
When using a supplier with these extensive capabilities, speed to market
is greatly accelerated. Turnaround times are reduced as there is no need to factor transportation time for offsite analytical testing into the project.
It is not only in transportation that efficiencies can be made. Qualifying a new supplier can be time-consuming; carrying out site visits and audits can add delays to already tight project timelines. Using one pre-approved facility for regular projects promises accredited facilities that are trusted and maintained to an agreed standard.
By using one expert team, complexities can be speedily identified and resolved and adaptations that may be required to the project design can be expedited quickly and at a lower cost. Using one supplier will also guarantee the consistency and accuracy of analytical methods and results, meaning that further delays are avoided by transference from another party.
Leveraging costs and expertise
In order to retain competitive advantage in the aggressive pharmaceutical market, companies need to address their strategic direction. Outsourcing has the potential to deliver extraordinary business value and additional operational efficiencies above and beyond cost savings.
Utilising a company that has laboratories in different geographical locations can be beneficial when looking to enter several markets. Choosing a partner with knowledge and experience of a chosen region as well as the ability to easily manage the internal transfer of drug product and analytical methods can ensure significant savings.
Costs are also lowered in areas such as shipping, staffing and other business overheads; more and more companies are realising exceptional benefits from leveraging global expertise and talent in all areas of their projects.
Reducing risk
The integrity of a drug is paramount throughout all stages of a project. Reducing risk in all areas is vital to maintain the quality and success of the drug development process. By utilising one supplier, risks are significantly mitigated through fewer opportunities for error and variation during transportation, document and method transfer and communication. Furthermore, having one supplier ensures continuity across the project with one dedicated project manager and team.
Conclusion
With pharmaceutical companies increasingly looking to improve their time to market while reducing costs and maintaining their competitive advantage, outsourcing enables companies to leverage the global marketplace and drive the greatest profit.
The success of a project and the level of benefit achieved are highly dependent on the outsourcing partner’s ability to continually deliver at a high level and maintain the trust of its stakeholders, placing their interests first and offering quality advice, unrivalled expertise and measurable added value.
Choose a partner carefully and you will realise faster and more cost-effective time to market.
References
1Forbes 2 Oct 2012: Matthew Herpers 2012, The Truly Staggering Cost of Inventing New Drugs.
2www.medicinenet.com, Drug Approvals — From Invention to Market ... A 12-Year Trip.