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Outsourcing in a bioanalytical laboratory

Bioana­lysis invited a selection of leading researchers to express their views on outsourcing in the bioanalytical laboratory. The topics discussed include the challenges that the modern bioanalyst faces when outsourcing bioanalytical work including effectively managing costs but still maintaining productivity and quality of work. Their enlightening responses provide a valuable insight into the impact of outsourcing and the future of the constantly evolving bioanalytical laboratory.

„„Patrick

Bennett, Thermo Fisher [email protected] QQ In your opinion, what are the main advantages & disadvantages of outsourcing bioanalytical processes? The main advantages are better resource utilization. By treating the CRO as a flexible capacity and the ability to use specialized services when needed, companies can focus internal resources on more complex issues related to drug discovery or development. Depending on the size of the sponsor organization, there are many reasons to view a CRO as a flexible capacity. For a smaller organization, it may be the only way to perform bioana­lysis. For midsized and large companies, it can allow larger studies to be outsourced, while smaller studies or studies with complex issues can be retained internally. The main disadvantages include the potential loss of control over both the data and study quality, the ability to assign specific personnel or resources, and the timing of the project initiation and conclusion. There may also be a loss of some information on potential issues/challenges and solutions for projects that are distributed between different CROs. QQ What challenges do we face when outsourcing bioanalytical work? The biggest challenge is the identification of the appropriate laboratory. Even when long-standing relationships are in place, not each project is the same in terms of requirements – including whether to combine the outsourcing of the in-life or other parts of the study. In some cases, it may be appropriate to outsource all or significant parts of the project to a single CRO. However, it may also make sense to segment the bioanalytical work to ensure the laboratory has the appropriate expertise and capacity, and can meet the desired timelines. The ability to monitor study progress – particularly with distribution of work within a CRO and between CROs – that is, clinical, formulations, bioanalytical, PK reporting and so on is also very challenging. This is particularly challenging in a time where corporate pressure to reduce travel or travel restrictions are in place. QQ Do you believe outsourcing is more successful via a preferred provider, vendor relationship or consulting model relationship? A preferred provider is ideal; however, there should be some flexibility to use specialty laboratories as needed. Vendor relationships focus on price as the key endpoint and less on customer service, quality improvements, time lines, and so on. This does not build any type of relationship between the sponsor and CRO organizations. Good relationships, communication capabilities and trust are very important. These are not always optimized with vendor relationships. Consulting relationships can be complicated by the mixture of relationships the consultant has – that is, they may have specific CRO preferences that do not always align with the bioanalytical requirements. Consultants with strong relationships with a broad variety of bioanalytical CROs can be beneficial for all.

10.4155/BIO.13.240 © 2013 Future Science Ltd

Bioanalysis (2013) 5(20), 2453–2462

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QQ What factors do you believe are important to consider when selecting an outsourcing partner? Aligning CRO skill sets and capacity with those required for the project – both short- and longterm objectives of the study and overall project. If the method development and validation will be challenging, the focus should be on identifying laboratories that have strong method-development depth and proven history. Similarly, first-in-man, rapid turn-around time and large studies also require specific capabilities. From a relationship perspective, strong project management and communication is required by both parties. Always having a direct contact and back-up contact are important in developing these relationships. QQ How do you believe that a CRO is able to effectively manage costs but still maintain productivity & quality of work? Although challenging, CROs can typically manage costs while maintaining productivity and quality of work because they follow a business model that requires this as well as profitability and growth. CROs have the flexibility to adjust their workflows and personnel to meet their forecasted capacity needs. Typically, this is a mixture of method development and validation, smaller studies and larger studies that they try to maintain at a certain ratio. Most CROs segment their workflows to support each of these types of work, for example, method development teams very experienced in developing the most effective methods in the least amount of time. While automation can often assist in reducing scientific expense, its real benefit is associated with reduced potential for error. Systems and automation that focus on reducing manual input and data exchange are ideal because they focus on improving quality and productivity. CROs also continuously optimize processes due to the exposure to a variety of customers, projects and auditors. Each time a process is optimized the laboratories typically take into account the cost and return on investment versus benefit to operations, quality and/or customer.

„„David

F Beyerlein, MicroConstants [email protected]

QQ In your opinion, what are the main advantages & disadvantages of outsourcing bioanalytical processes? CROs focused on bioana­lysis are tasked with developing methods for hundreds of compounds each year. Being exposed to such a wide variety of drugs, and overcoming the analytical challenges that each brings, makes method developers at CROs some of the strongest in the industry. Having solid bioanalytical methods is critical to the success of every drug program and sponsors can benefit from taking advantage of a CRO’s scientific expertise in this area. Furthermore, outsourcing the development of high-quality bioanalytical assays at the start of preclinical studies, and validating those methods for each species early on, can lead to more consistency in the data throughout the entire development process. For small- to mid-sized pharmaceutical and biotech companies, outsourcing regulated bioana­lysis allows them to achieve significant cost and time savings. They are able to move their compounds through preclinical and clinical studies without developing the quality systems and writing all the SOPs required to perform these regulated bioanalytical studies. They also save costs by not purchasing and maintaining the equipment and instrumentation required for the sample ana­lysis and the payroll expense for the additional scientific staff, QA personnel and management required for a GLP-compliant bioanalytical team. For larger pharmaceutical companies and companies with their own in-house bioanalytical team, outsourcing allows them to deal with capacity issues and enables their staff to focus their efforts on research instead of routine bioanalytical procedures. However, they sacrifice a certain level of control and direct oversight that they would have if they kept the bioanalytical in-house instead of outsourcing the ana­lysis. QQ Do you believe outsourcing is more successful via a preferred provider, vendor relationship or consulting model relationship? Success is really specific to the exact needs of the company looking for outsourcing partners and their own internal expertise in bioana­lysis. Typically, larger companies tend to benefit from a preferred

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provider approach. As pharmaceutical companies grow in size and number of programs, it is not always cost effective for them to qualify new vendors for each program and establish relationships with numerous vendors. Smaller companies on the other hand will typically benefit more from vendor or consulting model relationships, especially when they do not have the bioanalytical expertise in-house. Industry consultants can be a huge asset to smaller companies by helping them identify CROs; however, for companies that already have trusted CRO partners in mind, consultants may not be as necessary. In either case, small to mid-sized pharmaceutical companies can benefit greatly from forming a vendor relationship with a CRO that focuses on bioana­lysis. The scientific expertise and advice they contribute to help guide the company’s programs through development can be extremely valuable to the overall success. QQ What factors do you believe are important to consider when selecting an outsourcing partner? The two most important factors when selecting a bioanalytical vendor are the depth of their scientific expertise and the quality of their work. Speed of ana­lysis is always an important factor when the bioanalytical data is being used to drive decisions; however, the bioanalytical data is rarely the rate-limiting factor in most studies. Many companies are also very concerned with price, but the lowest cost is often inversely proportional to the success of any relationship between a bioanalytical vendor and the sponsor. If a pharmaceutical company is happy with their current bioanalytical partner, they would likely regret switching vendors based on price alone. We have worked with sponsors that have done exactly that and then brought the work back to us later. Only when a company has a group of qualified bioanalytical vendors who are deemed equal in terms of scientific expertise and quality, should the price or timelines be the deciding factor. QQ How do you believe that a CRO is able to effectively manage costs but still maintain productivity and quality of work? To operate a regulated bioanalytical laboratory, there are many fixed costs in terms of facilities, equipment, instrumentation and personnel. There is also a significant investment in training new employees. However, compared with a pharmaceutical company, the structure of a CRO allows it to operate more cost effectively by sharing these resources across many different studies as opposed to just supporting one company’s pipeline. With that said, CROs need to carefully manage workloads to fit their capacity, grow at a stable and manageable rate and ensure adequate training time for new employees. CROs that make good decisions regarding these three crucial parts of the business are able to fully realize the cost advantages that the CRO structure allows, while also maintaining productivity and quality standards. QQ What factors do you believe have driven pharmaceutical companies to increase outsourcing? The downsizing at several of the largest pharmaceutical companies has been a contributing factor. To keep costs down, these companies have shifted several of the functions they used to perform internally to CROs. Mid-sized pharmaceutical companies seem to have the fastest growth in the industry right now and these companies have historically outsourced a significant portion of their routine bioana­lysis. Additionally, a large amount of the private R&D investment and funding from government grants is driving the development of many small or even virtual biotech companies that typically outsource all or most of their bioana­lysis. As their studies advance and show positive results, these companies become targets for acquisition by mid- to large-sized pharmaceutical companies who often continue outsourcing the projects to the vendors who already have the validated methods in place.

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„„Richard

Hucker, A4P Consulting Limited [email protected] QQ In your opinion, what are the main advantages & disadvantages of outsourcing bioanalytical processes? The prime reason to outsource is to maintain productivity where internal resource gaps occur. This may be in personnel, in expertise or in technology. It may also be a way of resolving competing internal priorities or to fulfill demands caused by local geographical regulatory and business factors. The second reason is an attempt to control R&D costs and to maximize returns on investment. It is relatively easy for a sponsor to model resource issues and is probably where most organizations start. At one end of the spectrum is tactical outsourcing to cover temporary or imminent technology, or resource gaps. Here, lead times especially for regulatory standard bioana­lysis, can produce limitations on initial expectations. At the other end of the spectrum are organizations that strategically outsource, based on core multi-year business operating models. This ranges from total outsourcing sometimes referred to as the ‘virtual model’, to those who outsource from particular geographical locations or after certain project milestones. The advantages seen are the reduction in the need to secure capital funding and maintain that over the long time periods required in successful drug development. A potential disadvantage to this approach is that there is always a risk of a lack of supply when the need is urgent or immediate. Nevertheless, using outsourcing to control costs can often be misunderstood by sponsors. For example, internal costs of resource required for managing outsourcing can often be overlooked and not factored appropriately. As a working rule of thumb, sponsors should expect to commit around an additional 20% of a project’s outsourcing cost to fund the management of the outsourced project. QQ What challenges do we face when outsourcing bioanalytical work? As the wealth of scientific knowledge increases profoundly around basic disease processes, the need for more diverse bioanalytical data is increasing. Therapies are no longer restricted to small molecules. The demands placed by large-molecule therapies, for example in investigating immunogenicity effects, are changing needs. Clinical trial designs, responding, in part, to an increase in more sophisticated data needs, along with so called ‘kill it quick’ strategies, are becoming increasingly complex. The requirement to simply quantify the dosed agent in fixed time-point samples is being replaced in many studies by more complex bioanalytical needs. For example, ana­lysis for soluble biomarkers is now much more prevalent and important. This is, in turn, increasing the complexity of how to operate within the regulatory environment. The line between investigative data and primary data is increasingly blurred in programs, in studies and even within the same sample where multiple analytes are being measured. Therefore, the current operating environment is much less stable and predictable. Forward long term forecasting has become more difficult. Flexibility is now the key business driver for CROs in their operational responses and in costing models and charges. Sponsors have to pay increasing attention to the complex regulatory environment, including an awareness in their accountabilities for outsourced generated data. While there is increasing clarity and guidance being given around this, it can still be misunderstood or ignored. The initiatives to achieve at least some standardization and clarity across the various regulatory agency guidelines have much potential in allowing the necessary flexibility. A challenge for sponsors is that their data are accumulated over a wide time span and increasingly through multiple owners. Thus, issues may not be immediately apparent or even become inadvertently hidden. Reviews, especially during handovers will become more necessary. Some attempt at future proofing is necessary but demanding in a less predictable world. QQ Do you believe outsourcing is more successful via a preferred provider, vendor relationship or consulting model relationship? I actually believe that the business model chosen is less important than the product. Once a decision to outsource is made, irrespective of how it is set up, the sponsor requires quality timely quantitative data that answers the questions set by the experiment undertaken. If the data is of insufficient

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quality, is produced too late to be effective, or if it takes so much resource to achieve that the return on investment is uneconomic, then the resource model chosen becomes largely irrelevant. A key factor for clients is their need to effectively oversee the outsourced activities. Therefore, in considering which model to pursue, the internal effort required by a sponsor to oversee outsourcing has to be fully costed and the internal organizational consequences assessed. Where preferred provider models are set up, they require significant internal reorganizations and change to properly realize true gains. If sponsor organizations are reluctant or are for whatever reason, incapable of achieving those changes then less strategic models may be a better approach. In the currently increasingly complex and uncertain environment it is difficult to see that any particular approach is proving to be comprehensively more successful than another. As for virtually all businesses, the ability for bioanalytical CROs to generate repeat business from its client base is likely to be the most sustained way of securing revenues. Therefore, all operating models should be capable of consistently delivering those elements that are most likely to retain clients. From a client organization perspective, retaining control and flexibility are still fundamental. The most likely trend is for organizations to maintain a mix of approaches so that the organization can both respond quickly within an overall strategy. In the end circumstances will and should always dictate. It is a bad plan that cannot be changed. QQ What factors do you believe have driven pharmaceutical companies to increase outsourcing? Drug development is in the midst of profound and permanent change, operationally and fiscally. Downward productivity measured by the decrease in the numbers of successfully adopted new medicines is significantly pressuring returns on investment. The industry response particularly from the large global pharmaceutical companies has been to attempt to completely change their investment strategies. There have been concerted efforts to fundamentally reorganize R&D governance, reduce in-house resource and focus R&D efforts more tightly. The smaller, specialist companies and biotechnology companies are being forced to respond accordingly in how they are funding and developing their products. All disciplines including bioana­lysis are affected. The sourcing of products, of research substrate and the outsourcing of operations is now very complex. Various organizations have been candid about the fact that they will not look to have every potential technology solution and its required resource held in house. Partnerships are thus the new way forward. Perceived wisdom suggests that if internal resource is cut then outsourcing is increased to cover the shortfall and maintain productivity. However, the evidence at present is patchy and mainly anecdotal as to whether there has been a rise in outsourced output of anything equal to the concomitant reduction of the previous in-house effort. What is clear is the old paradigms are gone forever. Increase in bioanalytical outsourcing will not be driven by simply picking up the slack caused by reorganizations and in-fill of resource. CROs are already responding to this by becoming more innovative, offering services in areas such as discovery support, widening their technology platforms and looking to deliver added value in offerings that stretch wider than traditional bioanalytical support models. Obviously, they will need to remain focused on quality, productivity and cost factors, but innovative opportunities clearly exist, thus the medium to long term prospects look exciting.

„„Brian

O’Dwyer, ICON plc [email protected] QQ In your opinion, what are the main advantages & disadvantages of outsourcing bioanalytical processes? The principle benefits of outsourcing bioana­lysis include derisking the sponsor in the event that drugs fail during development, enabling sponsors to leverage investments made by CROs in technologies and ultimately reducing internal cost in supporting bioanalytical testing of development programs. Running a bioanalytical laboratory is expensive in terms of real estate and equipment, in addition to costs associated with the employment and retention of highly trained laboratory staff. As the pressure to reduce costs intensifies within the pharmaceutical industry, the need to outsource bioana­lysis is greater than ever before. The disadvantage to sponsors when

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outsourcing is a perceived lack of control on deliverables, both quality and timeliness. Often the bioanalytical group within the pharmaceutical or biotechnology company is under significant pressure from their clinical development teams to deliver data on time. The ability to rely upon providers to deliver a high quality set of data within the timelines required is critical and if either is not met reliably, it puts pressure on the sponsors’ bioanalytical teams, which in turn may put a strain on the relationship between the sponsor and CRO. Hence, the increasing concentration on fewer providers poses greater risk to sponsors and CROs who do not fully embrace a combined and mutually reliant relationship model. QQ Do you feel that there is some resistance to outsourcing? If so, what barriers do you believe are in place? I do not believe there is significant resistance to outsourcing as most sponsors do not have an option due to restructuring across the pharmaceutical industry. Many sponsors still work to develop the assays required internally and support some early discovery, preclinical and first-in-human studies within their own laboratories before outsourcing the larger sample volumes to contract laboratories. In these cases the sponsor carefully oversees the assay transfer into the partner laboratory, and is therefore confident in the assay and the results that will be generated in the contract laboratory. That said, there is always a risk that some inter-laboratory variability may arise when the assay is spun up in another laboratory or a concern that the CRO will not perform the same high quality analysis as their internal laboratory. This doubt can be the main driver of resistance to outsourcing. Where a sponsor has been disappointed by a provider this can compound the level of distrust and can extend to the broader outsourcing industry. Finally, there can be a sense among sponsors that their scientific expertise is superior to that within a CRO; therefore they may not be receptive to advice on how to improve methodologies that could be mutually rewarding. This results in a relationship that is neither open nor innovative, both of which are key elements to success in the dynamic bioanalytical arena. QQ How do you believe that a CRO is able to effectively manage costs but still maintain productivity & quality of work? From a CRO perspective, this is the key question. Capacity planning is one of the critical success factors for a laboratory; getting visibility into the potential pipeline and volume of activity across programs is vital to a CRO. As sponsors become more focused on fewer suppliers, providing adequate and readily accessible capacity (both in terms of staff and instrumentation) is a key requirement of their CRO partners. CROs aim to provide this for their sponsors in order to generate more secure future business streams but must balance this with their need to produce a reasonable financial return to their shareholders. When sponsors are unable to provide insights into their forcasted bioanalytical requirements, this creates uncertainty within a CRO that they will make the necessary returns on the investments their clients require of them. This may be out of the sponsor’s immediate control where they are not provided such transparency from their clinical teams and, in an effort to avoid misleading a CRO partner and potentially impacting the relationship, sponsors often choose not to disclose their pipeline activity. The solution to this issue is mutual openness and clarity. Sponsors need to put faith in their CRO partners to make a risk assessment on the information being shared, understanding that this will always be subject to change. Equally, CROs need to ensure that they balance their capacity across sponsors, so that they are not overly concentrated on a particular sponsor, which may expose them unnecessarily. ICON has seen many examples where this mutual trust and information sharing regarding risks being taken can benefit both parties in delivering successful results and creates a true innovative and open partnership arrangement. QQ How do you envisage the future of outsourcing in a bioanalytical laboratory? If you trace back the progression of outsourcing over the past 10 years there has been a continuation of the trend toward consolidation as the leading bioanalytical providers have grown in strength and market share. The high costs to enter the market prohibit smaller companies from making significant inroads and sponsors generally do not wish to take the risk on smaller, lesser known laboratories. Operational groups within pharmaceutical and biotechnology sponsors require a greater degree of flexibility and speed of delivery, without compromising quality. Meanwhile, procurement groups require this to be delivered at a much reduced cost. CROs can only deliver the economic and operational

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requirements of sponsors through greater collaboration, including future assurance and visibility of sample flows. CROs need to ensure that they are providing solutions for sponsors through increased coverage in the regions that sponsors are conducting their research and through maintaining appropriate scale and equipment range required to support the ever increasing complexities of the bioanalytical and biomarker testing industry. Finally, CROs need to invest in the scientific expertise required to support the needs of the sponsors. Provided this can be done at a reasonable economic return to the CRO the current trend of increasing concentration will continue. However, if the financial pressures become too great, a market for small niche providers in the industry who do not carry as much overhead as the larger CROs will emerge and may threaten the current drive towards consolidation. „„Noel

Premkumar, Alturas Analytics, Inc. [email protected] QQ In your opinion, what are the main advantages & disadvantages of outsourcing bioanalytical processes? Today, many pharmaceutical and biotechnology companies utilize outsourcing to accomplish a significant portion of the preclinical and clinical bioanalytical work. Outsourcing depends on various factors – business, financial, logistical and/or technical, therefore the advantages and disadvantages of outsourcing can be very subjective. Outsourcing can significantly reduce financial risk by limiting or eliminating the company’s capital investments (laboratory equipment and real estate) and converting overhead costs to variable costs. Routine bioanalytical activities, when outsourced will free up resources that can be focused on new R&D activities. Over the years, expertise in regulated bioanalytical work has shifted to the contract (collaborative) research organizations, making it attractive to have these experts in the field of bioana­lysis manage the projects. For small companies, outsourcing allows them to hold off on partnering with a major pharmaceutical company and keep a larger portion of the ownership of the original drug. Some of the disadvantages of outsourcing include eventual elimination of bioanalytical expertise within an organization, providing timely assistance in problem solving, scheduling and prioritizing the projects and managing outsourced activities in addition to internal research. QQ What challenges do we face when outsourcing bioanalytical work? Outsourcing is dependent on good and timely communication. Communication plans are essential for meeting expectations and keeping projects on track. Laboratories provide either a single point of contact or the sponsor is allowed to contact associates involved with the project. Regular interactions are needed to establish a strong working relationship and cannot be underestimated, particularly when deadlines are critically tight. Setting expectations for communication, protocols, reports, reviews and timing is crucial, and have to be well defined and monitored. Building a working relationship based on trust is essential and leads to long term collaborative relationships. QQ What factors do you believe are important to consider when selecting an outsourcing partner? A number of quantitative and qualitative elements should be examined when selecting a commercial bioanalytical laboratory as an outsourcing partner. The ana­lysis should include assessments of scientific talent, capabilities, capacity, regulatory knowledge and quality processes. QQ What factors do you believe have driven pharmaceutical companies to increase outsourcing? Outsourcing as a strategy has helped manage the flow of projects entering or leaving product development due to toxicity, changing priorities or plain economics. Outsourcing has allowed the pharmaceutical companies to leverage the strengths of a particular outsourcing partner and provide additional scientific and operational excellence to make decisions early. Outsourcing has provided sponsors with more flexibility, global reach and reduction in personnel and capital infrastructure, while expanding capabilities.

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„„Dieter

Zimmer, Zimmer BioAnalytics & More [email protected] QQ In your opinion, what are the main advantages & disadvantages of outsourcing bioanalytical processes? Advantages include flexible external capacity available on-demand if inhouse capacity on sponsor`s side is on short, or rather designated to more exciting or demanding research work than to routine analysis; sponsors get access to technologies, instrumentation, skills and knowledge that they do not have (anymore) in-house; good CROs are often consultants for their sponsors, which is especially the case for small companies which do not have bioanalytical expertise in-house; cost savings might be achieved by reduction of in-house bioanalytical laboratory capacity on the sponsor’s side. Disadvantages include sponsors becoming dependent on CROs, especially if they dramatically reduced their in-house laboratory capacity or even closed their bioanalytical unit completely; bioanalytical skills, experience and bioanalytical state-of-the-art awareness may get lost on the sponsor’s side; monitoring of outsourced projects including control of result delivery and assurance of quality, digest sponsor capacity; if the project/study is urgent or ‘online’ analysis (e.g., in Phase I clinical studies) is needed, then CROs may not be as rapid and flexible as in-house laboratories; frequent communication issues of sponsors with CROs, and inside the larger CROs; less convenient access to raw data if required and slow communication if CRO is located very far from the sponsor. QQ Do you feel that there is some resistance to outsourcing? If so, what barriers do you believe are in place? There was some resistance, or personal resentments, in the early days of outsourcing, since CROs were considered as competitors for the work that so far was done in-house. The sponsor`s bioanalytical experts initially transferred their knowledge to CROs then, after outsourcing was set-up and worked smoothly, in-house capacities were reduced, sometimes with the consequence that these experts became redundant. There were concerns that, for example, scientific quality of work, adherence to regulatory guidelines and timeliness of result delivery might not be appropriate. The non-negligible efforts to monitor outsourced studies was also considered a hurdle. However, due to restructuring processes in pharmaceutical companies there is no further debate regarding the need for outsourcing nor real resistance. Outsourcing has become an essential part of drug development. QQ How does the implementation of outsourcing in an individual laboratory affect overall drug development schedules & costing? It is believed, that cost is saved and excecution of projects becomes faster, which is indeed often the case but not axiomatic. The work of the sponsor monitors, their efforts and challenges are often not fully considered in the whole equation. Project excecution may even slow down, due to lack of capacity in the preferred CROs, communication and technical issues, slow progress with report finalization, and so on. In most cases this should not have a significant impact to a drug-development project. Bioanalytical work contributes, in my opinion, only towards a small part to the overall cost of drug-development projects. QQ How do you believe that a CRO is able to effectively manage costs but still maintain productivity & quality of work? This is indeed a major challenge for CROs, especially since sponsors negotiate service prices quite strongly, CROs may therfore only obtain small margins on their services, which is especially the case for method development (not cost-effective), but also for validation and for studies with low sample numbers. Therefore, CROs might either reduce headcount to be cost-effective or overload their staff with work instead of hiring additional people. This might have a negative impact on productivity, timeliness, quality, and at the end on customer satisfaction as well. A better way of cost management is investment into motivation of staff, automatization, intelligent software, process optimization and so on, with the aim to reduce labor required to get a study done and to avoid human failure, since frequent repeats in the laboratory reduce the margin of a study. Hiring and

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retention of qualified people is of major importance for CROs (but also for their sponsors), which does only work if they are happy with their jobs and their perspectives. Grouping of staff and processes into groups dedicated to method development, validation, routine analysis, data evaluation and reporting, QC, and so on, is a way to increase productivity, efficiency and probably quality, but creates interfaces bearing the potential of communication issues, reduced staffing liability and interruptions of the overall workflow. QQ How do you envisage the future of outsourcing in a bioanalytical laboratory? Outsourcing will further increase due to the increasing pressure for cost reduction in drug development, going alongside with further restructuring and process optimization in pharmaceutical companies. Outsourcing became an integral part of drug development, and I do expect more outsourcing in drug-discovery and early-development stages, in the near future. Sponsors will require more qualified staff to monitor outsourcing activities, for example, former laboratory heads or study directors will become outsourcing monitors working with external rather than in-house laboratories. Quality, productivity, efficiency and timeliness of CRO work can only be maintained or even improved if sponsors are willing to pay for the quality of work and, with this, enable CROs to get and retain qualified and experienced staff, to invest into staff training and motivation, state-of-the-art instrumentation and software.

„„Wei

Zhou, Novartis [email protected] QQ Do you believe outsourcing is more successful via a preferred provider, vendor relationship or consulting model relationship? There is no single model that fits all business needs. That being said, strategic outsourcing is usually more successful via preferred providers, rather than in a random, ad hoc fashion. When preferred providers are used, well established procedures can be followed to ensure consistent quality and output. This results in better and stronger long term partnerships. QQ What factors do you believe are important to consider when selecting an outsourcing partner? There are many important factors to consider when selecting an outsourcing partner, such as quality, flexibility, speed, cost and IP. An outsourcing partner is expected to deliver quality support on time, in compliance, at or below target cost. Furthermore, an outsourcing partner needs to have available resources, to ensure adequate capacity to remain flexible with shifting sponsor priorities. Moreover, scientific excellence is the foundation of an outsourcing partner. Strong method development capability is critical to its success. While cost should not be the only factor to consider when selecting a partner, keep in mind, this is what has driven outsourcing to its current state. A sustainable partnership must meet or exceed budget requirements. Lastly, effective and timely communication is a key to a successful collaboration. QQ What factors do you believe have driven pharmaceutical companies to increase outsourcing? The main factor that has driven pharmaceutical companies to increase outsourcing is cost savings. When routine work is outsourced, limited internal resources can be directed to core and strategic activities. QQ How do you envisage the future of outsourcing in a bioanalytical laboratory? Outsourcing will continue to grow in the near term driven by the promise of cost savings. However, in light of recent issues with outsourcing, pharmaceutical companies have begun repatriating their work back in-house. In addition, increasingly more companies have realized the importance of maintaining scientific expertise in-house. Eventually, a right balance will be achieved between insourcing and outsourcing, outsourcing will be reaching a sustainable steady state.

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Disclaimer The opinions expressed in this article are those of the interviewees and do not necessarily reflect the views of Future Science Ltd.

Financial & competing interests disclosure The interviewees have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert t­estimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

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