subject: Outsourcing as accelerator for drug development processes [print this page] Outsourcing as accelerator for drug development processes
Pharmaceutical companies out-license, co-partner, and prioritize elements of their clinical pipelines to control costs and share risks. In light of this trend towards pharma outsourcing, specialized knowledge, resources and infrastructure, all of which are often needed globally, are efficiently delivered by a third party on an as-needed basis. Nowadays, resource management is thus more and more characterized by outsourcing which is becoming commonplace throughout the world and in all types of pharmaceutical and biotech companies. It permits access to specialized service providers when a certain technology or service is required for adapting operations to the development strategy on-demand and for reducing costs.
Innovation is becoming increasingly expensive as a result of rising research costs and the pressure to accelerate time to market for innovative products. Fewer blockbuster drugs are being developed. Drug development attrition rates have not yet been optimized in order to avoid late-stage failures with new product candidates. In global development in particular, the interest in bridging marketing interests with clinical development and regulatory strategy is challenging. Healthcare systems are attempting to curtail the costs of healthcare, in particular with regard to pharmaceuticals. All these factors increase the costs of development programmes and they are thus a major challenge for the pharmaceutical industry. To address all these challenges successfully, companies involve external expertise and resources to complement their own capabilities and speed up the development processes.
Nowadays, resource management is thus more and more characterized by outsourcing which is becoming commonplace throughout the world and in all types of pharmaceutical companies. It permits access to specialized service providers when a certain technology or service is required for adapting operations to the development strategy on-demand and for reducing costs. The in-house team does not need to be kept complete to cover all functions, leading to less investment in human resources and minimization of investment into one's own equipment to that required for core processes. Specialized partner companies with the relevant equipment and expertise can be appointed to a project, covering all other functions related to the manufacture of small volumes, new products or pharmaceutical forms, to development and testing at specialized CROs, and to marketing such as in new markets.
Pharmaceutical companies out-license, co-partner, and prioritize elements of their clinical pipelines to control costs and share risks. In light of this trend towards pharma outsourcing, specialized knowledge, resources and infrastructure, all of which are often needed globally, are efficiently delivered by a third party on an as-needed basis, rather than by internal resources. Small biotech companies lacking significant operational capabilities for R&D, contract manufacturing, regulatory affairs, reimbursement and market access, are always looking for different types of services and partners.
Another aspect is that the pharmaceutical industry approaches academic groups or small biotechnology start-up companies to find appropriate drug candidates that complement their existing portfolio. Thus, the dual pressures of patent expiries and a lack of new drugs have not only led to mergers and acquisitions but also to the development of innovative collaborative concepts between pharma companies and academic institutions. They are installed in addition to the existing traditional in-licensing processes and even bring about structural changes within the pharma companies. Universities also benefit from such collaborations as the pharma industry helps to translate the results of their basic research into clinical practice using pharmaceutical and scientific methods.
New structures, functions and challenges emerge in this context. It starts with the time and costs required to search for the appropriate service providers and partners, to identify the goal of the project, to prepare the requests for proposals and to conduct due diligence. Moreover, managing the contractual and bidding process efficiently and controlling the execution of the outsourced service are challenges which require ongoing evaluation of the risk and benefit of the outsourcing process. Experience shows decision waves as companies constantly adapt their behaviour to the experience they have made with outsourcing. Thus, the decision in favour of external suppliers of services may later change into a decision against them, and for internal services once more. Hence there is constant movement in the pattern of a single company, though the overall trend is clearly moving towards the use of specialists on demand.
One of the most important aspects of successful outsourcing is to identify the right partner early on. If the partner is a perfect fit, the bidding process is kept short, the project can be started early and runs smoothly, efforts and costs are kept on a reasonable level. Not only this, a well-matched partner would contribute suggestions and know-how from the outset, leaving both partners with a specific and precise contract upon which the project can be based and preventing frustration to either side at a later date. It is in the interests of both the sponsor and the contractor to shorten this planning and selection process and make it more specific.
On the other hand, service companies such as Contractual Manufacturing Companies (CMOs), CROs, consultants and logistics companies constantly need to seek business to fill their specific capacities. Business development at this end is thus a critical factor which often does not result in the available capacities being filled.
www.pharmatching.com offers solutions to both sides, i.e. the sponsor or service buyer and the contractor or service provider. It delivers a platform which allows the immediate placement of specific service requests or the offer of services and technologies in a very dedicated and specific way. No company profile is needed, just the placement of requests for what is needed right now or what can be offered at present as free service capacities.
