During the course of the past two decades, the relationship between pharmaceutical companies and their outsourcing partners has changed significantly
Mike Valazza, VP of Drug Delivery Solutions, Catalent Pharma Solutions, looks at some of the factors that are crucial to the success of a partnership. The days when outsourcing in the pharmaceutical sector was regarded as no more than an adjunct to the business of drug making are long gone. Today, most outsourcing partners provide far more than a “fee for service” role. They can be instructed to allocate additional capacity to meet the need to scale-up as clinical trials progress toward commercialisation, or be a place to offload either whole programmes or parts of the manufacturing process that the originator does not want to handle itself.
The outsourcing sector is integral to every stage of the pharma industry and can add value by helping companies to plan for the next stage of development or manufacture, and to minimise risk. Far from a simple transactional relationship between provider and customer, many outsourcing partners are now working with originators on long-term projects at a much more strategic level. However, the fact that there is now such a wide range of technologies and services available in the outsourcing sector makes choosing the right partner ever more difficult.
Perhaps the most important question an originator should ask itself is why it is outsourcing in the first place. If that basic goal is kept in focus — whether that’s improving speed to market, the requirement for a particular technology or a specific drug delivery platform — then the search for the most appropriate partner will become narrower and more manageable.
Although customers contend that a choice of outsourcing partner does not come down to the cheapest option, and outsourcing partners vociferously assert that it should not, there is no denying that, with a squeeze on budgets and an increasing number of outsourcing providers, cost is always going to remain an important factor when it comes to selection.
But rather than paying too much attention to price, originators would perhaps be better advised to focus on value across the duration of the programme. Going for the cheapest option rarely turns out to be the best value and increases the risk of delays, quality issues and, often, disruption to the supply chain when a product approaches commercialisation and the outsourcing partner can no longer cope with its scale or the process they helped to devise early on. For these reasons, originators should look first at a prospective outsourcing partner’s quality reputation, and for proof of its ability to deliver reliably and on time. In the pharmaceutical business, time is money, and choosing the wrong partner can be a very costly mistake, particularly when measured in lost sales before a product’s patent expires.
Ultimately, the best outsourcing partner is not simply the one that meets all the technical requirements; there must also be a good cultural fit between companies and a demonstrable track record that gives the originator confidence in all aspects of the partner’s abilities.
Another factor that needs consideration by both parties from the outset is the scope of the project. If the extent of the work is not clearly defined and the deliverables are not properly set out, then both partners will run into difficulties as the programme progresses. The client may have to spend time and extra effort managing the project to “fill the gap” in what it thought would be done by the outsourcing partner — or the outsourcing company may try its best to fulfil services that could be outside of its comfort zone and capabilities. What seemed to be a lower cost option may turn out to be ridden with uncertainty, extra costs and, worse, repetition of work and subsequent lost time because of misunderstandings.
At Catalent, we always try to anticipate the work our partners need based on our experience of similar programmes with other customers, build that into a proposal and thoroughly explain it in advance. We try to put ourselves in the position of the decision maker and anticipate the best way to run the programme.
Given that the outcome of a project will affect the reputation of both companies — either positively or negatively — it is important to select a partner that shares your business culture and ethos. However, this may not be as straightforward as it sounds in today's marketplace, in which both the outsourcing sector and the pharma manufacturers are constantly subject to consolidation, mergers, takeovers and relocation. A record of proactive investment at the outsourcing company is a good thing, but a state of constant change can be stultifying when trying to establish or maintain relationships.
At Catalent, we believe that reputation is paramount; so, as a company, we are wary of taking on a programme that is not a perfect fit. Our intention would be to never undertake a project that results in a less than satisfactory experience for both parties and/or may have a detrimental effect on the potential for that company’s programme to succeed … or to work together on other projects in the future.
The complexity and the needs of a project — such as a product that requires special handling or involves a specific technology or needs a flexible, scalable approach to manufacturing — will also be a major factor in selecting an outsourcing partner. It is therefore essential to ensure that any transfer of technology will proceed smoothly, and this is more likely to happen if experts from the outsourcing partner have been involved early in the product development process. The outsourcing partner can then ensure that the requisite specialist equipment and skillsets are in place well in advance of the transfer.
Even seemingly minor differences in processing equipment used at development and manufacturing phases can cause unexpected delays and non-conformity. Although the major pieces of processing equipment, such as reactors, tablet presses, dosage form fillers and packaging machinery will be clearly defined, this may not be the case for ancillary equipment. Items such as the pumping system, the spraying system, the mixer and mixing tank and the fabricator can have a significant impact on the ultimate output of the process. The specification of a whole range of equipment must be considered, including filter bags or cartridges, vibratory sifting screens and mill baskets, and even the tooling for the tablet press.
A similar situation may arise with the transfer of analytical methods. There will inevitably be subtle differences in the equipment and techniques employed by the analytical groups in the research and development and manufacturing functions. Any differences that occur in the data between the two groups may indicate a problem with the product or process and should not therefore be ignored. It is vital that representatives from the two groups spend time carefully discussing the methods before the transfer takes place.
Setbacks and budget overspends are almost inevitable, so suitable levels of contingency funding should be built in. Partners should be in agreement regarding how capital investments will be shared and how any additional expenditure will be addressed. The more complicated the supply chain becomes and the greater the number of stakeholders involved, the higher the risk that something will not go as planned. But, in the final analysis, a project can be made or broken not by the relationship between the outsourcing company and its customer, but by the individuals working directly together.
The specification of a whole range of equipment must be considered, including filter bags or cartridges, vibratory sifting screens and mill baskets, and even the tooling for the tablet press
Drug makers are becoming increasingly selective in their choice of outsourcing partners. Those that are successful in winning business will be those that have gained experience from many programmes, have a wide range of customers and go out of their way to understand the individual needs of these customers, adopting a suitably flexible approach.
To be successful, a partnership requires honesty, openness, effective team management and excellent communication between all stakeholders. Technical expertise and efficient process transfer are crucial, but the most important factor will be the development of good working relationships at multiple levels that are based on mutual trust and co-operation. When it comes to selecting an outsourcing partner, one size will not fit all. But, every effort made at the selection stage will payback many times if the right partner is selected.