The Perfect Partner

As more companies try to establish profitable relationships with external clinical research experts, we asked Wyeth’s Ira Spector what companies should look for in their ideal match.

The needs of today’s modern pharmaceutical company sound relatively simple: improve productivity, strengthen the product portfolio and drive down costs. But if only it was that easy. The pressures of operating on a highly competitive global stage has meant an increase in the number of organizations looking to establish more profitable relationships with external partners, such as biotechnology companies and clinical research organizations, to tap into new technological breakthroughs and novel expertise, regardless of national or geographical boundaries.

Nonetheless, as in any good marriage, both parties have to work hard if they want to build and maintain a mutually beneficial and long lasting relationship. As Ira Spector, Vice President of Clinical Development Operations at Wyeth Research, points out: “Understanding the strategic needs of the other organization and understanding what a provider brings to the table is essential”. NGP asked him for his thoughts on how companies looking to collaborate or outsource with clinical service providers can find the perfect partner.

NGP. What is the strong suit that a good partnership provides in the clinical research arena?

IS. Well I think it’s going to vary from company to company. The first thing that really needs to be understood is what a specific company needs in the way of services and that requires them first to do some strategic analysis of their internal needs and to determine what core competencies they feel are essential for their success that they need to have internally. And at the same time what core competencies they feel they would be comfortable outsourcing or partnering on.

Once a pharma or biotech has determined the specific nature of their internal strength and what in fact they’re comfortable working externally in, they then have to decide what the framework should be. Whether or not those capabilities should be done through a contract relationship like outsourcing, whether they want to insource some of that capability, whether they want to offshore or it, or whether they want to have a partner.

I think the partner relationship is a special kind of relationship among all of the options that a company can choose. Partnerships work really well when each party can mutually gain or there’s a win-win associated with the relationship. They also work very well when you’re looking for a long-term relationship that’s mutually beneficial. Partnerships seem to work where you’re looking to be involved together for a long period of time, because of the effort that goes into structuring them and maintaining them, when each party has critical skills that the other does not. So as a developer of drugs, treatments or therapies, obviously you’re looking for another organization that can provide some critical skills you don’t have or don’t feel, in the timing that you’re looking at – it’s appropriate for you to develop.

Partnership relationships also usually demand very close strategic alignment between the organizations so they’re working very carefully together for mutual goals. That means setting up governance structures that allow very rapid and clear communication of what’s going on. Obviously this is also done to provide very high quality.

I’d say among the various options organizations have in terms of entering into relationships together contractually, the partnership one is the most difficult to set up and the most difficult to maintain, as it does require staff to operate differently – it requires they work as if they’re part of one entity. It usually works very well around a specific function, capability, or a rather specific submission where everyone is sharing the same goals. If they’re structured right they also provide a sharing of risk and reward to both parties. So it’s a special kind of relationship but probably one with the highest potential of all the types of outsourcing relationships that could be set up.

NGP. What is the main gap that needs to be bridged to allow outsource providers to build a stronger clinical research process.

IS. I don’t think there is a one-size-fits-all solution. It depends on what the other party needs, and the gaps can be different. Clearly, understanding the strategic needs of the other organization and understanding what a provider brings to the table is essential for this to occur. And sometime, neither party has 100 percent of what is needed, so the ability to figure out how to get the missing component and bring it into the work is critical. I think the biggest part of this is good communication and good strategic understanding.

NGP. What would you project industry trends will be in the next five years in clinical operation?

IS. I think the industry in the next five years will be virtually paperless in terms of case-report-form data. We’re on a rapidly accelerating trend in remote data-capture like product data-capture for case-report-form data, and I would expect the industry to be significantly electronic at that point – we’ll never be 100 percent paperless.

I also think that’s going to drive further downstream requirements in terms of electronic compatibility with other data. So not only will case-report-form data be electronic, but the ability to bring in lab data – and virtually any other kind of data – in a consistent format, digitally, is I think going to be part of how we operate five years from now. We’re already working along those lines, but further technological integration of data will be a key aspect of the industry.

I would expect standards like CDISC to continue to evolve and become tighter, and more well defined as specifications, so that anyone working in the industry who’s working in data, regardless of the type, has clarity on specifications of what’s going to be needed in order bring the data into a sponsor.

A totally different dimension is the ability to work globally and multi-culturally. I don’t just mean we might have studies going on in other countries, I mean we really have an understanding culturally of what it’s like to work in that country and how to work best there. Because the business is becoming a very global business, and we will need to be able to work round the clock and round the world very seamlessly, so the skills, the cultural aspects, the soft part as well as the technology part will need to be well developed within organizations.

NGP. What advice would you give to companies looking to collaborate or outsource with clinical service providers for the first time?

IS. The first is they need to choose a company with a reputation for performance. The sponsors have such pressure on them that we all need to be confident that we’re working with companies that are going to deliver consistently. We’re all familiar with circumstances where a provider had a great success in one circumstance, but not in another. What we’re looking for is consistent performance reliably across a range of studies. We treat our relationships with providers each time as sort of a moment of truth in terms of building trust. That’s number one.

Number two, I think providers need to solve their customers’ problems, not offer what they can sell. That means understanding enough about the sponsors processes and requirements to be flexible and not just say ‘we’ve got this great product and it’s going to solve all of your problems’. I think it really means taking a step back and understanding what business problem the sponsor is trying to solve, and helping them solve that.

NGP. What would you say is the greatest pitfall that still keeps clinical trials from taking a drug successfully to market?

IS. I don’t think of the question that way, I don’t think it’s a clinical trial that takes a drug to market. It’s an important step along the way but I view them as gathering the data that validates or disproves the hypothesis around a treatment in a rigorous statistical fashion.

That being said, the greatest pitfalls associated with running trials well are still around the fundamentals of enrolment. In more than one study we seem to have re-proved Lasagna’s law that basically says roughly one third of your sites will contribute the majority of your patients, one third will contribute the balance, and one third of your sites won’t contribute at all. And regardless of our sophistication in the way we gather data, we tend as an industry to continue to reprove this fundamental law. So one of the greatest challenges we face is identifying which sites will be successful, and identifying that in advance of enrolment. That’s a pretty tall order, but that’s what we’re all working on.

Enrolment continues to be the fundamental driver of the industry – I’ve likened it to the mantra used in real estate ‘location, location, location’ – I think it’s ‘enrolment, enrolment, enrolment’ for those of us conducting clinical trials. Determining the best sites, the best locations and designing the best trials is really what it’s always been about and what it will continue to be about.