Partner discovery

Tips on discovering partners, making a shortlist, and selecting the right partner

With so many factors to consider, deciding which CDMO to partner with can be an enormous challenge for drug sponsors. And while much of this report has focused on partner selection from the sponsors’ point of view, it is worth remembering that contract organisations are simultaneously assessing who they want to work with. Unsurprisingly, our experts recommend keeping criteria such as speed, capabilities, capacity, and reputation at the forefront of any selection strategy.

As we will discuss in a later section, accelerated pathways are becoming increasingly common, affecting about half of all drugs in clinical trials. While speed has always been a crucial consideration, Bikash Chatterjee, CEO of Pharmatech Associates, notes that it is even more important in light of the rapid timelines demonstrated by COVID-19 vaccine makers.

He says: ‘Time to market has always been a primary consideration. Moderna and Pfizer have shown us what is possible across the entire drug development lifecycle, including clinical. The ability to get access to the data from experimental and development work quickly is a tremendous asset.’

While speed is undoubtedly an important metric for drug sponsors across the board, an increased emphasis on quality may be more appropriate for some projects. For a company planning to develop a drug through Phase II before licensing the product or being acquired, speed will likely be the most important factor. But for a company planning on taking their product to market and looking for a longer-term CDMO relationship, quality of work and available capabilities will prove crucial. Chatterjee advises getting a feel for potential partners’ quality systems upfront to avoid issues down the line.

He says: ‘When we've got a drug sponsor that's looking for a contract manufacturer, we'll put together a questionnaire that fundamentally captures the key characteristics. So, capacity is one. Cost, of course, is always in there. We will look at technical expertise, the maturity of the quality management system (QMS) and try to understand what their availability and capacity is. Then we will whittle the list of potential CDMO partners down to a short list— maybe three to four that look viable—and go out and do an audit.’

We'll put together a questionnaire that fundamentally captures the key characteristics.

Bikash Chatterjee, CEO of Pharmatech Associates

Chatterjee says the next step is to meet with the potential partners’ quality team and ask a variety of questions, some technical and some related to the philosophy behind certain processes. He is looking for confirmation that the potential partner has ‘the ability to understand the regulatory expectation around that particular development activity.’

However, all of our experts acknowledge that CDMO capacity is constrained and finding a company to fit your desired timeline can be a challenge in itself. Chatterjee notes: ‘You have to ask them (CDMOs) what their capacity is. My biggest challenge with large molecules today, and even classical small molecules, is getting a spot in the queue. It might be six, eight months, 10 months down to do my studies. It's a problem.’

Finally, drug sponsors should consider location when settling on a CDMO partner, as selecting a partner outside their target market can pose significant logistical issues. According to Chatterjee, because of time, regulatory, and supply chain constraints, it is rarely worth selecting a European CDMO for a US-release drug, unless the vendor provides specific expertise that is difficult to find elsewhere.

‘I think you have to be very cognizant of the complexities around dealing with the logistics of making drugs outside the US or outside the market that you're intending to go into,’ he says.

‘I'm not saying it can't be done. I just think you must make sure that you are in sync with their capabilities in terms of timeline and the processes that they're going to use, their prerequisites. So, take the example of a low volume product, low turnover in the marketplace, high margin perhaps. I can use a manufacturer in Switzerland, or I can use a manufacturer in Germany for the US market if they do great work.

But if I'm making an OTC, maybe I don't want to use them. My concern is: do they have the ability to turn product around and get into the market and handle logistics while navigating the GMP pieces in Europe? That might be more than you want to take on.’