Outsourcing
(API), preferring to retain control of the later synthesis steps in-house, even the largest companies are now contracting out everything from drug discovery to final product manufacture. Meanwhile, smaller emerging biotech drug companies, often
‘virtual’ companies
without their own basic facilities, have been outsourcing their activities from start-up.
Julianne Hunt, director, research
operation, at Merck & Co, agrees there many different viewpoints on outsourcing, but ‘What do you need? Where do you need it?’ are key questions whatever size of company. The difference for emerging biotech concerns is that they don’t have the experience of Big Pharma companies, noted Bill Leonard, process chemistry lead at Ikaria. However, the approach used in selecting the right outsourcing partner is similar, based on existing relationships, knowledge, a history of success with an existing supplier etc – although there are more risks for smaller companies as they have less chance to run trial projects to test capabilities. In addition, emerging companies tend to be looking at new technologies so the experience base is smaller. ‘They have fewer eggs in one basket,’ he said. Intellectual property (IP) is an issue,
added Bill Leong, Celgene’s senior director responsible for process chemistry, as companies try to retain as much of the IP in-house. In selecting a potential supplier, Leong said he looked to build long-term partnerships with strategic fit. He added that, as a smaller oncology company, he too would be looking for specialists rather than full service providers, but ones that could handle very small volumes. Amenah Zeynalzadegan, a manufacturing specialist from Gilead Sciences, highlighted some specific criteria: • a potential partner should share the same philosophy;
• there should be clear and transparent communication;
• there should be an understanding about tight time lines; and
• and agreement on cost, although this is not so important in early phases, it
becomes a major issue as a project reaches commercialisation. Social media was suggested as a useful tool for contractor selection; however, Lenox noted that while smaller pharma concerns have used this approach, Big Pharma still prefers personal contacts and the use of former suppliers. Kenneth Drew, director, US sales and business development, at Flamma, added that he believed there might be future problems with this type of digital approach, which is tending to eliminate the ability to communicate. ‘You can’t beat face to face communication,’ he said.
Communication is a big concern.
Ellen Crawford, manager, chemistry outsourcing, at Novartis, highlighted three pre-requisites: • open and clear communications between the client and vendor;
• expectations clear and understood from the outset; and
• clear and precise information sharing to facilitate discussion of any issues during the project. David Perry, external research solutions chemistry lead at Pfizer, emphasised that the key relationships should be between scientists, bench chemist to bench chemist or team leader, at the CRO. Pfizer has even embedded staff members in the CRO for weeks at a time to build a better understanding. Jeff Saunders, vp, small molecule drug design, Ember Therapeutics, added: ‘Getting the right CRO isn’t always the challenge, it is getting the right person – it is just like recruiting into your own team.’
Communications can be through
regular meetings, preferably face-to- face or through teleconferencing, but Perry emphasised that email can drive information exchange in real-time so that problems can be solved within 24h. Yong-Jae Kim, senior research operation manager at Amgen, said the use of ‘live’ electronic lab books can also be an important communications tool. Cost is a consideration, said Leong, but it is crucial for start-ups that are using venture capital. It is also essential to look at other issues, including a provider’s location, the strength of its quality processes and R&D capabilities, which he described as ‘not just a dollar value’. In API development, the pitfalls include specifications that are too tight, for example, requiring 99% purity for non-reference samples. ‘Quick and dirty’ is usually good enough for first stage toxic
40 Chemistry&Industry • November 2012
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Even the largest pharma firms are contracting out everything
assessment. It is also essential to allow sufficient time for the work-up from 1g to 1kg and then full production. There are also the potential problems involved when working with the regulatory agencies as well as an acceptable return on investment for the CRO for process and analytical method development. Tom Niemeyer, API sourcing lead at
Pfizer, said that his company tried not to go to a different supplier for each project. ‘Even with a small pool of suppliers, one still needs to match the right supplier to the project,’ he added. Not having a pool of preferred
providers means that the reputation of a provider is a major factor, emphasised Richland Tester, principal scientist at Avila Therapeutics, ‘as you are putting the future of your own company in the hands of the supplier. We gain experience and will return to those vendors with whom we have had a good experience.’ Using CROs and CMOs in different time zones raises the problem of shipping materials and products. As Jeff Saunders, vp, small molecule drug design, from Ember Therapeutics, noted, ‘at small company level, it is a necessary evil’. But Hunt added that shipping products and materials around the world is equally hard for a big company, particularly as regards compliance, which can add to turnaround times. ‘One needs to plan turnaround times in advance while reducing other parts of the time cycle where possible,’ he added.
Maciocio singled out India as particularly challenging in not having the infrastructure of a sufficiently high level. He also believes that back integration in the supply chain is not as developed as in China. ‘When things go well, there is very little difference,’ he emphasised, ‘but when things go wrong, it is easier to troubleshoot with western suppliers.’ Evans emphasised, however, that
Open and clear communication is essential in outsourcing
there has been a levelling in the global playing field, and the differentials between different regions are not the concern that they were in the past. ‘Once India was a place to go for costs savings,’ he said. ‘Now it is a market.’
Integrated service providers In response to questions about the potential advantages of using integrated service providers, Hunt explained that it depends where you are in the drug discovery process. It also depends how such service providers are defined as
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