Drug Discovery Outsourcing: Strategy, Selection & Success

Richard Morphy from the Medicinal Chemistry Dept at the Schering-Plough Research Institute, joins Pharma IQ to discuss tactical and strategic partnerships and etablishing efficient discovery outsourcing strategies.

Pharma IQ: Please tell us about your current role.

R Morphy:  I’ve been responsible for chemistry outsourcing and partnering activities from Organon and Schering-Plough’s Newhouse site over a number of years. This has involved a wide diversity of different types of activity being outsourced, from the synthesis of libraries at the HIT generation stage. There we’re talking about many thousands of compounds to build up the corporate screening collection, the synthesis of smaller numbers, single compounds, building blocks, reference compounds for use within the projects; also high level medicinal chemistry as well, at the HIT to lead and the lead optimisation stage of projects. In those cases, we’ve had internal and external chemists working together on the project.

We’ve had a number of different collaborations over the years. Historically, we’ve done the synthetic chemistry mainly in Asia, India and China, and the medicinal chemistry more in the US, the UK and in Continental Europe. I think that has changed to some extent over the years, and there is certainly more interest now in taking more of the medicinal chemistry over to the Far East as well.

Pharma IQ: What are the key challenges in establishing efficient chemistry outsourcing strategies?

R Morphy: First and foremost, I think the key thing is to find the right partner to do the work in hand that needs to be done. Keeping the project on track, making sure you have a well worked out work plan in the first place that avoids slippage in terms of the timelines; obviously that has a knock-on effect in terms of the cost of doing the project. It is also key to find the right partner, and you need to strike the right balance between the capabilities of the partner and the basic cost structure. Some suppliers are certainly lower cost than others, but you need to factor in how good they are at solving the particular problem that you need to work on. There is always going to be a limit to how much internal resource and internal  involvement  you want to devote to a particular exercise in terms of troubleshooting, say, synthetic issues. One of the other things we found over the years that can delay projects is procuring the agents in certain parts of the world. You need to factor in that in terms of choosing what type of work you want to send to particular companies.

Pharma IQ: How can we seek to guarantee the quality of outsourced development?

R Morphy: I think, right from the start, you need to be clear on what you are looking for, what success really looks like, and make sure you and your partner really do have common expectations on what the deliverables are from the collaboration. We worked a fair bit over the years on coming out with suitable metrics for measuring success within different types of collaboration. If it is pure synthetic chemistry then you can use simple metrics in terms of maybe numbers of compounds, number of reactions per week. Certainly purity of compounds is a key thing for quality control, the speed of delivery. 

Medicinal chemistry is a bit different; it’s more complex in terms of how you measure quality there and the success. Certainly, innovation is a very key thing; it’s one of these things that’s more difficult to quantify. We’ve been looking for conceptual contributions from our partners in terms of medicinal chemistry, so inventorship could be one possible measure of quality in that respect. In any collaboration, clear lines of communication are obviously very important, and setting these clear goals at the start of the collaboration is really essential for guaranteeing that the output is of high quality at the end of the day.

Throughout the collaboration it is important to have a degree of continuity in terms of the project management, both internally and at the partner. If you’ve got that continuity with limited turnover in terms of the key people involved, then that certainly helps in building up the trust, and it improves the efficiency of the collaboration overall, and increases the probability of getting what you want out of it.

Pharma IQ: What new discovery partnership models or strategies are we seeing?

R Morphy: There has increasingly, over the years, been a move to outsourcing more of the complex parts of the drug discovery process. Historically, it was a question of outsourcing individual, rather small pieces of the process, maybe a few libraries here or there, but increasingly, most companies are looking to outsource in a more integrated way, so doing, say, medicinal chemistry and biology together at a partner, and that can certainly be much more efficient. I think that’s certainly the way that things are moving right now, and I can certainly see that continuing in the future.

Pharma IQ: How do you identify the right partner?

R Morphy: In terms of identifying the partner, I think the first thing is to be absolutely clear on what you actually want, what your needs are, conducting an internal analysis of what the bottlenecks are, what the gaps are in terms of your internal processes and capabilities, and really determining what is it you want to retain as your internal core competencies, and what is you’re happy outsourcing. Once you’ve done that I think then you can identify a range of possible solutions providers. There is a range of different ways of doing that – conferences, from the web, scouting, and really gathering information from a large number of organisations initially. 

Analyse their capabilities, have tele conferences, select a short list for further follow up. This could involve further tele conferences or video conferences, followed by site visits.

The site visits have certainly been key over the years in us selecting our preferred partners, to perform the rigorous due diligence that’s really needed.

Another key thing is to involve internal experts to assess the technical competencies of potential partners – that’s absolutely crucial – and the site visits, again, are important to assess compliance in terms of things like health and safety, working conditions, etc.

Pharma IQ: What would be your top three tips for managing collaboration?

R Morphy: I think, really, at the start of the collaboration just make sure that you and your partner have the same understanding in terms of what the goals are. So how exactly will you go about achieving those goals, as well.  I think one thing is just to write things down so it’s absolutely clear, not because of any lack of trust between the partners, just writing things down really helps to clarify that you do have the same understanding and this is a partner in terms of what the overall goals are.

I think it’s also very helpful to spend time on the ground at the collaboration stage. If it’s a big project, a long term project, have someone spend a few weeks over there, initially at least, learning about the culture of the organisation, maybe doing a bit of training in terms of your own internal processes as well. Really make sure that both parties are on the same page.

If problems arise, as they inevitably will from time to time, even in the most successful collaborations, I think it’s key to address those issues quickly and openly as they arise. This helps maintain and build the trust, and I think building that trust is a key factor in any successful collaboration. 

I would say another thing is to recognise and reward success when it occurs. This is obviously very motivating for the chemists involved, both internally and externally, that the work they’re doing is being recognised and that they do feel appreciated for that.

Pharma IQ: You mentioned success just now – what factors influence overall success?

R Morphy: Probably the number one thing is the communication that is so very important. I think it’s really impossible to over emphasise how important good communication is in any collaboration.

In terms of our collaboration, this takes many forms, depending geographically where the partner is located. We’ve had bi-weekly reports in terms of progress, regular tele and video conferences. They have formed the cornerstone of our many collaborations over the years. But I think that really not enough on its own; I think the face-to-face meetings are really key to building relationships and I think that’s obviously easier if the partner is geographically closely related to your own site.

And to have informal discussions as and when they’re needed - sharing knowledge. Something that we ‘ve learned over the years is it is very important to be as open as you can within the constraints, obviously, of the confidentiality we all operate under. But there’s certainly a big benefit in terms of sharing knowledge and the benefit of your own experience – make sure that you don’t get into problems with re-inventing the wheel, repeating chemistry that’s already been done and maybe tackle success internally.

I think, at the end of the day, basically you get out of any collaboration what you put into it; really invest the effort in terms of any training that may be necessary, either the collaborator to enhance their performance, or indeed training of internal staff, as well, to optimise their ability to manage the collaboration successfully.

IQPC

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