Over the past 5+ years, there has been a huge evolution in the strategic partnerships used to bring new therapies through clinical trials. I’ve witnessed this evolution from both sides of the partnership – working both within CROs and most recently within Merck..
One of the key challenges that sponsor companies face is in identifying the partnership characteristics the sponsor organisation needs most and being able to truly define their core and non-core competencies as desired.. Accomplishing this requires internal investment and analysis of organisational strengths and weaknesses. Through this process, existing core competencies need to be identified along with opportunities to invest in maintaining and growing those competencies.
One of the most under-rated areas of partnership launch is Change Management, despite all the discussion around it. Both parties need to be willing to invest, change and evolve with the partnership and make use of the expertise and experience that each bring. This of course requires the ability to really digest the cultural DNA and impact the organizational behaviours
Expectation alignment is also crucial - if internal strategy and external provision are not aligned, then no matter how strong the two partners are, challenges will arise.
And this draws back to the real goal of a true clinical development partnership – to bring new therapies to market and return efficiency to all parties. To do this, you have to achieve close alignment. All parties and players have to understand core strategy and the operating model in order to build a successful partnership.
Also essential is creating an environment within the partnership that empowers the functions accountable for the work. And you need a governance structure that is accountable and empowering and does not replace the functions that you are trying to optimize in the new structure.
In my opinion, one of the biggest red herrings is that many sponsors create or introduce strategic partnership as a result of external pressures that are misaligned to the above. In these instances, regulatory reaction stands in the way of successful partnerships. Most of the regulations that relate to partnerships are self-imposed. Yet, if we spend the time with the regulations, they actually provide a great deal of flexibility to deliver your vision and purpose in a strategic partnership.
In order to overcome these challenges, we have recently reorganized to deliver better service provider management. As head of this new function, my role is to provide clarity over who owns a relationship and ensure the relationship is managed effectively.
I’ve been a big believer in forums such as PCT-Europe for a long time; they are critically important as they bring people together from across the industry to discuss the issues in a very open and honest manner.