compound management workflows

It’s hard for one lab to “do it all.” When outsourcing is done properly, it can have great results for both parties. In this interview, Keith Miller, Senior Scientist at Pfizer and speaker at the upcoming IQPC Compound Management and Integrity Summit 2012 , joins Amber Scorah of Pharma IQ to discuss strategic evaluation of compound management workflows for outsourcing. He also reveals the best methodologies to use to benchmark performance, and how to ensure quality is kept to high standards when using an outsourced partner to perform compound management capabilities.

A Scorah: Can you talk about some elements of strategy as they relate to the outsourcing of Compound Management capabilities?

K Miller: Outsourcing adds value to Compound Management groups when non-proprietary, time consuming workflows are moved to a strategic partner who can mirror these workflows with the same (or faster) turn-around time and the same quality as "in-house". This can not only trim cost through reduction of facilities overhead and the carrying costs of instrumentation, but more importantly it provides Pfizer scientists added time to focus both on exploring new technologies & improving high-value proprietary processes.

At Pfizer, we made the strategic decision to outsource a significant portion of plate-based screening work this year. The implications of this broader Discovery initiative to Compound Management strategy boils down to identifying what are the processes that we can comfortably hand-off to our partner: where to draw the line on workflows to outsource such that we would position Pfizer CM to realize the highest level of cost-benefit.

A Scorah: Can you tell me about some of the methodology and tools used to enable outsourced Compound Management capabilities at external partners?

K Miller: Yes, I can give a taste of our approach for Compound Management. First, we identified in detail the specific processes to send to an external partner. We then established a robust system internally to quantitatively monitor the quality & turn-around times of these functions. Considerable time was spent creating standardized performance tests that provided necessary data. We had to keep in mind we would need a low barrier for transfer. Meaning, tests would have to be friendly enough that we could send along an easy to follow SOP, reagents could be procured, and operators with limited experience could implement. Tests were run internally to generate benchmarks, these allowed us to define very detailed expectations/criteria on throughput & quality for each individual function. The ability to meet these criteria, along with criteria set by other key stakeholders, helped identify our go-forward external partner.

Then came the time to move from plan to practice. While we did our best to make tests transferrable, in reality we benefitted greatly from a face-to-face training session & multiple follow-up web conferences. Open communication was really important to ensure the partner was running the targeted routine performance tests. Ideally you want apples-to-apples, though invariably some wiggle room finds its way in – for these cases the team would assess if we were still in line with set criteria. Another challenge of enormous importance fell around enabling data functions…to understand our data formats and enable our partner to robustly take in and return properly formatted data was the starting point for testing the processes we had built. I will be speaking in great detail to our specific methodology for enabling outsourcing during my podium talk.

A Scorah: Are there any other considerations that stand out as critical in successfully outsourcing a Compound Management function?

K Miller: Absolutely. One area that can easily be overlooked but is absolutely critical involves nurturing the relationship with our partners so they feel energized & engaged to make the transition a success. There are considerable barriers of time differences, language, and culture that we constantly were mindful of – we had to stay cognizant to recognize true roadblocks versus cultural or language gap misunderstandings. Face-to-face time, either at the external partner or at our site was very helpful in building relationships. [inlinead] Vesting energy into these relationships proved its worth when we would receive communications from our partner on reaching milestones that contained genuine excitement on achieving success. Other key considerations such as shipping, managing the transition space, etc. I will address at the upcoming IQPC Compound Management Summit.

A Scorah: Do you have any tips for companies looking to invest in infrastructure that will ultimately cut costs down the line?

K Miller: At Pfizer we look towards our scientific needs for driving our infrastructure – if certain technology assets, facilities, or workflow paradigms enable us to advance projects, that is where investment funds are focused. Operational cost reduction is of course also a major consideration when investing in new infrastructure, and we strive to find optimal synergy between investments that will both reduce cost and significantly impact project work. From a Compound Management perspective, there are numerous avenues to help progress science: improving the overall quality of deliverables (better volumetric accuracy and information on compound purity or true concentration), adding flexibility to deliverables CM can provide, to become more compound sparing, or simply becoming faster in our workflows.

One example that I think most Compound Management groups are familiar with as far as physical assets would be continued adaptation of acoustic technology. In my experience, when a project team is committed to looking for ways to use less starting material, which acoustic technology can enable, the resultant workflows almost always saves money in the long run. Additionally, there is the view on infrastructure from a personnel & facilities standpoint. We have to consider that we will continue to see opportunities to reduce costs through outsourcing of standardized processes…so it would be prudent for a company to invest in their colleague’s knowledge of bottom-line goals and build skill sets for enabling & supporting the transition of work. This involves building people management skills – not only does this help with communication to external partners, but in some cases it may be more cost effective to temporarily ramp up internal contract employees who need good management for training and to understand project goals.

Whether outsourcing a function or running an in-house continuous improvement project, Pfizer scientists still need to effectively drive the work. I feel investment to harmonize data is also always a good idea; with mergers or new technologies it is very easy for data compatibility issues to balloon and slow workflows.

Finally I would recommend that Compound Management groups constantly revisit their overall strategy, looking to become more dynamic, impact more areas, and keep compound collections at manageable size. All of these strategies help reduce cost and to generate actionable plans from such will spawn processes that should guide investment to infrastructure.

A Scorah: Have the recent outsourcing efforts been a success?

Keith Miller: As an exercise of moving workflows to an external partner, I feel we have been highly successful. We made the decision to fully embrace the need for a more cost effective yet highly productive approach to research…that was the primary driver behind the workflows we decided to outsource. Key colleagues from all Research & Discovery disciplines who may be impacted were assembled to sit on teams to ensure quality would not be compromised through the outsourcing. We were very diligent to ensure requirements were being met and target dates hit.

I applaud my colleagues’ passion throughout the project, and this outsourcing initiative ended up as a great experience for all involved. Outsourcing work functions forces you to really take a deep dive into those workstreams and optimize on simplicity and cost. To summarize, I would say so far this has been a win for Pfizer. My talk will speak more to the outcomes of outsourcing CM capabilities on a quantitative level, which really is critical when measuring success. Join us in Boston, September 19–21, 2012, for the IQPC Compound Management and Integrity Summit. For more information, visit the 8th Compound Management & Integrity .

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compound management workflows

Integrating Outsourcing into Your Compound Management Strategy

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