Pharmaceutical Outsourcing

Running a Tight Request for Proposal Process; Part 2

In my last blog, I began discussing the front-end of the Request for Proposal (RFP) process that is typical in pharmaceutical outsourcing: research, confidentiality, publishing the RFP, and establishing clear deadlines. In Part 2 of this blog, I am going to discuss data normalization of the proposal information, shortlisting, and the process of qualifying a short-listed service provider.

The data normalization process can be quite tedious depending on the size of the program you are looking to outsource. More simple programs, such as a biologics process development project, can be easier to compare between service providers in contrast to a full biologics manufacturing program. However, even in the simplest of RFP processes, it is always a good idea to tabulate key data points into a spreadsheet to compare and contrast information gathered between service providers. The process of normalizing the proposal information allows for an apples-to-apples comparison between service providers, ensuring similar scope is being quoted and reviewed, and that base assumptions around costing is captured.  In certain situations, you may find that additional correspondence with the service provider is necessary to better define a quoted activity so that you have a clearer comparison between service providers.  Typically, our Bioprocess Consultants will generate a spreadsheet that captures information on 1) the service provider’s business history and track record, 2) certain quality related information that may be critical to GMP biomanufacturing project (based on a quality questionnaire published as an appendix to the RFP), 3) costing information against scope/activities, and finally special terms and conditions.  It is critical that a thorough read of the assumptions, and terms and conditions sections of each proposal is performed to ensure that you are clear on what is included and excluded from the proposal.

With the comparison spreadsheet in hand, and a relatively clear apples-to-apples comparison between service providers complete, it then becomes easier to use the tabulated data to make shortlist decisions.  In more complex programs, or when there are many service providers, it can sometimes be useful to take the tabulated data and create graphs and charts to better assess the landscape of responses to the RFP.  In one RFP process BPAI ran where the program included technology transfer through to GMP biomanufacturing, there were twenty global service providers that submitted proposals, which created a much too complex data set to merely rely on tabulated data to make a shortlisting decision on. The key point here is – use the appropriate tools available to help in shortlisting.

Shortlisting, or the decision to trim down the number of ‘interesting candidates’ to continue discussions with, should be based on the key parameters that are important in your selection process – which will vary in priority by company and situation – but will invariably include some of these typical attributes (in no particular order): cost, track-record, quality, location, timeline. BPAI Bioprocess Consultants recommend shortlisting down to at least 2 – 3 service provider candidates at minimum, provided that you have enough proposals in-hand to begin with.  The purpose for shortlisting is to be able to focus your efforts on qualifying a few service providers to a much greater degree of granularity.

With 2 – 3 service providers shortlisted, the qualification process typically begins with sharing of template contracts, and if the program requires GMP biologics manufacturing, also the template quality agreement. Additionally, site visits are typically performed at the service provider’s sites to meet the business and technical teams, review the facilities and generally ‘kick the tires’ to help make the best award decision possible. During site visits, it is typical to entertain technical discussions about how the program would potentially be transferred into the service provider’s facility, as well beginning the discussion on any process adaptations or optimizations that may be necessary for the process to be successfully transferred.  At this stage in the selection process, it is critical that you feel comfortable with the service provider’s capability, understand the facilities and how the process would operate therein, and that there is a good meshing of the technical and quality experts from both sides.

The question of “when is the best time to perform a quality audit – before or after contract signing?” comes up often. BPAI recommends that If the program is earlier stage and has significant biologics process development activities that must be achieved before there is the possibility of progressing to GMP biomanufacturing, then it is usually okay to proceed into a development contract without performing a quality audit upfront.  Conversely, for full GMP biologics manufacturing programs that have constrained timelines and are anticipated to move at a fast pace, it is ideal to perform the quality audit ahead of contract signing to ensure that the quality system is understood, that no surprises regarding compliance will occur when getting ready for GMP biologics manufacturing, and that any possible compliance concerns are addressable before signing the contract. Regardless of when you decide to perform a quality audit of your service provider, BPAI always recommends that you perform the audit well ahead of GMP biologics manufacturing to allow for runway to address any concerns.

Coming out of the qualification process, you’ll have a good idea of the strengths and weaknesses of the shortlisted service provider candidates, which should allow for a data-driven and informed decision on which service provider to advance to final discussions with. So, how do you let the other service providers know? Once a decision to go to exclusive negotiations with a single service provider occurs, I always like to touch base with the other shortlisted companies to give them an update. The update can range from, “We’ve selected a different service provider because of ….”, to “We’re entering exclusive negotiations and would like to keep you as a backup in case there are issues in closing the contract”. It is usually a good idea to have at least one backup company selected, just in case during final negotiations things occur that prevent closing. In any event, I urge you to be honest with the service providers throughout the selection process – for their benefit and for yours.

For the third part of this blog, I will be discussing the quality audit, contract review, and the very important activity of project kick-off.

In the meanwhile, if you or your company are being challenged with managing a complicated RFP process, I would highly encourage you to contact us at BPAI to speak with one of our Bioprocess Consultants who are experts in pharmaceutical outsourcing. This is a mainstay of our business, and we know it well. We can help provide you with a path towards selecting the ideal service provider, clarity in the process, and guidance to ensure that you are evaluating leaders in the biologics manufacturing field.

Until next time…..happy outsourcing!

Terry Cochrane
Managing Director
Bio-Processing Alliance, Inc.

Posted in Pharmaceutical Outsourcing