By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
One of the most informative sessions from last fall’s Outsourced Pharma West Conference & Exhibition in San Francisco discussed matching a vendor to your stage of development.
With a lineup of panelists that included Firelli Alonso-Caplen of Pfizer, Joe Guiles of Medivation, Bob Munday of CMC Biologics, Patrick Murphy of Versartis, David Enloe of Althea, and Jon Crate of FAI Testing Services, attendees were sure to hear from executives with first-hand knowledge of the topic. The speakers did not disappoint.
Finding a CMO that can manufacture your product, meet your requirements, and work closely with your team during bad times and good is not an easy endeavor. Several themes that emerged throughout the session can be culled into best practices to keep in mind throughout the selection process.
THE PROCESS CAN TAKE 6 MONTHS … OR LONGER
If you are conducting your search properly, expect it to take a considerable amount of time. There are agreements that will need to be completed at the outset of the qualification process, including the confidentiality agreement and nondisclosure agreement. One of the critical first steps should also be a site visit. “This is a must,” noted one panelist. “You have to see what you are getting into.”
Often a supplier will look good on its website, but you don’t know how old the facility is or if the photo is even of the facility in question. One Big Pharma executive told me the story of one such visit. The website showed a beautiful building which supposedly housed expertise in analytical testing. “I sent someone with experience in analytical testing to check out the facility,” he said. “When he found the laboratory, it was an empty building with the company name on the door.”
If the initial site visit goes well, the next step is to send a technical evaluation team to the vendor. That team should be crossfunctional and include personnel with expertise in processes, analytical, regulatory, and quality functions. If the CMO passes the technical evaluation, a quality audit will need to be performed. In the case of a drug-product facility, a sterility assurance assessment should also be performed. That can be a two- or three-day visit during which an actual fill activity is observed. The entire process, either an actual or engineering run, should be observed and analyzed.
According to at least one speaker, the entire process can take six months, if you’re lucky, perhaps longer if any deviations are noted.
RELATIONSHIPS ARE CRITICAL
Once a relationship is established, it must be properly developed and cultivated. That way, when things are not going so well, you have solid relationships that you can fall back on.
This process should include developing peer-to-peer relationships. These ties should range from the CEOs all the way down to the project managers. This is an organizational alignment where like folks are constantly interacting – finance to finance, lawyer to lawyer, regulatory to regulatory, project manager to project manager. When the relationship is thrown a curve ball, you will not have finger-pointing going on. Everyone will talk to their counterparts and get the situation resolved quickly.
This is especially important for smaller bio and pharma companies trying to establish working relationships with CMOs that also happen to be working with Pfizer, Merck, Lilly, and other large pharma companies. Many of those CMOs will have to decide whether or not you are worth their time and effort. In those situations, you will need to sell them on your company and why they should invest their time with you.
Treat these relationships as a marriage. They take time to develop, and they are designed to last a long time. The more time and effort you can put into building those personal relationships with key people in the company, the better it will work out for you in the long run.
WHEN YOU HAVE TO GO WITH ONE PROVIDER, CHOOSE CAREFULLY
Big Pharma companies do not like being put in a situation where they have product coming from a single source. Diversification reduces risk, and in no industry is that more true than life sciences. Unfortunately, for many smaller bio and pharma companies, having multiple suppliers is not a choice. Some may not have the money or resources to seek a secondary supplier, or there is not enough volume to make multiple suppliers cost-effective. Suddenly, the importance of selecting the right CMO is significantly magnified. Make the wrong choice and you may not get a second chance. No one knows which CMO will be the next to receive an FDA Warning Letter. In those situations, how do you go about mitigating risk of having your eggs in one basket?
"While you will always want to have a CMO’s A-team working on your project, we all know that will not always be the case."
Panel members stressed the necessity of having a consistent process in place to make the right selection. Identify all of the parameters that will be important to you in a CMO. Then thoroughly investigate and screen all of the candidates on your short list. That investigation should include the aforementioned site visits but also checking with other pharma professionals and consultants in your professional network. Take the time to find out if they are interested in producing your product, and whether they have the bandwidth to do it. Meet the people who will be working on your product and determine their level of expertise.
While you will always want to have a CMO’s A-team working on your project, we all know that will not always be the case. There will always be project managers with 30 years of experience and others that have 30 minutes. Do your best to ferret that out and know who will be doing your work. This is also a good time to develop those one-on-one relationships, so ask as many questions as you can.
Regardless of whether you get the best project team at the CMO, you can never waiver on quality. The CMO either has a quality operation or it doesn’t. It has a culture of quality or it doesn’t. It’s the job of your team to understand the company, its people, and its culture and its capabilities. If you cut corners during this selection process, you might be dooming your effort from the start. If you don’t like the team at one location, look into the possibility of relocating the project to a different site.
IS A ONE-STOP SHOP THE RIGHT CHOICE?
Finally, a decision always has to be made regarding whether to employ a number of specialty CMOs or select one that can do all of the tasks you might need done. Most CMOs today seem to be moving towards the one-stop shop model. One thing you should ask yourself at this point is whether you have ever found a CMO that is capable of doing everything. Most companies will have an advantage when performing a specific task, such as early clinical or late clinical. Every client will want to select a CMO that is honest about its capabilities. If you need someone to run your cell-based bio assays, do you want a company that specializes in that, or one that says it can do it and will then subcontract it out to a company you have never heard of?
If you ask who will perform the work, most CMOs will give you an honest answer. But even if they tell you they will send the work to another service provider, it is your responsibility to vet that service provider as if it is the CMO you selected.
The panel had one final piece of advice that might help you navigate your vendor relationships: a joint steering committee. Often, an issue might arise that cannot be resolved at the team level. When that happens, a team of decision makers is needed to resolve the issue. Typically, this committee should consist of VP-level executives from both the CMO and the client. They should represent all areas of a project where disputes might arise, including operations, quality, and regulatory. “On the pre-commercial side, we have employed a steering committee for the last 10 years,” noted one speaker. “We have found it to be quite successful at managing a number of disputes.”