Raymond Peck, VxP Pharma Services06.02.16
Choosing the wrong contract manufacturer can have disastrous consequences for pharmaceutical and biotech companies large and small. Delays in receiving clinical trial materials can jeopardize the trial itself, as well as, in many cases, regulatory approval. This being said, unless a company has sufficient capabilities and capacities internally, they are going to need to outsource some, or all, of the work.
The first step in the process of locating a contract partner is to conduct a thorough search to establish a database of potential vendors. The internet has made this process far simpler than what it was in the past, as detailed information about these potential vendors are no more than a few clicks away. Trimming down this list to a manageable number is generally not too difficult, especially if you focus on capabilities. You have to ask: Can they handle the work? If your compound is a controlled substance, are they licensed to work with schedule compounds? Or, if you want your finished dosage to be enterically coated, do they have the equipment necessary to get the work done, and if so, do they offer it under cGMP for your clinical trials? You will also need to learn if they are compliant where you need them to be compliant. What is their regulatory history? Have they been audited by the FDA? If so, what was the outcome?
Once you have your list narrowed down a bit, you will also need to determine what type of service provider you are looking for. One option is a soup-to-nuts CDMO who will potentially have the capability to take your program through its paces under one virtual roof. This option bears similarity to purchasing a tour package. Everything is laid out for you in advance, and you simply get on the air conditioned bus with the lady at the front with the microphone as you drive past Times Square. The business model of these fully integrated CDMOs is for them to hand off your molecule from one of their specialty groups to the next, while providing you with guidance and project management along the way. Keep in mind that the degree to which these groups are truly integrated is a matter of opinion, but overall, this is a tempting option. The benefits of these approaches are that you can have a single “Internal Champion” for your project, and they can guide you along the often rock-strewn drug development path. Complaints are often that the completed milestones seem to be simply “thrown over the wall” to the next functional group, and that they are really no more integrated than independent CROs, but the work is indeed completed under one all-encompassing logo.
The other option is to work with independent CROs/CMOS, often referred to as Functional Service Providers (FSPs). FSP’s are essentially specialists in one area, or at least some subset of the development process. This option would be more comparable to choosing independent travel, rather than a tour. With this option, you have much more control over the process, and your flexibility is not limited, as it often is with the larger CDMO. For example, try to suggest to your full-service CDMO that you like to take your polymorph work to an independent FSP, and see just how many seconds it takes before your phone rings with someone trying to talk you in off the ledge. FSPs might not be able to handle your cGMP clinical trial batch, but they would do an excellent job with the polymorphs, salt selection, and co-crystals.
The advantage of these FSPs is that, because they only have one trick in their bag, they usually really know their stuff, and are a great resource for you. The drawback is that you will invariably have to puzzle-piece these specialists together into a safe path that you can walk down with your lead molecule, and tech transfer is not always a seamless process. Unlike with the full-service CROs/CMOs, you will also need to consider hiring a consultant to help keep your project on track from both a development and a regulatory standpoint.
Each FSP will likely do a good job with their particular puzzle piece, but you will likely require some expertise overseeing the entire process of fitting the puzzle together. There are advantages and drawback to both types of service providers, but the decision of which way to go should be at least partially based upon the degree to which you can be a project manager. The integrated CDMOs are generally quite a bit more expensive than working with individual specialists, but then again, at some point, you might have to “hire the tour guide” at the front of the bus, to help you navigate regulatory hurdles, as well as to provide expertise.
The second factor is the more subjective area where you determine exactly how comfortable you are with each CRO or CMO. How do they come across on conference calls? Are they responsive to your emails, or do they all start with “Sorry that it’s take so long for me to respond to you, I’ve been swamped!” How easy is it to communicate with them? Can you get them on the phone, or do they reply to your emails. The question that you also have to ask is: “Can I understand them once I have them on a call, or when I am reading their email?” The pharma and biotech industries are populated with scientists from a wide variety of countries, speaking a wide variety of languages. English is a generally accepted common denominator, but accents and rudimentary language skills can easily result in misunderstandings and mistakes, some serious. With that in mind, finding someone that you can fully understand is not something to be taken lightly. This is your program, this is your horse in the race. Are you going to be comfortable saying, “Well, I think I understood what he/she meant.”
The above paragraph is a perfect lead in to the third factor in the decision process: Cost. The siren song of working across the pond in Asia can be irresistible. The costs of working in Asia are generally a fraction of what they are in North America. Fairly robust international laws now do a respectable job of protecting your intellectual property, and just think of the frequent flyer miles you’ll get. Before you pin your “Current Time in India vs. Current Time in Boston” sheet to the wall in your office, you have to understand that there is unquestionably a trade-off. Time zone issues make communication in real-time quite challenging. As mentioned above, languages and accents have to be factored in, as well as the regulatory hurdles involved in crossing international borders with your clinical materials. You have to determine your comfort level before committing to a vendor who works in the shadow of a different flag. Companies large and small choose to send their work offshore due to the cost savings, but many eventually choose to bring the work back due to the inevitable complications of working over international borders. To provide some perspective, according to an Outsourcing Survey conducted by Contract Pharma in 2014, “Vendor Qualification and Selection” was identified as the second most difficult aspect of any outsourcing—closely following the top most challenging problem, “Communication and Cultural Issues.”
In the end, the decision is yours to make, and make no mistake, your decision process will no doubt be the subject of scrutiny. A professor of mine once told me that a manager is someone who gets their job done through the efforts of other people. When you choose to outsource some, or all, of your project, you are in effect becoming a manager. If all goes well, your decision process will be vindicated, and you will be a hero. If, on the other hand, things do not go as planned, and the wheels start to fall off, you will likely find yourself, at the very least, on the receiving end of concerned looks. Never forget for a minute, that as a manager, you are choosing the vendors upon whom your success, and the success of your company, depends.
Raymond E. Peck is founder and chief executive officer of VxP Pharma Services based in Indianapolis, IN.
The first step in the process of locating a contract partner is to conduct a thorough search to establish a database of potential vendors. The internet has made this process far simpler than what it was in the past, as detailed information about these potential vendors are no more than a few clicks away. Trimming down this list to a manageable number is generally not too difficult, especially if you focus on capabilities. You have to ask: Can they handle the work? If your compound is a controlled substance, are they licensed to work with schedule compounds? Or, if you want your finished dosage to be enterically coated, do they have the equipment necessary to get the work done, and if so, do they offer it under cGMP for your clinical trials? You will also need to learn if they are compliant where you need them to be compliant. What is their regulatory history? Have they been audited by the FDA? If so, what was the outcome?
Once you have your list narrowed down a bit, you will also need to determine what type of service provider you are looking for. One option is a soup-to-nuts CDMO who will potentially have the capability to take your program through its paces under one virtual roof. This option bears similarity to purchasing a tour package. Everything is laid out for you in advance, and you simply get on the air conditioned bus with the lady at the front with the microphone as you drive past Times Square. The business model of these fully integrated CDMOs is for them to hand off your molecule from one of their specialty groups to the next, while providing you with guidance and project management along the way. Keep in mind that the degree to which these groups are truly integrated is a matter of opinion, but overall, this is a tempting option. The benefits of these approaches are that you can have a single “Internal Champion” for your project, and they can guide you along the often rock-strewn drug development path. Complaints are often that the completed milestones seem to be simply “thrown over the wall” to the next functional group, and that they are really no more integrated than independent CROs, but the work is indeed completed under one all-encompassing logo.
The other option is to work with independent CROs/CMOS, often referred to as Functional Service Providers (FSPs). FSP’s are essentially specialists in one area, or at least some subset of the development process. This option would be more comparable to choosing independent travel, rather than a tour. With this option, you have much more control over the process, and your flexibility is not limited, as it often is with the larger CDMO. For example, try to suggest to your full-service CDMO that you like to take your polymorph work to an independent FSP, and see just how many seconds it takes before your phone rings with someone trying to talk you in off the ledge. FSPs might not be able to handle your cGMP clinical trial batch, but they would do an excellent job with the polymorphs, salt selection, and co-crystals.
The advantage of these FSPs is that, because they only have one trick in their bag, they usually really know their stuff, and are a great resource for you. The drawback is that you will invariably have to puzzle-piece these specialists together into a safe path that you can walk down with your lead molecule, and tech transfer is not always a seamless process. Unlike with the full-service CROs/CMOs, you will also need to consider hiring a consultant to help keep your project on track from both a development and a regulatory standpoint.
Each FSP will likely do a good job with their particular puzzle piece, but you will likely require some expertise overseeing the entire process of fitting the puzzle together. There are advantages and drawback to both types of service providers, but the decision of which way to go should be at least partially based upon the degree to which you can be a project manager. The integrated CDMOs are generally quite a bit more expensive than working with individual specialists, but then again, at some point, you might have to “hire the tour guide” at the front of the bus, to help you navigate regulatory hurdles, as well as to provide expertise.
The second factor is the more subjective area where you determine exactly how comfortable you are with each CRO or CMO. How do they come across on conference calls? Are they responsive to your emails, or do they all start with “Sorry that it’s take so long for me to respond to you, I’ve been swamped!” How easy is it to communicate with them? Can you get them on the phone, or do they reply to your emails. The question that you also have to ask is: “Can I understand them once I have them on a call, or when I am reading their email?” The pharma and biotech industries are populated with scientists from a wide variety of countries, speaking a wide variety of languages. English is a generally accepted common denominator, but accents and rudimentary language skills can easily result in misunderstandings and mistakes, some serious. With that in mind, finding someone that you can fully understand is not something to be taken lightly. This is your program, this is your horse in the race. Are you going to be comfortable saying, “Well, I think I understood what he/she meant.”
The above paragraph is a perfect lead in to the third factor in the decision process: Cost. The siren song of working across the pond in Asia can be irresistible. The costs of working in Asia are generally a fraction of what they are in North America. Fairly robust international laws now do a respectable job of protecting your intellectual property, and just think of the frequent flyer miles you’ll get. Before you pin your “Current Time in India vs. Current Time in Boston” sheet to the wall in your office, you have to understand that there is unquestionably a trade-off. Time zone issues make communication in real-time quite challenging. As mentioned above, languages and accents have to be factored in, as well as the regulatory hurdles involved in crossing international borders with your clinical materials. You have to determine your comfort level before committing to a vendor who works in the shadow of a different flag. Companies large and small choose to send their work offshore due to the cost savings, but many eventually choose to bring the work back due to the inevitable complications of working over international borders. To provide some perspective, according to an Outsourcing Survey conducted by Contract Pharma in 2014, “Vendor Qualification and Selection” was identified as the second most difficult aspect of any outsourcing—closely following the top most challenging problem, “Communication and Cultural Issues.”
In the end, the decision is yours to make, and make no mistake, your decision process will no doubt be the subject of scrutiny. A professor of mine once told me that a manager is someone who gets their job done through the efforts of other people. When you choose to outsource some, or all, of your project, you are in effect becoming a manager. If all goes well, your decision process will be vindicated, and you will be a hero. If, on the other hand, things do not go as planned, and the wheels start to fall off, you will likely find yourself, at the very least, on the receiving end of concerned looks. Never forget for a minute, that as a manager, you are choosing the vendors upon whom your success, and the success of your company, depends.
Raymond E. Peck is founder and chief executive officer of VxP Pharma Services based in Indianapolis, IN.
