BioPharm

www.biopharminternational.com March 2018 BioPharm International eBook 9 Outsourcing Resources Complete Response Letters gets better and better at making this new product.' Think about it. Firms hire folks to run clinical trials to kick off the trials far before they hire qual- ity folks to do the manufacturing assessments. So inadvertently, they have set themselves up for failure because you can't add in quality later on. CONTRACT PARTNER OVERSIGHT BioPharm: What are the most chal- leng ing aspects of CRO/CDMO oversight for any dr ug develop- ment project? Ave llanet (Cerullean Associates): There is very little staffing for sup- plier and supply chain oversight until after the initial CRO, CDMO, and CMO choices have been made. Again, many of these smaller firms a re made up of sc ient ists a nd financial backers, many of whom don't realize that they should have dedicated supply chain and sup- plier oversight staffing. After all, they may reason, when t hey were w it h t hei r prev ious employers, they oversaw their lab suppliers. How much more diffi- cult could this be? Unfortunately, many of them never saw and were never involved in any of the back-office work that went into vetting and managing suppliers, from contractual terms and conditions to payables, to reviewing a supplier's internal con- trols. More often than not, it's a matter of not knowing what they don't know. Smith (The FDA Group): There are many challenges for the applica- tion sponsor in outsourcing these activities. A significant one is a cer- tain lack of control and having to recognize that you are but one of many, sometimes hundreds, of cli- ents that the service provider may have. Their systems, procedures, and priorities may not always be aligned with yours and must meet the needs of many masters. Thus, even when a compliance issue is raised, a service provider must address it in light of the needs of many clients and, some- t i me s, com m it me nt s made to other clients in procedures, quality agreements, contracts, etc. The bottom line is that the entire sup- ply chain has become much more complicated and addressing com- pliance issues in that chain have likewise become more complicated. PROJECT MANAGERS IN THE PLANT BioPharm: Where are sponsors fall- ing short in their responsibility to oversee contract partners? What should they be doing differently to decrease risk and liability? Smit h ( The FDA G roup): Vendor management is not just about vet- ting the vendor to add to your approved vendor list, then hav- ing the qualit y assurance (QA) department conduct an audit of their facility or standard operat- ing procedures (SOPs) every two or three years. In the past several years, I've seen a much needed increase in the use of project man- agers on both sides. This approach has helped to keep t h i ngs on track and to address issues that arise more quickly and efficiently. Communication and transparency are both crucial. Sponsors who share information, keep vendors appr ised of time- lines and application status, and work with their suppliers, with the understanding they are but one of many customers, will fare much better than those who don't. The same concepts apply to ven- dors as well. While client con- f ident ia l it y issues may hobble vendors somewhat, early and open communications regarding time- lines, hiccups, or unexpected prob- lems, can go a long way to decrease risk for all parties involved. Avellanet (Cerullean Associates): I teach a number of workshops on practical data integrity, and one of the sections is on supplier over- sight. I have a set of 'Have you ever observed?' type of interactive ques- tions and exercises, one of which is the following True/False statement: We pick our suppliers based on their experience with our indus- try so we know they know what they're doing. Typically, at this point, every- one in the audience—to a person— chuckles and nods. Despite all the FDA and regulatory exhortations, FDA-483s, warning letters, CRLs, etc., firms continue to have this belief that, just because a CRO or a CDMO has been in business for years, they must know what they're doing. Warning letters often spell this out, with the recurring phrase 'As a sponsor, you failed to oversee.' A manufacturer chooses to work with a particular CMO or CRO, starts using them, and then, per- haps, runs into problems. By the time the firm realizes that they picked the wrong partner, it's too late, and they're stuck in the middle of a seven-year contract or in the middle of a Phase II trial, etc. and now what you do you do? Even for large companies, going back to senior management and saying, 'Oh, we goofed, we need money and resources and time to start over with someone new …' That's not going to go over well. And, let's face it—many sponsors continue to believe that, if there is trouble during a clinical trial, that the CRO will be in the line of fire. It doesn't work that way. FDA sees the sponsor and only the sponsor; the CRO is just a 'department of your company that works at a dif- ferent location.'

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