Flexibility may also mean speed of progress needed, changes in batch sizes, amount of testing required, etc. Results from safety, pharmacology, clinical trials, or marketing assessments can impact the scope of activities at the CMO. Results obtained in the sponsors’ facilities or the CMOs can narrow, expand, or refocus the subsequent activities required to move the project along. Sponsors need flexibility to make scope changes in requested project activities as data is obtained and analyzed. Moreover, where production is all about scheduling, development projects are more about scope and flexibility.
#Rhinoceros success tickbird how to
"What becomes important in an outsourcing relationship is how to ensure the two parties effectively contribute to the business goals of each company." To accommodate the sponsors’ schedule changes for whatever reasons, CMOs have to maintain idle capacity, perhaps expand to a seven-day week to then shorten a production run, take on the expense of storing larger inventories of raw materials, and mess up the queue for analytical work. On the other side, the production facility tries to schedule six months to a year out so that it can more efficiently plan personnel and equipment needs to lower its costs and raise operating margins. For example, the inability to obtain material on time may be costing the sponsor in lost revenue, in extra costs for back-up options, or in marketing losses even before production starts. Sponsors are frustrated by long lead times and elongated production schedules, by back orders on raw material inventory, and a seemingly inability of CMOs to be more flexible and accommodate schedule change requests. While both parties want on-time delivery of ordered goods, the desirable delivery schedules are not always aligned. Two of the most challenging areas are in production scheduling and managing scope changes. While on-time batch release or a successful FDA audit may represent shared business goals, there are surrounding and various other activities that require compromise to get to business successes for both parties. This is easy when the goals are aligned, but often they are not, and it becomes more challenging if the parties’ measures of success for even the same activities differ. In my experience, what becomes important in an outsourcing relationship is how to ensure the two parties effectively contribute to the business goals of each company. Are CEO Kim’s the universal traits that make a CMO “world class”? What sponsors want out of CMOs - should want out of CMOs, or how they should rate CMOs - is the subject of an article once per month in some periodical or in some blog, authored by people on both sides of the fence. But does a sponsor select a CMO because it has the largest revenue and the greatest profit margins? Probably as much as a CMO would provide quotations only to those sponsors with the largest sales volume. While some might disagree with his comments, they were honest: For a CMO business to be viable, it needs to operate at high capacity, it needs reasonable operating margins, it wants return customers so there is less marketing spend required, and preferably long-term agreements with sponsors to stabilize finances. “I define the CMO champion as having the largest, top-quality manufacturing capacity, the largest revenue, and the greatest profit,” Kim said. Kim took the unusual step of talking about what a CMO business needs, from a business perspective, to be world class. Mid-last year, I read an interview with Samsung BioLogics’ President and CEO, Tae Han Kim, at OutsourcedPharma. Let’s start from the side less discussed.
They agree on what a sponsor wants from a service provider, but what the service provider wants for itself is a rarer focus of discussion.
But the fact is the sponsor and the service provider also want and need different things from the relationship. The relationship is symbiotic - to a far greater extent than a mere mouthful of insects. But would you say that the tickbird and rhino have the same needs and wants? Does the rhino want a nest on his or her back, and does the tickbird want to go swimming?īiotechnology and pharmaceutical sponsors and outsourcing service providers are in the same type of relationship, if not on the same savannah. The tickbird eats insects off the rhino, providing food for himself and insect control for his or her host. The rhinoceros and the tickbird have a symbiotic relationship. By Sue Wollowiz, President, Wollowitz Associates LLC
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