(Q) In large pharma companies, which organization typically makes decisions about brand protection investments?
(A) There are many organizations that have primary brand protection (BP) responsibility or share it cross-functionally. The BP discipline is still new and maturing. Originating out of the legal/corporate security ranks, where incidents were addressed tactically, BP professionals tend to now focus on preventive measures. Supply chain leaders are logical decision makers of BP programs. The supply chain functions have the best perspective from which to evaluate supply risks, and BP solutions are often included in the cost-of-goods-sold. Brand managers should be accountable as well, especially investing in BP during the pre-launch phases of drug development, but ongoing brand management is usually decentralized regionally. Ideally, brand protection should reside as a separate, enterprisewide function.
Ron Guido is the president of Lifecare Services, LLC, a management consulting firm specializing in healthcare marketing, brand protection, and strategic planning.
(Q) What is a common mentoring mistake and how can it be avoided?
(A) A common mentoring mistake is when the mentor becomes more directive rather than facilitating in the mentee’s development. A mentor’s impact can be accomplished by listening carefully to the situation the mentee is facing and then sharing relevant life experiences, providing anecdotes, and simply asking a lot of questions. For mentees, a common mistake is to not follow through, e.g., be a no-show for meetings, not complete actions, or not get back to the mentor with information. A mentor values a mentee’s follow-through because it demonstrates dedication and desire to succeed. This means learning something from your mentor, trying it out as soon as possible, and reporting back to your mentor about what happened, what worked, what you still need to learn, etc.
Laurie Cooke, BS, RPh, PGDip, CAE is the CEO of the Healthcare Businesswomen’s Association (HBA).
(Q) What advice do you have for executives seeking to incorporate single-use manufacturing technologies into their operations?
(A) Focus on your operation’s value drivers. Beyond cost, other drivers such as flexibility and risk should also be considered. For firms that have sufficient scale to dedicate capacity to single products, more traditional approaches may be more appropriate. Where flexibility is of greater importance, a risk/benefit analysis may lead a firm to pursue single-use.
The technologies are usually positioned as significantly more economical, but this may not be the case. For instance, there are limitations of scale that should be considered when demand forecasts have significant upside. Capital investment is often less, but operating cost savings may be partially offset by the cost of the consumables. Similarly, cleaning validation savings are reduced by some additional leachables and extractables costs. So, the number of products and the attendant multiproduct risks will drive the risk/benefit outcomes.
William F. Ciambrone
Bill Ciambrone is currently the executive VP of global technical operations at Shire, where he led a $470M capital expansion that included a $200M manufacturing facility centered around single-use cell culture technology