Life Science Leader Magazine Supplements

CMO 2017

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

Issue link:

Contents of this Issue


Page 21 of 81

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 20 By P. Bigelow FOR OUTSOURCING, MAKE SURE YOUR RISK MANAGEMENT IS REDUNDANT SUPPLY CHAIN risk setting priorities, both on a corporate and project level. We might like to believe that risks with the potential for highest impact get addressed first. Yet some miti- gation activities are inexpensive and easy to accom- plish and can immediately impact the risk scenario positively. Qualifying multiple packaging component suppliers could be an example of this. A thoughtful bal- ance between risks, time, and costs will go a long way in guiding your decisions. Actually, all the questions above in one way or anoth- er address your balancing risk and reward. Once these have been asked, hearty discussions by the right tech- nical and business experts have taken place, and honest assessments and analyses have been made, I suggest establishing (yet another) formal plan. This one would be a multi-year look to clearly outline priorities, iden- tify constraints, and mention mitigation strategies, that is brought to the organization's senior executive level for approval. With that, full internal socialization of the plan is critical. Two more points here: First, your best estimates of all costs should be built into all budgets being formulated for your development and manufacturing of a product. Second, don't forget your partners. Consult with them, and at the same time agree to put metrics in place that effectively measure performance and provide leading indicators of possible issues. This should be viewed as something that helps guide both you and your develop- ment and manufacturing service providers. The best policy is to develop a culture of collaboration with your suppliers. When that happens, those metrics more than measure; they drive the right behavior in the first place. This also means that issues are anticipated or recognized early, and performance improvement is the continued expectation. EXPECT RISK ASSESSMENT REVIEWS The intense focus on reducing drug shortages through- out the drug industry has created a fuller awareness of the impact of supply chain failures — and has created the expectation that bio/pharmaceutical companies must have robust programs to prevent shortages in the first place. Around the world, regulators are asking to review risk assessments and mitigation strategies, and you can expect this to become the norm. Having trans- parent and understandable risk-management plans and activities in place will go a long way in helping your organization get your products to patients. L It's also important to point out redundancy consider- ations can occur at different production and manage- ment levels. Consideration and analysis should reach down to individual systems within a plant, and even to specific product components. Should you install a complete secondary high-purity water loop within a manufacturing plant, in case the first one requires maintenance? Could you even approach your CMO with the idea? Should you qualify a second supplier of rub- ber stoppers for an aseptic vial product, in case the pri- mary supplier has a problem? Does your CMO already have this covered? There are no pat answers, but these types of questions should be addressed so you arrive at the responses best for you and your development and manufacturing partners. There are many strategies that may not be immedi- ately obvious, such as, for example, building strategic inventory, including work in progress (WIP) at key points in the supply chain to provide a buffer in case of a short-term interruption. In some cases — and we are starting to see this with Big Pharma — it may make sense to reserve capacity at a supplier even if the cur- rent forecast does not warrant it (as we touched on above). Of course, options like these will come with a cost. Don't forget about effective lean manufacturing/ Six Sigma programs: These programs have proved to improve performance, reduce cycle times, and allow a faster recovery period on a product-by-product basis. As most of us know, at times our products themselves come with inherent risks, but those can be reduced by improving the formula or manufacturing process. 5. WHAT IS THE RIGHT BALANCE? Understanding all the trade-offs involved in your redundancy-related decisions allows you to more clear- ly understand individual decisions and your entire supply chain. We might expect a company with a single new product in development to have a much lower tol- erance for risk than a generic firm or a company with many products. Trade-offs are decided in large part by PETER BIGELOW is president of xCell Strategic Consulting. You have to come to grips with the implications of any supply interruption, and even more importantly, your ability to recover quickly from such a disruption.

Articles in this issue

Links on this page

Archives of this issue

view archives of Life Science Leader Magazine Supplements - CMO 2017