Life Science Leader Magazine Supplements

CMO 2017

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Page 19 of 81

LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2017 18 By P. Bigelow FOR OUTSOURCING, MAKE SURE YOUR RISK MANAGEMENT IS REDUNDANT SUPPLY CHAIN risk — is essential. Members of your team or outside tech- nical and business specialists with deep knowledge of facilities and processes — and that may include a trusted CDMO or CMO partner — should systematically review all aspects of the supply chain, from raw materi- als to final product. Initially, your professionals can pro- vide an objective rating you've decided on for all areas of operation, particularly for those activities that you may already know from experience or product characteris- tics could potentially lead to supply problems. 2. HOW BIG ARE THOSE RISKS REALLY, AND CAN I RECOVER QUICKLY FROM A FAILURE? Next, it's imperative you understand the potential impact of any supply chain failures. To decide where risk mitigation tools should be employed, determine the resiliency of suppliers and try to assess the time to recover. For example, the time to recover from a prob- lem at a contract packager may be much shorter than at an API manufacturer, so you may prioritize the API manufacturer for further analysis and attention. Many factors can come into play here, starting with, as I'm sure we all recognize, adding a second (or third) manu- facturer to your network will require at least changes to filings/dossiers, and additional stability or bioavail- ability studies. Despite these hardships, I'd put it this way: 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 disrupution. ut the potential points of failure in a supply chain represent risks that investors and other stakeholders cannot stomach. Too many vital medicines do not get to patients and too many development programs are crippled because of a breakdown of the "weakest link" and the absence of viable backup plans. Therefore, drug development organizations need to be deliberate in decision making regarding building redundancy and managing supply chain risks. The fol- lowing key questions and initial answers can serve as a guide to those deliberations. 1. WHERE EXACTLY ARE THE RISKS? I suggest drug sponsors undertake a formal supplier risk-assessment process with the specific goal of iden- tifying potential failure points. This list should include quantifying risks associated with capacity, the ability to react to market changes, compliance, and technical capabilities, among other items. There are a number of effective techniques used to perform supply chain risk assessments. As an example, the ISPE Drug Shortage Gap Assessment Tool, available to ISPE members, is an excellent methodology to identify and understand the vulnerabilities in your supply chain. Additionally, some consultants who work in this field have created templates to guide assessments and identify potential points of failure. In all cases, a common-sense approach — something that makes sense for your organization and product(s) B For Outsourcing, Make Sure Your Risk Management Is Redundant P E T E R B I G E L O W Many biotechnology and pharmaceutical companies are struggling with what I call the "sourcing dilemma": How do I achieve redundancy in my supply chain while keeping costs down and incentivizing my primary suppliers — whether internal or external? Redundancy is expensive, it consumes precious time and resources, and it distracts your team from driving all-important development milestones.

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